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Contents

Chapters Pages
1. History of Pharmacy in India/Importance of Various Pharmacopeias ..... 1
2. Sources of Drugs ..... 16
3. Methods of Prepairing Herbal Remedies ..... 23
4. Prescription and Latin Words used in the Prescription ..... 32
5. Posology ..... 36
6. Communicable Diseases ..... 42
7. First Aid Treatment ..... 55
8. Classification of Microbes ..... 64
9. Contamination of Pharmaceuticals in Hospitals and
Environment by Microbes ..... 71
10. Sterilization ..... 83
11. Sterilization of Materials, Equipments and Utensils Used in Hospitals .... 92
12. Ophthalmic Preparations ..... 103
13. Blood Products and Plasma Substitutes ..... 112
14. Surgical Products ..... 119
15. Incompatability ..... 122
16. Cardiovascular System .... 127
17. Human Digestive System ..... 137
18. Brain and Spinal Cord .... 145
19. Drugs Acting on Cardiovascular System .... 151
20. Drugs Acting on Gastro-Intestinal Tract .... 162
21. Drugs Acting on Central Nervous System .... 169
22. Antigen, Antigen-antibody Reactions, Hypersensitivity,
Active and Passive Immunity and Types of Vaccines .... 193
23. History Development and Production of Antibiotics .... 207
24. Carbohydrate Metabolism .... 217
25. Chemotherapeutic Agents .... 224
26. Antiprotozal and Anthelmintic Drugs .... 252
27. Drugs and Cosmetic Acts, 1940 .... 261
28. Narcotic Drugs and Psychotropic Substances Act, 1985 .... 270
Aopendices (I to X) .... 277-336
Model Question Papers (1 to 5) .... 337-384
History of Pharmacy in India/ JL
Importance of various Pharmacopeias C h a pter

In ancient India, the sources of drugs were of vegetable, animal and mineral origin.
They were prepared empirically by few experienced persons. Knowledge of that medical
system was usually kept secret within a family. There were no scientific methods of
standardization of drugs.
Muslim Rule in India
The Indian system of medicine declined during the Muslim rule while the Arabic or
the Unani-Tibbi system flourished.
British Rule in India
The western or the so-called Allopathic system came into India with the British traders
who later become the rulers. Under British rule, this system got state patronage. At that
time, it was meant for the ruling race only. Later it descended to the people and become
popular by the close of 19th Century.
Before 1940
Initially, all the drugs were imported from Europe. Later some drugs of this system
began to be manufactured in this country.
1901: Establishment of the Bengal Chemical and Pharmaceutical Works, Calcutta by
Acharya Prafulla Chandra Ray.
1903 : A small factory at Parel (Bombay) by Prof. T.K. Gujjar.
1907 : Alembic Chemical Works at Baroda by Prof. T.K. Gujjar.
Drugs were mostly exported in crude form and imported in finished form. During
World War-I (1914 -1920), the imports of drugs were cut-off. Imports of drugs were resumed
after the War. There was complete absence of any restrictions on the quality of drugs
imported, so manufacturer abroad took advantage of the situation. The consequences
were as follows:
Foreign manufacturers dumped inferior quality medicines and adulterated drugs.
Markets were full of all sorts of useless and deleterious drugs were sold by unqualified
men.
Examples of maladie:
Poisoning due to quinine.
l
2 □ □ Drug Inspector Exam

Putting of croton oil into eye instead of atropine solution.


Selling of chalk powder tablets in place of quinine.
Drug santonin was badly adulterated.
Potent drugs like compounds of antimony and arsenic and preparations of digitalis
were dispensed without any standard.
At that time few laws were there having indirect connection to drugs, but they were
insufficient.
1878: Opium Act Dealt with cultivation of poppy and the manufacture,
transport, export, import and sale of opium.
1889: Indian Merchandise Act Misbranding of goods in general.
1894: Indian Tariff Act Levy of customs duty on goods including foods
drinks, drugs, chemicals and medicines imported
into India or exported there from.
1898 : Sea Customs Act Goods with 'false trade description' were prevented
from importing under this act.
1919: Poisons Act Regulated the import, possession and sale of poisons.
Indian Penal Code
Some sections of IPC have mention of intentional adulterations as punishable offence.
Some state-level law had indirect references to drugs :
1884: Bengal Municipal Act
1901: City of Bombay District Municipal Act. Concerned with food.
1909 : Bengal Excise Act
1911: Punjab Municipal Act
1912 : United Provinces (now Uttar Pradesh) Prevention of Adulteration Act. Refers to
adulteration of foods and drugs.
1916: United Provinces Municipalities Act. Inspection of shops and seizure of
adulterated substances.
1919 : Bengal Food Adulteration Act
1919 : Bihar and Orissa Prevention of Adulteration Act
1919: Madras Prevention of Adulteration Act
Chiefly concerned with food adulteration
1922 : Bihar and Orissa Municipal Act
1922: Central Provinces Municipalities Act
1925 : Bombay Prevention of Adulteration Act
1929: Punjab Pure Food Act
The laws were too superficial and had indirect link to drugs.
History o f Pharmacy in India/Importance o f various Pharmacopeias □ □ 3

DRUG ENQUIRY COMMITTEE


Government of India on 11th August, 1930, appointed a committee under the
chairmanship of Late Col. R.N.Chopra to see into the problems of Pharmacy in India and
recommend the measures to be taken. This committee published its report in 1931. It was
reported that there was no recognized specialized profession of Pharmacy. A set of people
known as compounders were filling the gap. Just after the publication of the report Prof.
M.L.Schroff (Prof. Mahadeva Lai Schroff) initiated pharmaceutical education at the
university level in the Banaras Hindu University. In 1935 United Province Pharmaceutical
Association was established which later converted into Indian Pharmaceutical Association.
The Indian Journal of Pharmacy was started by Prof. M.L.Schroff in 1939. All India
Pharmaceutical Congress Association was established in 1940. The Pharmaceutical
Conference held its sessions at different places to publicize Pharmacy as a whole.
1937: Government of India brought 'Import of Drugs Bill'; later it was withdrawn.
1940 : Government brought 'Drugs Bill' to regulate the import, manufacture, sale and
distribution of drugs in British India. This Bill was finally adopted as 'Drugs Act
of 1940'.
1941: The first Drugs Technical Advisory Board (D.T.A.B.) under this act was
constituted. Central Drugs Laboratory was established in Calcutta.
1945 : 'Drugs Rule under the Drugs Act of 1940' was established. The Drugs Act has
been modified from time to time and at present the provisions of the Act cover
Cosmetics and Ayurvedic, Unani and Homeopathic medicines in some respects.
1945 : Government brought the Pharmacy Bill to standardize the Pharmacy Education
in India
1946 : The Indian Pharmacopoeial List was published under the chairmanship of late
Col. R.N. Chopra. It contains lists of drugs in use in India at that time which
were not included in British Pharmacopoeia.
1948: Pharmacy Act, 1948 framed.
1948: Indian Pharmacopoeial Committee was constituted under the chairmanship of
late Dr. B.N. Ghosh.
1949: Pharmacy Council of India (P.C.I.) was established under Pharmacy Act, 1948.
1954: Education Regulation have come in force in some states but other states lagged
behind.
1954 : Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 was passed
to stop misleading advertisements (e.g., Cure all pills).
1955: Medicinal and Toilet Prepartions (Excise Duties) Act, 1955 was introduced to
enforce uniform duty for all states for alcohol products.
1955: First Edition of Indian Pharmacopoeia was published.
1985: Narcotic and Psychotropic Substances Act has been enacted to protect society
from the dangers of addictive drugs.
4 □ □ Drug Inspector Exam

Government of India controls the price of drugs in India by Drugs Price Order changed
from time to time.

PHARMACOPOEIA/FORMULARIES/COMPENDIA
The books containing the standards for drugs and other related substances are known
as pharmacopoeia and formularies - collectively these books are known as the drug
compendia.
The pharmacopoeias or formularies contain a list of drugs and other related substances
regarding their source, descriptions, standards, tests, formulae for preparing the same,
action and uses, doses, storage conditions etc.
These books are prepared under the authority of the Government of the respective
countries. The word "pharmacopoeia" is derived from the Greek words 'pharmacon'
meaning 'drug' and poieo' means 'make'. Literally it means that it is a list of medicinal
substances, crude drugs and formulae for making preparations from them.
These books are revised from time to time so as to introduce the latest information
available as early as possible after they become established. In order to keep the size of
book within reasonable limit it becomes necessary to omit certain less frequently used
drugs and pharmaceutical adjuvants from each new edition of the book. Therefore, in
each new edition of these books certain new monographs are added while the older ones
are deleted.
For the preparation of these books the expert opinion of medical practitioners, teachers
and pharmaceutical manufacturers are obtained.
CLASSIFICATION
The drug-compendia are classified as :
(i) Official compendia
(ii) Non-official compendia
A. Official Compendia
Official compendia are the compilations of drugs and other related substances which
are recognized as legal standards of purity, quality and strength by a Government agency
of respective countries of their origin. For example,
• British Pharmacopoeia (BP)
• British Pharmaceutical Codex (BPC)
• Indian Pharmacopoeia (IP)
• United States Pharmacopoeia (USP)
• National Formulary (NF)
• The State Pharmacopoeia of USSR and
• Pharmacopoeias of other countries
History o f Pharmacy in India/Importance o f various Pharmacopeias □ □ 5

B. Non-official Compendia
The book other than official drug compendia are used as secondary reference sources
for drugs and other related substances are known as non-official drug compendia. For
example, Merck Index
Extra Pharmacopoeia (Martindale), United States Dispensatory etc.

NATIONAL PHARMACOPOEIAS
Pharmacopoeias are generally prepared under the authority of the Government of the
respective countries - these pharmacopoeias are known as national pharmacopoeias.
Examples of some national pharmacopoeias are as follows :
Indian Pharmacopoeia, British Pharmacopoeia, United States Pharmacopoeia etc.
The drugs used may vary from nation to nation so, the respective pharmacopoeia
includes those drugs or dosage forms which are frequently used in that very country at
that time.
The National Pharmacopoeia is recognized as the reference book by the legislative
authority (by law) of the respective country, whenever a conflict arises regarding drugs,
these books will be referred.

INDIAN PHARMACOPOEIA

History
The historical developments of Pharmacopoeia in India traces back to 1563 and the
credit goes to Garcia da Orta a Portugese physician-cum-teacher. The idea of indigeneous
Indian Pharmacopoeia was conceived in 1837 which bore fruits in 1841 in the shape of
Bengal Pharmacopoeia and Conspectus of Drugs. The Bengali and Hindi version of London
Pharmacopoeia was made available in India from 1901 onwards.
The Indian Pharmacopoeial List, published in 1946 formed the seeding for the true
Official Indian Pharmacopoeia published in 1955. The first edition of Indian Pharmacopoeia
was published in 1955, but actually the process was started as early as 1944. In 1944,
Government of India asked the Drugs Technical Advisory Board to prepare the list of
drugs used, in India, having sufficient medicinal value to justify their inclusion in official
pharmacopoeia.
The Indian Pharmacopoeial List, 1946.
The list of drugs both included and not included in the British Pharmacopoeia along-
with standards to secure their usefulness, tests for identity and purity was prepared by
the committee and was published by the Government of India under the name 'The Indian
Pharmacopoeial List, 1946'.
The committee constituted under the chairmanship of Col. Sir R.N.Chopra along with
other nine members, prepared the list of drugs with the following details :
6 □ □ Drug Inspector Exam

Substances included in the British Pharmacopoeia for crude drugs, chemicals and their
preparations.
Substances not included in the British pharmacopoeia :
(a) Drugs of plant origin
(b) Drugs of animal origin
(c) Biological products
(d) Insecticides
(e) Colouring agents
(f) Synthetics
(g) Miscellaneous
(h) Drugs for veterinary use.
The Indian Pharmacopoeial List, 1946 was prepared by Department of Health.
Government of India in 1946.
The history of development of Indian Pharmacopoeia :
Years Events
1946 The Government of India published the Indian Pharmacopoeial List.
1948 The Government of India constituted a permanent Indian Pharmacopoeia
Committee. This committee was assigned the task of preparing Indian
Pharmacopoeia and to keep it up-to-date.
1955 The first edition of Indian Pharmacopoeia (IP) was published.
1960* Supplement of IP 1955 was published.
N.B. The work of revision of the Indian Pharmacopoeia as well as compilation
of new edition was taken up simultaneously under the chairmanship of Dr.
B.N.Ghosh, who died in 1958. After Dr. B.N.Ghosh, Dr. B. Mukherjee, the
Director of Central Drug Research Institute was appointed as the chairman
of Indian Pharmacopoeia committee.
1966* The second edition of IP was published.
1975 A supplement of IP 1966 was published.
1978 The Indian Pharmacopoeia Committee was reconstituted by the Government
of India, Ministry of Health and Family Welfare, under the chairmanship of
Dr. Nitya Nand, Director, Central Drug Research Institute, Lucknow.
1985 The third edition of IP was published in two volumes, Volume-I and Volume-
II by the Controller of Publications, on behalf of Government of India, Ministry
of Health and Family Welfare.
1989 Addendum (I) to IP 1985 was published.
1991 Addendum (II) to IP 1985 was published.
1996* The fourth edition of IP was published.
History o f Pharmacy in India/Importance o f various Pharmacopeias □ □ 7

VOLUME-I CONTAINS
Legal Notices, Preface, Acknowledgements, Introduction, General Notices, and
Monographs from A to O.
Volume-II Contains:
Monographs from P to Z, Appendices, Contents of Appendices and Index.
The Appendices includes the
(i Infra Red Spectra of drugs,
(ii Apparatus for tests and assays
(iii Biological tests and determinations,
(iv Chemical tests and assays,
(v Chromatography and electrophoresis
(vi Spectrophotometry
(vii Clarity and color of solutions
(viii Disintegration and dissolution tests
(ix Physical tests and determinations
(x Microbiological assays and tests,
(xi Limit tests of particulate matter
(xii Other tests and determinations
(xiii General information
(xiv Reagents and solutions
(xv Reference substances
(xvi Tables
Index
Under each monograph chemical structures, molecular weight, physical description,
solubility, identification tests, standards, assay method, storage etc., are given.
Published by: The Controller of Publications, Delhi, on behalf of Government of India,
Ministry of Health and Family Welfare. For the preparation of Pharmacopoeia of India,
the pharmacopoeias of other countries, like British, Europe, United States, USSR, Japan,
the National Formulary (USA) and Merck Index were consulted. The persons working in
pharmaceutical industry, drug control laboratories, research and teaching institutions also
actively participated. Under the Drugs and Cosmetics Act, 1940, the Indian Pharmacopoeia
is an official book that contains the standards for drugs and other related substances
included in the pharmacopoeia. The drugs and other related substances prepared by
pharmaceutical manufacturers must comply with these standards.
Example of a Monograph of an Official Drug
The w ord 'Monograph' m eans the written study of a subject. The pharm acopoeial
monographs (for example, in IP) give the following information about the drugs and
pharmaceutical aids :
8 □ □ Drug Inspector Exam

1. Main title : The main name of the substance.


2. Synonym : The common name(s), if any, of the substance.
3. Chemical formula and Molecular Weight of the substance : If necessary, its I.U.P.A.C.
chemical name and/or its chemical structure is also given.
4. Category : Indicates the use of the drug in medicine and pharmaceutical practices.
For example,. Antibacterial, antimalarial, diuretic, emetic, expectorant etc.
5. Doses : Represents the average range of quantities suitable for adults.
6. Description : This includes the general physical properties, i,ev whether the
substance is a solid or liquid, colourless or coloured, crystalline or amorphous, its
taste etc.
7. Solubility: According to IP the solubilities of the substances are mentioned in terms
of descriptive phrases as follows :
Descriptive phrase
Volume of solvent for dissolving 1 part of solute.
Very soluble Less than 1 part
Freely soluble 1 to 10 parts
Soluble 10 to 30 parts
Sparingly soluble 30 to 100 parts
Slightly soluble 100 to 1000 parts
Very slightly soluble 1000 to 10,000 parts
Practically insoluble/insoluble more than 10,000 parts
8. Standards: Prescribes the standards of purity and strength e.g., Sodium bicarbonate
IP contains not less than 99.0 % and not more than 100.5 % of NaHC03.
9. Identification : This includes some specific and some non-specific tests for identity
of substance.
10. Tests of purity : These tests include melting point, boiling point, weight per ml,
limit tests for chloride, sulfates, iron, heavy metals, lead and arsenic, specific optical
rotation, sulfated ash, loss on drying, pH of solution, etc., as may be applicable for
the substance.
11. Method of Assay : The term 'Assay' is used in pharmacopoeias for quantitative
determination of principal ingredients of the official substances and of their
preparations.
12. Storage : Prescribes some conditions for the storage of some official substances
which are likely to deteriorate if not properly stored.

THE INTERNATIONAL PHARMACOPOEIA


The International Pharmacopoeia is published by the World Health Organization and
is particularly used in developing countries. The object of this was to provide a uniform
History o f Pharmacy in India/Importance o f various Pharmacopeias DO 9

list which would avoid the confusion caused by different national standards, strengths
and names.
Published b y : World Health Organization
Prepared by : WHO Expert Advisory Panel on the International Pharmacopoeia and
Pharmaceutical Preparations.
1951: Volume-1 of First Edition of The International Pharmacopoeia was published.
1952: Volume-2 of First Edition of The International Pharmacopoeia was published
1959 : Supplement to First Edition was published
First Edition includes :
344 monographs on drug substances
183 monographs on dosage forms (capsules, injections, tablets and tinctures)
84 tests, methods and general requirements.
1967
Second Edition of The International Pharmacopoeia was published as Specification
for the Quality Control of Pharmaceutical Preparations.
Second Edition includes
New analytical techniques involving infrared spectroscopy, chromatography (column,
paper and thin-layer), non-aqueous titration, and radioactivity.
162 new pharmaceutical preparations were added.
114 monographs present in the first edition were deleted.
1975 Volume-1 of Third Edition of The International Pharmacopoeia was published.
1981 Volume-2 of Third Edition of The International Pharmacopoeia was published.
1982 Volume-3 of Third Edition of The International Pharmacopoeia was published.
1988 Volume-4 of Third Edition of The International Pharmacopoeia was published.
2003 Volume-5 of Third Edition of The International Pharmacopoeia was published.
Salient features of Third Edition
Emphasis on classical chemical techniques available in the developing world.
Drugs those are used all over the world by various WHO programs.
Drugs those degrade or are difficult to manufacture.
Drugs from WHO Model List of Essential Drugs, and their updates.
Volume-1: General methods of analysis
Volumes-2 and 3: Quality specifications of essential drug substances in the WHO
Model List of Essential Drugs.
Volume-4: Tests, methods, and general requirements. Quality specifications fori
pharmaceutical substances, excipients, and dosage forms.
10 □ □ Drug Inspector Exam

Volume-5: Contains tests and general requirements for dosage forms and quality
specifications for pharmaceutical substances and tablets, an a section on antimalarial drugs
and their most widely used dosage forms.

EXTRA PHARMACOPOEIA (MARTINDALE).


The Extra Pharmacopoeia was first produced in 1883 by William Martindale and is
still known as 'Martindale'. Produced by: The Royal Pharmaceutical Society of Great Britain
Meant fo r: Medical Practitioners and Pharmacists all over the world.
Sources of information : Journals and periodicals, licensed product literature, WHO
publications, government reports and legislation and other official and standard
publications.
Contains information: Drugs and medicines, selected investigational and veterinary
drugs, herbal medicines, pharmaceutical excipients, vitamins and nutritional agents,
vaccines, radiopharmaceuticals, contrast media and diagnostic agents, medicinal gases,
drugs of abuse and recreational drugs, toxic substances, disinfectants, and pesticides .
Monograph headings: Definitions and descriptions, pharmacokinetics, adverse effects
and treatments, uses, precautions, administration, interactions, tradenames of preparations.
Additional information
• Disease treatment reviews that provide overviews of diseases and the choice of
treatments available.
• Details of commercial preparations from a wide range of countries.
• Directory of drug-manufacturers and their addresses worldwide.

THE BRITISH PHARMACOPOEIA (BP)


History
1964 : First edition of BP
1968 : British Pharmacopoeia Committee was constituted.
1980: 13th Edition of BP was published.
1988: 14th Edition of BP was published. Contains two volumes with 2100
monographs.
1993 : 15th Edition of BP was published.
1998: A consolidated edition as published.
Salient features of BP 1998
• Three volumes.
• All monographs of the European Pharmacopoeia (third edition) included
• Includes British Pharmacopoeia (Veterinary)
• CD-ROM included in the package for easy search.
History o f Pharmacy in India/Importance o f various Pharmacopeias □ □ 11

• Annual publication from 1998 onwards. In every year a new edition is published.
• Free access to Pharmacopoeia website
Meant for
The pharmaceutical and chemical industries, quality control personnel, analysts,
government regulators, academics and students of pharmacy. Published by The British
Pharmacopoeia Commission.
The British Pharmacopoeia (BP) 2012 is the leading collection of standards for UK
medicinal products and pharm aceutical substances. Produced by the British
Pharmacopoeia Commission Secretariat of the Medicines and Healthcare products
Regulatory Agency, the BP makes an important contribution to public health by setting
publicly available standards for the quality of medicines.

NATIONAL FORMULARY OF INDIA


For the guidance of medical practitioners, medical students and pharmacists in
hospitals and in sales departments National Formulary of India has been formulated.
1960 : First edition was published by Government of India, Ministry of Health.
1966 : Second edition was published.
1979 : Third edition was published.
It contains information about drug interaction, resistance, cumulative effects, drug
dependence, prescription writing etc.

BRITISH PHARMACEUTICAL CODEX (BPC)


It was in 1903 that the council of Pharmaceutical Society of Great Britain decided to
prepare a reference book for the use of medical practitioners and dispensing pharmacists.
The first edition of BPC was published in 1907.
On the request of British Pharmacopoeia Commission, the Council of the
Pharmaceutical Society agreed in 1959 for the publication of Codex to coincide with that
of the BP, so that BP and BPC should come into effect on the same date.
The BPC differs from BP in that:
(a) It contains many more drugs and preparations some may be included in advance
to the pharmacopoeia while other drugs may have been included in the former
editions of pharmacopoeia but now they are retained in the Codex because they
are still commonly used.
(b) It provides information on the actions and uses of drugs, their undesirable effects,
precautions and the treatment of poisoning.
(c) It contains formulae, method of preparation, container and storage conditions of
most of the preparations that are still extemporaneously prepared in the pharmacy.
12 DD Drug Inspector Exam

THE UNITED STATES PHARMACOPOEIA (USP)


The USP was originally published in 1820 under the authority of United States
Pharmacopoeial Convention. The National Formulary (NF) was published in 1888 under
the guidance of American Pharmaceutical Association.
In 1974 the NF was purchased by the United States Pharmacopoeial Convention and
from 1980 onwards only one official book of drug standards was published under the
heading The United States Pharmacopoeia and The National Formulary (USP-NF).

THE MERCK INDEX


It is an encyclopaedia of chemicals, drugs and biologicals. The first edition was
published in 1889 and the eleventh edition was published in 1989 by Merck and Co., Inc.
Rahway, New Jersy, USA.

IMPORTANCE OF PHARMACOPOEIA
The Importance of Pharmacopoeia can be discussed from the following three angles :
(i) Drug industry
(ii) Administration
(iii) Academic
(i) From the point of view of drug industries. To market a new drug molecule
stupendous amount of money is required for the research and development. Very
few companies can bear this cost, especially the drug industries in developing
countries (like India) are unable to bear the expenditure. In that case the drugs of
products mentioned in the pharmacopoeias can be marketed without any further
research on it, because only the tested, safe and efficacious drugs and
pharmaceuticals are included in the pharmacopoeias.
Drugs and pharmaceuticals products are prepared from some raw materials, the
standards of which should rigorously be met with that of pharmacopoeia. Though
there are several other sources of information about the standard of drugs and
pharmaceuticals, the pharmacopoeia is the most reliable one. Assay methods and
identifications of drug of pharmaceuticals are given very clearly in the
pharmacQpoeias so it becomes easy for the drug industry to design the tests and
follow the methods confidently because the assay and identification methods are
tested and approved by the authority.
(ii) From the point of view of drug-administration. In every country there are drug
industries with varied intentions - among which the major one is 'to make profit'.
While making the profit some industries ignore the quality of the drugs and
pharmaceuticals. Since drugs are related to the health of human beings and animals,
this negligence is unpardonable. So every nation made his own Drugs and Acts
and Rules. Whenever a conflict surfaces between a drug industry and Government
History o f Pharmacy in India/Importance o f various Pharmacopeias □ □ 1j

the first reference book that is consulted, regarding the quality if the p oduct, is
the pharmacopoeia.
(iii) From the stand point of academic. The pharmacopoeias are mines of information
regarding drugs and pharmaceuticals. The researchers always consult it in first
hand for developing an assay method of certain drug, for testing the quality of a
dosage form. The microbiological and bioassays are given in details in the
appendices with statistical quality controls. The usage of the drug, the adverse
reaction, if any, and many more information are provided in the pharmacopoeias.
The reason for the popularity of pharmacopoeias among the students, researchers,
teachers is for the reliability of the information provided in it

MULTIPLE CHOICE QUESTIONS


1. Who initiated the pharmacy education (c) Prof. G. N. Ghosh
in india? (d) Dr. Nitya Nand
(a) Prof. M. L. Shroff 6. What is Drug Bill?
(b) Prof. Nitya Nand (a) Drug Act of 1940
(c) Prof. R. N. Chopra (b) Bill passed in 1940 to regulate
(d) Prof. G. N. Ghosh import, sale and distribution of
2. Who was the chairman of first Drug drugs in Birtish India(Drugs Act
Enquiry committee? of 1940)
(a) Prof. Col R. N. Chopra (c) Drug Acts of 1947
(b) Prof. Kapur (d) None of the above
(c) Prof. G. N. Ghosh 7. When the first IP was published?
(d) Prof. Srivastava (a) 1940 (b) 1947
3. In which year Drug Technical (c) 1955 (d) 1962
Advisory Board was constituted? 8. What is official compendia?
(a) 1941 (b) 1937 (a) IP (b) USP
(c) 1951 (d) 1946 (c) BP (d) BPC
4. Who was the chairman of first Indian (e) All of the above
Pharmacopoeial Committee? 9. What is non-official compendia?
(a) Prof. Col R. N. Chpora (a) Extra Pharmacopoeia
(b) Prof. G. N. Ghosh (b) National Formulary
(c) Prof. M. L. Shroff (c) BPC
(d) None of the above (d) None of the above
5. Who started the Indian Journal of jq
When first Indian Pharmacopoeial
Pharmacy? was published?
(a) Prof. Shroff (a) 1946 __ (b) 1955-----------------
____ (b) Prof. Srivastava----- ------- (c) 1940 (d) 1948
14 □ □ Drug Inspector Exam

11. When perm anent Indian (c) Ehrlich


Pharmacopoeial committee was (d) None of the above
constituted?
18. When the first edition of BP was
(a) 1937 (b) 1940 published?
(c) 1948 (d) 1954 (a) 1945 (b) 1960
12. Who was the chairm an of (c) 1963 (d) 1964
reconstituted Indian Pharmacopoeial
19. Who has produced the BPC?
committee?
(a) Pharmaceutical Society of Great
(a) Dr. Nitya Nand
Britain
(b) Prof. Harkrishan Singh
(b) Association of Medical
(c) Prof. Ghosh
Practitionars
(d) None of the above (c) A ssociation of Dispensing
13. Which is the Latest IP edition? Pharmacist
(a) 1985 (d) None of the above
(b) 1996 20. Who has published the National
(c) 2007 Formulary
(d) 2010 (a) Indian Pharmaceutical Association
14. If drug is soluble in less than one part (b) American Pharmaceurical
as per IP, it is designated as Association
(a) Soluble (c) British society of Pharmaceutical
(b) Very soluble Association
(c) Freely soluble (d) None of the above
(d) Extremly soluble 21. Who has published Merck index?
15. Who publish the International (a) Merck and Co. India
Pharmacopoeia ? (b) Merck and Co.,Inc.Rahway, New
(a) Health department,USA Jersy, USA
(b) Health department,UK (c) Merck and Co, UK
(c) WHO (d) Merck and Co, Germany
(d) Health department, Germany 22. The USP-NF is a United State
16. In how many volum es, first Pharmacopoeia combined with
International Pharmacopoeia was National formulary.
published? (a) True
(a) 1 (b) 2 (b) False
(c) 3 (d) 4 23. In com parison to British
17. Who has produced the first Extra Pharmacopoeia, BPC contains more
Pharmacopoeia? drug.
(a) William Martindale (a) True
(b) Flemming (b) False
History o f Pharmacy in India/Importance o f various Pharmacopeias □ □ 15

24. Who has published National (d) Ministry of Health, Gove nment of
Formulary of India? India
(a) APTI 25. Where Indian Pharmacopoeial Lab is
(b) MCI situated?
(c) PCI (a) Kolkata (b) Mumbai
(c) Ghaziabad (d) Lucknow

ANSWERS
1. (a) 2. (a) 3. (a) 4. (b) 5. (a) 6. (b) 7. (c) 8. (e) 9. (a) 10. (a)
I I. (c) 12. (a) 13. (b) 14. (b) 15. (c) 16. (d) 17. (a) 18. (d) 19. (a) 20. (a)
21. (b) 22. (a) 23. (a) 24. (d) 25. (c)

□ □ □
Sources of Drugs C h a pter

Drugs are obtained from six major sources :


1. Plant sources
2. Animal sources
3. Mineral/ Earth sources
4. Microbiological sources
5. Semi-synthetic sources/ Synthetic sources
6. Recombinant DNA technology
1. Plant Sources :
Plant source is the oldest source of drugs. Most of the drugs in ancient times were
derived from plants. Almost all parts of the plants are used i.e., leaves, stem, bark, fruits
and roots.
Leaves :
(a) The leaves of Digitalis Purpurea are the source of Digitoxin and Digoxin, which are
cardiac glycosides.
(b) Leaves of Eucalyptus give oil of Eucalyptus, which is important component of
cough syrup.
(c) Tobacco leaves give nicotine.
(d) Atropa belladonna gives atropine.
Flowers :
(a) Poppy, Papaver somniferum gives morphine (opoi (d)
(b) Vinca rosea gives vincristine and vinblastine
(c) Rose gives rose water used as tonic.
Fruits :
(a) Senna pod gives anthracine, which is a purgative (used in constipation)
(b) Calabar beans give physostigmine, which is cholinomimetic agent.
Seeds :
1. Seeds of Nux Vomica give strychnine, which is a CNS stimulant.
Sources o f Drugs □ □ 17

2. Castor oil seeds give castor oil.


3. Calabar beans give Physostigmine, which is a cholinomimetic drug.
Roots :
(a) Ipecacuanha root gives Emetine, used to induce vomiting as in accidental poisoning.
It also has amoebicidal properties.
(b) Rauwolfia serpentina gives reserpine, a hypotensive agent.
(c) Reserpine was used for hypertension treatment.
Bark :
(a) Cinchona bark gives quinine and quinidine, which are antimalarial drugs.
Quinidine also has antiarrythmic properties.
(b) Atropa belladonna gives atropine, which is anticholinergic.
(c) Hyoscyamus Niger gives Hyosine, which is also anticholinergic.
Stem :
Chondrodendron tomentosum gives tuboqurarine, which is skeletal muscle relaxant used
in general anesthesia.
2. Animal Sources :
(a) Pancreas is a source of Insulin, used in treatment of Diabetes.
(b) Urine of pregnant women gives Human Chorionic Gonadotropin (HCG) used for
the treatment of infertility.
(c) Sheep thyroid is a source of thyroxin, used in hypertension.
(d) Cod liver is used as a source of Vitamins A and D.
(e) Anterior pituitary is a source of pituitary gonadotropins, used in treatment of
infertility.
(f) Blood of animals is used in preparation of vaccines.
(g) Stomach tissue contains pepsin and trypsin, which are digestive juices used in
treatment of peptic diseases in the past. Nowadays better drugs have replaced
them.
3. Mineral Sources :
(i) Metallic and Non metallic sources :
(a) Iron is used in treatment of iron deficiency anemia.
(b) Mercurial salts are used in Syphilis.
(c) Zinc is used as zinc supplement. Zinc oxide paste is used in wounds and in
eczema.
(d) Iodine is antiseptic. Iodine supplements are also used.
(e) Gold salts are used in the treatment of rheumatoid arthritis.
18 □ □ Drug Inspector Exam

(ii) Miscellaneous Sources:


(a) Fluorine has antiseptic properties.
(b) Borax has antiseptic properties as well.
(c) Selenium as selenium sulphide is used in anti dandruff shampoos.
(d) Petroleum is used in preparation of liquid paraffin.
4. Synthetic/ Semi-Synthetic Sources :
(i) Synthetic Sources:
When the nucleus of the drug from natural source as well as its chemicai structure it
altered, we call it synthetic.
Examples include Emetine Bismuth Iodide
(ii) Semi-Synthetic Source:
When the nucleus of drug obtained from natural source is retained but the chemical
structure is altered, we call it semi-synthetic.
Examples include Apomorphine, Diacetyl morphine, Ethinyl Estradiol, Homatropine,
Ampicillin and Methyl testosterone.
Most of the drugs used nowadays (such as antianxiety drugs, anti-convulsants) are
synthetic forms.
5. Microbiological Sources :
(a) Penicillium notatum is a fungus which gives penicillin.
(b) Actinobacteria give Streptomycin.
(c) Aminoglycosides such as gentamicin and tobramycin are obtained from
streptomycis and micromonosporas.
6. Recombinant DNA technology :
Recombinant DNA technology involves cleavage of DNA by enzyme restriction
endonucleases. The desired gene is coupled to rapidly replicating DNA (viral, bacterial or
plasmi(d). The new genetic combination is inserted into the bacterial cultures which allow
production of vast amount of genetic material.
Antibody drugs are the largest class of biotech drugs, useful in oncology and in the
treatment of autoimmune diseases. These drugs have a range of highly selective target.
Herceptin (trastuzumab) targets the HER2 receptor on breast cancer tumours. Rituxan
(rituximab) targets the CD20 ligand (antigen) on plasma cells (B cells) and kills the B cell
population, both malignant and normal cells. It does not eradicate very immature
(progenitor) B cells so this cell population regenerates after the end of the therapy cycle.
Avastin (bevacizumab) is an antibody drug that binds to VEGF, blocking a protein needed
for growth of blood vessels to tumours (angiogenesis). Remicade (infliximab) binds to
Tumour Necrosis Factor (TNF) and blocks an immunostimulatory pathway implicated in
Sources o f Drugs □ □ 19

RA. TNF is a cytokine associated with the pathology of autoimmune disease. Erbitux
(cetuximab) is an antibody that blocks the EGF receptor. A recently approved drug, Soliris
(eculizumab), has a very unique target: C5 of the complement cascade.
Advantages:
1. Huge amounts of drugs can be produced.
2. Drug can be obtained in pure form.
3. It is less antigenic.
Disadvantages:
1. Well equipped lab is required.
2. Highly trained staff is required.
3. It is a complex and complicated technique.

MULTIPLE CHOICE QUESTIONS

1. Genetically engineered bacteria pre 4. Pomato is somatic


being used in commercial production (a) Poppy and Potato
of (b) Potato and Tomato
(a) Melatonin (c) Poppy and Tamarind
(b) Testoterone (d) Poppy and Tomato
(c) Human insulin
5. 'Nif gene' for nitrogen fixation is cereal
(d) Thyroxine crops like wheat, jowar etc., is
(e) Thyronine introduced by cloning
2. Gene is segment of (a) Rhizobium meliloti
(a) RNA (b) Bacillus thuringiensis
(b) DNA (c) Rhizopus
(c) RNA or DNA (d) Rhizophora
(d) Both DNA and RNA 6. Which one of these is a
3. In callus culture, roots can be induced biotechnological drugs?
by the supply of (a) Herceptin
(a) Auxin and no cytokinin (b) Rituxan
(b) Higher concentration of auxin and (c) Avastin
lower concentration of cytokinin (d) Erbitax
(c) Higher concentration of cytokinin (e) All of the above
and lower concentration of auxin
7. Which salt is used to treat mania and
(d) Both auxin and cytokinin in equal depression?
proportions.
(a) Calcium folinate
(b) Lithium citrate
20 □ □ Drug Inspector Exam

(c) Potassium citrate 14. Tick mark the anticancer drug of plant
(d) Bismuth subcarbonate origin.
8. Which is not unorganized drug? (a) Vincristine
(a) Gelatin (b) Cisplatin
(b) Opium (c) Methotrexate
(c) Musk (d) 5-Fluorouracil
(d) Aloes 15. Tick the anticancer drug belonging to
(e) None of these inorganic metal complexes:
(a) Dacarbazine
9. Which one of these drug is a entire
plant? (b) Cisplatin
(a) Lobelia (c) Methotrexate
(b) Senna (d) Vincristine
(c) Liquorice 16. Enzyme drug used for acute leukemia
(d) Belladonna treatment:
(a) Dihydrofolate reductase
10. What is Talc?
(b) Asparaginase
(a) Hydrated aluminium silicate
(c) Aromatase
(b) Hydrated magnesium silicate
(d) DNA gyrase
(c) Hydrated potassium silicate
(d) None of these 17. Which drug is recommended for the
treatment of sleeping disorder?
11. What is Light Kaolin?
(a) Rauwolfia serpentina
(a) Aluminium silicate having
(b) Valeriana officinalis
antidiarroeal action
(c) Centella asiatica
(b) Aluminium silicate having
antidiarroeal action (d) A1 of the above
(c) Aluminium magnesium silicate 18. Which drug is used for support of the
having antiseptic action excretory function of the kidney?
(d) Aluminium silicate having inert (a) Clove
nature (b) Melissa leaf
12. What is Bentonite? (c) Dandelion root
(a) Dry stigma of Crocus sativus (d) Hamamelis leaf
(b) Dry flower of Crocus sativus 19. What is source for green tea?
(c) Dry stigma of Citrullus sativus (a) Camellia sinensis
(d) Dry flower of Citrullus sativus (b) Centella asiatica
13. The Source for Saffron is— (c) Anthum
(a) Dry stigma of Crocus sativus (d) Sinensis
(b) Dry flower of Crocus sativus 20. What is goldenseal, yellow root?
(c) Dry stigma of Citrullus sativus (a) Root of Haemmalis
(d) Dry flower of Citrullus sativus (b) Root of Hydrastis canadensis
Sources o f Drugs □ □ 21

(c) Berberis sps 27. The antibiotic'Streptomycin ’is


(d) None of these produced from
21. Tick the psychoactive drugs of natural (a) S fradiae
origin. (b) S griseus
(a) Cannabis (c) S aureofaciens
(b) Opium (d) B polymyxa
(c) Coca products 28. The penicillin is obtained from
(d) Tinospora (a) Fungi (b) bacteria
(e) option a, b and c (c) Algae (d) Bryphytes
22. What is the category of Artemisinin? 29. Lycopodium is obtained from
(a) Anthelmintic (a) Fungi
(b) Antimalarial (b) Bryphytes
(c) Psychotic (c) Pteridophytes
(d) Antiseptic (d) Zymnosperm
23. What is Amalak# 30. The strychnine alkaloid is obtained
(a) Phyllanthus embilica from
(b) Withania somnifera (a) Seed
(c) Brahmi (b) rhizome
(d) Berberis aristata (c) Root
(d) Leaf
24. Which one of these has phytoestrogen
activity? 31. Which of the family act as important
(a) Phyllanthus embilica source of medicinal drug
(b) Withania somnifera (a) Rutaceae
(c) Brahmi (b) Rubiaceae
(d)* Azadirachta indica (c) Solanaceae
25. What is the source of Aesculetin used (d) Umbelliferae
for the treatment of dysentery? 32. The resein'Heeng' is obtained from
(a) Frazinus rhychophylla family
(b) Adonis vemalis (a) Rubiaceae
(c) Aesculus hippocastanum (b) Acanthaceae
(d) Andrographis paniculata. (c) Umbeliferae
26. Which of these contains allyl (d) Scrophulariaceae
isothiocyante? 33. Chemically, calamine is
(a) Brassica nigra (a) Zinc oxide
(b) Anabasis sphylla (b) Calcium carbonate
(c) Ardisia japonica (c) Aluminium silicate
(d) None of the above (d) Magnesium silicate
22 OO Drug Inspector Exam

34. Algae is a source of 36. Which one of these has anticoagulant


(a) Bentonite (b) Kaolin property,prepared by cell culture
(c) Kieselguhur (d) Asbestos method?
(a) Streptokinase
35. In which mineral drug, aluminium
silicate is not present? (b) Warferin
(a) Kaolin (b) Kieselguhr (c) Alteplase
(c) Shilajeet (d) Fueller's earth (d) Heparin

ANSWERS
! ■(c) 2. (b) 3. (b) 4. (b) 5. (a) 6. (d) 7. (b) 8. (e) 9. (a) 10. (b)
11. (a) 12. (a) 13. (d) 14. (a) 15. (b) 16. (b) 17. (b) 18. (c) 19. (a) 2 0 . (b)
21. (e) 22. (b) 23. (a) 24. (b) 25. (a) 26. (a) 27. (b) 28. (a) 29. (c) 3 0 . (d)
31. (c) 32. (c) 33. (a) 34. (c) 35. (c) 36. (d)

non
Methods o f Preparing Herbal 3

Remedies C h a p te r

In traditional herbal medicine systems, herbal remedies are prepared in several rather
standardized ways which usually vary based upon the plant utilized, and sometimes,
what condition is being treated. Some of these methods include: infusions (hot teas),
decoctions (boiled teas), tinctures (alcohol and water extracts), which are given here.
Infusions
Infusions are typically used for delicate herbs, leaves and fresh tender plants. Preparing
an infusion is much like making a cup of tea. Water is brought just to a boil and then
poured over an herb (or combination of herbs), it is covered and allowed to sit/steep for
10-15 minutes or so. It can be prepared in the drinking cup (by just pouring the heated
water over the herb in the cup) or by dropping the herb into the pot which the water was
heated in. Empty gauze tea-bags are even available at some herb stores which can be
filled with herbs and then sealed with a iron. If an infusion is prepared in the heating
pan/pot, it's best to use a ceramic pot with a lid (avoid metal pots). Stirring it a few times
while steeping (especially with cut herbs) is helpful. Keeping the infusion covered while
steeping is generally recommended as well (place a saucer on top of the cup, or a lid on
top of the pot). The ratio of herb to water can vary depending on the remedy, the plant,
and whether cut herb or powdered herb is used. Generally using 1 teaspoon of powdered
herb or 2 teaspoons of more bulky cut herb in a 6-8 ounce cup of water is sufficient. If
using a powdered herb; stir once halfway through the seeping time and let the powder
settle to the bottom of the cup, then drink the infusion off the top (leaving the sediment in
the bottom of the cup). If using a cut herb, strain the infusion with a tea-strainer after
seeping. Infusions are best prepared as needed and taken the same day it was prepared
and can be taken hot, warm, or cold.
Decoctions
Decoctions are usually the method of choice when herbal drug is tougher and more
fibrous plants, barks and roots (and which have water soluble chemicals). Instead of just
steeping it in hot water, the plant material is boiled for a longer period of time to soften
the harder woody material and release its active constituents. To prepare a decoction,
select a ceramic pot with a fitting lid. Measure the amount of herb needed (usually the
same ratio of 1 teaspoon powdered herb or 2 teaspoons of cut herb per 8 ounces of water)
into the pot and add the proper amount of cold water depending on how many cups of
23
24 □ □ Drug Inspector Exam

the decoction you wish to prepare. Turn on the heat to medium high and bring to a roiling
boil. Place the lid on the pot and reduce the heat to medium or medium-low so that the
mixture stays at a good simmer. If you can see steam escaping or smell the aroma of the
herb, your lid is not tight enough and valuable essential oils are escaping. After 20 minutes,
remove from heat and cool slightly. If using cut herbs, strain the mixture through a tea
strainer into a teacup. When straining, make sure to press on the cut herb pieces in the
strainer to get as much liquid/decoction out of the herb pieces as possible. If using
powdered herb, allow the powder to settle to the bottom of the pot and then pour off the
decoction from the top into a teacup (any sediment missed will settle to the bottom of the
teacup). Standard dosages for decoction are generally one-half to one cup, two or three
times daily. Again, the entire day’s dosage can be prepared in the morning (2-3 cups at
one time), and the remainder refrigerated until ready to use later in the day.
Tinctures
Tinctures are liquid preparations which are usually obtained using either 1 part of
herbal drug or animal matter and 10 parts of extraction solvent or 1 part of herbal drug or
animal matter and 5 parts of extraction solvent.
Tinctures are prepared by maceration or percolation (outline methodology is given
below) using only ethanol of a suitable concentration for extraction of the herbal drug or
animal matter, or by dissolving a soft or dry extract (which has been produced using the
same strength of extraction solvent as is used in preparing the tincture by direct extraction)
of the herbal drug or animal matter in ethanol of a suitable concentration. Selection of
process depends on nature of drug, cost of drug, and potency of drug. Tinctures are
usually clear. A slight sediment may form on standing which is acceptable as long as the
composition of the tincture is not changed significantly.
Production by maceration. Unless otherwise prescribed, reduce the herbal drug or
animal matter to be extracted to pieces of suitable size, mix thoroughly with the prescribed
extraction solvent and allow to stand in a closed container for an appropriate time. The
residue is separated from the extraction solvent and, if necessary, pressed out. In the latter
case, the 2 liquids obtained are combined.
Production by percolation. If necessary, reduce the herbal drug or animal matter to
be extracted to pieces of suitable size. Mix thoroughly with a portion of the prescribed
extraction solvent and allow to stand for an appropriate time. Transfer to a percolator and
allow the percolate to flow at room temperature slowly making sure that the herbal drug
or animal matter to be extracted is always covered with the remaining extraction solvent.
The residue may be pressed out and the expressed liquid combined with the percolate.
Percolation process is more efficient.
Methods o f Preparing Herbal Remedies □ □ 25

Liquid extracts
Liquid extracts are liquid preparations of which, in general, 1 part by mass or volume
is equivalent to 1 part by mass of the dried herbal drug or animal matter. These preparations
are adjusted, if necessary, so that they satisfy the requirements for content of solvent, and,
where applicable, for constituents.
Production. Liquid extracts are prepared by using ethanol of suitable concentration
or water to extract the herbal drug or animal matter, or by dissolving a soft or dry extract
(which has been produced using the same strength of extraction solvent as is used in
preparing the liquid extract by direct extraction) of the herbal drug or animal matter in
either ethanol of suitable concentration or water. Liquid extracts may be filtered, if
necessary.
Soft extracts
Soft extracts are semi-solid preparations obtained by evaporation or partial evaporation
of the solvent used for extraction.
Dry extracts
Dry extracts are solid preparations obtained by evaporation of the solvent used for
their production. Dry extracts usually have a loss on drying or a water content of not
greater than 5 percent.
Classification of Pharmaceutical dosage forms :
A. Gaseous dosage forms
B. Liquid dosage forms
C. Semisolid dosage forms
D. Solid dosage forms
A. Gaseous dosage form.
(i) Medicinal gases, inhalation/volatile anaesthetics (vaporised before administration
by inhalation)
(ii) Aerodispersions of solid particles (e.g., antiasthmatic inhalations) or liquid particles
(antiasthmatic inhalations or sprays)
B. Liquid dosage form
(i) Solutions - one homogenous phase, prepared by dissolving one or more solutes in
a solvent
(ii) Emulsions
• a dispersion system consisting of two immiscible liquids
• o/w or w/o
• cloudy appearance
26 □ □ Drug Inspector Exam

(iii) Suspensions
• A dispersion system where solid particles (dispersed phase) are dispersed in liquid
phase (dispersion medium)
• According to the size of dispersed particles (1 nm- 0,5 mm) a molecular, colloidal
and coarse dispersions can be distinguished
• May require shaking before administration
• Not intended for systemic administration of drugs with high potency
C. Semisolid dosage form
1. Unshaped (without specific physical shape)
(i) Ointments - Semisolid dosage forms with the oleaginous (hydrocarbon), water-
soluble or emulsifying base
- Oleaginous (hydrocabon) base: Petrolatum (Vaseline- white, yellow)
- Water-soluble base: Polyethylenglycol (PEG)- ointment - syn. macrogol
ointments
(ii) Pastes - semisolid dispersion system, where a solid particles (>25%, for example,
ZnO) are dispersed in ointments - mostly oleaginous (Petrolatum)
2. Shaped
(i) Suppositories (for rectal administration)
- Different shapes
- Melting/dissolving at body temperature
- Oleaginous (cocao butter) or aqueous (PEGs,glycerinated gelatine)
(ii) Pessaries (vaginal suppositories)
- Similar as above, PEGs or glycerinated gelatine are often used as base.
D. Solid dosage form
1. Unshaped (without specific shape)
- powders for external /internal use
2. Shaped
- Tablets
- Capsules
- Implants (Sterile disks inserted surgically into body tissues and designed to release
drug(s) over extended period of time)
- Transdermal patches
- Lozenges (consists of sugar and gum to medicate the mouth and throat)
Controlled-Release Dosage Forms
The release or liberation of the drug substance from the dosage form can be controlled
in certain types of dosage form. Release can be controlled in two ways, (1) the drug
Methods o f Preparing Herbal Remedies □ □ 27

substance is released at a specified rate or (2) the drug substance is released at a specified
location. These dosage forms are termed modified release dosage forms. Extended release
and delayed release are the most common type of modified release dosage forms. Extended
release dosage forms allow the rate of drug-substance release to be controlled in such a
manner as to allow a reduction in dosing frequency. The rate of drug-substance release is
controlled by the inclusion of excipients that retard drug substance release. Certain designs
of delayed release dosage forms contain functional excipients that release the drug
substance in response to a stimulus, such as the presence of a specific enzyme, biological
substrate or pH.
Novel Drug Delivery Systems
The method by which a drug is delivered can have a significant effect on its efficacy.
Some drugs have an optimum concentration range within which maximum benefit is
derived, and concentrations above or below this range can be toxic or produce no
therapeutic benefit at all. On the other hand, the very slow progress in the efficacy of the
treatment of severe diseases, has suggested a growing need for a multidisciplinary
approach to the delivery of therapeutics to targets in tissues.
Most of the pharmaceutical products are simple, fast-acting chemical compounds that
are dispensed orally (as solid pills and liquids) or as injectables. During the past three
decades, however, formulations that control the rate and period of drug delivery (i.e.,
time-release medications) and target specific areas of the body for treatment have become
increasingly common and complex.The goal of all sophisticated novel drug delivery
systems, therefore, is to deploy medications intact to specifically targeted parts of the
body through a medium that can control the therapy's administration by means of either
a physiological or chemical trigger. To achieve this goal, researchers are turning to advances
in the worlds of micro and nanotechnology. Some of the examples are given here.
(i) Micelles: These micelles are only tens of nanometers in diameter and are thus
ideally sized for enclosing individual drug molecules. Further, their hydrophilic
outer shells help protect the cores and their cpntents from chemical attack by the
aqueous medium in which they must travel. Finally, drug release is achieved via
common polymer degradation mechanisms, with the specificity of the delivery
(For example, cell-specific drug targeting) controlled by the synthetic design. For
example, micelles containing attached sugar-group ligands have been shown to
specifically target glyco-receptors in cellular plasma membranes.
(ii) Liposomes: Liposomes are a form of vesicles that consist either of many, a few or
just one phospholipid bilayer. The polar character of the liposomal core enables
polar drugrrtolecules to be encapsulated. Amphiphilic and lipophilic molecules
are solubilized within the phospholipid bilayer, according to their affinity towards
the phospholipids. Participation of nonionic surfactants instead of phospholipids
in the bilayer formation, results in niosomes. Channel proteins can be incorporated
28 □ □ Drug Inspector Exam

without loss of their activity within the hydrophobic domain of vesicle membranes,
acting as a size-selective filter, only allowing passive diffusion of small solutes
such as ions, nutrients and antibiotics. Thus, drugs that are encapsulated in a
nanocage-functionalized with channel proteins are effectively protected from
premature degradation by proteolytic enzymes. The drug molecule, however, is
able to diffuse through the channel, driven by the concentration difference between
the interior and the exterior of the nanocage.
(iii) Dendrimers and Fullerenes: Dendrimers also known as star polymers are
nanometer-sized, highly branched and monodisperse macromolecules with
symmetrical architecture. They consist of a central core, branching units and
terminal functional groups. The core together with the internal units, determine
the environment of the nanocavities and consequently their solubilizing properties,
whereas the external groups decides the solubility and chemical behaviour of these
polymers. Targeting effectiveness is affected by attaching targeting ligands at the
external surface of dendrimers, while their stability and protection from the
Mononuclear Phagocyte System (MPS) is being achieved by functionalization of
the dendrimers with Polyethylene Glycol Chains (PEG). To date, these delivery
systems remain largely unexplored, but researchers have demonstrated the
usefulness of attaching the anticancer agents 5-fluorouracil to polyaminoamine
dendrimers and methotrexate to hydrazide-terminated dendrimers formed from
poly (aryl ether).
( iv) Nanoparticles: Nanoparticles (nanospheres and nanocapsules of size 10-200 nm)
are in the solid state and are either amorphous or crystalline. They are able to
adsorb and/or encapsulate a drug, thus protecting it against chemical and
enzymatic degradation. Nanocapsules are vesicular systems in which the drug is
confined to a cavity surrounded by a unique polymer membrane, while
nanospheres are matrix systems in which the drug is physically and uniformly
dispersed. Nanoparticles as drug carriers can be formed from both biodegradable
polymers and non-biodegradable polymers. In recent years, biodegradable
polymeric nanoparticles have attracted considerable attention as potential drug
delivery devices in view of their applications in the controlled release of drugs, in
targeting particular organs / tissues, as carriers of DNA in gene therapy, and in
their ability to deliver proteins, peptides and genes through the oral route.
(v) Hydrogels: Hydrogels are three-dimensional, hydrophilic, polymeric networks
capable of imbibing large amounts of water or biological fluids. The networks are
composed of homopolymers or copolymers, and are insoluble due to the presence
of chemical crosslinks (tie-points, junctions), or physical crosslinks, such as
entanglements or crystallites. Hydrogels exhibit a thermodynamic compatibility
with water, which allows them to swell in aqueous media. They are used to regulate
Methods o f Preparing Herbal Remedies □ □ 29

drug release in reservoir-based, controlled release systems or as carriers in .wellable


and swelling-controlled release devices. On the forefront of controlled drug
delivery, hydrogels as enviro-intelligent and stimuli-sensitive gel systems modulate
release in response to pH, temperature, ionic strength, electric field, or specific
analyte concentration differences. In these systems, release can be designed to occur
within specific areas of the body (For example, within a certain pH of the digestive
tract) or also via specific sites (adhesive or cell-receptor specific gels via tethered
chains from the hydrogel surface). Hydrogels as drug delivery systems can be
very promising materials, if combined with the technique of molecular imprinting.

MULTIPLE CHOICE QUESTIONS

1. Promisomes are... 5. Dendrimers are


(a) dry product which on hydration (a) Three dimensional branched
produces niosomes structure
(c) protein based niosomes, used for (b) Two dimensional branched
peptide drug delivery structure
(c) precursor of niosomes, formed just (c) Four dimensional branched
before the aggregation structure
(d) derived from liposomes (d) None of the above
2. Nanoparticles are solid colloidal 6. Chemically, niosomes are
particles ranges in sizes from- (a) Non ionic surfactant
(a) 1 -100 pm (b) Ionic surfactant
(b) 10-1 yim (c) Cationic surfactant
(c) 100 -500 pm (d) anionic surfactant
(d) 500-1000 pm 7. Pharmacosomes are associated with
3. Which of the following serves as an the drawback of-
appropriate model for biological (a) drug leakage and entrapment
membranes? (b) stability problem
(a) Niosomes (c) oxidation
(b) Liposomes (d) None of the above
(c) both a and b
8. Synchromate C is an example of-
(d) None of the above
(a) Microreservior dissolution
4. Aquasomes are made of controlled drug delivery system
(a) Carbohydrate (b) membrane permeation controlled
(b) Protein drug delivery system
(c) Lipids (c) Matrix diffusion controlled drug
(d) All of the above delivery system
(d) None of the above
30 □ □ Drug Inspector Exam

9. The molecular weight of the drug for (a) Simple dissolution


transdermal drug delivery system is- (b) Maceration
(a) <1000 (c) Chemical reaction
(b) <100 (d) Distillation
(c) less than 10,000
15. Tincture of nux vomica is prepared by
(d) None of the above process-
10. Polymer used for implantable drug DS (a) Dilution
is- (b) Maceration
(a) Silicone elastomers (c) Percolation
(b) Hydrogels (d) Decoction
(c) Biodegradable polymer
16. The compound cardamom tincture is
(d) All of the above prepared by-
11. Phosphatidic acid and its derivative (a) Reserve percolation
form liposomes because- (b) Maceration
(a) in a fully hydrated condition, they (c) Percolation
are conical in shape (d) Decoction
(b) in a fully hydrated condition, they
17. Aromatic waters are prepared by-
are cyhderical in shape
(a) LnsLlIlation
(c) they contain only non polar
moiety in thieir structure (b) Maceration
(d) their saponification values are (c) Triple maceration
usually low (d) Decoction
12. A new drug delivery system which is 18. Tincture are prepared by
composed of phospholipids that (a) Dilution
spontaneously form a multicellular (b) Maceration
concentric layer vesicles with layer of (c) Percolation
aq njedia separating the lipid layer is- (d) All of the above
(a) prodrug
19. The non-ionic surfactant used as a
(b) Liposomes penetration enhancer is
(c) Osomotoc pump (a) Oleic acid
(d) Nanparticles (b) Glycerol
13. Elixirs are (c) Tween 80
(a) Clear liquid, alcoholic preparation (d) Propylene glycol
(b) Aromatic water preparation 20. The concentration of simple sugar
(c) Sugary preparation syrup BP is
(d) All of the above (a) 85% (b) 66.7%
14. Aromatic spirit of ammonia is (c) 60% (d) 40.5%
prepared by process- 21. Doxorubicin formulation is one of the
example of
Methods o f Preparing Herbal Remedies □ □ 31

(a) Liposomes (c) Nanoemulsion


(b) Pharmacosomes (d) Microemulsion
(c) Niosomes 27. The drugs delivered by nanoparticle
(d) None of the above are
22. Infusion is used for (a) amphotericin B
(a) Hard and woody drug (b) proteins
(b) Soft organized drug (c) antineoplastic drug
(c) Heat stable (d) All of the above
(d) all of the above 28. Reserve percolation is used for
23. The concentration of alcohol in preparation of
tincture is (a) liquid extract of liquorice
(a) 20-90% (b) 20-90% (b) tincture of orange
(c) 20-90% (d) 20-90% (c) tincture of ginger
24. Monophasic liquid dosage form (d) tincture of cardamom
include 29. The selection of extraction process
(a) Solution depends on
(b) Tincture (a) nature of drug
(c) Aromatic waters (b) cost of drug
(d) All of the above (c) therapeutic value of drug
25. Which is true for elixir? (d) stability of drug
(a) They are clear liquid preparation (e) all of the bove
(b) They contain alcohol 30. Triple maceration is recommended in
(c) They are less stable than mixture IP 66 for
(d) They are pleasantly flavored (a) concentrated infusion of quassia
(b) liquid extract of senna
26. Triamcilone acetonide is delivered by
which novel drug delivery system (c) liquid extract of ginger
(a) Neosomes (d) a and b
(b) Multiemulasion

ANSWERS

1. (a) 2. (b) 3. (b) 4. (a) 5. (a) 6. (a) 7. (a) 8. (a) 9. (a) 10. (d)
11. (b) 12. (b) 13. (c) 14. (d) 15. (c) 16. (c) 17. (a) 18. (d) 19. (c) 20. (b)
21. (a) 22. (b) 23. (a) 24. (d) 25. (b) 26. (a) 27. (d) 28. (a) 29. (e) 30. (d)

cm
Prescription and Latin Words used A

in the Prescription Chawer

The complete prescription should have the following parts:

Date
Date must be written on the prescription by the prescriber at the same time when it is
written. The date on the prescription helps a pharmacist to find out the cases where
prescription is brought for dispensing long time after its issue. Prescriptions containing
narcotic or other habit-forming drugs must bear the date.
Name, Age, Sex and Address of the Patient
Name, age, sex and address of the patient must be written on the prescription. If it is
not written then, the pharmacist himself should ask the patient about these particulars
and put down at the top of the prescription. This avoids the possibility of giving the
finished product to a person other than the one it is meant for. Patient's full name must be
written instead of surname or the family name.
Age and sex of the patient especially in the case of children helps the pharmacist in
checking the medication and the dose. Therefore, there will be less danger of its being
administered to the wrong member of the family or the hospital ward having similar
names. The address of the patient is recorded to help for any reference at a later stage, to
contact the patient or to deliver the medication personally.
Superscription
The superscription is represented by a symbol, Rx, which is always written at the
beginning of the prescription. In the days of mythology and superstition the symbol was
considered as a prayer to Jupiter, the God of healing, for quick recovery of the patient but
now this symbol is understood as an abbreviation of the Latin word recipe, meaning "take
thou" or "you take”.
Inscription
This is the main part of the prescription. It contains the names and quantities of the
prescribed ingredients. The names of the ingredients are written each on a separate line,
followed by the quantity ordered and the last item written is generally the vehicle or
diluent.

*30
Prescription and Latin Words used in the Prescription □ □ 33

In complex prescriptions containing several ingredients the inscription is divided into


three parts:
(i) The base or the active medicament which is intended to produce the therapeutic
effect;
(ii) The adjuvant which is included either to enhance the action of the medicament or
to make the productmore palatable;
(iii) The vehicle which is either used.to dissolve the solid substances and/or to increase
the volume of the preparation for ease of administration..
Subscription
This part of the prescription contains prescriber's directions to the pharmacist regarding
the dosage form to be prepared and number of doses to be dispensed. Since, now-a-days
only a few prescriptions are compounded therefore such directions are less frequent.
Signatura/Signa
It is usually abbreviated as "Sig" on the prescriptions and consists of the directions to
be given to the patient regarding the administration of the drug. It usually indicates the
quantity of medicament or number or dosage units to be taken, how many times in a day
or at what time it should be taken and the manner in which it is to be administered or
applied.
Signature, Address and Registration Number of the Prescriber
All other parts of the prescription may be printed or type-written but the prescriber's
name must be hand-written and should be signed with ink. This eliminates the danger of
dispensing medicament on a spurious order and it authenticates the prescription. The
prescriptions containing narcotic or other habit-forming drugs must bear the address and
registration number of the prescriber. This identifies the special license which a prescriber
must have to prescribe the narcotic and other habit-forming drugs.

" MULTIPLE CHOICE QUESTIONS


1. The latin term'Haustus' indicates 3. The latin word'Deglutiendus' is used
(a) Draught (b) Mixture for
(c) Ointment (d) Poultice (a) To be swallowed
2. The latin word'sumendus' is used for- (k) To be rubbed in
(a) To be taken <c> To be aPPlied
(b) To be used (d) To be mixed
(c) To be mixed 4. The latin term'Ter in die' indicates
(d) To be swallowed (a) Three times a day
(b) Six times a day
34 □ □ Drug Inspector Exam

(c) Four times a day 12. The latin term ’More dicto' is
(d) Once time a day designated to
5. The latin term'Primonano'indicates (a) as directed
(b) frequently
(a) Early in the morning
(c) when required
(b) In the morning
(d) none of the above
(c) Every morning
(d) During the night 13. The latin term'semen in die' indicates
(a) once in a day
6. The latin term'Mitte' indicates
(b) three times a day
(a) Send (c) Twice a day
(b) Take (d) four times a day
(c) Send such
14. The term ’More dicto' indicates
(d) In the manner prescribed
(a) in the manner prescribed
7. The latin term collutorium'designated ~ (b) send such
to (c) to be added
(a) A mouth wash (d) as directed
(b) a eye wash
15. The latin term'tussi urgent' indicates
(c) poultice (a) when cough is troublesome
(d) none of the above (b) immediately
8. In a prescription, the term signature’ (c) when pain is severe
indicates (d) frequently
(a) direction to patient 16. Supercription indicates
(b) direction to doctor (a) direction to patient
(c) direction to pharmacist (b) direction to physician
(d) None of the above (c) symbol Rx
9. The latin word'Auristille' indicates (d) none of the above
(a) ear drop (b) capsule 17. Subcription is directed to
(c) a powder (d) a draught (a) patient
10. Cataplasma is related to (b) pharmacist
(a) powder (b) poultice (c) doctor
(c) cream '(d). ointment (d) all of the above
18. The latin term'nebula' indicates
11. Latin word'Siopus sit' indicates
(a) a spray solution
(a) when necessary
(b) nasal drop
(b) immediately
(c) a paste
(c) slowly
(d) none of the above
(d) as directed
Prescription and Latin Words used in the Prescription □ □ 35

19. The latin term'auristille' means 23. The terifi 'Statim'indicates


(a) ear rop (a) immediately
(b) nasal drop (b) frequently
(c) an eye wash (c) slowly
(d) lotion (d) as directed
20. The latin word'doloreurgento' 24. The latin term'cochleare magnum'
indicates indicates
(a) immediately (a) one tablespoonful
(b) when pain is severe (b) one teaspoonful
(c) frequently (c) one dessertspoonful
(d) to make ointment (d) one large spoonful
21. The latin term'singulis horis' is related 25. The latin term'Cochleare minimum'
to indicates
(a) every hour (a) one tablespoonful
(b) every two hours (b) one teaspoonful
(c) every four hours (c) one dessertspoonful
(d) every alternate hour (d) one small teaspoonful
22. The term 'anti cibos' means 26. The name/quantity of each ingredient
(a) before meal in the prescription is related to
(b) after meal (a) inscription
(c) during meal (b) subscription
(d) with meal (c) superscription
(d) Signa

ANSWERS
l.(a ) 2. (a) 3. (a) 4. ( a ) . 5. (a) 6. (a) 7. (a) 8. (a) 9. (a) 10. (b)
11. (a) 12. (a) 13. (a) 14. (a) 15. (a) 16. (c) 17. (b) 18. (a) 19. (a) 2 0 . (b)
21. (a) 2 2 . (a) 23. (a) 24. (a) 25. (b) 26. (a)

□ □ □
5
C h a pt er

CALCULATION OF DOES FOR CHILDREN

1. Proportionate to age
(a) Young's Formulae
Age in yrs
Dose for the child x Adult dose
Age +12
(b) Dilling;s Formulae
Age in yrs
Dose for the child x Adult dose
20
(c) Fried's Formula
Age in yrs
Dose for the child x Adult dose
150
2. Proportionate to body weight
For example, adult dose of chloramphenicol is 25-50 mg/Kg
Suppose, the weight of Child is 30 Kg
Dose required is 30 mg/Kg body weight
Theefore, total dose = 30 x 30 = 900 me
Alcohol dilution
How would you prepare a 20ounce of 60% alcohol from 90% alcohol.
Solution. In this A1 and B2 are the strength of solution l(of 60% alcohol) and A2 and
B2 are the strength of concentrates(of 90% alcohol)
A1 = 60%,
and A2 = 90%,
B1 = 20 ounce
B2 = ?
60x20
B2 = ——— = 13.3 ounce
yu

36
Posology □ □ 37

Hence, 13.3 ounce of 90% alcohol must be diuted to 20 ounce with water to get 60%
alcohol.
Proof spirit
An alcohol-water mixture or a beverage containing a standard amount of alcohol, the
U.S. standard being 100 proof, or 50 percent, of ethyl alcohol by volume at 60°F
(approximately 15.6°(C). In India, 57.1 volumes of ethyl alcohol is considered to 100
volumes of Proof Spirit.
Examplel. Convert 90% v/v alcohol into proof spirit.
Solution.
57.1 volumes = 100 volumes
1 volume = 100/57.1 = 1.753
volumes of proof spirit 90 volumes of
alcohol volumes of proof spirit = 90 x 1.753 = 157.77
The proof strength of 90% alcohol = 157.77 - 100 = 57.770/P
Example 2. Convert 30% v/v alcohol into proof spirit.
Solution.
57.1 volumes = 100 volumes
1 volume = 100/57.1 = 1.753
volumes of proof spirit
30 volumes of alcohol = 30 x 1.753 = 52.59
volumes of proof spirit
The proof strength of 90% alcohol
= 52.59 - 100 = 47.41U/P
Isotonic solution
In the general sense, two solutions are isotonic when they contain the same amounts
of solutes, or dissolved substances, and therefore have the same osmotic pressure. As
commonly used in the medical field, though, isotonic solutions are solutions which have
the same concentration of solute as the cells in the human body. A cell placed in an isotonic
solution will neither gain nor lose water.
When two aqueous solutions of different concentrations or tonicities are separated by
a semi-permeable membrane such as a cell wall, water will migrate from the less
concentrated, or hypotonic, side to the more concentrated, or hypertonic, side in an attempt
to bring both sides into equilibrium. This process is known as osmosis. The greater the
difference in the two solutions' concentrations, the higher the osmotic pressure will be,
and the quicker the osmotic transfer will be.
Calculation for adjustment to Isotonicity
(a) Based on Freezing Point method
% w /v of adjusting substance required
0.52- a
38 □ □ Drug Inspector Exam

Where
a = Freezing point depression of unadjusted drug solution
b = Freezing point depression of 1% w /v adjusting substance
(b) Based on Molecular concentration
% w /v of adjusting substance required
0.03 x g molecular weight of the substance
No of ions into which the substance ionizes
Example 1 : Find out the proportion of dextrose needed to form a solution isotonic to blood
plasma.
Solution. The molecular weight of dextrose is 180 and it is non ionisable.
% w /v of adjusting substance required
0.03 x 180
= ----- ------ = 1.86%w/v

Example 2 : Find out a proportion of NaCl required to render a 1& solution o f cocaine HCl
isotonic to blood plasma.
Freezing point of 1% solution of Cocaine HCl = - 0.09°C
Freezing point of 1% solution of Cocaine HCl = - 0.576°C

% w /v of sodium chloride required = = 0.746%


0.576
Displacement Value
The displacement value of a medicament is the number of parts, by weight, of a
medicament that will displace one part of suppository base (normally theobroma oil).
Displacement values for various medicaments are given in the Pharmaceutical Codex.
Example. Calculate the quantities required to make 10 theobroma oil suppositories (2
g mould) each containing 400 mg of zinc oxide (Displacement value = 4.7)
Solution steps
1. Calculate the total weight of zinc oxide required.
2. Calculate what weight of base would be required to prepare 10 unmedicated
suppositories.
3. Determine what weight of base would be displaced by the medicament.
4. Calculate, therefore, the weight of base required to prepare the medicated
suppositories.
Total weight of zinc oxide required
= 400 mg x 10 = 4 g
Weight of base required for unmedicated suppositories
= 2 g x 10 = 20 g
As the displacement value of zinc oxidfe = 4.7
Posology □ □ 39

This means that 4.7 g of zinc oxide would displace 1 g of theobroma oil
1 g of zinc oxide would displace 1 -f 4.7 g of theobroma oil
So, 4 g of zinc oxide will displace (4 x 1) -r 4.7 g of theobroma oil = 0.85 g
Therefore, the weight of base required to make medicated suppositories
= 20 - 0.85 g = 19.15 g
= 19.15 g Ans.

MULTIPLE CHOICE QUESTIONS

1. The amount of the 190 proof required (a) 41.6%w/v


to make 500 c.c of 70% alcohol is (b) 4.26%w/v
(a) 350 cc (c) 0.426%w/v
(b) 520 cc (d) 42.6%w/v
(c) 184 cc
6. Find out the concentration of NaCl
(d) 368 cc required to make a 1% solution of
2. What is the strength of 95% v /v boric acid isoosmotic to blood plasma.
alcohol in terms of proof spirit? (a) 40.6%w/v
(a) 66.53°OP (b) 4.06%w/v
(b) 6.653°OP (c) 0.402%w/v
(c) 62.5°OP (d) 40.1%w/v
(d) 56.71°UP 7. Find out the concentration of NaCl
3. Proof spirit is required to make 5 0 -ml of isotonic
(a) 57.1%v/v solution containing 0.5%
(b) 58.91 %v/v ephedrineHCl.
(c) 57.79%w/v (a) 0.644 g (b) 0.322 g
(d) 57.01%w/w (c) 3.12 g (d) 3.23 g
4. What concentration of NaCl required 8. Calculate the displacement value of
to make 1% solution of cocaine HC1 ZnO in theobroma oil suppositories
isotonic with blood plasma? Freezing containing 40% ZnO, prepared in 1.0
point of 1% w /v NaCl is -0.576°C, g mould. The weight of 8
Freezing point of 1% w /v cocaine HC1 suppositories is 11.74 g
is -0.09°C (a) 4.192 (b) 4.2
(a) 0.746%w/v (c) 6 (d) 7
(b) 0.9%w/v 9. What concentration of NaCl is isotonic
(c) 0.57%w/v to blood plasma?
(d) 0.373%w/v (a) 0.5%w/v (b) 0.9%w/v
5. Find out the proportion of procaine (c) 1.5%w/v (d) 1.2%w/v
HC1 which yoelds a solution jq
Which of the following leads to
iosoosmotic to blood plasma. heamolysis
40 □ □ Drug Inspector Exam

(a) Hypertonic solution (a) 2 gr (b) 500 mg


(b) Hypotonic solution (c) 2 g (d) 5 gr
(c) Paratonic solution 17. What is the dose for a child that has
(d) None of the above body surface area of 0.57cm2, when
11. Calculate the amount of 95% alcohol adult dose is 50mg.
required to prepare 400 ml of 45% (a) 1.65 mg (b) 16.5 mg
alcohol. (c) 20.5 mg (d) 165 mg
(a) 19.0 ml (b) 170 ml 18. Calculate the dose of an 8month old
(c) 190 ml (d) 202 ml infant if the average adult dose of a
12. Calculate the amount of 95% alcohol drug is 250 mg.
required to prepare 600 ml of 60% (a) 13.3 mg (b) 133 mg
alcohol. (c) 1.33 mg (d) 120 mg
(a) 379 ml (b) 360ml 19. What will be the dose for a child of
(c) 380 ml (d) 350 ml 5yrs if the adult dose of a dru0 is
13. Calculate the amount of 95% alcohol 400 mg?
required to prepare 600ml of 70% (a) 11.7 mg (b) 177 mg
alcohol. (c) 170 mg (d) 150 mg
(a) 442 ml (b) 425 ml 20. The formula for isotonicity adjustment
(c) 420 ml (d) 430 ml bt freezing point method is—
14. What quantities of 95% v/v and (a) 0.52 - b/a (b) 0.52 - a/b
45%v/v alcohols are to be rrixcd to (c) b - 0.52/a (d) a - 0.52 -/b
make 800ml of 65% alcohol. 21. What is the dose of a boy of 16yrs
(a) 480 ml of 95% and 320 ml of 45% age when the adult dose of drug is
alcohol 100 mg?
(b) 320 ml of 95% and 480 ml of 45% (a) 8 mg (b) 0.8 mg
alcohol (c) 80 mg (d) 1.2 g
(c) 440 ml of 95% and 360 ml of 45%
alcohol 22. The Clark's formula for calculation of
dose,deals with
(d) 360 ml of 95% and 440 ml of 45%
alcohol (a) Weight
(b) age in month
15. What proportion of Nacl required to
(c) age in yrs
render a 1.5% solution of drug isotonic
with blood plasma? The freezing point (d) None of the above
of 1% w/v solution of drug is -0.122°C. 23. The Dilling's formula for calculation
(a) 0.65% (b) 0.585% of dose, deals with
(c) 0.9% (d) 1.25% (a) surface area
16.—The dose of a drug is 5mg/Kg of body (b) age in month
weight. What dose should be given to (c) age in yrs
110 lb women. (d) All of the above
Posology □ □ 41

24. Total body surface area is more than 28. The dose of morphine sulphatw is
(a) 20,000m2 (a) 10-20 mg
(b) 20,000cm2 (b) 20-40 mg
(c) 2000m2 (c) 10-40 mg
(d) 20,00,000cm2 (d) 50 mg
25. The dose of old age patient is 29. The dose of adrenalinr is
(a) more than adult dose (a) 0.2-0.5 mg
(b) less than adult dose (b) 0.5 -1 mg
(c) equal to adult dose (c) 1.5 mg
(d) None of the above (d) 2 mg
26. The Young's formula for calculation 30. What will be dose for llyrs child id
of dose, deals with adult dose is 500mg as per Clark's
(a) surface area formula?
(b) age in month (a) 245 mg (b) 235 mg
(c) age in yrs (c) 265 mg (d) 225 mg
(d) All of the above 31. Calculate the quantities required to
27. Posology deals with make six glycerogelatin suppositories
(a) ingredients of formulation (4 g mould), each containing 100 mg
aminophylline (Displacement value =
(b) dose of drug
1.3)
(c) type of formulation
(a) 28.25 g (b) 28.65 g
(d) calculation of quantity of
(c) 28.35 g (d) 28.45 g
ingredients

ANSWERS
1. ((d) 2. (a) 3. (a) 4. (a) 5. (b) 6. ( 0 7. (b) (a) 9.
00

(b) 1 0 . (b)
11. (c)i 12. (a) 13. (a) 14. (b) 15. (b) 16. (b) 17. ((d) 18. (a) 19. 2 0 . (b)
21. (c) 22. (a) 23. (c) 24. (a) 25. (b) 26. (c) 27. (b) 28. (a) 29. 3 0 . (b)
31. (a)

□ □ □
Communicable Diseases
6
C h a pter

The diseases which spread from one person to another through contaminated food,
water or contact or through insecticides, animals etc., are called the communicable diseases.
These are caused by different causative agents (pathogens).

A. DISEASES C A USEB^\^VfRUSES

1. Chicken pox
Pathogen: Chicken pox virus (varicella)
Mode of transmission: By contact or through scabs
Incubation period: 12-20 days
Symptoms
(i) Fever, headache and loss of appetite
(ii) Dark red-coloured rash on the back and chest which spreads on the whole body.
Later, rashes change into vessicles.
(iii) After few days these vessicles start drying up and scabs (crusts) are formed.
(iv) These scabs start falling (infective stage)
Prevention and Cure
There is no vaccine against chicken pox as yet. But precautions must be taken as
follows:
(i) The patient should be kept in isolation.
(ii) Clothings, utencils, etc., used by the patient should be sterilised.
(iii) Fallen scabs should be collected and burnt.
One attack of chicken pox gives life long immunity to the person recovered from
this disease.
2. Measles
Pathogen: Virus (Rubeola)
Mode of transmission: By air
Incubation period: 3-5 days
Symptoms
(i) Common cold
(ii) Appearance of small white patches in mouth and throat.
(iii) Appearance of rashes on the body.
Communicable Diseases □ □ 43

Prevention and Cure


(i) The patient should be kept in isolation.
(ii) Cleanliness should be maintained.
(iii) Antibiotics check only the secondary infections which can easily occur.
3. Poliomylitis
Pathogen: Polio Virus
Mode of transmissions: Virus enters inside the body through food or water.
Incubation period: 7-14 days
Symptoms
(i) The virus multiplies in intestinal cells and then reaches the brain through blood.
(ii) It damages brain and nerves and causes infantile paralysis.
(iii) Stiffness of neck, fever, loss of head support.
Prevention and Cure
Polio vaccine drop (Oral Polio Vaccine, OPV) are given to children at certain intervals
Pulse polio programme is organised in our country to give polio vaccine to children
4. Rabies (also called hydrophobia)
Pathogen: Rabies virus
Mode of Transmission: Bite by a rabid dog.
Incubation period: 10 days to 1-3 months depending upon the distance of bite
from Central Nervous System (CNS), that is the brain or spinal cord.
Symptoms
(i) Severe headache and high fever.
(ii) Painful contraction of muscles of throat and chest.
(iii) Choking and fear of water leading to death.
Prevention and Cure
(i) Compulsory immunisation of dogs.
(ii) Killing of rabid animals.
(iii) Anti-rabies injections or oral doses are given to the person bitten by a rabid animal.
5. Hepatitis
Pathogen: Hepatitis B virus.
Moae of Transmission: Mainly through contaminated water.
Incubation Period: Generally 15-160 days.
Symptoms
(i) Bodyache.
(ii) Loss of appetite and nausea.
(iii) Eyes and skin become yellowish, urine deep yellow in colour (due to bile pigments).
(iv) Enlarged liver.
44 □ □ Drug Inspector Exam

•Prevention and Cure


(i) Hepatitis B vaccine is now available in India.
(ii) Proper hygeine is to be observed.
(iii) Avoid taking fat rich substances.
6. Influenza
Influenza, commonly known as 'flu' is an illness caused by viruses that infect the
respiratory tract. Compared to common cold, influenza is a more severe illness.
Causes
Influenza is caused by a virus which attacks our body’s cells, resulting in various
effects depending on the strain of the virus.
There are many strains of influenza virus. The virus mutates all the time and new
variations (strains) arise. This constant changing enables the virus to evade the immune
system of its host. Unfortunately immunity against one strain (which is conferred by
exposure or immunisation) does not protect against other strains. A person infected with
influenza virus develops antibodies against that virus; as the virus changes, the antibodies
against the virus do not recognize the changed virus, and influenza can recur, caused by
the changed or mutated virus.
' Symptoms
Typical symptoms of influenza include :
(i) Fever (Usually 100° F to 103° F in adults and often even higher in children).
(ii) Respiratory tract infection symptoms such as, cough, sore throat, running
nose, headache, pain in the muscles, and extreme fatigue.
Although nausea and vomiting and diarrhoea can sometimes accompany Influenza
infection, especially in children, gastrointestinal symptoms are rarely prominent.Most
people who get flu, recover completely in 1 to 2 weeks, but some people develop serious
and potentially life-threatening complications, such as pneumonia.
Treatment and Control
(i) Much of the illness and death caused by influenza can be prevented by annual
influenza vaccination. Influenza vaccine is specifically recommended for those
who arc at high risk for complications with chronic diseases of the heart, lungs or
kidneys, diabetes, or severe forms of anemia.
(ii) The persons suffering from influenza should
• drink plenty of fluids
• take symptom relief with paracetamol, aspirin (not in children under the
age of 16) or ibuprofen etc., as recommended by the doctor.
• Consult doctor immediately for treatment.
7. Dengue
Dengue is an acute fever caused by virus. It is of two types: (i) Dengue fever, (ii)
Dengue hemorrhagic fever.
Communicable Diseases □ □ 45

Dengue fever is characterized by an onset of sudden high fever, severe he? iache,
pain behind the eyes and in the muscles and joints.
Dengue hemorrhagic fever is an acute infectious viral disease. It is an advanced stage
of dengue fever. It is characterized by fever during the initial phase and other symptoms
like headache, pain in the eye, joint pain and muscle pain, followed by signs of bleeding,
red tiny spots on the skin, and bleeding from nose and gums.
How does Dengue spread?
Dengue spreads through the bite of an infected Aedes aegypti mosquito. The
transmission of the disease occurs when a mosquito bites an infected person and
subsequently bites a healthy person. In doing so, it transmits blood containing the virus
to the healthy person and the person becomes infected with dengue. The first symptoms
of the disease occur about 5 to 7 days after the infected bite.
Aedes mosquito rests indoors, in closets and other dark places, and is active during
day time. Outside, it rests where it is cool and shaded. The female mosquito lays her eggs
in stagnant water containers such as coolers, tyres, empty buckets etc., in and around
homes, and other areas in towns or villages. These eggs become adults in about 10 days.
Incubation period
The time between the bite of a mosquito carrying dengue virus and the start of
symptoms averages 4 to 6 days, with a range of 3 to 14 days.
Diagnosis
Diagnosis is made through blood tests by scanning for antibodies against dengue
viruses. In addition the blood platelets counts also drastically reduce in the infected person.
Symptoms
Symptoms of Dengue fever
(i) Sudden onset of high fever, generally 104-105 °F (40 °(C), which may last 4-5 days.
(ii) Severe headache mostly in the forehead.
(iii) pain in the joints and muscles, body aches.
(iv) Pain behind the eyes which worsens with eye movement.
(v) Nausea or vomiting.
Symptoms of Dengue hemorrhagic fever
These include symptoms similar to dengue fever, plus other symptoms such as :
(i) Severe and continuous pain in the abdomen.
(ii) Rashes on the skin.
(iii) Bleeding from the nose, mouth, or in the internal organs.
(iv) Frequent vomiting with or without blood.
(v) Black stools due to internal bleeding.
(vi) Excessive thirst (dry mouth).
(vii) Pale, cold skin, weakness.
46 □ □ Drug Inspector Exam

Prevention
Following steps can be taken to prevent spread of dengue fever:
(i) Avoid water stagnation for more than 72 hours so that the mot quitoes do not breed
there.
(ii) Prevent mosquito breeding in stored water bodies, like ponds, wells etc.
(iii) Destroy discarded objects like old tyres, bottles, etc., as they collect and store rain
water.
(iv) Use mosquito repellents and wear long sleeved clothes to curtail exposure.
(v) Use mosquito nets, also during daytime.
(vi) Avoid outdoor activities during dawn or dusk when these mosquitoes are most
active.
(vii) Patients suffering from dengue fever must be isolated for at least 5 days.
(viii) Report to the nearest health centre for any suspected case of Dengue fever.
Treatment for dengue and dengue hemorrhagic fever
There is no specific treatment for dengue fever. Persons with dengue fever should rest
and drink plenty of fluids. Dengue hemorrhagic fever is treated by replacing lost fluids.
Some patients need blood transfusions to control bleeding.

B. DISEASES CAUSED.BY BACTERIA

1. Tuberculosis
Pathogen: A bacterium (Mycobacterium tuberculosis).
Mode of Transmission: Airbome-discharged through sputum, cough, sneeze, etc.
of the infected person.
Incubation period: 2-10 weeks during which the bacteria produce a toxin,
tuberculin.
Symptoms
(i) Persistent fever and coughing.
(ii) Chest pain and blood comes out with the sputum.
(iii) General weakness.
Prevention and Cure
(i) Isolation of patient to avoid spread of infection.
(ii) BCG vaccination is given to children as a preventive measure.
(iii) Living rooms should be airy, neat and with clean sorroundings.
(iv) Antibiotics be administered as treatment.
2. Typhoid
Pathogen: A Bacillus rod-shaped bacterium (Salmonella typhi)
Mode of transmission: Through contaminated food and water
Incubation period: About 1-3 weeks
Communicable Diseases □ □ 47

Symptoms
(i) Continuous fever, headache, slow pulse rate.
(ii) Reddish rashes appear on the belly.
(iii) In extreme cases, ulcers may rupture resulting in death of the patient.
Prevention and Cure
(i) Anti-typhoid inoculation should be given.
(ii) Avoid taking exposed food and drinks.
(iii) Proper sanitation and cleanliness should be maintained.
(iv) Proper disposal of excreta of the patient.
(v) Antibiotics should be administered.
3. Cholera
It often breaks out among crowded and areas with poor sanitary conditions.
Pathogen: Comma shaped bacterium (Vibrio cholerae)
Mode of transmission: Contaminated food and water. House - fly is the carrier.
Incubation period: 6 hours to 2-3 days.
Symptoms
(i) Acute diarrohoea, rice watery stool.
(ii) Muscular cramps.
(iii) Loss of minerals through urine.
(iv) Dehydration leads to death.
Prevention and Cure
(i) Cholera vaccination should be given.
(ii) Electrolytes (Na, K, sugar, etc.) dissolved in water should be given to the patient to
check dehydration (In market it is available as ORS-oral rehydration solution).
(iii) Proper washing and cooking of food.
(iv) Proper disposal of vomit and human excreta.
(v) Flies should not be allowed to sit on eatables and utensils.
4. Diphtheria
This disease generally occurs in children of 1-5 years of age.
Pathogen: Rod-shaped bacterium (Comybacterium diphtherea)
Mode of Transmission: Through air (droplet infection)
Incubation period: 2-4 days
Symptoms
(i) Slight fever, Sore throat and general indisposition.
(ii) Oozing semisolidmaterial in the throat which develops into a toughmembrane.
The membrane may cause clogging (blocking) of air passage, resulting into death.
48 □ □ Drug Inspector Exam

Prevention and Cure


(i) Immediate medical attention should be given.
(ii) Babies should be given DPT vaccine.
(iii) Sputum, oral and nasal discharges of the infected child should be disposed off.
(iv) Antibiotics may be given under doctor's supervision.
(v) Isolation of the infected child.
5. Leprosy
Pathogen: A bacterium (Mycobacterium leprae)
Mode of transmission: Prolonged contact with the infected person. Nasal
secretions are the most likely infectious material for family contacts.
Incubation period : 1-5 years
Symptoms
(i) Affects skin.
(ii) Formation of nodules and ulcer.
(iii) Scabs and deformities of fingers and toes.
(iv) Infected areas lose sensation.
Prevention and Cure
(i) The children should be kept away from parents suffering from leprosy.
(ii) Some medicine may arrest the disease and prevent from spreading.

C. DISEASES CAUSED BY PROTOZOANS

1. Malaria
Pathogen: Malarial parasite (different species of Plasmodium)
Mode of transmission: By bite of female Anopheles mosquitoes
Incubation period: Approximately 12 days
Symptoms
(i) Headache, nausea and muscular pain.
(ii) Feeling of chilliness and shivering followed by fever which becomes normal along
with sweating after some time.
(iii) The patient becomes weak and anaemic.
(iv) If not treated properly secondary complications may lead to death.
Prevention and Cure
(i) Fitting of double door and windows (with "Jali" i.e., wire mesh) in the house to
prevent entry of mosquitoes.
(ii) Use of mosquito net and mosquito repellents.
(iii) No water should be allowed to collect in ditches or other open spaces to prevent
mosquito breeding.
Communicable Diseases □ □ 49

(iv) Sprinkling of kerosene oil in ditches or other open spaces where water gets collected
(v) Antimalarial drugs to be taken.
2. Amoebiasis (Amoebic dysentery)
Pathogen: Entamoeba histolytica
Mode of transmission: Contaminated food and waterSymptoms
(i) Formation of ulcers in intestine.
(ii) Feeling of abdominal pain and nausea.
(iii) Acute diarrhoea and mucus in stool.
Prevention and cure
(i) Proper sanitation should be maintained.
(ii) Vegetables and fruits must be properly washed before eating.
(iii) Antibiotics may be given to the patients.

D. DISEASES CAUSED BY WORMS (HELMINTHS)

1. Filariasis
Pathogen: Filarial worm (Wuchereria bancrofti)
Mode of transmission: Bites of mosquitoes - Aedes and Culex.
Symptoms
(i) Fever
(ii) Collection of endothellial cells and metabolites in the wall of lymph vessels.
(iii) Swelling takes place in certain parts of the body like legs, breasts, scrotum, etc.
(iv) Swelling of legs which appear as legs of elephant, so this disease is also called
elephantiasis (Fig. 6.1)

Fig. 6.1. Patient suffering from Elephantiasis


50 □ □ Drug Inspector Exam

(v) Sprinkling of kerosene in ditches, etc.


(vi) Drugs may be administered

E. SEXUALLY TRANSMITTED DISEASES


The diseases that are transmitted through sexual contact are known as sexually
transmitted diseases. Sexually transmitted diseases are those infections that are transmitted
via the mucous membrane and secretions of the sexual organ, throat and the rectum.
Syphilis, gonorrhoea, AIDS, etc., are some sexually transmitted diseases.
AIDS (Acquired Immuno Deficiency Syndrome)
It is a pandemic disease. The word "immuno deficiency" signifies that the immune
system becomes very weak. It is a disorder of cell-mediated immune system of the body.
Lymphocytes are the main cells of the immune system i.e., T-lymphocytes and B-
lymphocytes. 'Helper T' lymphocytes play a great role in regulating the immune system.
Damages to or destruction of 'Helper' lymphocytes lead to the development of a cellular
immune deficiency which makes the patient susceptible to wide variety of infections.

Glycoprotein 120

Phospholipid membrane

Viraf capsid
Reverse transcriptise
■RNA
Protein 17

Transmembrane
Glycoprotein

Fig. 6.2.
Mode of transmission: AIDS maybe transmitted through any of the following means :
(i) Sexual contact with the affected person. In India, the most common route of HIV
transmission is through unprotected heterosexual sex.
(ii) Using the same syringe as that of affected person.
(iii) Blood transfusion which contains human immuno deficiency virus.
(iv) Organ transplantation of the affected person.
(v) Artificial insemination.
(vi) From mother to new born baby during the process of giving birth.
Incubation period: The average period is 28 months though it may range between 15
to 57 months
Symptoms : The sufferer may show one or more of the following symptoms :
Communicable Diseases □ □ 51

(i) A type of lung disease develops (tuberculosis).


