Evaluation of crude drugs

A natural substance is regarded as food if it is used for filling up the

stomach daily without experiencing any deleterious effects.

But, it may be referred to a drug if it results in changing a

pathological/ disease state of an individual or animal to a normal/
physiological state without producing any side effects in a specific
dose.

Why needed?:

The evaluation of crude drug is necessary because of three reason;

1. Biochemical variations in the crude drug

2. Deterioration due to treatment and storage
3. Substitution and adulteration, as a result of carelessness, ignorance
or fraud
 Drug evaluation may be defined as the determination of
identity, purity and quality of a drug.

(1) Identity – identification of biological source of the drug.

(2) Quality – the quantity of the active constituents present.

(3) Purity – the extent of foreign organic material present in a

crude drug.
Drug evaluation:

Evaluation of crude drug ensures its identification and determination

of its quality and purity.

These are needed to establish whether or not a substance qualifies to

be a drug or food or eliminated from general use.

Identification:

In every country, there is national herbarium where most of the native
plants are preserved.

Identification of the crude drug is usually done by;

A qualified, specialized and experienced personnel (Botanist, Herbal

specialist) Comparison with the standard/authenticated sample
specimens Identification
quality:

It refers to intrinsic value of the crude drug i.e. nature and amount of
active/medicinal principles.

These active principles may be; Alkaloids, Glycosides, Carbohydrates ,

Volatile oils, Fixed oils, Tannins etc.

To maintain quality of the crude drugs, it is necessary to;

Select proper source of crude drugs (either wild or cultivated)

Collect the crude drugs at appropriate time
Collect the required parts of the plants
Preparation of collected drugs by proper cleaning and drying
Properly preserve the crude drugs in order to avoid contamination due
to microbes and against moisture, heat, air and light.
• Purity:

• Purity of the crude drug can be achieved by; Proper

identification Quality assurance
Methods of Drug Evaluation:

The evaluation of a drug is done by studying its various

properties.

The various properties are

(1) Organoleptic property,

(2) Microscopic property,
(3) Physical property.
(4) Chemical property,
(5) Biological property,
Organoleptic (Morphological) Evaluation

It refers to the evaluation of crude drugs using organs of sense. The study includes; Macroscopic
or external appearance External/ Internal Color, Odor, Taste, Sounds, Size, Shape, its fractures
etc….

External color:
The crude drugs may acquire a variety of colors. The color of the crude drugs vary from white to
yellowish gray, yellowish brown, reddish orange or brownish black. The fruits and seed crude
drugs have different colors whilst barks posses brownish gray to brownish black color. The
internal and external color of the barks varies; internal color is little lighter than the outer one.

Odor of crude drugs:

The crude drugs may be odorless or pose an odor which may be; Distinct ,Indistinct .
General terms for describing odor are; Aromatic, Balsamic ,Spicy, Fruity ,Pungent, acetous etc….

Taste of crude drugs:

The crude drugs may posses a characteristic taste or may be tasteless. The different terms used
to define taste of a crude drug are; General terms used in describing taste are: 1- Acid (sour) 2-
Saccharine ( sweet)-liquorice 3- Saline (salty) 4- Alkaline 5- Bitter-picrorriza 6- Tasteless
Taste of crude drugs:
Mucilaginous -Starches, Oily -Linseed oil, Astringent -Pomegranate, catechu, Pungent -Ginger,
Acrid- Coca, Nauseous- Ipecac

Size:
The size of crude drug encompasses measurements of; Length, Breadth, Diameter.
It may be measured in mm or cm.

Shape:
The crude drug may be having different shapes
Sarsaparilla root -Cylindrical, Podophyllum -Sub-cylindrical , Aconite -Conical, Jalap-Ovoid,
Nuxvomica –Disk , cinnamon–quills

Fractures (broken surfaces)and internal color:

The crude drugs refer to the external markings that are characteristics of a particular drug and
color after breaking the crude drug.