(ii) A skin cancer may be observed.
(iii) Nerves are effected.
(iv) Brain is badly damaged with the loss of memory, ability to speak and to think.
(v) The number of platelets (thrombocytes) become less which may cause haemorrhage.
(vi) In severe cases the patient shows swollen lymph nodes, fever and loss of weight. A
full blown (disease at its peak) AIDS patient, may die within three years.
Prevention and Cure
No medicine or vaccine is known to be available against HIV infection. Therefore,
care has to be taken through following measures :
(i) There should not be any sexual contact with the person who has HIV infection or
STI. Since STI causes some damage to the gemital area and mucous layer, and
thus facilitates the entry of HIV into the body.
(ii) Use disposable syringe and needle.
(iii) The blood to be transfused to the needy person, should be free from HIV germ.
(iv) Prostitution and homosexuality should be avoided.
(v) Condom should always be used during intercourse.
Control
AIDS can be detected by ELISA test.
There are three points which may be important to control STD.
(i) Partner notification: Identification of potential infected contact, examination and
treatment.
(ii) Education of STD: This should be a part of general education.
(iii) Screening for STD: Serological screening of groups, such as, blood donors, women
before giving birth.
Facts about HIV transmission
• HIV is a weak virus and hard to get infected with. It cannot be transmitted through
air or water outside the human body.
• Aperson cannot getAIDS by hugging or sneezing of an infected person, insect
bites (including mosquito), sharing the same comb, plates, glass, handkerchiefs,
knives or cutlery.
• A person cannot get AIDS by using public toilets, swimming pools, showers and
telephones.
• HIV does not transmit by being near to someone, touching someone or working
with someone who is suffering from AIDS.
52 □ □ Drug Inspector Exam

MULTIPLE CHOICE QUESTIONS

1. The disease that is non-communicable 8. An insect which transmits a disease is


is_________. known as_________.
(a) malaria (b) marasmus (a) intermediate host
(c) AIDS (d) jaundice (b) parasite
2. Malaria is caused by a_________. (c) vector
(a) protozoan (b) fungi (d) prey
(c) virus (d) bacteria 9. Which one is a communicable disease?
3. The husk of the isabgol seed with (a) Malaria
water produces relief from_________. (b) Diabetes
(a) malaria (b) jaundice (c) Hypertension
(c) flu (d) diarrhoea (d) Helminth
4. Oral rehydration solution does not 10. Which one of the diseases is not
contain_________. communicable?
(a) sodium chloride (a) Typhoid (b) Leprosy
(b) sodium bicarbonate (c) Measles (d) Leukemia
(c) sodium cyanide 11. BCG vaccine is used to curb
(d) glucose (a) pneumonia (b) tuberculosis
5. The vitamin that is not fat soluble (c) polio (d) amoebiasis
is_________. 12. AIDS virus has_________.
(a) vitamin A (a) single strand DNA
(b) vitamin B complex (b) double strand DNA
(c) vitamin D (c) single strand RNA
(d) vitamin E (d) double strand RNA
6. Which organism require living cell to 13. Causative agent of T.B. is_________.
grow? (a) defective liver
(a) Clostridium tetani (b) defective thymus
(b) M. leprae (c) AIDS virus
(c) Bacillus Anthranze (d) weak immune system
(d) All of the above
14. Immuno-deficiency syndrome could
7. Maize interferes with the absorption develop due to_________.
of________ . (a) defective liver
(a) ascorbic acid (b) defective thymus
(b) nicotinic acid (c) AIDS virus
(c) thiamine (d) weak immune system
(d) iodine
Communicable Diseases □ □ 53

15. T.B. is cured by_________. 22. In the immune system:


(a) griseofulvin (a) B lymphocytes secrete antibodies
(b) ubiquinone (b) Vaccines provide passive
(c) streptomycin immunity
(d) encitol (c) B cells stimulate T cells to produce
antibodies
16. AIDS is due to_________.
(d) Cell-mediated immunity is
(a) reduction in number of helper T-
controlled by T lymphocytes
cell
(e) Macrophages neutralise toxins
(b) reduction in number of killer T-
cell 23. Which of the following is/are true
(c) auto-immunity about conjugated vaccines:
(d) non-production of interferons (a) Conjugated vaccines are those in
which there is more than one
17. Typhoid is caused by_________.
vaccine antigen for example, MMR
(a) escherichia (b) giardia (b) Conjugated vaccines tend to
(c) salmonella (d) shigella induce a poorer response than
18. Which of the following is a mismatch? polysaccharide vaccines
(a) Leprosy - Bacterial infection (c) Meningitis C vaccine is not
(b) AIDS - Bacterial infection available in a conjugated form
(c) Malaria - Protozoan infection (d) Hib vaccine is an example of a
(d) Elephantiasis - Nematode infection conjugated vaccine
(e) Conjugation involves attaching a
19. Fever, delirium, slow pulse, abdominal polysaccharide antigen to a
tenderness and rose coloured rash carbohydrate carrier
indicate the disease_________.
(a) Typhoid (b) measles 24. Premature infants should receive their
first dose of the primary
(c) tetanus (d) chicken pox
immunisation:
20. Calcium deficiency occurs in the (a) 2 months from the actual date of
absence of vitamin_________. delivery
(a) D (b) A (b) 2 months from the estimated date
(c) C (d) B of delivery
21. Which of the following confer(s) (c) Only when they weigh at least
passive immunity: 1.5kg
(a) Hepatitis B vaccine (d) Only once they have been
(b) MMR vaccine discharged from hospital
(c) Hepatitis B immunoglobulin (e) None of the above
(d) Infection with measles virus 25. A further dose of the same vaccine
(e) Cross placental transfer of should not be given if the patient
maternal antibodies develops:
54 □ □ Drug Inspector Exam

(a) Pain, swelling or redness of the 28. A defect in a vaccine product should
site be reported:
(b) Irritability (a) Using the Yellow Card Scheme
(c) Headache (b) Using the Black Triangle Scheme
(d) Cardiovascular collapse and other (c) To a report centre of the Medicines
anaphylactic reactions and Healthcare products
(e) Temperature above 37.5°C Regulatory Agency (MHRA)
26. If a vaccine carries the Black Triangle (d) Only to the vaccine manufacturer
symbol this indicates: (e) Only if it has caused an adverse
(a) It is a vaccine which must be reaction in a patient
adm inistered under hospital 29. The combined vaccine given at 2, 3
supervision and 4 months of age is:
(b) The vaccine is not yet licensed (a) DTaP/IPV/Hib
(c) All suspected reactions (serious (b) DTaP/IPV/PCV
and non-serious must be reported) (c) DTaP/IPV/MenC
(d) The vaccine can only be used on a (d) DTP/IPV/Hib
named-patient basis (e) DTaP/IPV/PPV
(e) Only reactions in children need to
30. By 14 months of age all children
be reported
should have received:
27. The Yellow Card Scheme: (a) Three doses of DTaP/IPV/Hib
(a) Reports submitted to the Yellow (b) Three doses of PCV
Card Scheme are entered on a (c) Two doses of MenC and one of
database operated by the riealth Hib/MenC
and Safety Executive (HSE)
(d) Two doses of MMR
(b) Is not applicable to vaccines given
(e) One dose of Td/IPV
Black Triangle status
(c) Allows patients to report 31. The number of doses of diphtheria/
suspected adverse reactions tetanus and polio vaccines required to
(d) Only serious adverse reactions ensure long-term protect throughout
should be reported for vaccines adulthood is:
that have been marketed for 6 (a) Three (b) Four
months or more (c) Five (d) Six
(e) Is a compulsory reporting system (e) None of the above
for suspected adverse reactions

ANSWERS
1. (b) 2. (a) 3. (d) 4. (b) 5. (b) 6. (c) 7. (b) 8. (c) 9. (a) 10. (d)
11. (b) 12. (c ) 13. (b) 14. (c ) 15. (c) 16. (a) 17. (c) 18. (b) 19. (a) 20. (a)
21. (e) 22. (a) 23. (d) 24. (a) 25. (a,b) 26. (c) 27. (c ) 28. (a) 29. (a) 30. (a)
31. (d)
□ □ □
First Aid Treatment
7
C h a pter

First Aid is the temporary help given to an injured or a sick person before professional
medical treatment can be provided. This timely assistance, comprising of simple medical
techniques, is most critical to the victims and is, often, life saving.

1. EMERGENCY TREATMENT FOR SHOCK


The circulatory system distributes blood to all parts of the body, carrying oxygen and
nutrients to the tissues. If the circulatory system fails, and insufficient oxygen reaches the
tissues, the medical condition known as shock occurs. If the condition is not treated quickly,
the vital organs can fail, ultimately causing death. Shock is made worse by fear and pain.
Causes of Shock
Shock can develop when the heart pump fails to work properly, causing a reduction in
the pressure of the circulating blood. The most common cause of this type of shock is a
heart attack.
Shock can develop as a result of a reduction in the volume of fluid circulating around
the body. The most common examples of this are external or internal bleeding, 01 loss of
other bodily fluids through severe diarrhoea, vomiting, or bums. The blood supply is
diverted from the surface to the core of the body. The main symptoms and signs of shock
relate to such redistribution of the circulation.
Symptoms
Cool, clammy skin, Lackluster eyes, Dilated pupils, Vomiting/nausea, Feeling weak,
Confusion, Excitement, Anxiety, Shallow/ slow breathing or rapid/ deep breathing, Weak
and rapid pulse
Treatment Get emergency medical help. Meanwhile-
Make the person lie down on the back
• Raise the legs above head level
• If raising the legs is painful, keep the person still
• Check for breathing
• If not breathing, do Cardio Pulmonary Resuscitation (CPR)
• Make the person comfortable by loosening tight clothes
• Cover the person with a blanket
55
56 □ □ Drug Inspector Exam

• If vomiting or bleeding from mouth -turn the patient on the side


• Do not feed the person orally

2. FIRST AID FOR SNAKE BITE


• Thousands suffer from snake bites, globally, every year
• People who live near wilderness/trekkers - more prone
• Even bite from a harmless snake can cause allergic reaction
Causes Some common venomous snakes include -
• Viper, Cobra, Rattle snake, Water moccasin,Coral snake, Copper head
Symptoms
Fang marks,Swelling/severe pain at the site, Bloody discharge from wound,Burning,
Diarrhea, Excessive sweating, Blurred vision, Numbness/tingling sensation, Increased
th irst, Vomiting, Fever, Loss of muscle co-ordinations, Convulsions, Rapid pulse,
Weakness /Dizziness /Eainting
Treatment: Seek Medical help as soon as possible. Meanwhile -
• Wash wound with soap/water. DO NOT COVER THE BITE AREA AND
PUNCTURE MARKS. The wound should be gently cleaned With antiseptic.
• Immobilize the affected area
• Keep area slightly elevated
• Apply cool compress/wet clcth to affected part
• Apply a firm bandage 2-4 inches above bite to
(i) Prevent venom from spreading
(ii) Take care of any bleeding
• Keep the victim calm, restrict movement.
• Assure the victim and do not let him panic. When under panic, it will enhance
heart rate and would circulate the venom faster in the body.
• Remove any rings or constricting items; the affected area may swell.
• A snakebite victim is under tremendous psychological stress. It is necessary to
keep the patient warm. However, no alcohol/hot beverages should be given. The
patient should not be allowed to exert himself in any manner.
• Try to aspirate the venom out of the puncture marks with standard suction devices.
It has been identified that a suction more than 270 mm Hg can initiate the flow
from the puncture marks. Suction instruments often are included in commercial
snakebite kits. But, the suction should be applied within 5 minutes of the bite.
• The only remedy for venomous snakebite is the anti-venom serum, which is
First Aid Treatment □ □ 57

available at most government hospitals and public health centers. Some private
nursing homes have also started stocking it and treat snakebite cases.

3. FIRST AID FOR BURNS


Bums are caused by dry heat, corrosive substances and friction. Scalds are caused by
wet heat - hot liquids and vapours. Burns can also be produced by extreme cold, and by
radiation, including the sun's rays. Bums may be related to, or a result of, a more life-
threatening situation. Fires may be started accidentally by victims of drug or alcohol
overdose. An explosion, or jumping from a burning building, may cause other serious
injuries. When burns have been treated, the casualty should be thoroughly examined.
Assessing a Burn
There are a number of factors to consider when assessing the severity of a bum and
the method of treatment, including the cause of the bum, whether the airway is involved,
the depth of the bum, and its extent.
The extent of the bum will indicate whether shock is likely to develop, as tissue fluid
(serum) leaks from the burned area and is replenished by fluids from the circulatory system.
The greater the extent of the burn, the more severe the shock will be. The cause of the burn
may also signal any other possible complications. Bums also carry a serious risk of infection,
which increases according to the size and depth of the burn. The body's natural barrier,
the skin, is destroyed by burning, leaving it exposed to germs.
Bums can be categorised as follows :
Superficial Burns
These involve only the outer layer of the skin, and are characterised by redness, swelling
and tenderness. Typical examples are mild sunburn, or a scald produced by a splash of
hot tea or coffee. Superficial burns usually heal well if prompt first aid is given, and do
not require medical treatment unless extensive.
Partial-thickness Burns
These damage a partial thickness' of the skin, and require medical treatment. The
skin looks raw, and blisters form. These bums usually heal well, but Gan be serious, if
extensive. In adults, partial-thickness bums affecting more than 50% of the body's surface
can be fatal. This percentage is less in children and the elderly.
FuII-thickness Burns
These damage all layers of the skin. Damage may extend beyond the skin to affect
nerves, muscle and fat. The skin may look pale, waxy, and sometimes charred. Full­
thickness bums of any size always require immediate medical attention, and usually require
specialist treatment.
58 □ □ Drug Inspector Exam

Extent of Burns
The area of a burn gives an approximate indication of the degree of shock that will
develop and, in conjunction with depth, can be used as a guide to the required level of
treatment. The 'rules of nine' is a guide used to calculate the extent of a bum as a percentage
of the body’s total surface area, and to assess what level of medical attention is required.
In an otherwise healthy adult:
• Any partial-thickness burn of 1% or more (an area approximating to that of the
casualty's hand) must be seen by a medical practitioner.
• A partial-thickness bum of 9% or more will cause shock to develop, and the casualty
will require hospital treatment.
• A full-thickness burn of any size requires hospital treatment.
Severe Burns and Scalds
The priority is to cool the injury; the longer the burning goes unchecked, the more
severely the casualty will be injured. Resuscitate the casualty only when cooling is
underway. All severe bums carry the danger of shock.
Treatment of Severe Burns and Scalds
DO NOT overcool the casualty; this may dangerously lower the body temperature.
DO NOT remove anything sticking to the bum; this may cause further damage and
cause infection.
IX) NOT touch or interfere with the injured area. _________
DO NOT burst blisters.
DO NOT apply lotions, ointment, or fat to the injury.
• Lay the casualty down, protecting the burned area from contact with the ground,
if possible.
• Douse the burn with copious amounts of cold liquid. Thorough cooling may take
10 minutes or more, but this must not delay the casualty's transmission to hospital.
• While cooling the bums, check airway, breathing, and pulse, and be prepared to
resuscitate.
• Gently remove any rings, watches, belts, shoes, or smouldering clothing from the
injured area, before it starts to swell. Carefully remove burned clothing unless it is
sticking to the burn.
• Cover the injury with a sterile burns sheet or other suitable non-fluffy material, to
protect from infection. A clean plastic bag or kitchen film may be used. Bums to
the face should be cooled with water, not covered.
• Ensure that the emergency service is on its way. While waiting, treat the casualty
for shock. Monitor and record breathing and pulse, and resuscitate, if necessary
First Aid Treatment □ □ 59

4. FIRST AID FOR POISONING


• Poisons are substances that cause injury, illness or death
• These events are caused by a chemical activity in the cells
• Poisons can be injected, inhaled or swallowed
• Poisoning should be suspected if a person is sick for unknown reason
• Poor ventilation can aggravate Inhalation poisoning
• First aid is critical in saving the life of victims
Causes
• Medications
• Drug overdose
• Occupational exposure
• Cleaning detergents/paints
• Carbon mono oxide gas from furnace, heaters
• Insecticides
• Certain cosmetics
• Certain household plants, animals
• Food poisoning (Botulism)
Symptoms
Blue lips, Skin Rashes, Difficulty inbreathing, Diarrhea,Vomiting/Nausea, Fever, Head
ache, Giddiness/drowsiness, Double vision, Abdominal/chest pain, Palpitations/
Irritability, Loss of appetite/bladder control, Numbness, Muscle twitching, Seizures,
Weakness, Loss of consciousness
Treatment
Seek immediate medical help. Meanwhile :
• Try and identify the poison if possible
• Check for signs like burns around mouth, breathing difficulty or vomiting
• Induce vomiting if poison swallowed
• In case of convulsions, protect the person from self injury
• If the vomit falls on the skin, wash it thoroughly
• Position the victim on the left till medical help arrives

5. FIRST AID FOR FRACTURES


• A broken or cracked bone
• Occurs when pressure is applied to bone
• Occurs with / without displacement of bone fragments
60 □ □ Drug Inspector Exam

Types
• Open fracture: Skin breaks causing open wound
• Closed fracture: Skin not broken
• Complicated fractures: Damage of adjacent organs
• Stress fracture: Hairline crack due to repeated stress
• Greenstick fracture: In children’s flexible bones
Symptoms
• Severe pain, Difficulty in movement, Swelling/ bruising / bleeding, Deformity /
abnormal twist of limb, Tenderness on applying pressure
First-aid
• Depends on type & location of fracture
For open fractures
• Control bleeding before treatment
• Rinse and dress the wound
For open/closed fractures
• Check the breathing
• Calm the person
• Examine for other injuries
• Immobilize the broken wound
• Apply ice to reduce pain / swelling
• Consult a doctor
DO NOT
Massage the affected area
• Straighten the broken bone
• Move without support to broken bone
• Move joints above / below the fracture
• Give oral liquids / food

MULTIPLE CHOICE QUESTIONS

1. When making a 911 call, what are the 2. What is first aid?
three W's? (a) Completing a primary survey
(a) Who, What, Where (b) The first help giverrto the victim
(b) Where, What and Why of an accident
(c) Why, When and Where (c) Assessing a victim's vital signs
(d) Who, What and When (d) Treating a victim for shock
First Aid Treatment □ □ 61

3. What treatment does a victim who's 9. A small animal that is almost tvisible,
life threatening condition is "not burrows into the skin an i causes
breathing" need? itching:
(a) The Heimlich Maneuver, two (a) Common wood tick
rescue breaths and CPR (b) Limon-Lyme tick
(b) Start CPR immediately (c) Rocky mountain spotted tick
(c) Twelve to fifteen rescue breaths (d) Chigger
per minute and correct CPR
The accepted treatment for a sprained
(d) You should follow the steps for ankle is:
rescue breathing
(a) Remove the shoe and check for
4. The best treatment for all heart attack swelling using the capillary reflex
victims is immediate CPR. method
True/False (b) Keep the shoe on, apply an ankle
5. Sharp, stabbing twinges of pain in the bandage for support, elevate and
chest is a sure sign of a heart attack. apply cold towels
True /False (c) Keep the shoe on, apply an ankle
splint and apply heat if possible
6. The accepted treatment for a femor or
(d) Have the victim walk or move as
thigh fracture is:
soon as possible to prevent
(a) Place a short padded splint on stiffness
each side of the leg
(b) This type of fracture is best 11. The accepted treatment for a nose
handled by a traction splint bleed is:
applied by those with special (a) Use direct pressure, elevation and
training pressure points to control the
(c) Move the victim before properly bleeding
applying a leg splint (b) Tilt the head back and tightly
(d) Bind both legs with two long squeeze the nostrils
splints using two cravats, one (c) Have the victim lean forward.
above and one below the break Apply gentle pressure on the
nostril. Apply cold towels.
7. The victim of a poisonous snake bite
(d) Lay the victim on his back and
is not at risk for getting rabies.
treat for shock. Apply heat if
True /False available
8. Some people are very allergic to insect. y2 What is the best definition of the
bites and stings. This condition is "Hurry Cases"?
called: '
(a) Breathing, bleeding and broken
(a) Septic shock v bones
(b) Cardiac arrest (b) Any condition that threatens a
(c) Toxic shock syndrome victim's life
(d) Anaphylactic shock
62 □ □ Drug Inspector Exam

(c) Any illness where the victim (d) Immediately scratch and rub the
vomits effected area to provide long-term
(d) Any accident requiring rescue relief from the itching
breathing 17. Which of the following techniques is
13. After you have surveyed an accident not suitable for moving an
scene and provided for your own unconscious victim?
safety you should: (a) Improvised stretcher
(a) Take charge, remain calm and act (b) Four-handed seat carry
with confidence to the level of your (c) Two person carry
training (d) Blanket drag
(b) Provide primary treatment for
18. Assuming you are properly trained,
shock
the best procedure to follow for a
(c) Call 911 or your local emergency water rescue is:
number
(a) Throw, row then go
(d) Provide immediate treatment for
(b) Try to reach from the shore, then
the "hurry cases"
#» throw a rope or rescue device, last
14. It is not necessary to determine if a go with support
person with an obstructed airway has (c) Swim with support, throw a rope
a pulse. or flotation device, reach with a
True/False pole from shore
15. To treat a first degree burn you should: (d) Reach, paddlef swim ________
(a) Apply a good quality bum cream 19. What is the appropriate treatment for
or ointment a suspected broken collarbone or
(b) Clean the area thoroughly with hot shoulder?
soapy water (a) Apply a simple sling. Bind the
(c) Apply a constricting band between sling to the chest with a cravat
the burn and the heart (b) Use the cross your heart padded
(d) Apply cool running water until chest support method
there is little or no remaining pain (c) Use the flail chest protection
16. A victim that has come in contact with system
poison ivy should: (d) Apply a m odified "Johnson
(a) Wait at least 20 minutes before Traction Splint"
washing the effected area with hot 20. Which statement about a simple sling
water and soap is true?
(b) Rinse the effected area (a) The part of the sling against the
immediately with soap and water chest goes over the shoulder on the
(c) Continue to wear clothes that have injured arm
come in contact with the plant (b) The "pigtail" protects the neck from
injury from the sling
First Aid Treatment □ □ 63

(c) The injured hand should be four (e) The part of the sling furthf t away
to six inches higher than the elbow from the chest passes over the
21. White or grayish-yellow patches on shoulder on the injured arm
someone's ears, noses or cheeks are 25. What is the best procedure for treating
signs of a known poisonous snake bite?
(a) Frostbite (a) Capture the snake. Place it in an
(b) Cold related stress disorder ice chest and take the snake and
(c) Anaphylactic shock victim to a hospital.
(d) Hypothermia (b) Place a constructing bandage 4
inches above the L ^ad of the snake
22. The primary symptom of the
to slow the spread of venom
advanced stages of hypothermia
(c) Keep the victim calm, keep the bite
requiring immediate medical attention
location lower than the heart, get
is violent shivering.
medical help immediately
True/False
(d) Treat the victim for shock and
23. The symptoms of Heat Stroke and continue the planned activity
Heat Exhaustion are very similar and
26. What is antidote in the poisoning of
are often confused.
heavy metals?
True/False
(a) Dimercaprol
24. Whitch of the following correctly (b) Calcium salt
describes the CPR technique for an (c) Normal saline
adult:
(d) Adrenaline
(a) Four cycles of 15 compressions
followed by 1 breath each minute 27. How the morphine poisoning is
(b) One cycle of one breath and 10 recognized?
compressions each 2 to 3 inches (a) Constipation
deep per minute (b) Redness on face
(c) Twelve cycles of one breath and 5 (c) cessation of breathing
compressions per minute (d) Pin point pupil
(d) Four cycles of two breaths and 15
compressions per minute

ANSWERS
1- (a) 2. (b) 3. (d) 4. (false) 5. (false)6. (b) 7. (true) 8. (d) 9. (d) 10. (b)
11. (c) 12. (b) 13. (a) 14. (true) 15. (d) 16. (b) 17. (b) 18. (b) 19. (a) 20. (c)
2 1 . (a) 22 . (false) 23. (false) 24. (d) 25. (c) 26. (a) 27. (d).

non
Classification of Microbes
8
Chapter

Microorganisms are unicellular, meaning they contain only a single cell. The cellular
organisms are broadly classified as prokaryotes and eukaryotes, aerobic and anaerobic,
and by type of metabolism.
Prokaryotes
These are microorganisms that are characterized by the absence of a distinct membrane-
bound nucleus and by DNA that are not organized into chromosomes. They can be sub­
classified into archaebacteria and eubacteria with further sub-classification under those
types.
Archaebacteria
Methanogens- Anaerobic methane producing bacteria
Extreme halophiles- Bacteria that require high salt concentration to survive
Extreme thermophiles- Bacteria that require high temperatures and sulphur
Eubacteria
Gram-positive bacteria- Bacteria whose cell walls retain crystal violet dye during iodine
treatment, for example, lactic acid bacteria.
Gram-negative bacteria- Bacteria that vary in cell-wall structure and do not retain
crystal violet dye during iodine treatment.
Eukaryotes
These are organisms that have a membrane bound nucleus in the cell containing
chromosomes, and other membrane bound organelles, for example, fungi. These fungi
can be further classified into myxomycota and eumycota.
Myxomycota
These are fungi that do not contain a cell wall. They are also called slime-molds.
Eumycota
These are true fungi. They are the most important class of fungi and are exploited l^r
commercial purposes like fermentation. Examples are yeasts, mushrooms, sponge fungi,
rusts, and mildews.
Microorganisms can be classified according to their oxygen requirements, as aerobic
or anaerobic.
64
Classification o f Microbes □ □ 65

Aerobic
These are microorganisms that can grow and live in the presence of oxygen. In compost
heaps bacteria of this type generate heat when they convert carbon and nitrogen, reducing
the volume of waste. As they exhaust the oxygen in the compost pile they die leaving a
germ free product.
Anaerobic
These organisms are averse to air. They are useful in biodegradation, breaking down
organic chemicals into smaller compounds, producing methane and carbon dioxide. Some
anaerobic organisms can break down organic chemicals by fermentation. Such organisms
are useful at hazardous waste sites.
Types of Metabolism
Microorganisms can also be classified according to type of metabolism. Types include
autotrophs, heterotrophs, chemotrophs, chemoheterotrophs, and phototrophs.
Autotrophs {
These are microorganisms that use carbon dioxide as their carbon source.
Heterotrophs
These are microorganisms that use organic compounds as their carbon source.
Chemotrophs
These are microorganisms that use chemical bonds for production of adenosine tri­
phosphate (ATP).
Chemoheterotrophs
These are microorganisms (such as fungi) that use organic compounds for a carbon
source and the energy of chemical bonds to produce ATP.
Phototrophs
/
These are microorganisms that use light for production of ATP.
Classification of Bacteria: Until recently classification has done on the basis of such
traits as:
_Shape
• b acilli: rod-shaped
• cocci: spherical
• spirilla : curved walls
• ability to form spores
• method of energy production (glycolysis for anaerobes, cellular respiration for
aerobes)
• nutritional requirements
• reaction to the Gram stain.
66 □ □ Drug Inspector Exam

The Gram stain is named after the 19th century Danish bacteriologist who developed
it.
• The bacterial cells are first stained with a purple dye called crystal violet.
• Then the preparation is treated with alcohol or acetone.
• This washes the stain out of Gram-negative cells.
• Bacteria that are not decolorized by the alcohol/acetone wash are Gram-positive.
• Gram-positive bacteria are encased in a plasma membrane covered with a thick
wall of peptidoglycan. Gram-negative bacteria are encased in a triple-layer. The
outermost layer contains lipopolysaccharide (LPS)

MULTIPLE CHOICE QUESTIONS

1. Obligate anaerobes grow in (a) bacillus anthracis


(a) absence of air (b) s. aureus
(b) absence of oxygen (c) peptostreptococcus faecalis
(c) presence of carbon dioxide (d) all of the above
(d) presence of carbon dioxide or 6. Which of these is an anaerobic
oxygen bacterium?
2. Which of the following is a gram +ve (a) clostridium tetani
bacteria? (b) pyrogenes
(a) Staphylococcus aureus (c) pneumonia
(b) enterococcus faecium (d) none of these
(c) both— 7 Example of enteric bacteria is
(d) none of these (a) pseudomonas auruginosa
3. Which of the following is a spherical (b) salmonella typhi
bacterium? (c) yersinia pestis
(a) staphylococcus aureus (d) bordetella pertusis
(b) streptococcus bovis
8. Which is a non enteric bacterium?
(c) entrococcus fecalis
(a) eschericia coli
(d) all of the above
(b) vibrio cholera
4. Which of the following is a gram -ve (c) klebsiella pneumonia
bacteria? (d) pseudomonas auruginosa
(a) streptococcus bovis
9. Bacteria have affinity for basic dyes
(b) bacillus anthracis
because their protoplasm is
(c) neisseria gonorrhea
(a) basic in nature
(d) all of the above
(b) acidic in nature
5. Which of the following is a rod shaped (c) neutral in nature
bacteria (d) none of the above
Classification o f Microbes □ □ 67

10. Acid fastness of mycobacterium (a) imparts colour to the to the dye.
tuberculosis is due to (b) imparts ionization properties to
(a) presence of mycoloic acid the dye
(b) presence of techoic acid (c) helps in the fixation of the material
(c) both of the above to the glass slide.
(d) none of the above (d) all of the above
11. Giemsa stain was developed for the 17. Negative staining is a techniq usefull
staining of in demonstrating
(a) mycobacteria (a) mychobacteria
(b) neisseria (b) spirochetes
(c) microfilariae (c) pasturella
(d) malarial parasite (d) clostridia.
12. Acid fast stain was first described by 18. In gram staining iodine is used as
(a) ziehl and neelsen (a) a stain for clouring the cell
(b) ehrlich (b) a decolourising agent
(c) Christian gram (c) a counter stain to colour the
(d) newman decolourised celld.
(d) mordant to fix the primary stain.
13. Which of the following is a basic dye
(a) methylene blue 19. In gram staining tech gram +ve cells
(b) Rose Bengal, appear
(c) acid fuchsin (a) Blue (b) Green.
(d) eosin (c) Red (d) Violet

14. Which of the following is an acidic 20. The colour of acid fast and non acid
dye? fast bacteria are respectively
(a) safranine (a) blue purple (b) purple blue
(b) Basic fuchsin, (c) red green (d) green red.
(c) crystal violet, 21. Three fundamental divisions of the
(d) rose Bengal bacterial cell occur in all species
(a) cell wall, cell or cytoplasmic
15. The process by which the internal and
membrane, and cytoplasm
external structures of cells and
microorganisms are preserved and (b) nucleus, cytoplasmic membrane,
fixed in position is called and cytoplasm
(a) staining (b) mounting (c) nucleus, cytoplasmic membrane,
chromatin
(c) fixation (d) decolourisation
(d) cell wall, nucleus and cytoplasmic
16. the auxochrome group presnt in a membrane
staining dye has which of the
following function
68 □ □ Drug Inspector Exam

22. A molecule, typically a protein, which (d) lacks lipids


mediates bacterial attachment by 28. Purple and green sulphur bacteria are
interacting with specific Receptors,
placed under the category of
known as
(a) Photolithographic autotrophy
(a) Latin (b) isoreceptor
(b) Photoorganotrophic heterotrophy
(c) adhesion (d) peptidoglycan
(c) Chemolithotrophic autotrophy
23. Bacillus anthracis, the causative (d) Chemoorganotrophic heterotrophy
organism of anthrax, possesses a
capsule composed of 29. hanging drop preparations indicate
the following about the cells
(a) mucopolysaccharides
(a) shape and size
(b) polyglutamic acid
(b) arrangement
(c) peptidoglycans
(c) motility
(d) glycoproteins
(d) all of the above
24. Reproduction involving genetic
exchange is 30. Bacterial spores are destroyed by
(a) transduction (a) desiccation (b) phenol
(b) transformation (c) boiling (d) autoclaving
(c) conjugation 31. Streptococci cause
(d) all of the above (a) "strep throat"
25. The genome of bacteria consists of (b) impetigo
(a) single chromosome which is (c) middle ear infections
circular, double stranded DNA (d) scarlet fever (a result of a toxin
(b) single chromosome which is linear, produced by the organism)
single stranded DNA (e) all of the above
(c) multiple chromosomes which are Use this typical bacterial growth curve
linear, single stranded DNA to answer the following question.
(d) Multiple chromosomes which are 32. Which section shows a growth phase
circular double stranded DNA where the number of cells dying
26. Bacterial cell envelop consists of which equals the number of cells dividing?
of the following (a) A (b) B
(a) cell wall only (c) C (d) D
(b) cell wall and cell membrane (e) A and C
(c) cell membrane only 33. /7 Which section shows a growth
(d) none of the above phase where the number of cells dying
27. The cell wall of gram -ve bacteria is greater than the number of cells
possesses the following characteristics dividing?
(a) lacks proteins, (a) A (b) B
(b) lacks- carbohydrates (c) C (d) D -
(c) lacks techoic acid (e) A and C
Classification o f Microbes □ □ 69

34. /8.Which section shows a growth 39. Which of the following defines a
phase where the cells dividing at their Heterotroph?
maximum rate of division? (a) An organism that must obtain its
(a) A (b) B carbon in an organic form
(c) C (d) D (b) An organism that does not require
(e) A and C essential nutrients for growth
35. The term facultative anaerobe refers (c) An organism that produces all the
to an organism that trace elements it requires for
growth
(a) doesn't use oxygen but tolerates it
(d) An. organism that must obtain its
(b) is killed by oxygen.
carbon in an organic form
(c) uses oxygen when present or
grows w ithout oxygen when 40. Molecules that satisfy heterotophic
oxygen is absent nutritional requirements include all
(d) requires less oxygen than is but which of the following?
present in air (a) Water (b) Lipids
(e) prefers to grow without oxygen36. (c) Proteins (d) Water
The term obligate anaerobe refers 41. The primary sources of nitrogen for
to an organism thata) doesn't use heterotrophs include all except which
oxygen but tolerates itb) is killed of the following?
by oxygenc) uses oxygen when (a) Glucose
present or grows without oxygen (b) RN
when oxygen is absentd) requires
(c) Amino Acids
less oxygen than is present in
aire)prefers to grow without (d) Glucose
oxygen 42. Gram-negative bacteria: ^
37. A culture started with 4 cells and (a) bind crystal violet
ended with 128 cells. How many (b) are negatively charged
generations did the cells go through: (c) retain safranin
(a) 64 (b) 32 (d) bind Gram’s iodine
(c) 6 (d) 5 (e) all of the above
- ( e) 4 43. Gram-positive bacteria subjected to
38. Which of the foods listed would be lysozyme or penicillin may become
most likely to spoil as a result of (a) acid-fast
bacterial growth. (b) non-L forms
(a) a meat product with near neutral (c) mycoplasmas
PH (d) spheroplasts
(b) fruit in a high sugar syrup (e) Protoplasts
(c) a vegetable in a high salt, acid 44. What would be the term used to
brine (liquid) describe the shape of these
(d) all of the above e)there is no basis bacteria?
on wfych to make this judgment.
70 □ □ Drug Inspector Exam

(a) sarcina (b) streptobacillus (a) Crystal Violet, Ethanol, Iodine,


(c) diplococci (d) vibrio Safranin,
(e) spirilla (b) Crystal Violet, Safranin, Ethanol,
Iodine
45. Which one of the following statements
(c) Crystal Violet, Iodine, Ethanol,
about the Gram stain is false?
Safranin
(a) In the Gram stain, a dye called
(d) Safranin, Iodine, Crystal Violet,
crystal violet is used to stain the
Ethanol
cells purple.
(e) Iodine, Safranin, Ethanol, Crystal
(b) Gram negative cells have thinner Violet
cell walls than Gram positive
bacteria. 48. All of the follow ing statements
describe Escherichia coli except one.
(c) In the Gram stain, alcohol is used
Which one of the following statements
to kill the bacteria.
is false?
(d) Gram positive cells end up being (a) Escherichia coli is a Gram positive
stained purple. coccus.
(e) Gram negative cells end up being (b) Escherichia coli can grow on
stained pink or red. MacConkey agar.
46. The Gram stain divides (c) Most samples of mammalian feces
microorganisms into two groups, contain some Escherichia coli.
purple vs. red, on the basis of (d) Escherichia coli does not produce
differences in the: amylase, lipase or gelatinase.
(a) presence of a capsule. (e) Escherichia coli is a common
(b) presence of an outer membrane. inhabitant of mammalian large
intestines.
(c) thickness of the peptidoglycan
layer of the cell wall. 49. A virus that infects bacteria is a.
(d) presence of waxy mycolic acids in (a) retrovirus (b) capsid
the cell wall. : (c) bacteriophage
(e) presence of endospores. (d) prion
47. What is the correct order in which 50. A rod-shaped prokaryote is called a
these reagents are used in the Gram (a) flagellum (b) spirillum
stain? (c) coccus (d) bacillus

ANSWERS
1. (b) 2. (d) 3. (d) 4. (c) 5. (a) 6. (a) 7. (b ) 8. (a) 9. (b) 10. (a)
11. (d) 12. (a) 13. (a) 14. (d) 15. (c) 16. (b) 17. (b) 18. (c) 19. (a) 2 0 . (b)
21. (a) 22. (c ) 23. (b ) 24. (d) 25. (a) 26. (b) 27. (c) 28. (a) 29. (c) 30. (a)
31. (e) 32. (c ) 33. (d) 34. (b) 35. (c ) 36. (b ) 37. (d) 38. (a) 39. (d) 4 0 . (d)
41. (d) 42. (e)- 43. (e) 44. (d) 45. (c ) 46. (c) 47. (c) 48. (a) 49. (c) 50. (d)

□ □ □
Contamination o f Pharmaceuticals in 3 7

Hospitals and Environment by Microbes C h a p te r

A spoiled product may be described as one that has been rendered unfit for use. As
pharmaceutical and cosmetics are consumed by, or applied to, the user, manifestation of
spoilage are essentially subjective, spoiled products becoming objectionable perhaps even
therapeutically inactive. Microbial spoilage can be caused by bacteria, yeast or fungi which
are all extremely versatile their metabolic activities.This capacity for variation whether
due to mutation in genetic composition followed by selection or to change in behaviour
unaccompanied genetic change, allows adaptation to a very broad range of environmental
conditions.

MANIFESTATIONS AND MECHANISMS OF MICROBIAL SPOILAGE


\

Before spoilage can occur organisms whi&i are capable of altering the components of
a product insitu must first be introduced via raw materials, the processing plant, packaging ,
materials, operatives or elsewhere in the environment. Although spoilage does not
necessarily depend upon the growth of these contaminants it is generally facilitated if the
formulation and the ambient conditions of temperature and humidity encourage their
multiplication. When these criteria are satisfied changes in the product will occur and
may ultimately manifest themselves to the user in one or more of the following ways:

TOXIC EFFECTS

Microbial Toxins
Several species of microorganisms produce toxic molecules and may render a product
dangerous if they grow in it under conditions supporting toxin production. Endotoxins,
produced by Gram-negative bacteria such as Escherichia coli, are intimately bound to the
cell, lipopolysaccharidien nature and are not necessarily in activated by sterilization as
they are heat stable. Toxins of this type are poorly absorbed by the oral route but are very
important in connection with injectable products, particularly perfusion fluids. Exotoxins
are much more highly lethal and are bound less rigidly to the cell so that they are readily
liberated into the growth medium. The outstanding example, of course, is that produced
by Clostridium botulinum which is lethal to mice in doses of the order of 0.1 ng. Fortunately
conditions for growth and toxin production are quite strict; anaerobiosis, the presence of
suitable pH and nutrients and of few competing bacteria is required. Such conditions are
71
72 □ □ Drug Inspector Exam

not often attained in pharmaceuticals and cosmetics and we know of no case of botulism
arising from their use. Certain strains of Staphylococcus aureus produce a toxin,
characterized a specific polysaccharide but the organism must grow to a density of several
million cells per gram before its toxin become as problem. The evidence in connection
with other bacteria for example, Clostridiump erfringens, Bacilluscereus, Streptococcus
faecal, Proteus and Pseudomonas sp ecies less clear, but poisonous metabolites are certainly
produced by a variety of fungi. Over the last decade there has been much interest shown
in the aflatoxins produced by Aspergillus flayus. These heat-stable compounds exhibit
potent toxic and carcinogenic properties in animals A. flayus commonly infects peanuts,
cotton seed and grain which are all components of animal foods. Under poor storage
conditions mould growth occurs and toxic doses of aflatoxin accumulatein the food stuff.
While it is difficult to visualize his occurring with cosmetics or pharmaceuticals it is wise
to ensure that ingredients such as talc, kaolin or starch are not stored for long periods
under conditions supporting mould growth.
Metabolic Products
In addition to microbialt oxins, which are complex molecules and may be looked upon
as biosynthetic products, simpler catabolic products such as organic acids and amines,
whi<ph can be toxic to man, may be produced. Indeed, many microbial metabolites exhibit
pharmacological activity.
As these compounds are considerable toxic than are the classic bacterial toxins,
relatively high concentration have to be attained before spoiled product causes illness
and the senses often detect that something is wrong before food spoiled to this extent is
swallowed. This may not apply to medicine as they are expected to be unpleasant and,
indeed, frequently contain a flavouring agent in order to mask an unpleasant taste.
However, well-documented examples incriminating specific metabolic products in
pharmaceuticals are not easy to find.
Irritancy
Incidents of irritation following the application of cosmetics occasionally occur, and
the offending preparation may subsequent be shown to contain a high level of microbial
contamination. Direct evidence that irritation is caused by the presence of the micro­
organism is lacking but it is reasonable suppose that, on some occasions the contaminant
provide a source of foreign protein evoking an allergic contact dermatitis reaction or that
high levels of a microbial metabolite will cause a primary irritant reaction. The eye, of
course, is particularly susceptible to infection from contaminated cosmetics and it is also
at risk from the direct effect of irritant metabolites left in a product even after the organisms
producing them have been eradicated.
Contamination o f Pharmaceuticals in Hospitals and Environment by Microbes □ □ 73

Change of Activity
An interesting aspect, but perhaps not one of great significance is the inactivation of
biologically active molecules by organisms contaminating a formulation. Several examples
have now been demonstrated in the laboratory and in some cases have been observed to
occur in practice A. classic example is the destruction of penicillins by penicillinases
enzymes produced by a broad range of microorganisms. Microbial enzymes which
inactivate chloramphenicol are also known and the destruction of preservatives and
disinfectants is established. Pharmacologically active substances can also be degraded.
For instance Kedzia, Lewon and Wisniewsk found t hat a loss of atropine of up to 20% in
eye drops could be caused by Corynebacterium and pseudomonas spp. Isolated from the
eye drops and atropine itself. Recently, Grant, de Szors and Wilson have shown that in the
laboratory, a strain of Acinetobacter lwoffi, obtained from distilled water, utilized aspirin
as a sole carbon source in a mineral salt solution. The same organism metabolized other
active esters; for instance it could degrade heroin to morphine. Another organism,
Corynebacterium hoffnaii, which was isolated from laboratory dust, metabolized the
analgesics aspirin, phenacetin and paracetamol. Loss of useful activity is not restricted to
pharmaceutical products. For instance emphasis on the need for detergents which are
biodegradable has had some repercussion and shampoos have been known to lose their
surface-active properties due to degradation of the surfactants by contaminating bacteria.

VISIBLE EFFECTS

Visible Growth
When microorganisms can actually be observed in or on a product then there is
obviously no doubt that microbial spoilage has occurred. I n fact, this is probably the most
common way in which it is manifest. In liquid formulations contaminants may be seen as
a sediment, turbidity or a pellicle while on more solid preparations colonies, often coloured,
of bacteria, yeasts or moulds may form.
Colour Changes
Sometimes visible spoilage is more striking, particularly if a colour change is involved.
Colour changes due to alterations in the components of a product may result from pH,
redox or other changes caused by the metabolic activities of an organism, or to pigment
production by the contaminants themselves.
Members of the Pseudomonas genusa reoften implicated in spoilage of this type. These
organisms metabolize a very broad range of compounds, and can also produce soluble
pigments ranging in colour from blue-green to brown. In addition, they can render conditions
suitable for less adaptable spoilage organisms for example, they can create conditions
favouring the growth of anaerobes. Similarly, in an acidic product, oxidative yeasts can
cause a rise in pH by utilizing organic acids and this will encourage bacterial growth.
74 □ □ Drug Inspector Exam

Gas Production
If microbial metabolism produces gas in a sufficient amount to exceed its solubility in
a product, visible bubbles frothing and other manifestations of an increase in pressure
occur. Products containing carbohydrate or other fermentable substrates are particularly
susceptible this type of spoilage. Of the latter, glycerol an essential ingredient in many
cosmetic preparations, is fermented particularly readily by some common water borne
organisms.
Other Changes
Microbial metabolism can result in the composition of a homogeneous product
becoming visibly heterogeneous Emulsions, for instance are notoriously susceptible
changes in physicochemical conditions; hydrolysis of the oil phase or changes in the pH
of the aqueous phase will upset the equilibrium and thus cause visible changes. In liquid
products changes of viscosity can be seen to occur when contaminants have broken down
large molecules, utilized sugars or caused the aggregation of particles in suspension.
Olfactory Effects
It has long been known that many microorganisms produce characteristic odours and
as early as 1923a variety of aroma-producing bacteria had been listed. These aromas include
the highly characteristic ones of sulphur-containing metabolites such as hydrogen sulphide,
the sickly smells of the fatty acids, the 'fishy' odours of the amines and the astringency of
ammonia. Often these are combined to produce the 'off odours of a spoiled product.
Changes in the aroma of a product due to contaminants vary from the production of a
nauseating smell to a slight change in the bouquet but all can be disastrous particularly to
cosmetic and toiletry preparations which depends so much upon their specific perfumes.
One of the most common olfactory warnings of spoilage is the typical smell of mould. The
responsible aromatic elements have not been clearly identified but some actinomycete
which taint water with undesirable earthy odours have recently been shown to produce
geosmina, strongly earth-smellingn, eutral oil . An alcoholic odour, producedf rom
fermentable substratesi, stypical of spoilage by yeasts.
Taste
Reports that products taste peculiar are often the first indications that they may be
spoiled. The sense of taste varies widely between individuals and these reports do not
invariably indicate microbial contamination. For this reason, and because of the hazards
involved, taste is not a practicable control procedure with which to detect spoilage at an
early stage. Nevertheless, the combined senses of smell and taste are highly perceptive to
changes in flavour, particularly in bland, unflavoured preparations where the presence of
microbial metabolites is not masked. Margalith and Schwartz have listed over 100 organic
compounds involved in the production of flavour by micro-organisms. These consist
mainly of alcohols, aldehydes, ketones, acetals, acids, amines, esters and phenols.
Contamination o f Pharmaceuticals in Hospitals and Environment by Microbes □ □ 75

Texture
The feel of topical preparations particularly cosmetic and toiletry ones, is vital to their
acceptability but texture may be marred by contaminants. For instance, creams can become
lumpy or ’gritty' and changes in viscosity of liquid preparations, which can be detected
when applied to the skin, may occur.
Audible Effects
Apart from immediate manifestations of toxicity, which happily appear to be rare,
audible manifestations of spoilage are the most dramatic. If visible effects of spoilage are
obscured by the pack, an explosion can be the first indication that a gas-producing micro­
organism has successfully adapted itself to what may have been considered inimical
conditions.

TYPES OF SUSCEPTIBLE PRODUCT


Title range and composition of pharmaceutical and cosmetic products are so varied
and the species and evens trains, of microorganism capable of causing spoilage are so
multifarious that, each spoilage incident tends to be unique. Generalizations about
susceptible products are therefore likely to be inaccurate and are made more difficult
today because of the inclusion, particularly in cosmetics, of increasingly sophisticated
often highly biodegradable ingredient. Nevertheless some types of product are more
susceptible than others to spoilage by specific organisms and those of which we have
experience are described below.

LIQUIDS

Water
Water is a major constituent of living material and participates in many metabolic
reactions. Bacteria, in particular, require high concentrations of water in their immediate
environment and may be regarded as aquatic organisms. Hence, all products containing
large amounts of free water can be particularly susceptible to spoilage by bacteria. Without
effective treatment to minimize contamination, water can, within a few days, contain
large numbers of initially Gram-negative and Gram-positive bacteria, and subsequently a
wide variety of bacteria, moulds and yeasts. At this stage visible and olfactory spoilage
occurs and a foul taste may develop. Indeed contaminated deionized water has often
been incriminated as the original source of spoilage in a formulation. Often the responsible
organisms are pseudomonades which are not only highly resistant o preservative but are
also able to use the wide strange of organic compounds as substrate
Simple Aqueous Solutions
Some moulds will grow on such unlikely media as strong solutions of copper sulphate
or sulphuric acid and simple solutions of inorganic compounds support the growth of
76 □ □ Drug Inspector Exam

many sorts of microbe. The presence of organic material greatly increases the chance of
growth occurring as it not only provides a utilizable substrate but may serve to introduce
contaminants into the solutions. There may be deposition of turbidity due to algae, moulds,
bacteria or yeasts in a multiplicity of different solutions including ammonium carbonate,
neutral ammonium tartrate, calcium digluconate, potassium citrate and Amaranth Solution
B ., even when apparently preserved with chloroform. Many solutions are included in the
great diversity of mixtures in the B.P.C. and oiher formularies. These are often prepared
from aqueous concentrates which are themselves adequately preserved. However, the
preservative can be diluted out on mixing and the resulting preparation is then at risk. An
example of recent interest is peppermint water which has been implicated as a source of
contaminants in formulations containing this ingredient. In at least one case there is
evidence that potential pathogens have been transmitted to patients from i t .
Suspensions
Aqueous suspensions of inorganic material of or pharmaceutical subsequently support
microbial growth, particularly as added preservatives tend to be absorbed and inactivated
by the suspended matter. Unless growth is at the surface, as with mould contaminants, it
is not easily detected visually because of the opacity of these products. When the lid is
removed spoilage is sometimes manifested by an offensive odour or an unpleasant taste,
but otherwise large numbers of bacteria may unwittingly be taken with the preparation.
Thus, a medicament for the treatment of an intestinal disorder may exacerbate, rather
than alleviate, the condition.The oils often become blackened due to bacterial action, the
first organism lowering the redox potential and allowing the proliferation of anaerobic
sulphate-reducing bacteria, Desulphovibrio or Desulphotomaculum species, which oxidize
simple organic compounds and reduce sulphate so hydrogen sulphide. This then deposits
iron sulphide due to the abundance of iron present in the environment where the oil is
used.
Emulsions
O/w emulsions are particularly susceptible to spoilage as the water in the continuous
phase allows contaminant so spread throughout the product. Preservatives generally exert
their influence only within this phase, and at its boundaries but their concentration depends
on their relative solubilities in the particular oil and in water and on the oil water ratio in
the emulsion. In addition to partition effects the activity of preservatives may be further
diminished due to inactivation by compound such as the non-ionic emulgents. These
posses list bactericidal and may even be utilized by pseudomonad. In a comprehensive
view Wedderburn pointed out that many other material used in emulsions are susceptible
to microbial degradation.
Spoilage in emulsions can be manifest by change in rheological properties, including
separation or breaking down. Discolouration and decolonization, changes in odour and
taste and signs of visible growth also occur.
Contamination o f Pharmaceuticals in Hospitals and Environment by Microbes □ □ 77

Creams and Lotions


A wide variety of complex cosmetic and toiletry preparations are included under this
heading. A part from the usual ingredients there is a current tendency to employ substances
of natural origin including animal proteins and vitamins. These materials are not only
highly nutrient to microorganisms but may inactivate preservatives and even serve as a
source of contamination. Glycerol is commonly used in both pharmaceutical and cosmetic
formulations and may be metabolized by organisms frequently found in water. For instance
K lebsiella species frequently produce gas in poorly preserved products when used to
challenge creams and lotions containing this component. Mould growth is one of the
most common causes of spoilage of creams of all types and can occur in products as varied
as antifungal, calamine, baby and hair creams and a number of other cosmetic formulations
including moisture and cleansing creams. The difficulties of preserving these products
against could growth are enhanced by the risk of contamination from containers the
presence of large air spaces and poor storage conditions.
Ointments and Oils
As these are anhydrous materials, in theory they do not support the growth of micro­
organisms. However, in practice they are often filled into jars or other containers with
large air-spaces and this introduces the possibility of mould spoilage as for creams because
these organisms can utilize atmospheric moisture. Whereas creams can supply moisture
by evaporation, oils and ointments require the accidental ingress of water or the presence
of a humid atmosphere. Fortunately a much smaller incidence of this kind of spoilage
therefore occurs but we have seen a few examples of mould colonies on the surfaces of
ointments, including white petroleum jelly, and ironically, fungicidal ointment. Oils are
at a slightly greater risk than ointments as, being more fluid, they allow condensed water
to carry organisms to the bottom of the container and remain trapped. Moulds have been
reported to metabolize arachis oil and liquid paraffin and obnoxious odours, tastes and
slimy deposits have been found in liquid paraffin while lumps of moulds, yeasts or bacteria
have been seen in maize and olive oil. Without exception traces of water are found in
these spoiled samples and the detection of foreign substances, such as food particles often
indicates the origin of the contamination.
Syrups
The sugar content of syrups inhibits the growth of many microorganisms by virtue of
its high osmotic pressure but osmotolerant moulds and yeasts are a source of trouble.
Fermentation of the sugar by these organisms causes foul flavoured due to the production
of alcohol, lactic acid and other organic acids while the production of carbon dioxide
leads to gassing and troublesome pressure increase. In addition, these products including
syrup B. P. and various syrup-containing remedies can be spoiled by the presence of
suspended or deposited osmophilic moulds. As with other products spoilage in syrup
78 □ □ Drug Inspector Exam

can be accelerated by an excessive air space in the container. Fluctuating storage


temperatures then cause sufficient condensation of water vapour to dilute the syrup at its
surface so that growth can occur. Cork closures now happily uncommon have in the past
provided the necessarily inoculums of mould spores. Osmophilic organisms may also
cause trouble in malt extracts which largely depend on their high concentration of low
molecular weight saccharide for preservation. The effect of a number of environmental
factors on fermentation caused by Saccharomyces rouxii in malt extract has been studied.
Compounds formulated in syrup may be metabolized with the production of toxic
substances. For instance, Wills isolated a species of Penicillium from a sample of Syrup of
Tolu which smelled of toluene. He showed that this organism could grow benzoic or
cinnamic acid as a sole carbon source and that a toluene-like odour was produced from
the latter. The toluene-like product was not characterized because of the presence of
interfering substance but rupture of the unsaturated linkage in the cinnamic acid molecule
could have yielded toluene itself.
Tinctures, Elixirs and Linctuses
In general, these formulations do not allow microbial survival because of their high
concentration of alcohol, sugars or glycerol. For instance, even in concentration as low as
alcohol will kill most bacteria and moulds in time, while yeasts are generally killed at
concentrations above 15%. Nevertheless isolated incidents of spoilage due to suspension
or deposits of dead mould have occurred. The organisms presumably row in the container
or a while before becoming immersed by the formulation and succumbing.

SOLIDS

Raw Materials
Solid raw materials may serve as a source of contaminants which will later spoil a
formulated product. Natural earths such as kaolin, bentonite, Fuller'se arthor French chalk
contain anaerobics pore-bearing rods, moulds or Gram-negative bacteria which can render
a product objectionable or even dangerous. These materials are best sterilized by a gaseous
or heating process before formulation. Solids of biological origin, including egg and milk
products and dried animal and plant extracts, may also contain pathogens including
salmonellae E, coli and staphylo cocci. Spoilage of the solid raw material itself is largely
due to mould growth on the surface due to impropers to rage with inadequate coverings
in a damp environment or under conditions of fluctuating temperature.
Powders
Spoilage of products in powdered form due to visible mould growth also occurs under
damp conditions A. gain the possibility of illness due to microbial contamination is an
important consideration and it is particularly necessary to ensure that topical preparations
Contamination o f Pharmaceuticals in Hospitals and Environment by Microbes □ □ 79

do not contain Clostridia spores. There is no clear evidence of a relationship bt cween the
presence of contaminants and irritation due to cosmetic powders but more than a few
hundred organisms per gram is undesirable and powders for use on broken skin should
be prepared from sterilized raw materials. This precaution also applies to those powders
and other solid cosmetics which are intended to be applied in the region of the eyes.
Tablets, Pastilles and Lozenges
Visible spoilage of tablets, generally manifested as surfaced is colouration, may be
caused by the growth of moulds. Spores from the environment, container or tablet itself
may find sufficient moisture to initiate growth on the tablet surface ever under apparently
dry conditions. In experiments with Paracetamol Tablets, B.P. we have found that, while
spoilage could be prevented by attention to storage conditions and the value of
preservatives was limited, the incorporation of 0.1 % propyl p-hydroxybenzoate retarded
the onset and extent of mould growth, even under damp storage conditions in laboratory
and large-scale trials.
Interest has recently been shown in the carriage of contaminating pathogens by
products of this type. Synthetic drugs in tablet form usually carry less than 100 organisms
per tablet but those compounded with natural drugs may contain up to 105 organisms of
ten Gram-positive pore bearing bacteria, per tablet. Large numbers of enteric pathogens
such as salmonellae have also been found and tablets containing biological products have
been incriminated in out break so of salmonellosis. Pastilles and lozenges of the boiled
sweet type are not generally found to suffer from microbial spoilage as heating during
manufacture has a sterilizing action and often individual dry wrappings are used to prevent
surface contamination. However, when pastilles are dusted with starch powder, moulds
may be introduced and these can give rise to discolouration under poor storage conditions.
Solid Cosmetics
Lipsticks often contain preservatives but some are still subject to mould 'blooms'. Mould
grows on the lipstick while it is inside the lipstick case, often after the product has become
moistened by breath during use. Moisture, perhaps from saliva, may also initiate growth
in preparations of mascara which often contain many bacteria. There is also a danger of
contamination via the brush which can pick up organism from the skin during use and
similar dangers are present with solid cakes of make-up. Preservatives have limited use
in this situation, perhaps because they are adsorbed onto the solid material. In addition
their concentration must be limited for fear of irritation to the eyes.
Packaging Materials
Containers for pharmaceuticals and cosmetics are becoming increasingly elegant and
are now made from a large variety of materials, particularly plastics. This should result in
a reduction in microbial spoilage because plastics are not biodegradable like the cellulose
80 □ □ Drug Inspector Exam

materials, paper and card. In addition the latter, being absorbents, oak up liquids thus
providing a substrate for moulds. In any case, liners of paper and card and cork closures
often contain many micro-organisms and therefore frequently are a source of mould
contamination where as plastic closures are free from this defect. However, plastics suffer
from some disadvantage. They are porous to varying degrees and some allow the diffusion
of oxygen and carbon-dioxide and may thus facilitate microbial growth in the packed
product. They also encourage condensation of water and, if mould spores are present, can
facilitate spoilage by these organisms. Soap, for instance gives off moisture, and, if wrapped
with an impermeable plastic over paper or card, may become discoloured due to mould
growth on the damp paper. Sometimes paper wrappings can be protected from spoilage
by the incorporation of a preservative in to them, but this is not entirely without difficulties.

MULTIPLE CHOICE QUESTIONS

1. The contaminant found in antibiotic 5. Tyndallisation is


eye ointment is (a) 80°C for 20 m in three successive
(a) pseudomonas cepacia days
(b) staphylococcus aureus (b) 100°C for 20 m in three successive
(c) pseudomonas auruginosa days
(d) serratia mercescens (c) 60°C for 20 m in three successive
days
2. The contaminant found in talcum
powder is (d) none of the above
(a) clostridium tetani 6. Rideal-walker test is used for
(b) staphylococcus aureus (a) streptococci
(c) pseudomonas auruginosa (b) staphylococci
(d) salmonella agona (c) phenol
3. The contaminant found in saline water (d) pseudomonas
solution is 7. Antisera are sterilized by
(a) salmonella cubana (a) autoclaving
(b) salmonella agona (b) steam under low pressure
(c) serratia mercescens (c) hot air areas
(d) none of the above (d) filteration
4. Cold sterilization is 8. Aseptic technique may be defined as
(a) sterilization under low (a) procedure that excludes the accecc
temperature of viable microorganisms into the
(b) sterilization by ultra-sonic - —product
vibrations (b) procedure that destroys all viable
(c) sterilization in refrigerator forms of microorganisms
(d) sterilization by (gamma) rays
Contamination o f Pharmaceuticals in Hospitals and Environment by Microbes □ □ 81

(c) procedure that destroys only 14. Opportunities for contamination of


pathogenic microorganisms pharm aceutical product may be
(d) none of the above greatly reduced by
9. The following is not true for pyrogens (a) effective hand washing
(a) They increase the body temper­ (b) by using disposable applicators for
ature topical products
(b) They are chemically lipopolysac- (c) by taking oral products by
charides disposable spoon
(c) They are water soluble, heat (d) all of the above
soluble, non - volatile 15. Which of the following microorganism
(d) They are unaffected by oxidizing is responsible for the contamination
agents of most of the ophthalmic products
leading to sever eye infections
10. Presence of particulate matter in
parenterals could lead to (a) Salmonella bareilly
(a) physical occlusion (b) Bacillus subtilis
(b) inflammatory reaction (c) Pseudomonas aeruginosa
(c) antigenic responses (d) Staphylococcus aureus
(d) all of the above 16. Which of the following contaminated
products cause the most serious
11. The microbial contaminants may affect
problems?
the spoilage of pharm aceutical
products through (a) products injected directly into the
bloodstream
(a) chemical changes
(b) products instilled into the eye
(b) physical changes
(c) products applied topically
(c) aesthetic changes
(d) option a and b
(d) all of the above
17. The most crucial step undertaken so
12. After the contam ination of a
as to prevent the microbial
pharmaceutical the changes which can
contamination of pharmaceutical
be observed in it include
products is
(a) visible surface growth on solids
(a) observing good manufacturing
(b) formation of slimes
practices
(c) pellicles or sediments in liquids
(b) ensuring quality of raw materials
(d) all of the above
(c) training of the manufacturing
13. Which pharmaceutical products are personnel ____
considered to be most at risk by (d) quality control of the
microbial contamination during their manufactured products
use
18. Salmonplla spp. infections have arisen
(a) topical (b) parenteral
from contaminated
(c) oral (d) intra-nasal
82 □ □ Drug Inspector Exam

(a) parenteral preparations (c) Nursing atis


(b) tablets and capsules (d) option b and c
(c) ointments and creams 22. A highly sensitive semi-quantitaive
(d) all of the above method for detecting microbial
19. The overall rate of deterioration of a antigen in biological fluid is done by
chemical will depend upon: (a) Radioimmune electrophoresis
(a) its chemical structure; (b) Counterimmune electrophoresis
(b) the physico-chemical properties of (c) HPLC
a particular environment; (d) Freeze dried centrifugal method
(c) the type and quantity of microbes 23. Infected blood products may produce
present serum hepatitis. It is due to
(d) all of the above (a) hepatitis A virus
20. In hospital, the most of the contamina­ (b) hepatitis B virus
tion is caused by free living (c) hepatitis C virus
opportunistic pathogens like (d) None of the above
(a) P aeruginosa
24. Contaminated water in hospitals
(b) Clostridium botulinum
serves as source of which of the
(c) Salmonella typhi following organism
(d) M tuberculi (a) opportunistic pathogenic gram(+)
21. In hospitals which of the following bacteria
serves as the source of cross (b) opportunistic pathogenic gram(-)
contamination from one patient to bacteria
another (c) opportunistic pathogenic gram(+)
(a) Contaminated multidose and gram(-)bacteria
formulations I (d) both a and b
(b) Reusable applicators

ANSWERS
1. (c) 2. (a) 3. (c ) 4. (d) 5. (a) 6. (c) 7. (d) 8. (a) 9. (d) 1 0 . (d)
11. (d) 12. (d) 13. (a) 14. (d) 15. (c) 16. (d) 17. (a) 1M b) 19. (d) 20. (a)
21. (a) 22. (a) 23. (c) 24. (a).

□□□
Sterilization
10
C h a pter

Sterilization can be defined as any process that effectively kills or eliminates


transmissible agents (such as fungi, bacteria, viruses and prions) from a surface, equipment,
foods, medications, or biological culture medium. In practice sterility is achieved by
exposure of the object to be sterilized to chemical or physical agent for a specified time.
Various agents used as steriliants are: elevated temperature, ionizing radiation, chemical
liquids or gases etc. The success of the process depends upon the choice of the method
adopted for sterilization.
Pharmaceutical Importance of Sterilization
• Moist heat sterilization is the most efficient biocidal agent. In the pharmaceutical
industry it is used for: Surgical dressings, Sheets, Surgical and diagnostic
equipment, Containers, Closures, Aqueous injections, Ophthalmic preparations
and Irrigation fluids etc.
• Dry heat sterilization can only be used for thermo stable, moisture sensitive or
moisture impermeable pharmaceutical and medicinal. These include products like;
Dry powdered drugs, Suspensions of drug in non-aqueous solvents, Oils, fats
waxes, soft hard paraffin silicone, Oily injections, implants, ophthalmic ointments
and ointment bases etc.
• Gaseous sterilization is used for sterilizing thermolabile substances like; hormones,
proteins, various heat sensitive drugs etc.
• U.V light is perhaps the most lethal component in ordinary sunlight used in
sanitation of garments or utensils.
• Gamma-rays from Cobalt 60 are used to sterilize antibiotic, hormones, sutures,
plastics and catheters etc.
• Filtration sterilizations are used in the treatment of heat sensitive injections and
ophthalmic solutions, biological products, air and other gases for supply to aseptic
areas. They are also used in industry as part of the venting systems on fermentors,
centrifuges, autoclaves and freeze driers. Membrane filters are used for sterility
testing.

83
84 □ □ Drug Inspector Exam

TERMS COMMONLY USED

Survivor curves
They are plots of the logarithm of the fraction of survivors (microorganisms which
retain viability following a sterilization process) against the exposure time or dose.
Expression of resistance

D-value
D-value is indicative of the resistance of any organism to a sterilizing agent. For
radiation and heat treatment, D-value is the time taken at a fixed temperature or the
radiation dose required to achieve a 90% reduction in viable count.
Z-value
Z-value represents the increase in temperature needed to reduce the D-value of an
organism by 90%.
Methods of Sterilization
The various methods of sterilization are given in Tablel along with their merits,
demerits and applications.

Table lO.l.Merits, Demerits and Applications of Different Methods of Sterilization

Types Mechanism Merits Demerits Applications


Heat Destroys Most widely Can be applied Dry heat is
sterilization bacterial used and only to the applicable for
endotoxins reliable thermostable sterilizing gla­
method of products sswares and
sterilization, metal surgical
involving instruments
destruction of and moist heat
enzymes and is the most
other essential dependable
method for
decontamin
-ation of
laboratory
waste and the
sterilization of
laboratory
glassware,
media and
reagents.
Sterilization □ □ 85

Gaseous Alkylation Penetrating Gases being Ethylene oxide


sterilization ability of gases alkylating gas has been
agents are used widely to
potentially process heat-
mutagenic and sensitive
carcinogenic devices.
Radiation Ionization of It is a useful Undesirable Radiation
sterilization nucleic acids method for changes sterilization is
the industrial occur in generally
sterilization of irradiated applied to
heat sensitive products, an articles in the
products. example is a dry state;
queous solution including
where radioly­ surgical
sis of water instruments,
occurs. sutures,
prostheses, unit
dose ointments,
plastics
Filtration It is used for Does not This method is
sterilization Does not destroyJ r both the clarif­ differentiate Sterilizing
but removes the ication and between grade filters
microorganisms sterilization of viable and non are used in the
liquids and viable particles treatment of
gases as it is heat sensitive
capable of injections and
preventing the ophthalmic
passage of both solutions,
viable and non biological
viable particles. products and
air and other
gases for
supply to
aseptic

TESTS FOR STERILITY


Tests for sterility are carried out by two methods :
(a) Membrane Filtration Method
86 □ □ Drug Inspector Exam

(b) Direct Transfer / Inoculation Method.


The Membrane Filtration Method is used as the method of choice wherever feasible.
Media used in Sterility Testing
Fluid Thioglycollate Medium (Medium 1) and Soybean-Casein Digest Medium
(Medium 2) are the two media generally used for tests for sterility.
MEDIUM 1 : (Fluid Thioglycollate Medium)
Composition :
Pancreatic Digest of Casein— 15.0 g
Yeast Extract (water-soluble)— 5.0 g
Glucose monohydrate/anhydrous---- 5.5 g/5.0 g
Sodium chloride------2.5 g
L-Cystine------ 0.5 g
Sodium thioglycollate------0.5 g
0.1% Resazurin Sodium Solution (freshly prepared)—1.0 ml
Granulated Agar (moisture not more than 15%) — 0.75 g
Purified Water----- 1000 ml
Polysorbate 80-----5.0 ml
pH after sterilization (measured at room temperature): 7.1± 0.2
MEDIUM 2 : (Soybean-Casein Digest Medium)
Composition :
Pancreatic Digest of Casein— 17.0 g
Papain Digest of Soybean Meal— 3.0 g
Glucose monohydrafte/anhydrous—2.5 g /2.3 g
Sodium chloride— 5.0 g
Dipotassium hydrogen phosphate (K2H P 0 4 )---- 2.5 g
Purified Water— 1000 ml
Polysorbate 80— 5.0 ml
pH after sterilization (measured at room temperature): 7.3±0.2

METHOD OF MEMBRANE FILTRATION

Procedure
The filter should be a membrane filter disc of cellulose esters or other suitable plastics,
having a nominal average pore diameter not exceeding 0.45 jam. The membrane should
be held firmly in a filtration unit which consists of a supporting base for the membrane, a
receptacle for the fluid to be tested, a collecting reservoir for the filtered fluid, and the
Sterilization □ □ 87

necessary tubes or connections. The apparatus is so designed that the solution to be filtered
can be introduced and filtered under aseptic conditions. It permits the aseptic removal of
the membrane for transfer to medium or it is suitable for carrying out the incubation after
adding the medium to the apparatus itself.
Cellulose nitrate filters are recommended for aqueous, oily and weakly alcoholic
solutions and cellulose acetate filters for strongly alcoholic solutions. The entire unit should
be sterilized by appropriate means with the membrane filter and sterile airways in place.
The method of sterilization should not be deleterious to the membrane, e.g., weaken it or
change the nominal average pore diameter. The sterile airways should provide free access
to the sterilizing agent. After sterilization, the apparatus should be free of leaks to the
atmosphere except through the sterile airways.

METHOD OF DIRECT TRANSFER

Procedures
Liquids and soluble or dispersible solids: Appropriate quantities of the preparation to
be examined are added directly into Medium 1 and Medium 2. Approximately equal
quantities of the preparation should be added to each vessel of medium. The test vessels
of Medium 1 is incubated at 30 - 35°C and the vessels of Medium 2 is incubated at 20-
25°C.
The volume of Medium 1 should be such that the air space above the medium in the
container is minimized. The volume of Medium 2 should be such that sufficient air space
is left above the medium to provide conditions that permit the growth of obligate aerobes.
Unless otherwise prescribed, in no case should the volume of material under test be greater
than 10% of the volume of the medium alone, i.e., 90% medium and 10% product. If a
large volume of product is to be tested it may be preferable to use concentrated media,
prepared so as to take the subsequent dilution into account. Where appropriate the
concentrated medium may be added directly to the product in its container. Wherever
possible solid articles such as devices should be tested by immersion in or filling with
culture media. Immerse all parts of each article in sufficient medium contained in one
vessel to completely cover all parts. The volume of Medium 1 should be such that the air
space above the medium in the container is minimized. The volume of Medium 2 should
be such that sufficient air space is left above the medium to provide conditions that permit
the growth of obligate aerobes. Place half the articles into Medium 1 and the remaining
half into Medium 2. Incubate the test vessels of Medium 1 at 30 - 35°C and the vessels of
Medium 2 at 20 - 25°C.
Ointments and oily preparations: Ointments and oily preparations may be tested by
the method of Direct Transfer if testing by the method of Membrane Filtration is not feasible,
i.e., when a suitable solvent is not available .
88 □ □ Drug Inspector Exam

Incubation and examination of sterility tests: All test vessels of Medium 1 are incubated
at 30 - 35°C. The vessels of Medium 2 are incubated at 20 - 25°C. All test and control
vessels, other than the subcultured vessels referred to below, must be incubated for at
least 14 days unless microbial contamination is detected at an earlier time.
If turbidity, precipitate, or other evidence of microbial growth during incubation is
seen: the suspected growth is examined microscopically by Gram stain; attempts are made
to grow single colonies using appropriate microbiological methods; colonies of each type
of micro-organism present are examined for colonial morphology and cellular morphology
by Gram stain; attempts are made to identify the isolates, as far as the genus, and preferably
species.
Interpretation of the test results: If microbial growth is not evident in any of the vessels
inoculated with the product, the sample tested complies with the test for sterility, if
microbial growth is evident the product does not comply with the test for sterility unless
it can be clearly demonstrated that the test was invalid for causes unrelated to the product
being examined. If the test is declared to be invalid it may be repeated with the same
number of units as in the original test. If there is no evidence of growth in any vessels
inoculated with the product during the repeat test the product passes the test for sterility.
This interpretation applies even if growth occurs in negative product control vessels. If
there is evidence of growth in the test vessels the product fails the test for sterility. Further
testing is not permitted under any circumstances.

MULTIPLE CHOICE QUESTIONS

1. Sterilization involves the use of a (c) pH


physical or chemical procedure to: (d) vacuum
(a) remove visible soil from surgical 3 The most wMely use{J effectiv6/
instruments economical and reliable method of
(b) destroy non-pathogenic organisms sterilization used in the health care
(c) destroy all forms of microbial life setting is:
including highly resistant bacterial gag piasma
spores ^ ethylene oxide
(d) destroy all forms of microbial life ^ peracetic acj j
except highly resistant bacterial - „ steam
spores
T, , , . , 4. The essential parameters of steam
2. If the is too hieh the ...... r
i i T , sterilization are:
established sterilization parameters , , , ,
may not be adequate rendering the <a> secure|y wrapped packages
sterilization process ineffective: time, temperature, saturated steam
(a) temperature and Pressure
(b) bioburden (c) chemical and biological indicators
(d) both (a) and (c)
Sterilization □ □ 89

5. Ethylene Oxide is a highly toxic agent, (a) alcohol


which destroys microorganisms by a (b) peracetic acid
process called_____________ (c) glutaraldehyde
(a) cavitation (d) formaldehyde
(b) oxidation
11. The absorption of UV light is leads
(c) osmosis
with-----
(d) alkylation
(a) Formation of T-T dimer
6. has established (b) Formation of purine dimer
permissible exposure limits to EO and
(c) Breakdown of DNA strand
requires continuous monitoring of the
work area and personnel: (d) all of the above
(a) OSHA 12. In Laminar air flow------- type of filter
(b) EPA is located.
(c) JCAHO (a) membrane filter
(d) DPH (b) Seitz Filter
7. EO sterilized products (c) HEPA
require________________ hours of (d) all of the above
aeration at 140°F: 13. is referred as biological
(a) 12 indicator of autoclave.
(b) 10 (a) Bacillus stearothermophilus
(c) 8 (b) Bacillus subtilis
(d) cannot be aerated at 140°F (c) Bacillus megatorium
8. Gas plasma is not compatible with: (d) Bacillus cereus
(a) heat sensitive devices
14. What is D-value?
(b) items with lumens
(a) Time required to decrease the
(c) paper products
microbial population by 90%
(d) Both (b) & (c)
(b) Time required to decrease the
9. An advantage of gas plasma microbial population by 60%
sterilization is: (c) Time required to decrease the
(a) it is less expensive than EO and microbial population by 50%
total cycle times are shorter (d) Time required to decrease the
(b) it is free of environm ental, microbial population by 100%
occupational and patient safety
concerns 15. What does high Z-value indicates?
(c) all peel pouches, disposable (a) low resistane of microbial
wraps, and containers can be used population
(d) Both (a) & (b) (b) high resistance of microbial
population
10. The most frequently used liquid
chemical sterilant is:
90 □ □ Drug Inspector Exam

(c) medium resistance of microbial (c) ionizing radiation


population (d) gaseous sterilization
(d) None of the above 22. The membrane used for sterilization
16. What is condition for sterilization by is made of
autoclave? (a) cellulose acetate
(a) 1210C, 151b,15 min (b) cellulose nitrate
(b) 1210C, 151b, 10 min (c) polypropylene
(c) 1210C, 151b,5 min . (d) polyvinyl chloride
(d) 1210C, 151b,30 min (e) all of the above
17. The culture media is sterilized by
23. Which media is used for sterility
(a) Hot air oven testing under aerobic condition?
(b) autoclave
(a) fluid thioglycollate media
(c) Tydallisation
(b) Soyabean-casein digest media
(d) radiation
(c) agar media
18. Tydallisation is method of sterilization. (d) option (a) and (b)
In this
24. In sterility testing, the culture media
(a) heating of material at 60°C for lhr
is incubated in direct inoculation
for three successive days
method for
(b) heating of material at 60°C for 2hrs
(a) for 7 days
for three successive days
(b) 10 days
(c) heating of material at 90°C for lhr
for three successive days (c) 14 days
(d) heating of material at 80°C for lhr (d) any temperature depending on
for three successive days temperature

19. For sterilization, the aqueous solution 25. The Q10 indicates
may be heated in presence of (a) thermal resistance of
bactericide microorganism
(a) 60°C for lhr (b) 80°C for lhr (b) viability of microorganism
(c) 98°C for 30 min (c) death time of microorganism
(d) 100°C for 15 min (d) either (a) or (c)
20. Which method is used for sterilization 26. Which is not true regarding
of silicones? advantafes of sterilization by ionizing
(a) autoclave radiation?
(b) heating with bactericide (a) short sterilisation time
(c) hot air oven (b) reliability of sterilisation
(d) tydallisation (c) negligible rise in temperature
(d) ability to sterilise equipment made
21. The kaolin is sterilized by of heat-sensitive materials, for
(a) autoclave example, polystyrene
(b) hot air oven
Sterilization □ □ 91

(e) no deleterious effects on glassware (a) Horizontal


or textile fibres (b) Vertical
27. With a Laminar Flow Hood, the (c) Either
orientation of the direction of airflow (d) Neither
can be:

ANSWERS
l.(c) 2. (b) 3. (d) 4. (b) 5. (d) 6. (a) 7. (c) 8. (c) 9. (d) 10. (b)
11. (c) 12. (d) 13. (a) 14. (b) 15. (b) 16. (a) 1 7 .(b) 18. (d) 19. (b) 2 0 .(c)
21. (b) 22. (e) 23. (d) 24. (c) 25. (a) 26. (e) 27. (c).

□ □ □
Sterilization of Materials,
Equipments and Utensils Used in
Hospitals C h a pter

STERILIZATION OF MATERIALS, EQUIPMENTS AND UTENSIL USED IN


HOSPITALS, CENTRALIZED AND DECENTRALIZED STERILIZATION,
DRUG DISTRIBUTION SYSTEM IN HOSPITALS
The Sterile Processing Department (Central Supply, or Sterile Supply as it is also
known), comprises that service within the hospital in which medical/surgical supplies
and equipment, both sterile and nonsterile, are cleaned, prepared, processed, stored, and
issued for patient care.
As the number and variety of surgical procedures grew and the types of medical
devices, equipment, and supplies proliferated, it became apparent that a centralized
processing is needed for efficiency, economy, and patient safety.
Functions
Sterile Processing Departments are typically divided into four major areas to accomplish
the functions of decontamination, assembly and sterile processing, sterile storage, and
distribution.
In the decontam ination area, reusable equipment, instruments, and supplies are
cleaned and decontaminated by means of manual or mechanical cleaning processes and
chemical disinfection.
Clean items are received in the assem bly and packaging area from the decontamination
area and are then assembled and prepared for issue, storage, or further processing (like
sterilization).
After assembly or sterilization, items are transferred to the sterile storage area until
its time for them to be issued.
Several major functions are carried out in the distribution area: case cart preparation
and delivery; exchange cart inventory, replenishment and delivery; telephone-order and
requisition-order filling; and, sometimes, patient care equipment delivery.

THE DECONTAMINATION PROCESS


Introduction
Decontamination is the physical or chemical process that renders an inanimate object
that may be contaminated with harmful microbial life safe for further handling. The
Sterilization o f Materials, Equipments and Utensils used in Hospitals □ □ 93

objective of decontamination is to protect the preparation and package workers wb :ome


in contact with medical devices after the decontamination process from contracting <lseases
caused by microorganisms on those devices.

THE ASSEMBLY AND PACKAGING PROCESS


Introduction
After the instruments have been cleaned and inspected, they are typically assembled
into sets or trays according to recipe cards that detail instructions for assembling each set
or tray.
Instruments and other items that are prepared for sterilization must be packaged so
that their sterility can be maintained to the point of use. The materials and techniques
used for packaging must allow the sterilant to contact the device during the sterilization
process as well as to protect the device from contamination during storage and handling
before it is used. The time between sterilization and use may range from a few minutes to
several weeks to many months. The packaging material selected must also permit the
device to be removed aseptically.
Types of Packaging
• Textiles
• Non-wovens
• Pouchpackaging
• Rigid container systems

THE STERILIZATION PROCESS


Introduction
Bacterial spores are the most resistant of all living organisms because of their capacity
to withstand external destructive agents. Although the physical or chemical process by
which all pathogenic and non-pathogenic microorganisms, including spores, are destroyed
is not absolute, supplies and equipment are considered sterile when necessary conditions
have been met during a sterilization process.
Methods
Reliable sterilization depends on contact of the sterilizing agent with all surfaces of
the item to be sterilized. Selection of the agent to achieve sterility depends primarily upon
the nature of the item to be sterilized. Time required to kill spores in the equipment available
for the process then becomes critical.
Steam
Heat destroys microorganisms, but this process is hastened by the addition of moisture.
Steam in itself is inadequate for sterilization. Pressure, greater than atmospheric, is
necessary to increase the temperature of steam for thermal destruction of microbial life.
Death by moist heat in the form of steam under pressure is caused by the denaturation
94 □ □ Drug Inspector Exam

and coagulation of protein or the enzyme-protein system within the cells. These reactions
are catalyzed by the presence of water. Steam is water vapor; it is saturated when it contains
a maximum amount of water vapor.
No living thing can survive direct exposure to saturated steam at 250 F (120 (C) longer
than 15 minutes. As temperature is increased, time may be decreased. A minimum
temperature-time relationship must be maintained throughout all portions of load to
accomplish effective sterilization. Exposure time depends upon size and contents of load,
and temperature within the sterilizer. At the end of the cycle, re-evaporation of water
condensate must effectively dry contents of the load to maintain sterility.
Ethylene Oxide
Ethylene oxide is used to sterilize items that are heat or moisture sensitive. Ethylene
Oxide (EO) is a chemical agent that kills microorganisms, including spores, by interfering
with the normal metabolism of protein and reproductive, processes, (alkylation) resulting
in death of cells. Used in the gaseous state, EO gas must have direct contact with
microorganisms on or in items to be sterilized. Because EO is highly flammable and
explosive in air, it must be used in an explosion-proof sterilizing chamber inn a controlled
environment. When handled properly, EO is a reliable and safe agent for sterilization, but
toxic emissions and residues of EO present hazards to personnel and patients. Also, it
takes longer than steam sterilization, typically, 16-1C brs. for a complete cycle.
EO gas sterilization is dependent upon four parameters: EO gas concentration,
temperature, humidity, and exposure time. Each parameter may be varied. Consequently,
EO sterilization is a complex multi-parameter process. Each parameter affects the other
dependent parameters.
Others
Dry Heat
Dry heat in the form of hot air is used primarily to sterilize anhydrous oils, petroleum
products, and bulk powders that steam and ethylene oxide gas cannot penetrate. Death of
microbial life by dry heat is a physical oxidation or slow burning process of coagulating
the protein in cells. In the absence of moisture, higher temperatures are required than
when moisture is present because microorganisms are destroyed through a very slow
process of heat absorption by conduction.
Microwaves
The non-ionizing radiation of microwaves produces hyperthermic condition? that
disrupt life processes. This heating action affects water molecules and interferes with cell
membranes. Microwave sterilization uses low-pressure steam with the nonionizing
radiation to produce localized heat that kills microorganisms.
Formaldehyde Gas
Formaldehyde kills microorganisms by coagulation of protein in cells. Used as a
fumigant in gaseous form, formaldehyde sterilization is complex and less efficacious than
Sterilization o f Materials, Equipments and Utensils used in Hospitals □ □ 95

other methods of sterilization. It should only be used if steam under pressure wil’ damage
the item to be sterilized and ethylene oxide and glutaraldehyde are not available.
Hydrogen Peroxide Plasma
Hydrogen peroxide is activated to create a reactive plasma or vapor. Plasma is a state
of matter distinguishable from solid, liquid, or gas. It can be produced through the action
of either a strong electric or magnetic field, somewhat like a neon light. The cloud of
plasma created consists of ions, electrons, and neutral atomic particles that produce a
visible glow. Free radicals of the hydrogen peroxide in the cloud interact with the cell
membranes, enzymes, or nucleic acids to disrupt life functions of microorganisms
Ozone Gas
Ozone, a form of oxygen, sterilizes by oxidation, a process that destroys organic and
inorganic matter. It penetrates membrane of cells causing them to explode. Ozone is an
unstable gas, but can be easily generated from oxygen.
Chemical Solutions
Liquid chemical agents provide an alternative method for sterilizing heat sensitive
items if a gas or plasma sterilizer is not available, or the aeration period makes ethylene
oxide sterilization impractical. To sterilize items, they must be immersed in a solution for
the required time specified by the manufacturer to be sporicidal. All chemical solutions
have advantages and disadvantages; each sterilant has specific assets and limitations.
These chemicals are: peracetic acid, glutaraldehyde, and formaldehyde.
Ionizing Radiation
Some products commercially available are sterilized by irradiation. It is the most
effective sterilization method but is limited for commercial use only. Ionizing radiation
produces ions by knocking electrons out of atoms. These electrons are knocked out so
violently that they strike an adjacent atom and either attach themselves to it, or dislodge
an electron from the second atom. The ionic energy that results becomes converted to
thermal and chemical energy. This energy causes the death of microorganisms by disruption
of the DNA molecule, thus preventing cellular division and propagation of biologic life.
Their usefulness in sterilizing an object is limited by density and thickness of the
object and by the energy of the electrons. They produce their effect by ionizing the atoms
they hit, producing secondary electrons that, in turn, produce lethal effects on
microorganisms.
Cobalt 60 is a radioactive isotope capable of disintegrating to produce gamma rays.
Gamma rays are electromagnetic waves. They have the capability of penetrating to a much
greater distance than beta rays before losing their energy from collision. Cobalt 60 is the
most commonly used source for irradiation sterilization. The product is exposed to
radiation for 10 to 20 hours, depending on the strength of the source.
96 ZJD Drug Inspector Exam

Quality Assurance
To ensure that instruments and supplies are sterile when used, monitoring of the
sterilization process is essential.
Administrative Monitoring
Work practices must be supervised. Written policies and procedures must be strictly
followed by all personnel responsible and accountable for sterilizing and disinfecting
items, and for handling sterile supplies. If sterility cannot be achieved or maintained, the
system has failed. Policies and procedures pertain to;
1. Decontaminating, terminally sterilizing, and cleaning all reusable items; disposing
of disposable items.
2. Packaging and labeling of items.
3. Loading and unloading the sterilizer.
4. Operating the sterilizer.
5. Monitoring and maintaining records of each cycle.
6. Adhering to safety precautions and preventive maintenance protocol.
7. Storing of sterile items.
8. Handling sterile items ready for use.
9. Making sterile transfer to a sterile field.
Mechanical Indicators
Sterilizers have gauges, thermometers, timers, recorders, and/or other devices that
monitor their functions. Most sterilizers have automatic controls and locking devices.
Some have alarm systems that are activated if the sterilizer fails to operate correctly. Records
are maintained and review for each cycle. Test packs (Bowie-Dick test) are run at least
daily to monitor functions of each sterilizer, as appropriate. These can identify process
errors in packing or loading.
Chemical Indicators
A chemical indicator on a package verifies exposure to a sterilization process. An
indicator should be clearly visible on the outside of every on-site sterilized package. This
helps differentiate sterilized from unsterilized items. Several types of chemical indicators
are available :
1. Tape, labels, and paper strips printed with an ink that changes color when exposed
to one or more process parameters.
2. Glass tube with pellets that melts when a specific temperature is attained in
sterilizer.
3. Integrating or wicking paper with an ink or chemical tablet at one end that melts
and wicks along paper over time under desired process parameters. The color bar
reaches the "accept" area if parameters are met.
Sterilization o f Materials, Equipments and Utensils used in Hospitals □ □ 97

Biological Indicators
Positive assurance that sterilization conditions have been achieved can be obtained
only through a biologic control test. The biologic indicator detects nonsterilizing conditions
in the sterilizer. A biologic indicator is a preparation of living spores resistant to the
sterilizing agent. These may be supplied in a self-contained system, in dry spore strips or
discs in envelopes, or sealed vials or ampoules of spores to be sterilized and a control that
is not sterilized. Some incorporate a chemical indicator also. The sterilized units and the
control are incubated for 24 hours for Bacillus stearothermophilis at 131 to 141 F (55 to 66
(C) to test steam under pressure, for 48 hours for Bacillus Subtilis at 95 to 98.6 F (35 to 37
(C) to test ethylene oxide.
There are four systems in general use for dispensing drugs for inpatients.

DRUG DISTRIBUTION SYSTEMS IN HOSPITAL

For in patient department


They may be classified as follows :
(i) Individual Prescription Order System
(ii) Complete Floor Stock System.
(iii) Combination of (i) and (ii)
(iv) The unit dose method.
Individual prescription order system. This system is generally used by the small and/
or private hospital because of the reduced manpower requirement and the desirability for
individualized service. Inherent in this system is the possible delay in obtaining the required
medication and the increase in cost to the patient.
Advantages of this system:
(i) All medication orders are directly reviewed by the pharmacist.
(ii) Provides for the interaction of pharmacist, doctor, nurse and patient.
(iii) Provides closer control of inventory.
Complete floor stock system
Under this system, the nursing station pharmacy carries both "charge" and "non­
charge" patient medications. Rarely used or particularly expensive drugs are omitted from
floor stock but are dispensed upon the receipt of a prescription or medication order for
the individual patient.
Although this system is used most often in governmental and other hospitals in which
charges are not made to the patient or when the all inclusive rate is used for charging, it
does have applicability to the general hospital
Advantages o f com plete flo o r stock system :
(i) Ready availability of the required drugs.
98 □ □ Drug Inspector Exam

(ii) Elimination of drug returns.


(iii) Reduction in the number of drug order transcriptions for the pharmacy.
(iv) Reduction in the number of pharmacy personnel required.
Disadvantages o f com plete flo o r stock system :
(i) Medication errors may increase because the review of medication orders is
eliminated.
(ii) Increased drug inventory on the pavilions.
(iii) Greater opportunity for pilferage.
(iv) Increased hazards associated with drug deterioration.
(v) Lack of proper storage facilities on the ward may require capital outlay to provide
them.
(vi) Greater inroads are made upon the nurse's time.
To be borne in mind by the student is the fact that in some hospitals the complete floor
stock system is successfully operated as a decentralized pharmacy under the direct
supervision of a pharmacist.
Obviously, when this occurs, many of the disadvantages associated with such a system
disappear. In addition, the use of the decentralized pharmacy concept provides for a "home
base" for the clinically oriented pharmacist.
In the past, floor stock containers were pre-labeled multiple dose units. Today, the
floor stock is in unit-of-use packaging thereby assuring better packaging, control and
identity of the medication.
Charge floor stock drugs and non-charge floor stock drugs
Each pavilion in the hospital, regardless or its size or specialty care, has a supply of
drugs stored in the medicine cabinet even though the nursing unit is serviced by a unit
dose system. However, the use of floor stock medications should be minimized. In addition,
research has shown that the system of drug distribution has an effect upon the incidence
of adverse drug reactions. These medications may be classified under two separate
headings, each of which serves a specific purpose. Drugs on the nursing station may be
divided into "charge floor stock drugs" and "noncharge floor stock drugs".
Charge floor stock drugs may be defined as those medications that are stocked on the
nursing station. It is the responsibility of the hospital pharmacist, working in cooperation
with the nursing service, to develop ways and means whereby adequate supplies of each
are always on hand and, in appropriate situation that proper charges are made to the
patients account.
Combination of Individual prescription order system and complete floor stock
system
Falling into this category are those hospitals which use the individual prescription or
medication order system as their primary means of dispensing, but also utilize a limited
Sterilization o f Materials, Equipments and Utensils used in Hospitals □ □ 99

floor stock. This combination system ie probably the most commonly used in hospitals
today and is modified to include the use of unit dose medications.

UNIT DOSE SYSTEM


Unit-dose medications have been defined as:"Those medications which are ordered,
packaged, handled, administered and charged in multiples of single dose units containing
a predetermined amount of drugs or supply sufficient for one regular dose application or
use."
Advantages of unit dose system :
(i) Patients receive improved pharmaceutical service 24 hours a day and are charged
for only those doses, which are administered to them.
(ii) All doses of medication required at the nursing station are prepared by the
pharmacy thus allowing the nurse more time for direct patient care.
(iii) Allow the pharmacists to interpret or check a copy of the physician's original order
thus reducing medication errors.
(iv) Elimination excessive duplication of orders and paper work at the nursing station
and pharmacy.
(v) Eliminates credits.
(vi) Transfers intravenous preparation and drug reconstitution procedures to the
pharmacy.
(vii) Promotes more efficient utilization of professional and non-professional personnel.
(viii) Reduces revenue losses.
(ix) Conserves space in nursing units by eliminating bulky floor stock.
(x) Eliminates pilferage and drug waste.
(xi) Extends pharmacy coverage and control throughout the hospital from the time
the physician writes the order to the time the patient receives the unit-dose.
(xii) Communication of medication orders and delivery systems are improved.
(xiii) The pharmacists can get out of the pharmacy and onto the wards where they can
perform their intended function as drug consultants and help provide the team
effort that is needed for better patient care.

MULTIPLE CHOICE QUESTIONS

1. Which one of the following is not a 2. Open Wove Bandage is a type of


type of a bandage? __________bandage?
(a) non-elastic (b) elastic (a) non elastic (b) impregnated
(c) adhesive (d) non-adhesive (c) elastic (d) adhesive
100 □ □ Drug Inspector Exam

3. Which one of the following is not a (c) 40%


type of surgical dressings? (d) 2%
(a) fibres-plain and medicated
9. Which of the following is the correct
(b) self adhesive plaster storage condition for all type of
(c) bandages surgical dressings?
(d) all of the above (a) protect from harmful vapour and
4. What is the impregnated material contaminants
used in fabrics? (b) keep in dry place
(a) water proofing oil and resins (c) keep at a temp of 15-20 degree
(b) soft paraffin (d) all of the above
(c) both (a) and (b) 10. Which type of dressings has the label
(d) none of the above "apply to clean dry skin"?
5. Which one is not an example of non (a) self adhesive plaster and wound
impregnated fabrics? dressings
(a) absorbent cotton gauge (b) bandages
(b) absorbent muslin (c) fabrics
(c) unbleached calico (d) fibres
(d) oiled silk 11. Which one of the following is a type
6. Which of the self adhesive plaster is of catherter?
not made from zinc oxide? (a) straight catherter
(a) zinc oxide self adhesive plaster (b) balloon catherter
(b) extension plaster (c) both (a) and (b)
(c) zinc oxide elastic self adhesive (d) none of the above
plaster 12. Which of the following is not a type
(d) belladonna self adhesive plaster of corner clips?
7. Which one of the following is a type (a) gray's type
of plastic film self adhesive plaster? (b) backhaus type
(a) perforated plastic self adhesive (c) allis type
plaster (d) moynihan's tetra towel forceps
(b) waterproof plastic self adhesive 13. Which one of the following is not a
plaster type of surgical needles?
(c) waterproof micro porous self (a) straight needle
adhesive plaster (b) ound shaft curved needle
(d) all of the above
(c) flat shaft curved needle
8. What is the optimum water content (d) straight pointed scissor
of absorbent cotton wool?
14. Tensile strength testing is done for
(a) 9% which of the following?
(b) 20%
Sterilization o f Materials, Equipments and Utensils used in Hospitals □ □ 101

(a) belladonna plaster (c) to measure pulse


(b) salicylic acid plaster (d) none of the above
(c) zinc paste bandage 21. What does CT scan stand for?
(d) both (a) and (b) (a) computer topography
15. Which are the different types of (b) computed tomography
forceps? (c) computerized transfer
(a) tissue forcep (d) none of the above
(b) haemostatic forcep
22. What does MRI stand for ?
(c) bone cutting forcep
(a) magnetic resonance imaging
(d) all of the above
(b) magnetic resonance index
16. What are the different type of (c) magnetic resonance impulse
scissors? (d) none of the above
(a) straight blunt scissors
23. What does outpatient stands for?
(b) straight pointed scissors
(c) lister 's bandage scissors (a)patient standing outside hospital.
(d) all of the above (b) visitors of patients.
(c) patient going to opd
17. Which are thedifferent type of
(d) none of the above
needles?
(a) straight needle 24. Methods of procurement of drugs
(b) round shaft curved needle from hospital pharmacy?
(c) triangular shaft curve needle (a) direct from m anufacturer or
wholesaler.
(d) all of the above
(b) by invinting tenders.
18. What are different types of cervical (c) through retail pharmacy.
collar?
(d) all of the above.
(a) foam cervical collar
(b) hard cervical collar 25. What is drug basket method?
(c) philedelphia cervical collar (a) nurses checks the drugs in all
rooms and prepare master list
(d) all of the above
from pharmacy.
19. Back support are given for which of (b) nurses check all medicines in
the following spinal cord disorders? refrigerator and prepare a master
(a) kyphosis list for pharmacy.
(b) scoliosis (c\ both (a) and (b)
(c) lordosis (d) Yione of the above.
(d) all of the above
26. Scheduled X of drug and cosmetic act
20. What is the use of sphygmo­ represents?
manometer? (a) prescriptions drugs.
(a) to measure heart rate (b) non-prescriptions drugs.
(b) to measure bp
102 □ □ Drug Inspector Exam

(c) control drugs. (a) shake well before use.


(d) none of the above. (b) for external use only.
27. What are the special labeling (c) not be chewed.
directions to be maintained for topical (d) keep out of reach from
use only?

ANSWERS
l.(d ) 2. (a) 3. (d) 4. (c) 5. (d) 6. (d) 7. (d) 8. (a) 9. (d) 10. (a)
11. (c) 12. (c) 13. (d) 14. (d) 15. (d). 16. (d) 17. (d) 18. (d) 19. (d) 20.- (b)
21. (b) 22. (a) 23. (c ) 24. (d) 25. (c) 26. (c) 27. (b)
Ophthalmic Preparations
12
Chapter

The solutions, suspensions, and ointments are commonly used as ophthalmic products.
Most of the ophthalmic products are no longer prepared in the pharmacy.
Ophthalmic preparations are sterile products that are intended to be applied to the
eyelids or placed in the space between the eyelids and the eyeball.

TYPES OF OPHTHALM IC PREPARATIONS


Three types of ophthalmic preparations are commonly encountered in the pharmacy.
Each type of preparation has its advantages and disadvantages.
(a) Solutions. Ophthalmic solutions are rather easily placed into the eye. However,
care must be taken to ensure the solution remains in the eye in order to produce
the desired therapeutic effect.
(b) Suspensions. Ophthalmic suspensions are also easily placed into the eye. In
— general, suspensions produce a longer effect than do solutions. Suspensions do
have one disadvantage; it is difficult to ensure that the suspension does not contain
particles large enough to produce eye irritation.
(c) Ointments. Ophthalmic ointments (for example, certain antibiotic ointments) are
commonly used. They are relatively easy to apply (except in the eyes of children).
Ophthalmic ointments remain in contact with the eye tissues for an extended
period.
Characteristics of Ophthalmic Preparations
(a) Solutions. Ophthalmic solutions must be sterile and particle-free. Moreover,
ophthalmic solutions should be isotonic, if possible.
(b) Suspensions. Ophthalmic suspensions must be sterile and free from large particles
that might irritate the eye.
General principles involved in the extemporaneous compounding of ophthalmic
preparations
There are several important factors to consider while converting a compound to a
sterile ophthalmic preparation. In many cases, the drugs involved have a narrow
therapeutic range and even small errors when introduced have the potential to cause
irreversible damage to the eye.
1. Ensure that there is adequate support in the literature for the product that is
prescribed and that the requested concentration is within an acceptable range.
103
104 □ □ Drug Inspector Exam

Also make sure that there is not a suitable commercial product available that would
eliminate the need to extemporaneously prepare a product. The advent of new
formulations in the past few years has already drastically reduced the need for
many previously compounded items.
2 . Sterility of the final product is a must: strict adherence to aseptic technique as well
as any other preventative measures must be in place.
3. The pH of the final product must be within an acceptable range.
4. Anticipated stability of the final product must be known, as well as the
recommended storage requirements.
5. Adequate knowledge of potential diluents or vehicles is required in order to ensure
proper tonicity, viscosity, or dissolution of the final product.
6. Establishment of written procedures that fully document each step is an important
consideration in order to reduce the likelihood of errors. Whenever calculations
are required, there should be a secondary source available to verify the accuracy.
Also, if multiple dilutions are needed, it is recommended that a new syringe be
used for each step in order to minimize the impact of residual contents.
7. If the preparation of a product requires the breaking of an ampule or the
reconstitution of a powder (for example, cefazolin), it is recommended that the
final product be filtered prior to packaging in order to eliminate any particulate
matter.
8. The preparation of intra-ocular products requires the use of preservative-free
ingredients. Many preservatives have been found to be toxic to the inner ocular
tissues.
9. Finally, before dispensing the finished product, always indicate the storage
requirements, concentrations of ingredients, and the expected expiration date

PREPARATION OF EYE DROPS


Extemporaneous preparation of eye drops involves the following :
• Preparation of the solution
• Clarification
• Filling and sterilization
Preparation of the Solution
The aqueous eye drop vehicle containing any necessary preservative, antioxidant,
stabilizer, tonicity modifier, viscosity modifier or buffer should be prepared first. Then
the active ingredient is added and the vehicle made up to volume.
Clarification
The IP has stringent requirements fbr the absence of particulate matter in eye drop
solutions. Sintered glass filters or membrane filters of 0.45 -1 .2 Mm pore sizes are suitable.
Ophthalmic Preparations □ □ 105

The clarified solution is either filled directly into the final containers which are sealed
prior to heat sterilization or filled into a suitable container prior to filtration sterilization.
Clarified vehicle is used to prepare eye drop suspensions which are filled into final
containers and sealed prior to sterilization.
Sterilization
This can take the form of :
• Autodaving at 115°C for 30 minutes or 121°C for 15 minutes
• Heating at 98 - 100°C for 30 minutes together with either benzalkonium chloride
0.01 % w/v or chlorhexidine acetate 0.01 % w/v or phenylmercuric acetate or nitrate
0.002% w/v or thiomersal 0.01 % w/v.
• Filtration through a membrane filter having a 0.22% m pore size into sterile
containers using strict aseptic technique. Filling should take place under Grade A
laminar airflow conditions. A suitable filter holder for extemporaneous preparation
is needed. The filter assembly is sterilized by autoclaving before use.
• Dry heat sterilization at 160°C for 2 hours is employed for non-aqueous preparations
such as liquid paraffin eye drops. Silicone rubber teats must be used.
— Immediately following sterilization theeye drop containers must be converted with
readily breakable seal, such as a viskring, to distinguish between opened and unopened
containers.Labelling requirements are summarised in Tables 12.1 and 12.2.
Table 12.1. General Labelling requirements for eye drop containers Requirement

Include on label
Fully identify Title;either name and concentration of active ingredients or
the product reference to official monograph giving these details. If monograph
allows more than one concentration then state the one used
Specify storage "Store in a cool place" or "Protect from light"
conditions
State product Month and year of expiry
expiry date
Warning label "Not to be taken"
Specify volume e.g. 5mL
Ensure correct use e.g. "Shake the bottle" for a suspension

Table 12.2. Additional labelling requirements for use in specific locations

All locations Include concentration of active ingredient and name and


concentration of any antimicrobial present
106 □ □ Drug Inspector Exam

Hospital Wards Patient's name. The eye to be treated. Date of opening of bottle
Operating Theatres and/or date to discard Single dose for once-only use. Marked with
Clinics indication and concentration of active ingredient. No preservative.
Outer package fully labelled Single dose or multidose used once
only
Domiciliary "Avoid contamination of contents during use" Discard 4 weeks
after opening" Keep out of reach of children Plus instructions on
how to use

PREPARATION OF EYE LOTIONS


The purpose of eye lotions is to assist in the cleaning of the external surfaces of the
eye. This might be to help remove a non-impacted foreign body or to clean away
conjunctival discharge. Eye lotions intended for use in surgical or first-aid procedures
should not contain anti-microbial preservatives and should be in single-use containers.
There is no intention to use an eye lotion to deliver any active ingredient to th^e eye but
rather to remove unwanted gross contaminants from the eye. Thus, these preparations
should be very simple and the most common eye lotion consists of sterile normal saline.
This preparation typifies the requirements of an eye lotion which are :
• Sterile and usually containing no preservative
• Isotonic with lachrymal fluid
• Neutral pH
• Large volume but not greater than 200mL
• Non-irritant to ocular tissue
Labelling
These should include:
• Title identifying the product and concentration of contents
• 'Sterile until opened'
• 'Not to be taken'
• 'Use once and discard remaining solution'
• Expiry date
Preserved eye lotion would need the additional labelling :
• Avoid contamination of contents during use'
• 'Discard remaining solutions not more than 4 weeks after first opening' .The lotions
should be supplied in coloured fluted bottles and sealed to exclude microorganisms.

PREPARATION OF EYE OINTMENTS


Eye ointments are popular and duplicate many of the therapeutic options offered by
eye drops. Ointments have the disadvantage of temporarily interfering with vision, but
Ophthalmic Preparations □ □ 107

have the advantage over liquids of providing greater total drug bioavailability. However,
ointments take a longer time to reach peak absorption.
Eye ointments must be sterile and may contain suitable antimicrobial preservatives,
antioxidants and stabilizers. USP ophthalmic ointments packaged in multi-dose containers
are to contain an anti-microbial substance unless otherwise directed in the monograph or
if the formulation itself is bacteriostatic. The most commonly used agents include the two
mercurials, phenylmercuric nitrate and thiomersal, the parabens and chlorobutanol. It is
necessary also that such ointments are free from particulate matter that could be harmful
to the tissues of the eye. The EP and BP have limits for the particle size of incorporated
solids which will be met if all particles have been reduced to <25pm.
The basic components of an eye ointment are given below :
• Liquid paraffin 1 part
• Wool fat 1 part (to facilitate incorporation of water)
• Yellow soft paraffin 8 parts
• Hard paraffin as required to produce required consistency in hot climates
Preparation of Eye Ointments
Eye ointments are normally prepared using aseptic techniques to incorporate the finely
powdered active ingredient or a sterilized concentrated solution of the medicament into
the sterile eye ointment basis. Immediately after preparation the eye ointment is filled
into the sterile containers which are then sealed so as to exclude microorganisms. The
screw cap should be covered with a readily breakable seal.
All apparatus used in the preparation of eye ointments must be scrupulously clean
and sterile.
Certain commercial eye ointments may be sterilized in their final containers using
ionising radiation.
Preparation of Eye Ointment Basis
The paraffins and the wool fat are heated together and filtered, while molten, through
a coarse filter paper in a heated funnel into a container which can withstand dry heat
sterilization temperatures. The container is closed to exclude microorganisms and together
with contents is maintained at 160°C for 2 hours.
Containers for Eye Ointments
Eye ointments should be supplied in small sterilized collapsible tubes made of metal
or in a suitable plastic. The tube should not contain more than 5 g of preparation and must
be fitted or provided with a nozzle of a suitable shape to facilitate application to the eye
and surrounds without allowing contamination of the contents. The tubes must be suitably
sealed to prevent microbial contamination. Eye ointment may also be packed in suitably
designed single-dose containers.
108 □ □ Drug Inspector Exam

Labelling
This includes the following :
• The names and percentages of the active ingredients
• The date after which the eye ointment is not intended to be used
• The conditions under which the eye ointment should be stored - normally at a
temperature not exceeding 25°C
• The name and concentration of any antimicrobial preservative or other substance
added to the preparation
• A statement to the effect that the contents are sterile providing the container has
not been opened

MULTIPLE CHOICE QUESTIONS

1. Ophthalmic preparations come under (c) dilute with equal volume of sterile
which category? isotonic saline solution
(a) sterile (d) none of the above
(b) non-sterile 5 Common viscosity increasing agent in
(c) parenteral ophthalmics:
(d) none of the above (a) Polyvinyl alcohol
2. Which one of the following (b) Povidone
preservative should not be used in eye (c) Dextran
drops intended for prolonged use? (d) All of the above
(a) chlorhexidine acetate 0.01 % 6. pH of human tear is:
(b) phenylmercuric nitrate (a) 7.2 (b) 7.8
(c) benzalkonium chloride (c) 8 (d) 4.6
(d) methyl parabens
Ophthalmic solution is sterilized by:
3. Which of the following preservative (a) Autoclaving
is not suitable for eye drops containing
(b) Bacterial retentive filters
local anaesthetic?
(c) a and b above
(a) propyl parabens
(d) Hot air oven
(b) benzalkonium chloride
(c) phenyl ethyl alcohol ® Isotonicity value of ophthalmics:
(d) phenulmercuric acetate (a) 0.9% sodium chloride
(b) 2 .0% sodium chloride
4. The label for ophthalmic boric acid
should contain : (c) 0.6% sodium chloride
(a) dilute with equal volume of (d) None of the above
distilled water 9 The mean volume of tears in human
(b) dilute with equal volume of sterile eye under normal conditions is:
distilled water
Ophthalmic Preparations □ □ 109

(a) 25 micro litre 15. Ineffectiveness of a single pit ,ervative


(b) 7 microlitre causes blindness & abraded cornea,
(c) 5 microlitre the causative microorganism is:
(d) 30 microlitre (a) S.typhi
(b) Clostridium defficle
10. How much volume is administerd by
a normal dropper as a drop: (c) Pseudomonas aeruginosa
(a) 50 microlitre (d) S.aureus
(b) 10 microlitre 16. At what concentration antioxidants
(c) 30 microlitre like sodium m eiabisulphite and
(d) 100 microlitre sodium sulphite used in ophthalmic
preparations?
11. Which of the following is a viscosity (a) 0.1 % w/v
adjusting agent in ophthalmics:
(b) 0.5% w/v
(a) Macrogel
(c) 0.2%w/v
(b) Dextran
(d) 0.01 % w/v
(c) Methyl cellulose derivative
(d) All of the above 17. Which one of the following is the most
suitable storage temperature for eye
12. Ideal particle size of opthalmics drops?
tolerated by the eyes should be less
(a) 0-5 degree (b) 10 degree
than______:
(c) 37 degree (d) 0-8 degree
(a) 10 micrometer
(b) 20 micrometer 18. Which one of the following is not true
(c) 5 micrometer about eye lotions?
(d) 2 micrometer (a) they are isotonic
(b) they are at neutral pH
13. Commonly used preservatives which
(c) they are at acidic pH
is not used in multiple dose
(d) they are non irritant
ophthalmics incude:
(a) benzalkonium chloride 0.01 % 19. Which one of the following is a
(b) benzalkonium chloride 1 % suitable method of sterilization in BP
(c) thiomersal 0.01 % 1980 for sterilizing of eye drops?
(d) chlorobutanol 0.01 % (a) autoclaving at 115 degree for 30
minutes or 12 1 degree for 15
14. Commonly used surfactant in minutes
opthalmics: (b) heating at 98 degree with either
(a) Polysorbate 80 benzalkonium chloride, or
(b) Polysorbate 60 chlorhexidine acetate or
(e) Benzalkonuium chloride thiomersal.
(d) None of the above (c) filteration through membrane
filters.
(d) dry heat sterilization for 2 hours
at 160 degree.
110 □ □ Drug Inspector Exam

20. Labels on the ophthalmic eye lotions (a) chlorbutol


should include the following (b) chlorhexidine acetate
informa tion- (c) benzalkonium chloride
(a) 'Sterile until opened' (d) phenylmercuric salts
(b) 'Use once and discard the
25. Which one is used as viscosity
remaining solution'
modifier in ophthalmic eye drop?
(c) 'Avoid contamination of contents
(a) Hydroxymethyl cellulose
during use'
(b) Polyvinyl alcohol
(d) All of the above
(c) Dextran
21. Which one of the following is a wrong (d) Macrogol
statement about eye lotions-
(e) Anyone from the above
(a) eye lotions intended for surgeries
donot contain any antimicrobial 26. Polysorbates are used in ophthalmic
agents. preparations as
(b) they deliver active ingredient to (a) wetting agent
the eye. (b) tonicity modifier
(c) they are used for removing of (c) preservative
unwanted contaminants. (d) stabilizer
(d) they should be supplied in 27. The container used for eyedrops is
coloured fluted bottles. made of
22. Tetracycline hydrochloride is used as (a) Soda glass
a__________ in formulation of an eye (b) surfacetreated soda lime glass
drop. (c) Neutral glass
(a) an oily vehicle (d) borosilicate glass
(b) preservative (e) option (b) and (c)
(c) viscosity enhancers
28. Which buffer is used in ophthalmic
(d) tonicity adjuster products to maintain pH?
23. __ is the most commonly (a) borate buffer
used chelating agent along with other (b) phosphate buffer
preservatives to enhance the stability (c) citrate buffer
of ophthalmic preparations. (d) All of the above
(a) dimercaprol
29. Which on of these is controlled release
(b) disodium edetate
ophthalmic product?
(c) both (a) and (b)
(a) ophthalmic ointment
(d) none of the above
(b) ocular insert
24. Disodium edetate reduces the activity (c) eye drop
of which one of the following (d) none of the above
preservative?
Ophthalmic Preparations □ □ 111

30. Why eyedrop contains 10-15ml of (c) drug is liable to be o idized/


solution/suspension? reduced
(a) it is meant for one month only (d) all of the above
(b) drug is costly

ANSWERS
1. (a) 2. (b) 3. (b) 4. (c) 5. (d) 6. (a) 7. (c) 8. (a) 9. (b) 10 . (a)
11. (c) 12. (a) 13. (b) 14. (a) 15. (c) 16. (a) 17. (d) 18. (c) 19. (b) 20. (d)
21. (b) 22. (a) 23. (b) 24. (d) 25. (e) 26. (a) 27. (e) 28. (d) 29. (b) 30. (a)

nnn
Blood Products and 13
Plasma Substitutes C h a pter

BLOOD PRODUCTS
Whole blood. In most circumstances, blood component therapy has replaced the use
of whole blood. However, whole blood is still occasionally used for massive transfusion
in circumstances in which rapid correction of acidosis, hypothermia and coagulopathy is
required. This mainly occurs in military situations for trauma patients who require
resuscitation.
Red Blood Cells
RBCs are prepared from whole blood by removal of most of the plasma. They are
indicated in both acute haemorrhage and chronic anaemia. Red cell units have a
haematocrit of 70% (Citrate Phosphate Dextrose Adenine (CPDA-1) solution) or 55-60%
(Additive Solutions (AS)) with a shelf life of 35 days and 42 days respectively when
refrigerated at 1-6°C. A decision to give a transfusion should be reached both on the patient's
clinical situation and laboratory findings, not on Hb alone.3,4 Transfusion is often not
considered until Hb <7 g/dL but patients with unstable angina or acute Myocardial
Infarction (MI) may require transfusion at Hb <10 g/dL. A single unit of red blood will
typically increase Hb by lg/dL. Other RBC products include leukocyte-reduced
components, which can reduce febrile reactions and are an alternative to cytomegalovirus
(CMV)-seronegative components and prevent HLA alloimmunisation. Also, washed
components (RBC and platelets) remove harmful plasma antibodies.
Platelets
Each unit of platelets is prepared from a single whole blood collection by differential
centrifugation and contains at least 5.5 x 1010 platelets in 50 ml of plasma. They are stored
at 20-24°C in plastic containers under agitation and have a shelf life of 5 days. Each unit
can raise platelet count by 5-10 x 109/L. Alternatively, platelets are prepared by apheresis
(a process of filtration), contain >3 x 1011 platelets suspended in 200 ml plasma, and are
equivalent Lo 6 random donor platelet units. Platelets are not usualiycross matched will:
the recipient, but ABO type-specific platelets should be provided where possible as,
otherwise, the increment is 10-20% less in platelet count. Platelets are given to patients
with thrombocytopenia who are bleeding or those with severe thrombocytopenia as a
precaution. Patients rarely bleed spontaneously when platelet count is >20 x 109/L and
patients receiving chemotherapy can often tolerate counts of 5-10 x 109/L.
Blood Products and Plasma Substitutes □ □ 113

Granulocytes
These are mainly given to neutropenic cancer patients developing bacterial sepsis
unresponsive to conventional antibiotic therapy for at least 24-48 hours. Preparations
collected from normal donors by apheresis contain at least 1 x 1010 neutrophils/unit, but
the concentration can be increased by using donors stimulated by steroids and/or growth
factors. Granulocyte preparations can only be stored for 24 hours at 20-24°C. They need to
be crossmatched with the recipient's serum because of the large number of red cells they
contain and need to be irradiated because of the large number of lymphocytes present.
Granulocytes are only usually considered for patients with an absolute neutrophil
count <0.5 x 109/L and a good chance of marrow recovery. They usually need to be given
daily until patients can maintain an absolute neutrophil count >0.5 x 109/L without
transfusion or until the infection has resolved. Patients frequently have a febrile reaction
to granulocytes and these are more severe when amphotericin is infused at around the
time of the granulocyte infusion.
Fresh Frozen Plasma
Fresh Frozen Plasma (FFP) is produced by centrifugation of one donation of whole
blood, and collecting the supernatant liquid. The plasma is frozen within 8 hours of
collection in order to maintain the activity of factor V and factor VII. The main indication
for FFP is deficiency of multiple coagulation factors found in liver disease and Disseminated
Intravascular Coagulation (DIC). It is also often used for urgent reversal of warfarin
anticoagulation. Because of the large volume that would be required, FFP is not generally
used to replace individual clotting factors. In these situations specific factors are given
(see below under 'Factor' headings).
Cryoprecipitate is made by thawing FFP at 1-6°C and is generally used for patients
with von Willebrand's disease or severe hypofibrinaemia. A commercial preparation of
solvent /^detergent-treated frozen human plasma called Octaplas® is available but needs
ABO compatibility checks. Uniplas® is a human plasma product which has been shown
to be independent of ABO compatibility, but it is not yet widely used in the UK.
Plasma-transfused patients need to be observed for circulatory overload.6 The main
side-effects include fever, 7 chills, 7 bronchospasm,5 and adult respiratory distress
syndrome.
Albumin
This is available as 5% or 25% solution for the treatment of hypovolaemia and
hypoalbuminaemia. The cost-benefit of albumin in the treatment of hypovolaemia is
controversial, and it is largely being replaced by non-plasma colloidal solutions. It does,
however, still have a place in the management of liver disease and ascites. It is tested for
hepatitis C virus (HCV) RNA and virally inactivated, and not considered as a risk factor
for viral transmission. Its use has now largely been superseded by non-plasma colloidal
solutions.
114 □ □ Drug Inspector Exam

Immunoglobulin
Intravenous (IV) imm unoglobulin is used in the treatm ent of immuno-
thrombocytopenia, Guillain-Barre syndrome and autoimmune haemolytic anaemias. RhD
immunoglobulin is used to prevent exposure to D-positive red cells causing Rh sensitisation
in D-negative patients. This is usually given in pregnancy and immediately after birth to
prevent haemolytic disease of the newborn in future babies.
Antithrombin III Concentrate
This is prepared from human plasma and used to treat congenital deficiency of
antithrombin III. This condition presents as thromboembolic phenomena at an early age.
Side-effects of concentrate transfusion may include flushing, nausea, headache, and rarely
fever and allergic reactions. There may be a place for antithrombin III concentrate in the
management of acquired deficiency (for example, heparin resistance, cirrhosis with
coagulation disorders).
Drotrecogin Alfa (Activated)
This is recombinant activated protein C. In cases of severe sepsis, the protein C pathway
regulates thrombin production, preventing the formation of the microvascular thrombosis
which can lead to multiple organ failure. Caution needs to be used in patients with bleeding
diatheses, comorbidity leading to, or medication causing, increased bleeding tendency.
The preparation is contra-indicated in cases of internal bleeding, cerebral herniation,
intracranial neoplasm, chronic severe hepatic disease, and thrombocytopenia. There are
little safety data concerning pregnancy or breast-feeding, so the drug should only be given
if there is a definite indication. A study in 477 paediatric patients did not show any benefit,
although there are isolated reports that it promotes improvement in selected cases. Adverse
effects include headache, 5 bleeding, 16 pain, 5 and ecchymoses.14
Factor Vila (Recombinant)
This is used in patients with inhibitors to factors VIII and IX. It is indicated in patients
with haemophilia A and B, and in uncontrolled bleeding in a number of clinical situations.
Theoretical concerns about an increased risk of deep vein thrombosis and pulmonary
embolus have not been borne out in randomised trials.
Factor VIII Fraction, Dried
Also known as human antihaemophilic fraction, this is prepared from human plasma
by a suitable fractionation technique and indicated for the treatment and prophylaxis of
haemorrhage in haemophilia A. Large or frequently repeated doses in patients with blood
groups A, B or AB can lead to intravascular haemolysis. This is less likely to occur with
high-potency purified concentrates. Side-effects include allergic reactions, including chills
and fever.
Blood Products and Plasma Substitutes □ □ 115

Factor VIII Inhibitor Bypassing Fractions


This is prepared from human plasma. It is indicated for the control of spontaneous
bleeding episodes or to cover surgical interventions in haemophilia A and haemophilia
B patients with inhibitors. It has also been used in non-haemophiliac patients with
acquired inhibitors to factors VIII, XI and XII. Intravascular coagulation is the main
adverse effect.
Dried Factor IX Fraction
«• This is prepared from fractionating human plasma, and may also contain factors II,
VII, and X. It is used for the treatment of haemophilia B (congenital factor IX deficiency)
or acquired haemophilia. The risk of thrombosis has largely been obviated by increasing
the purity of the product. DIC is the main contra-indication. Side-effects include allergic
reactions, chills and fever, but these are usually infrequent and mild.
Factor XIII dried.This is also known as human fibrin-stabilising factor, and is indicated
for congenital factor XIII deficiency. It has also been used to promote the healing of
anastomoses in gastrointestinal surgery. Adverse effects, which include allergic reactions
and fever, are rare. Recombinant factor XIII has been shown to be a safe and effective
alternative in trials.
Plasma Substitutes
Dextran 70 and polygeline are macromolecular substances which are metabolized
slowly; they may be used to expand and maintain blood volume in shock arising from
conditions such as burns or septicaemia. They are rarely needed when shock is due to
sodium and water depletion as, in these circumstances, the shock responds to water and
electrolyte repletion. Plasma substitutes should not be used to maintain plasma volume
in conditions such as burns or peritonitis where there is loss of plasma protein, water and
electrolytes over periods of several days. In these situations, plasma or plasma protein
fractions containing large amounts of albumin should be given. Plasma substitutes may
be used as an immediate short-term measure to treat massive haemorrhage until blood is
available, but large volumes of some plasma substitutes can increase the risk of bleeding
by depleting coagulation factors. Dextran may interfere with blood group cross-matching
or biochemical measurements and these should be carried out before the infusion is started.
Dextran 70
Dextran is a representative plasma substitute. Various preparations can seive as
alternatives Infusion (Solution for infusion), dextran 70 6% in glucose intravenous
infusion 5% or sodium chloride intravenous infusion 0.9%
Uses: short-term blood volume expansion
Contraindications
Severe congestive heart failure, renal failure; bleeding disorders such as
thrombocytopenia and hypofibrinogenaemia.
116 □ □ Drug Inspector Exam

Polygeline
Polygeline is a representative partially degraded gelatin. Various preparations can
serve as alternatives Infusion (Solution for infusion), polygeline 3.5% with electrolytes,
500-ml bottle
Uses: Correction of low blood volume
Contraindications: Severe congestive heart failure; renal failure

MULTIPLE CHOICE QUESTIONS

1. Blood is collected from which part of (c) heparin


the body? (d) disodium edentate
(a) median cubital vein in front of the 6. What is the pormal storage
elbow
temperature for whole human blood?
(b) femoral vein in the thigh (a) 4-6 degree (b) 0-5 degree
(c) ulnar vein of the wrist (c) -18 degree (d) 37 degree
(d) none of the above
7. What is the Ph of blood ?
2. Acid citrate produces a pH o f______ ? (a) 7.2 (b) 6.8
(a) 7.2 (b) 4 (c) 6.2 (d) 4.6
(c) 5 (d) 8
8. Which blood group is the universal
3. Which clotting factor is called as donor ?
STUART PROWER FACTOR? (a) blood group A+
(a) factor 7 (b) factor 9 (b) blood group AB-
(c) factor 10 (d) factorll (c) blood group O-
4. Dextrin is produced from which of the (d) blood group 0+
following bacteria?
9. What is the standard method used in
(a) leuconostoc mesenteroids protein identification of human
(b) aspergillus niger serum?
(c) penicillium notatum (a) coagulation test
(d) s.aureus (b) precipitation test
5. Conversion of fibrinogen to fibrin for (c) sedimentation test
clot formation occurs b y __________? (d) complexation test
(a) thromboblastin 10. In the assay of whole blood and
(b) prothrombin concentrated red cells which factor is
(c) calcium determined ?
(d) thrombin (a) haemoglobin value
6. Which of the, following is not an Anti­ (b) protein content
coagulant? (c) RH factor
(a) citrates (d) clotting factor
(b) bicarbonates
Blood Products and Plasma Substitutes □ □ 117

11. Which of the following is not an (a) 100,000-2,50,000


absorbable haemostat ? (b) 2,50,000 or more
(a) oxidized cellulose (c) 60,000-1,'00,000
(b) calcium alginate (d) 60,000 or less
(c) absorbable gelatin sponge
18. For a normal healthy adult of 65-70
(d) pvp kg body weight.
12. Which of the following factor is not (a) The blood pH is 7.0
involved in the activation of clotting (b) There are about 4.5 x 1012 red cells
factor 10 ? per liter.
(a) factor 7 (b) factor 9 (c) The blood volume would be about
(c) factor 8 (d) factor 1 4 liters.
13. What is the maximum stoarage limit (d) There are about 1 x 109 leukocytes
of dried human plasma? per liter.
(a) 6 months (b) 1 year 19. Dextran of suitable size is not
(c) 3 hours (d) 5 years produced by which of the following
methods?
14. Which organic solvent is used in
(a) ultrasonic disintegration
fractionation of plasma ?
(b) acid hydrolysis
(a) ethyl alcohol
(c) base hydrolysis
(b) butyl alcohol (d) thermal degradation
(c) ether
20. Calcium alginate haem ostat is
(d) acetone
obtained from which of the following
15. What is the consequence if Rh+ blood sea weeds?
is transfused into Rh- recipient in large (a) Laminaria digitata
quantities? (b) Carpometra costata
(a) blood coagulation (c) focus serratus
(b) haemolytic reaction (d) Ascophullum nodosum
(c) allergic reaction 21. Injection of Sodium Chloride is a
(d) none of these synonym of one of the following ?
16. The plama of normal adult is ? (a) PVP
(a) is about 60% water (b) Dextran
(b) accounts for about 10 % of body (c) gum saline
weight (d) oxidized cellulose
(c) Contains about 8 mmoles 1-1 of 22. Coagulation factor 12 is also known
potassium (K+) as ._________ ?
(d) Contains about 140 mmoles 1-1 of (a) labile factor
sodium (Na+). (b) stable factor
17. The acceptable range of molecular (c) Hageman factor
weight of dextran is? (d) fibrin stabilizing factor
118 □ □ Drug Inspector Exam

23. Which one of the following is not an (c) reconstituted plasma


property of plasma substitute ? (d) Human fibrinogen
(a) low rate of excretion and
27. What are the components of citrates
destruction from the body.
(anti coagulants)?
(b) low stability in liquid form and
(a) sodium acid citrate
during transport and storage.
(b) water for injection
(c) viscosity similar to plasma.
(d) a molecular weight such that the (c) dextrose
molecule donot diffuse easily (d) all of above
through the capillary walls. 28. To what extent does acid citrate
24. Which one of the following is not true dextrose prolongs the storage life of
for very large molecular weight whole blood?
dextran ? (a) one day (b) 3 weeks
(a) they produce optimal osmotic (c) one month (d) one week
pressure. 29. For the blood group AB, plasma
(b) they yield very viscous solutions antibody or agglutinin will be
which are very difficult to
administer. (a) none
(c) they cause renal damge and (b) anti-B
allergic reaction. (c) anti-A
(d) interferes with blood matching (d) anti-A and anti-B
and effects blood sedimentation
rate. 30. What is the use of concentrated
human RBC?
25. Which one of the following is the most
(a) chronic anemia
abundant plasma proteins?
(b) exchanged transfusion in infants
(a) albumin
(c) both a and b
(b) Alpha acid glycoprotein
(d) none of the above
(c) fibrinogen
(d) immunoglobulin 31. Gas-gangrene antitoxin is prepared
from
26. Which one of the blood products is
(a) Clostridium novy
used in treatment of severe burns and
(b) C perfringens
scalps?
(c) C septicum
(a) concentrated human RBC.
(d) combination of the above
(b) dried human serum
(e) any above option

ANSWERS
1. (a) 2. (c) 3. (c) 4. (a) 5. (d) 6. (b) 7. (a) 8. (c) 9. (b) 10. (a)
11. (d) 12. (d) 13. (d) 14. (a) 15. (b) 16. (d) 17. (a) ‘ 18. (b) 19. (c) 20. (a)
21. (c) 22. (c) 23. (b) 24. (a) 25. (a) 26. (c) 27. (d) 28. (b) 29. (a) 30. (c)
31. (e)
□ □ □
Surgical Products
14
C h a pt er

Surgical Cotton and Bandage


Surgical cotton is an essential thing in medical services. In order to stay away from
infections and other problems, it is necessary that you should be aware of the different
types of surgical cottons. There are various types of cottons available for different
surgical needs. Absorbent cotton is available in different sizes and packing for various
surgical needs, such as rolled packing absorbent cotton is useful for cleaning and
swabbing wounds and useful for applying cosmetic, hospitals and in dental clinics.
Zig-zag packing cotton is suitable for orthopedic uses and sterilized absorbent cotton
or SURGICOT is suitable for domestic uses.
Along with surgical cotton there are also many types of cottons being used in
surgical needs. Uncarded bleached cotton is another type of cotton frequently used in
medical services for various uses. These cottons are hydrogen peroxide bleached and
are available in 175 to grams. These are mainly used in production of absorbent gauze.
Absorbent cotton wool is also widely used type of surgical cotton. Available in rolled
packing, it is perfect for wound swabbing, cosmetic uses and dental clinics. This is most
commonly used surgical cotton due to its economical prices.
Surgical Bandage
Surgical Bandage is the products manufactured from white bleached cotton gauge
cloth of suitable quality. Absorbent cotton also known as surgical cotton is used mainly
for medical purposes. Raw cotton is purified by a series of processed and rendered
hydrophile in character besides rendering it free from other external organic impurities.
Purified cotton is made from superior grade cotton fibers. It is bleached to pure white
colour, softened and freed from pieces of thread, leaf, shell, fiber, dust and other organic
matters. The absorbent cotton when impregnated with capscuium celnrsin and methyl
salicylate gives capscuium cotton/wool which can be used as counter irritant and in the
treatment of rheumatic producing heat on undamaged skin.
Surgical Gauze
It is High-quality and good adsorbent surgical grade made of 100% bleached cotton
with a 28 x 24 mesh count, can be used folded or unfolded.
Suture
Suturing is the joining of tissues with needle and "thread," so that the tissues bind
together and neal. The "thread" is actually specialized suture material. Suture sizes
119
120 □ □ Drug Inspector Exam

range from 00 (very large, used to close the abdominal wall-about the size of large
fishing line) to 10-0 (very tiny, used for microvascular anastomosesas fine as a human
hair). Many different suture materials are available. The main classifications are
absorbable or nonabsorbable. A more subtle sub-classification is whether the suture
material is braided or non-braided. Non-absorbable sutures remain in place until they
are removed.
Because they are not dissolved by the body, they are less tissue-reactive and therefore
leave less scarring as long as they are removed in a timely fashion. They are best used
on the skin. Absorbable sutures are dissolved by the body's tissues. The great advantage
is that the sutures do not need to be removed. However, absorbable sutures tend to
leave a more pronounced scar when used as skin sutures. Absorbable sutures are
primarily used under the skin, where they are well hidden.
Braided sutures are made up of several thin strands of the suture material twisted
together. Braided sutures are easier to tie than non-braided sutures. However, braided
sutures have little interstices in the suture material, which can be a place for bacteria
to hide and grow, resulting in an increased risk of infection.
Non-braided sutures are simply a monofilament, a single strand. They are not made
up of the little subunits found in a braided suture. Nonbraided sutures are recommended
for most skin closures, especially wounds that may be at risk for infection.
Ligature
It is a cord, wire, or bandage used for tying or binding, used in surgery to close
vessels or tie off ducts.
Catgut
Catgut is the name applied to cord of great toughness and tenacity prepared from
the intestines of the sheep or goat, or occasionally from those of the hog, horse, mule,
pig, and donkey. To prepare it, the intestines are cleaned, freed from fat, and steeped
for some time in water, after which their external membrane is scraped off with a blunt
knife. They are then steeped for some time in an alkaline lye, smoothed and equalized
by drawing out, subjected to the antiseptic action of the fumes of burning sulphur, if
necessary dyed, sorted into sizes, and twisted together into cords of various numbers
of strands according to their uses.

MULTIPLE CHOICE QUESTIONS

1. Catgut is prepared from the intestine (a) Chromic salt


of: (b) chromic acid
(a) Camel (b) sheep (c) Pot. Chromate
(c) goat (d) lamb (d) none
2. Chromic suture is prepared by soaking
in solution of:
Surgical Products □ □ 121

3. The diameter of anvil of the gauge is: (a) 11 mm (b) 12 mm


(a) 55 mm (b) 45 mm (c) 13 mm (d) 14 mm
(c) 50 mm (d) 40 mm 10. Suture size is designated by
4. In irradiation process, the prepared (a) Metric size (b) gauge no.
gut is packed in: (c) both (d) none
(a) Gold foil 11. The concentration of pot. dichromate
(b) aluminium foil used dye the suture is:
(c) cobalt foil (a) 2.83 ]igm/ml (b) 2.53 pgm/ml
(d) none (c) 1.83 pgm/ml(d) 1.53 pgm/ml
5. In irradiation process the prepared gut 12. Class III suture is composed of
is packed in the envelope having: (a) Multifilament metal wire
(a) 90% isopropyl alcohol (b) coated metal wire
(b) 90% ethanol (c) copper wire
(c) 90% propenol (d) none
(d) none
13. Surgical sutures may be colored by a
6. If the tubing fluid contains any water colored additive approved by
the tubes of catgut are labeled: (a) IP (b) USP
(a) Boilable (b) absorbable (c) BP (d) FDA
(c) non-boilable (d) non-absorbable
14. Silver wire meets the tensile strength
7. Nylon and polyester sutures are of
prescribed in (a) Class I suture
(a) BPC (b) IP (b) Class II suture
(c) USP (d) none (c) class III suture
8. The USP size of the needle for the 0.1 (d) none
no. gauge non-absorbable suture is:
15. The metric size 0.4 is equal to which
(a) 11-0 (b) 10-0 USP size?
(c) 9-0 (d) 8-0 (a) 10-0 (b) 9-0
9. For surgical suture of small size,the (c) 8-0 (d) 11-0
length of flat gripping surface of
clamp is:

ANSWERS
1 . (b) 2. (a) 3. (c) 4. (b) 5. (a) 6. (c) 7. (a) 8. (a) 9. (c) 10. (c)
1 1 . (a) 12. (a) 13. (d) 14. (a) 15. (c).

ana
Incompatibility
15
C h a pter

Many of the drugs and preparations are given only in combination. The selection
of drugs and preparations to be used in combination with each other requires a great
deal of care to avoid unwished for changes being brought about by their admixture.
Two drugs are said to be "incompatible," when on being brought into intimate contact
with each other unwished for changes either physical or chemical are brought about or
when their pharmacological actions would so interfere with each other as to be
detrimental. It is by no means an infrequent occurrence for a physician to prescribe
together two medicines which have almost opposite pharmacological actions but he
does so in such proportions that the action of the one serves but to correct some undesired
action of the other.
Incompatibility dependent upon the differing pharmacological actions of the drugs
administered together is known as Therapeutical or better Pharmacological
Incompatibility. An extreme example would be the administration of atropine and
pilocarpine together.
Incompatibility dependent upon chemical and physical changes can only occur when
the drugs are brought into intimate physical contact either by trituration in a mortar or
by solution. The incompatibility due to chemical changes occurring between preparations
dispensed together is known as Chemical Incompatibility. The changes may be of several
types and may be classified as follows: -
1. Resulting in chemical change without any visible change.
(a) The neutralization of acids by bases. *
(b) The breaking up of glycosides by acids (sugar is set free and the glycoside loses
in activity).
(c) The action of acids on the activity of pancreatic ferments and of alkali on gastric
ferments.
2. Resulting in precipitation of newly formed chemical substances due to the
interaction of two other chemical substances in solution.
* Important cases are printed in italics.
(a) Salts of the alkaline earths are precipitated by alkali hydroxides and carbonates,
phosphates, borates, oxalates (the corresponding insoluble salts of the alkaline
earths being formed). The free acids which would form corresponding salts are
also incompatible.
(b) Salts of the metals in solution are incompatible with hydrates, carbonates,
phosphates, oxalates and the corresponding acids; in many cases with proteins,
122
Incompatibility □ □ 123

tannins, acacia and often alkaloids and phenozone. Silver, mercurous, lead, and
bismuth salts also with bromides and iodides: the same metals and calcium,
barium and strontium, with sulphates and sulphuric acid.
(c) Hydrates or carbonates of the alkalies, sodium, potassium, and ammonia with
salts of metals and alkaline earths, and with alkaloids and some glucosides.
(d) Alkaloids form insoluble salts with other organic acids than acetic and citric; the
free alkaloid being very much less soluble than the salts is precipitated by alkali
hydrates and carbonates and by borax. Ammonium carbonate and the
bicarbonates do not so readily cause precipitation. Iodides, bromides, salicylates,
benzoates, usually cause a precipitate tannic acid, and iodine in a solution of
mercuric iodide; precipitation may be prevented in many of these cases by from
15-50% of alcohol. About 15% suffices to prevent that by bicarbonates and
carbonates. Alkaloides may give a precipitate with many metallic salts especially
those of mercury.
(e) Proteins are precipitated by alkaloids, many metal salts, tannin and alcohol.
3. Resulting in a change of color owing to the formation of some soluble but undesired
body owing to the interaction of two other substances in solution.
(a) Giving an objectional appearance tannic and gallic acids and iron preparations,
ammonia and carbolic acid; gallic acid and thymol. Ferric chloride with salicylates,
carbolic acid, creasote, guaiacol, salol, acetanilid, phenazone, phenacetin, oils of
wintergreen, cloves, pimenta, and thyme, podophyllin, aloin, gamboge, asafetida,
storax, myrrh, balsam of Peru, balsam of Tolu, morphine and apomorphine.
(b) The change in color is the indication of a chemical change objectionable from the
pharmacological side also. Salicylates, phenozone, acetanilid, with the free nitrous
acid in Spirits of Nitrous Ether (isonitroso-compounds are formed).
4. Resulting in the chemical splitting of one of the bodies and the formation of an
undesired body.
(a) Resulting in the freeing of a volatile body, which may in part or entirely,
dependent upon the amount formed, remain in solution. Hydrochloric acid with
nitric acid (nitrous oxides freed); strong acids with alcohol (ethers); acids and
carbonates; acids and sulphides; mineral acids with iodides, bromides, and
chlorates; ammonium salts and hydrates and carbonates of the alkalies.
(b) Resulting in the freeing of a liquid body, chloral and butylchloral with alkalies
(chloroform freed).
(c) Resulting in the freeing of dextrose or other sugar, glucosides with acids and
alkalies.
(d) Resulting in liberation of so much gas suddenly as to cause an explosion. Chromic
acid, concentrated nitric acid, nitrates, permanganates, chlorates, with such
substances as sulphur and sulphides, sulphites, iodides, phosphorus,
hypophosphites, reduced iron, and many organic bodies, sugar, tannin, etc. These
reactions only occur when the dry substances are triturated together or in some
cases when mixed in very concentrated solutions.
124 □ □ Drug Inspector Exam

5. In some cases when two solids are triturated together a soft sticky or a damp
mass, or a liquid is formed: the reaction is probably always to a certain extent chemical.
Such substances are camphor, carbolic acid, thymol, phenozone, phenacetin, chloral,
sodium phosphate, lead acetate.

MULTIPLE CHOICE QUESTIONS

1. Physical incompatibility is due to 7. Liquefaction of dry solid material may


(a) Mixing (b) solubility result from:
(c) insolubility (d) miscibility (a) Eutexia
2. Insoluble phenacetin and salol (b) water of hydration
requires the use of: (c) both (a) and (b)
(a) Emulsifying agent (d) none of above
(b) surfactants 8. Which of the following is known as
(c) thickening agent immediate incompatibility:
(d) suspending agent (a) Physical incompatibility
3. If terpin hydrate is prescribed with (b) chemical incompatibility
simple syrup, it’s a type incompatility: (c) therapeutic incompatibility
(a) Precipitation (d) none of the above
(b) insolubility 9. If sodium salicylate is prescribed with
(c) liquefaction sodium bicarbonate, the solution
(d) physical complexation darken on standing due to:
(a) Oxidation
4. If phenol is prescribed with PEG,
phenol is inactivated due to: (b) reduction
(a) Precipitation (c) changing in pH
(b) chilation (d) none of the above
(c) salt formation 10. Identify the incompatibility in the
(d) complexation prescription having potassium
chlorate, syruo ferric iodide with
5. Incompatibility of phenol and PEG is purified water:
removed by:
(a) Liquefaction
(a) Calamine (b) zinc oxide
(b) acid-base
(c) bentonite (d) bentonite magna
(c) oxidation-reduction
6. Liquefaction occurs at room (d) none of the above
temperature due to:
11. If ethyl nitrite spirit is prescribed with
(a) Depression in melting point
potassium citrate, what happen:
(b) Depression in freezing point
(a) Spirit layer will separate out
(c) Depression in vapour pressure
(b) potassium citrate will separate out
(d) None of the above
(c) aqueous layer will separate out
(d) none of the above
Incompatibility □ □ 125

12. Soluble inorganic salts react with 18. If sulphonamides are prescrib ,d with
hydroxides to yield: water what will happen
(a) Water soluble salts (a) Soluble free acids will be formed
(b) water-insoluble compound (b) insoluble free acids will be formed
'c) precipitate (c) insoluble base will be formed
(d) both (b) and (c) (d) soluble free base will be formed
13. In presence of strong base soluble salts 19. Identify the incompatibility, if the
of amine drugs liberate: sodium salicylate and Phenobarbital
(a) Free acids sodium is prescribed with Vit. B
(b) free base complex:
(c) both (a) and (b) (a) Hydrolysis
(d) none of the above (b) recemization
(c) oxidation
14. In a prescription cocain HC1, boric
acid, and sod. benzoate is prescribed (d) precipitation
with water, identify the correct 20. To overcome the above incompatibility
reaction: the salts should be dispensed:
(a) Sod. Borate will be precipitated (a) With acid
(b) cocaine will be precipitated (b) with base
(c) benzoic acid will precipitated (c) in form of solution
(d) none of the above (d) separately
15. Incompatibility of the above question 21. Identify the incom patibility in
will be eliminated by: following prescription:
(a) Boric acid Potassium chlorate - 0.6 gm
(b) sod. Benzoate Tannic acid Sucrose - 0.3 gm
(c) both (a) and (b) DTD ? 20
(d) none of the above (a) Recemization
16. Gentian violet in presence of acid (b) polymerization
compounds turns: (c) explosive combination
(a) Blue to green (d) none of the above
(b) green to yellow 22. Identify the incom patibility in
(c) purple to green following prescription:
(d) yellow to green Atropine sulphate - 0.006
17. To prevent change of color of dye in Phenobarbital 0.015
acid or base medium: Aspirin 0.300
(a) Another dye will be added (a) Therapeutic
(b) buffer will be added (b) chemical
(c) water will be added (c) physical
(d) none of the above (d) none of the above
126 □ □ Drug Inspector Exam

23. Combination of penicillin and (a) Acid (b) base


probenacid is the example of: (c) electrolyte (d) none
(a) Antagonism 26. C rystallization is an example of
(b) drug interaction ............... Incompatibility.
(c) contraindication (a) Immediate
(d) synergism (b) Delayed
24. Combination of antacid and (c) Instantaneous
tetracycline is the example of: (d) both (a) and (b)
(a) Antagonism
27........... ............. Compatibility may be
(b) drug interaction corrected by changing the order of
(c) synergism mixing.
(d) none of the above (a) Delayed (b) Immediate
25. Salting of camphor and volatile oils (c) Tolerated (d) Adjusted
may be prevented by the addition of:

ANSWERS
I. (c) 2, (c) 3. (b) 4. (d) 5. (d) 6. (a) 7. (c) 8. (b) 9. (a) 10. (c)
11. (a) 12. (b) 13. (b) 14. (b) 15. (b). 16. (J) 17. (b) 18. (b) 19. (a) 20. (d)
21. (c) 22. (a) 23. (d) 24. (b) 25. (c) 26. (b) 27. (c)

□ □ □
Cardiovascular System
16
C h a pter

The heart is the pump responsible for maintaining adequate circulation of oxygenated
blood around the vascular network of the body. It is a four-chamber pump, with the
right side receiving deoxygenated blood from the body at low presare and pumping it
to the lungs (the pulmonary circulation) and the left side receiving oxygenated blood
from the lungs and pumping it at high pressure around the body (the systemic
circulation).
The myocardium (cardiac muscle) is a specialised form of muscle, consisting of
individual cells joined by electrical connections. The contraction of each cell is produced
by a rise in intracellular calcium concentration leading to spontaneous depolarisation,
and as each cell is electrically connected to its neighbour, contraction of one cell leads
to a wave of depolarisation and contraction across the myocardium.
This depolarisation and contraction of the heart is controlled by a specialised group
of cells localised in the sino-atrial node in the right atrium- the pacemaker cells.
1. These cells generate a rhythmical depolarisation,
which then spreads out over the atria to the atrio­
ventricular node.
2. The atria then contract, pushing blood into the
ventricles.
3. The electrical conduction passes via the Atrio­
ventricular node to the bundle of His, which divides
into right and left branches and then spreads out from
the base of the ventricles across the myocardium.
4. This leads to a 'bottom-up' contraction of the
ventricles, forcing blood up and out into the
pulmonary artery (right) and aorta (left).
5. The atria then re-fill as the myocardium relaxes.
The ’squeeze’ is called systole and normally lasts for about 250 ms. The relaxation
period, when the atria and ventricles re-fill, is called diastole; the time given for diastole
depends on the heart rate.
The ECG
The Electrocardiograph (ECG) is clinically very useful, as it shows the electrical
activity within the heart, simply by placing electrodes at various points on the body
surface. This enables clinicians to determine the state of the conducting system and of
127
128 □ □ Drug Inspector Exam

the myocardium itself, as damage to the myocardium alters the way the impulses travel
through it.
When looking at an ECG, it is often helpful to remember that an upward deflection
on the ECG represents depolarisation moving towards the viewing electrode, and a
downward deflection represents depolarisation moving away from the viewing electrode.
• The P wave represents atrial depolarisation- there is little muscle in the atrium
so the deflection is small.
• The Q wave represents depolarisation at the bundle of his; again, this is small
as there is little muscle there.
• The R wave represents the main spread of depolarisation, from the inside out,
through the base of the ventricles. This involves large ammounts of muscle so
the deflection is large.
• The S wave shows the subsequent depolarisation of the rest of the ventricles
upwards from the base of the ventricles.
• The T wave represents repolarisation of the myocardium after systole is complete.
This is a relatively slow process- hence the smooth curved deflection.

■Vrh of aorta

Pulmonary trunk

Left coronary artery


Sinuatrial nodal

Circumflex branch
Right coronary atery Anterior interventricular
Left marginal
Antrioventricular nodal
Diagonal
Post, interventricular

Right marginal

Fig. 16.2.

The Coronary Circulation


The heart needs its own reliable blood supply in order to keep beating- the coronary
circulation. There are two main coronary arteries, the left and right coronary arteries,
and these branch further to form several major branches. The coronary arteries lie in
grooves (sulci) running over the surface of the myocardium, covered over by the
epicardium, and have many branches which terminate in arterioles supplying the vast
capillary network of the myocardium. Even though these vessels have multiple
anastomoses, significant obstruction to one or other of the main branches will lead to
ischaemia in the area supplied by that branch.
Cardiovascular System Anatomy and Physiology □ □ 129

CARDIOVASCULAR DISEASES
Types of cardiovascular disease includes angina, heart attack (myocardial infarction),
atherosclerosis, heart failure, cardiovascular disease, and cardiac arrhythmias (abnormal
heart rhythms). Other forms of cardiovascular disease include congenital heart defects,
cardiomyopathy, infections of the heart, coronary artery disease, heart valve disorders,
myocarditis, and pericarditis.
1. Heart Attack
Heart attack also called myocardial infarction, is a very serious condition in which
the heart is not receiving enough oxygen to function properly. Heart attack is a common
cause of death. The heart requires a steady supply of o*ygen in order to pump blood
effectively to all of the body. Oxygen is supplied to the heart in the blood that flows
through the coronary arteries. If a coronary artery becomes blocked, the portion of the
heart that gets its oxygen-rich blood from that specific artery becomes damaged. This
injury can become permanent within minutes and result in the death of the affected
heart tissue. Medically this is called myocardial necrosis or infarction.
Heart attacks often result from a build-up of plaque and inflammation in the arteries,
called atherosclerosis. This process narrows the coronary arteries and lowers the amount
of oxygen-rich blood that reaches the heart muscle. This is called angina. Arteries
narrowed by atherosclerosis are more likely to develop a blood clot that completely
blocks blood flow, resulting in a heart attack. Risk factors for atherosclerosis include
having high cholesterol.
2. Angina
Angina is a common type of chest pain that can occur when the heart muscle is not
receiving sufficient blood flow and oxygen. Angina is a symptom of some heart diseases,
especially atherosclerosis. Atherosclerosis is the build-up of plaque and inflammation
in the arteries of the body, including the arteries that supply blood to the heart muscle
(coronary arteries). Atherosclerosis narrows the coronary arteries and lowers the amount
of oxygen-rich blood that reaches the heart muscle. Arteries narrowed by atherosclerosis
are more likely to develop a blood clot that completely blocks blood flow, resulting in
a heart attack The chest pain of angina can be mild to severe.
The chest pain of angina is different from the chest pain of a heart attacK in that
angina generally occurs with activity or exertion and goes away with rest and/or
medication, such as nitroglycerin. In contrast, the chest pain of a heart attack does not
go away with rest or after taking nitroglycerin. To learn more about other important
symptoms and complications of angina, refer to symptoms of angina.
Angina can also be a symptom of other types of heart disease, such as aortic valve
disease, coronary artery spasm and cardiac arrhythmias, which can all reduce the amount
of blood and oxygen that reaches the heart muscle.
Angina can also be a symptom of anemia, in which a low number of red blood cells
in the blood reduces the amount of oxygen supplied to the heart muscle.
130 □ □ Drug Inspector Exam

Risk factors for developing angina are the same risk factors for developing heart
disease. These include having high cholesterol, hypertension, diabetes, high cholesterol
(hypercholesterolemia, hyperlipidemia), obesity, and a sedentary lifestyle.
3. Congestive Heart Failure
Congestive Heart Failure (CHF) is a condition in which the heart's function as a
pump is inadequate to deliver oxygen rich blood to the body. Congestive heart failure
can be caused by :
(a) diseases that weaken the heart muscle
(b) diseases that cause stiffening of the heart muscles, or
(c) diseases that increase oxygen demand by the body tissue beyond the capability
of the heart to deliver adequate oxygen-rich blood.
The heart has two atria (right atrium and left atrium) that make up the upper
chambers of the heart, and two ventricles (left ventricle and right ventricle) that make
up the lower chambers of the heart. The ventricles are muscular chambers that pump
blood when the muscles contract. The contraction of the ventricle muscles is called
systole.
Many diseases can impair the pumping action of the ventricles. For example, the
muscles of the ventricles can be weakened by heart attacks, infections (myocarditis) or
toxins (alcohol, some chemotherapy agents). The diminished pumping ability of the
ventricles due to muscle weakening is called systolic dysfunction. After each ventricular
contraction (systole) the ventricle muscles need to relax to allow blood from the atria
to fill the ventricles. This relaxation of the ventricles is called diastole.
Diseases such as hemochromatosis (iron overload) or amyloidosis can cause stiffening
of the heart muscle and impair the ventricles' capacity to relax and fill; this is referred
to as diastolic dysfunction. The most common cause of this is longstanding high blood
pressure resulting in a thickened (hypertrophied) heart. Additionally, in some patients,
although the pumping action and filling capacity of the heart may be normal, abnormally
high oxygen demand by the body's tissues (for example, with hyperthyroidism or anemia)
may make it difficult for the heart to supply an adequate blood flow (called high output
heart failure).
Congestive heart failure can affect many organs of the body. For example :
• The weakened heart muscles may not be able to supply enough blood to the
kidneys, which then begin to lose their normal ability to excrete salt (sodium)
and water. This diminished kidney function can cause the body to retain more
fluid.
• The lungs may become congested with fluid (pulmonary edema) and the person’s
ability to exercise is decreased.
• Fluid may likewise accumulate in the liver, thereby impairing its ability to rid
the body of toxins and produce essential proteins.
• The intestines may become less efficient in absorbing nutrients and medicines.
Cardiovascular System Anatomy and Physiology □ □ 131

* Fluid also may accumulate in the extremities, resulting in edema (swelling) of


the ankles and feet.
4. Hypertension
High Blood Pressure (HBP) or hypertension means high pressure (tension) in the
arteries. Arteries are vessels that carry blood from the pumping heart to all the tissues
and organs of the body. High blood pressure does not mean excessive emotional tension,
although emotional tension and stress can temporarily increase blood pressure. Normal
blood pressure is below 120/80; blood pressure between 120/80 and 139/89 is called
"pre-hypertension", and a blood pressure of 140/90 or above is considered high.
The top number, the systolic blood pressure, corresponds to the pressure in the
arteries as the heart contracts and pumps blood forward into the arteries. The bottom
number, the diastolic pressure, represents the pressure in the arteries as the heart relaxes
after the contraction. The diastolic pressure reflects the lowest pressure to which the
arteries are exposed.
An elevation of the systolic and/or diastolic blood pressure increases the risk of
developing heart (cardiac) disease, kidney (renal) disease, hardening of the arteries
(atherosclerosis or arteriosclerosis), eye damage, and stroke (brain damage). These
complications of hypertension are often referred to as end-organ damage because damage
to these organs is the end result of chronic (long duration) high blood pressure. Fc?r that
reason, the diagnosis of high blood pressure is important so efforts can be made to
normalize blood pressure and prevent complications.
5. Hypotension
Low blood pressure (hypotension) is pressure so low it causes symptoms or signs
due to the low flow of blood through the arteries and veins. When the flow of blood
is too low to deliver enough oxygen and nutrients to vital organs such as the brain,
heart, and kidney, the organs do not function normally and may be temporarily or
permanently damaged. Unlike high blood pressure, low blood pressure is defined
primarily by signs and symptoms of low blood flow and not by a specific blood pressure
number. Some individuals routinely may have blood pressures of 90/50 with no
symptoms and therefore do not have low blood pressure. However, others who normally
have higher blood pressures may develop symptoms of low blood pressure if their
blood pressure drops to 100/60.

MULTIPLE CHOICE QUESTIONS

1. ' Which is true regarding the (b) The cardiac action potential is
conduction system of the heart: conducted through the atria via
(a) Between action potentials, the cells Purkinje fibers.
of the sino-atrial node have a (c) The Purkinje fibers are specialized
steady resting potential. cardiac myocytes linked by gap
junctions.
132 □ □ Drug Inspector Exam

(d) The spread of cardiac excitation 5. Which is true for cardiac output:
speeds up at the atrio-ventricular (a) Is increased by aldosterone
node. released from the adrenal medulla.
2. Which is true regarding the ECG: (b) Is increased by stimulation of the
(a) The P wave of the ECG reflects vagus nerve.
atrial contraction. (c) Can be measured by dividing the
(b) The P-Q interval is normally about oxygen consumption by the
0.1s. difference in P 0 2 of the venous
(c) The QRS complex reflects the start and arterial blood.
of ventricular contraction. (d) Is largely determined by the end-
(d) The peak amplitude of the ECG diastolic volume.
recorded by the limb leads is about 6. The arterial blood pressure:
10 mV. (a) Is 120/80 mm Hg (16/10.6 kPa)
3. Which is true during the cardiac cycle (b) Depends solely on the cardiac
of a normal healthy young adult: output.
(a) During ventricular diastole the (c) Is the arithmetic average of the
pressure in the left ventricle is systolic and diastolic pressures.
close to 80 mm Hg (10.6 kPa). (d) Is due to the vascular resistance of
(b) During ventricular systole, the the capillaries.
pressure in the left ventricle 7. Concerning the control of the
reaches a maximum of about 25 vasculature:
mm Hg (3.3 kPa). (a) Autoregulation refers to the
(c) During the initial stage of nervous control of the blood
ventricular contraction the volume vessels.
of the ventricle does not change. (b) Reactive hyperemia is due to
(d) During ventricular systole, all the vasodilatation caused by
blood in the ventricles is ejected. accumulation of metabolites
4. Which is true concerning the normal during a period of exercise.
heart sounds: (c) Parasympathetic vasodilator fibers
(a) The first heart sound corresponds innervate the blood vessels of the
with the closure of the mitral and exocrine glands of the gastro­
tricuspid valves. intestinal tract.
(b) The first heart sound occurs just (d) The diameter of the arterioles is
before the R wave of the ECG. entirely regulated by the
(c) The first heart sound is split into sympathetic nervous system.
two components during 8. Concerning the microcirculation:
inspiration. (a) The exchange of solutes between
(d) The second heart sound occurs the capillaries and tissues occurs
during the T-wave. mainly by bulk flow.
Cardiovascular System Anatomy and Physiology □ □ 133

(b) The capillaries provide a (a) great cardiac vein


significant source of vascular (b) coronary sinus
resistance. (c) inferior vena cava
(c) All of the fluid that passes from (d) superior vena cava
the capillaries to the tissues is
returned to the blood via the 13. If communication between the SA
lymphatic circulation. node and the AV node becomes
blocked which is most certainly
(d) The plasma proteins play an
affected:
important role in tissue fluid
exchange. (a) the ventricles will contract at a
slower rate
9. Concerning the nervous regulation of (b) afterload will increase---------------
------ the circulation: ---------
(c) the atria will contract at a slower
(a) The baroreceptors are mainly rate
responsible for the long-term
(d) stroke volume will increase
regulation of systemic blood
(e) all of the above
pressure.
(b) If the arterial pressure suddenly 14. If there is a blockage between the AV
falls the baroreceptor reflex node and AV bundle, how will this
increases the heart rate. affect the appearance of the ECG:
(c) The baroreceptors are found in the (a) P-R interval would be smaller
aortic and carotid bodies. (b) QRS interval would be longer
____ (d) The coronary^ixloocLJElow—is^ ------ (c) there would be more P waves than
regulated by the cardiac volume QRS complexes
receptors. (d) there would be more QRS
10. The space in the middle of the thoracic complexes than P waves
cavity where the heart resides is the: (e) the T wave would not be present
(a) pericardial cavity 15. What effect would compressing the
(b) pericardium inferior vena cava just below the
(c) pleural cavity diaphragm have on cardiac function:
(d) mediastinum (a) stroke volume would decrease
(e) dorsal cavity (b) cardiac output would decrease
(c) sympathetic stimulation of the
11. The foramen ovale in the fetal heart is
heart would eventually increase
located in the:
(d) heart rate would eventually
(a) right atrium
increase
(b) left atrium
(e) all of the above
(c) interventricular septum
(d) interatrial septum 16. A valve damaged by rheumatic fever
(e) pulmonary trunk fails to open completely. This is called:
(a) stenosis
12. Which blood vessel does NOT bring
(b) heart block
blood directly to the heart:
134 □ □ Drug Inspector Exam

(c) ischemia (c) EDV-ESV


(d) MI (d) EDV-SV x HR
(e) fibrillation (e) HR x BP
17. A patient with CAD (coronary artery 22. During ventricular systole:
disease) is experiencing severe angina (a) the atria are contracting
and self-adm inisters sublingual (b) the AV valves are closed
nitroglycerin. This will act as a(n): (c) the pressure inside the ventricles
(a) cardiac beta-blocker is less than in the atria
(b) coronary vasodilator (d) the mitral valve is closed
(c) coronary vasoconstrictor (e) blood is ejected into the atria
(d) anticoagulant blood-thinner
23. In general, veins exhibit this
(e) angioplastic agent characteristic when compared to
18. Blood returning from the lungs enters arteries:
the heart through the: (a) are thinner walled
(a) pulmonary semilunar valve (b) have more smooth muscle in the
(b) mitral valve tunica media
(c) right ventricle (c) carry faster moving blood
(d) left atrium (d) have thicker endotheliume) are
(e) vena cava more elastic
19. According to Starling's Law of the 24. The blood vessels that play the most
heart, cardiac output is directly related important role in the regulation of
to: blood flow to a tissue and blood
(a) the size of the ventricles pressure are the'
(b) the heart rate (a) arterioles
(c) amount of blood returning to the (b) capillaries
heart (c) venules
(d) end-systolic volumee) cardiac (d) arteries
reserve (e) veins
20. The T wave on an ECG represents: 25. As blood travels from the aorta to the
(a) ventricular depolarization capillaries:
(b) ventricular repolarization (a) pressure increases
(c) atrial depolarization (b) viscosity increases
(d) atrial repolarization (c) resistance increases
(e) ventricular systole (d) velocity increases
21. Cardiac output is equal to: (e) flow increases
(a) diastolic BP + l/3(systolic BP- 26. The internal carotids and the basilar
diastolic BP) ' artery are interconnected by an
(b) HR x SV anastomosis call the:
Cardiovascular System Anatomy and Physiology □ □ 135

(a) brachiocephalic trunk 32. What are the mechanisms involved in


(b) common carotid artery the return of venous blood to the
(c) coronary sinus heart?
(d) throughway channel (a) The venous pump
(e) circle of Willis (b) Peripheral resistance
(c) Respiratory pump
27. A patient with an hypothalamic tumor
causes excessive ADH secretion. When (d) Venous valvese. option (a), (c) & (d)
her blood pressure is taken which of 33. With regards to the venous pump
the following readings would you (a) Calf muscles contract and
expect: compress the nearby blood vessels
(a) 95/65 (b) 115/80 propelling blood towards the
(c) 120/65 (d) 165/100 heart.
28. The difference between the systolic (b) If this system fails to work
and diastolic pressures is called the: effectively, the high pressure in the
deep veins, is transmitted to the
(a) mean arterial blood pressure
much weaker, unsupported
(b) blood pressure
superficial veins.
(c) pulse pressure (c) During exhalation, the internal
(d) end-ventricular pressure pressure in the thoracic cavity
(e) none of the above rises. Air is forced out of the lungs,
29. Which of the following is NOT a risk and venous blood pushed
factor for developing atherosclerosis: into the right atrium.
(a) high andrigenic hormone 34. Which of the following statements are
(b) diabetes true?
(c) smoking (a) Venous valves point in the
(d) high HDL level opposite direction to blood flow.
(e) high dietary fat intake (b) Venous valves are folds of tissue
formed from the endothelial lining
30. Which of the following is not one of of the tunica intima.
the three main factors influencing (c) In the absence of valves, pooling
blood pressure? of blood in the leg veins would
(a) cardiac output occur.
(b) peripheral resistance (d) During movement, smooth
(c) emotional state muscles surrounding veins
(d) blood volume squeeze the blood towards the
heart.
31. Which tunic of an artery contains
endothelium ? (e) option (b), (c) & (d)
(a) tunica intima — 35. Which is true regarding pain of
(b) tunica media x myocardial ischemia:
(c) tunica externa (a) Is typically Induced by exercise
and relieved by rest.
(d) basement membrane
136 □ □ Drug Inspector Exam

{b) Radiates to the neck and Jiw but 38. Drug used in treating CHF: associated
not teeth. with a reversible thrombocytopenia:
(c) Rarely lasts longer than 10 seconds (a) dopamine (Intropin)
after resting. (b) hydralazine (Apresoline)
(d) Invariably worsens as exercise (c) methyldopa (Aldomet)
continues. (d) amrinone (Inocor)
(e) options (a) & (d) are true (e) digoxin (Lanoxin, Lanoxicaps
36. Diastolic pressure is related to 39. Precipitating causes of congestive
(a) resistance of the blood vessels to heart failure:
blood flow. (a) AV dissociation
(b) the amount of force developed (b) severe bradycardia
during contraction of the heart. (c) reduce synchrony of ventricular
(c) the volume of blood leaving the contraction
heart. (d) tachyarrhythmias
(d) the arteries' elasticity (e) All of the above
37. Males are at greater risk for 40. Mechanism by which vasodilators
hypertension improve myocardial performance in
(a) across the life span. CHF:
(b) before age 50. (a) increase heart rate
(c) after age 50. (b) promote diuresis
(d) none of the above (c) reduce afterload
(d) reduce pulmonary blood flow

ANSWERS

1. (c) 2. (b) 3- (c) 4. (a) 5- (d) 6. (a) 7. (a) 8. (d) 9. (b) 10.(d)
H. (d) 12. (a) 13. (a) 14. (c) 15. (e). 16. (a) 17. (b) 18. (d) 19. (c) 2 0 .<b)
21- (b) 22. (b) 23. (a) 24. (a) 25. (c) 26. (e) 27. (d) 28. (c) 29. (d) 3 0 .(c)
31. (a) 32. (e) 33. (a) 34. (e) 35. (e) 36. (a) 37. (b) 38. (d) 39. (e) 40. (c)

nnn
Human Digestive System
17
C h a pter

The human digestive system is a complex process that consists of breaking down
large organic masses into smaller particles that the body can use as fuel. The breakdown
of the nutrients requires the coordination of several enzymes secreted from specialized
cells within the mouth, stomach, intestines; and liver. The major organs or structures
that coordinate digestion within the human body include the mouth, esophagus, stomach,
small and large intestine, and liver.

Fig. 17.1. Digestive System

Mouth
In the human body, the mouth (oral cavity) is a specialized organ for receiving food
and breaking up large organic masses. In the mouth, food is changed mechanically by
biting and chewing. Humans have four kinds of teeth: incisors are chisel-shaped teeth
in the front of the mouth for biting; canines are pointed teeth for tearing; and premolars
and molars are flattened, ridged teeth for grinding, pounding, and crushing food.
In the mouth, food is moistened by saliva, a sticky fluid that binds food particles
together into a soft mass. Three pairs of salivary glands—the parotid glands, the sub-
138 □ □ Drug Inspector Exam

maxillary glands, and the sublingual glands—secrete saliva into the mouth. The saliva
contains an enzyme called amylase, which digests starch molecules into smaller molecules
of the disaccharide maltose.
During chewing, the tongue moves food about and manipulates it into a mass
called a bolus. The bolus is pushed back into the pharynx (throat) and is forced through
the opening to the esophagus.
Esophagus
The esophagus is a thick-walled muscular tube located behind the windpipe that
extends through the neck and chest to the stomach. The bolus of food moves through
the esophagus by peristalsis: a rhythmic series of muscular contractions that propels
the bolus along. The contractions are assisted by the pull of gravity.
Stomach
The esophagus joins the stomach at a point just below the diaphragm. A valve like
ring of muscle called the cardiac sphincter surrounds the opening to the stomach. The
sphincter relaxes as the bolus passes through and then quickly closes.
The stomach is an expandable pouch located high in the abdominal cavity. Layers of
stomach muscle contract and chum the bolus of food with gastric juices to form a soupy
liquid called chyme.
The stomach stores food and prepares it for further digestion. In addition, the stomach
plays a role in protein digestion. Gastric glands called chief cells secrete pepsinogen.
Pepsinogen is converted to the enzyme pepsin in the presence of hydrochloric acid.
Hydrochloric acid is secreted by parietal cells in the stomach lining. The pepsin then
digests large proteins into smaller proteins called peptides. To protect the stomach
lining from the acid, a third type of cell secretes mucus that lines the stomach cavity.
An overabundance of acid due to mucus failure may lead to an ulcer.
Small Intestine
The soupy mixture called chyme spurts from the stomach through a sphincter into
the small intestine. An adult's small intestine is about 23 feet long and is divided into
three sections: the first 10 to 12 inches form the duodenum; the next 10 feet form the
jejunum; and the final 12 feet form the ileum. The inner surface of the small intestine
contains numerous fingerlike projections called villi. Each villus has projections of cells
called microvilli to increase the surface area.
Most chemical digestion takes place in the duodenum. In this region, enzymes
digest nutrients into simpler forms that can be absorbed. Intestinal enzymes are
supplemented by enzymes from the pancreas, a large, glandular organ lying near the
stomach. In addition, bile enters the small intestine from the gall bladder to assist in fat
digestion.
The enzymes functioning in carbohydrate digestion include amylase (for starch),
maltase (for maltose), sucrase (for sucrose) and lactase (for lactose). For fats, the principal
enzyme is lipase. Before this enzyme can act, the large globules of fat must be broken
Human Digestive System □ □ 139

into smaller droplets by bile. Bile is a mixture of salts, pigments, and cholesterol that is
produced by the liver and stored in the gall bladder, a saclike structure underneath the
liver.
Protein digestion is accomplished by several enzymes, including two pancreatic
enzymes: trypsin and chymotrypsin. Peptides are broken into smaller peptides, and
peptidases reduce the enzymes to amino acids. Nucleases digest nucleic acids into
nucleotides in the small intestine also.
Most absorption in the small intestine occurs in the jejunum. The products of
digestion enter cells of the villi, move across the cells, and enter blood vessels called
capillaries. Diffusion accounts for the movement of many nutrients, but active transport
is responsible for the movement of glucose and amino acids. The products of fat digestion
pass as small droplets of fat into lacteals, which are branches of the lymphatic system.
Absorption is completed in the final part of the small intestine, the ileum. Substances
that have not been digested or absorbed then pass into the large intestine.
Large intestine
The small intestine joins the large intestine in the lower right abdomen of the body.
The two organs meet at a blind sac called the cecum and a small fingerlike process
called the appendix. Evolutionary biologists believe the cecum and appendix are vestiges
of larger organs that may have been functional in human ancestors.
The large intestine is also known as the colon. It is divided into ascending, transverse,
and descending portions, each about one foot in length. The colon's chief functions are
to absorb water and to store, process, and eliminate the residue following digestion and
absorption. The intestinal matter remaining after water has been reclaimed is known as
feces. Feces consist of nondigested food (such as cellulose), billions of mostly harmless
bacteria, bile pigments, and other materials. The feces are stored in the rectum and
passed out through the anus to complete the digestion process.
Liver
The liver has an important function in processing the products of human digestion.
For example, cells of the liver remove excess glucose from the bloodstream and convert
the glucose to a polymer called glycogen for storage.
The liver also functions in amino acid metabolism. In a process called deamination,
it converts some amino acids to compounds that can be used in energy metabolism. In
doing so, the liver removes the amino groups from amino acids and uses the amino
groups to produce urea. Urea is removed from the body in the urine. Fats are processed
into two-carbon units that can enter the Krebs cycle for energy metabolism. The liver
also stores vitamins and minerals, forms many blood proteins, synthesizes cholesterol,
and produces bile for fat digestion.
Common Digestive System Disorders
There are five basic symptoms indicating a GIT problem. These symptoms are
generally associated with dietary problems or specific food allergies. It is critical that
140 □ □ Drug Inspector Exam

anyone suffering from serious GIT problems work closely with a physician to test for
the more developed and serious GIT diseases. The physician should also be experienced
in working with dietary factors and food allergies.
Nausea and Vomiting
Nausea and vomiting can vary from an unsettled feeling in the stomach to the
violent action of immediate vomiting. Patients with nausea and vomiting symptoms
should assume the ingestion of a reactive food i.e., food containing toxins) or poisoning
with a pathogen such as salmonella. Vomiting immediately after eating is usually
proceeded by excessive watery salivation. Some chronic low-intensity nausea can occur
for a protracted time due to sustained low-level food allergies or problems with food
combinations. Patients with low-level nausea usually have their symptoms disappear
with diet revision. Nausea and vomiting are also linked with migraines caused by food
allergies..
Bloating
Bloating can result from excessive gas in the digestive system, failure of the digestive
tract to sustain youthful peristaltic contractions, or a lack of sufficient quantities of
digestive enzymes and bile acids to rapidly break down food. Intestinal gas results from
food fermentation and from swallowing air while eating. The bloating from intestinal
gas is different from that which occurs in the colon.
Constipation
Constipation is the decreased frequency, or slowing, of peristalsis, resulting in harder
stools. When the GIT is slowed down, feces can accumulate in the colon with attending
pain and toxic reactions. A spastic colon results when the colon contracts out of rhythm
in painful spasms blocking movement of the stool. Some patients experience painful
days of constipation followed by forceful diarrhea and watery stool, often accompanied
with abdominal cramps.
Diarrhea
Diarrhea is the increased frequency of bowel movements that is also loose or watery.
If diarrhea increases, the possibility of celiac disease is considered. Celiac disease is a
seriou^ disease that allows certain macromolecules to pass through the intestinal wall.
If blood appears in the stool, ulcerative colitis is likely. Protracted bouts with diarrhea
can result in nutritional deficiencies due to the poor absorption of essential nutrients.
Abdominal Pain
Abdominal pain appears in different patterns and with varying intensities. Cramping
occurs because of muscle spasms in the abdominal organs. Severe cramping pain, often
called colic, usually occurs from problems with strong allergic response to food.
Abdominal cramping near the navel is typically from the small intestine, and near the
sides, top, and bottom of the lower abdomen, the pain is associated with the colon.
Human Digestive System □ □ 141

Diseases associated with central GIT disorders and diagnoses include aepression,
migraine, asthma, sinusitis, and fibromyalgia. These diseases have been identified with
specific patterns of food allergy response. All of these diseases also have links to Irritable
Bowel Syndrome. (IBS is more accurately referred to as RBS—Reactive Bowel Syndrome.)
Peptic Ulcer
A peptic ulcer is a hole in the gut lining of the stomach, duodenum, or esophagus.
A peptic ulcer of the stomach is called a gastric ulcer; of the duodenum, a duodenal
ulcer; and of the esophagus, an esophageal ulcer. An ulcer occurs when the lining of
these organs is corroded by the acidic digestive juices which are secreted by the stomach
cells.
For many years, excess acid was believed to be the major cause of ulcer disease.
Accordingly, treatment emphasis was on neutralizing and inhibiting the secretion of
stomach acid. While acid is still considered significant in ulcer formation, the leading
cause of ulcer disease is currently believed to be infection of the stomach by a bacteria
called "Helicobacter pyloricus" (H. pylori). Another major cause of ulcers is the chronic
us^ of anti-inflammatory medications, commonly referred to as NSAIDs (nonsteroidal
anti-inflammatory drugs), including aspirin. Cigarette smoking is also an important
cause of ulcer formation and ulcer treatment failure.
Jaundice
Jaundice is not a disease but rather a sign that can occur in many different diseases.
Jaundice is the yellowish staining of the skin and sclerae (the whites of the eyes) that
is caused by high levels in blood of the chemical bilirubin. The color of the skin and
sclerae vary depending on the level of bilirubin. When the bilirubin level is mildly
elevated, they are yellowish. When the bilirubin level is high, they tend to be brown.
Bilirubin comes from red blood cells. When red blood cells get old, they are destroyed.
Hemoglobin, the iron-containing chemical in red blood cells that carries oxygen, is
released from the destroyed red blood cells after the iron it contains is removed. The
chemical that remains in the blood after the iron is removed becomes bilirubin.
The liver has many functions. One of the liver's functions is to produce and secrete
bile into the intestines to help digest dietary fat. Another is to remove toxic chemicals
or waste products from the blood, and bilirubin is a waste product. The liver removes
bilirubin from the blood. After the bilirubin has entered the liver cells, the cells conjugate
(attaching other chemicals, primarily glucuronic acid) to the bilirubin, and then secrete
the bilirubin/glucuronic acid complex into bile. The complex that is secreted in bile is
called conjugated bilirubin. The conjugated bilirubin is eliminated in the feces. (Bilirubin
is what gives feces its brown color.) Conjugated bilirubin is distinguished from the
bilirubin that is released from the red blood cells and not yet removed from the blood
which is termed unconjugated bilirubin.
Jaundice occurs when there is (a) too much bilirubin being produced for the liver
to remove from the blood. (For example, patients with hemolytic anemia have an
abnormally rapid rate of destruction of their red blood cells that releases large amounts
142 □ □ Drug Inspector Exam

of bilirubin into the blood), (b) a defect in the liver that prevents bilirubin from being
removed from the blood, converted to bilirubin/glucuronic acid (conjugated) or secreted
in bile, or (c) blockage of the bile ducts that decreases the flow of bile and bilirubin from
the liver into the intestines. (For example, the bile ducts can be blocked by cancers,
gallstones, or inflammation of the bile ducts). The decreased conjugation, secretion, or
flow of bile that can result in jaundice is referred to as cholestasis: however, cholestasis
does not always result in jaundice.

MULTIPLE CHOICE QUESTIONS

1. Which is true regarding salivary (c) Contractions of the stomach wall


secretion and swallowing? do not begin until food enters the
(a) The food bolus is propelled down stomach.
the esophagus by segmentation (d) The contractions of the stomach
movements. depend on activity in the vagus
(b) The pH of saliva rises as its rate of nerve.
secretion increases. 4. Which is true regarding pancreatic
(c) Swallowing is a purely voluntary secretion?
activity. (a) Pancreatic secretion is inhibited by
(d) Hormones are more important gastrin secreted by the G cells of
than nerves in the regulation of the antrum.
salivary secretion. (b) Pancreatic acinar cells contain
2. Which is true regarding the control of trypsin.
gastric secretion? (c) Cholecystokinin inhibits secretion
(a) Gastric acid is secreted by parietal from the exocrine pancreas.
cells of the gastric glands in (d) The introduction of acid into the
response to hormonal stimulation. duodenum stimulates pancreatic
(b) Most of the acid and pepsinogen secretion.
secreted by the stomach occurs 5. Which is true regarding the bile?
during the intestinal phase of (a) Bile is diluted in the gall bladder.
gastric secretion. (b) Bile salts are hydrophobic
(c) Gastric secretion does not begin molecules.
until food enters the stomach. (c) Most bile salts are absorbed in the
(d) Secretin secreted by the duodenum terminal ileum.
stimulates gastric secretion. (d) Bile salts are the breakdown
3. Which is true regarding gastric products of hemoglobin.
motility? 6. Which is true regarding digestion and
(a) Gastric emptying is inhibited by absorption by the small intestine?
the enterogastric reflex. (a) Intestinal digestive enzymes are
(b) The antral region of the stomach secreted by cells of the crypts of
is important for the storage of Lieberkuhn.
food.
Human Digestive System □ □ 143

(b) About half of the digested 10. The most common cause jf upper
carbohydrate is absorbed in the gastrointestinal hemorrhage
small intestine. (hematemesis or melena) is:
(c) Small peptides are absorbed in the (a) esophageal varices
small intestine. (b) gastric carcinoma
(d) The liver is the first organ to (c) peptic ulcer
receive the digestion products of (d) gastritis
dietary fats.
11. Hematochezia is found with:
7. Which is true regarding gastro­ (a) upper gastrointestinal bleeding
intestinal function?
(b) lower gastrointestinal bleeding
(a) The presence of large amounts of
(c) both
fat in the chyme will accelerate
(d) neither
gastric emptying.
(b) Distension of the ileum stimulates 12. Choose the best statement concerning
gastric motility. the pathogenesis of peptic ulcer.
(c) Total gastrectom y leads to (a) Acid must be increased.
malabsorption of vitamin B12. (b) Acid must be at least normal in
(d) Aldosterone inhibits the amount.
absorption of sodium and water (c) Acid must be present.
by the large intestine. (d) Acid need not be present.
8. Digestion begins in the mouth. Which 13. Which one of the following is a feature
of the follow ing statem ent is of the Zollinger-Ellison syndrome?
INCORRECT? (a) hypoglycemic attacks
(a)- The tongue aids in the digestion (b) obesity
of the food. (c) gastric hyperchlorhydria
(b) The saliva changes some of the (d) diabetes
starches in the food to sugar. (e) fainting spells
(c) The tongue keeps the food in place
in the mouthwhile the food is 14. The most common site of chronic
being chewed. gastric peptic ulcer is:
(d) The digestive juices can react more (a) lesser curvature at antral-body
easily with the food when chewed. junction
(b) anterior wall at duodenal verge
9. A two-week-old boy develops
(c) greater curvature in mid-antrum
persistent projectile vomiting. The
most likely diagnosis is: (d) esophago-gastric junction
(a) pyloric stenosis 15. The most frequent complication of
(b) esophageal atresia chronic duodenal ulcer is:
(c) annular pancreas (a) hemorrhage
(d) incomplete rotation of the gut (b) obstruction
(c) perforation
(d) malabsorption
144 □ □ Drug Inspector Exam

16. Chronic peptic ulcer of the stomach 20. Which cells produce pepsinogen?
occurs predominantly: (a) Zymogenic cells
(a) on the acid-secreting portion of the (b) Parietal cells
gastric mucosa (c) Mucous cells
(b) in an area of the stomach that has (d) Enteroendocrine cells
undergone squamous metaplasia
21. Crypts of Lieberkuhn is present in
(c) on areas of the gastric mucosa
adjacent to the acid secreting (a) oesophagus
mucosa (b) jejunum
(d) at the cardio-esophageal junction (c) large intestine
(e) adjacent to carcinoma (d) pharynx
17. Which is inconsistent with a diagnosis 22. Which is not true about Helicobacter
of benign gastric ulcer? pylori bacteria:
(a) absence of ulcer crater (a) Adhere to the gastric mucosa in
radiologically an alkaline layer "
(b) achlorhydria even after histamine (b) Are never seen in healthy people
challenge (c) Can be simply identified in the
(c) multiple defects seen endoscopy room by their urease
radiologically activity
(d) age less than 20 years (d) Are associated with peptic ulcer
relapse
18. Which of the follow ing is an
inflammatory bowel disease? 23. Effective ulcer treatment which works
(a) Crohn's disease without any action on gastric acid
secretion is:
(b) ulcerative colitis
(a) Lactulose
(c) both
(b) Aluminium hydroxide
(d) neither
(c) Sucralfate (d) Lactitol
19. What is Dysphagia? (e) Magnesium trisilicate
(a) inability to swallow or difficulty
in swallowing 24. Chagas’ disease may be suspected if a
patient has:
(b) lack of HC1 in stomach
(a) Constipation (b) Dysphagia
(c) decreased intestinal movement
(c) Heart failure (d) Jaundice
(d) all of the above
(e) option (a), (b) & (c)
ANSWERS
1. (b) 2. (a) 3. (a) 4. (d) 5. (c) 6. (c) 7. (c) 8. (a) 9. (a) 10. (c)
11. (b) 12. (c) 13. (c) 14. (a) 15. (a) 16. (c) 17. (b) 18. (c) 19. (a) 20. (a)
21. (b) 22. (b) 23. (c) 24. (e)

□ □ □
Brain and Spinal Cord
18
C h a pt er

The brain and spinal cord form the central nervous system. This complex system is
part of everything we do. It controls the things we choose to do -- like walk and talk
— and the things our body does automatically — like breathe and digest food. The
central nervous system is also involved with our senses — seeing, hearing, touching,
tasting, and smelling — as well as our emotions, thoughts, and memory.

The Brain and Spinal Cord


The brain is a soft, spongy mass of nerve cells and supportive tissue. It has three
major parts: the cerebrum, the cerebellum, and the brain stem. The parts work together,
but each has special functions.
The cerebrum, the largest part of the brain, fills most of the upper skull. It has two
halves called the left and right cerebral hemispheres. The cerebrum uses information
from our senses to tell us what's going on around us and tells our body how to respond.
The right hemisphere controls the muscles on the left side of the body, and the left
hemisphere controls the muscles on the right side of the body. This part of the brain
also controls speech and emotions as well as reading, thinking, and learning.
The cerebellum, under the cerebrum at the back of the brain, controls balance and
complex actions like walking and talking.
The brain stem connects the brain with the spinal cord. It controls hunger and thirst
and some of the most basic body functions, such as body temperature, blood pressure,
and breathing.

145
146 □ □ Drug Inspector Exam

Fig. 18.2.

Spaces that contain cerebrospinal fluid.


The brain is protected by the bones of the skull and by a covering of three thin
membranes called meninges. The brain is also cushioned and protected by cerebrospinal
fluid. This watery fluid is produced by special cells in the four hollow spaces in the
brain, called ventricles. It flows through the ventricles and in spaces between the
meninges. Cerebrospinal fluid also brings nutrients from the blood to the brain and
removes waste products from the brain.
The spinal cord is made up of bundles of nerve fibers. It runs down from the brain
through a canal in the center of the bones of the spine. These bones protect the spinal
cord. Like the brain, the spinal cord is covered by the meninges and cushioned by
cerebrospinal fluid.
Spinal nerves connect the brain with the nerves in most parts of the body. Other
nerves go directly from the brain to the eyes, ears, and other parts of the head. This
network of nerves carries messages back and forth between the brain and the rest of the
body.