Short-kurchi, granular-cassia, splintery-cinnamon, fibrous-cinchona, laminated-quillaia fractures

Internal color of a crude drug is usually lighter compared to the external colour.
Example is turmeric, ginger etc…..
MICROSCOPIC EVALUATION OF THE CRUDE DRUGS

DEFINITION:

This evaluation is based on microscopic examination of entire or powdered form of

organized crude drug. Microscopy techniques may be simple or complex.

The powdered crude material can be observed using only chloral hydrate (simple
technique) but the presence of starch in that crude material is detected using iodine
tincture. The starch will be stained blue and other components of the sample will not
be stained.

importance:

Microscopic evaluation of the crude drug is indispensable in;

Initial identification of herbs,
Identification of small fragments of crude or powdered drugs,
Detection of adulterants (insects, animal feacal matter, moulds, fungi),
Identification of plant by its characteristic tissue features
MICROSCOPIC EVALUATION OF THE CRUDE DRUGS

types:

Identification of crude drug using qualitative microscopy

Every plant possess a characteristic tissue structure that can be demonstrated through study of;
Tissue arrangement ,Cell walls structure ,Cell contents (calcium oxalate crystals, fibers,
trichomes, parenchyma etc.)

when properly mounted on the slide (chemo microcopy for effective results)

Lignin stains red or pink with a drop of phloroglucinol and concentrated Hcl
Mucilage are stained pink with ruthenium red
Starches stained blue with iodine solutions

example:
Powdered clove- contain no scleroids and calcium oxalate crystals
Clove stalks- contain both
Microscopic linear measurements:
These include identification of crude drug by measurements like; Size of starch grains (e.g.
diameter of starch grain in cassia bark distinguishes from cinnamon) Size of the stomata
Diameter of phloem fibers (e.g. detection of cassia in cinnamon) Width of the vessel (e.g.
detection of clove stalks in powdered cloves) Length and width of fibres

Determination of leaf constants (Quantitative microscopy):

Stomatal index:
It is the percentage which the numbers of stomata form to the total number of epidermal cells
(each stomata being counted as one cell). S Here; S = Number of stomata per unit area E =
Number of epidermal cells in the same unit area.  

Vein-islet number:
It is defined as the number of vein islets per square mm of leaf surface midway between the
midrib and the margin. This value is constant for a given specie of a plant and used as a
characteristic for the identification of allied specie.

Veinlet termination number:

It is defined as the number of veinlet termination per square mm of leaf surface midway
between the midrib and the margin (unbroken leaf part is required). A vein termination is the
ultimate free termination of the veinlet. Hall and Melville in 1951, determined veinlet
termination number of Indian and Alexandrian Senna which was quite different for each other.
Palisade ratio:
It is the average number of the palisade cells beneath each epidermal cell. This ratio can be
determined with powdered drug.

Quantitative microscopy:
is an important technique employed in identification of crude drug when physicochemical
methods are inapplicable. The powdered crude drugs with well-defined particles that can
be counted or the objects with measurable diameter and thickness under suitable
magnification are calculated using lycopodium spore method. Adulterated starchy drugs
can be determined by counting the number of starch grains per mg and calculating the
amount from the known umber of starch grains per mg of the pure starch/starchy material.

calculation:
Here; N = Number of characteristic structures (e.g. starch grains) in 25 fields W = Weight in
mg of lycopodium taken S = Number of lycopodium spores in the same 25 fields M =
Weight in mg of the same (calculated on the basis of sample dried at 105 degree centigrade
P = Standard value of characteristic structure  
PHYSICAL EVALUATION OF THE CRUDE DRUGS
Physical evaluation:
The physical evaluation of the crude drugs is accomplished by the determination of various
physical characteristics/parameters by using various physico-chemical techniques. In crude plant
evaluation, physical methods are used to determine; Solubility Specific gravity Optical rotation
Viscosity

Physical evaluation:
Refractive index Melting point Water content Degree of fiber elasticity Ash values Extractive
values Foreign organic matter etc…….