MULTIPLE CHOICE QUESTIONS

1. Regarding the sympathetic division of (d) the sympathetic chain extends


the autonomic nervous system: from the thoracic to the sacral
(a) acetylcholine is secreted by some regions of the spinal cord.
sympathetic postganglionic fibers. 2. Regarding the parasym pathetic
(b) most sympathetic preganglionic division of the autonomic nervous
fibers secrete norepinephrine system:
(noradrenaline). (a) parasympathetic preganglionic
(c) sym pathetic postganglionic fibers are found in all cranial
neurons are found in spinal nerves.
segments from LI to L2.
Brain and Spinal Cord □ □ 147

(b) parasympathetic - vasoconstrictor 5. Regarding the functions of the cerebral


fibers are present in the salivary hemispheres
glands. (a) the parietal lobes are involved in
(c) paraympathetic postganglionic pain perception
neurons are found in spinal (b) the parietal lobes are involved in
ganglia from LI to L2. pain perception
(d) parasympathetic postganglionic (c) damage to the temporal lobes can
fibers secrete acetylcholine onto lead to a failure of object
their target organs. recognition
3. Regarding the role of the autonomic (d) the parietal lobe on the right side
innervation: of the brain plays a significant role
(a) stimulation of the sympathetic in the comprehension of speech
nerves to the eyes causes pupillary 6. Which is true regarding speech
constriction. (a) in left-handed people the faculty
(b) activation of the sympathetic of speech is mainly located in the
system causes vasodilatation in the right hemisphere.
skin. (b) individuals affected by Broca's
(c) activation of the sympathetic aphasia are able to speak only with
system causes vasoconstriction in great difficulty.
the viscera and vasodilatation in (c) an individual with Broca's aphasia
skeletal muscle. will have paralysis of the lips and
(d) stimulation of the vagus nerves tongue
speed up the heart. (d) Wernicke's aphasia results from
4. Regarding synaptic transmission in damage to the frontal speech area
the autonomic nervous system: 7. The sympathetic nervous system is
(a) The acetylcholine receptors in both primarily concerned w i t h ______
parasympathetic and sympathetic whereas the parasympathetic system
ganglia are predominantly is primarily concerned w ith ______.
muscarinic. (a) Mobilising the body in response
(b) Norepinephrine (noradrenaline) to stress, maintaining the body at
secreted by sympathetic rest
postganglionic fibers acts (b) The release of acetylcholine onto
preferentially on 6-adrenoceptors. targe organs, the release of
(c) The adrenal medulla secretes adrenaline
epinephrine (adrenaline) in (c) Activation of skeletal muscle,
response to activation of activation of smooth muscle
muscarinic sympathetic postgang­ (d) All of the above
lionic fibers in the splanchnic
nerves. 8. All the following are the actions of
(d) Acetylcholine secreted by acetylcholine except
parasympathetic postganglionic
fibers acts on muscarinic receptors.
148 □ □ Drug Inspector Exam

(a) Increase in heart rate (b) Unbalanced and uncontrolled


(b) Dilatation of pupil walk
(c) Contraction of detrusor muscle (c) Jerky with defective speech
(d) Increased salivation (d) Jerky with uncontrolled walk
9. Voluntary activities of body are 15. Cerebral hemisphere is not the centre
controlled by:- of:-
(a) Diecephalon (a) taste (b) smell
(b) Cerebrum (c) balance (d) memory
(c) Cerebellum 16 . Which part of brain control emotion
(d) Hypothalmus like tone, anger and pleasure?
10. Respiratory control in brain occurs in:- (a) Medulla pblangata
(a) Medulla oblongata (b) Hypothalmus
(b) Cerebellum (c) Cerebrum
(c) Hypothalmus (d) Cerebellum
(d) Pericardium 17. All are the functions of medulla
11. Which part of brain regulates the body oblongata except:
temperature, hunger and water (a) regulation of respiration
balance? (b) regulation of Heart rate
(a) Hypothalmus (c) vomiting reflux
(b) Infundibulum (d) body balance
(c) Medulla oblongata 18. Which cranial nerve is the longest and
(d) Pons veroli supplies all part of body other than
12. Which of the following is responsible head?
for control of reflex action? (a) Trochlear nerve
(a) Motor nerves (b) vagus nerve
(b) Sensory nerves (c) occulomotor nerve
(c) CNS (d) auditory nerve
(d) Sympathetic nervous system 19. The neurotransmitter in sympathetic
13. Most of the involuntary actions are nervous
controlled by:- (a) Nor adrenaline
(a) Medulla oblongata (b) Acetylchloine
(b) Cerebrum (c) adrenaline
(c) Cerebellum (d) option (a) and (c)
(d) Diencephalon 20. Autonomic nervous system controls:
14 In case of damaged cerebeluum, the (a) Reflex action
movement of a person becomes:- (b) spinal cord function
^ i Shaky with defective speech (c) functioning of visceral organs
(d) All of the above
Brain and Spinal Cord □ □ 149

21. All the cranial nerves are related to 27. Increased vagal tone causes
parasympathetic nerves except (a) hypertension
(a) oculomotor (b) tachycardia
(b) facial (c) bradycardia
(c) accessory spinal (d) increase in cardiac output
(d) vagus 28. When a pheochromocytoma suddenly
22. Cholinergic fibre are present in:- discharges a large amount of
(a) Preganglionic Sympathetic nerve epinephrine into the circulation the
fibre patients heart rate would be expected
(b) Postganglionic Sympathetic nerve to
fibre (a) increase because epinephrine has
(c) Postganglionic parasympathetic a direct chronotropic effect on the
nerve fibre heart
(d) all of the above (b) increase because of increased
parasympathetic discharge to the
23. In parkinsons disease, the heart
concentration of which transmitter is
(c) decrease because the increase in
decreased?
blood pressure stimulates the
(a) adrenaline carotid and aortic baroreceptors
(b) nor adrenaline (d) decrease because of increased tonic
(c) dopamine parasympathetic discharge to heart
(d) acetylcholine
29. Which of the following conducting
24. Which of these vessels does not have systems has the slowest conducting
sympathetic control velocity
(a) cerebral (b) splanchnic (a) SAN
(c) cardiac (d) cutaneous (b) atrial muscle
25. Blood brain barrier is made up of (c) purkinje fibres
(a) astrocytes (d) AVN
(b) oligodendrocytes 30. Absolute refractory period in the heart
(c) oligodendroglia (a) corresponds to the duration of
(d) microglia relaxation
26. Positive bathmotropic effect on heart (b) lasts till half of cardiac contraction
is produced by (c) shorter than refractory period in
(a) stimulation of vagus nerve skeletal muscle
(b) stimulation of sympathetic nerves (d) lasts till cardiac contraction
(c) atropin 31. In contrast to the somatic nervous
(d) sectioning of vagus system, the autonomic nervous system
150 DO Drug Inspector Exam

(a) has two efferent neurons (a) is characterized by exaggerated


(b) has two afferent neurons vasoconstriction in the extremities
(c) stimulates its effector cells (b) is induced by heat stress
(d) has both afferent and efferent (c) occurs primarily in association
fibers with injury to the spinal cord
32. Over 90% of all parasympathetic fibers (d) is frequently life-threatening
are derived from cranial nerve number 35. Where would you not find an
autonomic ganglion?
(a) V (b) VII (a) in the head
(c) X (d) XII (b) in the cervical region
33. Which of these effectors is not directly (c) close to the visceral effectors they
controlled by the autonomic nervous serve
system? (d) in the armpit
(a) smooth muscle 36. The vagus nerve does not innervate
(b) cardiac muscle th e ________.
(c) skeletal muscle (a) pancreas
(d) most glands (b) kidneys
34. Raynaud's disease________. (c) parotid gland
(d) gallbladder

ANSWERS
I. (a) 2. (d) 3. (c) 4. (d) 5. (d) 6. (b) 7. (a) 8. (b) 9. (b) 10. (a)
11. (a) 12. (c) 13. (a) 14. (b) 15. (b). 16. (b) 17. (a) 18. (b) 19. (d) 20. (c)
21. (c) 22. (d) 23. (c) 24. (a) 25. (a) 26. (b) 27. (c ) 28. (a) 29. (c) 30. (d)
31. (a) 32. (c) 33. (c) 34. (a)

ooo
Drugs Acting on
Cardiovascular System
19
C h a pter

1. CARDIAC GLYCOSIDE
These are important class of naturally occurring drugs whose actions include both
Cardiotonic and toxic effects. The desirable Cardiotonic has a great value in the treatment
of congestive heart failure and edema. The cardiac glycosides can be obtained both
from the plants (for example, Digitalis and Strophanthus) and certain animals, (for
example, poisonous toad).
Chemistry: Structurally, the cardiac glycosides are composed of sugar component
and steroid component.The steroid component is usually termedras genin or aglycone.
The aglycone component is responsible for pharmacological activity while sugar portion
is for its absorption. Some examples of cardiac glycosides and their sources are listed
in Table 19.1.
Aglycone. The steroid portion of the cardiac glycosides is characterized by its unusual
shape. The 'U-shape' is imparted by the A-B c is and C-D cis and B-C Trans ring. The
below given tructure shows the effect of unusual confirmation on the orientation of C-
18 and C-19 angular methyl groups relative to 14-OH and 5-H groups. Other important
steroidal substances can be distinguished fitom the cardiac glycoside by viewing the
'backbone' Skelton. For example, adrenocortical steroids typically possess A-B, B-C, C-
D all Trans configuration while the bile salts characterized by A-B cis and B-C, C-D
Trans orientation.
Table 19.1. List of naturally occurring glycosides along with their
composition and sources

Source Glycoside Aglycone Sugar

Digitalis lanata Lanatoside A Digitoxigenin glucose, 3-acetyl


digitoxose,
dogitoxose2
Lanatoside B Gitoxigenin -same as above
Lanatoside C Digoxigenin -same as above

D purpurea Purpurea glycoside A Digitoxigenin glucose


N
digitoxose3
Purpurea glycoside B Gitoxigenin -same as above

151
152 □ □ Drug Inspector Exam

Strophanthus gratus g - strop anthin Quabagenin Rhamnose


Strophanthus kombe k - stropanthoside strophanthidin glucose cyamarose
There are two types of aglycones :
(a) Cardenolides: These are characterized by the presence of a, (3-unsaturated five
member lactone ring at C-17 position of aglycone like digoxin, digitoxin, etc. It
is beta in configuration. The presence of a, p-unsaturated lactone ring is
responsible for biological activity.
(b) Bufadenolides: These are characterized by presence of a-pyrone ring at C-17
position like bufatalin. It is not of much importance.

Digitoxigenin(Cardenolide), R , =

Bufatalin(Bufadenolide), R 1 = —

Structure of Cardenolides and bufadenolide

Digoxigenin, R=OH

The Cardenolides and Bufadenolides both contain 3-f3 and 14-P hydroxyls, the former
being the point of attachment for glycoside or sugar component. The Cardenolides may
contain additional hydroxyl group at C-12 or C-16 position, whose presence or absence,
differentiates the important genins, digitoxigenin, digoxigenin and gitoxigenin.
Drug Acting on Cardiovascular System □ □ 153

Sugar: Various types of monosaccharide-sugar, present in naturally occurring cardiac


glycosides. The usual monosaccharide sugar moieties are glucose, digitoxose, etc. The
digitoxose (desoxy sugar) is most prevalent.
Mechanism of action: The cardiac glycosides act by inhibiting the membrane bound
Na+, K+ ATPase (Na+,K+ adenosine triphosphate) pump. By inhibiting the pump, the
amount of intracellular sodium increases and consequently, as the intracellular sodium
increases, it interacts with membrane bound sodium-calcium exchange in the myocardial
muscle that exchanges calcium for sodium. This leads to increased strength of contraction
of myocardial fiber (or increased inotropic effect).
Toxicity: Toxicity is induced by inhibition of Na+ K+ ATPase pump that results in
increased intracellular levels of Ca++. Hypoalkemia(decreased K+) that can be induced
by co administration of thiazide diuretics, glucocorticoids or by other means can be
important factor for initiating toxic response.
Other Inotropic Agents
Phosphodiestrase inhibitors: The cyclic adenosine monophosphate(c-AMP) performs
important roles in regulating intracellular Ca++. The Phosphodiestrase inhibitors
especially Phosphodiestrase F III in the myocardium leads to elevated level of c-AMP
(the well known second messenger' substance). Drugs such as Amirinone(Valmedin)
and M ilirin on e (Prim acor) exert their inotropic actions by inhibiting the
Phosphodiestrase enzyme.

2. ANTI HYPERTENSIVE DRUGS


Drugs used to treat the hypertension will be illustrated according to pharmacological
categories as :
(a) Adrenergic System Inhibitors
These drugs decrease the sympathetic nervous system activity to reduce the blood
pressure. It can be done in several ways like depletion of stores of neurotransmitters;
reduction in number of impulses through sympathetic nerves; antagonism of actions of
neurotransmitter on the effector cells; inhibition of neurotransmitter release.
(i) Reserpine: It is absorbed after oral administration and metabolized to methyl
reserpate and 3, 4, 5-trimethoxy benzoic acid.
, 0 CH,3
Reserpine, R^OCHg, R2= O CH,
OCH,
OCH3
Rescinnamine, R,=OCH3, R2= -CH=CI OCH,
OCH,
OCH,
19 Deserpidine, R,=H, R2= — O CH,
OCH,
CH.OCO^>^\
OCO-R,
154 □ □ Drug Inspector Exam

Guanethedine monosulphate (Ismelin Sulphate).It prevents the nor epinephrine


release from post ganglionic neurons in response to adrenergic stimulation.
(b) Selective a-adrenergic antagonist
a - adrenergic antagonists are used in the treatment of catecholamine dependent
hypertension. Classic drugs such as phentolamine and phenylbenzamine are non specific
blocking agents of a 1 and a 2 receptors on the presynaptic membrane of adrenergic
neuron. Specific antagonist of otj receptors are effective antihypertensive agents by
blocking the vasoconstricting effect on smooth muscle and not interfering with the
activation of a 2 receptors on the adrenergic neuron, which on activation further inhibit
release of nor epinephrine. Prazocine HC1 and Terazocin HC1 are some examples of al
receptor blockers.
(c) Selective p1 -adrenergic antagonists.
(d) Centrally acting adrenergic drugs
Methyldopate hydrochloride: a-Methyl dopa lowers blood pressure by inhibiting
the outflow of vasoconstrictor impulses from brain. Methyl dopa upon conversion to a
-methyl nor epinephrine, act on a 2-adrenergic receptor to inhibit the release of nor
epinephrine resulting in a decrease of Sympathetic outflow from CNS and an activation
of parasympathetic outflow.
Clonidine hydrochloride: It is a a 2 agonist but used commonly for the treatment of
hypertension
(e) Vasodilators
Anti hypertensive drugs that produce vasodilatation of smooth muscles can be
divided into two categories - direct acting and indirect acting vasodilators. Indirect
acting vasodilators act by interfering with the vasoconstrictor stimuli for example,
sympatholytic drugs (reserpine), a-adrenergic antagonist (Prazocine HC1), and ACE
inhibitors. Direct acting vasodilators are hydralazine, sodium nitroprusside, potassium
channel openers and calcium channel blockers.
(f) Potassium channel agonists
Diazoxide and minoxidil are usually called potassium channel openers. These agents
activate ATP sensitive potassium channels, which leads to a decrease of intracellular
calcium and reduces the excitability of smooth muscle and subsequent vasodilation.
(g) Renin angiotensin system inhibitors
The renin angiotensin system is a hormonal system that plays a central role in the
control of sodium excretion and body fluid volume. The angiotensinogen, glycopeptide,
primarily synthesized in liver comes into the blood circulation. Renin is an aspartyl
protease enzyme, synthesized from kidney cleaves the angiotensinogen polypeptide to
release the deca polypeptide, angiotensin I which later on converted into octapeptide
molecule, angiotensin II by the ACE (angiotensin converting enzyme). The octapeptide,
Drug Acting on Cardiovascular System □ □ 155

angiotensin II(is a potent vasoconstrictor. The angiotensin II is also further cleaved into
angiotensin III which is also a vasoconstrictor but less potent. The angiotensin III has
a significant role in controlling sodium excretion by renal tubules. The regulatory action
of renin - angiotensin system in controlling sodium and potassium balance and arterial
blood pressure is modified by vasodilators called 'kinin'.
The ACE is a zinc containing glycoprotein with a molecular weight of about 150,000.
ACE inhibitors prevent the conversion of angiotensin I into angiotensin II and thus act
as anti hypertensive drugs. These do not possess so many toxic effects as other
antihypertensive agents.
Captopril (Capoten). It was the first inhibitor introduced in clinical use.
Lisinopril (Zestil).It is a lysine derivative of enalaprilate, active metabolite of
enalapril. Like all ACE inhibitors, it is an active site directed inhibitor enzyme, using
the zinc ion in an effective binding interaction. It is similar to captopril and enalapril
in pharmacological action.
ACE inhibitors in prodrug form: Various ACE inhibitors are available as prodrug,
using captopril as prototype. On metabolic conversion, the active metabolite is generated.
The side effects associated with captopril like skin rashes, loss of sense of taste, etc., due
to presence of thio group in it which are not present in prodrugs. With the exception
of phosphorous containing fosinopril, these antihypertensive drugs have 2-(S)-
aminophenyl butyric ethyl ester moiety. These only differ in the substituents on the
amino group. These drugs are used in the treatment of mild to moderate hypertension
either alone or in combination with diuretics or calcium channel blockers.
Enalapril maleate (Vasotec). It is along acting ACE inhibitors. It, first metabolically
converted into diacid enalaprilate which is actual ACE inhibitor. Its half life is llhrs.
Benzapril hydrochloride (Lotensin). It is useful in the treatment of mild to moderate
hypertension in a dose of 10 mg/ day.
Quinapril hydrochloride (Acuretic). It is a tetrahydro isoquinoline analogue of
enalapril. It is first converted to active metabolite, quinaprilate to decrease the high
blood pressure.
Remipril (Altace). It unlike enalapril possesses high lipophilic properties which
facilitates its penetration in various tissues and consequently leading to high degree of
ACE inhibition.
Fosinopril sodium (Monorail). It is a phosphorous containing ACE inhibitor. It is
first converted into diacid, fossinoprillate by intestinal and liver enzyme to show anti
hypertensive action.
(h) Calcium channel blockers
These are vasodilators. The vasodilation action is due to uncoupling of the contractile
mechanism of vascular smooth muscle which requires calcium ions. CCBs can be divided
into three different drugs like phenyla lkylamines (verapamil); 1, 4 dihydropyridines
(nefidipine); and benzothiazepines (diltiazem). Table 19.2. Theseprototype compounds
sometimes are termed 'first generation' of calcium channel blockers as two of the groups
156 □ □ Drug Inspector Exam

drug classes have been expanded by the introduction of a 'second generation'of more
potent analogues.
Table 19.2. First and second generation CCBs
Chemical classification First generation Second generation
Phenylalkylamines Verapamil Bepridil, Anipamil
1, 4dihydropyridine Nifedipine Amlodipine, felodipine
Nicardipine, nimodipine
Benzothiazepine Diltiazem
It is used in the treatment of patient with variant angina. The side effects include
flush and headache. It has no effect on the heart rate.

3. ANTI ANGINAL DRUGS


Angina is chest pain or discomfort that occurs when there is too little blood flowing
to the heart muscle. It is often the result of coronary artery disease and narrowing of
the blood vessels that supply the heart muscle.
The anti anginal drugs include various vasodilators (nitrites &nitrates and calcium
channel blockers), P-adrenergic blockers and some miscellaneous drugs.

MULTIPLE CHOICE QUESTIONS

1. This drug reduces blood pressure by (d) Metoprolol


acting on vasomotor centers in the
4. Pick out the sympatholythic drug:
CNS:
(a) Labetalol
(a) Labetalol
(b) Prazosin
(b) Clonidine
(c) Guanethidine
(c) Enalapril
(d) Clonidine
(d) Nifedipine
5. Tick the drug with nonselective beta-
2. All of the following are central acting adrenoblocking activity:
antihypertensive drugs EXCEPT:
(a) Atenolol
(a) Methyldopa
(b) Propranolol
(b) Clonidine
(c) Metoprolol
(c) Moxonidine
(d) Nebivolol
(d) Minoxidil
6. Choose the selective blocker of beta-1
3. A ganglioblocking drug for .adrenoreceptors:
hypertension treatment is:
(a) Labetalol
(a) Hydralazine
(b) Prazosin
(b) Tubocurarine
(c) Atenolol
(c) Trimethaphan
(d) Propranolol
Drug Acting on Cardiovascular System □ □ 157

7. Pick out the drug - an alpha and beta (a) Propranolol


adrenoreceptors blocker: (b) Enalapril
(a) Labetalol (c) Diazoxide
(b) Verapamil (d) Losartan
(c) Nifedipine 14 This drug is a non-peptide angiotensin
(d) Metoprolol II receptor antagonist:
8. This drug inhibits the angiotensin- (a) Clonidine
converting enzyme: (b) Captopril
(a) Captopril (c) Losartan
(b) Enalapril (d) Diazoxide
(c) Ramipril 15 This drug is a potassium channel
(d) All of the above activator:
9. This drug is a directly acting (a) Nifedipine
vasodilator: (b) Saralasin
(a) Labetalol (c) Diazoxide
(b) Clonidine (d) Losartan
(c) Enalapril 16 All of the follow ing statements
(d) Nifedipine regarding angiotensin II are true
10. Pick out the diuretic agent for EXCEPT:
hypertension treatment: (a) It is a peptide hormone
(a) Losartan (b) It stim ulates the secretion of
(b) Dichlothiazide aldosterone
(c) Captopril (c) Angiotensin I is almost as potent
(d) Prazosin as angiotensin II
(d) It is a potent vasoconstrictor
11. This drug blocks alpha-1 adrenergic
receptors: 17. This drug is contraindicated in
(a) Prazosin patients with bronchial asthma:
(b) Clonidine (a) Propranolol
(c) Enalapril (b) Clonidine
(d) Nifedipine (c) Enalapril
(d) Nifedipine
12 This drug activates alpha-2 adrenergic
receptors: 18 This drug is converted to an active
(a) Labetalol metabolite after absorption:
(b) Phentolamine (a) Labetalol
(c) Clonidine (b) Clonidine
(d) Enalapril (c) Enalapril
(d) Nifedipine
13. This drug is an inhibitor of renin
synthesis: 19. This drug routinely produces some
tachycardia:
158 □ □ Drug Inspector Exam

(a) Propranolol (a) Angiotensinogen


(b) Clonidine (b) Angiotensin I
(c) Enalapril (c) Angiotensin II
(d) Nifedipine (d) Angiotensin-converting enzyme
20. All of the follow ing statem ents 25. Choose the group of antihypertensive
regarding vasodilators are true drugs which dim inishes the
EXCEPT: metabolism of bradykinin:
(a) Hydralazine causes tachycardia (a) Ganglioblockers
(b) Nifedipine is a dopamine receptor (b) Alfa-adrenoblockers
antagonist (c) Angiotensin-converting enzyme
(c) N itroprusside dilates both inhibitors
arterioles and veins (d) Diuretics
(d) Minoxidil can cause hypertrichosis 25
Hydralazine (a vasodilator) can
21. All of the follow ing statements produce:
regarding verapamil are true EXCEPT: (a) Seizures, extrapyramidal
(a) It blocks L-type calcium channels disturbances
(b) It increases heart rate (b) Tachycardia, lupus
(c) It relaxes coronary artery smooth ?rhy throma tosis
muscle (c) Acute hepatitis
(d) It depresses cardiac contractility (d) Aplastic anemia
22. Choose the unwanted effects of 27. Choose the vasodilator which releases
clonidine: NO:
(a) Parkinson’s syndrome (a) Nifedipine
(b) Sedative and hypnotic effects (b) Hydralazine
(c) Agranulocytosis and aplastic (c) Minoxidil
anemia (d) Sodium nitroprusside
(d) Dry cough and respiratory
depression The reason of diuretics administration
for hypertension treatment is:
23. The reason of beta-blockers (a) Block the adrenergic transmission
adm inistration for hypertension
(b) Diminishing of blood volume and
treatment is:
amount of Na+ ions in the vessels
(a) Peripheral vasodilatation endothelium
(b) Diminishing of blood volume (c) Depression of rennin-angiotensin-
(c) Decreasing of heart work aldosterone system
(d) Depression of vasomotor center (d) Depression of the vasomotor
24. An endogenous vasoconstrictor that center
can stimulate aldosterone release from 29. Tick the diuretic agent - aldosterone
suprarenal glands: antagonist:
Drug Acting on Cardiovascular System □ □ 159

(a) Furosemide (a) Treatment of glaucoma.


(b) Spironolactone (b) Treatment of hypertension.
(c) Dichlothiazide (c) Treatment of asthma.
(d) Captopril (d) Treatment of pain.
30. Tick the diuretic agent having a potent 36. To which class of compounds do
and rapid effect: adrenaline, noradrenaline and
(a) Furosemide dopamine belong?
(b) Spironolactone (a) Phenethylamines
(c) Dichlothiazide (b) Diphenolethylamines
(d) Indapamide (c) Catecholamines
31 Which of the following is a natural (d) Adrenergics
chemical messenger for the adrenergic 37. Identify the tactic which is used to
receptor? obtain p-adrenoceptor selectivity for
(a) Acetylcholine adrenergic agonists.
(b) Dopamine (a) Introduction of a naphthalene ring.
(c) Serotonin (b) Introduction of a bulky N-alkyl
(d) Noradrenaline substituent.
(c) Removal of one of the catechol OH
32. What is the predominant adrenoceptor
groups.
in heart muscle?
(d) Addition of an a-methyl group
(a) al-adrenoceptor
(alpha to the carbon bearing the
(b) a2-adrenoceptor amine).
(c) pi-adrenoceptor
38. What disadvantage is there in using
(d) p2-adrenoceptor
adrenaline as an adrenergic agonist?
33. What is the predom inant 6- (a) Poor activity.
adrenoceptor in bronchial smooth (b) Rapid metabolism.
muscle?
(c) Poor selectivity.
(a) pi-adrenoceptor
(d) All of the above.
(b) p2-adrenoceptor
(c) p3-adrenoceptor 39. Salbutamol is an important clinical
agent. The bulky group is the
(d) p4-adrenoceptor
modifications that distinguish the
34. What is the main clinical use for molecule from adrenaline or
agonists of the p2-adrenoceptor? noradrenaline.
(a) Treatment of angina. What role does the t-butyl group play?
(b) Treatment of hypertension. (a) It acts as steric shield to reduce
(c) Treatment of asthma. metabolism.
(d) Treatment of pain. (b) It increases hydrophobicity such
35. What is the main clinical use for that the molecule can cross cell
antagonists of the pi-adrenoceptor? membranes.
160 □ □ Drug Inspector Exam

(c) It introduces selectivity for 8- (a) It interacts as a hydrogen bond


adrenoceptors. donor.
(d) It introduces selectivity for a- (b) It interacts as a hydrogen bond
adrenoceptors. acceptor.
40. Salbutamol is an important clinical (c) It is protonated and binds by ionic
agent. The bulky group is the interactions.
modifications that distinguish the (d) It has no interactions with the
molecule from adrenaline or binding site.
noradrenaline. 43. The diagram below indicates some of
Why was the hydroxymethylene the groups present in propranolol.
group introduced? How does the alcohol group interact
(a) It was a chain extension to place with the binding site?
the OH group closer to its binding (a) By ionic interactions.
region in the binding site. (b) By hydrogen bonding.
(b) It was introduced to increase the (c) By van der Waals interactions.
area of conform ational space
(d) It remains solvated and has no
available to the OH group.
interactions.
(c) It was introduced to reposition the
phenol OH such that it was not 44. Tht diagram below indicates some of
recognised by metabolic enzymes. the groups present in propranolol.
(d) It was introduced to reduce the How does the ether group interact
electronic influence of the OH with the binding site?
group on the aromatic ring. (a) It has no interactions and remains
solvated.
41. The following diagram illustrates
(b) By hydrogen bonding as a
some of the compounds that were
hydrogen bond donor.
involved in the development of the
important clinical agent - propranolol. (c) By van der Waals interactions.
(d)By hydrogen bonding as a
What effect does the naphthalene ring hydrogen bond acceptor.
have?
(a) It makes the agent an agonist. 45. Captopril causes:
(b) It makes the agent an antagonist. (a) Hyperkalemia
(c) It makes the agent a partial (b) Hypernatremia
agonist. (c) Hypokalemia
(d) It makes the agent inactive. (d) Hypercalcemia
42. The diagram below indicates some of 46. Patient after an ischemic attack hao
the groups present in propranolol. ventricular Tachycardia. Drug of
choice is:
How does the amine group interact
(a) Amiodrone (b) Metoprolol
with the binding site?
(c) Lidocaine (d) Verapamil
Drug Acting on Cardiovascular System □ □ 161

ANSWERS
1 (b ) 2. (d) 3. (c) 4. (c) 5. (b) 6. (c) 7. (a) 8. (d) 9. (d) 10. (b)
11. (a) 12. (c) 13. (a) 14. (c) 15. (c). 16. (c) 17. (a) 18. (c ) 19. (d) 2 0 . (b)
21. (b) 22. (b) 23. (c) 24. (c ) 25. (c) 26. (b) 27. (d) 28. (b ) 2 9 . (b) 3 0 . (a)
31. (d) 32. (c) 33. (b) 34. (c) 35. (b) 36. (a) 37. (c ) 38. (c ) 39. (c) 40. (c)
41. (a) 42. (c) 43. (b) 44. (d) 45. (a) 46. (d)

□ □ □
Drugs Acting on
Gastro-Intestinal Tract
20
C h a pter

DIGESTANTS
These drugs are used to promote digestion of food as a replacement therapy in
condition of their deficiency specially in atrophic gastritis, gastric carcinoma, pernicious
anaemia or pancreatic insufficiency etc. Various proteolytic (pepsin, papain), lipolytic
(lipases) and amylolytic (diastase and takadiastase) enzymes are used in combination
as appetite stimulants and health tonics. Dilute hydrochloric acid (HC1) is advocated in
severe achlorhydria)
Emetics and Antiemetics Drugs
Vomiting or emesis is a protective mechanism which leads to expulsion of harmful
substances from the upper gastrointestinal tract (GIT). It involves the active participation
of Vomiting Centre (VC) present in the medulla oblongata either through direct afferent
input to it or via Chemoreceptor Trigger Zone (CTZ) and Nucleus Tractus Solitarius
(NTS) present in area postrema) Emetics may either act directly (apomorphine) or reflexly
on CTZ (Ipecacuanha). Apomorphine is a semisynthetic derivative acting as dopaminergic
agonist on CTZ. Apomorphine (6 mg) induces vomiting within 5-10 minutes when
injected intramuscularly or subcutaneously. Ipecacuanha containing emetine is used as
syrup (15-20 ml in adults). Copper sulphate, powdered mustard suspension or oil or
strong salt solution can also be used in emergency.
Antiemetics
These drugs are generally employed for the treatment of nausea or vomiting induced
by motion sickness, morning sickness, gastrointestinal disturbance, postoperative emesis,
cytotoxic drug or radiation-evoked emesis. Variety of drugs, having different chemical
and pharmacological profiles is useful antiemetic agents. They are classified as follows :
1. Antimuscarinic - Hyoscine, dicyclomine etc.
2. Hj-antihistaminics - Promethazine, Diphenhydramine dimenhydrinate,
cyclizine, Meclizine, Cinnarizine, etc.
3. Neuroleptics - Chlorpromazine, prochlorperazine, haloperidol, droperidol etc.
4. Prokinetics- They promote gastroduodenal peristalsis and speed gastric emptying
-Metoclopramide, domperidone, cisapride etc.
5. 5HT3 antagonist- Ondansetron, granisetron, bemesetron, renzapride, zacopride
etc.
6. Miscellaneous - Dexamethasone, benzodiazepine, Cannabinoids etc.
162
Drugs Acting on Gastro-Intestinal Tract □ □ 163

Choice of antiemetic drugs


• HI receptor antagonist
— Cyclizine - motion sickness
— Promethazine - severe morning sickness of pregnancy and space motion
sickness
— Cinnarizine - Motion sickness, vestibular disorder (meniere's disease)
• Muscarinic receptors antagonists
— Hyosine - Motion sickness
• D2 receptor antagonists
— Phenothiazines - Emesis induced by uraemia, radiation, viral gastroenteritis
and severe morning sickness of pregnancy.
— Metoclopromide - Emesis induced by uraemia, radiation, GI disorder,
cytotoxic agents
• 5HT3 antagonist
— Ondansetron - Emesis induced by cytotoxic anti cancer drugs and radiation
and postoperative vomiting
• Cannabinoids
— Nabilone - Emesis induced by cytotoxic anticancer drugs
Antacids
Antacids are weak bases that neutralize gastric acid, raise pH of gastric contents
(optimum peptic activity between pH 2-4). The beneficial effect of antacids can also be
due to their mucosal-protecting actions such as stimulation of bicarbonate production,
enhancement of PG synthesis or reduction of H. pylori colonization. The potency of
antacids is determined by acid neutralizing capability (ANC) i.e., number of mEq of
HCl that is brought to pH 3.5 in 15 minutes by unit dose of antacid preparation.
Systemic antacids: NaHC0 3 is water^obuble, short acting and acts instantly. It is a
potent neutralizer. pH may rise above 7 which can cause dramatic acid rebound
phenomenon, alkalosis and C 0 2 accumulation in stomach.
Non systemic antacids: These are insoluble in water and are poorly absorbed, form
chloride salt in stomach and in turn reacts with intestinal H C 03_ so that there is no final
acid base disturbanca) Antacid combinations preferable: Fast (Mg2+) and slow (Al3+):
Mg2+ (laxative) and Al3+ (constipating). This can decrease the dose and toxicity of
individual component.
Purgatives and Antidiarrhoeal Drugs
Diarrhoea and constipation are very common disorders of gastrointestinal tract (GIT)
which although seem to be a part of our day to day life but can prove to be very severe
or life threatening exacting an enormous toll in terms of morbidity and loss of work
productivity. Constipation can be treated by increasing the fibre content of diet (20 to
30 g daily), taking plenty of fluids, appropriate bowel habit and training and giving
164 □ □ Drug Inspector Exam

attention to certain psychosocial and emotional factors. If the above modifications are
insufficient then bulk forming agents should be the second line preferenca) Stimulants
should be used at last with least effective dose and for short period of tima)
Purgatives
Laxatives / aperients are agents having milder action and helps in elimination of
soft but formed stools. Purgatives / cathartics are agents having stronger action resulting
in more fluid evacuation.
Classification
I. Luminally active agents
(i) Bulk forming - Dietary fibre, psyllium, ispaghula, methyl cellulose
(ii) Stool softener - Dioctyl sodium sulphosuccinate (Docusates, Doss)
(iii) Lubricants - Liquid paraffin
(iv) Osmotic - Magnesium sulphate, magnesium hydroxide, sodium sulphate,
sodium potassium tartarate, lactulose, sorbitol, mannitol, polyethylene glycol
(PEG)
II. Stimulant (Contact) Purgatives
(i) Diphenylmethanes - Phenolphthalein, bisacodyl
(ii) Anthraquinones - Senna, cascara, rhubarb, aloes, danthron
(iii) Fixed oil - Castor oil
III. Prokinetic agents - 5 HT4 agonists, for example, Tegaserod
- Opioid receptor antagonists
Antidiarrheal Drug Therapy
Specific anti-microbials: Antimicrobials are useful in cases of severe infective diarrhea
produced by microorganisms like Shigella, Campylobacter, Salmonella, Y. enterocolitis etc
but very limited response is seen even in these cases. Rota virus diarrhea is generally
self-limiting and does not need any drug therapy. Antimicrobials should be regularly
used in cases of cholera (tetracyclines co-trimoxazole), Campylobacter (norfloxacin and
other fluroquinolones), Clostridium difficile (metronidazole, vancomycin), amoebiasis /
giardiasis (metronidazole).
Non-specific anti-diarrhoeal agents: Non-specific antidiarrhoeals constitutes mainly
absorbants, antisecretory and antimotility agents.
(a) Absorbants: Ispaghula, psyllium and methylcellulose are the most commonly
used absorbants. They absorb water and increase the stool bulk. They increase
stool viscosity and promote perception that there is decreased stool fluidity.
(b) Anti-Secretory agents- Sulfasalazine, mesalazine, olsalazine, balsalazine, bismuth
subsalicylate, atropine, octreotide etc.)
(c) Antimotily drugs: Codeine, dipheno.xylate, atropine, difenoxin, loperamide, a2
adrenergic agonist
Drugs Acting on Gastro-intestinal Tract □ □ 165

Opioids mainly act through 1 (motility) and a (secretory) receptors present in the
ENS, epithelial cells and muscles. Their function is to increase the tone of GIT.
Diphenoxylate, atropine, difenoxin are related to meperidina) Atropine is added to
decrease the abusive liability. Common side effects include CNS depression and
anticholinergic effects like dry mouth, flushing etc.)
Loperamide is an opioid analogue with a weak anticholinergic property. It is quickly
absorbed orally and is about 40 to 50 times more potent than morphine as an anti­
motility agent. Available as capsule, solution and chewable forms, it has got poor CNS
penetration and no abuse liability with longer duration of action.
Cannabinoid receptor agonists decrease gut motility by decreasing Ach release from
enteric nerves. Certain calmodulin inhibitors which include chlorpromazine also have
antisecretory property. Zaldaride maleate is a novel drug effective against traveller's
diarrhea)

MULTIPLE CHOICE QUESTIONS

1. Tick the main approach of peptic ulcer (c) Histamine


treatment: (d) Carbonate mineral waters
(a) Neutralization of gastric acid ^ Which of the following drugs is an
(b) Eradication of Helicobacter pylori agent of substitution therapy?
(c) Inhibition of gastric acid secretion (a) Gastrin
(d) All the above (b) Hydrochloric acid
2. Gastric acid secretion is under the (c) Hystamine
control of the follow ing agents, (d) Carbonate mineral waters
EXCEPT: ,
6. Choose the drug which is a H2-
(a) Histamine receptor antagonist:
(b) Acetylcholine (a) Omeprazole
(c) Serotonin (b) Pirenzepine
(d) Gastrin (c) Carbenoxolone
3. Indicate the drug belonging to proton (d) Ranitidine
pump inhibitors: j
All of the following drugs are proton
(a) Pirenzepine pump inhibitors EXCEPT:
(b) Ranitidine (a) Pantoprozole
(c) Omeprazole (b) Omeprazole
(d) Trimethaphan (c) Famotidine
1. All of the following agents intensify (d) Rabeprazole
the secretion of gastric glands „
Indicate the drug belonging to Ml-
EXCEPT:
cholinoblockers:
(a) Pepsin
(a) Cimetidine
(b) Gastrin
(b) Ranitidine
166 □ □ Drug Inspector Exam

(c) Pirenzepin 15. Choose the drug that causes


(d) Omeprazole constipation:
9. Which of the following drugs may (a) Sodium bicarbonate
cause reversible gynecomastia? (b) Aluminium hydroxide
(a) Omeprazole (c) Calcium carbonate
(b) Pirenzepine (d) Magnesium oxide
(c) Cimetidine 16. All of the following drugs stimulate
(d) Sucralfate appetite EXCEPT:
10. Tick the drug forming a physical (a) Vitamins
barrier to HCL and Pepsin: (b) Bitters
(a) Ranitidine (c) Fepranone
(b) Sucralfate (d) Insulin
(c) Omeprazole 17. Ethyl alcohol is an agent decreasing
(d) Pirenzepine appetita) It's:
11. Which drug is an analog of (a) True
prostaglandin El? (b) False
(a) Misoprostole 18. Select an anorexigenic agent affecting
(b) De-nol serotoninergic system:
(c) Sucralfate (a) Fenfluramine
(d) Omeprazole (b) Fepranone
12. Select the drug stim ulating ^he (c) Desopimone
protective function of the mucous (d) Masindole
barrier and the stability of the mucous 19. All of the following drugs intensify
membrane against damaging factors: gastrointestinal motility EXCEPT:
(a) De-nol (a) Papaverine
(b) Sucralfate (b) Metoclopramide
(c) Misoprostol (c) Domperidone
(d) Omeprazole . (d) Cisapride
13. Most of drugs are antacids EXCEPT: 20. Metoclopramide is a potent dopamine
(a) Misoprostol (b) Maalox antagonist. It's
(c) Mylanta (d) Almagel (a) True
14. Indicate the drug that cause metabolic (b) False
alkalosis: 21. Choose an emetic drug of central
(a) Sodium bicarbonate action:
(b) Cimetidine (a) Ipecacuanha derivatives
(c) Pepto-Bismol (b) Promethazine
(d) Carbenoxolone (c) Tropisetron
(d) Apomorphine hydrochloride
Drugs Acting on Gastro-Intestinal Tract □ □ 167

22. Tick the mechanism of 28. The mechanism of stimulant


Metoclopramide antiemetic action: purgatives is:
(a) HI and H2-receptor blocking effect (a) Increasing the volume of non­
(b) M -cholinoreceptor stimulating absorbable solid residue
effect (b) Increasing motility and secretion
(c) D2-dopamine and 5-HT3- (c) Altering the consistency of the
serotonin receptor blocking effect feces
(d) M-cholinoblocking effect (d) Increasing the water content
13. Select the emetic agent having a reflex 29. Choose the drug irritating the gut and
action: causing increased peristalsis:
(a) Ipecacuanha derivatives (a) Phenolphthalein
(b) Apomorphine hydroclorid (b) Methyl cellulose
(c) Chlorpromazine (c) Proserine
(d) Metoclopramide (d) Mineral oil
24. All of the follow ing drugs are 30. All of the following drugs stimulate
antiemetics EXCEPT: bile production and bile secretion
(a) Metoclopramide EXCEPT:
(b) Ondansetron (a) Chenodiol
(c) Chlorpromazine (b) Cholenszyme
(d) Apomorphine hydrochloride (c) Oxaphenamide
25. Indicate an antiemetic agent which is (d) Cholosas
related to neuroleptics: 31. Tick the stimulant of bile production
(a) Metoclopramide of vegetable origin:
(b) Nabilone (a) Oxaphenamide
(c) Tropisetron (b) Papaverine
(d) Prochlorperazine (c) Cholenzyme
26. All of these drugs reduce intestinal (d) Cholosas
peristalsis EXCEPT: 32. Select the drug which inhibits
(a) Loperamide peristalsis:
(b) Cisapride (a) Castor oil
(c) Methyl cellulose (b) Bisacodyl
(d) Magnesium aluminium silicate (c) Loperamide
27. Indicate the laxative drug belonging (d) Sorbitol
to osmotic laxatives: 33. Choose the drug affecting the biliary
(a) Docusate sodium system and relaxing Oddy sphincter:
(b) Bisacodyl (a) Cholosas
(c) Phenolphthalein (b) Oxaphenamide
(d) Sodium phosphate (c) fto-spa
(d) Cholenzyme
168 □ □ Drug Inspector Exam

34. Two regions of cim etidine are 37. Which of the following antiemetics is
susceptible to metabolism. Which least likely to cause an oculogyric
regions? crisis?
A (a) trifluoperazine
(b) domperidone
H (c) metoclopramide
.N
YN
(d) prochlorperazine
38. What are the main neurotransmitters
*CN in the induction of vomiting from the
CTZ?
(a) C-4Me and methylene attached to
imidazole ring. (a) dopamine and histamine
(b) C-4Me and sulphur. (b) serotonin and histamine
(c) sulphur and NHMe (c) dopamine and serotonin
(d) C-4Me and NHMa) 39. The antimuscarinic drug atropine is
added to the antidiarrhoeal agent
35. Which is not true with regards to
diphenoxylate in order to:
Antiemetics?
(a) increase the absorption of
(a) include 5HT3 antagonists
diphenoxylate
(b) include Dopamine 2 agonists
(b) decrease the incidence of
(c) m etochlopram ide is anti-
respiratory depression
dopaminergic
encountered with diphenoxylate
(d) cyclizine causes drowsiness
(c) decrease the incidence of cough
(e) cyclizine is anticholinergic suppression encountered with
36. Which one of the following laxatives diphenoxylate
is a lubricant? (d) decrease the incidence of euphoria
(a) senna (b) docussate encountered with diphenoxylate
(c) castor oil (d) liquid paraffin

ANSWERS
1. (d) 2. (c) 3- (c) 4. (a) 5. (b) 6. (d) 7. (c) 8. (c) 9. (c) 10. (b)
11. (a) 12. (c) 13. (a) 14. (a) 15. (b) 16. (c) 17. (b) 18. (a) 19. (a) 20. (a)
21. (d) 22. (c) 23. (a) 24. (d) 25. (d) 26. (b) 27. (d) 28. (b) 29. (a) 30. (a)
31. (d) 32. (c) 33. (c) 34. (a) 35. (b) 36. (d) 37. (b) 38. (c) 39. (d)

mo
Drugs Acting on
Central Nervous System
21
C h a ptef

ANTOPSYCHOTIC DRUGS
The psychotic disorders are classified into three major groups :
(a) Anxiety disorders (phobia and sleeping disorders).
(b) Effective/mood disorders (depression)
(c) Personality disorders (Schizophreni(a)
A. Anxiolytic Drugs
• Benzodiazepines(BDZ). Diazepam, Lurazepam, Midazolam
Mode of action
Binding of GABA to its receptor trigger an opening of chloride conductance. The
influx of chloride ions causes hyperpolarization that moves the post synaptic potential
away from its firing threshold and thus inhibits the formation of action potential and
neural firing.
Actions
Reduction of anxiety (at low doses), Sedative and hypotonic actions (at higher doses),
Anticonvulsant, Muscle relaxant
• Barbiturate.
Mode of action
Interfere with sodium and potassium transport across cell membranes.
Actions
Depression of CNS (at low doses), Hypnosis and anesthesia (at high doses),
Respiratory depression, Enzyme induction (P-450 microsomal enzyme in liver
• Buspirone. Useful in the treatment of generalized anxiety disorders.
Action
The action is mediated by serotonin receptors.
B. Antidepressant Drugs
• Tricyclic/Plycyclic
Mode of action
• Inhibit the neuronal reuptake of norepinephrine and serotonin into presynaptic
nerve terminals which leads to increased concentration of monoamine in the
synaptic clef.
170 □ □ Drug Inspector Exam

• Blocking serotonergic, a-adrenergic, histamine and muscurinic receptors.


Actions
• Elevate moods,Improve mental alertness, Increase physical activity
• Monoamine oxidase inhibitors
Mode of action
• Reverrsibly or irreversibly inactivate the enzyme, this result in increased
norepinephrine, serotonin and dopamine with in the neuron.
• Selective Serotonin-Reuptake Inhibitors (SSRI). Fluoxetine
Actions
• Inhibit serotonin reuptake (selective for serotonin)
• Therapeutic uses: Depression, Panic disorders, Pre menstrual syndrome
C. Neurolytic Drugs
Five important classes. Most important classes are :
• Phenothiazines
• Fluphenazine
• Bromethazine
• Butyrophenones
• Haloperidol
• Doroperidol
Mode of action
• Block dopamine and serotonin receptor in the brain
• Many of these drugs also block cholinergic, adrenergic and histamine receptors
Actions
• Antipsychotic actions( Reduce hallucinations by blocking dopamine receptors),
Extrapyramidal effects(Parkinson syndrome by blocking the dopamine receptors
in the nigrostriatal pathway), Antiemetic effects(By blocking dopaminergic
receptors),Antimuscarinic effects (Blurred vision, dry mouth, Sedation and
confusion).

SKELETAL M USCLE RELAXANT


Classification according to site of action
1. Centeral
• e.g: Benzodiazepine - Barbiturate - Baclofen
• Mephenesin - Methocarbamol
• Carisoprodol - Orphinadrine -Tizanidine
2. Peripheral
• 1. Decrease Synthesis of A.ch:
• H em icholenium - Triethylcholine_____________ _______________________
Drug Acting on Central Nervous System □ □ 171

• 2. Decrease Release of A.ch:


• Aminoglycoside - Botulinum - Procaine
3. Neuro-mascular blockers
• Depolarizing _ Succinylcholine - Decamethonium
• Competitive _
• Atracurium - Alcuronium - Pancuronium - Cis.atracurium -
• d-tubocurarine ( Curar(e)* - Erythrina alkaloid. - Fazadinium -
• Gallamine - Metocurine - Mivacurium (shortest duration) -
• Rapacuronium (most rapid onset) Rocuronium - Vecuronium
4. Direct skeletal muscle relaxants: For example, Dantrolene

AN TICON VULSA N T D RU G S
According to mechanisms of action, the classification of anticonvulsant drugs is as
follows :
1. Prolong inactivation of Na+ channels- reduces ability of neurons to fire at high
frequencies
• phenytoin
• carbamazepine
• valproic acid - may also enhance GABA activity
• lamotrigine
• topiramate - may also enhance GABA and decrease glutamatergic activity
2. Inhibit T-type Calcium channels
• ethosuximide
• valproic acid
3. Enhance GABA-ergic activity by increasing receptor response to neurotransmitter
• phenobarbital
• primidone
• diazepam
• clonazepam
4. Increase synaptic availability of GABA
• vigabatrin - inhibits gaba-transaminase, the enzyme that degrades GABA
• tiagabine - inhibits GABA uptake
5. Enhance depolarization-induced GABA release
• gabapentin
Structural features anti convulsant drugs. Most of the anticonvulsant drugs have
the common structure (shown below). For example, Hydantoins, succinnimides and
oxazolinodiones are isosterically related: NH(7+1 electrons), CH2(6+2 electrons) and
0(8electrons) all have 8 electrons.
172 □ □ Drug Inspector Exam

Hydantoin, X=-NH- -------


R1 Oxazolidinedione, X= -O- -Isoster
>
R2 Succinimides, X= -C H ,--------
O ^N 0
Phenecamide, X= -NH 2
Barbiturate, X = -CO NH-
In the above generalized structure, if both R1 and R2 are lower alkyl groups, the
drug is effective against petitmal seizures and not active against grandmal epilepsy. If
either Rj or R2 is an aryl group, activity is increased toward grandmal epilepsy and not
toward petitmal epilepsy.
Narcotic analgesics

CLASSIFICATION OF OPIOIDS
Several classifications have been proposed (Table 21.1).
• Traditional: based upon analgesic potency
• Origin of drug: i.e., naturally occurring or manufactured
• Function: their action at the opioid receptor
In the traditional classification, the "strong" group includes drugs that are pure
agonists, whereas intermediate group includes partial agonists.
Table 21.1. Classification of opioids
Traditional O rigin Function

Strong N aturally occurring Pure agonists


Morphine Morphine M orphine
Pethidine Codeine Fentanyl
Fentanyl Papavarine Alfentanil
Alfentanil Thebaine Remifentanil
Remifentanil Sem isynthetic Sufentanil
Sufentanil Diamorphine Partial agonist
Interm ediate Dihydrocodeine Buprenorphine
Buprenorphine Buprenorphine A gonists
Pentazocine Synthetic -antagonists
Butorphanol Phenylpyperidines: Pentazocine
Nalbuphine pethidine, fentanyl, alfentanil, N albuphine
Weak sufentanil Naloxone
Codeine Diphenylpropylamines: Pure A ntagonists
m ethadone, dextropropoxyphene N alorphine
Morphinans: Naltrexone
butorphanol, levorphanol
Benzomorphans:
pentazocine
Drug Acting on Central Nervous System □ □ 173

NON NARCOTIC ANALGESICS


Table 21.2. Classification of NSAIDs
1. Salicylates for example, aspirin, methyl salicylate, phenyl salicylate, benorylate,
diflunisal, etc
2. Aryl alkanoic acid for example, diclofenac, indomethacin, sulindac, etc
3. 2-Aryl propionic acids (profens) for example, ibuprofen, naproxen, flurbiprofen,
fenoprofen, ketoprofen, caproprofen, etc.
4. N-Aryl anthranilic acids (fenamic aci(d) for example, mefenamic acids, meclofenamic
acid.
5. Enolic acids
(a) Pyrazolidine derivatives for example, phenylbutazone, oxyphenbutazone.
(b) Oxicams for example, piroxicam, meloxicam.
6. Coxibs for example, celecoxib, rofecoxib, valdecoxib, parecoxib, etoricoxib.
7. Sulphanilamides for example, Nimusulide

MULTIPLE CHOICE QUESTIONS

1. Narcotics analgesics should: (a) BETA-endorphin


(a) Relieve severe pain (b) Met- and leu-enkephalin
(b) Induce loss of sensation (c) Dynorphin
(c) Reduce anxiety and exert a (d) All of the above
calming effect 5. Which of the following mediators is
(d) Induce a stupor or somnolent state found mainly in long descending
2. Second-order pain is: pathways from the midbrain to the
(a) Sharp, well-localized pain dorsal horn?
(b) Dull, burning pain (a) Prostaglandin E
(c) Associated with fine myelinated (b) Dynorphin
A-delta fibers (c) Enkephalin
(d) Effectively reduced by non­ (d) Glutamate
narcotic analgesics 6. Select the brain and spinal cord
3. Chemical mediators in the nociceptive regions, which are involved in the
pathway are all of the following transmission of pain?
EXCEPT: (a) The limbic system, including the
(a) Enkephalins amygdaloidal nucleus and the
(b) Kinins hypothalamus
(c) Prostaglandins (b) The ventral and medial parts of
(d) Substance P the thalamus
(c) The substantia gelatinosa
4. Indicate the chemical mediator in the
(d) All of the above
antinociceptive descending pathways:
174 □ □ Drug Inspector Exam

7. Mu (p) receptors are associated with: 12. Indicate the neurons, which are
(a) Analgesia, euphoria, respiratory located in the locus ceruleus or the
depression, physical dependence lateral tegmental area of the reticular
(b) Spinal analgesia, mydriasis, formation:
sedation, physical dependence (a) Dopaminergic
(c) Dysphoria, hallucinations, (b) Serotoninergic
respiratory and vasomotor (c) Nonadrenergic
stimulation (d) Gabaergic
(d) Analgesia, euphoria, respiratory
13. Which of the following analgesics is a
stimulation, physical dependence
phenanthrene derivative?
8. Which of the following opioid receptor (a) Fentanyl
types is responsible for euphoria and (b) Morphine
respiratory depression? (c) Methadone
(a) Kappa-receptors (d) Pentazocine
(b) Delta-receptors
14. Tick narcotic analgesic, which is a
(c) Mu-receptors
phenylpiperidine derivative:
(d) All of the above
(a) Codeine
9. Indicate the opioid receptor type, (b) D°7ocine
which is responsible for dysphoria and (c) Fentanyl ,
vasomotor stimulation:
. (d) Buprenorphine
(a) Kappa-receptors
(b) Delta-receptors 15. Which of the follow ing opioid
analgesics is a strong mu receptor
(c) Mu-receptors
agonist?
(d) All of the above
(a) Naloxone
10. Kappa and delta agonists: (b) Morphine
(a) Inhibit postsynaptic neurons by (c) Pentazocine
opening K+ channels (d) Buprenorphine
(b) Close a voltage-gated Ca2+
16. Indicate the narcotic analgesic, which
channels on presynaptic nerve
is a natural agonist:
terminals
(a) Meperidine
(c) Both (a) and (b)
(b) Fentanyl
(d) Inhibit of arachidonate
cyclooxygenase in CNS (c) Morphine
(d) Naloxone
11. Which of the following supraspinal
structures is im plicated in pain- 17. Select the narcotic analgesic, which is
modulating descending pathways? an antagonist or partial mu receptor
(a) The midbrain periaqueductal gray agonist:
(b) The hypothalamus (a) Fentanyl (b) Pentazocine
(c) The aria postrema (c) Codeine (d) Methadone
(d) The limbic cortex
Drug Acting on Central Nervous System □ □ 175

18. Which of the following agents is a full (a) Inhibiting brain stem respiratory
antagonist of opioid receptors? mechanisms
(a) Meperidine (b) Suppression of the cough reflex
(b) Buprenorphine leading to airway obstruction
(c) Naloxone (c) Development of truncal rigidity
(d) Butorphanol (d) Both (a) and (c)
19. The principal central nervous system 24, Most strong mu receptor agonists
effect of the opioid analgesics with cause:
affinity for a mu receptor is: (a) Hypertension
(a) Analgesia (b) Increasing the pulmonary arterial
(b) Respiratory depression pressure and myocardial work
(c) Euphoria (c) Cerebral vasodilatation, causing an
increase in intracranial pressure
(d) All of the above
(d) All of the above
20. Which of the follow ing opioid
analgesics can produce dysphoria, ^ W hich of the follow ing opioid
anxiety and hallucinations? analgesics can produce an increase in
the pulmonary arterial pressure and
(a) Morphine
myocardial work?
(b) Fentanyl
(a) Morphine
(c) Pentazocine
(b) Pentazocine
(d) Methadone
(c) Meperidine
21. Indicate the opioid analgesic, which (d) Methadone
has 80 times analgesic potency and ^
Morphine causes the following effects
respiratory depressant properties of
EXCEPT:
morphine, and is more effective than
morphine in maintaining (a) Constipation
hemodynamic stability? (b) Dilatation of the biliary duct
(a) Fentanyl (c) Urinary retention
(d) Bronchiolar constriction
(b) Pentazocine
(c) Meperidine 27. Therapeutic doses of the opioid
(d) Nalmefene analgesics:
(a) Decrease body temperature
22. Which of the follow ing opioid
(b) Increase body temperature
analgesics is used in combination with
droperidol in neuroleptanalgesia? (c) Decrease body heat loss
(d) Do not affect body temperature
(a) Morphine
(b) Buprenorphine 28. Which of the follow ing opioid
(c) Fentanyl analgesics is used in obstetric labor?
(d) Morphine (a) Fentanyl
(b) Pentazocine
23. Fentanyl can produce significant
(c) Meperidine
respiratory depression by:
(d) Buprenorphine
176 □ □ Drug Inspector Exam

29. Indicate the opioid analgesic, which (c) Mydriasis, chills and abdominal
is used for relieving the acute, severe cramps
pain of renal colic: (d) Miosis, tremor and vomiting
(a) Morphine 34. Which of the following opioid agents
(b) Naloxone is used in the treatment of acute opioid
(c) Methadone overdose?
(d) Meperidine (a) Pentazocine
30. Which of the follow ing opioid (b) Methadone
analgesics is used irt the treatment of (c) N aloxone
acute pulmonary edema? (d) Remifentanyl
(a) Morphine
35. Indicate the pure opioid antagonist,
(b) Codeine which has a half-life of 10 hours:
(c) Fentanyl (a) Naloxone
(d) Loperamide (b) Naltrexone
31. The relief produced by intravenous (c) Tramadol
morphine in dyspnea from pulmonary (d) Pentazocine
edema is associated with reduced:
36. In contrast to morphine, methadone:
(a) Perception of shortness of breath
(a) Causes tolerance and physical
(b) Patient anxiety
dependence more slowly
(c) Cardiac preload (reduced venous (b) Is more effective orally
tone) and afterload (decreased
(c) W ithdrawal is less severe,
peripheral resistance)
although more prolonged
(d) All of the above
(d) All of the above
32. Rhinorrhea, lacrim ation, chills,
37. Which of the follow ing opioid
gooseflesh, hyperventilation,
analgesics is a partial mu receptor
hyperthermia, mydriasis, muscular
agonist?
aches, vomiting, diarrhea, anxiety, and
hostility are effects of: (a) Morphine
(a) Tolerance (b) Methadone
(b) Opioid overdosage (c) Buprenorphine
(c) Drug interactions between opioid (d) Sufentanyl
analgesics and sedative-hypnotics 38. Indicate a partial mu receptor agonist,
(d) Abstinence syndrome which has 20-60 times analgesic
potency of morphine, and a longer
33. The diagnostic triad of opioid
duration of action:
overdosage is:
(a) Pentazocine
(a) M ydriasis, coma and
hyperventilation (b) Buprenorphine
(b) Coma, depressed respiration and (c) Nalbuphine
miosis (d) Naltrexone
Drug Acting on Central Nervous System □ □ 177

39. Which of the follow ing opioid (a) Ionic interactions.


analgesics is a strong kappa receptor (b) Hydrogen bonding interactions.
agonist and a mu receptor antagonist? (c) Van der Waals binding
(a) Naltrexone (b) Methadone interactions.
(c) Nalbuphine (d) Buprenorphine (d) The group has no binding role.
40. Which of the following drugs has 43. The following structure is used as an
weak mu agonist effects and inhibitory analgesic. Name the structure.
action on norepinephrine and
serotonin reuptake in the CNS?
(a) Loperamide (b) Tramadol
(c) Fluoxetine (d) Butorphanol
41. The follow ing structure is an
important m edicine. Suggest the
name.

(a) Diamorphine
(b) Morphine
(c) Codeine
(d) Thebaine
44. Which of the following statements is
false regarding codeine?
(a) The structure is a weaker analgesic
than morphine.
(a) Diamorphine (b) Morphine (b) The structure acts as a prodrug.
(c) Codeine (d) Thebaine (c) The structure is converted to
morphine in the brain.
42. Morphine is an important analgesic.
(d) The coloured methyl group masks
What type of interactions are involved
an important binding group.
in binding the phenol group to the
target site? 45. Name the following structure. What
is this structure called?
Phenol
178 □ □ Drug Inspector Exam

(a) 6-acetylmorphine
(b) 3-acetylmorphine
(c) heterocodeine
(d) heteromorphine
46. Compare analgesic activity of 3-
acetylm orphine relative to
diamorphine and 6-acetylmorphine.
(a) 3-acetylmorphine should be more (a) There is an increase in activity.
active than 6-acetylmorphine and (b) There is a decrease in activity.
diamorphine.
(c) There is a loss of all activity.
(b) 3-acetylmorphine should be less
(d) The compound becomes an
active than 6-acetylmorphine and
antagonist.
diamorphine.
(c) 3-acetylmorphine should be more 49. The following molecule (etorphin(e)
active than 6-acetylmorphine and is used in veterinary medicine. What
less active than diamorphine. is it used for?
(d) 3-acetylmorphine should be less
active than 6-acetylmorphine and
more active than diamorphine.
17. Levorphanol is an analgesic which is
five times more active than morphine.
To which class of compounds does this
structure belong?

(a) Sedation
(b) Analgesia
(c) Treatment of diarrhoea
(d) Pupil constriction
50. Etorphine is used in veterinary
(a) Benzomorphans medicine. Name its antagonistic drug?
(b) 4-phenylpiperidines
(c) Morphinans
(d) Enkephalins
48. Levorphanol is an analgesic which is
five times more active than morphine.
What happens when the N-methyl
group is replaced with an N-allyl
group?
Drug Acting on Central Nervous System □ □ 179

(a) Buprenorphine (b) The above structure achieves the


(b) Etorphine same level of pain relief at lower
(c) Diprenorphine doses than those required by
(d) Thebaine morphine.
(c) The above structure has no side
51. The following agent is used clinically
effects.
as an analgesic. What is it called?
(d) The above structure can be taken
orally.
53. The binding site of analgesic receptors
has two hydrophobic binding regions
in the vicinity of the ionic binding
region. One is responsible for agonist
activity and the other is responsible
for antagonist activity. Which of the
following statements is true?
(a) The antagonist hydrophobic
(a) etorphine binding region is closer to the ionic
binding region than the agonist
(b) thebaine
hydrophobic binding region.
(c) buprenorphine
(b) The agonist hydrophobic binding
(d) diprenorphine
region is closer to the ionic binding
52. Buprenorphine is used clinically as an region than the antagonist
analgesic. hydrophobic binding region.
(c) The antagonist hydrophobic
binding region and agonist
hydrophobic bind regions are
equidistant from the ionic binding
region.
(d) The relative positions of the
hydrophobic regions vary
depending on the type of analgesic
receptor concerned.
54. Consider the following analgesic.
M e

Which of the following statements is


true?
(a) The above structure is more
effective than morphine at treating
severe pain.
180 □ □ Drug Inspector Exam

What is the source of this structure? (c) Baclophen


(a) Opium (d) Paracetamol
(b) Frog 60. Which of the following non-narcotic
(c) An endogenous compound agents is salicylic acid derivative?
present in the body (a) Phenylbutazone
(d) Snake venom (b) Ketamine
55. Morphine is the structure chiefly (c) Aspirin
responsible for the biological activity (d) Tramadol
of opium. What is the name given to
61. Tick pirazolone derivative:
the chemical that is chiefly responsible
for the biological activity of a natural (a) Methylsalicylate
extract? (b) Analgin
(a) Lead compound (c) Paracetamol
(b) Active principle (d) Ketoralac
(c) Pharmacophore 62. Which one of the following non­
(d) Lead principle narcotic agents inhibits mainly
cyclooxygenase (COX) in CNS?
Non-narcotic analgesics
(a) Paracetamol
56. Non-narcotic analgesics are mainly (b) Ketorolac
effective against pain associated with: (c) Acetylsalicylic acid
(a) Inflammation or tissue damage (d) Ibuprofen
(b) Trauma
63. Most of non-narcotic analgetics have:
(c) Myocardial infarction
(a) Anti-inflammatory effect
(d) Surgery
(b) Analgesic effect
57. Non-narcotic agents cause: (c) Antipyretic effect
(a) Respiratory depression (d) All of the above
(b) Antipyretic effect
64. Indicate the non-narcotic analgesic,
(c) Euphoria
which lacks an anti-inflammatory
(d) Physical dependence
effect:
58. Non-narcotic analgesics are all of the (a) Naloxone
following drugs EXCEPT: (b) Paracetamol
(a) Paracetamol (c) Metamizole
(b) Acetylsalicylic acid (d) Aspirin
(c) Butorphanol
65. Correct statements concerning aspirin
(d) Ketorolac include all of the following EXCEPT:
59. Select the non-narcotic drug, which is (a) It inhibits mainly peripheral COX
a paraaminophenol derivative: (b) It does not have an anti­
(a) Analgin inflammatory effect
(b) Aspirin (c) It inhibits platelet aggregation
Drug Ading on Central Nervous System □ □ 181

(d) It stimulates respiration by a direct 71. Correct the statements concerning


action on the respiratory center ketorolac include all of the following
66. For which of the following conditions EXCEPT:
could aspirin be used (a) It inhibits COX
prophylactically? (b) It is as effective as morphine for a
(a) N on-cardiogenic pulmonary short-term relief from moderate to
edema severe pain
(b) Peptic ulcers (c) It has a high potential for physical
(c) Thromboembolism dependence and abuse
(d) Metabolic acidosis (d) It does not produce respiratory
depression
67. All of the following are undesirable
effects of aspirin EXCEPT: 72. Indicate the non-opioid agent of
central effect with analgesic activity:
(a) Gastritis with focal erosions
(a) Reserpine (b) Propranolol
(b) Tolerance and physical addiction
(c) Clopheline (d) Prazosin
(c) Bleeding due to a decrease of
platelet aggregation 73. Select the antiseizure drug with an
(d) Reversible renal insufficiency analgesic component of effect:
(a) Carbamazepine
68. Characteristic findinds of salicylism
include: (b) Ethosuximide
(c) Phenytoin
(a) Headache, mental confusion and
drowsiness (d) Clonazepam
(b) Tinnitus and difficulty in hearing 74. Which of the following nonopioid
(c) Hyperthermia, sweating, thirst, agents is an antidepressant with
hyperventilation, vomiting and analgesic activity?
diarrhea (a) Fluoxetine
(d) All of the above (b) Moclobenude
69. Analgin usefulness is limited by: (c) Tranylcypramine
(a) Agranulocytosis (d) Amitriptyline
(b) Erosions and gastric bleeding 75. Tick mixed (opioid/non-opioi(d) agent:
(c) Methemoglobinemia (a) Paracetamol
(d) Hearing impairment (b) Tramadol
70. M ethemoglobinemia is possible (c) Sodium valproate
adverse effect of: (d) Butorphanol
(a) Aspirin Anxiolytic agents
(b) Paracetamol 76. Anxiolytics are used to treat:
(c) Analgin (a) Neurosis
(d) Ketorolac (b) Psychosis
(c) Narcolepsy
(d) Bipolar disorders
182 □ □ Drug Inspector Exam

77. Anxiolytic agents should: (b) Triazolam


(a) Relieve pain (c) Diazepam
(b) Reduce anxiety and exert a (d) Clorazepate
calming effect
83. Which of the following
(c) Improve mood and behaviour in benzodiazepines has the shortest
patient with psychotic symptoms duration of action?
(d) Produce drowsiness, encourage (a) Triazolam
the onset and maintenance of a (b) Clorazepate
state of sleep
(c) Prazepam
78. Anxiolytics are also useful for: (d) Clordiazepoxide
(a) Treatment of epilepsy and seizures
84. Which of the following benzodia­
(b) Insomnia
zepines is less likely to cause
(c) Muscle relaxation in specific cumulative and residual effects with
neuromuscular disorders multiple doses?
(d) All of the above (a) Clorazepate
79. Indicate the agents of choice in the (b) Quazepam
treatment of most anxiety states: (c) Lorazepam
(a) Barbiturates (d) Prazepam
(b) Benzodiazepines 85. Anxiolytic dosage reduction is
(c) Lithium salts recommended:
(d) Phenothiazines (a) In patients taking cimetidine
80. The choice of benzodiazepines for (b) In patients with hepatic
anxiety is based on: dysfunction
(a) A relatively high therapeutic index (c) In elderly patients
(b) Availability of flumazenil for (d) All of the above
treatment of overdose 86. W hich of the following
(c) A low risk of physiologic benzodiazepines is preferred for
dependence elderly patients?
•(d) All of the above (a) Clorazepate
81. Which of the following anxiolitics is a (b) Clordiazepoxide
benzodiazepine derivative: (c) Triazolam
(a) Buspirone (d) Prazepam
(b) Clordiazepoxide 87. Which of the following anxiolytics is
(c) Meprobamate preferred in patient with limited
(d) Chloral hydrate hepatic function?
82. Indicate the benzodiazepine, which (a) Buspirone
has the shortest elimination half-life: (b) Quazepam
(a) Quazepam (c) Diazepam
(d) Chlordiazepoxide
Drug Acting on Central Nervous System □ □ 183

88. Indicate the mechanism of hypnotic (b) A high risk of drug interactions
benzodiazepine action: based on liver enzyme induction
(a) Increasing the duration of the (c) Synergic CNS depression with
GABA-gated Cl- channel openings concomitant use of other drugs
(b) Directly activating the chloride (d) The form ation of active
channels metabolites
(c) Increasing the frequency of Cl- 94. Indicate the anxiolitic agent, which
channel opening events relieves anxiety without causing
(d) All of the above marked sedative effects:
89. Which of the following anxiolytics is (a) Diazepam
a partial agonist of brain 5-HT1A (b) Chlordiazepoxid
receptors? (c) Buspirone
(a) Buspirone (d) Clorazepate
(b) Alprazolam
95. Which of the following anxiolytics has
(c) Chlorazepat minimal abuse liability?
(d) Lorazepam (a) Oxazepam
90. Indicate the competitive antagonist of (b) Buspirone
BZ receptors: (c) Flumazenil
(a) Flumazeni’ (d) Alprazolam
(b) Buspirone 96. In contrast to benzodiazepines,
(c) Picrotoxin buspirone:
(d) Diazepam (a) Interact directly with gabaergic
91. Indicate the agent, which interferes system
with GABA binding: (b) Has more marked hypnotic,
(a) Chlordiazepoxide anticonvulsant, or muscle relaxant
(b) Bicuculline properties
(c) Thiopental (c) Causes less psychomotor
(d) Picrotoxin impairment and does not affect
driving skills
92. Antianxiety agents have:
(d) Has maximal abuse liability
(a) Sedative and hypnotic activity
(b) Muscle relaxing and anti­ 97. Which of the following sedative-
convulsant effects hypnotic drugs does not potentiate the
(c) Amnesic properties CNS depressant effects of
(d) All of the above ethanol,phenothiazines, or tricyclic
antidepressants?
93. Which of the following disadvantages (a) Buspirone
does not limit using benzodiazepines
(b) Phenobarbital
as antianxiety agents?
(c) Diazepam
(a) Tendency to develop psychologic
(d) Chloralhydrate
dependence
184 □ □ Drug Inspector Exam

98. Limitation of buspirone is: severe tremor, vivid hallucination, and


(a) A low therapeutic index psychosis are possible symptoms of:
(b) An extremely slow onset of action (a) Tolerance
(c) A high potential of development (b) Withdrawal
of physical dependence (c) Drug interactions between
(d) Impairment of mentation or motor barbiturate and diazepam
functions during working hours (d) None of the above
99. Which drugs may be used as 104. Flumazenil is used to:
antianxiety agents? (a) Reverse the CNS depressant effects
(a) BETA-blocking drugs of hypnotic benzodiazepines
(b) Clonidine - a partial agonist of overdose
alfa2 receptors (b) Hasten recovery following use of
(c) Tricyclic antidepressants hypnotic benzodiazepines in
(d) All of the above anesthetic and diagnostic
procedure
100. Which of the following
(c) Reverse benzodiazepine-induced
benzodiazepines is more likely to
respiratory depression
cause "hangover" effects such as
drowsiness, dysphoria, and mental or (d) All of the above
motor depression the following day? 105. Flumazenil given intravenously:
(a) Oxazepam (a) Has interm ediate onset and
(b) Triazolam duration of action about 2 hours
(c) Clorazepat (b) Acts rapidly but has a short half-
(d) Lorazepam life
(c) Has an effect lasting 3-5 hours
101. Additive CNS depression can be
predicted if benzodiazepines are used (d) Has duration of action longer than
with: 6 hours hypnotics
(a) Ethanol 106. Hypnotic drugs are used to treat:
(b) Morphine (a) Psychosis
(c) Clorpromazine (b) Sleep disorders
(d) All of the above (c) Narcolepsy
102. Which dosage of benzodiazepines for (d) Parkinsonian disorders
60-90 days may produce severe 107. Hypnotic drugs should:
withdrawal symptoms? (a) Reduce anxiety and exert a
(a) 50-60 mg/d calming effect
(b) Less than 400 mg/d (b) Induce absence of sensation
(c) More than 800 mg/d (c) Produce drowsiness, encourage
(d) Less than 40 mg/d the onset and maintenance of sleep
103. Restlessness, anxiety, orthostatic (d) Prevent mood swings in patients
hypotension, generalized seizures, with bipolar affective disorders
Drug Acting on Central Nervous System □ □ 185

108. Which of the following chemical 114. Indicate the barbituric acid derivative,
agents are used in the treatment of which has 4-5 days elimination half-
insomnia? life:
(a) Benzodiazepines (a) Secobarbital
(b) Imidazopyridines (b) Thiopental
(c) Barbiturates (c) Phenobarbital
(d) All of the above (d) Amobarbital
109. Select a hypnotic drug, which is a 115. Indicate the hypnotic benzodiazepine,
benzodiazepine derivative: which has the shortest elimination
(a) Zolpidem half-life:
(b) Flurazepam (a) Temazepam
(c) Secobarbital (b) Triazolam
(d) Phenobarbitone (c) Flurazepam
110. Tick a hypnotic agent - a barbituric (d) Diazepam
acid derivative: 116. Which of the following hypnotic drugs
(a) Flurazepam is more li’;ely to cause cumulative and
(b) Zaleplon residual effects?
(c) Thyopental (a) Zolpidem
(d) Triazolam (b) Temazepam
(c) Phenobarbital
111. Select a hypnotic drug, which is an
(d) Triazolam
imidazopyridine derivative:
(a) Pentobarbital 117. Which of the following hypnotic drugs
(b) Temazepam increases the activity of hepatic drug-
metabolizing enzyme systems?
(c) Zolpidem
(d) Chloral hydrate (a) Phenobarbital
(b) Zolpidem
112. Which of the following hypnotic
(c) Flurazepam
agents is absorbed slowly?
(d) Zaleplon
(a) Phenobarbital
(b) Flurazepam 118. Hepatic microsomal drug-
metabolizing enzyme induction leads
(c) Triazolam
to:
(d) Temazepam
(a) Barbiturate tolerance
113. Which of the following barbiturates (b) Cumulative effects
is an ultra-short-acting drug?
(c) Development of physical
(a) Secobarbital dependence
(b) Amobarbital (d) "hangover" effects
(c) Thiopental
119. Hypnotic benzodiazepines are more
(d) Phenobarbital
powerful enzyme inducers than
barbiturates.
186 □ □ Drug Inspector Exam

(a) True (a) Zolpidem


(b) False (b) Amobarbital
120. Indicate the hypnotic drug, which (c) Flurozepam
does not change hepatic drug- (d) Pentobarbital
metabolizing enzyme activity? 126. Indicate the mechanism of barbiturate
(a) Flurazepam (b) Zaleplon action (at hypnotic doses):
(c) Triazolam (d) All of the above (a) Increasing the duration of the
121. Barbiturates increase the rate of GABA-gated Cl- channel openings
metabolism of: (b) Directly activating the chloride
(a) Anticoagulants channels
(b) Digitalis compounds (c) Increasing the frequency of Cl-
(c) Glucocorticoids channel opening events
(d) All of the above (d) All of the above

122. Which of the following agents inhibits 127. Imidazopyridines are:


hepatic metabolism of hypnotics? (a) Partial agonists at brain 5-TH1A
(a) Flumasenil receptors
(b) Cimetidin (b) Selective agonists of the BZ1
(omega 1) subtype of BZ receptors
(c) Phenytoin
(c) Competitive antagonists of BZ
(d) Theophylline
receptors
123. Which of the following factors can (d) Nonselective agonists of both BZ1
influence the biodisposition of and BZ2 receptor subtypes
hypnotic agents?
128. Which of the following hypnotic
(a) Alterations in the hepatic function
agents is a positive allosteric
resulting from a disease
modulator of GABAA receptor
(b) Old age function?
(c) Drug-induced increases or (a) Zaleplon
decreases in microsomal enzyme
(b) Flurazepam
activities
(c) Zolpidem
(d) All of the above
(d) All of the above
124. Which of the following hypnotics is
preferred for elderly patients? 129. Indicate a hypnotic drug - a selective
agonist at the BZ1 receptor subtype:
(a) Phenobarbital
(a) Flurazepam
(b) Flurozepam
(b) Zolpidem
(c) Temazepam
(c) Triazolam
(d) Secobarbital
(d) Flumazenil
125. Which of the following hypnotics is
preferred in patients with limited 130. Which of the ^following hypnotic
hepatic function? agents is able to interact with both BZ1
and BZ2 receptor subtypes?
Drug Acting on Central Nervous System □ □ 187

(a) Zaleplon (c) High potential of physical


(b) Phenobarbital dependence and abuse
(c) Flurazepam (d) All of the above
(d) Zolpidem 137. Which of the following
131. Indicate the competitive antagonist of benzodiazepines is used mainly for
BZ receptors: hypnosis?
(a) Flumazenil (a) Clonozepam
(b) Picrotoxin (b) Lorazepam
(c) Zolpidem (c) Flurazepam
(d) Temazepam (d) Midazolam
132. Flumazenil blocks the actions of: 138. Indicate the main claim for an ideal
(a) Phenobarbital hypnotic agent:
(b) Morphine (a) Rapid onset and sufficient
duration of action
(c) Zolpidem
(b) Minor effects on sleep patterns
(d) Ethanol
(c) Minimal "hangover" effects
133. Indicate the agent, which interferes (d) All of the above
with GABA binding:
(a) Flurazepam 139. Which stage of sleep is responsible for
the incidence of dreams?
(b) Bicuculline
(a) REM sleep
(c) Thiopental
(b) Slow wave sleep
(d) Zolpidem
(c) Stage 2NREM sleep
134. Which of the following agents blocks (d) All of the above
the chloride channel directly?
(a) Secobarbital 140. During slow wave sleep (stage 3 and
4 NREM sleep):
(b) Flumazenil
(a) Dreams occur
(c) Zaleplon
(b) The secretion of adrenal steroids
(d) Picrotoxin
is at its highest
135. Which of the following agents is (c) Somnambulism and nightmares
preferred in the treatm ent of occur
insomnia? (d) The secretion of somatotropin is
(a) Barbiturates at its lowest
(b) Hypnotic benzodiazepines 141. All of the hypnotic drugs induce:
(c) Ethanol (a) Increase the duration of REM sleep
(d) Phenothiazide (b) Decrease the duration of REM
136. Barbiturates are being replaced by sleep
hypnotic benzodiazepines because of: (c) Do not alter the duration of REM
(a) Low therapeutic index sleep
(b) Suppression in REM sleep
188 □ □ Drug Inspector Exam

(d) Increase the duration of slow wave drowsiness, dysphoria, and mental or
sleep motor depression the following day?
142. Which of the following hypnotic drugs (a) Temazepam
causes least suppression of REM (b) Triazolam
sleep? (c) Flurazepam
(a) Flumazenil (d) None of the above
(b) Phenobarbital 147. Indicate the hypnotic drug, which
(c) Flurazepam binds selectively to the BZ1 receptor
(d) Secobarbital subtype, facilitating GABAergic
143. Although the benzodiazepines inhibition:
continue to be the agents of choice for (a) Thiopental
insomnia, they have: (b) Zolpidem
(a) The possibility of psychological (c) Flurazepam
and physiological dependence (d) Phenobarbital
(b) Synergistic depression of CNS 148. Which of the following statements is
with other drugs (especially correct for zolpidem?
alcohol) (a) Causes minor effects on sleep
(c) Residual drowsiness and daytime patterns
sedation (b) The risk of development of
(d) All of the above tolerance and dependence is less
144. Hypnotic benzodiazepines can cause: than with, the use of hypnotic
(a) A dose-dependent increase in both benzodiazepines
REM and slow wave sleep (c) Has minimal muscle relaxing and
(b) Do not change sleep patterns anticonvulsant effects
(c) A dose-dependent decrease in both (d) All of the above
REM and slow wave sleep 149. Which agent exerts hypnotic activity
(d) A dose-dependent increase in REM with minimal muscle relaxing and
sleep and decrease in slow wave anticonvulsant effects?
sleep (a) Flurazepam
145. Which one of the following hypnotic (b) Triazolam
benzodiazepines is more likely to (c) Zaleplon
cause rebound insomnia? (d) None of the above
(a) Triazolam 150. Zolpidem and zaleplon have
(b) Flurazepam effectiveness sim ilar to that of
(c) Temazepam hypnotic benzodiazepines in the
(d) All of the above — management of sleep Disorders
146. Which of the following hypnotic (a) True
benzodiazepines is more likely to (b) False
cause "hangover” effects such as
Drug Acting on Central Nervous System □ □ 189

151. Which of the following hypnotic drugs (a) Slurred speech


is used intravenously as anesthesia? (b) Uncoordinated motor movements
(a) Thiopental (c) Im pairm ent in attention and
(b) Phenobarbital memory
(c) Flurazepam (d) All of the above
(d) Zolpidem 156. Which of the following is derived from
152. Indicate the usual cause of death due the hemp plant "cannabis sativa"?
to overdose of hypnotics: (a) Opium
(a) Depression of the medullar (b) Marijuana
respiratory center (c) MDMA
(b) Hypothermia (d) Crack
(c) Cerebral edema 157. A synthetic form of opium was
(d) Status epilepticus developed by Germany during WWII.
153. Toxic doses of hypnotics may cause a This is known as?
circulatory collapse as a result of: (a) Prednisalone
(a) Blocking alfa adrenergic receptors (b) Cortisone
(b) Increasing vagal tone (c) Methadone
(c) Action on the medullar vasomotor (d) Polyheroin
center 158. A long-term user of cocaine may well
(d) All of the above develop symptoms of other
154. Which of the following statements psychological disorders, such as:
correctly associates a CNS drug with (a) Major depression
its mechanism of action? (b) Social phobia
(a) bupropion-activation of (c) Eating disorders
endocannabinoid receptors (d) All of the above
(b) diazepam -facilitation of
159. Amotivational syndrome in cannabis
GABAstimulated chloride channel
users suggests that those who use
opening
cannabis regualry are more likely to:
(c) fluoxetine-selective inhibition of
(a) Exhibit apathy
presynaptic norepinephrine
(b) Exhibit loss of ambition
reuptake
(d) pentobarbital-inhibition of NMDA (c) Have difficulty concentrating
receptors (d) All of the above
(d) tranylcypromine-inhibition of O- 160. Lysergic Acid Diethylamide (LS(D)
methylation of catecholamines starts to take effect around 30 to 90
Sedatives and hypnotics minutes after taking it and physical
effects include:
155. With Barbiturate and Benzodiazepine
Abuse and Dependency, sedative (a) R a ise d b o d y tem p e ra tu re
intoxication is generally associated (b) Increased heart rate and blood
with: pressure
190 □ □ Drug Inspector Exam

(c) Sleeplessness (b) Doctors prescribing their own


(d) All of the above drugs
161. Individuals w ith Hallucinogen (c) Motive for using a substance
Dependency can spend many hours (d) Deciding the drug of choice
and even days recovering from the Antiepileptic drugs
effects of the drug some hallucinogens 165. The drug of choice for juvenile
- such as MDMA-are often associated myoclonic epilepsy
with physical 'hangover' symptoms. (a) Sodium valproate
Which of the following are MDMA (b) Phenobarb
hangovers? (c) Carbamazepine
(a) Insomnia (d) Gabapentin
(b) Fatigue
166. Dreaming occurs during
(c) Drowsiness
(a) REM sleep
(d) All of the above
(b) NREM sleep
162. Which of the following is an important (c) Both
factor in substance abuse? (d) None of the above
(a) W hether the substances are
regularly used by other family 167. Which form of epilepsy carries best
members prognosis?
(b) Whether the family environment (a) Partial seizures
is rural or urban (b) Tonic -clonic seizures
(c) Whether you are a twin (c) Petit-mal
(d) Whether you are born in the (d) Atonic seizures
winter 168. In GTCS all the following are effective
163. The alcohol intoxicated individual has except
less cognitive capacity available to (a) Gabapentin
process all on-going information, and (b) Lamotrigine
so alcohol acts to narrow attention and (c) Vigabatrin
means that the drinker processes (d) Clobazam
fewer cues less well. This is known 169. The most feared complication of
as: prolonged Valproate therapy ia
(a) Alcohol myopia (a) Anorexia
(b) Alcohol dependency (b) Drowsiness
(c) Alcohol abuse (c) Hepatic necrosis
(d) Alcohol amnesia (d) Wt gain
164. In substance abuse, the term self- (e) Drug rash
medication refers to? 170. Long-term side effects of Phenytoin
(a) Amelioration or psychological therapy include all except
distress thorough substance use (a) Gum hypertrophy
(b) Hirsutism
Drug Acting on Central Nervous System □ □ 191

(c) Folate deficiency 176. Ethosuximide is used in th treatment


(d) Alopecia of :
(e) Neuropathy (a) Tonic-clonic seizure.
171. Drug capable of causing seizure is (b) Absence seizure.
(a) Anti-depressants (c) Myoclonic seizure.
(b) Phenothiazines (d) Simple partial seizure.
(c) Metronidazole 177. Which of the following
(d) Local anaesthetics anticonvulsants acts via the
(e) All of the above enhancement of GABA activity?
(a) carbonic anhyarase inhibitors like
172. The trigeminal neuralgia is most likely acetazolamide
to be due to
(b) benzodiazepines like diazepam
(a) Demyelinating plaque at root
(c) succinimides like ethosuximide
entry zone (MS)
(d) hydantoins like phenytoin Skeletal
(b) Root flet compression by aberrant
muscle relaxant drug
vessel loop
(c) Compression by CP angle tumor 178. Cyclobenzaprine is a:
(d) Idiopathic (a) Anticancer drug
(b) Skeletal muscle relaxant
173. Factors which may trigger seizures
include (c) Antithyroid drug
(a) Sleep deprivation (d) Antiepileptic drug
(b) Pyrexia 179. Which one of the following muscle
(c) Alcohol ingestion/withdrawl relaxant has the maximum duration
(d) Emotion / physical stress of action ?
(e) All of the above (a) Atracurium (b) Vecuronium
(c) Rocuronium (d) Doxacurium
174. Concomitant adm inistration of
clonazepam with which of the 180. Which of the following drugs or drug
following antiepileptic drug can groups causes skeletal muscle
precipitate absence status? relaxation by acting within the muscle
(a) Sodium valproate. itself?
(b) Phenobarbitone. (a) dantrolene (dantrium)
(c) Carbamazepine. (b) muscarinic antagonists
(d) Phenytoin (c) benzodiazepines
(d) baclofen (lioresal)
175. Which one of the following drugs does
not interfere w ith folic acid 181. Which of the following drugs can be
metabolism? classed precisely as a muscle relaxant?
(a) Phenytoin (a) Suximethonium
(b) Gabapentin (b) dantrolene
(c) Phenobarbitone (c) orphenadrine
(d) Primidone (d) panacuronium
192 □ □ Drug Inspector Exam

ANSWERS
1. (a) 2. (b) 3. (a) 4. (d) ' 5. (c) 6. (d) 7. (a) 8. (c) 9. (a) 10. (b)
11. (a) 12. (c) 13. (b) 14. (c) 15. (b) 16. (c) 17. (b) 18. (c) 19. (d) 20. (c)
21. (a) 22. (c) 23. (d) 24. (c) 25. (b) 26. (b) 27. (a) 28. (c) 29. (d) 30. (a)
31. (d) 32. (d) 33. (b) 34. (c) 35. (b) 36. (d) 37. (c) 38. (b) 39. (c) 4 0 .(b)
41. (b) 42. (b) 43. (c) 44. (c) 45. (a) 46. (b) 47. (c) 48. (d) 49. (a) 50. (c)
51. (c) 52. (b) 53. (a) 54. (c) 55. (b) 56. (a) 57. (b) 58. (c) 59. (d) 60. (c)
61. (b) 62. (a) 63. (d) 64. (b) 65. (b) 66. (c) 67. (b) 68. (d) 69. (a) 70. (b)
71. (c) 72. (c) 73. (a) 74. (d) 75. (b) 76. (a) 77. (b) 78. (d) 79. (b) 80. (d)
81. (b) 82. (b) 83. (a) 84. (c) 85. (d) 86. (c) 87. (a) 88. (c) 89. (a> 90. (a)
91. (b) 92. (d) 93. (b) 94. (c) 95. (b) 96. (c) 97. (a) 98. (b) 99. (d) 100. (c)
101. id) 102. (a) 103. (b) 104. (d) 105. (b) 106. (b) 107. (c) 108. (d) 109. (b) 110. (c)
111. (c) 112. (d) 113. (c) 114. (c) 115. (b) 116. (c) 117. (a) 118. (a) 119. (b) 120.(d)
121. (d) 122. (b) 123. (d) 124. (c) 125. (a) 126. (a) 127. (b) 128. (d) 129. (b) 130. (c)
131. (a) 132. (c) 133. (b) 134. (d) 135. (b) 136. (d) 137. (c) 138. (d) 139. (a) 140. (c)
141. (b) 142. (c) 143. (d) 144. (c) 145. (a) 146. (c) 147. (b) 148. (d) 149. (c) 150. (a)
151. (a) 152. (a) 153. (c) 154. (b) 155. (d) 156. (b) 157. (c) 158. (d) 159. (d) 1 60.(d)
161. (d) 162. (a) 163. (a) 164. (a) 165. (a) 166. (a) i67. (c) 168. (a) 169. (c) 170. (d)
171. (e) 172. (b) 173. (e) 174. (a) 175. (b) 176. (b) 177. (b) 178. (b) 179. (d) 180. (a)
181. (b)

□no
Antigen, Antigen-antibofly Reactions, ^

Hypersensitivity, Activd and Passive ^ ■ ■

Immunity and Types of Vaccines C h a p te r

ANTIGEN
Antigens are foreign substances that when introduced into a body, can induce an
immune response. The antigens in vaccines can be killed or modified-live viral or
bacterial strains. The sole purpose of antigens in vaccines is to stimulate the body's
immune system with an harmless version of the agent in order to protect against more
virulent strains later.

ANTIGEN-ANTIBODY REACTIONS
The antigens and the antibodies combine specifically with each other. This interaction
between them is called Antigen-Antibody reaction. It may be abbreviated as Ag-Ab
reaction. These form the basis for humoral immunity or antibody mediated immunity.
These reactions form the basis for detection of infectious disease causing agents and
also some non-specific Ag's like enzymes. When Ag-Ab reactions occur invitro, they are
known as serological reactions. The reactions between Ag and Ab occur in three stages.
1. Primary stage: This reaction involves formation of Ag-Ab complex. The reaction
is rapid and it obeys the general laws of physical chemistry and thermodynamics.
The two molecules are held together by non-covalent forces, hydrogen bonding,
ionic bonding and sometimes hydrophobic bonding.
2. The second stage leads to visible events like precipitation, agglutination, lysis of
cells, killing of Ag, neutralization of toxins, fixation of complement and
enhancement of phagocytosis.
3. The third stage includes destruction of Ag or its neutralization.
Salient features of Ag-Ab reactions
1. Immune complex: Since the reaction is specific, an Ag combines only with its
homologous Ab and vice versa.
2. Specificity of Ag-Ab reaction: An Ab will combine only with that Ag which
causes its production. The specificity may be compared to a Lock and Key system.
3. Binding sites of Ag and Ab: The entire of the Ag participates in the reaction.
But the part of the Ag that combines wi h the Ab is called epitope or antigenic
determinant. An Ag may have 10, 50 or upto 100 antigenic determinants. The
part of the Ab that combines with Ag is called paratope or antigen binding site.
Most Ab's are bivalent, whereas IgM has 5 to 10 paratopes.
193
194 □ □ Drug Inspector Exam

HYPERSENSITIVITY
It refers to undesirable (damaging, discomfort producing and sometimes fatal)
reactions produced by the normal immune system. Hypersensitivity reactions require
a pre-sensitized (immune) state of the host. Hypersensitivity reactions can be divided
into four types: type I, type II, type III and type IV, based on the mechanisms involved
and time taken for the reaction. Frequently, a particular clinical condition (disease) may
involve more than one type of reaction.
Type I Hypersensitivity. It is also known as immediate or anaphylactic
hypersensitivity. The reaction may involve skin (urticaria and eczema), eyes
(conjunctivitis), nasopharynx (rhinorrhea, rhinitis), bronchopulmonary tissues (asthma)
and gastrointestinal tract (gastroenteritis). The reaction may cause from minor
inconvenience to death. The reaction takes 15-30 minutes from the time of exposure to
the antigen. Sometimes the reaction may have a delayed onset (10-12 hours). Immediate
hypersensitivity is mediated by IgE. The primary cellular component in this
hypersensitivity is mast cell or basophil. The reaction is amplified and/or modified by
platelets, neutrophils and eosinophils. A biopsy of the reaction site demonstrates mainly
mast cells and eosinophils. The mechanism of reaction involves preferential production
of IgE, in response to certain antigens, allergens.
Type II Hypersensitivity: It is also known as cytotoxic hypersensitivity and may
affect a variety of organs and tissues. The antigens are normally endogenous, although
exogenous chemicals (haptens) which can attach to cell membranes can also lead to
type II hypersensitivity. Drug-induced hemolytic anemia, granulocytopenia and
thrombocytopenia are such examples. The reaction time is minutes to hours. It is primarily
mediated by antibodies of IgM or IgG class and complement. Phagocytes and K cells
may also play a role.
Type III Hypersensitivity: It is also known as immune complex hypersensitivity.
The reaction may be general (for example, serum sickness) or may involve individual
organs including skin (for example, systemic lupus erythematosus, Arthus reaction),
kidneys (for example, lupus nephritis), lungs (for example, aspergillosis), blood vessels
(for example, polyarteritis), joints (for example, rheumatoid arthritis) or other organs.
This reaction may be the pathogenic mechanism of diseases caused by many
microorganisms. The reaction may take 3-10 hours after exposure to the antigen (as in
Arthus reaction). It is mediated by soluble immune complexes. They are mostly of IgG
class, although IgM may also be involved. The antigen may be exogenous (chronic
bacterial, viral or parasitic infections), or endogenous (non-organ specific autoimmunity:
e.g.systemic lupus eythematosus, SLE). The antigen is soluble and not attached to the
organ involved. Primary components are soluble immune complexes and complement
(C3a, 4a and 5a). The damage is caused by platelets and neutrophils.
Antigen, Antigen-antibody Reactions, Hypersensitivity, Active and Passive Immunity □ □ 195

Type IV Hypersensitivity: It is also known as cell mediated or delayed type


hypersensitivity. The classical example of this hypersensitivity is tuberculin (Montoux)
reaction which peaks 48 hours after the injection of antigen (PPD or old tuberculin). The
lesion is characterized by induration and erythema. Type IV hypersensitivity is involved
in the pathogenesis of many autoimmune and infectious diseases (tuberculosis, leprosy,
blastomycosis, histoplasmosis, toxoplasmosis, leishmaniasis, etc.) and granulomas due
to infections and foreign antigens. Another form of delayed hypersensitivity is contact
dermatitis (poison ivy, chemicals, heavy metals, etc.) in which the lesions are more
popular.

ACTIVE AND P A SSIV E IM M U N ITY


Active immunity refers to the process of exposing the body to an antigen to generate
an adaptive immune response: the response takes days/weeks to develop but may be
long lasting-even lifelong. Active immunity is usually classified as natural or acquired.
Wild infection for example with hepatitis A virus (HAV) and subsequent recovery gives
rise to a natural active immune response usually leading to lifelong protection. In a
similar manner, administration of two doses of hepatitis A vaccine generates an acquired
active immune response leading to long-lasting (possibly lifelong) protection. Hepatitis
A vaccine has only been licensed since the late 1980s so that follow-up studies of
duration of protection are limited to <25 years-hence, the preceding caveat about duration
of protection.
Passive immunity refers to the process of providing IgG antibodies to protect against
infection; it gives immediate, but short-lived protection-several weeks to 3 or 4 months
at most. Passive immunity is usually classified as natural or acquired. The transfer of
maternal tetanus antibody (mainly IgG) across the placenta provides natural passive
immunity for the newborn baby for several weeks/months until such antibody is
degraded and lost. In contrast, acquired passive immunity refers to the process of
obtaining serum from immune individuals, pooling this, concentrating the
immunoglobulin fraction and then injecting it to protect a susceptible person.
The four most commonly used immunoglobulin preparations are as follows.
Human Hepatitis B Immunoglobulin. Human hepatitis B immunoglobulin is
presented as two vial sizes of 200 and 500 IU. Each millilitre contains 10-100 mg/ml
human protein of which at least 95% are gammaglobulins (IgG). This product is prepared
from plasma from screened donors. One millilitre contains not <100 IU of hepatitis B
antibody. Its use occupationally is for the immediate protection of non-immune health
care workers exposed to hepatitis B viruses (together with an appropriate vaccination
programme).
Human Rabies Immunoglobulin. Human rabies immunoglobulin is presented as a
vial size of 500 IU. Each millilitre contains 40-180 mg/ml human protein of which at
least 95% are gammaglobulins (IgG). This product is prepared from plasma from screened
196 □ □ Drug Inspector Exam

donors, selected from the USA. One millilitre contains not <150 IU of rabies antibody.
It is given as part of post-exposure prophylaxis to non-immune individuals with a
rabies prone exposure.
Human Tetanus Immunoglobulin. Human tetanus immunoglobulin is presented as
a vial size of 250 IU. Each millilitre contains 40-180 mg/ml human protein of which at
least 95% are gammaglobulins (IgG). This product is prepared from plasma from screened
donors, selected from the USA. One millilitre contains not <100 IU of tetanus antibody.
It is unlikely that this preparation would be used for health care workers; it is given
both as part of the management of tetanus prone wounds where there is heavy soil/
manure contamination and as part of the management of all wounds if the individual
is thought to be non-immune.
Human Varicella-Zoster Immunoglobulin. Each vial contains 250 mg protein (40-180
mg/ml) of which at least 95% are gammaglobulins (IgG). This product is prepared from
plasma from screened donors, selected from the USA. One millilitre contains not <100
IU of Varicella-Zoster antibody. It is given as part of post-exposure prophylaxis to
specified non-immune individuals exposed to chickenpox.

TYPES OF VACCINES
There are many approaches to design vaccines against a microbe. These choices are
typically based on fundamental information about the microbe, such as how it infects
cells and how the immune system responds to it, as well as practical considerations,
such as regions of the world where the vaccine would be used. The following are some
of the options that researchers might pursue:
• Live, attenuated vaccines
• Inactivated vaccines
• Subunit vaccines
• Toxoid vaccines
• Conjugate vaccines
• DNA vaccines
• Recombinant vector vaccines
Live, Attenuated Vaccines
Live, attenuated vaccines contain a version of the living microbe that has been
weakened in the lab so it can't cause disease. Because a live, attenuated vaccine is the
closest thing to a natural infection, these vaccines are good "teachers'1 of the immune
system: They elicit strong cellular and antibody responses and often confer lifelong
immunity with only one or two doses.
Inactivated Vaccines
Scientists produce inactivated vaccines by killing the disease-causing microbe with
chemicals, heat, or radiation. Such vaccines are more stable and safer than live vaccines:
Antigen, Antigen-antibody Reactions, Hypersensitivity, Active and Passive Immunity □ □ 197

The dead microbes can’t mutate back to their disease-causing state. Inactivated vaccines
usually dttn't require refrigeration, and they can be easily stored and transported in a
freeze-dried form, which makes them accessible to people in developing countries.
Most inactivated vaccines, however, stimulate a weaker immune system response than
do live vaccines. So it would likely take several additional doses, or booster shots, to
maintain a person's immunity. This could be a drawback in areas where people don’t
have regular access to health care and can't get booster shots on time.
Subunit Vaccines
Instead of the entire microbe, subunit vaccines include only the antigens that best
stimulate the immune system. In some cases, these vaccines use epitopes the very
specific parts of the antigen that antibodies or T cells recognize and bind to. Because
subupjt vaccines contain only the essential antigens and not all the other molecules that
make up the microbe, the chances of adverse reactions to the vaccine are lower. Subunit
vaccines can contain anywhere from 1 to 20 or more antigens. Of course, identifying
which antigens best stimulate the immune system is a tricky, time-consuming process.
Toxoid Vaccines
For bacteria that secrete toxins,‘or harmful chemicals, a toxoid vaccine might be the
answer. These vaccines are used when a bacterial toxin is the main cause of illness.
Scientists have found that they can inactivate toxins by treating them with formalin,, a
solution of formaldehyde and sterilized water. Such "detoxified" toxins, called toxoids,
are safe for use in vaccines. Vaccines against diphtheria and tetanus are examples of
toxoid vaccines. ;
Conjugate Vaccines
If a bacterium possesses an outer coating of sugar molecules called polysaccharides,
as many harmful bacteria do, researchers may try making a conjugate vaccine for it
Polysaccharide coatings disguise a bacterium’s antigens so that the immature immune
systems of infants and younger children can't recognize or respond to them. Conjugate
vaccines, a special type of subunit vaccine, get, around this problem. The vaccine that
protects against Haemophilus influenzae type B (Hib) is a conjugate vaccine.
DNA Vaccines
Once the genes from a microbe have been analyzed, scientists could attempt to
create a DNA vaccine against it. Still in the experimental stages, these vaccines show
great promise, and several types are being tested in humans. DNA vaccines take
immunization to a new technological level. These vaccines dispense with both the
whole organism and its parts and get right down to the essentials: the microbe's genetic
il. In particular, DNA vaccines use the genes that code for those all-important
198 □ □ Drug Inspector Exam

Recombinant Vector Vaccines


Recombinant vector vaccines are experimental vaccines similar to DNA vaccines,
but they use an attenuated virus or bacterium to introduce microbial DNA to cells of
the body. "Vector" refers to the virus or bacterium used as the carrier.
The chart below is a list of some vaccines and the diseases they protect against.
Table 22.1. The various Types of Common Vaccines
Vaccine D isease Advantage D isadvantage
Type

Live, M easles, mumps, Produces a strong N ot safe for people


w eakened rubella (Germanimmune with compromised
vaccines response so m easles), immune systems.
poliocan provide life-long N eeds refrigeration
(Sabin vaccine) and immunity to stay potent.
with 1-2 chicken pox doses.

Inactivated Cholera, flu, Safe for people with Usually requires


or "k ille d " hepatitis A, rabies^ compromised im m une — - booster shots every few
vaccines polio (Salk vaccine) systems. Easily stored y eafv to remain
and transported; does effective.
not require refrigeration.

Subm it H epatitis B Lower chance of Research can be time-


Vaccines adverse reaction. consum ing and difficult.
Conjugate H aem ophilus Safe for people with immune Usually requires booster
vaccines influenzae B (or Hib compromised systems. shots every few years to
and pneum ococcal rem ain effective
vaccine

MULTIPLE CHOICE QUESTIONS

1. Which of the following confer(s) (a) In a laboratory from deactivated


passive immunity: viruses and bacteria
(a) Hepatitis B vaccine (b) From the plasma of a person in
(b) MMR vaccine the acute phase of an infectious
(c) Hepatitis B immunoglobulin disease
(d) Infection with measles virus (c) From the pooled plasma of blood
(e) Cross placental transfer of donors
maternal antibodies (d) From protein produced artificially
in a laboratory
2. Immunoglobulins are made:
(e) From treating red blood cells
Antigen, Antigen-antibody Reactions, Hypersensitivity, Active and Passive Immunity □ □ 199

3. In the immune system: (c) Tetanus


(a) B lymphocytes secrete antibodies (d) Rubella
(b) Vaccines provide passive (e) Varicella Zoster
immunity 7. Maintaining the cold chain ensures
(c) B cells stimulate T cells to produce that vaccines are stored according to
antibodies the manufacturer's instructions at:
(d) Cell-m ediated immunity is (a) 0 - +4°C
controlled by T lymphocytes (b) -1 - +5°C
(e) Macrophages neutralise toxins (c) +2 - +10°C
4. Which of the following is/are true (d) +4 - +8°C
about conjugated vaccines: (e) +2 - +8°C
(a) Conjugated vaccines are those in
8. Which of the following is/are true of
which there is more than one
a vaccine refrigerator:
vaccine antigen for example, MMR
(a) An ordinary domestic refrigerator
(b) Conjugated vaccines tend to
is sufficient provided it has only
induce a poorer response than
vaccines stored in it
polysaccharide vaccines
(b) Can be used to store urine samples
(c) M eningitis C vaccine is not
(c) Should be lockable or in a lockable
available in a conjugated form
room
(d) Hib vaccine is an example of a
(d) Should be away from radiators
conjugated vaccine
(e) Are best plugged into a switchless
(e) Conjugation involves attaching a
socket
polysaccharide antigen to a
carbohydrate carrier 9. Vaccines should be:
5. Which of the following is/are true: (a) Taken out of their original
packaging to save space in the
(a) Immunological memory is only
refrigerator
present if there are detectable
antibodies (b) Stored in the bottom drawers of
the refrigerator
(b) The response to vaccine antigen is
dom inated by IgG initially (c) Packed tightly in the refrigerator
followed by IgM (d) Protected from light during
(c) Herd immunity reduces the risk storage
of unvaccinated individuals being 10. Which of the following vaccines is/
exposed to infection are given by the intramuscular route:
(d) Pertussis vaccine contains an (a) Influenza
inactivated toxin (toxoid) (b) BCG
(e) BCG is a live vaccine (c) Cholera
6. S p e c ific im m u n o g lo b u lin s a re (d) MMR
available for: (e) Varicella
(a) Rabies (b) Pertussis
200 □ □ Drug Inspector Exam

11. The most suitable site(s) for (b) A 25 mm needle length is suitable
intram uscular and subcutaneous for all age groups
vaccination is/are: (c) A 16 mm needle length is only
(a) Anterolateral aspect of the thigh recommended for pre-term or very
(b) Deltoid area of the upper arm small infants
(c) Fatty area of buttock (d) The deltoid area of the upper arm
(d) Anywhere in buttock is generally preferred for infants
(e) All of the above under 1 year old
{e\ The anterolateral region of the
12. Which of the following is/are true ^ thigh is generally preferred for
when giving a vaccine:
older children and adults
(a) If the skin is clean no further
cleaning is necessary 15. If given in the same limb as another
. (b) The skin should be disinfected ! vaccine, the second vaccine should be
| separated by at least:
prior to administering any vaccine
(a) 0.5 cm
(c) Only visibly dirty skin needs to
be washed with soap and water (b) 1.5 cm
(d) The needle should be sufficiently (c) 2.5 cm
long (25 mm) for all ages except (d) 3.5 cm
for pre-term and very small (e) None of the above
children 16. Which of the following is/are true
(e) Skin should be stretched, not about anthrax:
bunched (a) It is spread by spores of the
13. After giving a vaccine you should anaerobic bacillus Bacillus
always: anthracis
(a) Observe the recipient for (b) H al an incubation period of 2-7
immediate adverse reactions days
(ADRs) (c) Can cause cutaneous, inhalational
(b) Keep the recipient under longer and gastrointestinal infections
observation in the surgery (d) The treatm ent of choice is
(c) Dispose of equipment used for erythromycin
vaccination in a 'sharps' box (e) Human cases require isolation to
(d) Keep accurate and accessible control spread
records of both the recipient and 17. W hich of the follow ing may be
the vaccine given considered for anthrax vaccine:
(e) All of the above (a) Textile workers working with goat
L4. Which of the following is/are true hair
about vaccine administration: (b) Veterinary surgeons
(a) It is better to inject vaccine into (c) Household contacts of a human
fat than muscle case of anthrax
(d) Bonemeal workers
Antigen, Antigen-antibody Reactions, Hypersensitivity, Active and Passive Immunity □ □ 201

(e) Health Care staff working on an (b) Can be used for post exposure
Infectious Diseases Unit prophylaxis
18. Which of the following is/are true (c) Should be protected from light in
about anthrax vaccine: storage
(a) It is a live attenuated vaccine (d) Can be used safely after freezing
(b) The vaccine course consists of (e) Can be stored at room temperature
three doses given at 3 week 22. Which of the following is/are true
intervals about oral cholera vaccine:
(c) It can be given to pregnant women (a) The vaccine is recommended for
(d) It is administered by intramuscular use in children under the age of 2
injection years
(e) A reinforcing dose should be given (b) There is data suggesting a excellent
every 3 years to those at continued protective efficacy profile after
risk booster doses
19. Anthrax: (c) The vaccine when constituted
(a) Is a notifiable disease should be a blue liquid
(b) Prim arily affects carnivorous (d) The vaccine is not recommended
for prevention of travellers
animals
diarrhoea
(c) Is a common animal disease in
(e) Immunisation does not protect
Western Europe
against V Cholerae serogroup 0139
(d) Is fatal in around 20% of cases
(e) Is almost an entirely occupational 23. Cholera vaccine should not be given
disease in the UK to the following:
(a) Severely immunocompromised
20. Adverse reactions to anthrax vaccine
individuals
can include:
(b) Anyone who is acutely unwell
(a) Swelling at the injection site
(c) Pregnant and breast-feeding
(b) Urticaria
women
(c) Regional lymphadenopathy
(d) Anyone who is HIV positive
(d) Generally a higher risk of a
(e) Those with pre-existing gastro­
reaction after subsequent doses if
intestinal disorders
there was a reaction to the first
dose 24. Which of the following is/are true
(e) Cutaneous anthrax at the injection about Diphtheria:
site in a very small number of (a) Corynebacterium diphtheriae is
cases the only bacterium causing
diphtheria
21. Cholera vaccines:
(b) Those carrying C diphtheriae are
(a) Should be stored in their original
always ill
packaging
(c) Diphtheria toxin affects the heart,
nerves and adrenal tissues
202 □ □ Drug Inspector Exam

(d) Infected people may be infectious (b) Has been conjugated with either
for up to four weeks if untreated non-toxic variant of diphtheria
(e) Corynebacterium diphtheriae may vaccine or tetanus toxoid
cause skin infections (c) Is available as DTaP/IPV/Hib or
25. Which of the following is/are true Hib/PC V
about Diphtheria vaccines: (d) Is thiomersal-free
(a) They are live attenuated vaccines (e) Contains live organisms
(b) They are produced in two 28. Which of the following is/are true
strengths about Hepatitis A vacdne:
(c) They contain an adjuvant to (-a) The vaccine may cause mild
improve immunogenicity jaundice 2-6 weeks after
__ (d) Higher dose diphtheria vaccines administration_______________
should be used for primary (b) It can be given to pregnant women
immunisation in the UK schedule when clinically indicated
in those under 10 years (c) Hepatitis A antibody levels should
(e) Diphtheria vaccine is thiomersal be tested to check for a response
free (d) Is only effective if given to
26. Which of the following is/are true unvaccina tec&cpntacts f>f Hepatitis
about Diphtheria vaccine: A within 72 hours of the onset of
(a) It is only available in combination jaundice in the index case
with other vaccines (e) Should not be given to someone
(b) When given as a primary who may already be incubating
immunisation course 2 weeks Hepatitis A infection
should be allow ed between 29. Which of the following Hepatitis A
vaccinations vaccine products is/are available:
(c) The first booster dose of diphtheria (a) Combined H epatitis A and B
vaccine should be given at least vaccine
12 months after the last in the (b) Combined H epatitis A and C
primary course vaccine
(d) There should be 3 years between (c) Monovalent Hepatitis A Vaccine
the first and second booster doses (d) Combined H epatitis A and
(e) If it has been given as part of a typhoid vaccine
vaccination following a tetanus (e) Combined Hepatitis A and cholera
prone wound the routine booster vaccine
is always necessary
30. Which of the following is/are true:
27. Which of the following statements is/ (a) Influenza is caused by type A, B
are true about Hib vaccine: or C viruses
(a) Made from capsular (b) In flu e n z a A is th e u su a l ca u se o f
polysaccharide that has been epidemics
extracted from cultures of Hib
bacteria
Antigen, Antigen-antibody Reactions, Hypersensitivity, Active and Passive Immunity □ □ 203

(c) Minor changes in the surface (a) IgA


antigens of influenza A occur (b) IgD
every year (c) IgE
(d) "Antigenic shift" means a major (d) IgM
changes in the influenza A virus
36. Toxoid is prepared from
has occurred
(a) Endotoxin
(e) Influenza vaccine is recommended
for all over the age of 50 years (b) exotoxin
(c) both (a) and (b)
31. Which of the following is/are true
(d) either (a) or (b)
about Influenza vaccine:
(a) Must be given annually 37. Wasserman test for Syphilis is
(b) Current y:«ce«res have two (a) tube flocculation
influenza A subtypes and one B (b) complement fixation
subtype in them (c) slide flocculation
(c) Is grown in embryonated hens (d) tube agglutination
eggs 38. Serological test carried out for
(d) Is a live vaccine Brucellosis is
(e) May cause influenza in some (a) Eleh test
individuals (b) Paul bunnel test
32. The humoral immune response results (c) duerey test
in production of (d) coumb's test
(a) Lymphokines
39. Secretory antibodies are
(b) Antibody
(a) IgD (b) Ig F
(c) Complement
(c) IgA (d) IgE
(d) White blood cell
40. Commonly used tetanus vaccine is
33. The immunoglobulin which crosses produced by
placenta is
(a) treatm ent of the causative
(a) IgA organism with heat or UV and
(b) IgD finally obtaining the toxoid
(c) IgG (b) sub culturing the virus at pH10.4
(d)IgM (c) artificially generating antibodies to
34. Kahn test is viral glycoprotein
(a) Neutralization (d) isolating the antogenecity genes
(b) complement fixation test from the causative organism
(c) tube flocculation test ^ ^ 41. The montoux test use
(d) slide flocculation test (a) old tuberculin
35. Immunoglobulin with shortest half life (£*> diphtheria toxin
is (c) seru., antjgen
(d) polysacciu-.^g an^gen
204 □ □ Drug Inspector Exam

42. Small pox vaccine contains (b) tkey occur on the surface of
(a) living virus vaccine lwnphocytes
(b) living culture of B.C.G (c) thjey predominate in the primary
(c) attenuated staphylococcus response to antigen
(d) dead virus vaccine (d) they are glycoproteins
(e) they mediate allergic reaction
43. Gamma globulin is separated from
serum by 48. 5-T-cell antigen receptors are
(a) agglutination distinguished from antibodies by
(b) dialysis which of the following
(c) centrifugation —— (a) T-Cell receptors are glycosylated
(d) salting out <b) T-cell receptors must interact with
/• antigen uniquely presented by
44. Chemically, Interferon's are other cells but nof~witi»__ijee
(a) carbohydrate antigen
(b) protein (c) T-Cell receptors bind various
(c) lipid cytokines
(d) phospholipid (d) T-Cell receptors bind complement
45. The adult dose of tuberculin in to lyse cells
Montoux test is (e) T-cell receptors are mediators of
(a) 0.1 ml allergic reactions
(b) 1 ml 49. All of the following are true of antigen
(c) 0.001 ml EXCEPT which one of the following?
(d) 0.01 ml I (a) They contain epitopes .
(b) They will react with antibodies .
46. Which is true for Rubella infection?
(c) They contain antigenic
(a) Can be asymptomatic
determinants .
(b) May be indistinguishable from
(d) They can elicit an immune
parvovirus B19
response .
(c) Is usually preventable by
(e) They contain paratopes
vaccination
(d) May be acquired by having close 50. Which of the following
contact with an infant with immunoglobulins is present normally
congenital rubella syndrome in plasma at the highest
(e) Can have serious side effects when concentration?
occurring in a woman in the third (a) IgG (b) IgM
trimester of pregnancy (c) IgA - (d) IgD
(e) IgE
47. All of the following are true with
respect to IgM antibodies EXCEPT 51. All of the following are true about
which one antibodies, EXCEPT which one ?
(a) they fix complement (a) They fix complement .
Antigen, Antigen-antibody Reactions, Hypersensitivity, Active and Passive Immunity □ □ 205

(b) T h e y o c c u r o n th e su rfa c e o f B - (b) Complement fixation


ly m p h o c y te (c) Virus neutralization
(c) They predominate the primary (d) All the above
immune response to antigen
55. J-cell receptors or Antibodies react
(d) They are glycoproteins with antigens
(e) They are molecule with a single, (a) because both are made by
defined amino acid sequence lymphocytes
52. Which of the following statements (b^because of complementary of
best characterizes an antibody ? | Imolecular fit cf both with antigen
(a) An antibody contains high (c) because both 'have light chain and
molecular weight RNA as its basic heavy chain polypeptides
structure. (d) cause histamine release
(b) An antibody is composed of (e) facilitate perforin release
protein and----- cannot— be
distinguished from the albumin 56. Type B adverse drug reactions:
fraction of the serum proteins. (a) are a subgroup of adverse drug
(c) An antibody is composed of four events
identical protein subunits which (b) are reactions that are unrelated to
may be caused to dissociate by the drug
treatment with urea. (c) relate to type A hypersensitivity
(d) An antibody contains protein as reactions
its major chemical component and (d) occur as a part of the normal
its synthesis may be elicited by the pharmacological profile of the
administration of a foreign protein particular drug
or polysaccharide. 57. Type B adverse drug reactions
(e) An antibody contains (a) occur as a part of the normal
mucopolysaccharides as its major pharmacological profile of t]4e
chemical Component and the particular drug
synthesis of these may be elicited (b) relate to type B hypersensitivity
by the administration of a foreign reactions
protein or polysaccharide. (c) are a subgroup of adverse drug
53. Antibodies are events
(a) Immunoglobulins (d) are reactions that are unrelated to
(b) composed of variable and constant the drug
region domains 58. Type A adverse drug reactions:
(c) m a d e o f h e a v y a n d lig h t c h a in s (a) occur when the underlying
(d) all the above mechanism is not known
54. A ntigen-antibody reactions can result (b) occur soon after the drug is
in the following: initiated
(a) Agglutination
206 □ □ Drug Inspector Exam

(c) occur as im m unologically (a) keratin (b) cilia


mediated effects (c) gastric juice (d) phagocytes
(d) involve genetic differences in drug ^ Monoclonal antibodies are used for
metabolism the diagnosis of all of the following
>9. Type B adverse drug reactions: except________.
(a) occur with aminoglycosides and (a) juvenile diabetes
insulin (b) hepatitis
(b) when a m edication dose is (c) rabies (d) pregnancy
increased
65. Delayed hypersensitivities _______ .
(c) occur as im m unologically
(a) are mediated by B cells
mediated effects take place soon
after the drug is initiated (b) include allergic contact dermatitis
(c) include anaphylactic shock, a
30. Which of the following is not a type systemic vasodilation that results
of T cell? in inadequate blood delivery to all
(a) cytotoxic (b) antigenic tissues
(c) helper (d) regulatory (d) do not involve T cells
61. The antibody m olecule is held 55 Which of the following is not an
together b y ________bonds. autoimmune disease?
(a) disulfide (b) hydrogen (a) multiple sclerosis
(c) amino acid (d) sodium (b) type II diabetes
62. The only T cells that can directly attack (c) systemic lupus erythematosus
and kill other cells are th e ________. (d) glomerulonephritis
(a) regulatory cells 67 Which of the following is not a
(b) helper cells method by which antibodies work?
(c) cytotoxic cells (a) neutralizing antigen
(d) plasma cells (b) activating cytokines
63. Which of the following is a part of (c) enhancing phagocytosis
the second line of defense against (d) agglutinating and precipitating
microorganisms? antigen

ANSWERS
1. (c) 2. (c) 3. (a) 4. (d) 5. (c) 6. (e) 7. (e) 8. (c) 9. (d) 10 . (a)
11. (b) 12 . (d) 13. (a) 14. (c) 15. (c) 16. (b) 17. (a) 18. (c) 19. ,(a) 20. (b)
2 1. (a) 22. (d) 23. (a) 24. (c) 25. (b) 26. (a) 27. (a,b) 28. (b) 29. (c) 30. (a)
31. (d) 32. (b) 33. (c) 34. (d) 35. (c) 36. (b) 37. (b) 38. (d) 39. (c) 40. (a)
41. (a) 42. (a) 43. (b) 44. (b) 45. (a) 46. (a) 47. (e) 48. (b) 49. (e) 50. (a)
51. (e) 52. (d) 53. (d) 54. (d) 55. (b) 56. (d) 57. (d) 58. (b) 59. (c) 60. (b)
61. (a) 62. (c) 63. (d) 64. (a) 65. (b) 66. (b) 67. (c)

mn
History Development and
Production of Antibiotics
23
C h a pter

The great modern advances in chemotherapy have come from the chance discovery
that many microorganisms synthesize and excrete compounds that are selectively toxic
to other microorganisms. These compounds are called an tibiotics and have
revolutionized medicine. The period since World War II has seen the establishment and
extremely rapid growth of a major industry, using microorganisms for the synthesis of,
amongst other compounds, chemotherapeutic agents. The development of this industry
has had a dramatic and far-reaching impact. Nearly all bacterial infectious diseases that
were, prior to the antibiotic era, major causes of human death have been brought under
control by the use of chemotherapeutic drugs, including antibiotics.
The first chemotherapeutically effective antibiotic was discovered in 1929 by
Alexander Fleming (1881-1955), a British bacteriologist,\who had long been interested
in the treatment of wound infections. On returning from a vacation in the countryside,
he noticed among a pile of petri dishes on his bench one that had been streaked with
a culture of Saphyloccocus aureus which was also contaminated by a single colony of
mold. As Fleming observed the plate, he noted that the colonies immediately surrounding
the mold were transparent and appeared to by undergoing lysis. He reasoned that the
mould was excreting into the medium a chemical that caused the surrounding colonies
to lyse. Sensing the possible chemotherapeutic significance of his observation, Fleming
isolated the mold, which proved to be a species of Penicillium, and established that
culture filtrates contained an antibacterial substance, which he called penicillin.
Ten years later a group of British scientists headed by H. W. Florey (1898-1968) and
E. Chain (1906-1979) resumed the study of penicillin. Clinical trials with partly purified
material were dramatically successful. By this time, however, Britain was at war; and
the industrial development of penicillin was undertaken in the United States, where an
intensive program of research and development was begun in many laboratories. Within
three years, penicillin was being produced on an industrial scale. Today it remains one
of the most effective chemotherapeutic agents for the treatment of many bacterial
infections.
Rather than being a single substance, penicillin turned out to be a class of compounds.
The various penicillins vary with respect to the chemical composition of their side
chain. The penicillin that was first isolated in Peoria, Illinois, designated penicillin G,
carried a benzyl side chain. The penicillin isolated soon after in England, designated
penicillin F, carried an isopentanyl side chain. By varying the composition of the fungal
growth media, a variety of penicillins collectively termed biosynthetic penicillins, have
207
208 □ □ Drug Inspector Exam

been synthesized. Penicillin G proved the most successful and later it became possible
to remove the side chain and replace it by a variety of chemical substituents, thereby
producing semisynthetic penicillins. For example, penicillin V is resistant to acid and
therefore can be administered orally because it is not inactivated in the stomach;
ampicillin is also acid resistant and also effective against enteric bacteria; oxacillin is
resistant to the action of -lactamase, the enzyme produced by certain "penicillin-resistant"
strains of bacteria.
The remarkable chemotherapeutic efficacy of penicillin for certain bacterial infections,
primarily those caused by Gram-positive bacteria, prompted intensive research into
new antibiotics. In the 1940s, a second clinically important antibiotic, streptomycin,
effective against both Gram-negative bacteria and Mycobacterium tuberculosis, was
discovered by A. Schatz and S. Waksman. This was the first example of a broad-
spectrum antibiotic. Other antibiotics with even broader spectra of activity, such as the
tetracyclines, were subsequently discovered. The search for new antibiotics remains an
empirical enterprise. So far, they have proved very effective as antibacterial agents,
although some bacteria do acquire resistance to antibiotics^ so there is a continuous
search for new and effective antibacterial agents. Antibiotics have proved less effective
in the treatment of fungal infections. Antifungal antibiotics, such as nystatin and
amphoterecin B are considerably less successful therapeutically than their bacterial
counterparts, at least in part because their toxicu_y is far less selective. There are no
known antiviral antibiotics.
Since 1945, thousands of different antibiotics produced by fungi, actinomycetes or
unicellular bacteria have been isolated and characterized. A small fraction of these are
of therapeutic value. Their nomenclature is complicated as one antibiotic may be sold
under several different names. For example, in the United States the compound, which
in Europe has the generic name rifampicin, is called rifampin.

FERMENTATION PROCESS
Though there are different perceptions of the nature of the process, fermentation can
be defined as the breakdown or catabolism of organic compounds by microorganisms
under both aerobic and anaerobic conditions. This breakdown yields end products.
End-products Obtained by Fermentation
Types of end products of fermentation include:
• Microbial cells (for example, bacteria, yeast, fungal spores)
• Microbial enzymes (for example, milk clotting enzymes or rennets, recombinant
fungal and bacterial rennets for cheese manufacture)
• Microbial metabolites (for example, alcohols- ethanol, butanol, 2, 3-butanediol,
isopropanol; chemicals- lactate, propionate, proteins, vitamins, antibiotics; and
fuels- methane)
• Recombinant products (for example, hormones)
History Development and Production o f Antibiotics □ □ 209

Alcohol Fermentation
Various bacteria and yeasts metabolize sugars into ethanol through different pathways
using different enzyme systems. Alcohol fermentation is used for the industrial
production of alcohols and alcoholic beverages. In the preparation of alcoholic beverages
several factors have to be considered, such as flavor, taste, appearance, and safety.
These require special procedures and standards. The commercial producers of alcoholic
beverages each have their own protocols which give their product a distinct taste and
flavor, and these are often kept confidential. The process is as follows:
Sugar (Carbohydrate)---------2Ethanol + 2Carbon Dioxide
There are four different phases in bacterial growth during fermentation. A good
understanding of these phases is very important for effective management of the whole
fermentation process.
Lag Phase
At the start of the process microorganisms are added to the nutrient medium and
allowed to grow. The number of microorganisms will not increase because they try to
adapt to the environment.
Log Phase
The microorganisms are adjusted to the new environment and they multiply at a
4very rapid pace thus increasing the cell number exponentially.
Stationary Phase
As the microorganisms grow they produce metabolites which are toxic to microbial
growth. Also, the nutrient medium is used up, slowing down or stopping cell growth.
Death Phase
Microorganisms produce toxic metabolites to the extent that they cause the death of
the microorganisms
Factors That Influence Microbial Growth
Temperature, water, pH, and nutrients can influence microbial growth.
Temperature
Most microorganisms that are mesophiles require temperatures of 25-40 C for optimum
growth. As temperatures increase or decrease the growth rate is adversely affected.
Thermophiles require high temperatures over 50 C; they cannot survive at low
temperatures. Psychrophiles require very low temperatures -15 to 20 C for survival and
growth.
Water
Microorganisms require optimum amounts of water to maintain their metabolism
and produce required products.
PH
Optimum pH for bacteria is 6.5-7.5, yeasts 4-5, molds 4-7. The pH of the medium
should be maintained at optimum level for the microorganism being employed to ensure
better product yield. Nutrients
210 □ □ Drug Inspector Exam
V

Microorganisms require optimum concentrations of nutrients like nitrogen, vitamins,


and minerals for maximum growth rate. This will be different for each of the different
types. The -optimum concentration of nitrogen is 0.1-lmg/L.
Sources of Microorganisms
Microorganisms are ubiquitous. Pond water and sand are the commonly used
microbial sources since they offer greatest diversity of organisms. A sample of the
microbial source is added to a sterile nutrient medium (such as agar) and incubated at
suitable temperatures. This facilitates the growth of all microorganisms that are present
in the initially selected sample. The process is called microbial culture.
Identification and isolation of required microorganisms is very critical for any
microbiological process, since some microorganisms may be toxic to the useful microbes
and may use up the nutrients all by themselves, producing metabolites that are different
from the desired ones. Isolation of micro-organisms also helps to screen them to determine?’
if they can be used for any industrial process.
Isolation Techniques
Several techniques could be employed for isolating micro-organisms for microbial
culture growth. These include the liquid culture method, the solid culture method, and
the screening of microorganisms.
Liquid Culture Method
This is carried out in shaker flasks containing nutrient liquid culture medium. The
initial inoculum contains different types of microorganisms and the desired one can be
isolated from others in the sub-culturing process, since each has a different maximum
growth rate.
Solid Culture Method
This technique is used mainly for microorganisms that produce industrially important
enzymes. The solid culture medium contains a substrate which is converted by the .
enzymes that are produced. Soil is first pasteurized to eliminate spores and then spread
on an alkaline agar medium that contains an insoluble protein. The microorganisms
which produce the desired enzyme then leave clear zones on the medium as the enzyme
dissolves the protein.
Screening of Microorganisms
This process is very tedious and time consuming since the microorganisms have to
be tested for desired property at different concentrations and at different environmental
conditions.
Preservation of Microorganisms
There are different methods for microbial preservation. Suitable methods are selected
based on:
Type of microorganism, effect of the preservation method on the viability of the
microorganism, frequency at which the cultures are withdrawn,size of the microbial population
to be preserved, availability of resources, and cost of the preservation method.,
History Development and Production o f Antibiotics □ □ 211

Dessiccation
This involves removal of water from the culture. Dessiccation is used to preserve
actinomycetes (a form of fungi-like bacteria) for very long period of time. The
microorganisms can be preserved by desiccating on sand, silica gel, or paper strips.
Agar Slopes
Microorganisms are grown on agar slopes in test tubes and stored at 5 to -20 C for
six months. If the surface area for growth is covered with mineral oil the microorganisms
can be stored for one year.
Liquid Nitrogen
This is the most commonly used technique to store microorganisms for a long
period. Storage takes place at temperatures of less than -196° C and even less in vapor
phase. Microorganisms are made stationary and suspended in a cryo-protective agent
before storing in liquid nitrogen. ■
Drying
This method is especially used for sporulating microorganisms (organisms that
produce spores). They are sterilized, inoculated, and incubated to. allow microbial growth,
then dried at room temperature. The resultant dry soil is stored at 4° to 5° C.
Lyophilization
This process is also known as freeze-drying. The microbial culture is first dried
under vacuum, filled in ampoules (glass vessels) then frozen. This is a most convenient
technique, since it is'cheap to store and easy to ship. The disadvantage is that it is
difficult to open the freeze dried ampoules; also, several subcultures have to be done
to restore the original characteristics of the microorganisms.
Strain Improvement v
The yield of products will be much less when naturally available microorganisms
are used for fermentation in optimum growth medium. Providing optimum growth
conditions increases the yield only marginally. To increase the productivity of the
microorganisms it is necessary to modify their genetic structure since it is genomes that
determine the productivity of organisms. The culture medium and nutritional
requirements also change slightly when the genetic structure’ of the microorganism is
changed and hence they are also modified according to the new requirements'to ensure
maximum product yield. Genetic change of the microorganism can be done by inducing
mutations in the microorganisms, recombinant technology, end selecting natural variants.
Preparation of the Inoculum
Microbial inoculum has to be prepared from the preservation culture so that it can
be used for the fermentation process. The aim of inoculum preparation is to select
microorganisms with high productivity and to minimize low productive, mutant strains.
The process involves several steps.
First generation culture is prepared from the preservation culture on agar slants
which is then sub-cultured to prepare "working culture". At this stage the microorganisms
212 □ □ Drug Inspector Exam

start growing. In small scale fermentation processes working culture is used as inoculum,
but for large scale fermentation inoculum preparation involves additional steps.
Second, sterile saline water or liquid nutrient medium containing glass beads is
added to the agar slants and shaken so that microbial suspension is prepared. This
suspension is transferred to a flat bed bottle which contains sterile agar medium. The
microorganisms are allowed to grow by incubating the bottle.
Third, the microbial cells from the flat bed bottles are transferred to a shaker flask
containing sterile liquid nutrient medium and is placed on a rotary shaker bed in an
incubator. Microorganisms grow at a rapid rate due to aeration.
Fourth, microbial cells from the shaker flask can be used as seed culture which are
then added to a small fermenter and allowed to grow for 1-2 days. This simulates
conditions that exist in the larger fermenter to be used for production of metabolites.
Finally, the microorganisms are transferred to the main fermentation vessel containing
essential media and nutrients.
Culture Medium
Media requirements depend on the type of microorganism being used in the
fermentation process, but the basic requirements remain the same—source of energy,
water, carbon source, nitrogen source, vitamins, and minerals. Designing the media for
small scale laboratory purpose is relatively easy, but media for industrial purpose are
difficult to prepare.
The culture medium should: allow high yield of the desired product and at fast rate,
allow low yield of undesired products, be sterilized easily, yield consistent products
i.e., minimum batch variation, be cheap and readily available, be compatible with-the
fermentation process, and not pose environmental problems before, during, or after the
fermentation process.
The culture medium will affect the design of the fermenter. For example,
hydrocarbons in the media require high oxygen content so an air-lift fermenter should
be used. Natural media ingredients are cheap but they have high batch variation. On
the other hand pure ingredients (also called defined media or formulated media) have
very little batch variation but are expensive. The media should support the metabolic
process of the microorganisms and allow bio-synthesis of the desired products.
Carbon & Energy source + Nitrogen source + Nutrients
Product(s) + Carbon Dioxide + Water + Heat + Biomass
Media are designed based on the above equation using minimum components
required to produce maximum product yield.
Important components of the medium are carbon sources, nitrogen sources, minerals,
growth factors, chelating agents, buffers, antifoaming agents, air, steam, and
fermentations vessels.
Carbon Sources
Product formation is directly dependent on the rate at which the carbon source is
metabolized; also the main product of fermentation determines the type of carbon
source to be used. Carbon sources include carbohydrates, oils and fats, and hydrocarbons.
History Development and Production o f Antibiotics □ □ 213

Carbohydrates
These are the most commonly used carbon sources in the fermentation process.
Starch is easily available carbohydrate obtained from maize, cereals, and potatoes. It is
widely used in alcohol fermentation. Grains like maize are used directly in the form of
ground powder as carbohydrate. Malt and beer made from barley grains contain high
concentrations of different carbohydrates like starch, sucrose, cellulose and other sugars.
Sucrose is obtained from sugar cane and molasses. Molasses is one of the cheapest
sources of carbohydrate. It contains high sugar concentration and other components
like nitrogenous substances and vitamins and is used in alcohol, SCP (Single-cell Protein),
amino acid, and organic acid fermentations.
Oils and Fats
Vegetable oils are used as a carbon source. Oils provide more energy per weight
compared to sugars. They also have anti-foaming properties but are generally used as
additives rather than as the sole carbon source. Examples are olive oil, cotton seed oil,
soya bean oil, linseed oil, and lard (animal fat).
Hydrocarbons
C12-C18 alkanes can be used as carbon sources. They are cheap, and have more
carbon and energy content per weight than sugars. They can be used in organic acids,
amino acids, antibiotics, enzymes, and proteins fermentation.
Nitrogen Sources
Ammonia, ammonium salts, and urea are the most commonly used nitrogen sources
in the fermentation process. Ammonia also serves the purpose of pH control. Other
substances used as nitrogen sources are corn-steep liquor, soya meal, peanut meal,
cotton seed meal, amino acids, and proteins.
Minerals
Calcium, chlorine, magnesium, phosphorous, potassium and sulfur are the essential
minerals for all media. Other minerals like copper, cobalt, iron, manganese, molybdenum,
and zinc are needed in trace amounts and are generally present as impurities in other
components. Ihe specific concentration on these elements depends on the microorganism
being used.
Growth Factors
Vitamins, amino acids, and fatty acids are used as growth factors in the fermentation
process to complement the cell components of the microorganisms.
Chelating Agents
Chelating agents prevent formation of insoluble metal precipitates. They form
complexes with the metal ions present in the medium and can be utilized by the
microorganisms. Chelating agents are not required in large scale fermentation processes
since some of the other ingredients like yeast extract will perform the function of
forming complexes with the metal ions.
214 □ □ Drug Inspector Exam

One example of a chelating agent is EDTA (ethylenediaminetetraacetic acid). EDTA


is a versatile, being able to form six bonds with a metal ion. It is frequently used in
soaps and detergents because it forms a complex with calcium and magnesium ions.
These ions are in hard water and interfere with the cleaning action of soaps and
detergents. Other chelating agents are citric acid and pyrophosphates.
Buffers
Buffers are used to maintain the pH of the medium as microbial growth is affected
by the pH changes. Optimum pH for most microorganisms is 7.0. Commonly used
buffers are calcium carbonate, ammonia, and sodium hydroxide.
Antifoaming Agents
Microbial process produces a large amount of foam in the fermentation vessel. This
is due to microbial proteins or other components of the medial Foaming causes removal
of cells from the media and their autolysis, thus, releasing more microbial foam-producing
proteins, hence, aggravating the problem. Foam will reduce the working volume in the
fermentation vessel, decrease rate of heat transfer, and deposit cells on the top of the
fermenter. The air filter exits then become wet allowing growth of contaminating
microorganisms. Antifoaming agents are also called surfactant, i.e., they reduce the
surface tension in the foam and destabilize the foam producing proteins.
Commonly used antifoaming agents are stearyl alcohol, cotton seed oil, linseed oil,
olive oil, castor oil, soy bean oil, cod liver oil, silicones, and sulphonates.
Air
Air is required for aeration and is supplied to the fermenter by means of pumps or
compressors. It is sterilized by passing through filters before being introduced. The
amount of air required and the extent of purity depends on the fermentation process
being carried out.
Steam
Steam is used to sterilize fermenters and other equipment and to control temperature.
Continuous dry steam supply is required for the fermentation process and care should
be taken to prevent condensation.
Fermentation Vessels
Laboratory scale fermentations are carried out in shaker flasks, and flat bed bottles.
Large scale fermentations are carried out in glass or stainless steel tank fermenters. A
fermentation vessel should: be cheap, not allow contamination of the contents, be non-
* toxic to the microorganism used for the process, be easy to sterilize, be easy to operate,
be robust and reliable, allow visual monitoring of the fermentation process, allow
sampling, and be leak proof:
Production of Antibiotics
Now most antibiotics are produced by staged fermentations in which strains of
microorganisms producing high yields are grown under optimum conditions in nutrient
media in fermentation tanks holding several thousand gallons. The mold is strained out
History Development and Production o f Antibiotics □ □ 215

of the fermentation broth, and then the antibiotic is removed from the broth by filtration,
precipitation, and other separation methods.
The penicillin was first made at the end of the second world war using the fungus
Penicilium notatum, the process made 1 mg dm"3. Today, using a different species (P.
chrysogenum) and a better extraction procedures the yield is 50 g dm"3.
The production of tetracycline by fermentation was disclosed by Minieri et. al. in
1953. The composition of the medium and the strain of streptomycete are both important
factors, since Streptomyces aureofaciens is capable of producing at least two antibiotic
substances as pointed out by Backus et. al. in 1954.

MULTIPLE CHOICE QUESTIONS

1. What species produces about 60 mg/ (b) 28°C


dm3 of penicillin? (c) 32°C
(a) P notatum (d) 20°C
(b) P chrysogenum 6. Amount of inocculum to be added in
(c) P griseus the production of tetracycline is
(d) P sporum (a) 2- 10 %
2. Penicillin is a secondary metabolite. ■(b) 5-15% '
(a) True ‘ (c) 20-255
(b) False (d) <5%*
(c) depends on factors 7. In production of TC, liquid nutrieni
(d) None of the above media are usually sterilized for
3. The strain used for industrial (a) 20 min, 120°C
preparation of tetracycline is (b) 40 min, 120°C
(a) Staphylococcus aureofacien (c) 30 min, 110°C
(b) Streptoccocus aureofacien (d) 30 min, 120°C
(c) Streptomyces aureofacien 8. What is the aeration level in tht
(d) Streptomyces venezuelae fermentor producing tetracyclines
4. Penicillin amidases(acylases)which (a) 0.5-1.0 volume of air/volume ol
catalyse the removal of the side chain liquid/min
from benzylpeniciilin is found in (b) 0.25- 0.5 volume of air/volume ol
(a) E coli liquid /min
(b) S aureus (c) 1.0-1.5 volume of air/volume
(c) clostridium tetani liquid/min '
(d) all of the above (d) 2.0-2.5 volume of air/volume'df
liquid/min ^
5. Optimum tem perature for TC
biosynthesis varies around 9. Which m icrobial strain produces
(a) 25°C tetracycline even in the presence of
.Cl"* ions?
216 □ □ Drug Inspector Exam

(a) S viriditaciens 13. Satisfactory source of carbon in


(b) S. rimosus penicillin production is
(c) S.aureofacien (a) lactose, 10%
(d) S mediolanum (b) lactose, 15%
10. For laboratory scale batch fermentor, (c) lactose, 6%
sizes ranges from (d) lactose,20%
(a) 2-5L 14. Penicillin is produced by
(b) 5 - 10L (a) surface culture
(c) 1-2L (b) submerged culture
(d) >10L (c) both (a) and (b)
11. In penicillin fermentation, the stock (d) None of the above
cultures can be preserved by 15. Precursor used in penicillin
(a) freeze drying production is
(b) by fixing the spores in sterilized (a) phenylacetic acid
soil mixture (b) phenoxyacetic acid
(c) storage under liquid nitrogen (c) phenylacetamide
(d) all of the above (d) all of the above
12. Tributyl citrate in the production of 16. Thiazolidine ring in penicillin is
penicillin is used as synthesized from
(a) antioxidant (a) L-cystine
(b) chelating agent (b) methionine
(c) antifoaming (c) valine
(d) none of the above (d) Both (a) and (c)

ANSWERS
1. (b) 2. (a) 3. (c) 4. (a) 5. (b) 6. (a) 7. (b) 8. (a) 9. (d) 10. (c)
11. (d) 12. (c) 13. (c) 14. (c) 15. (d) 16. (d)

□□ □
Carbohydrate Metabolism
24
C h a pter

Carbohydrate metabolism begins with digestion in the small intestine where


monosaccharides are absorbed into the blood stream. Blood sugar concentrations are
controlled by three hormones: insulin, glucagon, and epinephrine. If the concentration
of glucose in the blood is too high, insulin is secreted by the pancreas. Insulin stimulates
the transfer of glucose into the cells, especially in the liver and muscles, although other
organs are also able to metabolize glucose.
In the liver and muscles, most of the glucose is changed into glycogen by the
process of glycogenesis (anabolism). Glycogen is stored in the liver and muscles until
needed at some later time when glucose levels are low. If blood glucose levels are low,
then eqinephrine and glucogon hormones are secreted to stimulate the conversion of
glycogen to glucose. This process is called glycogenolysis (catabolism).
If glucose is needed immediately upon entering the cells to supply energy, it begins
the metabolic process called glycolysis (catabolism). Glycolysis is the pathway for the
catabolism of glucose that leads to pyruvate. A net of two molecules of ATP per molecule
of glucose are produced by substrate level phosphorylation. (Phosphate transfers from
organic compounds to ADP, forming ATP). Two molecules of ATP are consumed in the
conversion of glucose to fructose-1,6-biphosphate. The first substrate-level
phosphorylation of glycolysis is a phosphoryl group transfer from 1,3-biphosphoglycerate
to ADP. The second is a phosphoryl group transfer from phosphoenolpyruvate to ADP.
NAD+ is also reduced to NADH as glyceraldehyde-3-phosphate is oxidized. Pyruvate
from glycolysis enters into the Citric Acid Cycle . This cycle occurs in the mitochondria
of the cell in aerobic conditions. The pyruvate loses a carbon dioxide group, forming
acetyl-CoA, the compound which forms a link for many other pathways and helps
build other compounds. The citric acid cycle pathway consists of eight reactions that
process incoming molecules of Acetyl CoA. The carbon atoms leave the cycle in the
form of molecules of carbon dioxide. The hydrogen atoms and electronsleave the cycle
in the form of reduced coenzymes NADH and FADH2. The cycle is regulated by three
allosteric enzymes in response to cellular levels of ATP. One Acetyl CoA molecule
entering the citric acid cycle produces three molecules of NADH, one of FADH2, and
one of GTP. The majority of the ATP is made from oxidations in the citric acid cycle in
connection with the electron transport chain.
During strenuous muscular activity, pyruvic acid is converted into lactic acid rather
than acetyl CoA. During the resting period, the lactic acid is converted back to pyruvic
acid. The pyruvic acid in turn is converted back to glucose by the process called
217
218 □ □ Drug Inspector Exam

gluconeogenesis (anabolism). If the glucose is not needed at that moment, it is converted


into glycogen by glycogenesis.
The pentose phosphate pathway synthesise the pentoses with the release of tht
reducing power needed for anabolic reactions.
Uronic Acid Pathway is an alternative oxidative pathway for glucose that, like the
pentose phosphate pathway, does not lead togeneration of ATP. It includes oxidation of
glucose to Glucuronic acid (which is used in detoxication and enters in the formation
of mucopolysaccharide) and ascorbic acid. It occurs in liver cytoplasm, mainly.
There are multiple diseases that arise from improper carbohydrate metabolism.
Diabetes mellitus is caused by a lack of, or a resistance to, insulin leading to hypo- or
hyperglycemia. Lactose intolerance is a common allergy in adults and results from a
lack of the enzyme lactase, which converts lactose disaccharides (found in dairy products)
into glucose monosaccharides. Much rarer diseases such as galactosemia and von Gierke's
diseases are caused by congenital mutations in enzymes involved in glucose metabolic
pathways.

MULTIPLE CHOICE QUESTIONS

1. Which of the following statements reaction into an aldehyde and a


about the reactions of glycolysis is ketone.
correct? (b) In glycolysis fructose-6-phosphate
(a) In glycolysis glucose-6-phosphate is an aldol so once phosphorylated
is split into glyceraldehyde-3- to fru cto se -l: 6-bisphosphate
phosphate and dihydroxyacetone cannot be split by the aldol
phosphate. reaction into an aldehyde and a
(b) In glycolysis fructose-1: 6- ketone.
bisphosphate is split into (c) In glycolysis fructose-6-phosphate
glyceraldehyde-3-phosphate and is converted to glucose- 6-
dihydroxyacetone phosphate. phosphate and can then be split
(c) In glycolysis fructose-6-phosphate by the aldol reaction into an
is split into glyceraldehyde-3- aldehyde and a ketone.
phosphate and dihydroxyacetone (d) In glycolysis fructose-6-phosphate
phosphate. is an aldol but is not itself split by
(d) In glycolysis glucose-6-phosphate the aldol reaction until
is isom erized to fructose- 1 :6- phosphorylated to fructose-1 :6-
bisphosphate. bisphosphate.
2. Which of the following statements 3. Which of the following statements
about the glycolytic intermediate, about the citric acid cycle is
fructose-6-phosphate is true? appropriate?
(a) In glycolysis fructose-6-phosphate (a) Oxygen is used to oxidise the
is formed from glucose- 6- acetyl group carbons of acetyl-CoA
phosphate and is split by the aldol in the citric acid cycle.
Carbohydrate Metabolism □ □ 219

(b) Three molecules of NADH and (d) The FO subunit of the ATP
one molecule of FADH 2 are synthase contains the catalytic
produced in one turn of the citric centre that synthesizes ATP.
acid cycle. g The reaction w hich irreversibly
(c) Oxygen is not used in the citric commits sugar to the glycolytic
acid cycle, so the cycle can occur pathway is catalyzed by:
in anaerobic conditions. (a) hexokinase or glucokinase.
(d) The citric arid cycle produces the (b) phosphofructokinase.
water that is formed during the
(c) phosphoglucomutase.
complete oxidation of glucose.
(d) glucose phosphate isomerase.
4. Which of the following statements (e) aldolase.
about the electron transport chain is
correct? ^• NAD+ contains which of the
following?
(a) The electron transport chain is
made up of a chain of electron (a) thiamine
carriers with decreasing electron (b) lipoic acid
affinity. (c) niacin
(b) The electron transport chain is (d) riboflavin
made up of a chain of electron (e) CoA
carriers with increasing redox g Phosphoglycerate kinase functions in
potential. carbohydrate metabolistn to produce
(c) The electron transport chain is ATP via:
made up of a chain of electron (a) oxidative phosphorylation.
carriers with decreasing oxidising
(b) substrate level phosphorylation.
power.
(c) oxidative decarboxylation.
(d) The electrons transferred from
carrier to carrier in the electron (d) phosphorolysis.
transport chain gain energy. 9. Glucose-l-phosphate is produced from
5. Which of the following statements glycogen via:
about the generation of ATP in the (a) oxidative phosphorylation.
electron transport chains is correct? (b) substrate phosphorylation.
(a) The FI subunit of the ATP (c) glycogen kinase activity.
synthase contains the motor which (d) phosphorolysis.
is driven to rotate by the proton jq
Which of the following is important
flow. in transferring energy frorri the
(b) The FI subunit of the ATP glycolytic pathway to the TCA cycle?
synthase contains the catalytic (a) NADH + H+
centre that synthesizes ATP.
(b) FADH2
(c) The FO subunit of the ATP
(c) citrate
synthase binds ADP and Pi tightly
(d) acetyl CoA
before ATP synthesis occurs.
(e) GTP
220 □ □ Drug Inspector Exam

11. Which enzyme is deficient in the liver (b) gluconeogenesis


in cases of fructose intolerance? (c) glycogenosis
(a) hexokinase (d) glycogenesis
(b) aldolase 16. In the citric acid cycle, which one of
(c) glucokinase the following enzymatic activities
(d) phosphofructokinase would be decreased by thiamine
(e) triose kinase deficiency?
12. Riboflavin is a part of the structure of (a) Fumarase
which of the following? (b) Isocitrate dehydrogenase
(a) FAD (c) Malate dehydrogenase
(b) NAD+ (d) Succinate dehydrogenase
(c) CoA (e) a-Ketoglutarate dehydrogenase
oW complex
(d) ATP
(e) UTP 17. The reaction of the citric acid cycle that
*t,c U produces an ATP equivalent (in the
o CH3OH 0 form of GTP) by substrate level
« L I «
Hj9 — o - P - O - P -O.CHj - C - C - C v phosphorylation is the conversion of:
O' CH,H (a) citrate to isocitrate
ch2
I (b) fumarate to malate
CH,
HS - CH, - CH, - N -C
H ^
(c) malate to oxaloacetate
(d) succinate to fumarate
13. The above is the structure of: (e) succinyl-CoA to succinate
(a) CoA 18. All of the oxidative steps of the citric
(b) thiamine pyrophosphate acid cycle are linked to the reduction
(c) FAD of NAD+ except the reaction catalyzed
(d) lipoic acid by:
14. A deficiency in UDP-glucose: (a) isocitrate dehydrogenase.
galactose-l-phosphate uridylyl- (b) malate dehydrogenase.
transferase ■* w ill lead to an (c) pyruvate dehydrogenase
accumulation of: (d) succinate dehydrogenase.
(a) galactose (e) the a-ketoglutarate dehydrogenase
(b) glucose complex.
(c) glycogen 19. Which of the following cofactors is
(d) UDP required for the conversion of
(e) UTP succinate to fumarate in the citric acid
cycle?
15. Cori's, McArdle's, von Gierke's and
Andersen's diseases are all examples (a) ATP (b) Biotin
of: (c) FAD (d) NAD+
(a) glycogenolysis (e) NADP+
Carbohydrate Metabolism □ □ 221

20. In the citric acid cycle, a flavin (c) Oxaloacetate is used as e ubstrate
coenzyme is required for: but is not consumed in the cycle.
(a) condensation of acetyl-CoA and (d) Succinate dehydrogenase channels
oxaloacetate electrons directly into the electron
(b) oxidation of fumarate transfer chain.
(c) oxidation of isocitrate (e) The condensing enzyme is subject
(d) oxidation of malate to allosteric regulation by ATP and
(e) oxidation of succinate NADH

21. The conversion of 1 mol of pyruvate 24. Mitochondrial preparation that is


to 3 mol of C 0 2 via pyruvate oxidizing pyruvatt as a substrate,
dehydrogenase and the citric acid which of the following compounds
cycle also yields_____mol of NADH, would you expect to decrease in
_____mol of FADH2, a n d _____ mol concentration?
of ATP (or GTP). (a) Citrate
(a) 2; 2; 2 (b) Fumarate
(b) 3; 1; 1 (c) Isocitrate
(c) 3; 2; 0 (d) Pyruvate
(d) 4; 1; 1 (e) Succinate
(e) 4; 2; 1 25. In mammals, each of the following
22. Citrate synthase and the NAD+- occurs during the citric acid cycle
specific isocitrate dehydrogenase are except:
two key regulatory enzymes of the (a) formation of a-ketoglutarate.
citric acid cycle. These enzymes are (b) generation of NADH and FADH2.
inhibited by: (c) metabolism of acetate to carbon
(a) acetyl-CoA and fructose 6- dioxide and water.
phosphate. (d) net synthesis of oxaloacetate from
(b) AMP and/or NAD+ acetyl-CoA
(c) AMP and/or NADH (e) oxidation of acetyl-CoA
(d) ATP and/or NAD+ 26. Which of the following is not an
(e) ATP and/or NADH intermediate of the citric acid cycle?
23. Which of the following is not true of (g) Acetyl-coA
the citric acid cycle? (b) Citrate
(a) All enzymes of the cycle are (c) Oxaloacetate
located in the cytoplasm, except (d) Succinyl-coA
succinate dehydrogenase, which is (e) a-Ketoglutarate
bound to the inner mitochondrial
27. Conversion of 1 mol of acetyl-CoA to
membrane.
2 mol of C 0 2 and Co A via the citric
(b) In the presence of malonate, one acid cycle results in the net production
would expect succinate to of:
accumulate.
222 □ □ Drug Inspector Exam

(a) 1 mol of citrate. (b) oxidation of pyruvate


(b) 1 mol of FADH2. (c) Krebs cycle
(c) 1 mol of NADH. (d) fermentation
(d) 1 mol of oxaloacetate. (e) chemiosmosis
(e) 7 mol of ATP 32. Which pathway participate in the
28. The end product of glycolysis is detoxification mechanism?
(a) NADH (a) uronic acid pathway
(b) FADH2 (b) Glycolysis
(c) ATP (c) HMP pathway
(d) co 2 (d) Kreb cycle
29. What substance is produced by the 33. Which of the following statements
oxidation of pyruvate and feeds into about the role of the pentose
the citric acid cycle? phosphate pathway is correct?
(a) pyruvate (a) The pentose phosphate pathway
(b) glucose produces ribose-5-phosphate and
(c) acetyl-CoA NADPH
(d) o 2 (b) The pentose phosphate pathway
oxidises glucose- 6-phosphate
(e) CC2
completely to carbon dioxide and
30. The proper sequence of stages in water
glycolysis is (c) The rate-limiting reaction of the
(a) glucose priming, cleavage and pentose phosphate pathway is
rearrangement, oxidation, ATP catalyzed by transketolase
generation (d) The pentose phosphate pathway
(b) cleavage and rearrangem ent, occurs in the mitochondria of most
glucose priming, ATP generation, cells
oxidation ,
34. Which of the following statements
(c) glucose prm yng, oxidation, about the oxidative section of the
,i ^ • cleavage and rearrangement, ATP pentose phosphate pathway is correct?
generation ■
(a) The pentose phosphate pathway
(d) ATP generation, oxidation, glucose generates NADH
* priming, cleavage and
(b) The pentose phosphate pathway
rearrangement
oxidizes NADPH to NADP+.
(e) oxidation, cleavage and
(c) The rate-limiting reaction of the
rearrangement, ATP generation,
pentose phosphate pathway is
glucose priming
catalyzed by glucose- 6-
31. During what stage of cellular phosphatase
respiration is the most ATP (d) The pathway supplies ribose-5-
synthesized? phosphate and NADPH in the
(a) glycolysis quantities the cells require
\
f
Carbohydrate Metabolism HO 223

35. Which of the following statements 36. In which disease, ( ,lucose- 6-


about the nonoxidative section of the phosphatase is either or deficient
pentose phosphate pathway is correct? (a) Von Gierke's disease
(a) The nonoxidative reactions of the (b) diabetes
pentose phosphate pathway are (c) Cori's disease
not reversible (d) McArdle's disease
(b) Transketolase is an enzyme that
transfers three-carbon units in the 37. Under anaerobic conditions, how
many moles of ATPare produced in
pentose phosphate pathway.
the glycolysis by one mole of glucose.
(c) Transaldolasq is an enzyme that
(a) One
transfers two-carbon units in the
pentose phosphate pathway. (b) Two
(d) Pentoses undergo isomerizations (c) Eight
in the pentose phosphate pathway. (d) Thirty

ANSWERS
1. (b) 2 . (d) 3. (b) 4. (b) 5. (b) 6. (a) 7- (c) 8. (a) 9. (b) 10 . (a)
11. (b) 12 . (a) 13. (a) 14. (a) 15. (c) 16. (e) 17. (e) 18. (d) 19. (c) 20. (e)
2 1. (d) 22 . (e) 23. (a) 24. (b) 25. (d) 26. (a) 27. (b) 28. (a) 29. (c) 30. (a)
31. (e) 32. (a) 33. (a) 34. (d) 35. (d) 36. (a) 37. (b)

□ □ □
Chemotherapeutic Agents
/

25
C h a pter

Chemotherapeutic agents are chemicals that have selective action either on Parasites
or microorganisms. They are used for the treatment or control of diseases caused by
pathogenic invading organisms or cells. Depending on parasites on which they act,
they are classified as Anthelmintic, antiprotozoal, antifungal, antibacterial, antiviral,
and antimalarial, etc.
The term 'Sulphonamides' is a generic name for the derivatives of p-amino benzene
sulphonamide (sulphanilam ide).The Sulphonamides was the first effective
chemotherapeutic drug, used for the treatment of bacterial infections in man. Once,
Domagh in 1932 discovered the antibacterial effect of azodye, Prontosil, it was concluded
that its metabolic product, sulphanilamide is responsible for antibacterial activity.
Although, these remain effective antibacterial agents but their uses are decreased in the
present era due to availability of better antibiotics. However, still combination of
sulphamethoxazole and trimethoprim is commonly used to treat microbial infection
These are classified as follows :
1. Sulphonamides employed for treatment of systemic infection. Depending upon
duration, they can be further subdivided into:
(z) Short to intermediate acting Sulphonamides, for example, Sulphadiazine,
sulphafurazole, Sulphamethoxazole, sulphaphenazole. These are absorbed rapidly,
with plasma half life up to 5-11 hrs.
(ii) Long acting Sulphonam ides for example, Sulpham ethoxypyridazine,
sulphadimethoxine. These are rapidly absorbed but excreted slowly. These have
long duration of action.
2. Poorly absorbed Sulphonamides, employed for the treatment of local
gastrointestinal infection for example, sulphaguanidine, succinyl sulphathiazole,
phthalyl sulphathiazole.
3. Topically used Sulphonamides for example, silver sulphadiazine, mefenide,
suphacetamide. These are meant for ophthalmic use and for wound & bum
infection.
Antibiotics are specific substances derived from or produced by living organise.
These substances in small concentration are capable of inhibiting the life processes of
other organisms.
Classification of antibiotics
Among the several criteria used to classify antibiotics, the main ones are (i)
biosynthesis; (ii) spectrum of activity; (iii) chemical structure.
224
Chemotherapeutic Agents □ □ 225

A. Biosynthesis
According to biosynthesis, antibiotics can be divided into following classes :
1. Antibiotics derived from amino acids: Cycloserine, Chloramphenicol, penicillin's,
cephalosporins, gramicidin, polymixin, viomycin, and capreomycin.
2. Antibiotics derived from carbohydrates: Streptomycin, kanamycin, neomycin,
gentamicin, lincomycin, and spectinomycin.
3. Antibiotics derived from acetate and propionate: Fusidic acid, griesofulvin,
macrolide antibiotics, polyene antibiotics, tetracyclines.
4. Miscellaneous antibiotics: Novobiocin, puromycin, rifamycin, vancomycin
(B) Spectrum of activity
1. Broad spectrum antibiotics: Some penicillin's (e.(g) ampicillin, carbenicillin), some
cephalosporin's (cephaloridine), Chloramphenicol, macrolides, rifamycins,
tetracycline's, sparsomycins, some aminoglycosides (neomycin, kanamycin,
gentamicin, paromomycin).
2. Antibiotics active predominantly against Gram positive bacteria: Bacitracin, most
penicillin's (e.(g) benzylpenicillin, cloxacillin, dicloxacillin, oxacillin), fusidic acid,
erythromycin, lincomycin.
3. Antibiotics active against Gram negative bacteria: Polymixin B, Sulphomyxin.
4. Antifungal Antibiotics: Amphotericin B, candicidin, fumagillin, haymycin,
nystatin.
5. Anti amoebic antibiotics: Paromomycin, puromycin.
6. Anti neoplastic antibiotics: Adriamycin, bleomycin, daunorubicin, methramycin,
mitomycin C, actinomycins.
(C) Chemical structure
Here, antibiotics are classified based on chemical structure. None of classification is
satisfactory. However, in the present chapter, this classification is followed to classify
the antibiotics into penicillin's, cephalosporin's, Chloramphenicol and derivatives,
tetracycline's? polyene antibiotics, macrolide antibiotics, aminoglycoside antibiotics,
antracyclines;’lincomycin group, nucleoside antibiotics.
Table 25.1. Classes of antibiotics and their properties
Chem ical Exam ples B iological Spectrum M ode of
Class sources (effective action
against)

Beta-lactams Penicillin G, Penicillium Gram-positive Inhibits steps


(penicillins and Cephalothin notatum and bacteria in cell wall
cephalosporins) Cephalosporium (peptidoglycan)
species synthesis and
murein assembly
226 □ □ Drug Inspector Exam

Semisynthetic Ampicillin, Gram positive Inhibits steps in


penicillin Am oxycillin and Gram cell wall
-negative (peptidoglycan)
bacteria synthesis and
murein assembly
Clavulanic Clavam ox is Streptomyces Gram-positive Suicide
Acid clavulanic clavuligerus and Gram- inhibitor of
acid plus negative beta-lactam ases
am oxycilin bacteria
Monoibactams Aztreonam Chromobacter Gram-positive Inhibits steps in
violaceum and Gram- cell wall
negative (peptidoglycan)
bacteria synthesis and
murein assembly
Carboxypenems Imipenem Streptomyces Gram-positive Inhibits steps
cattleya and gram- in cell wall
negative (peptidoglycan)
bacteria synthesis and
I
murein assembly
Aminoglycosides Streptom ycin Streptomyces Gram-positive Inhibit
griseus and Gram- translation
negative (protein
bacteria synthesis)
Gentam icin Micromonos- Gram -positive Inhibit
pora species and gram- translation
negative (protein
bacteria esp. synthesis)
Pseudomonas
Glycopeptides Vancomycin Streptomyces Gram-positive Inhibits steps in
orientales bacteria, esp murein
Staphylococcus (peptidoglycan)
aureus biosynthesis
and assembly
Lincomycins Clindam ycin Streptomyces Gram -positive Inhibits
lincolnensis and Gram - translation
negative (protein)
bacteria esp. synthesis
anaerobic
Bacteriodes
Macrolides Erythromycin Streptomyces Gram -positive Inhibits
erythreus bacteria-Gram - translation
negaive bacteria (protein
not enterics, synthesis)
Chemotherapeutic Agents □ □ 227

Neisseria,
Legoinella,
M ycocplasm a
Polypeptides Polymyxin Bacillus gram-negative Damages
polymyxa bacteria cytoplasmic
membranes
Bacitracin Bacillus Gram- Inhibits steps in
subtilis positive murein
bacteria (peptidoglycan)
biosynthesis
and assembly
Polyenes Am photericin Streptomyces Fungi Inactivate
modosus membranes
containing
sterois
N ystatin Streptomyces Fungi Inactivate
noursei (Candida) membranes
containing
sterois
Rifamycins Rifampicin Streptomyces Gram-positive Inhibits
mediterranei and Gram- transcription
negaive (eubacerial
bacteria, RNA
M ycobac­ polymerase)
terium
tuberculosis
Tetracyclines Tetracycline Streptomyces Gram -positive Inhibit
species an Gram- translation
negative (protein
bacteria synthesis)
Rickettsias'
Semisynthetic Doxycycine Gram -positive Inhibit
tetracycline and gram- translation
negative (protein
bacteria synthesis)
Rickettsias
Ehrlichia,
Borrelia
Chloramphenicol Chloram p­ Streptomyces Gram-positive Inhibits
henicol venezuelae and Gram- translation
negative (protein
bacteria synthesis)
228 □ □ Drug Inspector Exam

ANTI TUBERCULAR DRUGS


The anti tubercular drugs are better classified into two types:-
First line anti tubercular drugs: These are highly effective bactericidal drugs with
a compromised degree of toxicity for example, Isoniazid, ethambutol, rifampin,
streptomycin and pyrazinamide.
Second line anti tubercular drugs: These include ethionamide, amino salicylic acid,
Cycloserine, amikacin and capreomycin. These are only used when there is microbial
resistance to first line drugs or first line drugs are not acceptable to patient.
Isoniazid (INH, Laniazid): It is bacteriostatic foror Besting M. bacilli but bactericidal
for rapidly growing tubercle bacilli. It is believed to inhibit the synthesis of mycolic
acid, high molecular weight branched hydroxy fatty acid which is important cell wall
constituent of bacteria. If Isoniazid used alone, resistance develops soon. The peripheral
neuritis is due to inhibition of co-enzyme-pyridoxal phosphate. This inhibition can be
prevented by Co administration of pyridoxine.
Pyrazinamide (PZA): It has tuberculocidal activity at high concentration but
itsinactiveness toward metabolically inactive tubercle bacilli and its hepatotoxicity, make
only suitable for shot term therapy.
Ethambutol(Myambutol): It is bacteriostatic and highly effective in combination
with other drugs, Isoniazid and rifampin. It is active only against multiplying
mycobacteria. It has no effect on encapsulated or other non proliferating forms. The
compound is steriospecific in anti tubercular activity. It has been shown that toxicities
of dextro, levo and meso isomers are equal but these isomers differ in activity. The
dextro isomer is 16 times more active than meso isomer. It acts by inhibiting the
incorporation of mycolic acids into the cell walls of these organisms.
Rifampin(Rifadin, Rimactane): It is a semi-synthetic derivative of rifamycin b
produced by Streptomyces mediterranei. It is produced by reacting 3-formyl rifamycin
SV with l-amino-4-methyl piperazine in tetrahydrofuran. (Note: The rifamycins are a
group of chemically related antibiotics obtained from S.mediterranci. They belong to a
class of antibiotics called anamysins that contain a macro cyclic ring bridged across two
non adjacent positions of an aromatic nucleus). Rifampin occurs as red brown, tasteless,
crystalline powder, very slightly soluble in water. It is most active agent for the treatment
of tuberculosis. It is also active >against Staphylococci, Nisei, Hemophilus, legionella
and Chlamydia. As resistance tq rifampin develops rapidly in most of the species of
bacteria including the tubercle bacillus, it is used only in combination with other anti
tubercular drug.
The body fluids, urine, saliva, tears are stained reddish-orange by rifampin and its
metabolite. Adverse effects include hepatotoxicity, abdominal symptom and leg cramps,
rashes, etc. Rifampin shows its anti mycobacterial action by inhibiting the DNA
dependent RNA polymerase in' bacteria, leading to suppression of initiation of chain
formation.
Streptomycin sulphate: Acid hydrolysis of streptomycin gives streptidine and
streptobiosamine. The later compound is a combination of 1-streptose and N-methyl
Chemotherapeutic Agents □ □ 229

glucosamine. Streptomycin acts as a triacidic base due to presence of two strong basic
guanidine and weakly basic methyl amino group.
It is bactericidal drug, often used in combination with other drugs such as
ethambutol and Isoniazid, to treat pulmonary infection in patients with resistant tubercle
bacilli.
Ethionamide(TrectorSC): Its mechanism of action is supposed to be similar to
Isoniazid. Gastrointestinal intolerance is its common side effects.
p-Amino salicylic acid(PAS): It is a bacteriostatic and highly specific for M
tuberculosis. At one time, PAS was considered a first line drug alongwith Isoniazid and
streptomycin. However, due to introduction of more effective and better tolerated drugs
like rifampinand ethambutol, it has an alternative status. Cycloserine (Seromycin). It is
an antibiotic, isolated from three different Streptomyces species, S. orchidaceous,
garyphalus and S. lavenulus. It shows its antibacterial action by inhibiting the step of
cross linking of peptides in the formation of bacterial cell wall.
Capreomycin sulphate(Capsalate sulphate): It is a polypeptide complex, isolated
from Streptomyces capreolus. It consists of four components like la, IB, IIA and IIB.
Damage to the 8th cranial nerve(hearing loss) and renal damage are its serious toxic
effects. Hence, it is only given in place of streptomycin in the treatment of tuberculosis
when organism is resistant.

ANTI LEPROTIC DRUGS


Leprosy, also known as Hansen's disease, is an infectious disease caused by the
Mycobacterium leprae bacterium; it may disfigure the body or skin. The modern term
for the disease is named after Gerhard Armauer Hansen, the discoverer of the bacterium
in 1873.
The disease affects the skin, nerves and mucous membranes. The most effective
drugs available for the treatment of leprosy are sulphones ?e.(g) dapsone must be
administered for many years to alleviate the skin lesions. •
Other drugs include the clofazimine, Rifampicin and ethionamide. Generally, in
routine process, multi drug regimens are used to prevent the emergence of resistant
strain of M leprae.
A. Sulphones
These are chemically related to Sulphonamides very useful in treatment of tuberculoid
and lepromatous type of leprosy. These are bactericidal in nature and mechanism is
probably similar to Sulphonamides (Chapter-21). Dapsone, solapsone and diacetyl
dapsone belong to this group.
i
(B) Miscellaneous ]
Clofazimine (Lamprene). It belongs to an iminophenazine dye, initially known as
B663; It is an effective drug in leprosy because of its simultaneous bactericidal and anti­
inflammatory actions. It has very long half life time(tl/2) about 70 days. It is generally
used in combination with other drug to prevent the emergence of resistant strain. Its
major side effect is skin discoloration due to photosensitivity.
230 □ □ Drug Inspector Exam

Thalidomide
It is the drug of choice for the treatment of Erythema nodosum leprosum but
contraindicated in pregnancy or child bearing age due to its teratogenic nature.
Anti HIV drugs
Several distinct classes of drugs are now used to treat HIV infection like:
1. Nucleoside Analogue Reverse Transcriptase Inhibitors (NARTI): These drugs
contain faulty version of the building blocks (nucleotide) used by reverse transcriptase
to convert RNA to DNA. When reverse transcriptase uses these faulty building blocks,
the new DNA can’t be built correctly. In turn, HIV's genetic material of the cell and
prevents the cell from producing new virus (they are chain-terminating drugs). Hence,
they act by incorporating themselves into DNA of the virus to stop the building process.
Zidovudine (AZT = ZDV, Retrovir),Didanosine (ddl, Videx), Zalcitabine (ddC, Hivid),
Stavudine (d4T, Zerit), Lamivudine (3TC, Epivir) are the examples.
2. Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs): In contrast to NRTIs,
NNRTIs are not incorporated into viral DNA; they inhibit HIV replication directly by
binding non-competitively to reverse transcriptase at its catalytic site. These drugs,
unlike the nucleoside analogues, don't require phosphorylation to become active. These
are highly selective against HIV-1 and very potent in vitro.Nevirapine (Viramune) and
Delavirdine (Rescriptor) are the examples.
3. Protease Inhibitors: These drugs are specific for the HIV-1 protease and
competitively inhibit the enzyme, preventing the maturation of virions, capable of
infecting other cells. Saquinavir (Invirase), Ritonavir (Norvir), Indinavir (Crixivan),
Nelfinavir (Viracept) are the examples.
4. Fusion inhibitors(FI's): HIV enters cells in a series of steps: (i) HIV attaches to
the cell (ii) HIV binds to the cell, and (iii) HIV fuses to the host cell. These act by
blocking HIV from fusing to the cell, preventing the virus from entry into a healthy cell.
Enfuvirtide is the example of this class.

ANTIFUNGAL DRUGS
Drugs for the treatment of Systemic mycotic infections
The drugs used in the treatment of subcutaneous and systemic mycoses are
amphotericin B, flucytosine, and the new group of azoles, ketoconazole, fluconazole
and itraconazole.
A. Amphotericin B (Fungizone)
It is a naturally occurring polyene macrolide antibiotic, produced by Streptomyces
nodosus. In spite of its toxic potential, amphotericin B is the drug of choice used in the
treatment of systemic mycoses. It is sometimes used in combination with flucytosine so
that lower(less toxic) levels of amphotericin are possible.
(B) Flucytosine (Ancobon)
It is a synthetic pyrimidine anti metabolite, used only in combination with
amphotericin for the treatment of systemic mycoses and meningitis caused by
Cryptococcus neoformans and Candida species.
Chemotherapeutic Agents □ □ 231

(C) Imidazole derivatives


(a) Ketoconazole (Nizoral): It is a substituted imidazole, useful for the treatment of
systemic mycoses. Ketoconazole interacts with C-???-demethyIase (a Cytochrome P-450
enzyme) to block demethylation of lanosterol to ergosterol, the principal sterol of fungal
membranes. This inhibition disrupts membrane function and increases permeability. It
is selectively toxic because in human cells the major sterol is cholesterol rather than
ergosterol, and Ketoconazole (and other triazoles) have lower incidence of side
(b) Fluconazole (Diflucan): It is a new member of azoles family. Fluconazole is
indicated for the treatment of systemic Candida infections and cryptococcal meningitis,
frequently occurred in AIDS patients. It inhibits the synthesis of fungal membrane,
ergosterol in same manner as ketoconazole. Its adverse effects are less problematic than
ketoconazole. Fluconazole has no endocrinological effects because it does not inhibit
the Cytochrome P450 responsible for the synthesis of androgens.
(c) Itraconazole (Sporonox): It is a recent addition to the triazole family. It also lacks
the endocrinologic side effects of ketoconazole. Its mode of action is the same as that
of the other azoles.

DRUGS FOR SUPERFICIAL MYCOTIC INFECTIONS

A. Griseofulvin (Fulvicin)
It is naturally occurring spirane> isolated from Penicillium griseofulvum. The drug
is principally fungistatic, effective against the dermatophytes-Trichophyon, Microsporum
and Epidermophyton. It interacts with microtubules within the fungus to disrupt the
mitotic spindle and inhibits mitosis. It also accumulates in infected, newly synthesized
keratin containing tissues, making them unsuitable for the growth of fungi.
(B) Polyene antibiotic
(*') Nystatin(Mycostatin): It is effective against Candida albicans infection of the
skin, G I tract and vagina. It is isolated from Streptomyces noursei. Its structure, chemistry,
mode of action and resistance resemble those of amphotericin (B) The aglycone portion
of nystatin is called nystatinolide. It consists of lactone ring containing single tetraene
and diene moieties separated by two methylene group.
(ii) Natamycin(Pimaricin): It is polyene antibiotic, obtained from cultures of S.
natalensis. It consists of 26 member lactone ring containing tetraene chromophore, an
?,?-unsaturated lactone carbonyl group, three hydroxyl groups, a carbonyl group, a
trans epoxide and a glycosidically joined mycosamine.
It causes both potassium leakage and cell lyses at the same concentration. This is
unlike to amphoteracin B which shows potassium loss at fungistatic concentration and
cell lyses at fungicidal concentration. The drug is supplied as a 5% ophthalmic suspension
intended for the treatment of fungal conjunctivitis, blepharitis and keratitis.
(C) Imidazoles
(i) Miconazole nitrate(Monistat-Derm).It is a broad spectrum, effective against
dermatophytes, C an d id a species and vaginal infections caused by Trichophyton
232 □ □ Drug Inspector Exam

glabrata. Its mechanism of action, anti fungal spectrum and metabolism are same
as ketoconazole.
(ii) Econazole nitrate(Spectrazole). It is the deschloro derivative of miconazole. Its
actions are like miconazole.
(iii) Clotrimazole(Lotrimin).It is used primarily as topical agent, effective against
dermatophytic infections, cutaneous candidiasis, vulvovaginal candidiasis.
(iv) Other imidazoles
Sulconazole nitrate (Exelderm), Oxiconazole (oxistat), Tioconazole, etc are other
imidazbles, used for the treatment of superficial infection
(D) Triazoles
Terconazole (Terazol). It is a ketal triazole with mechanism of action similar to
imidazoles. It is used for vaginal candidiasis.
(E) Tolnaftate (Tinactin)
It is a thioester of ?-naphthol and fungicidal against dermatophytes, Microsporum
and Epidermophytes species that is responsible for tinea infections.
(F) Phenols and their derivatives
Clioquinol and haloprogin are phenolic derivatives, still used as antifungal drugs
for superficial mycoses. Ciclopirox olamine is not a phenol but has properties like those
of phenols is a good antifungal drug. All of these agents appear to interfere with cell
membrane integrity.
Haloprogin (Halotrex).It is used as a 1% cream for the treatment of superficial tinea
infections.
Clioquinol (Vioform). It is light sensitive yellowish white powder that is insoluble
in water. It has been used as a powder for many skin conditions, such as atopic dermatitis,
eczema, psoriasis and impetigo. A 3% ointment or cream has been used for trichomonas
vaginalis vaginatis.
Ciclopirox olamine (leprox). It is a broad spectrum anti fungal drug, for topical use.
It is a drug of choice in the cutaneous candidiasis, tinea corporis, tinea pedis, etc.
(G) Acids and their derivatives
Benzoic acid, salicylic acid, propionic acid, zinc propionate, sodium caprylate,
undecylenic acid, triacetin are either acids or their derivatives which show anti fungal
activity. These are useful for the treatment of superficial mycoses.

ANTINEOPLASTIC AGENTS
Antineoplastics drugs are the drugs that prevent or inhibit the maturation and
proliferation of neoplasms. Antineoplastic agents travel the body and destroy cancer
cells. Man}> of the side effects associated with antineoplastic agents occur because
treatment destroys the body's normal cells in addition to cancerous cells.
General Toxicities of Antineoplastic / Anticancer Drugs are:
(/) Bone marrow depression
Chemotherapeutic Agents □ □ 233

(ii) Lymphocytopenia
(iii) GIT Stomatitis
(iv) Diarrhoea
(i>) Nausea and Vomiting
(xfi) Alopecia
(vii) Hyperuricaemia
(viii) Hair loss.
Classification of Antineoplastic Agents / Anticancer Drugs
1. Alkylating Agents
• Nitrogen mustards: Melphalan, Cyclophosphamide, Ifosfamide
• Nitrosoureas
• Alkylsulfonates
• Ethyleneimines
• Triazene
• Methyl Hydrazines
• Platinum Coordination complexes: Cisplatin, Carboplatin, Oxaliplatin
2. Antimetabolites
• Folate Antagonists: Methotrexate
• Purine antagonists :6-mercaptopurine
• Pyrimidine antagonists: 5-Fluorouracil, Cytarabine
3. Natural Products
(a) Plant Products
• Vinca Alkaloids: Vincristine, Vinblastine
• Taxanes: Paclitaxel, Docetaxel
• Epipodophyllotoxins: Etoposide
• Camptothecins: Irinotecan
(b) Microorganism Products
• Antibiotics: Doxorubicin, Bleomycin
• Enzymes: L-Asparaginase
Miscellaneous
• Hydroxyurea, Imatinib Mesylate, Rituximab, Epirubicin, Bortezomib, Geftinib,
Leucovorin, Pamidronate, Gemcitabine

HORMONES AND ANTAGONISTS


• Corticosteroids : Prednisone, Dexamethasone
• Estrogens : Ethinyloestradiol
• Antiestrogens : Tamoxifen
• Progesteron derivative : Megestrol Acetate
• Androgen : Testosterone propionate
234 □ □ Drug Inspector Exam

Antiandrogen : Flutamide , Bicalutamide


Aromatase inhibitor : Letrozole , Anastrazole
5-alpha reductase inhibitor : Finasteride
GnRH Analogue : Leuprolide, Buserelin
Growth Hormone, glucagon and insulin inhibitor : Octreotide

MULTIPLE CHOICE QUESTIONS

1. All of the following antiviral drugs are 6. Tick the drug, inhibiting viral reverse
the analogs of nucleosides, EXCEPT: transcriptase:
(a) Acyclovir (a) Zidovudine
(b) Zidovudine (b) Vidarabine
(c) Saquinavir (c) Rimantadine
(d) Didanozine (d) Gancyclovir
2. Tick the drug, a derivative of 7. Tick the drug, inhibiting viral
adamantane: proteases:
(a) Didanozine (a) Rimantadine
(b) Rimantadine (b) Acyclovir
(c) Gancyclovir (c) Saquinavir
(d) Foscamet (d) Zalcitabine
3. Tick the drug, a derivative of 8. Tick the drug of choice for herpes and
pyrophosphate: cytomegalovirus infection treatment:
(a) Foscamet (a) Saquinavir
(b) Zidovudine (b) Interferon alfa
(c) Vidarabine (c) Didanozine
(d) Acyclovir (d) Acyclovir
4. Tick the drug, inhibiting viral DNA 9. Tick the drug which belongs to
synthesis: nonnucleoside reverse transcriptase
(a) Interferon inhibitors:
(b) Saquinavir (a) Zidovudine
(c) Amantadine (b) Vidarabine
(d) Acyclovir (c) Nevirapine
5. Tick the drug, inhibiting uncoating of (d) Gancyclovir
the viral RNA: 10. All of the following antiviral drugs
(a) Vidarabine are antiretroviral agents, EXCEPT:
(b) Rimantadine (a) Acyclovir
-(c) Acyclovir (b) Zidovudine
(d) Didanozine (c) Zalcitabine
(d) Didanozine
Chemotherapeutic Agents □ □ 235

11. T ick th e d ru g u se d fo r in flu e n z a A 17. Tick the unwanted effects of


p re v en tio n : intravenous acyclovir infusion:
(a) A c y c lo v ir (a) Renal insufficiency, tremors,
(b) R im a n ta d in e delerium
(c) S a q u in a v ir (b) Rash, diarrhea, nausea
(d) F o s c a rn e t (c) Neuropathy, abdominal pain
12. T ick th e d ru g u se d fo r H IV in fe c tio n
(d) Anemia, neutropenia, nausea,
trea tm en t, a d e riv a tiv e o f n u cleo sid es:
insomnia
(a) A c y c lo v ir 18. Tick the drug that can induce peripheral
(b) Z id o v u d in e neuropathy and oral ulceration:
(c) G a n c y c lo v ir (a) Acyclovire
(d) T riflu rid in e (b) Zalcitabine
(c) Zidovudine
13. T ick th e a n tiv ira l d ru g w h ic h b e lo n g s
to e n d o g e n o u s p ro tein s:
(d) Saquinavir
(a) A m a n ta d in e 19. Tick the unwanted effects of
(b) S a q u in a v ir didanozine:
(c) In te rfe ro n a lfa (a) H allucinations, dizziness,
(d) P e n c y c lo v ir insomnia
(b) Anemia, neutropenia, nausea
1 4 . T ic k t h e d r u g w h i c h b e l o n g s to
(c) Hypertension, vomiting, diarrhea
n u c le o s id e re v e r s e tr a n s c r ip ta s e
(d) Peripheral neuropathy,
in h ib ito rs:
pancreatitis, diarrhea,
(a) D id a n o sin e
hyperuricemia
(b) G a n c y c lo v ir
(c) N e v ira p in e
20. Tick the unwanted effects of indinavir:
(d) Vidarabine (a) Hypotension, vomiting, dizziness
(b) N ephrolithiasis, nausea,
15. A ll o f th e fo llo w in g an tiv ira l d ru g s are
hepatotoxicity
a n ti-in flu e n z a a g e n ts, E X C E P T :
(c) Peripheral neuropathy,
(a) A cy c lo v ir
pancreatitis, hyperuricemia
(b) A m a n ta d in e
(d) Anemia, neutropenia, nausea
(c) In te rfe ro n s
21. Tick the drug that can induce nausea,
' (d) R im a n ta d in e
diarrhea, abdominal pain and rhinitis:
16. T ic k t h e u n w a n t e d e ffe c ts of (a) Acyclovire (b) Zalcitabine
z id o v u d in e:
(c) Zidovudine (d) Saquinavir
(a) H a llu c in a tio n s , d iz z in e ss
Antineoplastic Drugs
(b) A n e m ia , n e u t r o p e n i a , n a u s e a ,
in so m n ia
22. All of the follow ing effects are
disadvantages of anticancer drugs,
(c) H y p e rte n sio n , v o m itin g
EXCEPT:
(d) P e rip h e ra l n e u ro p a th y
236 □ □ Drug Inspector Exam

(a) Low selectivity to cancer cells (a) Fluorouracil


(b) Depression of bone marrow (b) Carboplatin
(c) Depression of angiogenesis (c) Vinblastine
(d) Depression of immune system (d) Busulfan
23. Rational combination of anticancer 28. Tick the anticancer drug of plant
drugs is used to: origin:
(a) Provide synergism resulting from (a) Dactinomycin
the use of anticancer drugs with (b) Vincristine
different mechanisms combination (c) Methotrexate
(b) Provide synergism resulting from (d) Procarbazine
the use of anticancer drugs with
the same mechanisms combination 29. Action m echanism of alkylating
agents is:
(c) Provide stimulation of immune
system (a) Producing carbonium ions altering
protein structure
(d) Provide stim ulation of cell
proliferation (b) Producing carbonium ions altering
DNA structure
24. Tick the anticancer alkylating drug, a (c) Structural antagonism against
derivative of chloroethylamine: purine and pyrimidine
(a) Methotrexate (d) Inhibition of DNA-dependent
(b) Cisplatin RNA synthesis
(c) Cyclophosphamide
30. Tick the anticancer drug, a pyrimidine
(d) Carmustine antagonist:
25. Tick the anticancer alkylating drug, a (a) Fluorouracil
derivative of ethylenimine: (b) Mercaptopurine
(a) Mercaptopurine (c) Thioguanine
(b) Thiotepa (d) Methotrexate
(c) Chlorambucil
31. Methotrexate is:
(d) Procarbazine
(a) A purine antagonist
26. Tick the group of hormonal drugs (b) A folic acid antagonist
used for cancer treatment: (c) An antibiotic
(a) M ineralocorticoids and (d) An alkylating agent
glucocorticoids
(b) G lucocorticoids and gonadal 32. Tick the antibiotic for cancer
hormones chemotherapy:
(c) Gonadal hormones and (a) Cytarabine
somatotropin (b) Doxorubicin
(d) Insulin (c) Gentamycin
(d) Etoposide
27. Tick the anticancer alkylating drug, a
derivative of alkylsulfonate:
Chemotherapeutic Agents □ □ 237

33. Fluorouracil belongs to: (c) Endometrial cancer


(a) Antibiotics (d) Brain tumors
(b) Antimetabolites 39 Enzyme drug used for acute leukemia
(c) Plant alkaloids treatment:
(d) Bone marrow growth factor (a) Dihydrofolate reductase
34. Tick the action mechanism of (b) Asparaginase
anticancer drugs belonging to plant (c) Aromatase
alkaloids: (d) DNA gyrase
(a) Inhibition of DNA-dependent 40. All of the follow ing drugs are
RNA synthesis derivatives of nitrosoureas, EXCEPT:
(b) Cross-linking of DNA (a) Carmustine
(c) Mitotic arrest at a metaphase (b) Vincristine
(d) N on-selective inhibition of (c) Lomustine
aroma tases
(d) Semustine
35. General contraindications for
41. Tick the group of drugs used as
anticancer drugs are:
subsidiary m edicines in cancer
(a) Depression of bone marrow treatment:
(b) Acute infections (a) Cytoprotectors
(c) Severe hepatic and/or renal (b) Bone marrow growth factors
insufficiency
(c) Antimetastatic agents
(d) All of the above
(d) All of the above
36. Action mechanism of methotrexate is:
42. Tick the estrogen inhibitor:
(a) Inhibition of dihydrofolate
(a) Leuprolide
reductase
(b) Tamoxifen
(b) Activation of cell differentiation
(c) Flutamide
(c) Catabolic depletion of serum
(d) Anastrozole
asparagine
(d) All of the above 43. Tick the antiandrogen drug:
(a) Flutamide
37. Tick the anticancer drug belonging to
inorganic metal complexes: (b) Aminoglutethimide
(a) Dacarbazine (c) Tamoxifen
(b) Cisplatin (d) Testosterone
(c) Methotrexate 44. Tick the drug belonging to aromatase
(d) Vincristine inhibitors:
38. Tick the indication for estrogens in (a) Octreotide
oncological practice: (b) Anastrozole
(a) Leukemia (c) Flutamide
(b) Cancer of prostate (d) Tamoxifen
238 □ □ Drug Inspector Exam

45. Tick the drug belonging to 49. Which of the following statements is
gonadotropin-releasing hormone true regarding the properties of
agonists: benzylpenicillin?
(a) Leuprolide (a) It is a bacteriostatic agent.
(b) Tamoxifen (b) It is active over a wide range of
(c) Flutamide bacterial species.
(d) Anastrozole (c) It is resistant to 6-lactamases.
46. Which of the following statements is (d) Certain individuals may have an
false? allergic response to it.
(a) A bacterial cell is prokaryotic 50. What essential feature of a penicillin
whereas an animal cell is is involved in its mechanism of action?
eukaryotic. (a) Carboxylic acid
(b) A bacterial cell has a cell wall (b) p-lactam ring
whereas an animal cell does not. (c) Acyl side chain
(c) Bacterial and animal cells both (d) Thiazolidine ring
have a well defined nucleus.
51. What type of reaction is catalysed by
(d) Bacteria may contain enzymes that a 13-lactamase enzyme?
are not present in animal cells.
(?) The final cross-linking reaction to
47. Which of the following is the general form the bacterial cell wall.
mechanism of action for (b) The hydrolysis of the acyl side
erythromycin? chain from penicillin structures.
(a) Inhibition of a metabolic enzyme. (c) The hydrolysis of the four-
(b) Inhibition of cell wall synthesis. membered ring present in
(c) Disruption of protein synthesis. penicillins.
(d) Inhibition of nucleic acid (d) The biosynthesis of the penicillin
transcription and replication. structure from the amino acids
48. Below given is the general structure valine and cysteine.
is representative of sulfonamides. 52. The following structure (methicillin)
was an important penicillin that was
introduced in the 1960s to counter the
R !HN---- ^ V - S=G threat of penicillin-resistant strains of
^ —& H ER 2 S. aureus.
Which of the following statements is
true for active sulfonamides?
(a) R1 can be H or an alkyl group
(b) R2 must be hydrogen
(c) The aromatic ring is essential
(d) The sulfonamide functional group
can be replaced with an ester
Chemotherapeutic Agents □ □ 239

Which is true for the above structure?