solubility:
In this evaluation, the specific behavior of the drugs towards solvents is taken into consideration.
Crude drugs Characteristic solvents Colophony Light petroleum Peru B alsam Chloral hydrate
Castor oil Light petroleum (half to the volume of castor oil) Alkaloidal bases Organic solvents
Alkaloidal salts Polar solvents

Optical rotation:
Certain drug substances may have capability of rotating the plane polarized light to specific
orientation (+, dextrorotatory and -, levorotatory). Substances that rotate the plane polarized
light to the right/clockwise are dextrorotatory (d) or (+). Substances that rotate the plane
polarized light to the left/anti-clockwise are levorotatory (l) or (-). Measuring optical rotation
helps in determining; Whether a substance is optically active or not Purity Quality Strength
Crude drugs Optical rotation Eucalyptus 0 ° – (+)10° Honey (+)3 ° - (-)15°
Refractive index:
Refractive index is the property of a material that changes the speed of light, computed as the
ratio of the speed of light in a vacuum to the speed of light through the material. n = c/v Where;
n = Refractive index c = Speed of light in vacuum v = Speed of light in the substance Its measure
gives an idea of; Identification of a substance Purity Concentration Crude drugs Refractive index
Castor oil 1.4758-1.527 Clove oil 1.527-1.535

Specific gravity:
It is also referred to as the “relative density”. It is the ratio of the mass of a solid or liquid to the
mass of an equal volume of distilled water at 4°C or of a gas to an equal volume of air or
hydrogen under prescribed condition of temperature or pressure. Its measurement gives the
idea of floatability of the drug. Specific gravity > 1: Substance sinks Specific gravity < 1:
Substance floats Crude drugs Specific gravity Cottonseed oil 0.88-0.93 Coconut oil 0.925 Castor
oil 0.95  

viscosity:
It refers to the resistance of a liquid to flow. This resistance acts against the motion of any solid
object through the fluid and also against the motion of a fluid itself past stationary surfaces. It is
a constant value.

Melting point:
It refers to a temperature at which it changes state from solid to liquid. Plant constituents have
very sharp and constant melting points. Crude drugs Melting point (°C) Beeswax 62-65 Wool fat
34-44 Agar 85
Moisture content:
The moisture content of a crude drug is responsible for decomposition of crude drug due to
chemical change or microbial attack. It is necessary to determine and control the moisture
content of the crude drug. It is determined by heating the drug at 105°C in an oven to a constant
weight. Crude drugs Moisture content Digitalis Not more than 5% w/w Ergot Not more than 8%
w/w

Ash values:
Determination of ash values is useful for detecting low-grade products, exhausted drugs and
excess of sandy or earthy material. Different ash values are calculated for such purposes e.g.
Total ash Acid-insoluble ash Water soluble ash Sulphated ash

Ash values:
Total ash It is useful for detection of the crude drug mixed with various minerals e.g. sand, soil,
calcium oxalate, chalk powder or other drugs with different inorganic contents to improve their
appearance. The maximum temperature used for total ash is not more than 450°C. It is because
of the fact that at higher temperatures, volatile alkali chlorides may be lost.
Ash values:
Acid-insoluble ash Acid-insoluble ash means ash insoluble in dilute hydrochloric acid. Its value is
higher than total ash. The majority of crude drugs contain calcium oxalate whose quantity varies
frequently. Therefore, total ash of a crude drug vary within wide limits for specimen of genuine
drug e.g . for Rhubarb, total ash ranges from 8-40% and in this case , determination of acid-
insoluble content is more preferable.
Ash values:
Acid-insoluble ash The calcium oxide formed due to incinerated oxalate is soluble in hydrochloric
acid. The insoluble as is then weighed. In this way, excessive earthy matter that is usually
present in root, rhizome and leaves can be determined. Water-soluble ash It is used to detect
the presence of material which is exhausted by water .

Ash values:
Sulphated ash This ash is produced after treating the drug with sulphuric acid to get sulphate
salts. percentage ash is calculated with reference to air-dried sample. Temperature used for the
procedure is more than 600°C. Crude drugs Ash values Ginger (acid-insoluble) 3% Ginger (total
ash ) 16%

Extract values:
Extracts of crude drugs are obtained with different solvents. These extract give approximate
measures of their chemical contents. Various solvents are used according to the type of
constituents to be analyzed. Water soluble extracts are used for determination of crude drugs
containing glycosides, tannins and mucilage and alcohol-soluble extracts are used for
determination of resins, certain glycosides whilst ether-soluble extracts are used for drugs
containg fats and volatile principles.

Foreign organic matter:

The parts of the organs or organs other than the required are called foreign organic matter.
These may include; Insects Moulds Earthy material Animal excreta Each crude drug has its own
limits for presence of foreign matter e.g . garlic and saffron should not contain more than 2%
CHEMICAL EVALUATION OF THE CRUDE DRUGS
Chemical tests:
These are carried out using various chemical reagents to identify the nature and quantity of
chemical constituents of crude drugs. Chemical tests may be; Qualitative Quantitative

Qualitative chemical tests:

Qualitative chemical tests involve identification tests for various phytochemical constituents e.g.
alkaloids, glycosides, tannins etc. these tests provide information regarding nature of active
principle. Examples include; Molisch's test for carbohydrate drugs e.g. Glucose, Sucrose etc.
Iodine test for identification of starches Spot test for identification of fixed oils

Quantitative chemical tests:

These tests give the value or amount of active constituent in the crude drug. Examples include;
Saponification values for lipids (number of milligrams of potassium hydroxide required to
saponify 1g of fat under the conditions specified. It gives a measure of molecular weight of the
crude drug.) Ester value for volatile oils (number of mg of potassium hydroxide required to
saponify the esters in 1.0 g of the substance) Acid number for resins
CHEMICAL ASSAYS:
These tests give an approximate value of total phytochemical constituents in a crude drug.
Examples include; Total alkaloid in belladonna leaf Total alkaloid in ipecacuanha Total resinous
principle in jalap Total vitamins in cod liver oil
Instrumental techniques:
These techniques identify the chemical group in phytoconstituents using chromatography and
spectroscopy techniques.
BIOLOGICAL EVALUATION OF THE CRUDE DRUGS

DEFINITION:
It refers to evaluation of therapeutic or pharmacological and toxicological activity of the whole crude drug or
its active principle by using animals or microbes. Biological evaluation determines; Therapeutic activity of
drug or active principle Potency Toxicity

importance:
There are several method by which the plant or extract can be evaluated for pharmacological activity. These
are a method of choice when the drug cannot be assayed satisfactorily by chemical and physical methods.
These are also necessary to carry out since the crude drug is considered important only if it exerts significant
biological effects.

types:
method:
These assays are conducted by determining the amount of drug of known potency required to produce a
definite effect on suitable test animals or organs under standard conditions. Reference standards are used in
procedures to minimize errors. Toxicity studies are performed in suitable animal models to decide the lethal
dose and effective dose of crude drugs.

Animal models:
Drugs Animal models Vaccines Mice Vasopressin injection Guinea pigs Oxytocin injection Domestic chickens
Digitalis glycosides Pigeons Depressor activity and mydriatic drugs Cats Anthelmintic drugs Worms Eye
preparations Rabbits GIT and cardiac drugs Dogs Next to the animal drugs, the studies are carried out in
humans and it is not necessary that same results be expressed by the human beings.
Microbiological studies:
Microbiological assays are carried out to determine anti-microbial activity of various drugs.
Various methods include; Agar diffusion methods Turbidimetric methods Disc-diffusion
methods Yeasts, moulds and living bacteria are used for assaying vitamins. Living bacterial
strains are used for testing antimicrobials.
Agar diffusion method, Turbidimetric method, Disc-diffusion