(a) There is no electron withdrawing
group on the side chain, and so it
is acid sensitive.
(b) It can be taken orally.
(c) It is more active than penicillin (G)
(d) It has a broader spectrum of
activity compared to penicillin (G)
Which of the following statements is
53. Which of the following statements is true for the methyl substituent at
accurate in explaining why Gram position 3?
negative bacteria are generally more (a) It is a good leaving group.
resistant to penicillins than Gram
(b) It is generally good for activity.
positive bacteria?
(c) It is good for oral activity.
(a) Gram negative bacteria have a
thicker cell wall (d)It acts as a steric shield.
(b) Gram negative bacteria have an 56. What is the target for clavulanic acid?
outer hydrophilic membrane that H
acts as an extra barrier
(c) Gram negative bacteria can
concentrate 6-lactamase enzymes
in the periplasmic space
(d) Gram negative bacteria produce
smaller quantities of (a) The transpeptidase enzyme
transpeptidase enzyme (b) L-ala racemase
54. What role does the acetoxy group at (c) p-lactamase
the 3-position of cephalosporins have (d) Penicillin acylase
in enhancing antibacterial activity?
57. Which of the following antibiotics is
(a) It acts as a steric shield and masks
a macrolide?
enzymatic attack at the 6-lactam
(a) Chloramphenicol
ring.
(b) Doxycycline
(b) It acts as a good leaving group
when the 6-lactam ring is opened. (c) Erythromycin
(c) It takes part in a transesterification (d) Streptomycin
reaction with the carboxylic acid 58. Which of the following antibiotics is
group at position a tetracycline?
(d) It increases the reactivity of the 6- (a) Chloramphenicol
lactam ring by neighbouring (b) Doxycycline
group participation. (c) Erythromycin
55. The following structure (cefalexin) is (d) Streptomycin
a first generation cephalosporin.
240 □ □ Drug Inspector Exam

59. Which of the following antibiotics is 63. Which of the following statements is
responsible for Gray Baby Syndrome? true regarding the following structure
(a) Chloramphenicol (nevirapine)?
(b) Doxycycline
(c) Erythromycin
(d) Streptomycin
60. The following structure is a synthetic
antibacterial agent.
O

(a) It is a N ucleoside Reverse


Transcriptase Inhibitor (NRTI).
(b) It binds to an allosteric binding
site next to the substrate binding
site of reverse transcriptase,
(c) It is an achiral molecule.
To which group of compounds does
(d) It is an example of a second-
the structure belong?
generation drug of its class.
(a) Aminoacridines
(b) Aminoglycosides 64. Which of the following statements is
(c) Fluoroquinolones true for non-nucleoside reverse
transcriptase inhibitors?
(d) Tetracyclines
(a) They cannot be used alongside
61. What are the two main targets nucleoside reverse transcriptase
currently used in anti-HIV therapy? inhibitors.
(a) Reverse transcriptase and (b) They bind to an allosteric binding
protease. site.
(b) Reverse transcriptase and (c) Resistance can arise due to a
integrase. mutation where an asparagine in
(c) Protease and integrase. the target binding site is mutated
(d) The viral glycoproteins gpl20 and to lysine.
gp41. (d) Binding interactions between
62. Which of the following enzymes is NNRTIs and the main protein
responsible for processing HIV chain in the binding site are not
proteins during the production of new important.
viruses? 65. The protease enzyme in HIV has tvrc
(a) Integrase important, identical amino acids
(b) Protease involved in the catalytic mechanism
(c) Reverse transcriptase which leads to peptide bond
(d) DNA polymerase hydrolysis. What are the two amino
acids?
Chemotherapeutic Agents □ □ 241

(a) Glutamic acid (b) Aspartic acid


(c) Lysine (d) Serine
66. The HIV protease enzyme is symmetrical, whereas mammalian proteases are not.
What significance might this have?
(a) Inhibitors of the HIV protease enzyme must also be symmetrical.
(b) It may be possible to design inhibitors that prove selective for the HIV protease
over mammalian proteases.
(c) Only symmetrical substrates are cleaved by HIV protease.
(d) There is no significance.
57. The following structure (saquinavir) is a protease inhibitor. The region marked in
blue is a hydro-xyethylamine moiety.

Quinoline rii

Decahydroisoquinoline ring

What does this moiety represent?


(a) A transition state. (b) A transition state isostere.
(c) An isostere. (d) A bioisostere.
68. The following structure (saquinavir) is a protease inhibitor.

The decahydro-isoquinoline ring system in the protease inhibitor shown above


was used to replace an amino acid residue that is present in the lead compound
used in the development of saquinavir. Which amino acid was replaced?
242 □ □ Drug Inspector Exam

(a) Proline (b) Phenylalanine


(c) Aspartic acid (d) Tryptophan
69. The following structure (saquinavir) is a protease inhibitor.

Quinoline i

Decahydroisoquinoline ring

Into which binding subsite of the protease enzyme's active site does the quinoline
ring system fit?
(a) SI (b)S2
(c) S3 (d)S4
70. The following structure (ritonavir) is a protease inhibitor.
thiazoly! ring thiazolyl ring

Ph

What feature of the protease enzyme was the inspiration for the design of this
particular structure?
(a) The presence of a flap region over the active site.
(b) The presence of isoleucine residues in the flap region.
(c) The presence of aspartyl groups in the active site.
(d) The symmetrical nature of the active site.
71. Which of the following protease inhibitors was developed by a hybridisation
strategy?
(a) Ritonavir (b) Indinavir
(c) Saquinavir (d) Amprenavir
72. The following protease inhibitor (palinavir) illustrates an extension strategy
involving the group shown in blue.
Chemotherapeutic Agents □ □ 243

Which subsites are occupied by the extended residue?


(a) SI' and S2' (b) SI' and S3’
(c) S2' and S3' (d) SI' and S4’
73. An enzyme carried by the flu virus catalyses the following reaction. Which enzyme
is it?
OH OH

f OH
VA
CQ f OH
HO glycoprotein (lipid) HO
O AcHN
•T'O “'OH
+ Glycoprotein or
glycoplipid
AcHN
HO HO
Sialic acid

(a) Hemagglutinin (b) RNA polymerase


(c) DNA polymerase (d) Neuraminidase
74. Which of the following statements is false regarding the characteristics of a good
protein target for antiviral drugs?
(a) It should be important to the life cycle of the virus.
(b) It should bear little resemblance to human proteins.
(c) It should be common to different types of virus.
(d) It should be important in the late stages of the virus life cycle.
75. Which of the following antiviral drugs does not result in the eventual appearance
of aciclovir triphosphate in virally infected cells?
244 □ □ Drug Inspector Exam

(a) Structure A (c) Angiostatin


(b) Structure B (d) Cyclins
(c) Structure C 78. Cyclophosphamide is commonly used
(d) Structure D in anticancer therapy.
76. What term is used to indicate the NH 0
ability of a cancer to invade other parts
of the body and to produce secondary A
o nr2
tumours?
(a) Carcinogenesis Which of the following statements is
(b) Apoptosis not true of the above structure?
(c) Metastasis (a) It is relatively non toxic.
(d) Mutagenesis (b) It acts as a prodrug.
(c) It cannot be taken orally.
77. Which molecules are involved in the
anchoring of cells to an extracellular (d) The structure is metabolised to
matrix? release acrolein.
(a) Integrins 79. What is the name of the following
(b) Interleukins anticancer drug?

(a) Spongistatin 1 (b) Cryptophycin 1


(c) Phyllanthoside (d) Maytansine 1
80. The following structure is an inhibitor of the enzyme responsible for adding a
famesyl chain to the Ras protein.
Which feature binds to the zinc cofactor of the enzyme?
Chemotherapeutic Agents □ □ 245

tricyclic system

(a) The tricyclic system (b) The piperazine ring


(c) The aromatic ring (d) The imidazole ring
81. The following structure is a natural product having anticancer properties, which
was isolated from a marine worm.

What is it called? (a) Biosynthesis


(a) Pancratistatin (b) Angiogenesis
(b) Cephalostatin 1 (c) Apoptosis
(c) Bryostatin 1 (d) Metastasis
(d) Dolostatin 15 83. Which of the follow ing inhibits
82. What is the term used to indicate the angiogenesis?
growth of new blood vessels? (a) VEGF (b) FGF-2
(c) Angiostatin (d) Interleukin-6
246 DO Drug Inspector Exam

84. The tetracyclines act as intercalating anticancer agents.

Tetracyclic system

Which of the following is a simplified analogue of tetracyclines?


(a) Mitoxantrone (b) Teniposide
(c) Daunorubicin (d) Dactinomycin
85. Pentostatin is a natural product u&ed for the treatment of leukaemia. What is the
role of the region shown in blue?

OH

(a) Transition-state isostere (b) Transition-state analogue


(c) Suicide substrate (d) Transition-state bioisostere
Chemotherapeutic Agents □ □ 247

86. What is the name of the following anticancer drug?

OAc

(a) Spongistatin 1 (b) Cryptophycin 1


(c) Phyllanthoside (d) Maytansine 1
87. Imatinib is an important anticancer drug which targets a protein kinase.

Pyrimidine ring

Me

The piperazine ring has an important interaction with an amino acid in the binding
site. Which amino acid is involved?
(a) Aspartic acid (b) Glutamic acid
(c) Methionine (d) Leucine
248 □ □ Drug Inspector Ejxam

88. The following structure is called marimastat and is a matrix metalloproteinase


inhibitor that has undergone clinical trials for the treatment of breast and prostate
cancers.

Hydroxamic acid

Hydroxymetl"

What role is played by the hydroxamic acid group?


(a) It acts as a transition-state isostere.
(b) It binds to the zinc ion cofactor.
(c) It binds to a binding sub pocket in the active site.
(d) It acts as a steric shield.
89. The following structure is a natural product currently being studied as an anticancer
agent.

What is the name of the structure? to an enzyme, such that the enzyme
(a) Thalidomide activates a prodrug?
(b) Fumagillin (a) ADAPT (b) GDAPT
(c) Depsipeptide (c) ADEPT (d) GDEP
(d) Aclarubicin 91. A patient has been taking anti-
90. What sort of therapy involves tuberculous therapy for MDR-TB. His
administration of an antibody linked drugs regimen contains 6 drugs. The
Chemotherapeutic Agents □ □ 249

patient eventually develops difficulty 97. Antitubercular drug having pyridine


in distinguishing red & green colours. nucleus is
Which of the following drugs is (a) Isoniazid
responsible for this effect? (b) ethionamide
(a) Amiodrone (c) both (a) and (b)
(b) Pyrazinamide (d) pyrizinamide
(c) Rifampicin 98. The antibiotic, cycloserine is obtained
(d) Ethambutol from
(e) Ciprofloxacin (a) Streptomyces orchidaceous
92. Dose of Gentamicin is reduced in the (b) Streptomyces griesus
elderly due to: (c) Streptomyces purpura
(a) Liver failure (d) Streptomyces monosperma
(b) Reduced renal function 99. Nystatin is
(c) Decreased GI absorption (a) mixture of antifungal polyenes
(d) Decreased metabolism (b) used for treatment of candidiasis
93. The iim portant side effect of (c) brand name is Mycostatin
gentamicin is (d) all of the above
(a) Ototoxicity 100. Tolnaftate is a
(b) Nephrotoxicity
(a) 2-N aphthyl N -m ethyl-N -(3-
(c) Neurmuscular dysfunction tolyl)thionocarbamate
(d) Teratogenic (b) 2-propyl - N -m ethyl-N -(3-
(e) all of the above tolyl)thionocarbamate
94. The antileprotic drug, dapsone act by (c) 2-m ethyl - N -m ethyl-N -(3-
(a) inhibition of incorporation of tolyl)thionocarbamate
PABA in folic acid (d) 2-Naphthyl N -m ethyl-N -(3-
(b) inhibition of protein synthesis tolyl)carbamate
(c) inhibition the cell wall synthesis 101. Which is not true for amphotericin B
(d) inhibition of ergosterol synthesis (a) A m photericin B is a polyene
95. Which of these is a thiourea derivative antifungal drug
used as antipeprotic dtug? (b) often used intravenously for
(a) dapsone systemic fungal infections
(b) clofazimene (c) cause disturbance in renal function
(c) thiambutosine (d) act by inhibiting the protein
(d) solapsone synthesis
96. Antibiotic used as antitubercular drug 102. Which of the following penicillins is
is (3-lactamase resistant?
(a) streptomycin (b) rifampin (a) amoxicillin
(e) cycloserine (d) all of the above (b) procaine penicillin
(c) Fluoxacillin
(d) Penicillin G
250 □ □ Drug Inspector Exam

103. Which of the following antimicrobial (c) the macrolide, erythromycic


drug groups has a narrow spectrum (d) the aminoglycoside, gentamicin
of activity?
108. W hich term best describes the
(a) aminoglycosides mechanism of action for
(b) sulphonamides fluoroquinolones?
(c) macrolides
(d) tetracycline
104. There are four generations of
cephalosporins. A general
characteristic of this group as you
move from the first generation to the
fourth is that:
(a) there is less risk of allergic reaction
(b) they possess a broader spectrum (a) Alkylating agent
of activity (b) Antisense agent
(c) later generation are available as (c) Chain cutter
oral preparation (d) Topoisomerase poison
(d) they have short half lives 109. The following structure is a synthetic
105. Which one of the following groups of antibacterial agent called
antimicrobial agents does not act by ciprofloxacin. What is its mechanism
inhibiting protein synthesis? of action?
(a) aminoglycoside (a) Topoisomerase poison
(b) tetracyclines (b) Metallating agent
(c) macrolides (c) Chain terminator
(d) quinolones (d) Antisense agent
106. When using isoniazid for the 110. The following anticancer agent is
treatment of tuberculosis, which of the called busulfan.
following vitamins from the vitamin O
B group is also recommended to
reduce the risk .o f peripheral
neuropathy? O
(a) pyridoxine
What is the drug's mode of action?
(b) riboflavin
(a) Metallating agent
(c) pantothenic acid
(b) Intercalator
(d) nicotinamide
(c) Chain terminator
107. Which of the following antimicrobial (d) Alkylating agent
agents has a time-dependent activity
111. What is the mode of action for the
on microorganisms?
anthracycline anticancer agents?
(a) the aminoglycoside, tobramycin
fb) the quinolone, norfloxacin
Chemotherapeutic Agents □ □ 251

(a) Alkylating agents (a) The chlorine groups are displaced


(b) Chain cutting agents before the drug becomes active.
(c) Antisense agents (b) Intrastrand cross linking of DNA
(d) Intercalating agents results from the action of the
agent.
112. The following structure is used in the
(c) Base pairing between adenine and
treatment of brain tumours.
thymine is disrupted by the agent.
(d) The compound acts as a
metallating agent
114. All of the following Anticancer agents
cause bone marrow depression
except?
(a) Chlorambucil
What is the structure called?
(b) Daunorubicin
(a) Carmustine
(c) Doxorubicin (d) Flutamide
(b) Lomustine
(c) Streptozotocin 115. Which people are said to be fastest
acetylators because they metabolize
(d) Cyclophosphamide
isoniazid by the process of acetylation
113. The following agent is used for the very quickly
treatment of testicular and ovarian (a) Canadian Eskimos
cancers. (b) Indians
(c) Asiatic Jews
(d) Chinese
(e) Europeans
Which of the following statements is (f) all the above
untrue regarding the above structure?

ANSWERS
1. (c) 2. (b) .3- (a) 4. (d) 5. (b) 6. (a) 7. (c) 8. (d) 9. (c) 10. (a)
11. (b) 12. (b) 13. (c) 14. (a) 15. (a) 16. (b) 17. (a) 18. (b) 19. (d) 20. (b)
21. (d) 22. (c) 23. (a) 24. (c) 25. (b) 26. (b) 27. .(d) 28. (b) 29. (b) 30. (a)
31. (b) 32. (b) 33. (b) 34. (c) 35. (d) 36. (a) 37. (b) 38. (b) 39. (a) 40. (b)
41. (d) 42. (b) 43. (a) 44. (b) 45. (a) 46. (c) 47. (c) 48. (c) 49. (d) 50. (b)
51. (c) 52. (a) 53. (c) 54. (c) 55. (c) 56. (a) 57. (b) 58. (b) 59. (a) 60. (c)
61. (a) 62. (b) 63. (b) 64. (b) 65. (b) 66. (b) 67. (b) 68. (a) 69. (c) 70. (d)
71. (b) 72. (b) 73. (d) 74. (d) 75. (d) 76. (c) 77. (a) 78. (c) 79. (b) 80. (d)
81. (b) 82. (b) 83. (c) 84. (a) 85. (a) 86. (c) 87. (b) 88. (b) 89. (cj 90. (c)
91. (d) 92. (b) 93. (e) 94. (a) 95. (c) 96. (d) 97. (c) 98. (a) 99. (d) 100. (a)
101. (d) 102. (c) 103. (c) 104. (b) 105. (d) 106. (a) 107. (c) 108. (d) 109. (a) 110.(d)
111. (d) 112. (b) 113. (c) 114. (d) 115. (a)
cm
Antiprotozal and Anthelmintic Drugs
26
C h a p te r

This group of antiprotozoal drugs includes the drugs effective against plasmodia,
entameoba, giradia, trichomonas and leishmania species etc. These can be classified as:
antimalarial drugs, antiamoebics, drugs for trichomoniasis, giardiasis, leishmaniasis,
antimonials, etc.

ANTIMALARIAL DRUGS
Anti-malarial drugs can be classified according to anti malarial activity and structure.
1. According to antimalarial activity:
(a) Tissue schizonticides for causal prophylaxis: These drugs act on the primary
tissue forms of the plasmodia which after growth within the liver, initiate the
erythrocytic stage. By blocking this stage, further development of the infection
can be theoretically prevented. Pyrimethamine and Primaquine have this activity.
(b) Tissue schizonticides for preventing relapse: These drugs act on the hypnozoites
of P. vivax and P. ovale in the liver that cause relapse of symptoms on reactivation.
Primaquine is the prototype drug; pyrimethamine also has such activity.
(c) Blood schizonticides: These drugs act on the erythrocytic forms of the parasite
and thereby terminate clinical attacks of malaria. The most important drugs in
anti malarial chemotherapy include chloroquine, quinine, mefloquine,
halofantrine, pyrimethamine, sulfadoxine, sulfones, tetracyclines etc.
(d) Gametocytocides: These drugs destroy the sexual forms of the parasite in the
blood and thereby prevent transmission of the infection to the mosquito.
Chloroquine and quinine have gametocytocidal activity against P. vivax and P.
malariae, but not against P. falciparum. Primaquine has gametocytocidal activity
against all plasmodia, including P. falciparum.
(e) Sporontocides: These drugs prevent the development of oocysts in the mosquito
and thus ablate the transmission. Primaquine and chloroguanide have this action.
2. According to the Structure:
(a) Aryl amino alcohols: Quinine, quinidine (cinchona alkaloids), mefloquine,
halofantrine.
(b) 4-aminoquinolines: Chloroquine, amodiaquine.
(c) Folate synthesis inhibitors: Type 1 - competitive inhibitors of dihydropteroate
synthase - sulphones, sulphonamides Type 2 - inhibit dihydrofolate reductase -
Antiprotozal and Anthelmintic Drugs CIO 253

biguanides like proguanil and chloroproguanil; diaminopyrimid .\e like


pyrimethamine
(d) 8-aminoquinolines: Primaquine, WR238, 605
(e) A ntim icrobials: Tetracycline, doxycycline, clindamycin, azithromycin,
fluoroquinolones
(f) Peroxides: Artemisinin (Qinghaosu) derivatives and analogues - artemether,
arteether, artesunate, artelinic acid
(g) Naphthoquinones: Atovaquone
(h) Iron chelating agents: Desferrioxamine
1. Chloroquine: Chloroquine is a 4-aminoquinoline that has marked and rapid
schizonticidal activity against all infections of P. malariae and P. ovale and against
chloroquine-sensitive infections of P. falciparum and P. vivax. It is also gametocytocidal
against P. vivax, P. malariae and P. ovale as well as immature gametocytes of P. falciparum.
It is not active against intrahepatic forms, and should therefore be used with primaquine
to effect radical cure of P. vivax. and P. ovale .
2. Amodiaquine: Amodiaquine is a 4-aminoquinoline antimalarial drug similar in
structure and activity to chloroquine. Like chloroquine, it also possesses antipyretic and
anti-inflammatory properties.
3. Quinine: Quinine is normally effective against falciparum infections that are
resistant to chloroquine and sulfa drug-pyrimethamine combinations.
4. Mefloquine: Mefloquine is a 4-quinoline methanol chemically related to quinine.
It is a potent long-acting blood schizonticide active against P. falciparum resistant to 4-
aminoquinolines and sulfa drug-pyrimethamine combinations. It is also highly active
against P. vivax and, P. malariae and most probably P. ovale. It is not gametocytocidal and
is not active against the hepatic stages of malaria parasites. Owing to its long elimination
half-life and consequent long-lived subtherapeutic concentrations in the blood, the
development of resistance is to be expected especially in areas of high transmission. P.
falciparum resistance to mefloquine is accompanied by cross-resistance to halofantrine
and reduced sensitivity to quinine.
5. Halofantrine: Halofantrine, a phenanthrene methanol, is a blood schizonticide
that is active against all malaria parasites. It is active against P. falciparum infections that
are resistant to chloroquine and to sulfa drug-pyrimethamine combinations. Halofantrine
is not active against gametocytes or the hepatic stages of malaria parasites.
6. Antifolate Drugs: The only useful combinations of antifolate drugs for the
treatment of malaria are synergistic mixtures that act against the parasite-specific
enzymes, dihydropteroate synthetase and dihydrofolate reductase. Available
combinations include the sulfa drug (sulphodoxime)-pyrimethamine combinations,
sulfadoxine-pyrimethamine and sulfalene-pyrimethamine, the former being more widely
available.
7. Proguanil: Proguanil is a synthetic biguanide derivative of pyrimidine with a
marked effect on the primary tissue stages of P. falciparum, P. vivax and P. ovale. Its effect
254 □ □ Drug Inspector Exam

on the primary exoerythrocytic forms of P. malariae is unknown. It has some causal


prophylactic effect against sensitive strains in contrast to the suppressive prophylactic
activity shown by pyrimethamine.
8. Artemisinin and Its Derivatives: Artemisinin (qinghaosu) is the antimalarial
principle isolated by Chinese scientists from Artemisia annua L. It is a sesquiterpene
lactone with a peroxide bridge linkage. Its various derivatives include artemether,
arteether, artesunate, dihydroartemisinin and artelinic acid. Artemisinin is poorly soluble
in oils or water but the parent compound has yielded dihydroartemisinin, the oil-
soluble derivatives artemether and arteether, and the more water-soluble derivatives
sodium artesunate and artelinic acid. These derivatives have more potent blood
schizonticidal activity than the parent compound and are the most rapidly effective
antimalarial drugs known.
9. Primaquine: Primaquine is an 8-aminoquinoline highly active against the
gametocytes of all malaria species found in humans and against hypnozoites of the
relapsing malarial parasites, P. vivax and P. ovale. It is the only drug currently used for
the treatment of relapsing malaria, although another 8-aminoquinoline, CDRI 80/53
(bulaquine) has recently completed phase III clinical trials and another, tafenoquine, is
still undergoing clinical trials.
10. Antibiotics Used As Antimalarial Drugs
(a) Doxycycline: Doxycycline is derived from and related to oxytetracycline, and
has an identical spectrum of activity.
(b) Clindamycin : Clindamycin is a semi-synthetic antibiotic derived from
liricomycin. Like tetracycline, it is an efficient blood schizonticide with a relatively
slow action and a similar spectrum of activity.
(c) Azithromycin: Azithromycin belongs to a new class of macrolide antibiotics. It
is structurally similar to erythromycin but is better tolerated, has a broader
antimicrobial spectrum of action, and provides prolonged tissue levels. It is an
efficient blood schizonticide but has a relatively slow action.
Combinations of Drugs for Malaria
1. Atovaquone-Proguanil 2. Artemether-Lumefantrine 3. Mefloquine-Sulfadoxine-
Pyrimethamine.
Antiamoebics
Amoebiasis is an infection caused by the protozoa Entamoeba histolytica. About
90% of the patients are asymptomatic and the remaining produce a spectrum of clinical
syndrome ranging from dysentery to abscesses of the liver and other organs.
Classification
1. Tissue amoebicides
•Nitroimidazole: M etronidazole, Tinidazole, Secnidazole, Ornidazole,
Satrinidazole
Antiprotozal and Anthelmintic Drugs □ □ 255

•Alkaloids: Emetine, Dehydroemetine


•Others: Chloroquine
2. Luminal amoebicides
•Amide - Diloxanide furoate
•8-Hydroxyquinolines - Quiniodochlor, Diiodohydroxyquinoline
•Antibiotic: Tetracycline, Paromomycin
Metronidazole: It is the prototype nitroimidazole for the treatment of amoebiasis.
Tinidazole - It is a congener of metronidazole similar to it in every respect,
except
•Less side effects, better tolerability
•Longer tVi (12 hrs), so once daily dosing can be done.
Secnidazole: A newer congener of metronidazole has the same spectrum and
potency except :
Longer half life (26 hrs), so a single dose of 2 g has comparable result with
metronidazole and tinidazole.
Satrinidazole: Same as metronidazole, except
• Longer t Vi (14 hrs)
• Less side effects,
• No neurological, mutagenic and disulfiram like reactions.
Emetine & dehydroemetine: Emetine is an alkaloid, dehydroemetine is a synthetic
product. They are not used nowadays because of high systemic toxicity. They act by
inhibiting translocation of t-RNA-amino acid complex.
Diloxanide Furoate: It is an effective luminal amoebicide but not active tissue
amoebicide. It is hydrolysed in the intestine to its furoate ester. Diloxanide is rapidly
absorbed from the intestine and is conjugated to form the glucuronide which is promptly
excreted in urine.
8-Hydroxyquinoline: These are halogenated hydroquinoline. These are highly
effective luminal amebicide which were used in the past. Their absorption is quite
erratic, only 10-20% of the drug is absorbed.
Drug for Trichomoniasis
Trichomonas is a flagellated protozoan which causes vulvovaginitis. Many drugs
are available to treat it like:
1. Metronidazole - 400 mg TDS for 7 days.
2. Secnidazole - 2 g single dose
3. Nimorazole - 2 g single dose - -
4. Quiniodochlor - 200 mg vaginal pessaries may be used for 2 weeks at night.
5. Natamycin/Hamycin - Their vaginal pessaries are also available which can be
lised at night time.
256 □ □ Drug Inspector Exam

Drugs for Giardiasis


Giardia lamblia is a flagellate protozoan, commensel in the intestine of man. It may
cause malabsorption and diarrhea in man.
1. Metronidazole - 15 mg/kg for 7 days
2. Secnidazole - 2 g single dose
3. Furazolidone - may also be used
4. Quinidochlor - 100 mg TDS for five days should be given.
Drugs for Leishmaniasis

Classification
(a) Antimonials
(a) Sodium stibogluconate
(b) Meglumine antimonate
(b) Diamidine
(a) Pentamidine
(c) Miscellaneous
(a) Amphotericin B
(b) Ketoconazole
(c) Miltefosine
(d) Paromomycin sulfate
(e) Allopurinol
Antimonials: Sodium stibogluconate and meglumine antimonate are the pentavalent
antimonial compounds containing l/3rd antimony by weight.
Pentamidine: It is an aromatic diamidine derivative effective against Leishmania,
Pneumocystis and Trypanosoma. It is only available as parenteral preparation.
Others
Paromomycin sulfate: It is an aminoglycoside antibiotic, now the drug of choice for
Kala-Azar. It is not significantly absorbed from the GI tract. The amount absorbed is
excreted by glomerular Alteration.
Miltefosine: It is an alkylphosphocholine analog that has been approved by the
FDA for the treatment of Leishmaniasis. It is given in a dose of 2.5 mg/kg for 28 days
orally and has produced excellent results. Vomiting, diarrhea, elevation of liver enzymes
is the main side effects. The drug is teratogenic and should be cautiously used during
pregnancy
Antiprotozal and Anthelmintic Drugs □ □ 257

MULTIPLE CHOICE QUESTIONS

1. Tick the drug used for malaria 7. Tick the antimalarial drug belonging
chemoprophylaxis and treatment: to 8-aminoquinoline derivatives:
(a) Chloroquine (a) Doxycycline
(b) Quinidine (b) Quinidine
(c) Quinine (c) Primaquine
(d) Sulfonamides (d) Chloroquine
2. Tick the drug used for amoebiasis 8. All of the following antimalarial drugs
treatment: are 4-quinoline derivatives, EXCEPT:
(a) Nitrofurantoin (a) Chloroquine
(b) Iodoquinol (b) Mefloquine
(c) Pyrazinamide (c) Primaquine
(d) Mefloquine (d) Amodiaquine
3. Tick the drug used for trichomoniasis 9. Tick the antimalarial drug belonging
treatment: to pyrimidine derivatives:
(a) Metronidazole (a) Mefloquine
(b) Suramin (b) Pyrimethamine
(c) Pyrimethamine (c) Quinidine
(d) Tetracycline (d) Chloroquine
4. Tick the drug used for toxoplasmosis 10. Tick the drug used for trypanosomosis
treatment: treatment:
(a) Chloroquine (a) Melarsoprol
(b) Tetracyclin (b) Metronidazole
(c) Suramin (c) Tetracycline
(d) Pyrimethamine (d) Quinidine
5. Tick the drug used for balantidiasis 11. Tick the antimalarial drug having a
treatment:: gametocidal effect:
(a) Azitromycin (a) Mefloquine
(b) Tetracycline (b) Primaquine
(c) Quinine (c) Doxycycline
(d) Trimethoprim (d) Sulfonamides
6. Tick the drug used for leishmaniasis 12. All of the following antimalarial drugs
treat .lent: influence blood schizonts, EXCEPT:
(a) Pyrimethamine (a) Mefloquine
(b) Albendazole (b) Chloroquine
(c) Sodium stibogluconate (c) Primaquine
(d) Tinidazole (d) Quinidine
258 □ □ Drug Inspector Exam

13. Tick the antimalarial drug influencing (a) Iodoquinol


tissue schisonts: (b) Metronidazole
(a) Mefloquine (c) Diloxanide
(b) Chloroquine (d) Tetracycline
(c) Quinidine 20. Tick the drug, blocking acetylcholine
(d) Primaquine transm ission at the myoneural
14. Tick the group of antibiotics having junction of helminthes:
an antimalarial effect: (a) Levamisole
(a) Aminoglycosides (b) Mebendazole
(b) Tetracyclines (c) Piperazine
(c) Carbapenems (d) Niclosamide
(d) Penicillins 21. Tick niclosamide mechanism of action:
15. Tick the amebecide drug for the (a) Increasing cell membrane
treatment of an asymptomatic permeability for calcium, resulting
intestinal form of amebiasis: in paralysis, dislodgement and
(a) Chloroquine death of helminthes
(b) Diloxanide (b) Blocking acetylcholine
(c) Emetine transmission at the myoneural
(d) Doxycycline junction and paralysis of
helminthes
16. Tick the drugs for the treatment of an (c) Inhibiting microtubule synthesis in
intestinal form of amebiasis: helm inthes and irreversible
(a) Metronidazole and diloxanide impairment of glucose uptake
(b) Diloxanide and streptomycin (d) Inhibiting oxidative
(c) Diloxanide and Iodoquinol phosphorylation in some species
(d) Emetine and metronidazole of helminthes
17. Tick the drug for the treatment of a 22. Tick praziquantel mechanism of
hepatic form of amebiasis: action:
(a) Diloxanide or iodoquinol (a) Blocking acetylcholine
(b) Tetracycline or doxycycline transmission at the myoneural
(c) Metronidazole or emetine junction and paralysis of
(d) Erythromycin or azitromycir helminthes
(b) Inhibiting microtubule synthesis in
18. Tick the luminal amebecide drug:
helm inthes and irreversible
(a) Metronidazole impairment of glucose uptake
(b) Emetine (c) Increasing cell membrane
(c) Doxycycline permeability for calcium, resulting
(d) Diloxanide in paralysis, dislodgement and
19. Tick the drug of choice for the death of helminthes
treatment of extraluminal amebiasis:
Antiprotozal and Anthelmintic Drugs □ □ 259

(d) Inhibiting oxidative 26. Tick the drug, inhibiting oxidative


phosphorylation in some species phosphorylation in some species of
of helminthes helminthes:
23. Tick piperazine mechanism of action: (a) Niclosamide
(a) Inhibiting microtubule synthesis in (b) Piperazine
helm inthes and irreversible (c) Praziquantel
impairment of glucose uptake (d) Mebendazole
(b) Blocking acetylcholine 27. Tick the drug for neurocysticercosis
transmission at the myoneural treatment:
junction and paralysis of (a) Praziquantel
helminthes
(b) Pyrantel
(c) Inhibiting oxidative
(c) Piperazine
phosphorylation in some species
(d) Bithionol
of helminthes
(d) Increasing cell membrane 28. Tick the drug for nematodosis
permeability for calcium, resulting (roundworm invasion) treatment:
in paralysis, dislodgement and (a) Niclosamide
death of helminthes (b) Praziquantel
24. Tick the drug, a salicylam ide (c) Bithionol
derivative: (d) Pyrantel
(a) Praziquantel 29. Tick the drug for cestodosis
(b) Piperazine (tapeworm invasion) treatment:
(c) Mebendazole (a) Piperazine
(d) Niclosamide (b) Praziquantel
25. Tick mebendazole mechanism of (c) Pyrantel
action: (d) Ivermectin
(a) Inhibiting oxidative 30. Tick the drug for trematodosis (fluke
phosphorylation in some species invasion) treatment:
of helminthes (a) Bithionol
(b) Increasing cell membrane (b) Ivermectin
permeability for calcium, resulting (c) Pyrantel
in paralysis, dislodgement and
(d) Metronidazole
death of helminthes
(c) Inhibiting microtubule synthesis in 31. Tick the drug, a benzim idazole
helm inthes and irreversible derivative:
impairment of glucose uptake (a) Praziquantel
(d) Blocking acetylcholine (b) Mebendazole
transmission at the myoneural (c) Suramin
junction and paralysis of (d) Pyrantel
helminthes
260 □ □ Drug Inspector Exam

32. Tick the broad spectrum drug for (c) Bithionol


cestodosis, trem atodosis and (d) Ivermectin
cycticercosis treatment: 35. Tick the drug for echinococcosis
(a) Piperazine treatment:
(b) Ivermectine (a) Suramin
(c) Praziquantel (b) Mebendazole or Albendazole
(d) Pyrantel (c) Piperazine
33. Tick the drug for ascaridosis and (d) Iodoquinol
enterobiosis treatment:
36. Which antibiotic, usesd as
(a) Bithionol antiamoebic, acts by intercalating
(b) Pyrantel with DNA resulting in transcription
(c) Praziquantel error.
(d) Suramin (a) Paromomycin
34. Tick the drug for strongiloidosis (b) Cycloserine
treatment: (c) Diloxanilide
(a) Niclosamide (d) Furoxone
(b) Praziquantel

ANSWERS
1. (a) 2. (b) 3. (a) 4. (d) 5. (b) 6. (c) 7. (c) 8. (c) 9. (b) 10. (a)
11. (b) 12. (c) 13. (d) 14. (b) 15. (b) 16. (a) 17. (c) 18. (d) 19. (b) 20. (c)
21. (d) 22. (c) 23. (b) 24. (d) 25. (c) 26. (a) 27. (a) 28. (d) 29. (b) 3 0 .(a)
31. (b) 32. (c) 33. (b) 34. (d) 35. (b) 36. (a)

non
Drugs and Cosmetic Act; 1940
27
C h a pter

The object of the Act is to regulate the import, manufacture, distribution and sale
of drugs. Under the provisions of this Act, the Central Government appoints the Drugs
Technical Advisory Board to advise the Central Government and the State Governments
on technical matters arising out of the administration of this Act. The board can constitute
subcommittees for the consideration of a particular matter.
Drug
The definition of 'drugs' is an inclusive one. It includes all medicines for external
or internal use of human beings or animals or any substances itended to be used for or
in the diagnosis, treatment, mitigation or prevention of diseases in human beings or
animals.
The Drugs Technical Advisory Board.
The Central Government shall, as soon as may be, constitute a Board (to be called
the Drugs Technical Advisory Board) to advise the Central Government and the State
Governments on technical matters arising out of the administration of this Act and to
carry out the other functions assigned to it by this Act. The Board shall consist of the
following members, namely,
(i) The Director General of Health Services, ex officio, who shall be Chairman;
(ii) The Drugs Controller, India ex officio;
(iii) The Director of the Central Drugs Laboratory, Calcutta, ex-officio-,
(iv) The Director of the Central Research Institute, Kasauli, ex-officio;
(v) The Director of the Indian Veterinary Research Institute, Izatnagar, ex-officio;
(vi) The President of the Medical Council of India, ex-officio;
(vii) The President of the Pharmacy Council of India, ex-officio;
(viii) The Director of the Central Drug Research Institute, Lucknow, ex-officio;
(ix) Two persons to be nominated by the Central Government from among persons
who are in charge of drugs control in the States ;
(x) One person, to be elected by the Executive Committee of the Pharmacy Council
of India, from among teachers in pharmacy or pharmaceutical chemistry or
pharmacognosy on the staff of an Indian university or a college affiliated thereto;
(xi) One person, to be elected by the Executive Committee of the Medical' Council
of India, from among teachers in medicine or therapeutics on the staff of an
Indian university or a college affiliated thereto ;
262 □ □ Drug Inspector Exam

(xii) One person to be nominated by the Central Government from the pharmaceutical
industry
(xiii) One pharrmacologist to be elected by the Governing Body of the Indian Council
of Medical Research ;
(xiv) One person to be elected by the Central Council of the Indian Medical Association;
(xv) One person to be elected by the Council of the Indian Pharmaceutical Association;
(xvi) Two persons holding the appointment of Government Analyst under this Act,
to be nominated by the Central Government.
The nominated and elected members of the Board shall hold office for three years,
but shall be eligible for re-nomination and re-election
The Drugs Consultative Committee
(1) The Central Government may constitute an advisory committee to be called
"the Drugs Consultative Committee" to advise the Central Government, the
State Governments and the Drugs Technical Advisory Board on any matter
tending to secure uniformity throughout [(Note: Ins. by Act 3 of 1951, sec.3 and
Sch., for "the States") India] in the administration of this Act.
(2) The Drugs Consultative Committee shall consist of two representatives of the
Central Government to be nominated by that Government and one representative
of each State
(3) The Drugs Consultative Committee shall meet when required to do so by the
Central Government and shall have power to regulate its own procedure.
Sections 5 and 7 not to apply to Ayurvedic, Siddha or Unani drugs
Nothing contained in sections 5 and 7 shall apply to [(Note: Subs, by Act 68 of 1982,
sec.2, for certain words (w.e.f. 1-2-1983)). Ayurvedic, Siddha or Unani] drugs.
Standards of quality
[(l)(Note: Subs. Act 21 of 1962, sec. 2, for sub-section (1) (w.e.f. 27-7-1964)) For the
purposes of this Chapter, the expression "standard quality" means -
(a) In relation to a drug, that the drug complies with the standard set out in [(Note:
Subs, by Act 13 of 1964, sec.7, for "the Schedule" (w.e.f. 15-9-1964)) the Second
Schedule], and
((b) In relation to a cosmetic, that the cosmetic complies with such standard as may
be prescribed.]
(2) The Central Government, after consultation with the Board and after giving by
notification in the Official Gazette not less than three months' notice of its intention so
to do, may be a like notification add to or otherwise amend [(Note: Subs, by Act 13 of
1964, sec.7, for "the Schedule" (w.e.f. 15-9-1964)) the Second Schedule], for the purposes
of this Chapter, and thereupon [ (Note: Subs, by Act 13 of 1964, sec.7, for "the Schedule"
(w.e.f. 15-9-1964))the Second Schedule] shall be deemed to be amended accordingly/
Drugs and Cosmetics Act, 1940 □ □ 263

Misbranded Drugs
For the purposes of this Chapter, a drug shall be deemed to be misbranded, -
(a) If it is so coloured, coated, powdered or polished that damage is concealed or
if it is made to appear of better or greater therapeutic value than it really is ; or
(b) If it is not labeled in the prescribed manner ; or
(c) If its label or contained or anything accompanying the drug bears any statement,
design or device which is false or misleading in any particular.]
Adulterated Drugs
For the purposes of this Chapter, a drug shall be deemed to be adulterated, -
(a) If it consists, in whole or in part, of any filthy, putrid or decomposed substance
; or
(b) If it has been prepared, packed or stored under insanitary conditions whereby
it may have been contaminated with filth or whereby it may have been rendered
injurious to health ; or
(c) If its contained is composed in whole or in part, of any poisonous or deleterious
substance which may render the contents injurious to health; or
(d) If it bears or contains, for purposes of colouring only, a colour other than one
which is prescribed ; or
(e) If it contains any harmful or toxic substance which may render it injurious to
health; or
(f) If any substance has been mixed therewith so as to reduce its quality or strength.
Spurious Drugs
For the purposes of this Chapter, a drug shall be deemed to be spurious, -
(a) If it is imported under a name which belongs to another drug ; or
(b) If it is an imitation of, or is a substitute for, another drug or resembles another
drug in a manner likely to deceive or bears upon it or upon its label or contained
the name of another drug unless it is plainly and conspicuously marked so as
to reveal its true character and its lack of identity with such other drug ; or
(c) If the label or container bears the name of an individual or company purporting
to be the manufacturer of the drug, which individual or company is fictitious or
does not exist ; or
(d) If it has been substituted wholly or in part by another drug or substance ; or
(e) If it purports to be the product of a manufacturer of whom it is only truly a
product.
Misbranded Cosmetics
For the purposes of this Chapter, a cosmetic shall be deemed to be misbranded -
(a) If it contains a colour which is not prescribed ; or
(b) If it is not labeled in the prescribed manner ; or
264 □ □ Drug Inspector Exam

((c) If the label or container or anything accompanying the cosmetic bears any
statement, which is false or misleading in any particular.
Spurious Cosmetics
For the purposes of this Chapter, a cosmetic shall be deemed to be spurious,-
(a) If it is imported under a name which belongs to another cosmetic ; or
(b) If it is an imitation of, or is a substitute for, another cosmetic or resembles
another cosmetic in a manner likely to deceive or bears upon it or upon its label
or container the name of another cosmetic, unless it is plainly and conspicuously
marked so as to reveal its true character and its lack of identity with such other
cosmetic ; or
(c) If the label or container bears the name of an individual or a company purporting
to be the manufacturer of the cosmetic which individual or company is fictitious
or does not exist ; or
(d) If it purports to be the product of a manufacturer of whom it is.
Inspectors
(1) The Central Government or a State Government may, by notification in the
Official Gazette, appoint such persons as it thinks fit, having the prescribed
qualifications, to be Inspectors for such areas as may be assigned to them by the
Central Government or the State Government, as the case may be.
(2) The powers which may be exercised by an Inspector and the duties which may
be performed by him, the drugs or [(Note: Subs, by Act 21 of 1962, sec.17 for
"class of drugs" (w.e.f. 27-7-1964)) classes of drugs or cosmetics or classes of
cosmetics] in relation to which and the conditions, limitations or restrictions
subject to which, such powers and duties may be exercised or performed shall
be such as may be prescribed.
(3) No person who has any financial interest [(Note: Subs, by Act 21 of 1962, sec.17,
for "in the manufacture, import or sale of drugs" (w.e.f. 27-7-1964)) in the import,
manufacture or sale of drugs or cosmetics] shall be appointed to be an Inspector
under this section.
(4) Every Inspector shall be deemed to be a public servant within the meaning of
21 of the Indian Penal Code, and shall be officially subordinate to such authority.
[(Note: Ins. by Act 68 of 1982, sec.18 (w.e.f. 1-2-1983)), having the prescribed
qualifications,] as the Government appointing him may specify in this behalf.]
Qualification for Drug Inspector. Qualifications for drug inspector are:
(z) Degree in Pharmacy
(ii) Degree in medicine with one year post graduate training under a Government
analyst or a chemical examiner.
Drugs and Cosmetics Act, 1940 □ □ 265

Powers of Inspectors
(1) Subject to the provisions of sec 23 and of any rules made by the Central
Government in this behalf, an Inspector may, within the local limits of the area for
which he is appointed, -
(a) [(Note: Subs, by Act 68 of 1982, sec.19, for clauses (a), ((b) and ((c) (w.e.f. 1-2-
1983)). inspect, —
(/) Any premises wherein any drug or cosmetic is being manufactured and the
means employed for stand arising and testing the drug or cosmetic ;
(ii) Any premises wherein any drug or cosmetic is being sold, or stocked or exhibited
or offered for sale, or distributed ;
(b) Take samples of any drug or cosmetic, -
(z) Which is being manufactured or being sold or is stocked or exhibited or offered
for sale, or is being distributed ;
(ii) From any person who is in the course of conveying, delivering or preparing to
deliver such drug or cosmetic to a purchaser or a consignee ;
(c) At all reasonable times, with such assistance, if any, as he considers necessary,

(0 Search any person, who, he has reason to believe, has secreted about his person,
any drug or cosmetic in respect of which an offence under this Chapter has
been, or is being, committed ; or
(ii) Enter and search any place in which he has reason to believe that an offence
under this Chapter has been, or is being, committed ; or
(iii) Stop and search any vehicle, vessel or other conveyance which, he has reason
to believe, is being used for carrying any drug or cosmetic in respect of which
an offence under this Chapter has been, or is being, committed, and order in
writing the person in possession of the drug or cosmetic in respect of which the
offence has been, or is being, committed, not to dispose of any stock of such
drug or cosmetic for a specified period not exceeding twenty days, or, unless the
alleged offence is such that the defect may be removed by the possessor of the
drug or cosmetic, seize the stock of such drug or cosmetic and any substance or
article by means of which the offence has been, or is being committed or which
may be employed for the commission of such offence ;
[(cc) (Note: Ins. by Act 35 of 1960, sec.5 (w.e.f. 16-3-1961)) examine any record,
register, document or any other material object found [(Note: Subs, by Act 68 of 1982,
sec.19, for certain words (w.e.f. 1-2-1983)) with any person, or in any place, vehicle,
vessel or other conveyance referred to in clause ((c)], and seize the same if he has reason
to believe that it may furnish evidence of the commission of an offence punishable
under this Act or the rules made thereunder ;]
[(cca) (Note: Ins. by Act 68 of 1982, sec.19 (w.e.f. 1-2-1983)) Require any person to
produce any record, register, or other document relating to the manufacture for sale or
for distribution, stocking, exhibition for sale, offer for sale or distribution of any drug
266 □ □ Drug Inspector Exam

or cosmetic in respect of which he has reason to believe that an offence under this
Chapter has been, or is being, or is being, committed ;]
(d) Exercise such other powers as may be necessary for carrying out the purposes
of this Chapter or any rules made there under.
(2) The provisions of [(Note: Subs, by Act 68 of 1982, sec.19, for "the Code of
Criminal Procedure, 1898" (w.e.f. 1-2-1983)) the Code of Criminal Procedure, 1973] shall,
so far as may be, apply to any search or seizure under this Chapter as they apply to any
search or seizure made under the authority of a warrant issued under [(Note: Subs, by
Act 68 of 1982, sec.19, for "section 98" (w.e.f. 1-2-1983)) section 94] of the said Code.
[(2A) (Note: Ins. by Act 68 of 1982, sec.19 (w.e.f. 1-2-1983)) Every record, register or
other document seized under clause (cc) or produced under clause (cca) shall be returned
to the person, from whom they were seized or who produce the same, within a period
of twenty days of the date of such seizure or production, as the case may be, after copies
thereof or extracts therefrom certified by that person, in such manner as may be
prescribed, have been taken.]
(3) If any person willfully obstructs an Inspector in the exercise of the powers
conferred upon him by or under this Chapter [(Note: Ins. by Act 68 of 1982, sec.19
(w.e.f. 1-2-1983) or refuses to produce any record, register or other document when so
required under clause (cca) of sub-section (1),] he shall be punishable with imprisonment
which may extend to three years, or with fine, or with both.]
Persons bound to disclose place where drugs or cosmetics are manufactured or
kept. - Every person for the time being in charge of any premises whereon any drug
[(Note: Ins. by Act 21 of 1962, sec. 15 (w.e.f. 27-7-1964)) or cosmetic] is being manufactured
or is kept for sale or distribution shall, on being required by any Inspector so to do, be
legally bound to disclose to the Inspector the place where the drug [(Note: Ins. by Act
21 of 1962, sec. 15 (w.e.f. 27-7-1964)) or cosmetic] is being manufactured or is kept, as the
case may be.
Reports of Government Analysts
(1) The Government Analyst to whom a sample of any drug [(Note: Ins. by Act 21
of 1962, sec. 15 (w.e.f. 27-7-1964)) or cosmetic] has been submitted for test or analysis
under sub-section (4) of section 23, shall deliver to the Inspector submitting it is signed
report in triplicate in the prescribed form.
(2) The Inspector on receipt thereof shall deliver one copy of the report to the person
from whom the sample was taken [(Note: Subs, by Act 13 of 1964, sec. 17, for certain
words (w.e.f. 15-9-1964)) and another copy to the person, if any, whose name, address
and other particulars have been disclosed under section 18A], and shall retain the third
copy for use in any prosecution in respect of the sample.
(3) Any document purporting to be a report signed by a Government Analyst under
this Chapter shall be evidence of the facts stated therein, and such evidence shall be
conclusive unless the person from whom the sample was taken [(Note: Subs, by Act 13
of 1964, sec.17, for "or the said warrantor" (w.e.f. 15-9-1964)) or the person whose name,
Drugs and Cosmetics Act, 1940 □ □ 267

address and other particulars have been disclosed under section 18A] has, within twenty-
eight days of the receipt of a copy of the report, notified in writing the Inspector or the
Court before which any proceedings in respect of the sample are pending that he
intends to adduce evidence in contravention of the report.
(4) Unless the sample has already been tested or analysed in the Central Drugs
Laboratory, where a person has under sub-section (3) notified his intention of
adducing evidence in contravention of a Government Analyst's report, the Court
may, of its own motion or in its discretion at the request either of the complainant
or the accused cause the sample of the drug [(Note: Ins. by Act 21 of 1962, sec.15
(w.e.f. 27-7-1964)) or cosmetic] produced before the Magistrate under sub-section (4)
of Section 23 to be sent for test or analysis to the said Laboratory, which shall make
the test or analysis and report in writing signed by, or under the authority of, the
Director of the Central Drugs Laboratory the result thereof, and such report shall be
conclusive evidence of the facts stated therein.
(5) The cost of a test or analysis made by the Central Drugs Laboratory under
sub-section (4) shall be paid by the complainant or accused as the Court shall direct.

MULTIPLE CHOICE QUESTIONS

1. Drug consultative committee is 4. Which one of these disease comes


framed under:- under Schedule J
(a) Drug and Cosmetic Act, 1940 (a) Dengue
(b) Price control act (b) Bronchial asthma
(c) Narcotic and psychotropic act (c) Malaria
(d) Opium act (d) Small pox
2. Schedule FF is for: 5. How much doses of drug can be
(a) List of habit forming drugs imported without permit.
(b) List of drugs that are exempt from (a) 20 doses
certain provisions applicable to (b) 40 doses
manufacture and sale of drugs (c) 60 doses
(c) Standard for ophthalmic (d) lOOdoses
preparation
6. What penalties is indicated if
(d) Standards for cosmetics prohibited drug is imported?
3. Schedule W belongs to------ (a) Six month imprisonment or a fine
(a) Standards for mechanical of Rs 5000/-
contraceptives (b) Three years imprisonment or fine
(b) List of drugs which can be marked of Rs 5000/ or both
under generic names only (c) Fine of Rs 5000/- for first crime
(c) List of coal tars dyes (d) 1 year imprisonment or Rs 5000/ -
(d) None of the above
268 □ □ Drug Inspector Exam

7. Upto what period, records for (a) Degree in Pharmacy


manufacturing of drug is maintained, (b) Degree in medicine with one yr
(a) Two yrs from the date of expiry post graduate training
b) Five yrs from the date of (c) (a) and (b)
manufacture (d) degree in science
(c) Both (a) and (b) 13. The drug- phenobarbitone belongs to:
(d) lyrs from the date of expiry (a) Schedule X (b) Schedule C
8. What penalities is imposed if anyone (c) Schedule C l (d) Schedule P
manufacture misbranded drug?
14. Who grant the license for import of
(a) Five yrs imprisonment, extended drug?
upto life alongw ith fine of
(a) State drug authority
Rs. 10,000/-
(b) Central drug authority
(b) Three yrs imprisonment along
with fine of Rs 10,000/- (c) Central government
(c) Three yrs imprisonment along (d) Health Ministry
with fine of Rs 5,000/- 15. Where is Central Research institute?
(d) Five yrs imprisonment life along (a) Shimla (b) Kasauli
with fine of Rs 5,000/- (c) Kolkata (d) Lucknow
9. The word'Caution'it is dangerous to 16. Which item is exempted from import
take the preparation except under regulation?
medical supervision is written on the (a) Ginger (b) Condensed milk
label. The drug belongs to Schedule: (c) Cerelac (d) All of the above
(a) Schedule H
17. The manufacturing premises should
(b) Schedule H & L
comply with—
(c) Schedule G
(a) Schedule N (b) Schedule M
(d) Schedule F
(c) Schedule O (d) Schedule P
10. In which schedule, potency is
18. The Premises licensed for sale of
mentioned on the Label?
Drugs are:
(a) Schedule G (b) Schedule H & L
(a) Drugs store
(c) Schedule C (d) Schedule P
(b) Chemists and druggists
11. Who is the ex officio member of (c) Dispensing Pharmacy
DTAB? (d) All of the above
(a) Director, DGHS
19. Misbranded drugs are—
(b) Drug controller of India
(a) Imitation of other drug
(c) President MCI
(b) Adulterated drug
(d) PresidentPCI
(c) Patent whose true formulae is not
(e) All of the above
disclosed
12. Essential qualification for Drug (d) All of the above
inspector is—
Drugs and Cosmetics Act, 1940 □ □ 269

20. Drugs which can be imported— (a) 18 (b) 20


(a) All drugs specified in C and Cl (c) 22 (d) 19
(b) Small quantities of drugs for the 27. The qualification of a controlling
purpose of analysis authority has been prescribed under.
(c) Drugs for Personel use (a) rule 50a
(d) All of the above (b) rule 20b
21. In 1982,which new schedule was (c) rule 30c
added? (d) none of the above.
(a) P (b) Q 28. Ophthalimic preparations come under.
(c) X (d) A (A) Schedule C
22. When Schedule m and y introduced?, (B) Schedule E
(a) 1988 (b) 1882 (C) Schedule FF
(c) 1988 (d) 1983 (D) Schedule O
23. If the drug consists of in whole or in 29. The drugs excepted from the relating
part of any filthy, putrid or to manufacture sale & distribution of
decomposed substance then it called. drugs are specified in .
(a) misbranded drug (a) Schedule K
(b) spurious drug (b) Schedule M
(c) adulterated drug (c) Schedule C
(d) none of the above (d) Schedule B
24. If the drug is not labeled in prescribed 30. List of poisonous substances under the
manner then it called. ayurvedic & unani system of medicine
(a) misbranded drug has been given in.
(b) spurious drug (a) Schedule K (b) Schedule M
(c) adulterated drug (c) Schedule C (d) Schedule El
(d) none of the above 31. If irritations persist or increases
25. gmp come under . discontinue the use and consult the
(a) Schedule M (b) Schedule P physical labeled on
(c) Schedules Q (d) Schedules S (a) ointment (b) syrups
(c) powder (d) none of above
26. DTAB consists of following member.

ANSWERS
1. (a) 2. (c) 3. (b) 4. (b) 5. (b) 6. (b) 7. (c) 8. (a) 9. (c) 10. (c)
11. (e) 12. (c) 13. (a) 14. (b) 15. (b) 16. (d) 17. (b) 18. (d) 19. (d) 20. (d)
21. (c) 22. (a) 23. (c) 24. (a) 25. (a) 26. (a) 27. (a) 28. (c) 29. (a) 30. (d)
31. (a)
COT
Narcotic Drugs and Psychotropic
Substances Act, 1985
28
C h a pter

DefiniL~-;s
(i) "addict" means a person addicted to any narcotic drug or psychotropic substance;
(ii) "Board" means the Central Board of Excise and Customs constituted under the
Central Boards of Revenue Act, 1963 (54 of 1963),
(iii) "cannabis (hemp)" means -
(a) charas, that is, the separated resin, in whatever form, whether crude or
purified, obtained from the cannabis plant and also includes concentrated
preparation and resin known as hashish oil or liquid hashish;
(b) ganja, that is, the flowering or fruiting tops of the cannabis plant (excluding
the seeds and leaves when not accompanied by the tops), by whatever name
they may be known or designated; and
1. Ins. by Act 2 of 1989, s. 2 (w.e.f. 29.5.1989).
2. This Act came in to force in the whole of India on 14-11-1985: Vide
Notification No. S.O. 821 (E) dated, 14-11-1985, Gazette of India,
Extraordinary, 1985, Part II, sec-3 (ii).
(c) any mixture, with or without any neutral material, of any of the above forms
of cannabis or any drink prepared there from;
iv) "cannabis plant" means any plant of the genus cannabis;
(v) "coca derivative" means -
(a) crude cocaine, that is, any extract of coca leaf which can be used, directly or
indirectly, for the manufacture of cocaine;
(b) ecgonine and all the derivatives of ecgonine from which it can be recovered;
(c) cocaine, that is, methyl ester of benzoyl-ecgonine and its salts; and
(d) all preparations containing more than 0.1 percent, of cocaine;
(vi) "coca leaf" means -
(a) the leaf of the coca plant except a leaf from which all ecgonine, cocaine and
any other ecgonine alkaloids have been removed;
(b) any mixture thereof with or without any neutral material, out does not
include any preparation containing not more than 0.1 per cent, of cocaine;
(vii) "coca plant" means the plant of any species of the genus Frythroxylon;
1* (i)"controlled substance" means any substance which the Central
Government may, having regard to the available information as to its possible
use in the production or manufacture of narcotic drugs or psychotropic substances
270
Narcotic Drugs and Psychotropic Substances Act, 1985 □ □ 271

or to the provisions of any International Convention, by notificatic in the


Official Gazette, declare to be a controlled substance,
(viii) "conveyance" means a conveyance of any description whatsoever and includes
any aircraft, vehicle or vessel;
l*(a) "illicit traffic", in relation to narcotic drugs and psychotropic substances, means
• cultivating any coca plant or gathering any portion of coca plant;
• cultivating the opium poppy or any cannabis plant;
• engaging in the production, manufacture, possession, sale, purchase,
transportation, warehousing, concealment, use or consumption, import inter­
state, export inter-State, import into India, export from Indie’ or transhipment,
of narcotic drugs or psychotropic substances;
• dealing in any activities in narcotic drugs or psychotropic substances other
than those referred to in sub-clauses (i) to (ii); or
• handling or letting out any premises for the carrying on of any of the activities
referred to in sub-clauses (i) to (iv), other than those permitted under this
Act, or any rule or order made, or any condition of any licence, term or
authorisation issued, there under, and includes -
(1 ) financing, directly or indirectly, any of the aforementioned activities;
(2) abetting or conspiring in the furtherance of or in support of doing any of
the aforementioned activities; and
(3) harbouring persons engaged in any of the aforementioned activities;
(ix) "International Convention" means -
(a) the Single Convention on Narcotic Drugs, 1961 adopted by the United Nations
Conference at New York in March, 1961;
(b) the Protocol, amending the Convention mentioned in sub-clause (a), adopted
by the United Nations Conference at Geneva in March, 1972;
(c) the Convention on Psychotropic Substances, 1971 adopted by the United
Nations Conference at Vienna in February, 1971; and
(d) any other international convention, or protocol or other instrument amending
an international convention, relating to narcotic drugs or psychotropic
substances which may be ratified or acceded to by India after the
commencement of this Act;
(x) "manufacture", in relation to narcotic drugs or psychotropic substances, includes:
(1 ) all processes other than production by which such drugs or substances may
be obtained;
(2) refining of such drugs or substances;
(3) transformation of such drugs or substances; and
1. Ins. by Act 2 of 1989, sec. 3 (w.e.f. 29-5-1989.
(4) making of preparation (otherwise than in a pharmacy on prescription^ with
or containing such drugs or substances;
272 □ □ Drug Inspector Exam

(xi) "manufactured drug" means -


(a) all coca derivatives, medicinal cannabis, opium derivatives and poppy straw
concentrate;
(b) any other narcotic substance or preparation which the Central Government
may, having regard to the available information as to its nature or to a
decision, if any, under any International Convention, by notification in the
Official Gazette, declare not to be a manufactured drug;
(xii) "medicinal cannabis", that is, medicinal hemp, means any extract or tincture of
cannabis (hemp);
(xiii) "Narcotics Commissioner" means the Narcotics Commissioner appointed under
5;
(xiv) "narcotic drug" means coca leaf, cannabis (hemp), opium, popy straw and
includes all manufactured drugs;
(xv) "opium" means -
(a) the coagulated juice of the opium poppy; and
(b) any mixture, with or without any neutral material, of the coagulated juice
of the opium poppy, but does not include any preparation containing not
more than 0.2 5 of morphine;
(xvi) "op’um derivative" means -
(a) medicinal opium, that is, opium which has undergone the processes necessary
to adapt it for medicinal use in accordance with the requirements of the
Indian Pharmacopoeia or any other pharmacopoeia notified in this behalf
by the Central Government, whether in powder form or granulated or
otherwise or mixed with neutral materials;
(b) prepared opium, that is, any product of opium obtained by any series
of operations designed to transform opium into an extract suitable for smoking
and the dross or other residue remaining after opium is smoked;
(c) phenanthrene alkaloids, namely, morphine, codeine, thebaine and their salts;
(d) diacetylmorphine, that is, the alkaloid also known as diamorphine or heroin
and its salts; and
(e) all preparations containing more than 0.2 percent, of morphine or containing
any diacetylmorphine;
(xvii) "opium poppy" means' -
(a) the plant of the species Papaver somniferum L; and
(b) the plant of any other species of Papaver from which opium or any
phenanthrene alkaloid can be extracted and which the Central Governn^ul
may, by notification in the Official Gazette, declare to be opium poppy for
the purposes of this Act;
(xviii) "poppy straw" means all parts (except the seeds) of the opium poppy after
harvesting whether in their original form or cut, crushed or powdered and
whether or not juice has been extracted therefrom;
Narcotic Drugs and Psychotropic Substances Act, 1985 □ □ 273

(xix) "poppy straw concentrate" means the material arising when poppy straw has
entered into a process for the concentration of its alkaloids
(xx) "preparation", in relation to a narcotic drug or psychotropic substance, means
any one or more such drugs or substances in dosage form or any solution or
mixture, in whatever physical state, containing one or more such drugs or
substances;
(xxi) "Prescribed" means prescribed by rules made under this Act;
(xxii) "production" means separation of opium, poppy straw, coca leaves or cannabis
from the plants from which they are obtained;
(xxiii) "Psychotropic substance" means any substance, natural or synthetic, or any
natural material or any salt or preparation of such substance or material included
in the list of psychotropic substances specified in the Schedule;
(xxiv) "to import inter-State" means to bring into a State or Union territory in India
from another State or Union Territory in India;
(xxv) "to import into India", with its grammatical variations and cognate expressions,
means to bring into India from a place outside India and includes the bringing
into any port or airport or place in India of a narcotic drug or a psychotropic
substance intended to be taken out of India without being removed from the
vessel, aircraft, vehicle or any other conveyance in which it is being carried.
Explanation.—For the purposes of this clause and clause (xxvi), "India" includes
the territorial waters of India;
(xxvi) "to export from India", with its grammatical variations and cognate expressions,
means to take out of India to a place outside India;
(xxvii) "to export inter-State" means to take out of a State or Union territory in India
to another State or Union territory in India;
(xxviii) "to transport" means to take from one place to another within the same State
or Union Territory;
(xxviia)"use" in relation to narcotic drugs and psychotropic substances, means any kind
of use except personal consumption;
(xxix) Words and expressions used herein and not defined but defined in the Code of
Criminal Procedure, 1973 (2 of 1973) have the meanings respectively assigned to
them in that Code.

MULTIPLE CHOICE QUESTIONS

1. When 'The Narcotic Drugs and (a) 2 years imprisonment


Psychotropic Act' was framed? (b) 3 years imprisonment
(a) 1930 ' (b) 1940 (c) 5 years imprisonment
(c) 1957 (d) 1985 (d) 10 years imprisonment
2. What penalties is imposed if person 3. Who issue the license for cultivation
keeps opium without lincense? of opium?
21A DO Drug Inspector Exam

(a) Opium officer (a) schedule-I (b) schedule-II


(b) Narcotic inspector (c) schedule-III (d) schedule-IV
(c) Central Government inspector n Psychotropic substance not allowed to
(d) state drug controller be exported to specified countries
4. The term 'Manufactured Drug' refers come under
to (a) schedule-I (b) schedule-II
(a) Crude Cocaine (c) schedule-III (d) schedule-IV
(b) Coca derivatives 12. Grant of licence for manufacture of
(c) Opium derivatives Psychotropic substance for export
(d) Medicinal Hemp only come under
(e) All of the above (a) schedule-I (b) schedule-II
5. The Government opium factory is (c) schedule-III (d) schedule-IV
present at 13. The Central Government may
(a) Ghazipur constitute the national fund for control
(b) Ratlam of
(c) Neemuch (a) Misbranded drug
(d) (a) and (c) (b) Misbranded cosmetic
(c) Drugs abuse
6. Opium was brought under legislative
control in; (d) None of the above
(a) 1945 (b) 1857 14. The Central Government may
(c) 1888 (d) 1865 constitute a governing body to advise
the Government in regard to the
7. India participated in second application of the
international opium conference at
(a) National fund
Geneva in
(b) permission
(a) 1945 (b) 1857
(c) control
(c) 1925 (d) 1865
(d) None of the above
8. Government of India passed the
dangerous drugs act in The permission for cultivation of any
coca plant was given by
(a) 1945 (b) 1857
(a) State Government
(c) 1925 (d) 1930
(b) Dristic Magistrate
9. Narcotic Drugs and Psychotropic (c) District Judge
substance Act and rules come into
(d) Central Government
forced in
(a) 1985 (b) 1857 16- The Narcotic Drugs and Psychotropic
(c) 1925 (d) 1865 substance consultative committee is
headed by
10. Psychotropic substance whose import, (a) State Government
export & transshipment are prohibited
(b) Dristic Magistrate
come under
Narcotic Drugs and Psychotropic Substances Act, 1985 □ □ 275

(c) Distic Judge (a) 40 days before the expiry of


(d) chairman licence
17. Opium can be manufactured by (b) 10 days before the expiry of
licence
(a) Central Government at opium
factories (c) 30 days before the expiry of
licence
(b) private factories
(d) 7 days before the expiry of licence
(c) on loan licience
(d) none of the above 22. No person shall export any of the
narcotic drugs or psychotropic
18. Various substance & preparation have substance or preparation containing
been declared to be manufactured any such narcotic drugs or
drugs in psychotropic substance according to-
(a) 1985 (b) 1857 (a) schedule-I (b) schedule-II
(c) 1993 (d) 1865 (c) schedule-III (d) schedule-IV
19. In 1925 India participate in second 23. The record of the activity shall be
international opium conference held preserved for
at
(a) 1 year (b) 2 year
(a) Geneva (b) jaipur
(c) 3 year (d) 6 year
(c) Delhi (d) U.S.A
24. Psychotropic substance whose import,
20. The license to manufacturer export &transshipment are prohibited
manufactured drugs is
(a) Coca leaf
(a) Transferable
(b) codine
(b) Not transferable
(c) flurazepam
(c) Changeable
(d) snone of the above
(d) None of the above
21. For renewal of the license the licensee
shall apply to the licensing authority
at least

ANSWERS
1. (d) 2. (a) 3. (a) 4. (b) 5. (c ) 6. (b) 7. (c ) 8. (d) 9. (a) 10. (a)
11. (b) 12. (c ) 13. (c) 14. (a) 15. (d). 16. (d) 17. (a) 18. (c ) 19. (a) 2 0 . (b)
21. (b) 22 . (d) 23. (b) 24. (a).

□ □ □
Appendix-/ □ □ 211

LIST OF INORGANIC SUBSTANCES ALONG WITH CHEMICAL


COMPOSITION AND USES

S.No. Inorganic Compounds Chemical Composition Uses


1. Antimony potassium tartrate C4H40 7SbK.l/2H20 Emetic orally and Treatment o f
Kalaazar by I.V
2. Barium Sulphate BaS04 Radio-opaque contrast media for
the X-ray examination o f G IT
3. Borax Na2B 40 7.10H20 Anti-bacterial
4. Boric acid H3B O 3 Local anti-infective
5. Calcium carbonate C3CO1 Non-systemic antacid
6. Calcium chloride CaCl*> Electrolyte replenisher
7. Calcium gluconate C12^22® 14Ca.H20 Calcium replenisher
8. Chlorinated lime CaOCl2 Disinfection of water
9. Dicaicium phosphate CaH P04.2H20 Source o f calcium, phosphorus and
diluent in tablets
10. Ferrous sulphate F e S 0 4.7H20 , Haematinic
11. Hydrogen peroxide h 2o 2 Oxidising agent
12. Light kaolin Al20 v 2 S i0 2.2H20 Adsorbent (G IT infections)
13. Magnesium hydroxide Mg(OH)2 Antacid and Laxative
14. Magnesium oxide MgO Antacid
15. Magnesium sulphate M g S 0 4.7H20 Saline cathartic and sedative by
I.V/I.M
16. Magnesium trisilicate 2 M g 0 .3 S i0 2.XH20 Antacid
17. Mercurous chloride HgCI2 Cathartic
18. Nitrous oxide n 2o General Anaesthetic
19. Phosphoric Acid h 3p o 4 Pharmaceutical aid
20. Plaster o f Paris C a S 0 4.l/ 2H ,0 Surgical Aid
21. Potassium chloride KC1 Electrolyte replenisher
22. Potassium citrate C6H5K5H20 Systemic alkalaniser
23. Potassium iodide KI Expectorant
24. Potassium permanganate K M n 04 Antiseptic. Oxidising agent
25. Selenium sulphide SeS2 Anti-dandruff
26. Silver nitrate A gN 03 Anti-bacterial
27. Sodium acetate CH3C 0 0 N a .3H 20 Used for peritoneal dialysis
28. Sodium benzoate C6H5COONa Preservative
29. Sodium bicarbonate NaHCOj Antacid
30. Sodium carbonate Na2C 0 3. Pharmaceutical aid
31. Sodium chloride NaCl Electrolyte replenisher
32. Sodium citrate C6H,Na30 7.2H20 Urinary acidifier
33. Sodium dihydrogen phosphate NaHP04.2H20 Urinary acidifier
34. Sodium fluoride NaF To prevent dental caries
35. Sodium hydroxide NaOH Pharmacentical aid
36. Sodium metabisulphite Na2S 20 5 * Antioxidant
278 □ □ Drug Inspector Exam

S. No. Inorganic Compounds Chemical Composition Uses


37. Sodium nitrite N aN 02 Antidote in cyanide poison
38. Sodium potassium tartarate C4H4K N a06.4H20 Saline cathartic
39. Sodium thiosulphate Na2S 20 3 .5 20 Antidote in cyanide poison
40. Stannous tluoride SnF? Prevention o f dental caries
41. Strontium chloride SrCf2 Desensitizing agent in preparations
42. Talc 3 M g 0 .4 S i0 2.H20 Glidant in tablets, filter aid, used
in dusting powders
43. Titanium dioxide TiO , Topical protective, opacity agent
44. Yellow mercuric oxide HgO Local anti-bactcrial
45. Zinc chloride ZnCl2 Phamaceutical aid
46. Zinc oxide ZnO Mild astringent
47. Zinc stearate (C ,7H „C O O )2Zn Lubricant
48. Zinc sulphate Z n S 0 4.7 H ,0 Astringent and Antiseptic
Appendix

DETAILS OF SOME IMPORTANT CRUDE DRUGS


S. No. Name o f the crude B io lo gica l S o u rce Main Uses
drug (Common name) Family Constituents
1. Aloes Aloe Perryi 30% aloin anthra- Puragatives
Aloe vera quinone glycosides
( Liliaceae)
2. Castor oil Seeds of Ricinus com- o f glyceride o f Puragative
m unis (Euphor- ricinioleic acid
biaceae)
3. D ig ita lis le a v e s D ig it a lis p u rpu rea Digitoxin, Gitoxin Cadiac tonic used
(Foxglove) (Scropulariaceae) in congestive heart
failure
4. Isp h a g h u la seed s Plantago ovata (Plan- 10% o f mucilage Used in am oebic
(Isaphagol) taginaceae) dysentry, bacilary
dysentry and diar-
hoea
R h u b a rb (d ried Rheum Emodi, Rheum F re e an th ra- Purgative (in large
rhizome) Webbianum (Poly- q u in o n e s , e.g., doses), stom achic
gonaceae) emodi, emodin (in small doses)
6. Arjuna bark Terminalia arjuna T a n n in s , A r ju n ic Cardiac tonic
(Combretaceae) acid and arjunine
1. Senna leaves C a s s ia acu ti fo lia Sennosides (A & B) Purgative
(a) Alexandrian Senna (Leguminoseae) Sennosides (A & B) Purgative
(b) Indian senna (Tin- C a ssia an g u stifo lia
navelley senna) ( Leguminoseae)
Fennel fruits Foeniculum vulgare Volatile oil (Ane- Aromatic carmina­
(Umbelliferae) thole & Fenchone) tiv e , F la v o u rin g
agent, Respiratory
stimulant
C ard am on fru its Elettaria cardamonum Volatile oil Aromatic carmina­
(elachi) (Zingiberaceae) tiv e , s tim u la n t,
flav o u rin g agent
and spice.
10. Ginger (rhizome) Z in g ib e r o ffic in a le Volatile oil, pungent Spi«€Sf'w^ m u la r i{
(Zingiberaceae) princple.(Gingerol) aromatic carmina­
tive

719
280 □ □ Drug Inspector Exam

S. No. Name o f the crude B io lo g ic a l S ou rce Main Uses


drug (Common name) Family Constituents
11. Ajwain (fruits) Trachyspermum ammi Volatile oil, fats and A n t i s p a s m o d i c
( Umbelliferae) protiens stimulant, carmina­
tive
12. Black catechu (Kattha) A c a c ia c a te ch u Acacatechin Astringent
(, Leguminosae)
53. Black pepper (fruits) P ip e r longum Volatile oil, resin. S t i m u l a n t ,
( Piperaceae) pipeline stomachic digestant
14. Asafoctida (oleo gum Ferula asfoetida ( Um~ Resin, gum, vi'M ile Carminative, nerve
resin, Devil’s dung) belliferae) oil to n ic , flav ou rin g
agent, and intestinal
antiseptic
15. Cinnamon bark (Dal- C i n n a m o m u m Volatile oil (cinnmic Carminative,
chini) zeylanicum a ld e h y d e and stomachic, aromatic
( Lauraceae) eugenol) and tannins flav ou rin g agent,
stimulant and con­
diment.
16. N u tm eg ( K e r n e l, M y r is tic a fra g ra n s Volatile oil (M ris- Aromatic carinina-
Myristica) ( Myristicaceae) ticin) tiv e , fla v o u rin g
agent
17. Cloves (flower buds) Eugenia caryophyllus V o la tile o il Antiseptic, aromatic
( Myrtaccae) (eugenol) stimulant, carmina­
tiv e , fla v o u rin g
agent and used in
toothache
18. Hyoscyamus (fyerb) H y o scy a m u s n ig c r Hyoscyamine, A n tis p a s m o d ic ,
( Solanaceae) Hyoscine, Atropine sedative, used to
ch eck sa liv a ry
secretions.
19. Bellad onna (D eadly A tro p a b e lla d o n n a Tropane alkaloids A n t ic h o lin e r g ic ,
night shade leaves) ( Solanaceae) (hyoscyamine, a n t i - s p a s m o d ic .
Atropine) used to p rev en t
various secretions
used in parkin*
sonism
20. Aconite (root) A co n itu m n^pellus A c o n i t i n e T re a tm e n t of
(Ranunculaceae) (alkaloids) neuralgia, sciatica,
rh e u m a tic , an al­
gesic
21. Aswagandha (roots) W ithania som n ifera Alkaloids (tropine, Tonic, aphrodisiac,
( Solanaceae) pseudotropine, s e d a tiv e in in-
withasomnine) so m in a, used in
blood pressure
Appendix-II □ □ 281

S. No. Name of the crude Biological Source Main Uses


drug (Common name) Family Constituents
22. Ephedra (Ma-huang) E p h ed ra s in ic a l-ephedrine, psuedo Bronchial asthma,
E phed ra eq u isetin a ephedrine m y d ria tic , nasal
(Genetaceae) decongestant
23. Opium (dried latex) P a p a v er Som - Morphine, codeine Narcotic analgesic
mniferum p a p a v e rin e , nar­ cough suppressant
(Papaveraceae) cotine, narceine
24. C a n n a b is (In d ia n Cannabis sativa R e s in (T e tra ­ Narcotic analgesic,
hemp) ( Cannabinaceae) hydrocannabinol) sedative
25. N u x -v o m ic a seed s Strychnos nux-vomica Strychnine, brucine Spinal cord stimu
(crow-fig) (Loganiaceae) la n t, b itte r
stomachic
26. Corriander fruits Corriandrum sativum V o la tile o il (d - Aromatic carmina­
( Umbelliferae) linalol) t iv e . fla v o u rin g
agent
27. Rauwolfia roots (Sar- Rauwolifa serpentina Indole alkloids (res- Treatment o f hy-
pagandha) ( Apocynaceae) r e p in e , r e s c in - pertention, sedative
namine)
28. Vasaka (Leaves) A d h a to d a v a sic a V o la tile oi l , Expectorant,
(Acanthaceae) Qui nazol i ne bronchodilator
a lk a lo id s , (V as-
sicine, Vassicinone)
29. Tulsi (Sacred basil) O cim u m san ctu m V o la tile o il A n tibacterial, sti­
(iLabiatae) (eugenol) mulant expectorant,
aromatic carmina­
t iv e , fla v o u rin g
agent, and used in
cold
30. Tolu (Balsam o f tolu) Myroxolon balsamum Free cinnamic acid Expectorant,
(Leguminosae) and benzoic zcid flavou ring agent,
antiseptic
31. G uggul (O le o g u m C o m m i p h o r a Resin, gum, volatile Anti inflammatory,
resin) weightii oil antirheumatic,
( Burseraceae) hypol i pi di mi c,
hypocholesteremic
32. Indian Colchicum C o lc h ic u m lu tcum Tropolone alkaloids U se d in g o u t,
( Uliacaea ) (C olchicine, rheumatism; and to
demecolchine) cause pollyploidy
33. Chaulmoogra (Hydno- H y d n o ca rp u s an- U n sa tu ra te d fat- T re a tm e n t of
carpus oil) themintica, Hydnocar­ ty a c id o f ch a u l- leprosy
pus h e te ro p h y lla m o o g ric a c id ,
(Flacourtaceae) hydnocarpic acid
34. Vinca (Peri winkle) Catharanthus roseus In d o le a lk a lo id s Used in the treat­
(Apocynaceae) (vinblastine, vincris­ ment o f cancer
tine)
282 □ □ Drug Inspector Exam

S. No. Name o f the crude Biological Source Main Uses


drug (Common name) Family Constituents
35. Gymnema (Leaves) Gym nem a sylvestre Hentricontanc, pen- Antidiabetic,
(Asclepideceae) tatriaco tin e, gym- s t o m a c h i c
ncmic acid stimulant, laxative
diuretic.
36. Pterocarpus P te ro c a rp u s M ar- 70-80% o f Kino tan­ Powerful astringent
supuim nic acid used in the treat­
(Leguminoseae) ment o f diarrhoea
and dysentry
n. Gokhru T rib u lu s te r r e s tr is Steroidal saponins Diuretic
(Zygophyllaceae) <

38. Punamava B o e r h a v ia d iffu ssa A lk aloids (punar- D iu r e tic , e x p e c ­


(Nyctaginaceae) navine), potassium torant
nitrate
39. I p e c a c u a n h a Cephaelis ipecauanha I s o q u i n o l i n e Used in the treat­
(Rhizomes and roots) Cephaelis acuminata alkloids (Em etine, ment o f amoebir
(Rubiaceae) c c p h a 1 i n e dysentry, and al-
psychtrine) sourcd as emetic
40. Turm eric (rihzom es) Curcuma longa Volatile o il, resin Condiment, spice,
(Curcuma, Indian saf­ (Z>'\gineraceae) curcumin colouring agent,
fron) antiseptic
41. Benzoin S ty ra x p a r a lle lo Free balsamic acids I r r ita tin g e x p e c ­
ncurus. Styrax benzoin (B en zoic and cin­ to r a n t, c a rm in a -
(Styraeeae) namic acids) tive,diuretic,antisep
tic
42. M y rrh (O le o -g u m - Comminphora molmol V olatile oil, gum, Stimulant, antisep­
resin) (Burseraceae) resin tic
43. Neem A z a d ira ch ta in d ica Azadirachtin, salan- A n tisep tic, insec­
(Meliaceae) nin, neem oil con­ ticide
tains glycerides o f
o le ic and stearic
acids
44. C in c h o n a (P a n a m a C in ch o n a c a lis a y a , Quinoline alkaloids A ntim alarial, car­
bark) Cinchona ledgeriana, (quinine, quinidine) diac depressant
Cinchona pfficinalis
( Rubiaceae)
45. Ergot (Sclerotium) C la v ic e p s p u purea Indole alkloids ergo- Oxytoxic, also used
(Hypocreaceae) metrine, ergotamine, fo r treatm en t o f
I ergosine migraine
46. Shark liver oil (Oleum Hypoproin brevirotris Vitamin A Used in treatment
salachoids) o f night blindness
47. A ml a (In d ia n E m b lic a o ffic in a lis Vitamin C Used in treatment
gooseberri) ( Euphorbiaceae) o f scurvy
Appendix-II □ □ 283

S. Nc. Name of the crude Biological Source Main Uses


drug (Common name) Family Constituents
48. Diastase P r e s e n t in s a liv a , Digestant
pan creatic ju ic e o f
animals
49. Yeast (Unicellrar fun­ Saccharomyces Protiens, fats, rich in Source o f B-com ­
gal microorganisims) cerevisea B-complex vitamins p le x , used in
(Saccharomycetaceae) manufacture o f al-
cohal, beer, and in
various wines
50. Papain (P ro te o ly tic C a r ic a P ap ay a Used as digestant
ezymes) ( Caricaceae ) c la r i f ic a t io n of
b c v a r a g e s m eat
tcnderiser
51. P e p p e rm in t o il M en th a p ip e rita Menthol C a r m i n at i v e ,
(O le u m m en th a (Labiatae) aromatic, stimulant,
pioperita) flavou ring agent,
used in toothpastes
and tooth powders.
52. Sundal Wood Santalum album Volatile oil (Sandal The oil is mainly
( Santalaceae) wood oil) uesd as a perfume
in cosmetics
53. Lemon grass oil C y m b o p o g a n Citral Flavouring agent,
fle x u o u s u s cy m ­ used in perfumery
bopogan citrus
( Gaminae)
54. L em o n o il (fro m Citrus lemon Volatile oil contains C a r m i n at i v e ,
lemon peel) (Rutaceae) m ain ly lim o n en e stimulant, flavour­
(9 0 % ) and citra l ing agent, used in
(40% ) perfumes
55. O ra n g e o il (fro m C itru s au rantiu m Volatile oils Aromatic carmina­
orange peel) Rutaceae t iv e , fla v o u rin g
agent
56. Honey Apis mellifera 80% natrual invert D em u lcen t, mild
(Apidae) suger (glucose and laxative, nutritive,
fructose) sweetening agent
57. A ra c h is o il A ra c h is h y p o g ea Glycerides o f fat- S o lv e n t fo r in­
(Groundnut oil. Peanut (Leguminosea) ty a c id s (o le ic , tramuscular injec­
oil) linoeic, stearic and t io n s , n u tritiv e
arachidic acids) preparation o f oint­
ments, plasters and
soaps
284 □ □ Drug Inspector Exam

S. No. Name of the crude Biological Source Main Uses


drug (Common name) Family Constituents
58. S ta r c h (A m y lu m , W h ea t T ritic iu m A m y 1 o s e N utritive, demul­
stark) sativum. ( Gramineae) Amylopeetin cent, disintegrating
M a iz e (Z e a m a y s ) agent and diluent in
0Gramineae) P o ta to m a n u fa c tu re of
(Soianum tuberosum) tablets
( Solanaceae)
59. Acacia (Indian gum, A c a c ia a ra b ic a Arabin (mixture o f D e m u l c e n t ,
Gum arabic) (Leguminosea) Ca, Mg and K . salts suspending agent,
o f arabic acid) emulsifying agent,
binding agent.
■e?
60. Tragacanth Astragalus gummifer Tragacanthin (Water Suspending agent,
(Leguminosae) solu ble), B assorin binding agent in
(water insoluble) tablets, demulcent,
em ollient in co s­
metics
61. Guargum (from seeds) C y a m o p s i s G u ra in (w a te r Thickening agent,
tetragonolobus soluble) binding agent, dis­
( Leguminosae) integrating agent,
emulsifying agent
62. Agar-agar (Vegetable G e lid iu m am ansi Agarose, agaropec- Emulsifying agent,
gelatin) (Rhodophyceae) tin (polysaccharides) b u lk la x a tiv e ,
preparation o f bac­
teriological culture
medium
63. Olive oil O le a e u ro p o ea Triglycerides (olein, N u trie n t, dem ul­
(Oleaceae) palmitin, linolcin) cent, mild laxative
64. H y d rou s w o o lfa t Ovis aries ( Bovidae) C h o le s-tro l, is o - W ater absorbable
(Lanolin) c h o le s tr o l, o le ic , ointment base used
mristic and palmitic in preparation o f
acids cream s and c o s­
metics
65. Pectin Purified carbohydrates Polysaccharide In the treatment of
obtained from inner diarrhoea, emulsify­
protein o f rind o f ing agent
citrus peels ( RUtaceae)
66. Gelatin (Gelatinum) Protien derivative ob­ Protien (glutin) M a n u fa c tu re o f
tained after purifying capsu les, binding
and evaporating the agent in tablets
aqueous ex tra ct o f
skin, bones and ten­
d ons of a n im a ls
(Boviade)
Appendix-U □ □ 285

S. No. Name of the crude Biological Source Main Uses


drug (Common name) Family Constituents
67. S o d iu m a lg in a te Macrocusits pyrifera Alginic acid Suspending agent,
(Algin) ( Lesoniaceae ) (to in crease vis­
cosity), disintegrat­
in g a g en t and
binding agent in
lozenges and tablets
68. Kaolin (China clay) P u rifie d n a tiv e Aluminium silica:? Light kaolin is used
hydrared aluminium in tre a tm e n t o f
silicate free form grit­ e n t e r it is and
ty particles, derived d y en try . H eavy
from decomposition of kaolin is used in
the felsper or granite poultice preparation
rock
69. Bees wax Honey comb o f the 8 0 % o f M y fricy l Preparation o f onit-
bees ‘Apis dorsata' palm itate, ca ro tic ments, plasters and
( Apidae) acid polishing o f tablets
70. L iq u o ric e (G ly c y r- G ly c y rrh iz a g lab ra Triterpenoid Demulcent
rhiza) (Leguminoseae) saponins (G lycyr- sweetening agent,
rhizin) potassium antispasmodic, anti­
and calcium salts o f inflammatory, anti­
glycyrrhiznic acid ulcer drug
71. P y reth ru m (In s e ct Chrysanthemum P y r e t h r i n Insecticides
flowers) cinerarie folium (Phyrethrin-I,
(Compositae) Pyrethrin-II)
72. P i e r or r h i z a ‘ Picrorrhiza kurroa’ Picroside-I, B it t e r to n ic ,
(R h iz o m e s) (Indian (Scrophulariaceae) P icro s id e -II, Kut- f e b r i f u g e ,
gentian Kutki) koside stomachic
73. Linseed oil Linum usitatissimum Glycerides o f pal­ P re p a ra tio n of
( Unaceae) mitic, stearic, oleic, iodine ointment and
lin o le ic and cresol with soap,
lin o le n ic a c id , Nutritive emollient
cyanogenetic
g l y c o s i d e
(linamarin)
74. Dioscorea D ioscorea deltoidea diosgenin (steroidal Rich sourcs o f dios-
Dioscorea Composita sapogenin) g e n in , used in
(Dioscoreacea) rheumatic arthritis,
precursors for syn­
thesis o f cortico
steroids
75. G arlic (Lahsun, al­ A lliu m sativ u m Volatile, (allicin) Spice, antibacterial
lium) (Liliaceae) used in high B.P.
and artherosclerosis
and a lso in
rheumatism
286 □ □ Drug Inspector Exam

S. No. Name of the crude Biological Source Main Uses


drug (Common name) Family Constituents
76. Shatavari Asparagus racemosus S te r o id sa p o n in s tonic, diuretic, and
(Liliaceae) Shatararin-I to IV antacid
77. Tobacco N ic o tia n a tabacu m N ic o tin e (L iq u id Insecticide,
(iSolanaceae) alkaloids) stimulant o f heart
and nervous system

78. Cbtton (Cotton wool. G o ssy p iu m her- 90% o f cellouse Filtering medium,
Purified cotton) baceum , Gossypium surgical dresings
barbadense
(Malvaceae)
79. Silk Bombyx mori Protein (fibroin) Sutures, seives and
(Bombycidae)<> ligatures

80. Wool Ovis aries Sulphur containing Filtering and strain­


(Bovidae) protein, as Keratin ing medium
81. Datura herb D a tu ra m etel tro p a n e a ik lo id s A n t i s p a s m o d i c
(Solanaceae) h y o s c i n e C .N .S . depressant
Scopolamine) antuulcer drug
82. Shankhpushpi C o n v o l v u l u s Alkaloids-shankup Used in hyperten-
pluricaulis Evolvulus ushpine tion, as a transquil-
alsinioides liser and tonic
(Convolvulaceae)

MORPHOLOGICAL CLASSIFICATION OF CRUDE DRUGS

Part o f Plant Drugs


Woods Quassia, sandalwood
Barks Aijuna, cinchona, kurchi, cascara, cinnamon
Flowers Clove, rose, saffron, pyrethrum
Leaves Cocca, digitalis, senna, vasaka, eucalyptus.
Fruits Bael, colocynth, lemon, orange, fennel, corriander.
Seeds Linseed, nutmeg, colchicum, nux-vomica.
Subterranean Parts Ginger, turmeric, aconite, rauwolfia, podophyllum,
colchicum corm, squill, rhubarb.
Entire Organism Ephedra, ergot, cannabis, lobelia belladonna, colchicum
corm, squill, rhubarb.
Gums Acacia, tragacanth, sterculia, guar.
Lalex Opium, papaya.
Dried juices Aloe, kino, ted gum.
Extracts Catechu, agar, gelatin.
appendix-IIl □ □ 287

Glucose
l^-ATP
Hcxoktnase r
| v~—♦ ADP
Glucose 6-PtwsphMt
Ptiosphoglucose
KonwraM
1
Fructose A-phosphale
Phosphofnicto- l ^ AV>
Unn* f^~*.ADP
FractoM 1. S-tfsphosphato
am oum
!
Trios* phosphate

Dihydroxyacelooe Trtos* phosphate Glyccratdchyd*


phosphite .... — .. **B ^phosphate
Gtyceraldehyde — NAD + P,
3-phosptwte
dehydrogenase ' “-►NADH+H*
1 ,3-8isphosphoglyc«rate
Phosphoglycefrt* If' ^
^ — ►ATP
^Phosptoglycafate
Phoshogtycero
mutas*
2-phosohogfycer*le

EnoUse

Phosphomol pyruvate
P^. tr -" *
«"•“ Jp—^ATP
Pyruvate
Flow chart o f Glycolytic pathway.
288 □ □ Drug Inspector Exam

Acetyl CoA
O
ch3 ■ SCoA CoA — SH
Condensation

O r c — COO CH2 — COO


I i
ch2—coo" HO — C — COO
Oxaloacetate I
ch2 — coo"
I2HJ X Citrate
Dehydro- > Malate dehy­ Dehydration
genation drogenase Aconitase H2C

CH2— COO'
COO
I I
HO — CH C — COO'
| II
C H, CH — COO '
Cis Aconitate

COO Aconitase I I H20


Malate II Hydration
Hydratio
Hydration Fumarase
h 2o CH^ CO O '
I * ‘
COO H — C — CO O '
I II
CH
HO — C — COO'
II I
HC
H
Isocitrate
COO
umar
Fumarate {2HJ
m Succinate
dehydrogenase
Isocitrate oxidative
i (Dehydrogenation)
dehydrogenase decarboxylation

Succinate a-Ketoglutrate
thiokinase dehydrgenase
complex

CH2 — COO
CoASH GTP
(ATP) GDP
(ADP) I W2
Substrate liver + p;
C — SCoA o = C — COO
phosphorylation
Succinyl CoA a-Ketoglutarate
Oxidative
decarboxylation
^Citric Acid Cycle.
Appendix-Ill □ □ 289

Glucose-6-phosphate
Glucose - NADP
2* 2*
6-phosphate Mg or Ca
dehydrogenase
• S * NADPH+H*
6-Phosphogluconoladone
I h 2o
Hydrolase 2+ 2♦ „ 2*
1 Mg , Mn or Ca
6-Phosphogluconate
^ — NADP
6-Phosphogluconate 2+ 2+ _ 2+
dehydrogenase Mg , Mn or Ca
S * NADPH+H*
Ribose-5-phosphate
Enediol S-Keto-6-Phosphogluconate
form Ketoisomerase
P -C O ;

Ribulose 5-phosphate
5-p

I Epimerase

Xylulose 5-phosphate
Transketolase
Ribose-5-phosphate Sedoheotulose-7-phosphate
TPP, Mg

GtycerakJehyde
3-phosphate
Transaldolase

Erythrose Fructose
-4-phosphate -6-phosphate
Transketolase
Xylulose 5-phosphate -► Fructose-6-phosphate
TPP, Mg ^

Glyceraldehyde 3-phosphate

The HMP pathway.


290 □ □ Drug Inspector Exam

Lactate------------ - Pyruvate • -Some amino adds


ATP ♦ COj ♦ H jO ---- (
Pytuvata cartooxytasa
1 (Present
I only In mitochondria)
(Btotin dependent)
ADP + Pi <— (
Oxaloacetate
,TP
PEPCK (Phosphoenol pyruvate cartooxy Iwiase)
J (Present in mitochondria and cytoplasm in numans)
- - --------------
Phosphoenol pyruvate

lIb: ‘HjO
2-Phyosphogtycerate Glycerol

ATP “’"N Glycerokinase


3-Dhosphogtycerate ADP^|
II Glycerol 3—phosphate
1, 3-Diphosphogtycerate NAD*
Glycerol 3-P
NADH+H dehydrogenase
z .
Glyceraidehyde_ ^ Pihvdroxyacetone x-
3-phosphate — phosphate

Fructose 1,6 -bisphosphate

Fnjctose 1,6 diphosphatase

Fructose e-phosphate

!
Glucose 6 -phosphate
H,0 - J
Glucose 3-phosphafase

Glucose

ducom ogtnsis.
Appendix-fV D O 291

Appendix
NATIONAL IMMUNISATION SCHEDULE
Beneficiaries Age Vaccine No. o f doses Route o f administration
Infants 6 weeks to 9 months DPT 3 Intramuscular
OPV 3 Orftl
BCG 1 Intradermal
Children 9 -12 months Measles 1 S.C.
16-24 months DPT 1 I.M.
OPV 1 Oral
5-6 years DPT I.M.
Typhoid S.C.
10 years Tetanus toxoid I.M.
Typhoid 1 S.C.
16 years Tetanus toxoid l.M. ;
Typhoid 1 S.C. 1
Pregnant women 16-36 weakes Tetanus toxoid 2 l.M. j
Appendix
FORMULAE USED IN POSOLOGICAL CALCULATION

Young’s Rule. (Age below 12 years) Child’s dose = — ^- ar- _ x Adult dose
, ' Age in years + 12

Dilling’s Rule (Age between 12-20 years) Child’s dose = x Adult dose

Clark’s formula [Hamberger’s formula] Child’s dose = - -s ^ g ) x Adult dose

Clark’s formula Child’s dose = — — x Adult dose

Fried’s formula (for infants under 1 year) Child’s dose = x Adult dose

Cowling’s formula Child’s dose =-^ £5 — x Adult dose

Bastedo’s formula Child’s dose = - ^ f o y ears x Adult dose

Surface area basis Child’s dose = — “^ rfac^ ^ r-ea x Adult dose


1.73 sq.m
c __ . . . . Surface Area o f Child . . . ,
Surface area method Child s dose = —— ----------------— x Adult dose
Surface area of adult
Appendix- VI □ □ 293

LATIN TERMS AND ABBREVIATES COMMONLY USED IN


PRESCRIPTION WRITING

Latin Term or Pharse Abbreviation English Meaning


Ad ad. to, up to
Ad libitum ad. lib. at pleasure, as desired
Admove admov. apply
Agitaagit. shake, stir '
Alter alt. the other, alternate
Altemis horis alt. hrs altehiate hours
Ana a. a. of each
Ante a. before
Ante cibos a.c. before meals
Applicandus applicajid to be applied
Aquaaq. water
Aqua bulliens a q .b u ll. boiling wafer
Aqua destillata aq. dest. distilled water
Auris dextra a. d. rieht ear
294 □ □ Drug Inspector Exam

Latin Term or Phone Abbreviation English Meaning


Auristillae auristill ear drops
Bis in die b.i.d. twice a day
Capsula caps... capsule
Capiat cap. let him take
Capiendus capiend. to be taken
Cataplasma cataplasm poultice
Charta Chart. powder, powder paper
Cibos cibos. food meals
^ amplum / amp.
Cochleare— magnum coch — mag. one tablespoonful
^ maximum ' S ' max
^ medium . ^ med.
Cochleare coch one desertspoonful
\ modicum 'N mod.
^ minimum y min
Cochleare coch one teaspoonful
^ parvum ’S p a j- v .
Coilunarium collunar. a nose wash
Collutorium coilut. a mouth wash
Collyrium collyr. an eye wash
Congius cong; c. a gallon
Cum c. with
Cum duplo c. dup. with twice as much
Cum parte a equal . c.pt.aeq. with an equal quantity
Cyathus cyath. a. glass
Dentur dent. give, let it be given
Dexter dext. right.
Diebus alternis dieb. alt. every other day
Divide div. ‘ divide
Dolore urgente dol. urg.. when the pain is severe
Emulsio emul. an emulsion
E '— with
E. lacte e. lact. with milk
Ex. aqua ex. aq. with water
Ex. modo prescription e.m.p. in the manner prescribed
Fiat, fit, fiant. ft. make, let it be made .
Granum, grana gr. a grain
Gutta, guttae gtt- a drop, drops
Hac nocte hac noct. to night
Hora h. an hour
Hora somni h.s. at bed time
In dies In. d. daily
Inter cibos i.c. during nieals
Injectio Inj. an injection
Appendix-Vl □ □ 295

Latin Term or Pharse Abbreviation English Meaning


Lacvo I. left
Levis lev. light
Limimentum lin. a liniment
Liquor liq. solution
Mancm. morning
Minimum min. a minim
Misce m. mix, let («t) be mixed
Mistura mist, a mixture
M ittcm itt. send
Mitte tales mitt tal send such
Modo dicto m. diet, as directed, as staled
Modo prescripto m. pres as prescribed
Nebula nebul. a spray
Noctc maneque noct. maneq. night and morning
Non repetatur non rep. n.r. do not repeat
Octarius o. a pint
Oculo utro o.u. each eye
Oculus dexter 0.d right eye
Oculus laevus 01. left eye
Oculus sinister o.s. left eye
Omani omn. every
Omani hora omn. hor, o.h every hour
Omani quadranta hora omn. quadr. hor every quarter of an hour
Omani quarta hora omn. 4 hrs1. every four hours
Omani mane o.m. every morning
Omani nocte o.n. evesry night
Os, oris o.s. mouth
Parti affecti applicandus p.a.a. to be applied to the affected part
Per os p.o. orally by mouth
Phiaia pirns agitata p.p.a the bottle, being first shaken (i.e.,
attach a “Shake the bottle." label)
Post cibos p.c. after meals
Pro oculo laevo p.o.l for the left eye
Pro dose as a dose
Pro re nata p.m . when necessary* ocassionally
Pulvis pulv powder
Quantum sufficiat q.s. as much as sufficient
Quaque quarta hora q.q.h. every fourth hour
Quarter in die q.i.d. four times a day
Quolidie quot. Daily
Recipe Rx take
Secundum artum s.a. according to the art
Semis, Semi half
Signa, signetur write
296 □ □ Drug Inspector Exam

Latin Term or Pharse Abbreviation English Meaning


Si opus sit s.o.s. when necessary
Solve— dissolve
Solutio sol. a solution
Statim stat. immediately
Sumendus sum. to be taken
Suppositorium supp. a suppository
Tabella, tabletta tab. a tablet
Talis, tales tal. such
Ter in die t.i.d. three times a day
Ter quotidie — three times daily
Tussi urgente tuss. urg. when the cough is troublesome
Uncia — an ounce
Unguentum ung. an ointment
Utendus u. or utend. to be used
Unus i one
Duo ii two
Tres iii three
Quatuor iv four
Quinque V five
Sex vi six
Septem vii seven
Octo viii eight
Novem ix nine
Decern X ten
Undecim xi eleven
Duodecim xii twelve
Quindecim XV fifteen

Avoirdupois System
According to this system, the standard unit for weighing is pound and all other measures
of mass are derived from pound, it is represented by lb.
1 lb = 16 oz (Avoir)
1 lb = 7000 grains
1 oz = 7000/16 = 437.5 grains

Apothecaries System
It is known as troy system. The standard weight in this system is grain.
20 grain = 1 scruple
60 grain = 1 drachm
480 grain =1 ounce (Apothe)
8 drachm = 1 ounce (Apothe)
12 ounce (Apothe) = 1 pound (Apothe)
5760 grain = 1 pound (Apothe)
Appendix-VI! □ □ 297

POSOLOGICAL TABLE

Drug_______________________ Dose______________ - ________Category


Acetazolamide Initial dose 0.5 g; subsequent Carbonic anhydrase inhibitor
doses, 0.25 every 6 hr
Adrenaline By s.c. or i.m. injection, 0.2 Adrenergic
to 0.5 mg, as a single dose
Adrenaline Bitartarate By s.c. injection, 0.4 to 1 mg —do—
as a single dose
Human Normal Serum Albumin By i.v. injection, volume eq. Blood-volume supporter
to 25 g of albumin
Allopurinol 200 to 400 mg daily, in divided Gout suppressant
doses
Aluminium Hydroxide 7.5 to 15 ml Antacid
Gel
Dried Aluminium
Hydroxide Gel 0.5 to 1 g — do—
Amantadine HC1 200 mg daily, in a single dose Antiviral (Prophylactic)
or in two divided doses
Aminophylline 0.1 to 0.3 g by slow i.v. in­ Bronchodilator
jection, 0.25 to 0.5 g
Amitryptiline HC1 75 to 150 mg daily, in divided Antidepressant
doses; maintenance dose, 50
to 100 mg daily, in divided
doses
Ammonium Chloride 3 to 6 g daily, in divided doses Expectorant; diuretic; systemic
acidifier
Amodiaquine HCI Supressive, the eq. of 0.4 of Antimalarial
am odiaquine base weekly.
Therapeutic, the eq. of 0.4 to
0.6 of amodiaquine base daily
for 3 days
Amoxycillin Trihydrate The eq. o f 0.75 to 4.5 g of Antibacterial
amoxycillin daily, in divided
doses
298 □ □ Drug Inspector Exam

Drug________ ___________ Dm* Category


Amphotericin B Oral, upto 200 mg every 6 hr. Antifungal
B y slow i.v. injection, 2S0
lig/kg body weight daily, in­
>4c a c o d y l
creased to I mg/kg daily or
l.S mg/kg on alternate days
Ampiciilin 2 to 6 g daily, in divided doses Antibacterial
Ampicillin Trihydrate The eq. o f 2 to 6 g ampiciilin
daily, in divided doses
Ampiciilin Sodium By i.m. injection, the equation
o f 1 to 8 g of ampiciilin daily,
in divided doses
Amylobarbitone As hypnotic, 0.1 to 0.2 g. As Hypnotic and sedative
sedative, upto 0.6 g daily, ir
divided doses
Amylobarbittone sodium
Analgin 0.5 to 3 g daily, in divided Analgesic
doses
Ascorbic acid In prevention o f scurvy, 25 to Vitamin (antiscorbutic)
75 mg daily; in treatment o f
scurvy, not less than 250 mg
daily, in divided doses
Aspirin Analgesic, antipyretic-0.65 g 4 Analgesic; antipyretic
to 6 times a day
Antirheumatic- i g 4 to 6 times Antirheumatic
a day, upto 10 g daily
Atropine sulphate 0.3 to 0.6 mg, 3 or 4 times Anticholinergic
a day. by s.c. or i.m. injection,
0.4 to 0.6 mg
BCG Vaccine Prophylactic, by i.e. injection Active immunising agent
'as a single dose, 0.1 ml
Belladonna Dry Extract 15 to 60 mg Anticholinergic
Biphenium 5 g, as a single dose Anthelmintic (hookworms)
Hydroxynaphthoate
Berberine chloride 0.1 g as a single dose Bitter stomachic, antibacterial
Betamethasone 0.5 to 5 mg daily, in divided Adrenocortical steroid (anti-in-
doses flammatory)
Bethanidine Sulphate Initial dose, 10 to 20 mg daily, Antihypertensive
in divided doses; maintenance
dose, upto 200 mg daily, in
divided doses
Bisacodyl 5 to 10 mg daily, by mouth Laxative
Busulphan 2 to 4 mg daily Antineoplastic
0.3 to 0 .6 g CNS stimulant
Appendix-VII □ □ 299

Drug______________ Dose Category


Calcium Aminosalicylate 10 to 20 g daily, in divided Antibacterial (tuberculostatic)
doses
Calcium Carbonate I to 5 g Antacid
Calcium Chloride 1 to 2 g, by mouth; 5 to 10 Calcium replenisher
ml o f a 10% solution by slow
i.v. injection
Calcium Gluconate By i.m. or i.v. injection, I to Calcium replenisher
2 g; oral, I to 5 g
Calcium Lactate 1 to 5 g —do—
Calcium Levulinate 1 g daily
Calcium Pantothenate 10 to lOOmg daily Enzyme co-factor
Dibasic Calcium I to 5 g Calcium supplement,
Phosphate pharmaceutical aid
Carbamazcpine 0.2 g daily, increasing to 1.2 Analgesic
g daily, in divided doses, as
per the needs o f the patient
Castor Oil 1 to 15 ml Cathartic, plasticizcr
Cephalexin 1 to 4 g daily, in divided doses Antibacterial
Cephaloridin By i.m. injection, 1 to 4 g
daily in divided doses
Chloral Hydrate 0.3 2 g Hypnotic and sedative
Chloramphenicol For an. adult, 1.5 to 3 g daily, Antibacterial
in divided doses for a child,
25 to 50 mg/kg body weight
daily, in divided doses
Chloramphenicol For an adult, the eq. o f 1.5 to
Palmitate 3 g o f chloramphenicol daily,
in divided doses; for a child,
the cq. o f 25 to 50 mg of
c h lo ra m p h e n ic o l/ k g body
weight daily, in divided doses
Chloramphenical Sodium Succinate By i.v. injection, the eq. of 3 — do—
to 4 g o f chloramphenicol
daily, in divided doses
Chlorcyclizine HCI 50 to 200 mg daily, in divided Antihistaminic
doses
Chlordiazepoxide 10 to 100 mg daily, in divided Tranquilliser
doses
Chloioquine Phosphate In treatment o f malaria, sup­
p ressiv e, 5 0 0 mg weekly,
therapeutic, initial dose, Ig,
subsequent doses, 500 mg daily
300 □ □ Drug Inspector Exam

Drug Dose____________ _ Category


In treatment o f amoebiasis, 500 Antimalarial, antiprotozoal
mg 3 times a day for 2 weeks,
than 750 mg 2 times a week
for several months
Chloroquine Sulphate In treatment o f malaria; sup­ Antimalarial, anti-amoebic
p ressiv e, 4 0 0 mg w eekly;
therapeutic, 400 mg to 1.2 g
daily
In treatment o f amoebiasis;
4 0 0 to 800 mg daily, in divided
doses
Chlorpheniramine 4 to 16 mg daily, in divided Antihistaminic
Maleate doses
Chlorpromazine HCl In psychiatric states, 75 to 800 C e n tra l d e p re ssa n t, tran
mg daily, in divided doses; by quiliser; antiemetic -
i.m. injection, 25 to 100 mg
As an anti-emetic, 25 to 50
mg; by i.m. injection 25 to 50
mg
Chlorpropamide 100 to 500 mg daily Antidiabetic
Chlorthalidone 100 to 200 mg daily
Cholera Vaccine Prophylactic. By s.c. injection, Active-immunising agent
initial, 0.5 ml; second dose, 1
ml after an interval of 4 to 6
weeks
Cimetidine Oral, 200 mg increasing to H2-receptor antagonist
4 0 0 mg when necessary, 3
times a day, and 400 mg at
night; by i.v. injection, 200 mg
every 4 to 6hr. oral and
parenteral dose should not
exeed 2 g daily
Clofazimine F or leprosy, previously un­ Antibacterial (leprostatic)
treated patients, 100 mg 3
times weekly; sulphone-resis-
tant patients 100 mg 6 times
weekly. For suppression o f
lepra reactions, 200 mg daily
Clofibrate Upto 2 g daily, in divided Anthihyperlipidemic
doses
Clonidine HCl 100 to 300 jig daily, in divided Anti hypertensi ve
doses
Cloxacillin Sodium The eq. o f 1.5 to 3 g of Antibacterial
cloxacillin daily, in divided
doses
Appcndix-VII □ □ 301

D rug___________ Dose____________ ________ Category__________


Codeine Phosphate 10 to 60 mg Analgesic, antitussive
Codeine Phosphate Syrup Codeine phosphate, 10 to 40 —do—
mg
Colchicine Initial dose, lm g; subsequent Gout suppressant
doses, 0.5 mg every 2 hr
Cortisone Acelate By i.m. injection, 50 to 400mg. Adrenocortical steroid (anti-in­
For replacement therapy, 12.5 flammatory)
to- 50 mg daily, in divided
doses
Cyanocobalamin In treatment o f megaloblastic B grou p vi t a mi n;
anae mia by i.m. injection, 1 haematopoietic
to 2mg, in divided doses, in
the 1st w eek. Subsequent
doses, 250 jig weekly until the
blood count is normal main­
tenance dose, 250 (ig every 3
or 4 weeks
Cyclizine HC1 25 to 50 mg Antihistamine
Cyclobarbitone Calcium 200 to 400 mg Hypnotic, sedative
Cyclophosphamide By i.v. injection 100 to 150 Antineoplastic, immuno-
mg daily suppresive
Cycloserine 0.25 to 0.75 g, in divided doses Antibacterial (tuberculostatic)
Cyproheptadine HC1 4 to 20 mg daily, in divided Antihistaminic; antipruritic
doses
Dapsone Initial dose, 25 to i o mg twice Antibacteiu;! (Leprostatic)
weekly, increasing by 50 to
100 mg every month, to a
maximum o f 200 to 40 0 mg
twice weekly
Dehydroemetine HC1 By deep s.c. or i.m. injection, Anti-amoebic
60 to 90 mg daily
Demethylchlortetracycline HC1 0.6 to 1.8 g daily, in divided Antibacterial
doses
Desoxycortisone Acetate By i.m. injection, 2 to 5 mg Adrenocortical steroid (salt
daily regulating)
Dexamethasone 0.5 to 10 mg daily, in divided Adrenocortical steroid (anti-in
doses flammatory)
Dexamethasone Sodium Phosphate By i.v. or i.m. injection, the —do—
e q . o f 12 to 3 2 mg o f
dexamethasone phosphate, in
treatment of acute adrenal in­
sufficiency
Diazepam 5 to 30 mg daily, in divided Anticonvulsant, sedative
doses
302 DO Drug Inspector Exam

Drug________________ Dose_________________________ Category


Diethylcarbamazine Citrate 150 to 500 mg daily Antifilarial, anthelmintic
Digitoxin Initial dose, 1 to 1.5 mg, Cardiotonic
divided over 24 to 48 hr; main­
tenance dose, 0.05 to 0.2 mg
daily
Digoxin Initial dose, 1 to 1.5mg, main­ —do—
tenance dose, 0.25 mg, once
or twice daily. By i.v. injection,
initial dose, 0.5 to 1 mg
Di-iodohy droxyqu inol ine 1 to 2 g daily Antiprotozoal
Diloxanide Furoate 1.5 g daily, in divided doses Anti-amoebic
Dimenhydrinate 25 to 100 mg Anti-emetic
Dimcrcaprol By i.m. injection, 2 to 3 mg/kg A n tid o te in heavy m etal
body weight every 4hr during p oison ing, m etal com plex
first and subsequently in agent
accordance with the needs o f
the patient
Diphenhydramine HCI 50 to 200 mg daily, in divided Antihistaminic
doses
Diphenoxylate HCI 5 to 30 mg daily, in divided Antidiarrhoeal
doses
Diphenylpyraline HCI 5 to 20 mg daily, in divided Antihistaminic
doses
Dipihcria Antitoxin By s.c. or i.m. in jectio n , Immunising agent
prophylactic, 500 to 2000 In­
ternational Units; therapeutic,
not less than 10,000 Interna­
tional Units
Diptheria and Tetanus Vaccine By deep i.m injection, two in­ — do—
(Adsorbed) jections of 0.5 ml, 4 to 6
weeks apart, and a third, rein­
forcing dose of 0.5 ml, 6 to
8 months later
Diptheria, Tetanus and Pertussis By i.m. injection, three injec­ Active immunising agent
Vaccine (Adsorbed) tions of 0.5 ml, 4 to 6 weeks
apart, and a fourth, reinforcing
dose of 0.5 ml, 6 to 8 months
later
Doxycycline HCI Initial, the eq. o f 0.2 g of Antibacterial
doxycycline; subsequent doses,
the eq. of 0.1 g of doxycycline
daily
Emetine HCI By s.c. or i.m. injection, 30 Anti-amoebic
to 6.0mg daily
Appendix-Vll □ □ 303

Drug Dose_________________________ Category_______________


Ephedrine 15 to 60 mg Adrenergic (bronchodilator)
Ephedrine HCl 15 to 60 mg — do—
Ergocalciferol In prevention of rickets, not Vitamine D (antirachitic)
more than 20 ng (800 Units)
daily, allowance being made
for Vitamin D obtained from
other sources. In treatment of
rickets and osteomalacia, 0.125
to 1.25 mg (5000 to 50,000
Units) daily. In treatment of
hypoparathyroidism, 1.25 to 5
mg (50,000 to 200,000 Units)
daily
Ergometrine Maleate By i.m. injection, 0.2 to I mg; Oxytoxic
by i.v. injection, 0.1 to 0.5 mg
Ergotamine Tartrate 1 to 2 mg Analgesic
Erythromycin 1 to 2 g daily, in divided doses Antibacterial
Erythromycin Estolate T h e eq. o f I to 2 g o f
erythromycin daily, in divided
doses for not more than 10
days
Erythromycin Stearate T he eq. o f 1 to ' 2 g o f — do—
erythromycin daily, in divided
doses for not more than 10
days
Ethacrynic Acid 50 to 200 mg daily, in divided Diuretic
doses
Ethambutol HCl 15 to 25 mg/kg body weight Antibacterial (tuberculostatic)
daily, for two months, followed
by 25 mg/kg body weight daily
Ethionamide 0.5 to 1 g daily, in divided —do—
doses
Ethosuximide 500 mg daily, in divided doses Anticonvulsant
increasing to 2 g, as necessary
Ethylmorphine HCl 6 to 30 mg Narcotic analgesic
Ethyloestrenoi 2 to 40 mg daily Anabolic steroid
Eucalyptus oil 0.06 to 0.2 ml Counter-irritant, mild expec
torant
Fenfluramine HCl 40 to 80 mg daily, in divided Appetite suppressant
doses
Ferrous Fumarate 0.2 to 0.6 g daily Haematinic
Ferrous Gluconate Prophylactic, 600 mg daily. —do—
Therapeutic, 1.2 to 1.8 g daily
in divided doses
304 □ □ Drug Inspector Exam

Drug___________________ Dose______________________ Category


Ferrous Sulphate 0.2 to 0.3 Haematinic
Dried Ferrous Sulphate Prophylactic, 200 mg daily; —do—
therapeutic, 400 to 600 mg
daily, in divided doses
Fluorescein Sodium 0.5 to 1.^5 g Diagnostic aid
Fluorouracil By i.v. injection, 3 mg/kg on Antineoplastic agent
alternate days 12 mg/kg daily,
to a maximum o f 800 mg daily
Fluphenazine HC1 1 to 2 mg daily in single or Tranquilliser
divided doses (in anxiety
states). Upto 15 mg daily, in
divided doses (for treatment of
schizophrenia).
Folic acid In treatment of megaloblastic Vitamine B (haematopoietic)
anaemia associated with folic
acid deficiency, 5 to 20 mg
daily. In the prophylaxis o f
megaloblastic anaemia o f preg­
nancy, 0.2 to 0.5 mg dally
Frusemide 40 to 120 mg daily Diuretic
Furazolidone 4 00 mg daily, in divided doses Antibacterial and antiprotozoal
Gas Gangrene Antitoxin B y i.v. or i.m . in jectio n , Immunising agent
(cedematiens) prophylactic, 10,000 Interna­
tional Units; therapeutic, not
less than 30,000 International
Units
Gas Gangrene Antitoxin — do— — do—"
(Perfringens)
Gas Gangrene Antitoxin B y i.v. or i.m in je c tio n , —do—
(Septicum) prophylactic 5000 International
Units; therapeutic, not less than
15.000 International Units
Mixed Gas Gangrene B y i.v, or i.m in je c tio n , -do—
Antitoxin prophylactic. 25,000 Interna­
tional Units; therapeutic, not
less than 75,000 International
Units
Gentamycin Sulphate By i.m. injection, 80 to 240 Antibacterial
mg of gentamycin (80,000 to
2 4 0 .0 0 0 Uni t s ) dai l y, in
divided doses
Glibenclamide 2.5 to 20 mg once daily, after Antidiabetic (oral)
food
Appendix-Vll □ □ 305

Drug Dose Category


Glyceryl Trinitrate (Nitroglycerin) Glyceryl Trinitrate,- 0.5 to 1 Vasodilater (coronary)
Tablets mg. Usual strengths 0.2 mg;
0.3 mg; 0.5 mg; 0.6 mg
Grissofulvin 0.5 to 1 g daily, in divided Antifungal
doses
Guanethidine Sulphate Initial dose, 10 to 20 rrjg daily; Antihypertensive
subsequent doses, increasing at
weekly intervals to a maximum
o f 300 mg daily, in accordance
with the needs o f the patient
Heparin Sodium For treatment, by i.v. injection, Anticoagulant
20,000 to 50,000 Units daily.
For prophylaxis, by s.c. injec­
tion, 10,000 to 15,000 Units
daily, in divided doses
Histamine Acid Phosphate By s.c. injection, 0.5 to 1 mg; Diagnostic aid
after the administration o f an
antihistamine, 5 mg
Hydrallazine HCI Oral 10 mg 4 times a day, Antihypertensive
gradually increased upto 50 mg
4 times a day. By i.m. or i.v.
injecton, 20 to 40 mg, repeated
as necessry.
Hydrochlorothiazide 25 to 100 mg Diuretic
Hydrocortisone In treatment of adrenocortical Adrenocortical steroid (anti-in-
insufficiency, 10 to 40 mg daily flammatory)
Hydrocortisone Acetate By intra-articular injection, or
local infiltration, 5 to 50 mg
Hydroxycobalamine In treatment of megaloblastic Vitamin B 12 (haematopoietic)
anaemia, by i.m. injection, 1
to 2 mg, in divided doses, in
the first week; subsequent
doses, 250 jig weekly until the
blood count is normal; main­
tenance dose, lmg every two
months
Hydroxyethyltheophylline 100 to 300 mg by mouth or S m o o th m u s c le re la x a n t
by i.v. or i.m. injection (bronchiolar)
Ibuprofen 0.6 to 1.2 g daily, in divided A nalgesic and anti-inflam ­
doses matory
Imipramine HCI 50 to 150 mg daily, in divided Antidepressant
doses
306 □ □ Drug Inspector Exam

D ru g ____________ __________ Dose _____________________ Category

Indomethacin 75 to 100 mg daily, in divided Anti-inflammatory and anal­


doses gesic
Iron and Ammonium Citrate 1 to 3 g Haematinic
Iron Dcxtran Injection By deep i.m. injection, 1 —do—
to 2 ml daily
Isoniazid 0.3 to 0.6 g daily, in divided Antibacterial (tuberculostatic)
doses
Isoprenaline HCl By s c. or i.m. injection, 200 Adrenergic (bronchodilalor)
jig ; by i.v. injection, 10 to 20
Hg; 2 mg by infusion in
Dextrose injection according to
the needs o f the patient
Isoprenalinc sulphate 5 to 20 mg daily A drenergic (bronchodilatoi
cardiac stimulant)'
Diluted Isosorbide Dinitrate 20 to 300 mg o f isosorbide Anti-anginal
dinitrate daily, in divided doses
Isoxsuprine HCl Oral, 10 to 20 mg, 3 or 4 Peripheral vasodilator
times daily; by i.m. injection,
5 to 10 mg 3 times daily
Ispaghula Husk 3 to 5 g Laxative
Kanamycin S 0 4 By i.m. injection, the eq. o f Antibacterial
0 .5 to 1 g ( 5 0 0 ,0 0 0 to
1.000,000 Units) o f kanamycin
base daily, in divided doses
Kanamycin Acid Sulphate —do—
Light Kaolin 15 to 75 g Adsorbent (in treatment of
diarrhoea)
Lanatoside C For rapid digitalisation, 1 to Cardiotonic
1.5 mg in single or divided
doses. For maintenance 0.25
to 0.75 mg daily
Laptazol 50 to 100 mg CNS stimulant
Levodopa Initial, 250 mg daily, in divided Antiparkinsonian
doses, increasing gradually in
accordance with the needs o f
the patient, maintenance dose,
2.5 to 8 g daily
Lignocainc HCl As local anaesthetic, upto 200 L o cal a n a esth etic; cardi
mg or 500 mg as a single depressant
d o s e , w hen g iv e n w ith
adrenaline. For treatment o f
cardiac arrhythmias, by i.v. in­
jection, 5 0 to 100 mg
Appendix-VII 0 0 307

Drug Dose Category


Lincomycin HC1 The eq. o f 1.5 g o f lincomycin, Antibacterial
in divided doses, 30 minutes
before food. By i.m. injection,
the eq. o f 0.6 to 1.2 g of
lincomycin daily, in two doses.
By i.v. infusion, the eq. o f 600
mg o f lincomycin every 8 hr
Lithium Carbonate 0.25 to 1.6 g daily, in divided Antidcpressant
doses
Lynestrenol 2.5 to 15 mg daily Progestin
Milk of Magnesia As an antacid, 5 to 10 ml; as Laxative; antacid
a laxative, 15 to 30 ml
Heavy Magnesium Carbonate As an antacid, 0.3 to 0.6 g; Laxative; antacid
as a laxative, 2 to 4 g
Light Magnesium Carbonate —do—
Heavy Magnesium Oxide As gastric antacid, 0.3 to Antacid, Laxative
0.6 g; as a laxative, 2 to 4 g
Light Magnesium Oxide —do— —do—
Magnesium Sulphate 2 to 16 g Cathartic
Magnesium Trisilicate 0.5 to 2 g, repeated in accord­ Antacid
ance with the needs o f the
patient
Malt Extract 4 to 16 ml Nutritive
Measles Vaccine Live Pediatric, by 9 g injection. Active immunising agent
0.5 ml of reconstituted vaccine
Mebendazole For threadworm infestation, Anthelmintic
100 mg as a«vsingle dose; for
other infestations, 100 mg
twice daily for two days
Mecamylamine HCI Initial dose, 5 mg daily, in Antihypertensive
divided d oses; subsequent
doses, in accordance with the
needs of the patient
Meclizine HCi 25 to 50 mg Antihistaminic; anti-emetic
Menihe Oil 0.06 to 0.2 ml Carminative
Mephenesin By i.v infusion, 0.1 to 1 g Skeltal muscle relaxtant
Meprobamate 0.4 to 1.2 g daily, in divided Sedative
doses
Mepyramine Maleate 0.3 to 0.6 g daily, in divided Antihistaminic (H ( recep'Oi
doses. By i.m. or i.v. injection, antagonist)
25 to 50 mg
Mestranol 0.05 to 0.15 mg daily, usually Estrogen
in conjuction with a proges­
togen
308 □ □ Drug Inspector Exam

Drug________________ Dose Category


Metformin HCI 0.S to 2.0 g daily, in divided Oral hypoglycaemic
doses
Methadone HCI Oral, 5 to 10 mg. By s.c. Narcotic analgesic
injection, S to 10 mg
Methandienone Adults, 5 to 10 mg daily; A n a b o lic s te ro id , w eak
children, 0.5 to 1 mg daily androgen
Methotrexate 5 to 100 mg at suitable inter­ Antincoplastic; antipsoriatic
vals
Methlamphetamine HCI 2.5 to 10 mg. By i.m. or i.v. Adrenergic; central stimulant
injection, 10 to 30 mg
Methyldopa The eq. o f 0.5 to 3 g o f Antihypertensive
anhydrous methyldopa, daily,
in divided doses
Methylergometrine Maleate By s.c., i.m. or i.v. injection, Uterine stimulant; oxytoxic
0.1 to 0.2 mg
Metronidazole For trichomoniasis, 200 mg 3 Anti-amoebic; antitrichomonal;
times daily, for 7 days. For anti-giardial
amoebiasis, 4 0 0 mg 3 times
daily, for 5 to 10 days. For
giardiasis, 2 g daily for 3 suc­
cessive days for adults 1 g for
children and 4 00 mg daily for
infants
Morphine HCI 10 to 20 mg Narcotic, analgesic
Morphine Sulphate — do— —do—
Nalidixic Acid 2 to 4 g daily in four divided Antibacterial
doses
Nalorphine HCI B y i.v . in je c tio n , 5 mg, Antidote for narcotic anal­
repeated twice at 3 minutes gesics
intervals if necessary
Neomycin Sulphate For systemic use, the eq. o f Antibacterial (topical and sys­
0.7 to 2.0 g o f neomycin base temic)
daily, in divided doses
Neostigmine Br 15 to 30 mg, 3 to 6 times a Cholinergic
day
Niclosamide 2 g in divided doses Anthelmintic (teniacide)
Nicotinamide Prophylatic, 15 to 30 mg daily; B-group Vitamin
therapeutic, 50 to 250 mg
daily. By i.v. injection, 50 to
250 mg daily
Nicotinic Acid Prophylactic, 15 to 30 mg B-group Vitamin vasodilator
daily; therapeutic, 50 to 250
mg daily
Appendix-VII □ □ 309

Drug Dose_________________________ Category_______________


Nikethamide By s.c., i.m. or i.v. injection, Respiratory stimulant
0.25 to 2 g
Nitrofurantoin 50 150 mg — times daily Antibacterial (urinary)
Noradrenaline Acid Tartrate By i.v. infusion, 2 to 20 ng Adrenergic (vasopressor)
per minute, according to the
blood pressure o f the patient
Norethisterone 5 to 20 mg daily, in single or Progestin
divided doses
Noscapine 15 to 3 0 mg Antitussive
Novobiocin Sodium T h e eq . o f 1 to 2 g o f Antibacterial
novobiocin daily, in divided
doses
Nystatin In treatment o f alimentary Antifungal
moniliasis, 1 to 2 million Units
daily, in divided doses
Oestradiol Benzoate By i.m. injection, 1 to 5 mg Oestrogenic harmone
daily
Oestradiol By i.m. injection, initial, I to
5 mg every 1 to 2 weeks;
maintenance, 1 to 2.5 mg every
10 days to 2 weeks"
Opium 25 to 200 mg , Hypnotic, sedative, narcotic;
analgesic
Oxyphenbutazone 200 to 400 mg daily, in divided Anti-inflammatory analgesic
doses
Oxyphenonium Br 5 to 10 mg Anticholinergic
Oxytetracycline 1 to 2 g daily, in divided doses Antibacterial
Oxytetracycline HCl 1 to 2 g daily, in divided doses.
By i.v. infusion, in a concentra­
tion 0.1% w/v, 1 to 2 g daily
Paracetamol 0.5 to 1 g; upto 4 g daily, in Analgesic; antipyretic
divided doses
Paraldehyde By i.m injection, 2 to 8 ml. Hypnotic; sedative anticonvul­
By rectal injection, 15 to 30 sant
ml suitably diluted
Paramethadione 0.9 g daily, in divided doses, Anticonvulsant
increasing to 1.8 g in accord­
ance with the needs of the
patient
Benzylpenicillin B y i.m . or i.v. in je ctio n , Antibacterial
50 0 ,0 0 0 to 1,000,000 Units
daily, in divided doses
310 □ □ Drug Inspector Exam

Drug____________ __________ Dose___________________ ' Category__________


Pentobarbitone Sodium 0.1 to 0.2 Hypnotic; sedative
Pepsin 0.3 to 1 g Proteolytic enzyme
Pethidine HCI 25 to 100 mg. By s.c. or i.m. Analgesic
injection, 25 to 100 mg; by
1.v. injection, 25 to 50 mg
Phenformin HCI 50 to 200 mg daily, in divided Oral hypoglycaemic agent
doses
Phenindamine Tartrate 75 to 150 mg daily, in divided Antihistaminic
doses
Pheniramine Maleate 25 to 50 mg daily, in divided
doses
Phenobarbitone Upto 350 mg daily, in divided Hypnotic; sedative anticovul
doses sant
Phcnobarbitone Sodium Upto 350 mg daily, in divided Hypnotic; sedative
doses. By i.v; i.m. or s.c. in­
jection, 50 to 200 mg
Phenoxymethylpenic.illin Potassium The eq. of 0.5 to 1.5 g o f Antibacterial
phenoxymethlpenicillin daily,
in divided doses
Phenylbutazone 100 to 600 mg daily, in divided Anti-inflammatory; analges't
doses
Phenylephrine HCI By s.c. or i.m. injection, 5 mg; Adrenergic (vasopressor)
by i.v. injection, 0.5 mg
Phenytoin Sodium 50 mg daily, increasing to 400 Anticonvulsant
mg; by i.m. or slow i.v. in­
jection, upto 250 mg in
accordance with the needs o f
the patient
Phthalylsulphathiazole 5 to 10 mg daily, in divided Antibacterial (intestinary)
doses
Physostigminc Salicylatc 0.6 to 1.2 mg Anticholinergic
Piperazine Citrate For threadworms, 0.6 to 4.5 g Anthelmintic
daily, in divided doses. For
roundworms, upto 5 g in a
single dose according to the
age o f the patient
Plague Vaccine By s.c. injection, I ml (first Activc immunising agent
dose); 1ml (second dose) after
an interval o f 7 to 10 days.
A single dose o f 3ml may be
given in emergency
Potassium Bromide 0.3 to 1.2 g Sedative; anticonvulsant
Potassium Chloride I to 2 g Electrolyte replcnisher
Potassium Citrate 4 to 10 p Svslemic oi'"-'
Appendix-VII □ □ 311

Drug Dose_________________________ Category_____________________


Potassium Iodide As expectorant, 250 to 500 Antifungal; expectorant source
mg. In pre-operative treatment o f iodine
o f thyrotoxicosis, 30 to 6 0 mg
Prednisolone 5 to 6 0 mg daily, in divided Adrenocortical steroid (anti-in­
doses flammatory)
Prednisolone Acetate —do—
Prednisone
Prednisone Acetate —do— —do—
Primaquine Phosphate The eq. o f 15 mg of prima­ Antimalarial
quine base, once a day for 14
days
Primidone 0.5 to 2 g daily, in divided Anticonvulsant
doses
Procaine HCI Epidural, 25 ml o f a I.59J Local anaesthetic
solution. Infiltration, upto 200
ml o f a 0.25 to 5% solution.
Peripheral nerve block, upto
25 ml o f a 2% solution. Spinal,
1 to 3 ml of a 3.3 to 5%
solution
Procaine Penicillin By i.m. injection, 0.3 to 0.9 g Antibacterial
daily
Proguanil HCI As suppressant o f malaria, 0 .1 Antimalarial
to 0.3 g daily
Promethazine HCI 2 0 to 50 mg daily, in single Antihistaminic. anti-emetic
or divided doses
Propranolol HCI 20 mg to 2 g daily, in divided Adrencrgic, p-rcceptor anta­
doses; the initial daily dose gonist (anti-hypertensive, anti-
should not exceed 4 0 mg; by anginal; anti-arrhythimic)
slow i.v. injection, 3 to 10 mg
Pyrazinamide Upto 35 mg/kg body weight Tuberculostatic
daily, in divided doses
Pyridoxine HCI P rop h y lactic, 2 mg d aily; B-group vitamin
therapeutic, 10 to 150 mg 1
to 3 times daily
Pyrimethamine Suppressive, 25 mg once a Antimalarial
week; therapeutic, 25 to 50 mg
once a day for 2 days
Quinidine Sulphate In prophylaxis of cardiac ar­ Cardiac depressant (anti-
rhythmias, 0.2 g 3 or 4 times arrhythmic)
daily. In treatment o f atrial
fibrillation, 0.2 to 0.4 g every
2 to 4 hr to a total dose o f
3 g daily
3 12 O n Drug Inspector Exam

Drug________ Dose __________________ ____ Category


Quinine Bisulphate In suppression of malaria, 0.3 Antimalarial
to 0 .6 g daily. In treatment of
malaria, 1.2 to 2 g daily, in
divided doses
Quinine Sulphate - Jo—
Quiniodochlor 0.75 to 1.5 g daily, in divided Antiprotozoal topical and in­
doses i testinal antseptic
Rabies Vaccine By s.c. injection, 1 to 5 ml Specific immunising agent
daily, for 7 to 14 days accord­
ing to the site and severity o f
the bite and the risk of
exposure to infection
Reserpine In psychiatric states, 1 to 5 M ajor transquiliser antihyper­
mg daily, in divided doses. In tensive
treatment o f hypertension, 0.5
mg daily
Riboflavine Prophylactic, 1 to 4 mg daily; B-group vitamin
therapeutic 5 to 10 mg daily
Rifampicin 450 to 600mg Antibacterial
Salbutamol Sulphate The eq. o f 6 to 16 mg o f Adrenergic (bronchodilator)
salbutamol daily, in divided
doses
Scopolamine HBr By s.c. injection, 300 to 600 Anticholiner

Senna leaf 0.6 to 2 g Cathartic


Shark Liver Oil 0.1 to 1.0 ml Antixerophalnic Vitamin
Smallpox Vaccine (Freeze-Dried) For Prophylaxis o f smallpox, Immunising agent
about 0.02 ml applied to the
sk in and in o c u la te d by
scarilication or pressure
Sodium Acid Phosphate 2 to 4 g Urinary Acidifier
Sodium Aminosalicylate 10 to 15 g daify, in divided Antibacterial (tuberculostatic)
doses
Sodium Antimony Gluconate By i.m. or i.v. injection, 0.6 Sy stem ic anti Leishm aniac
to 2.0 g daily, for 10 to 30 agent
days
Sodium Ascorbate The eq. o f upto 1 g o f ascorbic Vitamin C
acid daily
Sodium Bicarbonate 1 to 4 g Alkaliser systemic
Sodium Citrate 1 to 10 g Systemic
Sodium Lactate Injection By i.v. infusion, as a 1/6 molar Fluid and sodium replenisher
solution, at the rate o f 5 ml
or less per minute
Appendix-VIl □ □ 313

D r u g ____________ Dose_____________________________ Category


Sodium Salicylate 0.6 to 2 g. In treatment o f Analgesic
acute rheumatism, 5 to 10 g
daily, in divided doses
Sodium Thiosulphate By i.v. or i.m. injection, 25 g A n tid ote used in cyanide
poisoning
Streptomycin Sulphate By i.m. injection, the eq. o f Antibacterial
0.5 to 1 g o f streptomycin base
daily, or at longer intervals.
As an intestinal antiseptic, the
eq. o f 0.5 g o f streptomycin
base every 8 hr.
Succinylsulphathiazole 10 to 20 g daily, in divided Antibacterial
doses
Sulphadiazine Initial dose 3 g; subsequent
doses, upto 4 g daily, in divided
doses
Sulphadimethoxine Initial dose, 1 to 2 g; sub­
sequent dose, 500m g daily
Sulphadimidine in treatment o f systemic infec­ Antibacterial
tions; initial dose, 3 g; sub­
sequently upto 6 g daily, in
'divided doses. In treatment of
urinary tract infection; initial
dose, 2 g; subsequently upto
4 g in divided doses
Sulphadimidine Sodium By i.m. or i.v. injection, 1 to — do—
2 g
Sulphadoxine Initial, 2 g by mouth; sub­
sequent doses, 1 to 1.5 g week­
ly. By deep i.m. or slow i.v.
injection 2.5 g initially, fol­
lowed by 1.5 g after 4 days
Suiphamethizole 100 to 200 mg every 4 to 6
hr
Sulphamethoxazole Initial, 2 g, then 1 g 2 or 3
times daily
Sulphaphenazole Initial dose, 1 g, every 12 hr, —do—
for 2 days, subsequent doses,
5 00 mg every 12 hr for 3 to
5 days
Testosterone Propionate By i.m. injection, 5 to 25 mg, Androgen
once or twice weekly
314 □ □ Drug Inspector Exam

Drug_________ _______________Dost___________________________ Category


Tetanus Antitoxin B y s .c . or i.m . in jectio n , Immunising agent
prophylactic, not less than
1 5 0 0 In tern atio n al U n its;
therapeutic, not less than
50,000 International Units
Tetanus Vaccine (Adsorbed) By deep i.m. injection, two Active Immunising Agent
injections o f 0.5 ml at an
interval 4 to 6 weeks, followed
by a third reinforcing dose o f
0.5 ml, 6 to 8 months later
Tetracycline 1 to 3 g daily, in divided doses Antibacterial
Tetracycline HCI For adults, 1 to 3 g daily, in Antibacterial; anti-ameobic
divided doses; for children, 10
to 30 mg/kg body weight daily,
in divided doses
Thiabendazole 1.5 g, twice daily for 2 or 3 Anthelmintic
days, in treatment o f nematode
infestation
Thiacetazone 0.15 g, daily Tuberculostatic
Thiamine HCI Prophylactic, 2 to 5 mg once Vitamin B t (enzyme co-factor)
a day, therapeutic, 25 to 100
mg daily
Thiamine Mononitrate Vitamin B t
Thiopentone Sodium By i.v. injection, 0.1 to 0.5 g; Anticonvulsant; general anaes­
by rectal injection, 4 0 mg/kg thetic
body weight. Maximum dose
2 g
Thyroid 30 to 250 mg daily Thyroid harmone
Thyroxine Sodium 0.05 to 0.3 mg daily —do—
Tolbutamide 0.5 to 1.5 g daily, in divided Antidiabetic
doses
Triamcinolone 4 to 12 mg, I to 4 times daily Adrenocortical steroid (anti-in-
flammatory)
'riamterene 150 to 250 mg daily, in divided Diuretic
doses
rifluoperazine HCI Oral, the eq. o f 2 to 30 mg Antipsychotic
o f trifluoperazine daily, in
divided doses; by i.m. injec­
tion, the eq. o f 1 to 2 mg o f
trifluoperazine every 4 to 6 hr
as required
Appendix-VU □ □ 315

Drug Dose Category


Trifluopromazine HCl Oral, the eq. of 30 to 150 mg Antipsychotic agent
o f trifluopromazine daily. By
i.m injection, the eq. of 5 to
10 mg o f trifluopromazine
repeated every 4 hr, if neces­
sary. By i.v. injection, the eq.
o f 1 to 3 mg o f triflu o­
promazine repeated every 4 hr
if necessary.
Troxidone For adults, 1 to 2 g daily, in Anticonvulsant
divided doses; for childern,
0.25 to 0.5 g daily, in divided
doses
Tubocurarine HCl By i.m. or i.v. injection, 0.1 Skeltal muscle relaxant
to 0.3 mg/kg body weight, not
exceeding 25 mg, then 0.025
to 0.1 mg/kg repealed as neces­
sary
Typhoid Vacciuc Prophylactic, by s,c. injection, Active immunising agent
0.5 ml as initial dose; second
dose o f 1 ml after an interval
of 4 to 6 weeks
Typhus Vaccine Prophylactic, by s.c. injection, -d o -
0.25 to 1 ml
Urea 5 to 15 g Diuretic
Vitamin A Prophylactic, 5000 Units of Antixcrophthalmic Vitamin
V itam in A activity, daily;
therapeutic, 10,000 to 200,000
Units o f Vitamin A activity
daily
Yellow Fever Vaccine Prophylactic, by s.c. injection, Active immunising ageni
not less than 1000 LD50 doses
316 □ □ Drug inspector Exam

CHEMICAL STRUCTURES
(Categorywise)

1. General Anaesthetics
Ultrashort acting barbiturates
CH3
H
OxXN'spP
V Nv SNa
C A -1 N CH2 - CH - CH2 ^ ____NH
CH3 — CH2 — CH2CH n CH3CH2 — C *C - ” C H ||
I 0 I 0
Ctt3 ch 3
Thiopentone sodium Methohexitone
5-Ethyi 5-(1-methylbutyl) 5-AflyH -methyl-5-(1 -methylpent-2-ynyl)
-2 -thiopentone sodium 1 barbituric acid
2. Local Anesthetics
(/') Ester Type (ii) Amide Type

H2N- f V COOC2H5
, ch3
Benzocaine
(Ethyl p-aminobenzoate)
CjHs (• 7 — NH CO CH,N y ° 2Hs
\=/ ^ C j Hj
NH COOCH2CH2N \ c h
2n 5
Lignocaine
Procaine
(2 -Oiethylamino-2 ‘, 6 ’-acetoxylide)
2-(Diethylamino ethyl p-aminobenzoate)
Appendix-VIll □ □ 317

3. Adrenergic Drugs
(/) Catecholamines
HO

H Q - f o - OH — CH2 — NHCH3 0 5
H ,-^ > - CH — C H j — NH,

OH OH
Adrenaline Nor-adrenaline
(1-{3’, 4'-Dihydroxyphenyl (1 -(3',4'-Dihydroxyphenyl)
2-methylamino ethanol) 2-amino ethanol

H O.

H0 O CH C H 2N H C H (C H 3>2
OH

■5oprenalin§
(1 -(3',4'-Dihydroxyphenyt) 2-is6propyiammo eiha«ol)
(/'/') Non Catecholamines
HOCH-j

H O - / 0 V CH — CH2NH C(CH3)3 CH — CHNHCH3

OH OH CH3

Salbutamol Ephedrine
1-(4'-hydroxy, 3'-hydroxymethy!) (2-methytamino 1-phenyl propan-1-ol)
2-tert butyl amino ethanol

HO HOy _
CH — CH2NHCCH3 CHiNHCiCHJz
OH HO OH

Phenylephrine Terbutaline
(1 -(3’-Dihydroxyphenyl) (2-(Tert butylamino)
2-methyiamino ethanol) 1'(3',5'-dihydroxyphenyl ethanol))

4. Cholinergic Drugs
(/') Ester of Choline
O O
II
(CH3)3 n — c h 2 c h 2 — O — C — CH3 (CH3)3 N — CH2 CH — O — c — CH3
I
Acetylcholine CH 3
Methacholine
((J-Methyl acetylcholine)
(ii) Cholinomimetic alkaloids

c 2h 5
Pilocarpine
(3-Ethyldihydro-4 (1 -methyl-1 H-imidazol-
5yl-methyl)-2(3H)-furanone)
3 18 □ □ Drug Inspector Exam

(Hi) Cholinestrase inhibitors


CH3 ch 3 N(CH3>3
I

CH3 Neostigmine bromide


Physostigmine (3-(Dimethyl carbamoyl oxy),
N, N, N-trimethyl anilinium bromide)
5. Adrenergic antagonists
(i) a-blocker

O n 'O
TolazoKne
(2-Benzyl 2-imidazoline)
(ii) P-blockers
OH

OCHjCH — CHoNHCH (CH,), /7 ~ ~ \


1 (CH^jCHNHCHjCH CH2O —^ y - NHCOCH3

OH

w ^ H s S mino1
6. Anticholinergic Drug
( 0 Solanaccous alkaloids
CHj — CH — CH2 CH2OH C H j— CH — CH2 CH;
/ I I
N — CH3 CH — O — COCH N — CH3 CH — O — CO — CH
I i \==/ \
C H j— CH — CH2 CH2 — CH — CH2
Atropine Hyoscine
CH2 — CH — CH2

N — CH3 CH — OCO — CH- x


I I I \=/
CH2 — CH — CH2 OH
Homatropine

(ii) Synthetic analogues


COCH CHj -
c o c h j2c N- [CH(CH3)2)2 CH20H ^

OCO CH* B{-

Propantheline bromide

(N, N-DHsopropyl N-methyl [2-(xanthene 9-yl carbanoyloxy)]


^ "V -C H -C -N ^
\=/ H V u _ jT \
0 CHzHW
Tropicamide ------
(N-Ethyl-a-(hydroxymethy!)-N-
ethyl ammonium bromide) (4-pyridinylmethyl) benzeneacetamide)
Appendix-VM □ □ 31V

7. Hypnotic and Sedatives


( 0 Barbiturates

ce,
c2h5 C -N
II H H
0
Phenobarbitone * Barbiton*
(5-Ethyl-5-phenyl (5,5-Diethyl barbituric add)
barbituric add)
(ii) Non Barbiturates
CH3

Diazepam Nitrazepam (3-Ethyl-3-phenytglutarimide}


(1,3-Dihydro 7-Ch|oro-1- ( 1 ,3-Dihydro, 7-nit ro
methyl 5-phenyl, 2H-1, 5-phenyl, 2H-1.
4-benzodiazepin-2-one) 4-benzodiazepin-2-one

0 CH3 — CH CH — CH3
II
0 , 0 . C H ,0 - - P — ONa
° 'C H '°
1 I
OH ch3

Tridofos sodium
Paraldehyde
(2.2,2-Trichloro ethanol dihydrogen
( 2 , 4 , 6-Trimethyl S-Moxane)
phosphate monosodium salt)
8. Anticonvulsant Drugs
(i) Hydantoins (ii) Oxazolidinediones
ch 3,
C ®H s
cshsY
NV,
T r ONe
4 ——N
nw
ch 3-x°y°
y " " N — CHj
^ V O ^ O
ch3-4 r
O? ..... —CHj
Phenytoinsodium Troxidone Paramethadione
(5 ,5-Diphenyl hydantoin) (2,4,4-Trimethyl oxazol (5-Ethyl 3,5-dimethyl
2 , 4-dione) oxazoHcNne 2,4-tSone)
(iii) Succinimides (iv) Miscellaneous
n
II I
*------(-CH3 <W
CjHg CzHg I
CONH2
Ethosuxirrvde Primidone Carbamazepine
(3-Ethyl 3-methyl (5H-Dibenz[b, qazepine
2,5-pyrolidine dione) -5-carboxamide)
320 □ □ Drug Inspector Exam

9. Psychoactive Drugs
(/) Phenothiazine derivatives
/— \
(C H 2)3 - N n -c h 3

I N— '
SN
Cl a
I I
(C H 2)3 - N ( C H 3)2

Chlorpromazine Prochlorperazine
2-chloro1Q[3-dimethylamino) 2-Chloro-10-[3-(4-methyl-1 -
propyl] phenolthiazine piperazinyl) propyl] phenothiazine
(ii) Butyrophenones
OH
COCH2 ch 2 CH2 ■
■ - 0 - ■ o o -
Haloperidol
(4-[4-(p-chlorophenyl)-4-hydroxypiperidino]
-4-fluorobutyro phepone)
(iii) Tricyclic Antidepressants

N
CH2 CH2 CH 2N (CH3)2 CH CH 2 C H 2N (CH3)2

Imipramine Amitriptyline
10,11-Dihydro M,N-dimethyl 3 -{ 1 0 ,11-Dihydro 5H dibenz
-5H-dibenz [b, f] azepine -5-propanolamine [a, d] cycloheptene-5-ylidene)
N'.N-dimethyl propylamine HCI.
(*v) MAO inhibitors
NH,

a ch 2 c h 2n h nh 2 H2 S0 4

Phenelzine
(P-Phenethylhydrazine) Tranylcypromine
(Trans-2-Phenylcyclopropanamine)
(v) Antianxiety Drugs
NHCH,

-> 0

Chlordiazepoxide
(7-Chloro-2-(methylamino)-5-phenyl-
3H-1, 4-benzodiazepine-4-oxide)
Appendix-VIII □ □ 321

10. CNS Stimulant Drugs


o
C H , — N ' T ! --------N — C H,

o K
CH3
K J Cr N
Nikethamide
CHa
Amphetamine
(N,N-Diethylnicotinamide) (1-Methyl phenylethyl amine)
Caffeine
( 1 , 3,7-Trimethylxanthine)
11. Opoid Analgesics
( 0 Naturally occurring opoid analgesics

Morphine
(ii) Synthetic opoid analgesics
C8h 5 c o o c 2h 5 Cr6n
H5 N(CH3)2

N
CH3CH2CO — C — CH2 _ CH — CH3
I
CH3
C6H5
Pethidine
(Ethyl 1-methyl 4-phenyl Methadone
piperidine 4-carboxylate)
(6-Dimethylamino-4, 4-diphenyl 3-heptanone)
(CH2)2 - C 6H5

C gH s^ — O — CH2CH3

C- . HCl
CbH5CH2/ ^ CH — CH3
I
CH2
I
NfCH^
Dextroproxyphene hydrochloride
(4-Dimethylamino-1, 2-diphenyl 3-methyl
2-butanol propionate)
(iii) Narcotic antagonist

Nalorphine
322 DO Drug Inspector Exam

12. Non-Steroidal Anti-inflammatory Drugs


(i) Salicylic acid derivatives
COOH

COOH COOH

ococh3 o -co

Aspirin F' ~ ' F Salsalate


(Acetylsalicyiic acid) Diflunisal
5-(2,4-dilluoropnenyl)-2- hydroxy
benzoic acid
(ii) N-Aryl anthranilic acid
ch3 ch.
COOH

Mefenamic acid
2-(2,3-dimethyl phenyl amino) benzoic acid
(iii) Indole acetic acid
c h 2c o o h

■ " O p : ch3

CO

Cl
Indonriethacin
(1 -p-chtorobenzoyO-5-methoxy
2-mefhyl indole-3-aceiic acid)
(iv) Arylpropionic acid derivatives
CH 3 ch ,
ch .
I
^ ch- ch. Y V CHCOOH CHCOOH
ch3/ \=/ CH3 ° - 4 ^ A ^ J
Ibu profen
(2(p-lsobulylphenyl) propionic acid) Naproxen
(li-(6-m ethoxy napthyl)-2-propionic acid)
(v) PyrazoJe derivatives
OH

c6hs
O. ,L
"n — <6h 5
- c
J ___ J = o X - i o 0""5
CH3 — CH j — CH2 — CH j ch3— ch2— ch2— ch2

Phenylbutazone Oxyphenbutazone
(1,2-OiphenyMn-butyl>3,S-pyrazoiidine dione) (1 p-HydroxyphenyK-phenyMi1
bu!yl*3.5-pyrazo!kiine t ! ;
Appendix-VIH OO 323

13. Antihistamines
(/') Aminoalkylethers (ii) Ethylenediamines

ch 3

■CH,

(2-Diphenmethoxy N,N-dimethyl ethylamine)

Mepyramine malsate
(2'-[(2-Dimethylaminoethyl)(p-niethoxy benzyl)
amono] pyridine)
(iii) Alkylamincs (iv) Phenothiazines

CHa
ci I •
O x ,CH— C H j c h 2 n ;
CH,
- O s c h — CH 2'CH 2 n;
.CH, CH* CH — N(CH3)2
'C H , 'C H ,

Pheniram ine Chlorpheniramine


(24o-(2-Dimethylaminoethyl) benzyll pyridine) (2-{(p-ehloro-a-(2-clinnethylafninoethy0 Prom ethazine
benzyl)) pyridine) (1(H2'-Oimethylainino propyl) phenolhiazine)

(v) Miscellaneous

ch 3

Cyprophetadine
(1-m ethyl-4-(5H-dibenz (a.d) cycio-heptenylidine) piperidine)
14. Cardiovascular Drugs
(/) Cardiac tonics
o
324 □ □ Drug Inspector Exam

(ii) Antiarrhythmic drug

/ -----v . c 2 h5 (ch 3 ) 2 c h x
W, * o
N H 2 —\ O V " CONH CH, CH2< .NCH2 CH2 — C — C — NH2
W c 2 hs (CH3 )2 C H / I h3 po4
Procainamide
(4-Amino N-[2 -(diethylamino) ethyl] I I I
benzamide)
Disopyramide Phosphate
g (4-(di-isopropyiamino)-2-phenyl
* ^ 2 -(2 '-pyridyl) carbamate phosphate)
N N
II |^
1
OH
°H ( CH
c h 33

O
CHCOOH
o c h 2 — C — CH2N CH— CH3 II
CH.COOH
ch3
Timolol maleate

(/ JT \
CH,________ CH(CH3 ) 2

CH3Q - V V\\- CH
CH-XHoN —
CH2N — fCH-X
2 (CH — —C—V 2 ) 3 y -O C H 3
CH3 O - S = Z / I \ = Z _ OCH, . HCl
3 ■ CN 3

Verapamil hydrochloride
(5-[N-(3',4'-Dimethoxyphenethyl) N-methylamine]
2-(3",4"-<fimethoxyphenyl)-2-isopropyl valeronitrile)
(Hi) Antihypertensivc agent
NH2

HO \ O V - CH2 — C — COOH
HO - * |
CH3
Methyldopa
(3-Hydroxy-«-methyl-2-tyrosine) [2-(2,6-dichloro anilino-2-imidazoline]

CH,
« , j O q O
h I I
OCHo

OCH3

X OCH3
Appendix-VM □ □ 325

(iv) Antianginal agents

CH20 N 0 2
I
chono2

I
c h 2o n o ?
Nifedipine
Glyceryl trinitrate (1 ,4-Dihydro-2,6-dimethyM-(2-nitro phenyl)
(v) Lipid lowering agents -3,5-py-ridine acid dimethylester)

CH,

ch 2c h 3

CH,
Clofibrate
(2-(4-Chlorophenoxy)-2-methyl propionate)
15. Steroidal Drugs
(i) Androgens
OH OH

Testosterone
(17-p-hydroxy androst-4-ene-3-one) (17-p-hydroxy estr-4-ene-3-one)
OH 1

(ii) Oestrogens
OH

Oestradiol Stiibosterol
(1,3,5-Estratriene 3,17-ft diol) (3,4-bis (p-hydroxy phenyl) hex 3,4-ene)
326 □ □ Drug Inspector Exam

(iii) Progestogens
CH,

(Preg-4-ene-3,20-dione)
(tv) Adrenocortical hormones
c h 2o h c h 2o h c h 2o h

Hydrocortisone Prednisolone Betamethasone


(11,17,21-Trihydroxy preg-4. (11 p,17,21-Trihydroxy-1, (9a fluoro-11(5,17,21 -trihydroxy-16fJ-methyI
ene-3,20-d»one) 4-diene-3,20-dione) pregna-1,4-diene-3, 20-dione)
16. Diuretics
(i) Carbonic anhydrase inhibitors
h 2n o 2s - ^ S ^ . n HCOCH3

N --------N
Acetazolamide
(2-(Acetylamino) 5-sulfonamido 1, 3 ,4-thiadiazole)
(ii) Thiazides
O,
h 2no 2s-

C l'
H
Chlorthiazide Hydrochlorthiazide
(6-chlo ro -2H -1,2, 4-benzothiadiazine (6-chloro-2H-1. 2 , 4-benzothiadiazine
-7-sulphonam ide-1,1-dioxide) 7-sulphomide-1, 1-dioxide)
(iii) High ceiling diuretics
CO O H

NH — CH.

H2N02S :1 _ 1

C*CH2

Frusemide l
(4-chioro-N-(urfuryU5-sulphamoyl <^5
anth ranic acid) Ethacrynic acid
(2,3-Dichloro-4-(2-methylene butyryl)
phenoxy acetic acid)
Appendix-VIIl □ □ 327

(/V) Potassium sparing diuretics

Spironol^ctpne
17. Antimalarials
(/) Naturally occurring alkaloid

Quinine
(//') 4-Ammoquinolines
Cl

/ C2HS ___ / CHj^Cj HsJj


NH — CH C H , CH2CH2N ^ OH
i ‘ x c 2h 5
CH3
Amodiaquine
Chloroquine
(4-(7-chloro-4-quinolyI) amino-a
(4-(4-Diethylami no-1-methyl butyl)
-(diethyl amino)-o-cresol)
-amino-7-chloro quinoline)
(iii) 8-Aminoquinolines (iv) Biguanides
NH NH CH3
CH30 II I
C I - ^ ~ ^ - N H - C - NH — C — NHCH . HCI
HN — CH — CH2 CH2 CH2 NH2
I
CH,
CH
I Proguanil hydrochloride 3
CH3 (1-(p-Chlorophenyl-5-isopropyl biguanide)

Primaquine
(8-(4-Amino-1-methyfbutylamino)
6 -methoxy quinoline)
(v) Diaminopyrinidines

Pyrimethamine
(2,4-Diamino-5-p-chlorophenyl-6-ethyl pyrimidine)
328 □ □ Drug Inspector Exam

18. Sulphonamides

COOH

s o 2nh - t s ( Y CONH s o 2nh


\=/ N =/ \=s \ = / N~U
Sulphadiazine Phthalyl sulphathiazole
(4-Amino-N-2-pyrimidinyl 4'-(2-Thiazolylsulphamoyl) phthalamic acid)
benzene sulphonamide)
.NL
• NH,
N—0 ch 3o _ I T
H2 N ~ f y s o 2n h - / / CH, 1 5N
■CH, NH,
Sulphamethoxazole CH30&
(4-Amino(-N-(5-methyl-3-isoxazoyl) OCH3
benzene sulphonamide) „.
, Trimethopnm
A (2,4-amino 5-(3, 4 ,5-trimethoxy phenylmethyl)
H2 N - / / \ V - s 0 2 NHCOCH 3 pyrimidine)

Sulphacetamide
(p-Amino benzene sulphacetamide)

19. Antibiotics

CHOH — CH — CH2OH

NHCO CHCI2
Chloramphenicol
(2,2-Dichloro-N[a-hydroxy methyl] p-hydroxy-p-nitro phenyl] acetamide)

C6 H5 CH2C — NH

COOH

CH3 OH n (CH3)2
Appendix-VIII □ □ 329

20. Antimycpbacterial agents


COOH

^>nN - conh2

N
CONHNH, .
1 Pynanamide
Aminosalicylic acid Isoniazid (Pyrazine-2-carboxamide)
(4-pyridine carboxyKc
acid hydrazide) CH

+ + I
c h 3c h 2 — ch — nh 2 ch 2 c h 2 nh 2 — c h — ch 2 ch 3 . 2 Cl"
I
CH2OH
Ethambutol hydrochloride
(2 , 2 ‘-(ethylenediamine) di-1 -butanol)

Dapsone
(4', 4'-Diaminodiphenyl sulphone)
21. Antineoplastic agents
(/') Alkylating agent

Cl CH2 c h 2 CH2v || / CH2


| N_ p _ N |
N —^ (CH2)3 — COOH un2
C H ,' |
Ji ^ ^ "H2,
C
Cl c h 2 c h 2
ch 2 — ch2
Chlorambucil
(4[4-b is (2-chloroethyl) aminophenyl) aminophenyl] butyric acid) ' '*epa
(ii) Antimetabolites
H

.^Cpr"' ,1>
ch 3— n
I
l2_L^ !L
nh 2
Jn^O
II
o
Fluorouracil
(2 ,4-Dioxo 5-fluoro pyrimidine)

SH H
I
CONHCH — CH2 CH2 COOH
Methotrexate
N-[4-[(2, 4-diamino-6-pteridinyl methyl]
methylamino]benzoyl] glutamic acid
60 ^N '
6 -Mercaptopurine
330 □ □ Drug Inspector Exam

22. Diagnostic agents


(/) Radiopaques
C,H
2n 5

COONa

CH.
If I II
I I O
topanoic acid Sodium diatrizoate
3-Amino a-ethyl 2, 4, 6-tri
iodohydrocinnamic acid CH2 cooch 2 ch 2 CH3

Diodone (3, 5-D iiodo-4-oxo-1-(4H )-


pyridine acetic acid propyl ester)
(ii) Dyes

S 03Na NaO .

S 03Na
Br O
Sodium Sulphobromophthalein Fluorescein sodium
23. Vitamins

-CH ,

Vitamin K (Phytomenadione)
Appendix-VIlI □ □ 331

N ^ V - CH2— N-------- p CH3


A t ,J - n h 2 I J L Ch 2c h 2o h
CH,
Vitamin B1 (Thiamine)

CH2 — CHOH — CHOH — CHOH — CHjOH


I
N«w M CH2OH

HO“ f ^ i r CH2OH
CH.

Vitamin B2 (Riboflavin) Pyridoxine


kl Kl

CH2 — NH NH — CH — {CH2)2 — COOH


I
COOH
Folic Acid
24. Antiseptics and disinfectants
(/) Phenol
OH OH OH OH

Cl
CH, "■per Cl Cl
Cl
CH,

Cl
CH,

Chlorcresol Hexachlorophene Chloroxylenol


(4-Chloro3-methylphenol) ( 2 , 2‘-Methylene-bis) (3, 4 , 6-trichlorophenol) (4-Chloro-3, 5-xylenol)
(ii) Dyes

NHj
N'
Proflavine
(3, 6-Diaminoacridine)
(iii) Surfactant
CH,
/n\ ©i e
(/ \V - C H 2— N — RC I
R * C8H 17 to C 18H3y
CH 3
Benzalkonium Chloride
(iv) Nitrofuran derivative
o
ll
,N - / ° V CH * N — N ' ^ N H
1 ll I____Uo
Nitrofurantoin
(1-([(5-Nitro-2-furanyl) methylene] amino]-2,4-imidazolkline dione)
332 □ □ Drug Inspector Exam

25. Oral hypoglycaemic agents


(a) Sulphonyl urea
O
II
ci S02NH C NH CaH7

Chlorpropamide
( b) Biguanides
NH NH
II II
a CH2 CHzNH C — NH — C — NHz

Phenformin

□ □
Appendix-lX □□ 333

MECHANISM OF ACTION OF IMPORTANT DRUGS

Drug Mechanism o f Action


Allopurinol (Zyioric) Acts by inhibiting the enzyme xanthine oxidase, involved
in the synthesis o f uric acid
Antipsychotics Block dopamine receptors and thus decrease dopaminergic
activity
Aspirin (Disprin) Acts by inhibiting enzyme cyclooxygenase and prevents
synthesis of prostaglandins
Acetazolamide (Diamox) Inhibits carbonic anhydrase and sodium ions are excreted
along with bicarbonate ions along with the accompanying
water
Antimetaboiites Inhibiting the metabolism _ .
Aminoglycoside-Antibiotics Inhibit bacterial protein synthesis by binding to 30s. ribosome
(Streptomycin, Kanamycin) and impeding the function of the ribosomal'subunit
Acyclovir (Zovirax) Incorporated into viral DNA and inhibits viral replication
Amantidine (Amantrel) Inhibits replication o f the influenza A virus by interfearing
with viral attachment and uncoating
Benzodiazapines By acting on specific benzodiazepine receptors and facilitate
(Diazepam, Nitrazepam) the effect of GABA (Gamma Amino Butyric Acid)
Clotrimazole, Ketoconazole Act by inhibition o f ergosterol biosynthesis, the principal
and Miconazole (Azoles) sterol in the fungal cell membrane
Cimetidine (Tagamet) By producing gastric hypochlorhydria as a result o f its H2
receptor blocking action
Chloramphenicol and Inhibition of protein synthesis
Tetracyclines
Chloroquine (Larigo) Binds to and alters the properties o f microbial and mammalian
DNA
Erythromycin (Macrolides) Bind to the 50s ribosomal subunit and inhibits bacterial
protein synthesis
Ephedrine Acts by causing the release of norepinephrine
Guanethidine It inhibits release o f norepinephrine
Grieseofulvin (Idifulvin) Inhibits fungal cell activity by interfearing with mitotic
spindle structure
Heparin (Beparin) Prevents the action o f thrombin in catalysing the conversion
of fibrinogen into fibrin
High Ceiling diuretics (or) Mainly acts oi) the ascending limb o f the loop o f
Loop diuretics (Frusemide) Henle and inhibits the active reabsorpdon o f chloride and
cause sodium and water loss
H2-Receptor antigonists Competitively inhibit the action of histamine at parieial cell
(Famotidine, Rantidine, receptor sites, reducing the volume and ion concentration of
Cimetidine) gastric acid secretions
Iodoxuridine Prevents the incorporation o f thymine into DNA
Isoniazid (INH) Act by inhibiting the synthesis o f mycolic acid, an important
constituent o f mycobacterium cell wall
334 □ □ D rug Inspector Exam

Drug Mechanism o f Action


Local Anaesthetics Prevent the generation and conduction o f nerve impulses
(Xylocaine, Procaine HCI)
Levodopa Acts mainly by replenishing depleted brain dopamine
Methotrexate (Folic Acid Competitively inhibits dihydrofolate reductoase. Preventing
Antagonist) folic acid reduclion o f tetrahydrofolate
Metronidazole (Metrogyl) Involves disruption o f the helical structure o f DNA
NSAID (Indocid, Ibuprofen,
Oxyphenbutzone) Inhibits prostoglandin synthesis
Nalidixic Acid (Neggram) Prevents DNA Synthesis
Oral Anti-coagulants (Warfarin)Act by competitively antagonising the action o f vitamin K
PAS Inhibits the enzymes responsible for folic acid synthesis
Pyrimethamine (Daraprim) Impedes folic acid reduction by inhibiting the enzyme
dihydrofolate reductase
Penicillin and cephalosporins Inhibition of cell wall synthesis leading to loss of viability
Polymyxin.B and Colistin Interfering with cell membrane function leading to leakage
o f intracellular compounds
Rifampin Interfering wit^i DNA, RNA Synthesis
Reserpine (Serpasil) Acts by reducing Nor-AJrenaline concentration in adrenergic
nerve and brain
Sulfinpyrazone and Block uric acid reabsorbtion at the proximal convoluted
probenecid tubule, there by increasing the rate o f uric acid excretion
Salicylates (Aspirin) Inhibit cyclooxygenase the enzyme that converts Arachidonic
acid to prostaglandin
Sodium Valproate (Valprol) Inhibits the metabolism of GABA by inhibiting the enzyme
GABA- transminase, there by increasing the brain GABA
Spironolactone (Aldactone A) Competitively inhibits the action o f aldosterone on the distal
tubule
Sulphonamides Interfere with the microbial growth by competitively inhibiting
incorporation of aminobenzoic acid
Sulfoncs (DDS) Act by inhibiting the biosynthesis of folic acid by mycobac­
terium leprae
Sulfonylureas Cause hypoglycemia by stimulating insulin release from
pancreatic beta-cells
Vinca Alkaloids Act by inhibiting mitosis (binds to tubulin and prevents the
(Vincristine, Vinblastine) formation of the mitosis spindle)
Quinacrine (Mepacrine) Inhibits DNA metabolism
Zidovudine (Azidothymidine), Inhibits the enzyme reverse transcriptase terminating synthesis
AZT o f viral DNA and preventing HIV replication.
Appendix-X □ □ 335

Appendix
SCHEDULES

Schedules to the Rules :


A— Proforma for application for the licences, issue and renewal o f licences, for sending
memoranda under the act. i
B— Rate o f fee for test or analysis by the Central Drugs Laboratory or the Government
Analyst.
C— List of biological and other special products whose import, sale, distribution and
manufacture are governed by special provisions.
C [— List of other special products whose import, sale, distribution and manufacture are
governed by special provision.
D— List of drugs exempted from the provisions of import of drugs.
E j— Lists o f poisonous substances under the Ayurvedic (including Sidha) and Unani systems
o f medicine.
F & F !— Provisions applicable to the production, testing, storage, packing, and labelling of biological
and other special products.
FF— Standards o f ophthalmic preparations.
G— List o f substances that are required to be used only under medical supervision and
which are to be labelled accordingly.
H— List of prescription drugs which are sold by retail only on prescription o f Registered
Medical Practioner.
J— Diseases or ailments which a drug may not purport to prevent or cure.
K— Drugs exempted from certain provisions relating to the manufacture of drugs.
M— List of minimum requirements o f factory premises.
N— List minimum requirements for efficient running o f a pharmacy.
O— Standards for disinfectant fluids.
P— Life periods o f drugs.
Q— List o f coalter colours permitted to be used in cosmetics.
R— Standards for mechanical contraceptives.
S— Standards for cosmetics.
T— Requirements o f factory premises and hygienic conditions for Ayurvedic (including Sidha)
and Unani drugs.
U— Particulars to be shown in manufacturing, raw material and analytical records o f drugs.
U|— Particulars to be shown in manufacturing, raw material and analytical records o f cosmetics.
V— Standards for patent or proprietory medicines.
W— List o f drugs which are to be marked under generic names only.
X— List o f drugs whose import, manufacture and sale, labelling and packaging are governed
_________by special provisions. ______________________________________________________________
336 □ □ Drug Inspector Exam

RULES RELATING TO DRUGS AND MEDICINES

Class o f drugs Nature o f Medicines in which Particulars which should


contained appear on lable__________
Schedule G Medicines made up ready for The words Caution. It is
internal use of human ailments dangerous to take the prepara­
tion ' except under medical
supervision.
Schedule H Medicines made up ready for (a) Schedule H drug.
internal use of human beings Warning : to be sold on the
prescription of a Registered
Medical Practitioner only.
( b) Symbol Rx prominently
displayed on the left hand top
corner of the lable.
Schedule H Drugs falling in purview of (a) Schedule H drug.
the Narcotic and Pyschotropic Warning : To be sold by retail
Substances Act. on the prescriptions of RMPs
only
(b) Symbol NRx displayed on
left top corner o f the label.
Schedule X Drugs in bulk Medicines for (a) Schedule X drug.
internal use of human beings Warning : To be sold by retail
on the prescription o f RMPs
only.
( b) Symbol NRx in red left
hand top comer o f the
label.
Schedule P Any (a) Date o f manufacture
( b) Date o f expiry o f the
potency. ______

□ □
Model Paper-1

1. W h ic h e d itio n o f IP w a s la u n c h e d in (b) Pompe disease


2010? (c) Acid maltase deficiency
(a) 3rd (b) 4 th (d) McArdle's disease
(c) 5 th (d) 6 th 9. Cori cycle represent an relation
2. T h e h e a d q u a rte r o f C D S C O is lo ca ted between one of the following.
at (a) Lactate-Glucose
(a) G h a z ia b a d (b) N e w D e lh i (b) Lactate-pyruvte
(c) C a lc u tta (d) B o m b a y (c) Pyruvate- Glucose
3. The h e a d q u a rte r fo r In d ia n (d) Pyruvate-Lactate
p h a rm a c o p o e ia is a t 10. Which one of the following pathway
(a) S u ra t (b) S rin a g a r provides NADPH for biosynthetic
(c) G h a z ia b a d (d) B o m b a y processes?
4. W h ic h o f th e f o llo w in g S c h e d u le s (a) Glycolysis pathway
in clu d e sh e lf life o f d ru g s? (b) Phosphogluconate pathway
(a) S c h e d u le F (b) S c h e d u le M (c) Glycogenolysis pathway
(c) S c h e d u le G (d) S c h e d u le P (d) Gluconeogenesis pathway
5. P h a rm a cy A c t w a s fra m ed in th e year: 11. Gluconeogenesis related to which one
(a) 1940 (b ) 1954 of the following.
(c) 1948 (d) 1958 (a) Conversion of pyruvate to glucose
(b) Conversion of pyruvate to
6. T h e D ru g A c t w a s in tro d u ce d in the
glycogen
year.
(c) Conversion of pyruvate to lactate
(a) 1960 (b) 1930
(d) Conversion of glycogen to glucose
(c) 1950 (d ) 1940
12. Which one of the following is a rate
7. P h a rm a cy c o u n c il of In d ia is
limiting step in glycolysis pathway?
reco n stitu ted every.
(a) Conversion of glucose to glucose-
(a) 6 y e a rs (b) 3 y e a rs
6-phosphate
(c) 5 y ea rs (d ) 2 y ea rs
(b) Conversion of fructose-6-
8. W h ic h o n e o f t h e f o l l o w i n g is phosphate to fructose-1,6-
a sso ciate w ith Type I g ly co g en storage diphosphate
d isea se? (c) Conversion of fructose-1,6-
(a) Von G ie rk e d ise a se diphosphate to glyceraldehyde-3-
phosphate
338 □ □ Drug Inspector Exam

(d) Conversion of glucose-6- 18. Smallpox Vaccine contain one of


phosphate to fructose-6-phosphate following .
13. Ouchter lony method related with one (a) Living Virus Vaccinia
of the following. (b) Living culture of (B)(C)G
(a) Radial diffusion (c) living virus Hepatitis
(b) Double diffusion (d) Attenuated Staphylococcus
(c) RIA 19. The Dick test is related to one of
(d) Immunofluroscence following.
14. Which one of the following is a test (a) Diphtheria (b) Leprosy
for protein? (c) Scarlet fever (d) Yellow fever
(a) Southern blotting 20. A microorganism can grow only in
(b) Northern blotting anaerobic condition but cannot grow
(c) Western blotting in aerobic condition but tolerate
(d) Eastern blotting oxygen is an example of one of the-
following.
15. Study the following two statements
(a) Microaerophilus
and choose the correct answer:
(b) Aerotolerant
[P] Antibodies are serum proteins
providing immunity. (c) Anaerobic
[Q]IgG provides immunity to new (d) Facultative anaerobic
born babies while IgM is the first 21. The normal cul-de sac volume is.
generated antibody. (a) 7]il (b) 20 ]il
(a) P is correct and Q is incorrect (c) 30 ]il (d) 10 jil
(b) P is incorrect and Q is correct
22. In autoclaving process which one of
(c) Both P and Q are correct the biological indicator is used?
(d) Both P and Q are incorrect (a) Clostridium sporogens
16. Radio labeled Ag is used in following (b) Bacillus subtilus
techniques. (c) Bacillus pumilus
(a) RIA (d) Pseudomonas diminuta
(b) ELISA 23. Government opium factory is situated
(c) Both (A) & (B) at
(d) None of the above (a) Delhi (b) Mumbai
17. Which one of the following is used (c) Hyderabad (d) Neemuch
for the staining of bacterial
24. Example of Narcotic drug is
endospore.c
(a) Coca (b) Charas
(a) Crystal violet stain
(c) Opiufn (d) All of the above
(b) Carbol fuchsin stain
(c) Schaeffer-Fulton stain 25. Papaverine is known as
(d) Nigrosin stain (a) 6 ,7-Dimethoxy-l ~(3', 4'-dimethoxy
benzly)isoquinoline
Model Paper-1 □ □ 3 39

(b) 6, 7-Diethoxy-l-(3', 4'-dimethyl (a) Respiratory failure


benzly)isoquinoline (b) Severe hypotension
(c) 6, 7-Dimethoxy-l-(3', 4'-dimethoxy (c) Prolongation of QT interval
benzly)isoquinoline (d) Myocardial ischemia
(d) 6, 7-Dimethoxy-l-(3'/ 4'--dimethyl
32. Benzyl chloride and potassium
benzly)isoquinoline
cyanide are used as the starting
26. Which of the following is a laxative compounds for the synthesis of:
antacid? (a) Ethosuximide
(a) Mg-salt (b) Ca-salt (b) Glutethimide
(c) Fe-salt (d) Al-salt (c) Malic add
27. How many mL of 50% (w/v) dextrose (d) Tartaric acid
solution and how many mL of 5% (w/ 33. Gray baby syndrome is due to the
v) dextrose solution are required to indiscriminate use of :
prepare 4500 mL of a 10% (w/v)
(a) Strptomycine
solution?
(b) Chloramphenicol
(a) 500 mL of 50% and 4000 mL of 5%
(c) Penicillin
(b) 1000 mL of 50% and 3500 mL of
5% (d) Tetracycline
(c) 4000 mL of 50% and 500 mL of 5% 34. BUSULFAN is anticancer alkylating
(d) 1500 mL of 50% and 3000 mL of agent that comes under the category
5% of.
(a) Nitrosoureas
28. Which of the following alkaloids is
(b) Alkyl sulfonates '
derived from tyrosine?
(c) Nitrogen mustard
(a) Quinine (b) Morphine
(d) Anthracycline
(c) Atropine (d) Ephedrine
29. Which of the following drugs does 35. Ptyalin is related to one of following,
NOT induce mydriasis? (a) lipase (b) urease
(a) Atropine (b) Ephedrine (c) anhydrase (d) amylase
(c) Ph^ntolamine(d) Cocaine 36. Phenobarbitone is metabolic product
of.
30. Which of the following beta blockers
has been shown clinically to reduce (a) Amobarbitol (b) Pyrimidine
mortality in patients of symptomatic (c) Barbitone (d) Primidone
heart failure? 37. Which one of the fallowing is the drug
(a) Atenolol (b) Carvedilol regulatory body of indi(a)
(c) Propranolol (d) Esmolol (a) DGHS (bj DTAB
31. Patients taking isosorbide mononitrate (c) DCGI (d) CDSCO
or nitroglycerine should be advised 38. Gas gangrene is caused by one of the
not to take sildenafil. This drug-drug following.
interaction causes which of the
following actions?
340 □ □ Drug Inspector Exam

(a) Clostridium botulism 45. Which of the following is best to


(b) Clostridium perfringens sterilize heat labile solutions?
(c) Streptococcus pyrogens (a) Autoclave
(d) Streptococcus pneumonia (b) Dry heat sterilization
39. The formula is used for calculating the (c) Pasturization
doses for children less than 12 years (d) Membrane filtration
of age. 46. Which of the follow ing is most
(a) Dilling's formula effective for sterilizing mattresses and
(b) Young's formula plastic Petri plates?
(c) Clark's formula (a) Chlorine (b) Autoclave
(d) Cowling's formula (c) Glutaraldehyde
40. Which one of the following is Dilling's (d) Ethylene oxide
formula? 47. From the dosage forms listed below,
(a) xAdult dose = Dose for the child select the type commonly used for
(b) xAdult dose = Dose for the child ophthalmic preparations.
(c) xAdult dose = Dose for the child (a) Lotion (b) Elixir
(d) xAdult dose = Dose for the child (c) Ointment (d) Emulsion
41. If the dose of a drug is 200mg, what 48- What is the chemical composition of
will be the dose for a child of 8 years? hard rigid hydrophobic lens?
(a) 60mg (b) 80mg (a) PMMA (b) HEMA
(c) lOOmg (d) 70mg (c) CAB (d) Pyrolidone
42. The mechanism of sterilization by 49. Which one of the following is not
autoclaving is. related to pseudomonas aeruginos(a)
(a) Protein coagulation (a) Bacillus pyocyanin
(b) Oxidation (b) Pseudomonas pyocyanin
(c) Plasmolysis (c) Blue pus Bacillus
(d) Destruction of DNA (d) Pseudomonas vulgaris
43. Which of the following is fractional 50. Which one of the following is not a
sterilization? preservative for ophthalmic
(a) Autoclave (b) Tyndallization preparation?
(c) Pasturization (a) Paraben (b) Chlorobutanol
(d) Sterilization by radiation (c) Benzalkonium chloride
(d) Phenyl Hg nitrate
44. Which of the following is bactericidal?
(a) Membrane filtration ^1- Class 100 area is referred to.
(b) Ionizing radiation (a) Manufacturing area
(c) Freeze-drying (b) Aseptic area
(d) Deep freezing (c) Clean room (d) Ware house
Model Paper-1 □ □ 341

52. From the group of statements below, (a) Cytomegalovirus


select the statement that contains the (b) Candida albicans
information the patient should be told (c) Herpes zoster virus
when an ophthalmic ointment is (d) Hepatitis B virus
being dispense(d)
(a) Vision may e impaired for a short 57. Which one of the followings is used
time after the Ointment has been as a mood stabilizer for bipolar
placed in the eye. disorder and also in certain epileptic
convulsions?
(b) The ointment should be stored in
a freezer in order to maintain its (a) Phenytoin (b) Lithium
sterility. (c) Sodium valproate
(c) Large particles in the ointment (d) Fluoxetine
may be reduced in size by rapidly 58. At physiological pH the following
batting the eyes after the ointment compound would be MOSTLY in the.
has been applie(d) (a) Cationic form
(d) Large particles in the ointment (b) Unionised form
may be removed by filtering the (c) Zwitterionic form
product through coarse grade
(d) Anionic form
gauze
59. Which one of the followings is correct
53. Stevens Johnson syndrome is the most chemical nomenclature of procaine is.
common adverse effect associated
(a) 2-D iethylam inoethyl 4-
with one of the following category of
aminobenzoate
drugs.
(b) N,N-Diethyl 4-aminobenzoate
(a) Sulphonamides
(c) 4-Aminobenzamidoethyl amine
(b) Macrolides
(d) 4-A m ino-2-diethylam inoethyl
(c) Penicillins (d) Tetracyclines
benzoate
54. Identify the one rational combination
60. Proton pump inhibitors like
which has clinical benefit:
omeprazole and lansoprazole contain
(a) Norfloxacin - Metronidazole
the following ring system :
(b) Alprazolam - Paracetamol
(a) Pyrimidine
(c) Cisapride - Omeprazole
(b) Benzimidazole
(d) Amoxycillin - Clavulanic acid (c) Benzothiazole
55. Digitalis toxicity is enhanced by co­ (d) Qxindole
adm inistration with one of the
61. The common structural feature
following.
amongst the three categories of
(a) Potassium (b) Quinidine
anticonvulsant drugs barbiturates,
(c) Diuretics (d) Antacids succinimides and hydantoins is.
56. Ganciclovir is mainly used for the (a) Ureide (b) Imidazolidinone
treatment of infection caused by. (c) Dihydropyrimidine
(d) Tetrahydropyrimidine
342 □ □ Drug Inspector Exam

62. Which one of the following one is true department follow ing onset of
regarding Ectopic pregnancy? symptoms of myocardial infarction.
(a) Occurs in about 10%' of Which of the follow ing is a
pregnancies ' • contraindication for treatment with t-
(b) The risk is increased in those with PA?
a history or pelvic inflammatory (a) Worsening chest pain that began
disease earlier in the evening.
(c) Usually presents between 2 and 4 (b) History of cerebral hemorrhage.
months of gestation (c) History of prior myocardial
(d) Patients usually have a negative infarction.
pregnancy test (d) Hypertension.
63. All are related with Pelvic 67. A patient is undergoing the induction
inflammatory disease except. stage of treatment for leukemi(a) The
(a) Usually arises from nurse teaches family members about
haem atogenous spread from infectious precautions. Which of the
another site following statem ents by family
(b) Is most commonly a chlamydial members indicates that the family
infection needs more education?
(c) Untreated can progress to a (a) We will bring in books and
pyosalpinx magazines for entertainment.
(d) 20% of patients develop chronic (b) We will bring in personal care
pain items for comfort.
(c) We will bring in fresh flowers to
64. A nurse is adm inistering IV
brighten the room.
furosemide to a patient admitted with
congestive heart failure. After the (d) We will bring in family pictures
infusion, which of the following and get well cards.
symptoms is NOT expected? 68. A nurse is caring for a patient with
(a) Increased urinary output. acute lymphoblastic leukemia (ALL).
(b) Decreased edem(a) Which of the fo llo w in g is the most
(c) Decreased pain. likely age range of the patient?
(d) Decreased blood pressure. (a) 3-10 years, (b) 25-35 years.
(c) 45-55 years, (d) over 60 years.
65. There are a number of risk factors
associated with coronary artery 69. A patient is admitted to the oncology
disease. Which of the following is a unit for diagnosis of suspected
modifiable risk factor? Hodgkin's disease. Which of the
(a) Obesity (b) Heredity. following symptoms is typical of
Hodgkin’s disease?
(c) Gender (d) Age
(a) Painful cervical lymph nodes.
66. Tissue plasminogen activator (t-PA) is (b) Night sweats and fatigue.
considered for treatment of a patient
(c) Nausea and vomiting.
who arrives in the emergency
(d) Weight gain.
Model Paper-] □ □ 343

70. The Hodgkin's disease patient 75. For laboratory scale batch fermentor,
undergoes a lymph node biopsy for sizes ranges from
definitive diagnosis. If the diagnosis (a) 2-5L (b) 5 - 10L
of Hodgkin's disease were correct, (c) 1-2L (d) >10L
which of the following cells would the
Precursor used in penicillin
pathologist expect to find?
production is
(a) Reed-Stemberg cells.
(a) phenylacetic acid
(b) Lymphoblastic cells.
(b) phenoxyacetic acid
(c) Gaucher's cells.
(c) phenylacetamide
(d) Rieder's cells
(d) all of the above
71. A patient is about to undergo bone
marrow aspiration and biopsy and Rideal-walker test is used for
expresses fear and anxiety about the (a) streptococci
procedure. Which of the following is (b) staphylococci
the most effective nursing response? (c) phenol (c) pseudomonas
(a) Warn the patient to stay very still 73 Antisera are sterilized by
because the smallest movement (a) autoclaving
will increase her pain. (b) steam under low pressure
(b) Encourage the family to stay in the (c) hot air areas
room for the procedure.
(d) Alteration
(c) Stay with the patient and focus on
slow, deep breathing for 79. Presence of particulate matter in
relaxation. parenterals could lead to
(d) Delay the procedure to allow the (a) physical occlusion
patient to deal with her feelings. (b) inflammatory reaction
72. Penicillin is ---------------------metabolite (c) antigenic responses
(a) Primary (b) Secondary (d) all of the above
(c) Both (d) None of these 80. Which salt is used to treat mania and
depression?
73. Amount of inocculum to be added in
the production of tetracycline is (a) Calcium folinate
(a) 2-10% (b) 5-15% (b) Lithium citrate
(c) 20-255 ; (d) <5% (c) Potassium citrate
(d) Bismuth subcarbonate
74. Which microbial strain produces
tetracycline even in the presence of Which one of these drug is a entire
Cl- ions? plant?
(a) S viriditaciens (a) Lobelia (b) Senna
(b) S. rimosus (c) Liquorice (d) Belladonna
(c) S.aureofacien 82. What is Light Kaolin?
(d) S mediolanum (a) Aluminium silicate having
antidiarroeal action
344 □ □ Drug Inspector Exam

(b) Aluminium silicate having 90. Which antibiotic,usesd as antiamoebic,


antidiarroeal action acts by intercalating with DNA
(c) Aluminium magnesium silicate resulting in transcription error.
having antiseptic action (a) Paromomycin(b) Cycloserine
(d) Aluminium silicate having inert (c) Diloxanilide (d) Furoxone
nature 91. Tick the drug for strongiloidosis
83. The penicillin is obtained from treatment:
(a) Fungi (b) bacteria (a) Niclosamide (b) Praziquantel
(c) Algae (d) Bryphytes (c) Bithionol (d) Ivermectin
84. Which of the family act as important 92. Tick the drugs for the treatment of an
source of medicinal drug intestinal form of amebiasis:
(a) Rutaceae (b) Rubiaceae (a) Metronidazole and diloxanide
(c) Solanaceae (d) Umbelliferae (b) Diloxanide and streptomycin
85. The resein'Heeng' is obtained from (c) Diloxanide and Iodoquinol
family (d) Emetine and metronidazole
(a) Rubiaceae (b) Acanthaceae 93. Tick the antimalarial drug influencing
(c) Umbeliferae tissue schisonts:
(d) Scrophulariaceae (a) Mefloquine (b) Chloroquine
86. Psychotropic substance whose import, (c) Quinidine (d) Primaquine
export &transshipment are prohibited 94. Tick the antimalarial drug having a
(a) Coca leaf (b) Codine gametocidal effect:
(c) Flurazepam (a) Mefloquine (b) Primaquine
(d) None of the above (c) Doxycycline (d) Sulfonamides
87. Physical incompatibility is due to 95. What is the mode of action for the
(a) Mixing (b) Solubility anthracycline anticancer agents?
(c) Insolubility (d) Miscibility (a) Alkylating agents
88. Insoluble phenacetin and salol (b) Chain cutting agents
requires the use of: (c) Antisense agents
(a) Emulsifying agent (d) Intercalating agents
(b) Surfactants 96. The following structure is used in the
(C) Thickening agent treatment of brain tumours.
(d) Suspending agent What is the structure called?
89. Crystallization is an example of (a) Carmustine (b) Lomustine
..................Incompatibility. (c) Streptozotocin
(a) Immediate (b) Delayed (d) Cyclophosphamide
(c) Instantaneous 97. All of the following Anticancer agents
(d) Both a and b cause bone marrow depression
except?
Model Paper-1 □ □ 345

(a) Chlorambucil (c) Nanoemulsion


(b) Daunorubicin (d) Microemulsion
(c) Doxorubicin (d) Flutamide 102. Who has produced the first Extra
98. Tick the drug belonging to Pharmacopoeia?
gonadotropin-releasing hormone (a) William Martindale
agonists: (b) Flemming
(a) Leuprolide (b) Tamoxifen (c) Ehrlich
(c) Flutamide (d) Anastrozole (d) None of the above
99. Action mechanism of methotrexate is: 103. When the first edition of BP was
(a) Inhibition of dihydrofolate published?
reductase (a) 1945 (b) 1960
(b) Activation of cell differentiation (c) 1963 (d) 1964
(c) Catabolic depletion of serum 104. Who has published Merck index?
asparagine
(a) Merck & Co. India
(d) All of the above
(b) Merck & Co.,Inc. Rahway, New
100. Reserve percolation is used for Jersy, USA
preparation of (c) Merck & Co, UK
(a) liquid extract of liquorice (d) Merck & Co, Germany
(b) tincture of orange
105. Who has published National
(c) tincture of ginger Formulary of India?
(d) tincture of cardamom (a) APTI (b) MCI
101. Triamcilone acetonide is delivered by (c) PCI
which novel drug delivery system (d) Ministry of Health, Govt of India
(a) Neosomes
(b) Multiemulasion

ANSW ERS
1. (d) 2. (b) 3. (c) 4. (c) 5. (c) 6. (d) 7. (d) 8. (a) 9. {a) 10. (b)
11. (a) 12. (b) 13. (b) 14. (c) 15. (c) 16. (a) 17. (c) 18. (a) 19. (c) 20. (b)
21. (c) 22. (a) 23. (d) 24. (d) 25. (a) 26. (a) 27. (a) 28. (b) 29. (c) 30. (b)
31. (b) 32. (b) 33. (b) 34. (b) 35. (d) 36. (d) 37. (c) 38. (b) 39. (b) 40. (a)
41. (b) 42. (?) 43. (b) 44. (b) 45. (d) 46. (d) 47. (c) 48. (a) 49. (?) 50. (?)
51. (?) 52. (a) 53. (a) 54. (a) 55. (c) 56. (a) 57. (c) 58. (d) 59. (a) 60. (b)
61. (a) 62. (b) 63. (a) 64. (c) 65. (a) 66. (b) 67. (c) 68. (a) 69. (b) 70. (a)
71. (c) 72. (b) 73. (a) 74. (d) 75. (c) 76. (d) 77. (c) 78. (d) 79. (d) 80. (b)
81. (a) 82. (a) 83. (a) 84. (c) 85. (c) 86. (a) 87. (C) 88. (c) 89. (b) 90. (a)
91. (d) 92. (a) 93. (d) 94. (b) 95. (d) 96. (b) 97. (d) 98. (a) 99. (a) 100. (a)
101. (a) 102. (a) 103. (d) 104. (b) 105. (d)
□ □ □
Model Paper-2

1. What is the full form of ISO? (a) Maceration (b) Percolation


(a) International standard (c) Cohobation (d) Dissolution
organization 7 Molisch test is not positive in case of
(b) International standard office following one.
(c) International organization for (a) Starch (b) Agar
standards (c) Plantago (d) Gelatin
(d) International substandard
organization Which of the following is not a
polymer of glucose?
2. CDTL located following places except. (a) Amylose (b) Cellulose
(a) Chenni (b) New delhi (c) Inulin (d) Dextrin
(c) Guhati (d) Bombay
The carbohydrate reserved in human
3. About 900 mg paracetamol dissolve body is:
in 2 It. of methanol then paracetamol (a) Starch (b) Glycogen
is? (c) Glucose (d) Inulin
(a) Freely soluble
(b) Soluble 10 Seliwanof's test is positive in one of
the following case.
(c) Sparingly soluble
(a) Glucose (b) Galactose
(d) Very slightly soluble
(c) Fructose (d) Mannose
4. What is the concentration of syrup
The cellular immune response is
USP? 11'
mediated by one of the following.
(a) 66.7%w/w (b) 66.7%w/v
(a) B cells (b) BT cells
(c) 64.7%w/w (d) 64.7%w/v
(c) T cells (d) Endothelial cells
5. Lugol's solution contains iodine and
potassium iodide is commonly known ^ Which one of the following techniques
as used for bacterial examination gives
3D image.
(a) Strong iodine solution
(a) Transmission electron microscopy
(b) Weak iodine solution
(b) Scaning electron microscopy
(c) Aqueous iodine solution
(c) Electron microscopy
(d) Non aqueous iodine solution
(d) Light microscopy
6. Tinctures prepared by all of the
following methods except. ^ W hich one of the following is
containing single stranded DNA?
346
Model Paper-2 □ □ 347

(a) Herpes viridae 21. Which of the following species is


(b) Pox viridae being inactivated by the enzyme
(c) Polyoma viridae (d) Parro viridae Dipeptidyl peptidase-4?
(a) Oxytocin (b) Vasopressin
14. Rocky mountain spotted fever is
caused by. (c) Incretin (d) Glucagon
(a) Virus (b) an amoeba 22. Choose the correct statement about the
(c) a rickettsia given four diseases?
(d) None of the above [P] Cardiomyopathy ],Q] Rheumatoid
15. Rabies vaccine (living) is prepared arthritis
using. [R] Myasthenia gravis [S] Ulcerative
(a) Sheep blood (b) Mice lymph colitis
(c) Horse plasma (a) Q & S are autoimmune disorders
(d) Fertile eggs (b) P & Q are autoimmune disorders
16. Bacteriophages are usually. (c) P & R are not autoimmune
disorders
(a) Lipoidal (b) Viruses
(c) Bacteria (d) R & S are not autoimmune
disorders
(d) None of the above
23. Antiretroviral Raltegravir is unique,
17. What is the unit of Z-value?
because of which of its following
(a) Dose (b) Time actions?
(c) Temperature (d) All of these (a) Integrase inhibition
18. In flash method of pasteurization (b) CCR5 Co-receptor antagonism
technique the microorganism kill by (c) Fusion inhibition
one of the following reason. (d) Reverse transcriptase inhibition
(a) Increase in temperature
24. Which of the following antibiotics
(b) Thermal shock
produces concentration dependent
(c) Both (a) & (b) bactericidal action and also possesses
(d) None of these post-antibiotic effect?
19. The maximum temperature required (a) Ceftazidime (b) Azithromycin
for storage of sterile preparation. (c) Amikacin (d) Piperacillin
(a) 25°C (b) 27°C 25. What is chemotaxis?
(c) 29°C (d) 23°C (a) Toxicity of chemicals
20. The quality of biotechnological (b) Taxonomy of chemicalsc
products comes under which one of (c) Inhibition of Inflammation
the following quality guideline of (d) M ovement of leucocytes in
ICH. inflammation
(a) Q1 (b) Q3
26. Which of the followings used in the
(c) Q5 (d) Q7 treatment of rheumatoid arthritis is
NOT a biologic response modifier?
348 □ □ Drug Inspector Exam

(a) Anakinra (b) Leflunomide (c) Antiprotozoal


(c) Etanercept (d) Infliximab (d) Antifungal
27. Which is the molecular target for the 34. Cycloserine contains which of the
vinca alkaloids as anticancer agents? following ring?
(a) Tyrosine kinase (a) Oxazole (b) Isoxazole
(b) DNA (c) Pyrrol (d) Imidazole
(c) Ribosomes (d) Tubulin 35. Primary amines are incompatibility
28. Of the four stereoisom ers of with one of following.
chloramphenicol which one is the (a) Mannitol (b) Acacia
biologically active isomer? (c) Lactose (d) Methyl cellulose
(a) L-Erythro (b) L-Threo 36. HYDRALAZINE is related to one of
(c) D-Erythro (d) D-Threo following.
29. Streptomycin can NOT be given orally (a) Venous dilator
for treatment of tuberculosis because (b) Arterial dilator
(a) It gets degraded in the GIT (c) Balanced venous dilator
(b) It causes severe diarrhoea (d) Ca + channel blocker
(c) It causes metallic tastein the mouth 37. What is the meaning of latin word
(d) It is not absorbed from the GIT collunarium.
30. The temperature condition for storage (a) Nose wash (b) Mouth wash
of drug products under cold (c) Eye wash (d) Ear wash
temperature is given as.
38. Which one of the following is an
(a) Temperature between 8°C and English translate of ter in die.
25°C
(a) Everyday (b) Twice a day
(b) Temperature below 20°C
(c) Thrice a day (d) Every morning
(c) Temperature at 0°C
(d) Temperature between 2and 8°C 39. In what proportions should 12%, 8%
and 3% alcohol be mixed to get
31. Which one of the following is known 5%alcohol?
Milk sugar? (a) 1 : 2 : 5 (b) 2 : 2 : 5
(a) Fructose (b) Glucose (c) 1 : 2 : 10 (d) 2 : 2 : 10
(c) Lactose (d) Sucrose
40. What is the body temperature of a
32. Fluoxetine is used in the treatment of patient in °C if the reading of
following one. thermometer is 104°F?
(a) Depression (b) Anxiety (a) 40° (b) 45°
(c) Hepatitis (d) Bronchitis (c) 50° (d) 55°
33. Zidovudine is used as choice of drug ^ What quantities of 95 % v/v and
in one of following disease. 45 % v/v alcohols are to be mixed to
(a) Antimala (b) Antiviral make 800 mL of 65 % v/v alcohol?
Model Paper-2 □ □ 349

(a) 480 mL of 95 % and 320 mL of 45 (a) Decimal reduction time


% alcohol (b) Thermal death point
(b) 320 mL of 95 % and 480 mL of 45 (c) D-value (d) F-value
% alcohol
47. Which one of the following is not an
(c) 440 mL of 95 % and 360 mL of 45 viscosity enhancing agent.
% alcohol
(a) HPMC (b) Dextran
(d) 360 mL of 95 % and 440 mL of 45
(c) Povidone (d) CMC
% alcohol
48. Which one of the following is true
42. If a canning procedure is not properly
regarding viscosity of ophthalmic
followed, which type of microbe is
preparation?
most likely to grow in the canned
food? (a) 15-50 cps (b) 130-230 cps
(a) Obligate aerobe (c) 50-100 cps (d) 5-10 cps
(b) Obligate anaerobe 49. What is allowed particle size for
(c) Microaerophile ophthalmic preparation is.
(d) Mesophile (a) >10>a (b) <10ji
(c) >20]i (d) <20|i
43. Sweet and salty foods frequently don't
require refrigeration to prevent 50. What is exact Human tear volume?
spoilage because they have. (a) 5]iL (b) 7]iL
(a) Insufficient nutrients (c) 9]iL (d) 15yiL
(b) High concentration of solutes. 51. How many colony forming units
(c) Low pH (CFU) present in water for injection,
(d) Naturally occurring antibiotics (a) 5 CFU/mL (b) 10 CFU/mL
44. If a 1: 600 dilution of a test compound (c) 15 CFU/mL (d) 20 CFU/mL
kills a standard population of 52. Select the correct combination of drugs
Staphylococcus aureus in 10 minutes for the treatment of patientssuffering
but not 5 minutes while a 1:60 dilution from Hepatitis C :
of phenol kills the population in the (a) Interferon with Ribavirin
same time, what is the phenol
(b) Interferon with Zidovudine
coefficient of the test compound?
(c) Interferon with Stavudine
(a) 5 (b) 10
(d) Interferon with Lamivudine
(c) 50 (d) 100
53. One of the following statements is
45. How many mL of a 1 : 500 w/v stock
NOT true :
solution should be used to make 5
liters of 1:2000 w/v solution? (a) Accuracy expresses the correctness
of measurement
(a) 750 mL (b) 1000 mL
(b) Precision represents
(c) 1250 mL (d) 1500 mL
reproducibility of measurement
46. The time in minutes at a specific (c) High degree of precision implies
temperature needed to kill a high degree of accuracy also
population of cells is the.d
350 □ □ Drug Inspector Exam

(d) High degree of accuracy implies (c) H2-blockers will heal 85-95% of
high degree of precesion also duodenal ulcers in 8 weeks
54. Streptomycin can NOT be given orally (d) Triple therapy can eradicate H.
for treatment of tuberculosis because. pylori in 80% of patients in one
week
(a) It gets degraded in the GIT
(b) It causes severe diarrhoea 60. Regarding Heparin all statement true
(c) It causes metallic taste in the except.
mouth (a) Is a heterogeneous mixture of
(d) It is not absorbed from the GIT sulphated polypeptides
(b) Potentiates the actions of
55. Cyclophosphamide as anticancer
antithrombin III
agent acts as.
(c) Can be reversed by protamine
(a) Alkylating agent before
sulphate
metabolism
(d) Can induce an idiosyncratic
(b) Alkylating agent after metabolism
thrombocytopenia
(c) Phosphorylating agent after
metabolism 61. Regarding Cushing's syndrome all
(d) DNA intercalating agent statement are wrong except.
(a) 80% of cases are due to pituitary
56. The Volume of distribution of a drug adenomas
administered at a dose of 300 mg and
(b) Most ACTH secreting pituitary
exhibiting 30 microgram/mL
adenomas are more than 2 cm in
instantaneous concentration in plasma
diameter
shall be.
(c) Cortisol production is suppressed
(a) 10 L (b) 100 L
by low-dose dexamethasone
(c) 1.0 L (d) 0.10 L
(d) Adrenal carcinomas are more
57. Barbiturates with substitution at the common than adrenal adenomas
following position possess acceptable
62. Following myocardial infarction, a
hypnotic activity :
hospitalized patient is encouraged to
(a) 1,3-Disubstitution practice frequent leg exercises and
(b) 5,5-Disubstitution ambulate in the hallway as directed
(c) 1,5-Disubstitution by his physician. Which of the
(d) 3,3-Disubstitution following choices reflects the purpose
58. Regarding peptic ulceration all of exercise for this patient?
statement true except. (a) Increases fitness and prevents
(a) Duodenal is more common than future heart attacks.
gastric ulceration (b) Prevents bedsores.
(b) Zollinger-Ellison syndrome is (c) Prevents DVT (deep vein
associated with gastrin thrombosis).
hyposecretion (d) Prevent constipations.
Model Paper-2 □ □ 351

63. A patient arrives in the emergency 66. A patient received surge y and
department w ith symptoms of chem otherapy for colon cancer,
myocardial infarction, progressing to com pleting therapy 3 months
cardiogenic shock. Which of the previously, and she is now in
following symptoms should the nurse rem ission. At a follow-up
expect the patient to exhibit with appointment, she complains of fatigue
cardiogenic shock? following activity and difficulty with
(a) Hypertension concentration at her weekly bridge
(b) Bradycardia games. W hich of the following
(c) Bounding pulse explanations could account for her
(d) Confusion symptoms?
(a) The symptoms may be the result
64. A patient with a history of congestive of anemia caused by
heart failure arrives at the clinic chemotherapy.
complaining of dyspnea. Which of the
(b) The patient may be
following actions is the first the nurse
immunosuppressed.
should perform?
(c) The patient may be depressed.
(a) Ask the patient to lie down on the
(d) The patient may be dehydrated.
exam table.
(b) Draw blood for chemistry panel 67. A 34 year old female has recently been
and arterial blood gas (ABG). diagnosed with an autoimmune
(c) Send the patient for a chest x-ray. disease. She has also recently
(d) Check blood pressure. . discovered that she is pregnant. Which
of the follow ing is the only
65. A clinic patient has recently been immunoglobulin that will provide
prescribed nitroglycerin for treatment protection to the fetus in the womb?
of angina. He calls the nurse (a) IgA (b) IgD
complaining of frequent headaches. (c) IgE (d) IgG
Which of the following responses to
the patient is correct? 68. A second year nursing student has just
(a) "Stop taking the nitroglycerin and suffered a needlestick while working
see if the headaches improve." with a patient that is ositive for AIDS.
(b) "Go to the emergency department Which of the following is the most
important action that nursing student
to be checked because
nitroglycerin can cause bleeding in should take?
the brain." (a) Immediately see a social worker
(c) "Headaches are a frequent side (b) Start prophylactic AZT treatment
effect of nitroglycerine because it (c) Start prophylactic Pentamide
causes vasodilation." treatment
(d) "The headaches are unlikely to be (d) Seek counseling
related to the nitroglycerin, so you 69. Grade -II disinfectants have minimum
should see your doctor for further RW coefficient is
investigation."
352 □ □ Drug Inspector Exam

(a) 18 (b) 10 77. Which of the following microorganism


(c) 15 (d) 5 is responsible for the contamination
of most of the ophthalmic products
70. Disinfectant classified in how many
leading to sever eye inactions
grades on the basis of RW coefficient.
(a) Salmonella bareilly
(a) 2 (b) 3
(b) Bacillus subtilis
(c) 4 (d) 5
(c) Pseudomonas aeruginosa
71. What is the temperature at which (d) Staphylococcus aureus
humans whole blood stored.
Salmonella spp. infections have arisen
(a) 4-6°C (b) 25°C 78'
from contaminated
(c) - 20°C (d) 8-25°C
(a) parenteral preparations
72. Thiazolidine ring in penicillin is (b) tablets and capsules
synthesized from (c) ointments and creams
(a) L-cystine (b) Methionine (d) all of the above
(c) Valine (d) (a) & (c)
79. A highly sensitive semiquantitaive
73. Penicillin amidases(acylases)which method for detecting microbial
catalyse the removal of the side chain antigen in biological fluid is done by
from benzylpeniciilin is found in
(a) Radioimmune electrophoresis
(a) E coli (b) S aureus
(b) Counterimmune electrophoresis
(c) Clostridium tetani
(c) HPLC
(d) All of the above (d) Freeze dried centrifugal method
74. What is antidote in the poisoning of The Source for Saffron i s ...................
heavy metals?
(a) Dry stigma of Crocus sativus
(a) Dimercaprol (b) Calcium salt
(b) Dry flower of Crocus sativus
(c) Normal saline
(c) Dry stigma of Citrullus sativus
(d) Adrenaline
(d) Dry flower of Citrullus sativus
75. How the morphine poisoning is ^
Tick the anticancer drug belonging to
recognized?
inorganic metal complexes:
(a) Constipation
(a) Dacarbazine (b) Cisplatin
(b) Redness on face
(c) Methotrexate (d) Vincristine
(c) cessation of breathing
(d) Pin point pupil ^2- Enzyme drug used for acute leukemia
treatment:
76. Some people are very allergic to insect
(a) Dihydrofolate reductase
bites and stings. This condition is
(b) Asparaginase
called:
(c) Aromatase (d) DNA gyrase
(a) Septic shock
(b) Cardiac arrest 83. Chemically, calamine is
(c) Toxic shock syndrome (a) Zinc oxide
(d) Anaphylactic shock (b) Calcium carbonate
Model Paper-2 □ □ 353

(c) Aluminium silicate 91. Identify the incompatibility, if the


(d) Magnesium silicate sodium salicylate and Phenobarbital
sodium is prescribed with Vit. B
84. In which mineral drug, aluminium
complex:
silicate is not present?
(a) Hydrolysis (b) Recemization
(a) Kaolin (b) Kieselguhr
(c) Oxidation (d) Precipitation
(c) Shilajeet (d) Fueller's earth
92. Tick the broad spectrum drug for
85. When 'The N arcotic Drugs and
cestodosis, trem atodosis and
Psychotropic Act' was framed?
cycticercosis treatment:
(a) 1930 (b) 1940
(a) Piperazine (b) Ivermectine
(c) 1957 (d) 1985
(c) Praziquantel (d) Pyrantel
86. Incompatibility of phenol and PEG is
93. Tick the drug, inhibiting oxidative
removed by:
phosphorylation in some species of
(a) Calamine (b) Zinc oxide
helminthes:
(c) Bentonite (d) Bentonite magna
(a) Niclosamide (b) Piperazine
87. If sodium salicylate is prescribed with (c) Praziquantel (d) Mebendazole
sodium bicarbonate, the solution
94. Tick the drug, a salicylam ide
darken on standing due to:
derivative:
(a) Oxidation (b) reduction
(a) Praziquantel (b) Piperazine
(c) changing in pH
(c) Mebendazole
(d) none of the above
(d) Niclosamide
88. In presence of strong base soluble salts
95. All of the following antimalarial drugs
of amine drugs liberate:
are 4-quinoline derivatives, EXCEPT:
(a) Free acids (b) free base
(a) Chloroquine (b) Mefloquine
(c) both (a) & (b)
(c) Primaquine (d) Amodiaquine
(d) none of the above
96. Tick the drug used for malaria
89. Gentian violet in presence of acid
chemoprophylaxis and treatment:
compounds turns:
(a) Chloroquine (b) Quinidine
(a) Blue to green
(c) Quinine (d) Sulfonamides
(b) green to yellow
(c) purple to green 97. Tick the drug used for toxoplasmosis
(d) yellow to green treatment:
(a) Chloroquine (b) Tetracyclin
90. If sulphonamides are prescribed with
(c) Suramin (d) Pyrimethamine
water what will happen
(a) Soluble free acids will be formed 98. Which molecules are involved in the
(b) insoluble free acids will be formed anchoring of cells to an extracellular
malr x?
(c) insoluble base will be formed
(a) Integrins (b) Interleukins
(d) soluble free base will be formed
(c) Angiostatin (d) Cyclins
354 □ □ Drug Inspector Exam

99. Which of the following statements is (a) Simple dissolution


false regarding the characteristics of a (b) maceration
good protein target for antiviral drugs? (c) chemical reaction
(a) It should be important to the life (d) distillation
cycle of the virus.
103. Tincture of nux vomica is prepared by
(b) It should bear little resemblance to
process-
human proteins.
(a) Dilution (b) maceration
(c) It should be common to different
(c) percolation (d) decoction
types of virus.
(d) It should be important in the late 104. The formula for isotonicity adjustment
stages of the virus life cycle. bt freezing point method is-
100. What are the two main targets (a) 0.52 - b/a (b) 0.52 - a/b
currently used in anti-HIV therapy? (c) b - 0.52/a (d) a - 0.52 -/b
(a) Reverse transcriptase and protease. 105. The Clark's formula for calculation of
(b) Reverse transcriptase and dose, deals with
integrase. (a) Weight (b) age in month
(c) Protease and integrase. (c) age in yrs
(d) The viral glycoproteins gpl20 and (d) None of the above
gp41. 106. Posology deals with
101. Monophasic liquid dosage form (a) ingredients of formulation
include (b) dose of drug
(a) Solution (b) Tincture (c) type of formulation
(c) Aromatic waters (d) calculation of quantity of
(d) All of the above ingredients
102. Aromatic spirit of ammonia is
prepared by process-

ANSW ERS
1. (c) 2- (b) 3- (d) 4- (c) 5. (c) 6. (c) 7. (d) 8- (c) 9- (b) 10. (c)
11. (?) 12. (b) 13. (d) 14. (c) 15. (d) 16. (b) 17. (c) 18. (b) 19. (c) 20. (c)
21. (c) 22. (a) ■23. (a) 24. (d) 25. (d) 26. (b) 27. (d) 28. (d) 29. (d) 30. (d)
31. (c) 32. (a) 33. (b) 34. (b) 35. (c) 36. (b) 37. (a) 38. (d) 39. (d) 40. (a)
41. (b) 42. (b) 43. (b) 44. (b) 45. (a) 46. (d) 47. (d) 48. (a) 49. (b) 50. (b)
51. (b) 52. (a) 53. (c) 54. (d) 55. (b) 56. (a) 57. (b) 58. (b) 59. (?) 60. (a)
61. (a) 62. (c) 63. (d) 64. (d) 65. (c) 66. (c) 67. (d) 68. (b) 69. (b) 70. (b)
71. (a) 72. (d) 73. (a) 74. (a) 75. (d) 76. (d) 77. (c) 78. (b) 79. (a) 80. (b)
81. :.b) 82. (?) 83. (a) 84. (c) 85. (d) 86. (d) 87. (a) 88. (b) 89. (d) 90. (b)
91. (a) 92. (c) 93. (a) 94, (d) 95. (c) 96. (a) 97. (d) 98. (a) 99. (d) 100. (a)
101. (d) 102. (d) 103. (c) 104. (b) 105. (a) 106. (b)
□ □ □
Model Paper-3

1. Narcotic Drugs and Psychotropic 7. In which of the follow ing form


substances Act comes in the year of. number a pharmacist apply for getting
(a) 1954 (b) 1985 a license to import small quantity of
(c) 1971 (d) 1995 drug for personal use.
(a) 12 (b) 12A
2. Pharmacist registration issue in which
of the following form numbers. (c) 12B (d) 12AA
(a) XIV (b) XV 8. Basophils have receptors for which
(c) XII (d) XVI one of the following antibodies.
(a) IgG (b) IgE
3. The solution used to rinse vagina is
called as: (c) IgM (d) IgA
(a) Douches (b) Liniments 9. Which of the following is the most
(c) Enema (d) Diluents specific in diagnosis of AIDS?
(a) IHA (b) ELISA
4. General requirem ents for sterile
formulation come in which subpart of (c) Western blot
schedule M. (d) Immuno electrophoresis
(a) Part-I (1A) (b) Part-I (IB) 10. Pregnancy test is an example which
(c) Part-I (1C) (d) Part-I (ID) one of the following antigen antibody
reaction.
5. Which of the following number of ISO
correspond with class- 100 area for (a) Agglutination reaction
manufacture of sterile formulation? (b) Compliment fixation
(a) 5 (b) 6 (c) Neutralization reaction
(c) 7 (d) 8 (d) Precipitation reaction
6. Which one of the following is NOT 11. When antibody treated with papain
an ex-officio member of Pharmacy enzyme then it gives which one of the
Council of India? following product.
(a) The Director General of Health (a) lFab and lFc
Services (b) 2Fab and lFc
(b) The Director of Central Drugs (c) lFab and 2Fc
Laboratory (d) 2Fab and 2Fc
(c) The Drugs Controller General of 12. Arthus reaction is an example of
India which one of the following type of
(d) The Director of Pharmacopoeia hypersensitivity reaction.
Laboratory
356 □ □ Drug Inspector Exam

(a) Type-I (b) Type-II [S] Hemp type cannabis contains


(c) Type-Ill (d) Type-IV elongated bast fibres
Which one of the given statements is
13. Which of the following statements is
correct?
INCORRECT?
(a) Chick Martin test uses organic (a) P is true, Q is true, R is true, S is
matter in media true
(b) The organism in Rideal-Walker test (b) P is true, Q is false, R is false, S is
is S. typhi true
(c) Rideal-Walker test uses organic (c) P is true, Q is true, R is false, S is
matter in media true
(d) The organism in Chick Martin test (d) P is false, Q is false, R is true, S is
is S. typhi false
19. Which one of the followings is a beta
14. Which one of the following is causes
syphilis lactamase inhibitor?
(a) Mycobacterium (a) Penicillanic acid
(b) T. pallidum (b) Embonic acid
(c) Leptospira (d) N. gonorrhea (c) Cephalosporanic acid
(d) Clavulanic acid
15. Which one of the following is causes
german measles. 20. Spina bifidia defects may occur by
(a) Togavirus (b) Enterovirus which one of the following anti­
seizure drugs?
(c) Paramyxovirus
(a) Ethosuximide
(d) Orthomyxovirus
(b) Vigabatrin
16. Which one of the follow ing is (c) Valproic acid
responsible for Filariasis.
(d) Primidone
(a) Ades (b) Fleas
(c) Qulex (d) Sand fly 21. All of the followings are indications
for use of ACE inhibitors EXCEPT for
17. Wassermann test for one of the one. Identify that.
following disease. (a) Hypertension
(a) Typhoid (b) Gonorrhoea (b) Myocardial infarction
(c) Syphilis (d) AIDS (c) Left ventricular dysfunction
18. Two genetic types of Cannabis i.e. (d) Pheochromocytoma
drug type and Hemp types are 22 Which one of these is used as
cultivated. isotonicity adjuster?
[P] Drug type cannabis is rich in (a) Dextrose (b) Boric acid
(-)A9-£rares-tetrahydrocannabinol.
(c) NaCl (d) All of the above
[Q] Hemp type cannabis is rich in
cannabidiol 23. Convert 90% v/v alcohol to Proof
[R] Drug type cannabis is rich in strength. Choose the correct answer.
cannabidiol -
Model Paper-3 □ □ 357

(a) 57.77° under proof (a) CVS (b) Liver


(b) 57.77° over proof (c) CNS
(c) 47.41° over proof (d) Autonomic ganglia
(d) 47.41° under proof 32. Which one of the following is drug of
24. Which of the follow ing is most choice in syphilis is.
effective antitubercular drug? (a) Penicillin (b) Sulphonamide
(a) INH (b) PAS (c) Cephalosporin
(c) Streptomycin (d) Tetracycline
(d) Ethambutol 33. An "orphan drug" is:
25. Which of the following is not a (a) A very cheap drug
calcium channel blocker. (b) A drug which has no therapeutic
(a) Verapamil (b) Diltiazam use
(c) Prenylamine (d) Propranolol (c) A drug needed for treatment or
prevention of a rare disease
26. The antidote of choice for morphine
poisoning is (d) A drug which acts on Orphanian
(a) Nalorphine (b) Naltrexone receptors
(c) Naloxone (d) Nalbuphine 34. What quantities of 95 % v/v and 45
% v/v alcohols are to be mixed to
27. The local anaesthetic recommended as
make 800 mL of 65 % v/v alcohol?
an antiarrhythimic is.
(a) 480 mL of 95 % and 320 mL of 45
(a) Lignocaine (b) Procaine
% alcohol
(c) Tetracaine (d) Bupivacaine
(b) 320 mL of 95 % and 480 mL of 45
28. Which is used as gastric cytoprotective % alcohol
agent? (c) 440 mL of 95 % and 360 mL of 45
(a) PGE1 ,C (Alprostadil) % alcohol
(b) PGF2a(Dinoprost) (d) 360 mL of 95 % and 440 mL of 45
(c) PGE2 (Dinoprostone) % alcohol
(d) Misoprostol 35. Which of the following is not a
29. Ethyl-4-aminobenzoate is the IUPAC chemical incompatibility?
name of : (a) Precipitation
(a) Aniline acetate (b) Oxidation-reduction
(b) Benzocaine (c) Hydrolysis (d) Acid-base
(c) Biotin (d) Bethanechol 36. Liquefication is an example of
30. All of the following are released as following incompatibility.
prohormones except. (a) Chemical (b) Physical
(a) vitamin D (b) Steroid (c) Therapeutic (d) All of these
(c) Insulin (d) Parathyroid 37. Morphine may produce excitation in
31. Atropine has least effect on one of some individuals, specially in women,
following. although normally it depresses CNS
such condition known as.
358 □ □ Drug Inspector Exam

(a) Pathological state (c) Antiseptic (d) Sanitizer


(b) Tolerance 4 4
Which of the following is a limitation
(c) Idiosyncrasy (d) Allergy of the autoclave?
38. In the mixing of thymol and menthol (a) It lacks the ability to inactivate
the following type of incompatibility viruses
occurs : (b) It lacks the ability to kill
(a) Chemical incompatibility endospores
(b) Therapeutic incompatibility (c) It will destroy heat lalale materials
(c) Physical incompatibility (d) It cannot be used with glassware
(d) Tolerance incompatibility 45. The ocular irritation potential of the
39. The mechanism of sterilization by hot ophthalmic product prior to marketing
air is. is performed by.
(a) Protein denaturation (a) In situ gel (b) Draize test
(b) Oxidation (c) Gelling capacity
(c) Plasmolysis (d) Rheological evaluation
(d) Destruction of DNA 46. Which one of the following used as
40. Which of the following was the first model drug for In situ gel test for
widely used antiseptic and opthalmics.
disinfectant? (a) Linezolid (b) Pilocarpine
(a) Chlorine (b) Phenol (c) Atropine (d) Cycloserine
(c) Alcohol (d) Merthiolate 47. Various types of ophthalmic
41. Which of the following disinfectants preparations are commonly
acts by disrupting microbial encountered in the pharmacy Except,
membranes? (a) Emulsion (b) Suspension
(a) Halogens (b) Aldehydes (c) Solution (d) Ointment
(c) Cationic detergents 48. From the group of definitions below,
(d) Heavy metals select the most correct definition of
the termophthalmic preparation.
42. Which of the following items could
be sterilized by dry heat sterilization? (a) A sterile product intended to be
applied to the eyelids or placed
(a) Intravenous (IV) solution
into the cornea.
(b) Plastic IV bags
(b) A sterile product intended tobe
(c) Glass pipets
applied to the eyelids or placed in
(d) rubber gloves the space between the eyelids and
43. Which one of the following is used to the eyeball.
prevent infection by killing or (c) A sterile product designed to be
inhibiting pathogen growth on animal injected in the muscle tissue
tissues. surrounding the eye
(a) Bacteriostatic agent
(b) Sterilant
Model Paper-3 □ □ 359

(d) A sterile product intended to be 53. The given antibiotic is an example of


applied to either the eyeball or the ansamycins
optic nerve (a) Roxythromycin
49. From the group of considerations (b) Adriamycin
below, select the consideration (c) Aureomycin (d) Rifamycin
involved with the preparation of 54. Which one of the statement about
ophthalmic solutions. ethambutol molecule has true.
(a) Ophthalm ic solutions can be (a) Two chiral centers and 3
sterilized using paper filters. stereoisomers
(b) Ophthalmic solutions can be (b) Two chiral centers and 4
contaminated with other drugs stereoisomers
without real concern for the
(c) Two chiral centers and 2
patient's welfare.
stereoisomers
(c) The ophthalm ic solution can
(d) One chiral center and 2
contain some large particles as
stereoisomers
long as a "Shake Well Before
Using" label is attached to the 55. Regarding muscle relaxants which one
product. of the following one is wrong.
(d) The ophthalmic solution should be (a) Vecuronium is a depolarising
made isotonic, if possible, to agent
prevent irritation to the eye. (b) Suxamethonium induces
histamine release and can produce
50. Which of the following monoclonal
a 'scoline rash'
antibodies is prescribed for patients
with non-Hodgkin's Lymphoma? (c) Suxamethonium has a duration of
action of about 5 minutes in most
(a) Infliximab (b) Abciximab
people
(c) Gemtuzumab
(d) Scoline apnoea is due to
(d) Rituximab
pseudocholinesterase deficiency
51. Sildenafil is used for treatment of one
56. Which one of the following one is true
of the following disorders : regarding the use of laxatives.
(a) Systolic hypertension
(a) Ispaghula husk (e.g. Fybogel) is a
(b) Unstable angina bulk forming agent
(c) Pulmonary hypertension (b) Lactulose is a glucose polymer
(d) Hypertension due to eclampsia (c) Lactulose is hydrolysed by bacteria
52. Which one of the following drugs is in the small intestine
prescribed for the treatm ent of (d) Senna is a GI stimulant that acts
Philadelphia chromosome positive within 30 minutes
patients with Chronic myeloid
57. All are true regarding opiate analgesia
Leukemia? except.
(a) Pentostatin (b) Methotrexate
(c) Imatinib (d) L-Asparaginase
360 □ □ Drug Inspector Exam

{a) Patient controlled analgesia (PCA) the following is the most accurate
is more effective than intermittent statement?
parenteral dosing (a) Transfusion reaction is most likely
(b) The total opiate dose is usually immediately after the infusion is
reduced with a PCA completed.
(c) Fentanyl is more water soluble (b) PRBCs are best infused slowly
than morphine through a 20g. IV catheter.
(d) Epidural morphine can result in (c) PRBCs should be flushed with a
late respiratory depression 5% dextrose solution.
58. Regarding cardiovascular disease in (d) A nurse should remain in the room
the surgical patient all are true except. during the first 15 minutes of
(a) Following a myocardial infarct infusion.
elective surgery should be deferred 61. A patient who has received
for over 6 months chemotherapy for cancer treatment is
(b) 60% of post-operative re­ given an injection of Epoetin. Which
infarctions are clinically silent of the following should reflect the
(c) The mortality of a post-operative findings in a complete blood count
myocardial infarct is about 40% (CBC) drawn several days later?
(d) The risk of a post-operative infarct (a) An increase in neutrophil count.
is reduced in hypertensive patients (b) An increase in hematocrit.
59. A clinic patient has a hemoglobin (c) An increase in platelet count.
concentration of 10.8 g/dL and reports (d) An increase in serum iron.
sticking to a strict vegetarian diet. 62. A nurse is caring for a patient with a
Which of the follow nutritional advice platelet count of 20,000/microlrter.
is appropriate? Which of the following is an important
(a) The diet is providing adequate intervention?
sources of iron and requires no (a) Observe for evidence of
changes. spontaneous bleeding.
(b) The patient should add meat to her (b) Limit visitors to family only.
diet; a vegetarian diet is not (c) Give aspirin in case of headaches.
advised. (d) Impose immune precautions.
(c) The patient should use iron
63. A nurse is caring for patients in the
cookware to prepare foods, such
as dark green, leafy vegetables and oncology unit. Which of the following
is the most important nursing action
legumes, which are high in iron.
when caring for a neutropenic patient?
(d) A cup of coffee or tea should be
added to every meal. (a) Change the disposable mask
immediately after use.
60. A hospitalized patient is receiving (b) Change gloves immediately after
packed red blood cells (PRBCs) for use.
treatment of severe anemia. Which of (c) Minimize patient contact.
Model Paper-3 □ □ 361

(d) Minimize conversation with the (a) salmonella cubana


patient. (b) salmonella agona
64. What is the temperature at which (c) serratia mercescens
polio vaccine stored for 24 month? (d) none of the above
(a) 4-6°C (b) 25°C 72. Cold sterilization is
(c) - 20°C (d) 8-25°C (a) sterilization under low
65. What is the temperature at which temperature
dried plasma stored? (b) sterilization by ultra-sonic
(a) <20 (b) <25°C vibrations
(c) - 20°C (d) 8-25°C (c) sterilization in refrigerator
(d) sterilization by (gamma) rays
66. The following are absorbable sutures
except. 73. Tyndallisation is
(a) Catgut (a) 80°C for 20 m in three successive
(b) Polyamide (Nylon) days
(c) Polyglyconate (Maxon) (b) 100°C for 20 m in three successive
(d) Polyglactin (Vicryl) days
(c) 60°C for 20 m in three successive
67. How many isomers are possible for
days
fructose?
(d) none of the above
(a) 8 (b) 10
(c) 12 (d) 16 74. Genetically engineered bacteria are
being used in commercial production
68. Cyclic form of glucose having which of
of the following ring. (a) Melatonin (b) Testoterone
(a) Furanose (b) Pyranose (c) Human insulin
(c) Pyperanose (d) All of these
(d) Thyroxine
69. What is first aid? 75. Gene is segment of
(a) Completing a primary survey (a) RNA (b) DNA
(b) The first help given to the victim (c) RNA or DNA
of an accident
(d) Both DNA and RNA
(c) Assessing a victim's vital signs
(d) Treating a victim for shock 76. 'Nif gene' for nitrogen fixation is cereal
crops like w heat, jowar etc. is
70. The contaminant found in antibiotic introduced by cloning
eye ointment is (a) Rhizobium meliloti
(a) pseudomonas cepacia
(b) Bacillus thuringiensis
(b) staphylococcus aureus (c) Rhizopus (d) Rhizophora
(c) pseudomonas auruginosa
77. Which drug is recommended for the
(d) serratia mercescens
treatment of sleeping disorder?
71. The contaminant found in saline water
solution is
362 □ □ Drug Inspector Exam

(a) Rauwolfia serpentina (a) Iodoquinol (b) Metronidazole


(b) Valeriana officinalis (c) Diloxanide (d) Tetracycline
(c) Centella asiatica 34 Tick the drug for the treatment of a
(d) All of the above hepatic form of amebiasis:
78. What is Amalaki? (a) Diloxanide or iodoquinol
(a) Phyllanthus embilica (b) Tetracycline or doxycycline
(b) Withania somnifera (c) Metronidazole or emetine
(c) Brahmi (d) Berberis aristata (d) Erythromycin or azitromycin
79. What penalties is imposed if person 85. The antileprotic drug,dapsone act by
keeps opium without lincense? (a) inhibition of incorporation of
(a) 2 years imprisonment PABA in folic acid
(b) 3 years imprisonment (b) inhibition of protein synthesis
(c) 5 years imprisonment (c) inhibition the cell wall synthesis
(d) 10 years imprisonment (d) inhibition of ergosterol synthesis
80. Opium was brought under legislative 86. Which of these is a thiourea derivative
control in; used as antipeprotic dtug?
(a) 1945 (b) 1857 (a) dapsone (b) clofazimene
(c) 1888 (d) 1865 (c) thiambutosine
81. Government of India passed the (d) solapsone
dangerous drugs act in 87. The antibiotic, cycloserine is obtained
(a) 1945 (b) 1857 from
(c) 1925 (d) 1930 (a) Streptomyces orchidaceous
82. Tick niclosamide mechanism of action: (b) Streptomyces griesus
(a) Increasing cell membrane (c) Streptomyces purpura
permeability for calcium, resulting (d) Streptomyces monosperma
in paralysis, dislodgement and 88. Tolnaftate is a
death of helminthes (a) 2-Naphthyl N-m ethyl-N -(3-
(b) Blocking acetylcholine tolyl)thionocarbamate
transmission at the myoneural (b) b)2-propyl - N-m ethyl-N -(3-
junction and paralysis of tolyl)thionocarbamate
helminthes (c) c)2-m ethyl - N -m ethyl-N -(3-
(c) Inhibiting microtubule synthesis in tolyl)thionocarbamate
helm inthes and irreversible (d) d) 2-Naphthyl N-methyl-N-(3-
impairment of glucose uptake tolyl)carbamate
(d) Inhibiting oxidative
phosphorylation in some species 89. Which of the following antimicrobial
of helminthes agents has a time-dependent activity
on microorganisms?
83. Tick the drug of choice for the (a) the aminoglycoside, tobramycin
treatment of extraluminal amebiasis: (b) the quinolone, norfloxacin
Model Paper-3 □ □ 363

(c) the macrolide, erythromycin (a) Health department, USA


(d) the aminoglycoside, gentamicin (b) Health department, UK
90. Which of the following antibiotics is a ■(c) WHO
tetracycline? (d) Health department, Germany
(a) Chloramphenicol 96. Where Indian Pharmacopoeial Lab is
(b) Doxycycline situated?
(c) Erythromycin (a) Kolkata
(d) Streptomycin (b) Mumbai
91. What essential feature of a penicillin (c) Ghaziabad
is involved in its mechanism of action? (d) Lucknow
(a) Carboxylic acid 97. The latin word'doloreurgento'
(b) p-lactam ring indicates
(c) Acyl side chain (a) immediately
(d) Thiazolidine ring (b) when pain is severe
92. Tick the drug belonging to aromatase (c) frequency
inhibitors: (d) to make ointment
(a) Octreotide 98. The term 'anti cibos' means
(b) Anastrozole (a) before meal
(c) Flutamide (b) after meal
(d) Tamoxifen (c) during meal
93. The non ionic surfactant used as a (d) with meal
penetration enhancer is 99. The latin term'Cochleare minimum'
(a) oleic acid indicates
(b) Glycerol (a) one tablespoonful
(c) Tween 80 (b) one teaspoonful
(d) Propylene glycol (c) one dessertspoonful
94. Chemically, niosomes are (d) one small teaspoonful
(a) Non ionic surfactant 100. The name/quantity of each ingredient
(b) Ionic surfactant in the prescription is related to
(c) Cationic surfactant (a) inscription
(d) anionic surfactant (b) subscription
95. Who publish the International (c) superscription
Pharmacopoeia? (d) Signa
364 □ □ Drug Inspector Exam

AN SW ERS
1. (c) 2. (b) 3. (d) 4. (c) 5. (c) 6. (c) 7. (d) 8. (c) 9. (b) 10. (c)
11. (?) 12. (b) 13. (d) 14. (c) 15. (d) 16. (b) 17. (c) 18. (b) 19. (c) 20. (c)
21. (c) 22. (a) 23. (a) 24. (d) 25. (d) 26. (b) 27. (d) 28. (d) 29. (d) 30. (d)
31. (C) 32. (a) 33. (b) 34. (b) 35. (c) 66. (b) 37. (a) 38. (d) 39. (d) 40. (a)
41. (b) 42. (b) 43. (b) 44. (b) 45. (a) 46. (d) 47. (d) 48. (a) 49. (b) 50. (b)
51. (b) 52. (a) 53. (c) 54. (d) 55. (b) 56. (a) 57. (b) 58. (b) 59. (?) 60. (a)
61. (a) 62. (c) 63. (d) 64. (d) 65. (c) 66. (c) 67. (d) 68. (b) 69. (b) 70. (b)
71. (a) 72. (d) 73. (a) 74. (a) 75. (d) 76. (d) 77. (c) 78. (b) 79. (a) 80. (b)
81. (b) 82. (?) 83. (a) 84. (c) 85. (d) 86. (d) 87. (a) 88. (b) 89. (d) 90. (b)
91. (a) 92. (c) 93. (a) 94. (d) 95. (c) 96. (a) 97. (d) 98. (a) 99. (d) 100. (a)

a s a
Model Paper-4

1. The profile of expected adverse effects What is the minimum time interval
associated with the thiazide diuretics necessary for the drug to reach the
during heart failure therapy include: plasma steady state?
(a) cardiac dysrhythmia, (a) 200 hours (b) 8 hours
gastrointestinal disturbances, (c) 40 hours (d) 15-30 minutes
nausea and vom iting, visual
5. Prior to administering a due dose of
disturbances
digoxin, a client's pulse rate is found
(b) hypotension, a non-productive to be 55 bpm. What is the most
cough and hyperkalaemia appropriate course of action?
(c) hypotension, hypokalaemia and (a) administer the dose as directed by
dehydration the medication order
(d) hypotension, bradycardia, (b) treat the client for digoxin
dizziness, headache and overdose
gastrointestinal upsets
(c) determ ine the client's blood
2. The cardiac glycosides produce which potassium level
of the following effects? (d) do not administer the dose and
(a) Negative chronotropic and indicate this on the medication
positive inotropic effects chart
(b) Positive chronotropic and negative 6. In general the means by which
inotropic effects antidysrhythmic agents control cardiac
(c) N egative chronotropic and dysrhythmias can involve:
inotropic effects (a) enhancing automaticity
(d) Positive chronotropic and (b) reducing the effective refractory
inotropic effects period
3. The use of ACE inhibitors in heart (c) decreasing the rate of
failure is directed towards: depolarization
(a) enhancing glomerular filtration (d) increasing impulse conduction
rate speed
(b) decreasing heart rate 7. The antidysrhythmic drug group that
(c) peripheral vasodilation acts by shortening the duration of the
(d) increasing cardiac output cardiac action potential belong in
4. The half-life of the cardiac glycoside class:
digoxin is approximately 40 hours.
366 □ □ Drug Inspector Exam

(a) 1A (b) 3C (c) When applied carelessly, it can


(c) 1C (d) IB induce adverse effects in the
person adm inistering the
8. Which of the following statements
medication
about ACE inhibitors is true? They:
(d) A tingling sensation in the mouth
(a) decrease myocardial contractility
after sublingual GTN
(b) stimulate myocardial contractility
administration indicates the drug
(c) decrease afterload has passed its expiry date.
(d) stimulate renin release
13. Which of the following drug groups
9. In effect, peripheral vasodilators would not be useful in the treatment
relieve acute angina attacks by: of angina pectoris?
(a) coronary vasodilation (a) calcium channel antagonists
(b) slowing heart rate (b) potassium channel openers
(c) decreasing cardiac work (c) organic nitrates
(d) increasing myocardial oxygen (d) P agonists
consumption
14. Which of the following does not play
10. The organic nitrates are a group of an important role in blood pressure
peripheral vasodilators. They act: (a) endothelin-1 (b) rennin
(a) via accumulation of intracellular c- (c) the carotid bodies
AMP (d) prolactin
(b) via all of the above mechanisms
(c) by being converted into nitric 15. Diuretics help reduce blood pressure
by
oxide (NO)
(d) by altering the availability of (a) producing a decrease in vascular
volume
sodium ion to the muscle cell
(b) reducing sympathetic outflow
11. In the treatm ent of erectile from the CNS
dysfunction, alprostadil (caverject):
(c) reducing the response of the
(a) is contraindicated in clients taking periphery to released adrenal
organic nitrate preparations medulla hormones
(b) is available as an oral preparation (d) causing an increase in systemic
(c) is a very short-acting medication vascular resistance (SVR)
(d) stimulates nitric oxide production
16. The angiotensin II receptor
12. Which of the following statements is antagonists:
not applicable to glyceryl trinitrate (a) induce a cough as a common
(GTN)? adverse reaction
(a) It is absorbed and metabolised (b) act by inhibiting the formation of
quickly.' angiotensin II
(b) The sublingual spray has a longer (c) do not appear to produce any
shelf-life than the tablets. clinical hyperkalaemic state
(d) are used in the management of
angina pectoris
Model Paper-4 □ □ 367

17. The calcium channel antagonists are 22. Which action below is affect ,d by an
not indicated in the treatment of: antihistamine?
(a) cerebral ischaemia (a) blood vessel dilation
(b) dysrhythmias (b) phagocytosis of antigens
(c) angina pectoris (c) MHC presentation by
(d) hypotension macrophages
(d) the secondary immune response
18. A common adverse effect of
spironolactone in men is due its 23. Which cells and which signaling
intrinsic sex hormone activity. What molecules are responsible for initiating
is thought to be the mechanism of an inflammatory response?
action of spironolactone here? (a) phagocytes: lysozymes
(a) its oestrogenic activity (b) phagocytes: chemokines
(b) its progestagenic activity (c) dendritic cells: interferons
(c) its antiandrogenic activity (d) mast cells: histamines
(d) its antigonadotrophic activity 24. Inflammatory responses may include
20. Both the eye and the respiratory tract which of the following?
are protected against infections by (a) clotting proteins migrating away
which of the Following? from the site of infection
(a) the mucous membranes that cover (b) increased activity of phagocytes in
their surface an inflamed area
(b) the secretion of complement (c) reduced permeability of blood
proteins vessels to conserve plasma
(c) the release of slightly acidic (d) release of substances to decrease
secretions the blood supply to an inflamed
(d) the secretion of lysozyme onto area
their surface 25. A bacterium entering the body
21. Which statem ent about the through a small cut in the skin will
complement system is true? do which of the following?
(a) These proteins are involved in (a) inactivate the erythrocytes
innate immunity and not acquired (b) stimulate apoptosis of nearby body
immunity. cells Study Guide for Lecture
(b) These proteins are secreted by Exam II for BIOL1407 Page 2
cytotoxic T cells and other CD8 (c) stimulate release of interferons
cells. (d) activate a group of proteins called
(c) This group of proteins includes complement
interferons and interleukins.
26. An invertebrate, such as an insect, has
(d) These proteins are one group of innate immunity that can be
antim icrobial proteins acting nonspecific about which pathogens
together in cascade fashion. are prevented from harming its
metabolism. Which of the following
368 □ □ Drug Inspector Exam

is most likely to function this way in a condemnation of the healer.


the insect's intestine? Study Guide for Lecture Exam II
(a) complement (b) ysozyme for BIOL1407 Page 3
(c) mucus (d) neutrophils (c) The ancients probably knew of
plant derivatives that could reduce
27. In some insects, such as Drosophila,
the pain of inflammation.
fungal cell wall elements can activate
the protein Toll. What is Toll’s (d) If these signs were present, they
function? would know that healing was
taking place; otherwise the patient
(a) acts as a receptor that, when
would likely die.
activated, signals synthesis of
antimicrobial peptides 30. Histamines trigger dilation of nearby
(b) functions directly to attack the blood vessels, and increase in their
fungi presented to it permeability. Which of the signs of
(c) produces antimicrobial peptides by inflammation are therefore associated
interaction with chitin with histamine release?
(d) secretes special recognition signal (a) redness and heat only
molecules that identifies specific (b) swelling only
pathogens (c) pain
28. Mammals have Toll-like receptors (d) redness, heat, and swelling
(TLRs) that act in a manner similar to 31. Septic shock, a systemic response
those of insects. While not specific to including high fever and low blood
a particular pathogen, a TLR can pressure, can be life threatening. What
recognize a kind of macromolecule causes septic shock?
that is absent from vertebrates but (a) certain bacterial infections
present in/on certain groups of (b) specific forms of viruses
pathogens. Which of the following is (c) the presence of natural killer cells
most likely to be recognized by a
(d) a fever of >103 degrees in adults
particular TLR that defends against
some viruses? 32. What are antigens?
(a) lipopolysaccharides (a) proteins found in the blood that
(b) double-stranded DNA cause foreign blood cells to clump
(c) double-stranded RNA (b) proteins embedded in J3 cell
(d) glycoproteins membranes
(c) proteins that consist of two light
29. Which of the following is the most and two heavy polypeptide chains
likely reason that ancient peoples
(d) foreign molecules that trigger the
sought to identify inflammation?
generation of antibodies
(a) Seeing such signs would be cause
for their seeking out a healer in 33. If a newborn were accidentally given
their community. a drug that destroyed the thymus,
(b) Presence of the signs of what would most likely happen?
inflammation in a patient could be
Model Paper-4 □ □ 369

(a) His cells would lack class I MHC (c) flat shaft curved needle
molecules on their surface. (d) straight pointed scissor
(b) His humoral immunity would be gg Tensile strength testing is done for
missing. which of the following?
(c) Genetic rearrangement of antigen (a) belladonna plaster
receptors would not occur.
(b) salicylic acid plaster
(d) His T cells would not mature and
(c) zinc paste bandage
differentiate appropriately.
(d) both (a) and (b)
34. Clonal selection implies that
39 Which are the different types of
(a) brothers and sisters have similar
forceps?
immune responses.
(a) tissue forcep
(b) antigens increase mitosis in
specific lymphocytes. (b) haemostatic forcep
(c) only certain cells can produce (c) bone cutting forcep
interferon. (d) all of the above
(d) B cell has multiple types of antigen 40. What are the different type of scissors?
receptors. (a) straight blunt scissors
35. Which of the following cell types are (b) straight pointed scissors
responsible for initiating a secondary (c) lister's bandage scissors
immune response? (d) all of the above
(a) memory cells What is the use of
(b) macrophages sphygmomanometer?
(c) stem cells (d) B cells (a) to measure heart rate
36. Which of the following differentiates (b) to measure bp
T cells and B cells? (c) to measure pulse
(a) T cells but not B cells are (d) none of the above
stimulated to increase the rate of ^ What does ct scan stand for?
their cell cycles.
(a) computer topography
(b) Only B cells are produced from
(b) computed tomography
stem cells of the bone marrow.
(c) computerized transfer
(c) T cells but not B cells can directly
attack and destroy invading (d) none of the above
pathogens. 43. What does MRI stand for ?
(d) T cells but not B cells have surface (a) magnetic resonance imaging
markers. (b) magnetic resonance index
37. Which one of the following is not a (c) magnetic resonance impulse
type of surgical needles? id) none of the above
(a) straight needle 44. C rystallization is an example of
(b) round shaft curved needle ................... Incompatibility.
370 □ □ Drug Inspector Exam

(a) Immediate (b) Delayed 51. The most common site of chronic
(c) Instantaneous gastric peptic ulcer is:
(d) Both (a) and (b) (a) lesser curvature at antral-body
junction
45......................... Compatibility may be
corrected by changing the order of (b) anterior wall at duodenal verge
mixing. (c) greater curvature in mid-antrum
(a) Delayed (b) Immediate (d) esophago-gastric junction
(c) Tolerated (d) Adjusted 52. The most frequent complication of
46. Effective ulcer treatment which works chronic duodenal ulcer is:
without any action on gastric acid (a) hemorrhage (b) obstruction
secretion is: (c) perforation (d) malabsorption
(a) Lactulose 53. What is the predominant p-
(b) Aluminium hydroxide adrenoceptor in bronchial smooth
(c) Sucralfate (d) Lactitol muscle?
(e) Magnesium trisilicate (a) pi-adrenoceptor
47. Chagas' disease may be suspected if a (b) p2-adrenoceptor
patient has: (c) p3-adrenoceptor
(a) Constipation (b) Dysphagia (d) p4-adrenoceptor
(c) Heart failure (d) Jaundice 54. What is the main clinical use for
(e) Option (a), (b) & (c) agonists of the p2-adrenoceptor?
48. Captopril causes: (a) Treatment of angina.
(a) Hyperkalemia (b) Treatment of hypertension.
(b) Hypernatremia (c) Treatment of asthma.
(c) Hypokalemia (d) Treatment of pain.
(d) Hypercalcemia 55. What is the main clinical use for
antagonists of the pl-adrenoceptor?
49. Patient after an ischemic attack has
ventricular Tachycardia. Drug of (a) Treatment of glaucoma.
choice is: (b) Treatment of hypertension.
(a) Amiodrone (b) Metoprolol (c) Treatment of asthma.
(c) Lidocaine (d) Verapamil (d) Treatment of pain.
50. Which one of the following is a feature 56. Which one of the following laxatives
of the Zollinger-Ellison syndrome? is a lubricant?
(a) hypoglycemic attacks (a) Senna (b) Decussate
(b) obesity (c) castor oil (d) liquid paraffin
(c) gastric hyperchlorhydria 57. Which of the following antiemetics is
(d) diabetes least likely to cause an oculogyric
(e) fainting spells crisis?
Model Paper-4 □ □ 371

(a) trifluoperazine (b) Transketolase is an enzyme that


(b) domperidone transfers three-carbon units in the
(c) metoclopramide pentose phosphate pathway.
(d) prochlorperazine (c) Transaldolase is an enzyme that
transfers two-carbon units in the
58. Choose the drug irritating the gut and pentose phosphate pathway.
causing increased peristalsis:
(d) Pentoses undergo isomerizations
(a) Phenolphthalein in the pentose phosphate pathway.
(b) Methyl cellulose
63. In which disease, Glucose-6-
(c) Proserine (d) Mineral oil
phosphatase is either or deficient
59. All of the following drugs stimulate (a) Von Gierke's disease
bile production and bile secretion (b) diabetes
EXCEPT:
(c) Cori's disease
(a) Chenodiol (b) Cholenszyme
(d) McArdle's disease
(c) Oxaphenamide
(d) Cholosas 64. What is the drug's mode of action?
(a) Metallating agent
60. Select the drug which inhibits
(b) Intercalator
peristalsis:
(c) Chain terminator
(a) Castor oil (b) Bisacodyl
(d) Alkylating agent
(c) Loperamide (d) Sorbitol
65. What is the mode of action for the
61. Which of the following statements
anthracycline anticancer agents?
about the oxidative section of the
pentose phosphate pathway is correct? (a) Alkylating agents
(a) The pentose phosphate pathway (b) Chain cutting agents
generates NADH (c) Antisense agents
(b) The pentose phosphate pathway (d) Intercalating agents
oxidizes NADPH to NADP+. 66. What is the structure called?
(c) The rate-limiting reaction of the (a) Carmustine (b) Lomustine
pentose phosphate pathway is (c) Streptozotocin
catalyzed by glucose-6- (d) Cyclophosphamide
phosphatase
67. The following agent is used for the
(d) The pathway supplies ribose-5-
treatment of testicular and ovarian
phosphate and NADPH in the
cancers.
quantities the cells require
cu nh3
62. Which of the following statements
about the nonoxidative section of the p<
Cl" nh3
pentose phosphate pathway is correct?
(a) The nonoxidative reactions of the Which of the following statements is
pentose phosphate pathway are untrue regarding the above structure?
not reversible (a) The chlorine groups are displaced
before the drug becomes active.
372 □ □ Drug Inspector Exam

(b) Intrastrand cross linking of DNA 74. Tick the drug for trematodosis (fluke
results from the action of the invasion) treatment:
agent. (a) Bithionol (b) Ivermectin
(c) Base pairing between adenine and (c) Pyrantel (d) Metronidazole
thymine is disrupted by the agent.
75. Tick the drug, a benzim idazole
(d) The compound acts as a derivative:
metallating agent
(a) Praziquantel (b) Mebendazole
68. All of the following Anticancer agents (c) Suramin (d) Pyrantel
cause bone marrow depression
76. Tick the broad spectrum drug for
except?
cestodosis, trem atodosis and
(a) Chlorambucil
cycticercosis treatment:
(b) Daunorubicin
(a) Piperazine (b) Ivermectine
(c) Doxorubicin (d) Flutamide
(c) Praziquantel (d) Pyrantel
69. Which people are said to be fastest
77. Dose of Gentamicin is reduced in the
acetylators because they metabolize
elderly due to:
isoniazid by the process of acetylation
very quickly (a) Liver failure
(b) Reduced renal function
(a) Canadian Eskimos
(c) Decreased GI absorption
(b) Indians
(d) Decreased metabolism
(c) Asiatic Jews (d) Chinese
(e) Europeans (f) all the above 78. The iim portant side effect of
gentamicin is
70. Tick the drug, inhibiting oxidative
(a) Ototoxicity
phosphorylation in some species of
helminthes: (b) Nephrotoxicity
(a) Niclosamide (b) Piperazine (c) Neurmuscular dysfunction
(c) Praziquantel (d) Mebendazole (d) Teratogenic
(e) all of the above
71. Tick the drug for neurocysticercosis
treatment: 79. The antileprotic drug,dapsone act by
(a) Praziquantel (b) Pyrantel (a) inhibition of incorporation of
(c) Piperazine (d) Bithionol PABA in folic acid
(b) inhibition of protein synthesis
72. Tick the drug for nem atodosis
(c) inhibition the cell wall synthesis
(roundworm invasion) treatment:
(d) inhibition of ergosterol synthesis
(a) Niclosamide (b) Praziquantel
(c) Bithionol (d) Pyrantel 80. Which of these is a thiourea derivative
used as antipeprotic dtug?
73. Tick the drug for cestodosis
(a) dapsone (b) clofazimene
(tapeworm invasion) treatment:
(c) thiambutosine
(a) Piperazine (b) Praziquantel
(d) solapsone
(c) Pyrantel (d) Ivermectin
Model Paper-4 □ □ 373

81. The permission for cultivation of any (b) Merck & Co.,Inc.Rahway,New
coca plant was given by Jersy,USA
(a) State government (c) Merck & Co,UK
(b) Dristic Magistrate (d) Merck & Co,Germany
(c) District Judge 88. What is Amalaki?
(d) Central government (a) Phyllanthus embilica
82. The narcotic drugs & Psychotropic (b) Withania somnifera
substance consultative committee is (c) Brahmi (d) Berberis aristata
headed by
89. Which one of these has phytoestrogen
(a) State government activity?
(b) Dristic Magistrate (a) Phyllanthus embilica
(c) Distic Judge (d) chairman (b) Withania somnifera
83. Opium can be manufactured by (c) Brahmi
(a) central governm ent at opium (d) Azadirachta indica
factories
90. What is the source of Aesculetin used
(b) private factories for the treatment of dysentery?
(c) on loan licience (a) Frazinus rhychophylla
(d) none of the above (b) Adonis vemalis
84. Various substance & preparation have (c) Aesculus hippocastanum
been declared to be manufactured (d) Andrographis paniculata.
drugs in
91. The latin term'tussi urgent' indicates
(a) 1985 (b) 1857
(a) when cough is troublesome
(c) 1993 (d) 1865
(b) immediately
85. In 1925 India participate in second (c) when pain is severe
international opium conference held
(d) frequently
at
(a) Geneva (b) jaipur 92. Supercription indicates
(c) Delhi (d) U.S.A (a) direction to patient
(b) direction to physician
86. Who has published the National
(c) symbol Rx
Formulary
(d) none of the above
(a) Indian Pharmaceutical Association
(b) American Phcirmaceurical 93. Subcription is directed to
Association (a) patient (b) pharmacist
(c) British society of Pharmaceutical (c) doctor (d) all of the above
Association 94. In hospital, the most of the
(d) None of the above contamination is caused by free living
87. Who has published Merck index? opportunistic pathogens like
(a) Merck&Co.India
374 □ □ Drug Inspector Exam

(a) P aeruginosa (a) autoclaving at 115 degree for 30


(b) Clostridium botulinum minutes or 121 degree for 15
(c) salmonella typhi minutes
(d) M tuberculi (b) heating at 98 degree with either
benzalkonium chloride, or
95. In hospitals which of the following chlorhexidine acetate or
serves as the source of cross thiomersal.
contamination from one patient to
(c) filteration through membrane
another
filters.
(a) Contaminated multidose
(d) dry heat sterilization ior 2 hours
formulations
at 160 degree.
(b) Reusable applicators
(c) Nursing staffs 100. Labels on the ophthalmic eye lotions
(d) option (b) and (c) should include the following
information-
96. A highly sensitive semiquantitaive (a) 'Sterile until opened'
method for detecting microbial
(b) 'Use once and discard the
antigen in biological fluid is done by
remaining solution'
(a) Radioimmune electrophoresis
(c) 'Avoid contamination of contents
(b) Counterimmune electrophoresis during use'
(c) HPLC (d) All of the above
(d) Freeze dried centrifugal method
101. Which one of the following is a wrong
97. Infected blood products may produce statement about eye lotions-
serum hepatitis. It is due to (a) eye lotions intended for surgeries
(a) hepatitis A virus donot contain any antimicrobial
(b) hepatitis b virus agents.
(c) hepatitis c virus (b) they deliver active ingredient to
(d) None of the above the eye.
98. Contaminated water in hospitals (c) they are used for removing of
serves as source of which of the unwanted contaminants.
following organism (d) they should be supplied in
(a) opportunistic pathogenic gram(+) coloured fluted bottles.
bacteria 102. Tetracycline hydrochloride is used as
(b) opportunistic pathogenic gram(-) a ................... in formulation of an eye
bacteria drop.
(c) opportunistic pathogenic gram(+) (a) an oily vehicle
and gram(-)bacteria (b) preservative
(d) both (a) & (b) (c) viscosity enhancers
99. Which one of the following is a (d) tonicity adjuster
suitable method of sterilization in BP
1980 for sterilizing of eye drops?
Model Paper-4 □ □ 375

ANSWERS
1. (c) 2. (b) 3. (d) 4. (c) 5. (c) 6. (c) 7. (d) 8. (c) 9. (b) 10. (c)
11. (?) 12. (b) 13. (d) 14. (c) 15. (d) 16. (b) 17. (c) 18. (b) 19. (c) 20. (c)
21. (c) 22. (a) 23. (a) 24. (d) 25. (d) 26. (b) 27. (d) 28. (d) 29. (d) 30. (d)
31. (c) 32. (a) 33. (b) 34. (b) 35. (c) 36. (b) 37. (a) 38. (d) 39. (d) 40. (a)
41. (b) 42. (b) 43. (b) 44. (b) 45. (a) 46. (d) 47. (d) 48. (a) 49. (b) 50. (b)
51. (b) 52. (a) 53. (c) 54. (d) 55. (b) 56. (a) 57. (b) 58. (b) 59. (?) 60. (a)
61. (a) 62. (c) 63. (d) 64. (d) 65. (c) 66. (c) 67. (d) 68. (b) 69. (b) 70. (b)
71. (a) 72. (d) 73. (a) 74. (a) 75. (d) 76. (d) 77. (c) 78. (b) 79. (a) 80. (b)
81. (b) 82. (?) 83. (a) 84. (c) 85. (d) 86. (d) 87. (a) 88. (b) 89. (d) 90. (b)
91. (a) 92. (c) 93. (a) 94. (d) 95. (c) 96. (a) 97. (d) 98. (a) 99. (d) 100. (a)
101. (c) 102. (b)

cm
Model Paper-5
1. Tick the main approach of peptic ulcer 6. Choose the drug which is a H2-
treatment: receptor antagonist:
(a) Neutralization of gastric acid ((a) Omeprazole
(b) Eradication of Helicobacter pylori ((b) Pirenzepine
(c) Inhibition of gastric acid secretion ((c) Carbenoxolone
(d) All the above ((d)Ranitidine
2. Gastric acid secretion is under the 7. All of the following drugs are proton
control of the follow ing agents pump inhibitors EXCEPT:
EXCEPT: (a) Pantoprozole
(a) Histamine (b) Omeprazole
(b) Acetylcholine (c) Famotidine
(c) Serotonin (d) Rabeprazole
(d) Gastrin 8. Indicate the drug belonging to M l-
3. Indicate the drug belonging to proton cholinoblockers:
pump inhibitors: (a) Cimetidine
(a) Pirenzepine (b) Ranitidine
(b) Ranitidine (c) Pirenzepin
(c) Omeprazole (d) Omeprazole
(d) Trimethaphan 9. Which of the following drugs may
4. All of the following agents intensify cause reversible gynecomastia?
the secretion of gastric glands (a) Omeprazole
EXCEPT: (b) Pirenzepine
(a) Pepsin (c) Cimetidine
(b) Gastrin (d) Sucralfate
(c) Histamine
11. Tick the drug forming a physical
(d) Carbonate mineral waters barrier to HCL and Pepsin:
5. Which of the following drugs is an (a) Ranitidine
agent of substitution therapy? (b) Sucralfate
(a) Gastrin (c) Omeprazole
(b) Hydrochloric acid (d) Pirenzepine
(c) Hystamine
12. Which drug is an analog of
(d) Carbonate mineral waters prostaglandin El?
376
Model Paper-5 □ □ 377

(a) Misoprostole (c) Fepranone


(b) De-nol (d) Insulin
(c) Sucralfate Ethyl alcohol is an agent decreasing
(d) Omeprazole appetite. It's:
13. Select the drug stim ulating the (a) True
protective function of the mucous (b) False
barrier and the stability of the mucous 20. Select an anorexigenic agent affecting
membrane against damaging factors: serotoninergic system:
(a) De-nol (a) Fenfluramine
(b) Sucralfate (b) Fepranone
(c) Misoprostol (c) Desopimone
(d) Omeprazole (d) Masindole
14. Antacids are weak bases that react 21. Hypnotic drugs are used to treat:
with gastric hydrochloric acid to form
(a) Psychosis
salt and water. It's
(b) Sleep disorders
(a) True
(c) Narcolepsy
(b) False
(d) Parkinsonian disorders
15. Most of drugs are antacids EXCEPT:
22. Hypnotic drugs should:
(a) Misoprostol
(a) Reduce anxiety and exert a
(b) Maalox
calming effect
(c) Mylanta
(b) Induce absence of sensation
(d) Almagel
(c) Produce drowsiness, encourage
16. Indicate the drug that causes the onset and maintenance of sleep
metabolic alkalosis: (d) Prevent mood swings in patients
(a) Sodium bicarbonate with bipolar affective disorders
(b) Cimetidine 23. Which of the following chemical
(c) Pepto-Bismol agents are used in the treatment of
(d) Carbenoxolone insomnia?
17. Choose the drug that causes (a) Benzodiazepines
constipation: (b) Imidazopyridines
(a) Sodium bicarbonate (c) Barbiturates
(b) Aluminium hydroxide (d) All of the above
(c) Calcium carbonate 24. Select a hypnotic drug, which is a
(d) Magnesium oxide benzodiazepine derivative:
18. All of the following drugs stimulate (a) Zolpidem
appetite EXCEPT: (b) Flurazepam
(a) Vitamins (c) Secobarbital
(b) Bitters (d) Phenobarbitone
378 □ □ Drug Inspector Exam

25. Tick a hypnotic agent - a barbituric 31. Which of the following hypnotic drugs
acid derivative: is more likely to cause cumulative and
(a) Flurazepam residual effects?
(b) Zaleplon (a) Zolpidem
(c) Thyopental (b) Temazepam
(d) Triazolam (c) Phenobarbital
26. Select a hypnotic drug, which is an (d) Triazolam
imidazopyridine derivative: 32. Which of the following hypnotic drugs
(a) Pentobarbital increases the activity of hepatic drug-
(b) Temazepam metabolizing enzyme systems?
(c) Zolpidem (a) Phenobarbital
(d) Chloral hydrate (b) Zolpidem
(c) Flurazepam
27. Which of the following hypnotic
agents is absorbed slowly? (d) Zaleplon
(a) Phenobarbital 33. Hepatic microsomal drug-
(b) Flurazepam metabolizing enzyme induction leads
(c) Triazolam to:
(d) Temazepam (a) Barbiturate tolerance
(b) Cumulative effects
28. Which of the following barbiturates
(c) Development of physical
is an ultra-short-acting drug?
dependence
(a) Secobarbital
(d) "hangover" effects
(b) Amobarbital
(c) Thiopental 34. Hypnotic benzodiazepines are more
(d) Phenobarbital powerful enzyme inducers than
barbiturates.
29. Indicate the barbituric acid derivative, (a) True
which has 4-5 days elimination half-
(b) False
life:
(a) Secobarbital 35. Indicate the hypnotic drug, which
(b) Thiopental does not change hepatic drug-
metabolizing enzyme activity?
(c) Phenobarbital
(a) Flurazepam
(d) Amobarbital
(b) Zaleplon
30. Indicate the hypnotic benzodiazepine, (c) Triazolam
which has the shortest elimination
(d) All of the above
half-life:
(a) Temazepam 36. Barbiturates increase the rate of
metabolism of:
(b) Triazolam
(c) Flurazepam (a) Anticoagulants
(d) Diazepam (b) Digitalis compounds
Model Paper-5 □ □ 379

(c) Glucocorticoids 42. Which of the following is derived from


(d) All of the above the hemp plant "cannabis sativa"?
37. Which of the following agents inhibits (a) Opium
hepatic metabolism of hypnotics? (b) Marijuana
(a) Flumasenil (c) MDMA
(b) Cimetidin (d) Crack
(c) Phenytoin 43. A synthetic form of opium was
(d) Theophylline developed by Germany during WWII.
This is known as?
38. Which of the following factors can
influence the biodisposition of (a) Prednisalone
hypnotic agents? (b) Cortisone
(a) Alterations in the hepatic function (c) Methadone
resulting from a disease (d) Polyheroin
(b) Old age 44. A long-term user of cocaine may well
(c) Drug-induced increases or develop symptoms of other
decreases in microsomal enzyme psychological disorders, such as:
activities (a) Major depression
(d) All of the above (b) Social phobia
39. Which of the following hypnotics is (c) Eating disorders
preferred for elderly patients? (d) All of the above
(a) Phenobarbital 45. Amotivational syndrome in cannabis
(b) Flurozepam users suggests that those who use
(c) Temazepam cannabis regualry are more likely to:
(d) Secobarbital (a) Exhibit apathy
40. Which of the following hypnotics is (b) Exhibit loss of ambition
preferred in patients with limited (c) Have difficulty concentrating
hepatic function? (d) All of the above
(a) Zolpidem 46. Narcotics analgesics should:
(b) Amobarbital (a) Relieve severe pain
(c) Flurozepam (b) Induce loss of sensation
(d) Pentobarbital (c) Reduce anxiety and exert a
41. With Barbiturate and Benzodiazepine calming effect
Abuse and Dependency, sedative (d) Induce a stupor or somnolent state
intoxication is generally associated 47. Second-order pain is:
with: (a) Sharp, well-localized pain
(a) Slurred speech (b) Dull, burning pain
(b) Uncoordinated motor movements
(c) Associated with fine myelinated
(c) Impairment in attention and A-delta fibers
memory (d) Effectively reduced by non­
(d) All of the above narcotic analgesics
380 □ □ Drug Inspector Exam

48. Chemical mediators in the nociceptive (d) Analgesia, euphoria, respiratory


pathway are all of the following stimulation, physical dependence
EXCEPT: 53. Which of the following opioid receptor
(a) Enkephalins types is responsible for euphoria and
(b) Kinins respiratory depression?
(c) Prostaglandins (a) Kappa-receptors
(d) Substance P (b) Delta-receptors
49. Indicate the chemical mediator in the (c) Mu-receptors
antinociceptive descending pathways: (d) All of the above
(a) BETA-endorphin 54. Indicate the opioid receptor type,
(b) Met- and leu-enkephalin which is responsible for dysphoria and
(c) Dynorphin vasomotor stimulation:
(d) All of the above (a) Kappa-receptors
50. Which of the following mediators is (b) Delta-receptors
found mainly in long descending (c) Mu-receptors
pathways from the midbrain to the (d) All of the above
dorsal horn? 55. Kappa and delta agonists:
(a) Prostaglandin E (a) Inhibit postsynaptic neurons by
(b) Dynorphin opening K+ channels
(c) Enkephalin (b) Close a voltage-gated Ca2+
(d) Glutamate channels on presynaptic nerve
terminals
51. Select the brain and spinal cord
regions, which are involved in the (c) Both a and b
transmission of pain? (d) Inhibit of arachidonate
(a) The limbic system, including the cyclooxygenase in CNS
amygdaloidal nucleus and the 56. Which of the following supraspinal
hypothalamus structures is implicated in pain-
(b) The ventral and medial parts of modulating descending pathways?
the thalamus (a) The midbrain periaqueductal gray
(c) The substantia gelatinosa (b) The hypothalamus
(d) All of the above (c) The aria postrema
52. Mu (i) receptors are associated with: (d) The limbic cortex
(a) Analgesia, euphoria, respiratory 57. Indicate the neurons, which are
depression, physical dependence located in the locus ceruleus or the
(b) Spinal analgesia, mydriasis, lateral tegmental area of the reticular
sedation, physical dependence formation:
(c) Dysphoria, hallucinations, (a) Dopaminergic
respiratory and vasomotor (b) Serotoninergic
stimulation (c) Nonadrenergic
Model Paper-5 □ □ 381

(d) Gabaergic 64. Indicate the non-narcotic analgesic,


which lacks an anti-inflammatory
58. Which of the following analgesics is a
effect:
phenanthrene derivative?
(a) Fentanyl (a) Naloxone (b) Paracetamol
(c) Metamizole (d) Aspirin
(b) Morphine
(c) Methadone 65. Correct statements concerning aspirin
(d) Pentazocine include all of the following EXCEPT:
(a) It inhibits mainly peripheral COX
59. Tick narcotic analgesic, which is a
phenylpiperidine derivative: (b) It does not have an anti­
inflammatory effect
(a) Codeine
(c) It inhibits platelet aggregation
(b) Dezocine
(d) It stimulates respiration by a direct
(c) Fentanyl
action on the respiratory center
(d) Buprenorphine
66. For which of the following conditions
60. Which of the follow ing opioid could aspirin be used
analgesics is a strong mu receptor prophylactically?
agonist?
(a) Noncardiogenic pulmonary edema
(a) Naloxone
(b) Peptic ulcers
(b) Morphine
(c) Thromboembolism
(c) Pentazocine
(d) Metabolic acidosis
(d) Buprenorphine
67. All of the following are undesirable
61. Tick pirazolone derivative: effects of aspirin EXCEPT:
(a) Methylsalicylate (a) Gastritis with focal erosions
(b) Analgin (b) Tolerance and physical addiction
(c) Paracetamol (c) Bleeding due to a decrease of
(d) Ketoralac platelet aggregation
62. Which one of the following non­ (d) Reversible renal insufficiency
narcotic agents inhibits mainly 68. Characteristic findinds of salicylism
cyclooxygenase (COX) in CNS? include:
(a) Paracetamol (a) Headache, mental confusion and
(b) Ketorolac drowsiness
(c) Acetylsalicylic acid (b) Tinnitus and difficulty in hearing
(d) Ibuprofen (c) Hyperthermia, sweating, thirst,
63. Most of non-narcotic analgetics have: hyperventilation, vomiting and
(a) Anti-inflammatory effect diarrhea
(b) Analgesic effect (d) All of the above
(c) Antipyretic effect 69. Analgin usefulness is limited by:
(d) All of the above (a) Agranulocytosis
(b) Erosions and gastric bleeding
382 □ □ Drug Inspector Exam

(c) Methemoglobinemia 75. Tick mixed (opioid/non-opioid) agent:


(d) Hearing impairment (a) Paracetamol
70. M ethem oglobinem ia is possible (b) Tramadol
adverse effect of: (c) Sodium valproate
(a) Aspirin (d) Butorphanol
(b) Paracetamol 76. Anxiolytics are used to treat:
(c) Analgin (a) Neurosis
(d) Ketorolac (b) Psychosis
71. Correct the statements concerning (c) Narcolepsy
ketorolac include all of the following (d) Bipolar disorders
EXCEPT: 78. Anxiolytic agents should:
(a) It inhibits COX (a) Relieve pain
(b) It is as effective as morphine for a (b) Reduce anxiety and exert a
short-term relief from moderate to calming effect
severe pain
(c) Improve mood and behavior in
(c) It has a high potential for physical patient with psychotic symptoms
dependence and abuse
(d) Produce drowsiness, encourage
(d) It does not produce respiratory the onset and maintenance of a
depression state of sleep
72. Indicate the nonopioid agent of central 79. Anxiolytics are also useful for:
effect with analgesic activity: (a) Treatment of epilepsy and seizures
(a) Reserpine (b) Insomnia
(b) Propranolol (c) Muscle relaxation in specific
(c) Clopheline neuromuscular disorders
(d) Prazosin (d) All of the above
73. Select the antiseizure drug with an 80. Indicate the agents of choice in the
analgesic component of effect: treatment of most anxiety states:
(a) Carbamazepine (a) Barbiturates
(b) Ethosuximide (b) Benzodiazepines
(c) Phenytoin (c) Lithium salts
(d) Clonazepam (d) Phenothiazines
74. Which of the following nonopioid 81. The choice of benzodiazepines for
agents is an antidepressant with anxiety is based on:
analgesic activity? (a) A relatively high therapeutic index
(a) Fluoxetine (b) Availability of flumazenil for
(b) Moclobemide treatment of overdose
(c) Tranylcypramine (c) A low risk of physiologic
(d) Amitriptyline dependence
Model Paper-5 □ □ 383

82. This drug reduces blood pressure by (a) Labetalol (b) Clonidin
acting on vasomotor centers in the (c) Enalapril (d) Nifedipine
CNS:
91. Pick out the diuretic agent for
(a) Labetalol (b) Clonidine hypertension treatment:
(c) Enalapril (d) Nifedipine (a) Losartan (b) Dichlothiazide
83. All of the following are central acting (c) Captopril (d) Prazosin
antihypertensive drugs EXCEPT:
92. Which action below is affected by an
(a) Methyldopa (b) Clonidine antihistamine?
(c) Moxonidine (d) Minoxidil (a) blood vessel dilation
84. A ganglioblocking drug for (b) phagocytosis of antigens
hypertension treatment is: (c) MHC presentation by
(a) Hydralazine macrophages
(b) Tubocurarine (d) the secondary immune response
(c) Trimethaphan 93. Which cells and which signaling
(d) Metoprolol molecules are responsible for initiating
85. Pick out the sympatholythic drug: an inflammatory response?
(a) Labetalol (a) phagocytes: lysozymes
(b) Prazosin (b) phagocytes: chemokines
(c) Guanethidine (c) dendritic cells: interferons
(d) Clonidine (d) mast cells: histamines
86. Tick the drug with nonselective beta- 94. Inflammatory responses may include
adrenoblocking activity: which of the following?
(a) Atenolol (b) Propranolol (a) clotting proteins migrating away
(c) Metoprolol (d) Nebivolol from the site of infection
(b) increased activity of phagocytes in
87. Choose the selective blocker of beta-1
an inflamed area
adrenoreceptors:
(c) reduced permeability of blood
(a) Labetalol (b) Prazosin
vessels to conserve plasma
(c) Atenolol (d) Propranolol
(d) release of substances to decrease
88. Pick out the drug - an alpha and beta the blood supply to an inflamed
adrenoreceptors blocker: area
(a) Labetalol (b) Verapamil 95. A bacterium entering the body
(c) Nifedipine (d) Metoprolol through a small cut in the skin will
89. This drug inhibits the angiotensin- do which of the following?
converting enzyme: (a) inactivate the erythrocytes
(a) Captopril (b) Enalapril (b) stimulate apoptosis of nearby body
(c) Ramipril (d) All of the above cells Study Guide for Lecture
Exam II for BIOL1407 Page 2
90. This drug is' a directly acting
vasodilator: (c) stimulate release of interferons
384 □ □ Drug Inspector Exam

(d) activate a group of proteins called (c) reducing the response of the
complement periphery to released adrenal
96. Which of the following cell types are ' medulla hormones
responsible for initiating a secondary (d causing an increase in systemic
immune response? vascular resistance (SVR)
(a) memory cells 99. The angiotensin II receptor
(b) macrophages antagonists:
(c) stem cells (a) induce a cough as a cohrtmon
(d) B cells adverse reaction
(b) act by inhibiting the formation of
97. Which of the following does not play
angiotensin II
an important role in blood pressure
(c) do not appear to produce any
(a) endothelin-1
clinical hyperkalaemic state
(b) rennin
(d) are used in the management of
(c) the carotid bodies
angina pectoris
(d) prolactin
100. What crucial feature of penicillin is
'8. Diuretics help reduce blood pressure involved in its mechanism of action?
by
Carboxylic acid
(a) producing a decrease in vascular (b) p-lactam ring
voiume
(c) Acyl side chain
(b) reducing sympathetic outflow
(d) Thiazolidine ring
from the CNS

ANSW ERS
1. (d) 2. c) 3- (c) 4. (a) 5. (b) 6. (d) 7. (c) 8. (c) 9. (c) 10. (?)
11. (b) 12. (a) 13. (c) 14. (a) 15. (a) 16. (a) 17. (b) 18. (c) 19. (b) 20. (a)
21. (b) 22. (c) 23. (b) 24. (b) 25. (c) 26. (c) 27. (d) 28. (c) 29. (c) 30. (b)
31. (c) 32. fa) 33. (a) 34. (b) 35. (d) 36. (d) 37. (b) 38. (d) 39. (c) 40. (a)
41. (b) 42. (b) 43. (c) 44. (d) 45. (d) 46. (a) 47. (b) 48. (a) 49. (b) 50. (c)
51. (d) 52. (a) 53. (c) 54. (a) 55. (b) 56. (a) 57. (c) 58. (b) 59. (c) 60. (b)
61. (b) 62. (a) 63. (d) 64. (d) 65. (b) 66. (c) 67. (b) 68. (d) 69. (a) 70. (b)
71. (c) 72. (c) 73. (a) 74. (d) 75. (b) 76. (a) 77. (c) 78. (b) 79. (d) 80. (b)
81. (?) 82. (b) 83. (d) 84. (c) 85. (c) 86. (b) 87. (c) 88. (a) 89. (d) 90. (d)
91. (b) 92. (a) 93. (d) 94. (b) 95. (d) 96. (a) 97. (d) 98. (a) 99. (c) 100.(b)

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