DRUG

STANDARDIZATION
DRUG

 A drug is any substance or product that is used or

intended to be used to modify or explore
physiological systems or pathological states for
the benefit of the recipient. – WHO

 It is defined as any substance used for the

purpose of diagnosis, prevention, relief or cure of
a disease or treatment in man or animals.
STANDARD

 The standard is numerical value which quantify

the parameter and thus denotes quality and
purity of a material.

Drug standardization is the method to evaluate a

drug for its purity, quality, safety and efficacy.
WHEN SCIENCE BECOMES INDUSTRY…..

 Indian market - estimated as Rs. 440 cr.

 Global market - Rs. 4205 cr.

 By 2020 – estimated as Rs. 7000 cr.

 Demand
Vs
Supply

65% population uses

Traditional Medicines

25% population uses

Traditional Remedies
 Mercury
BAN

Herbal Drugs
BAN
 RAJ-AASHRAY – IGNORANCE TOWARDS
AYURVEDA

 Govt. is not promoting Ayurved?????.

 Question on opportunities for ayurvedic graduates.

 Even Ayurvedic persons do not have faith in their science.

 (MIS)BELIEFS ABOUT AYURVEDIC DRUGS

 No effect, No side-effect.

 100% safe ***

 Acting slowly

 Have limitations***
STEPS OF STANDARDIZATION

o Raw material – Herbal, Mineral, Animal

o Process – Various according to dosage form

o Final product
RAW MATERIAL

o Identification – Morphological, Microscopy, XRD,

ICP-AES

o Authentification – TLC, HPTLC, Chemical analysis,

Elemental analysis etc.

o Heavy Metal analysis, Microbial Overload

PROCESS - SOP

o Pre-process : Equipment,
Type of Fuel,
Shodhana,
Kajjali Preparation

o Process : Temperature Regulation,

Duration,
Siddhi Lakshana

o Post-process : Pariksha,
Storage, Packing Etc.
 FINAL PRODUCT

o Analysis acc to dosage form

o Chemical / Elemental analysis – qualitative & quantitative

o Microbial over-load

o Heavy metal content

o Shelf-life studies

o Pre-clinical study – safety and efficacy in animals

o Clinical studies in human

 Dosage Form Parameters to be evaluated
Churna / Powder/ Lepa LOD, Ash Value, Acid insoluble Ash, pH, Water Soluble Extractives, Alcohol
Soluble Extractives, Particle Size determination, Microscopic Studies,
Chromatography

Gutika / Tablet / Guggulu LOD, Ash Value, Acid insoluble Ash, pH, Water Soluble Extractives, Alcohol
/Ghana / Lepa Guti Soluble Extractives, Chromatography, Hardness, Disintegration time, Weight
variation, Friability Test

Avaleha LOD, Ash Value, Acid insoluble Ash, pH, Water Soluble Extractives, Alcohol
Soluble Extractives, Chromatography, Sugar content
Sneha LOD, pH, Water Soluble Extractives, Alcohol Soluble Extractives,
Chromatography, Solid Content, Specific Gravity, Refractive Index,
Saponification Value, Acid Value, Fatty Acid (saturated/unsaturated)

Aasav-Arishta / Pravahi Solid Content, Specific Gravity, LOD, pH, Water Soluble Extractives, Sugar
Kwatha content, Alcohol Content, Chromatography
Bhasma, Kupipakva, Rasa LOD, Ash Value, Acid insoluble Ash, Atomic Emission Spectroscopy, XRD,
Kalpa XRF, Particle Size determination, Qualitative test for particular
Metal/Mineral.

Malhara / Ointment / pH, Saponification Value

Shatdhaut Ghrita
Kshaara / Lavan LOD, Ash Value, Acid insoluble Ash, pH, Sodium-Potassium-Iron content

Kshaarasutra LOD, Sulphated Ash, pH, Water Soluble Extractives, Hexane Soluble
Extractives, Total Alkalies, Sodium, Potassium, Curcumin, Length, Weight,
Diameter, Tensile Strength
 LOD – MOISTURE CONTENT

Microbial growth
Following Hydrolysis
Especially for hygroscopic materials

•2 gm accurately weighed sample,

•Taken in a dried and previously weighed Petri-dish,
•Dried in an oven 110°C till constant weight,
•The weight after drying is noted and loss on drying is
calculated in percentage.
ASH VALUE

To check adulteration
Content of inorganic materials like silica

•2 gm accurately weighed sample,

•Taken in a dried and previously weighed Crucible,
•Heated in EMF on 450°C to procure carbon free ash,
•Ash value is calculated in percentage.
 TABLET DISINTEGRATION
TABLET HARDNESS TIME
TLC
 HPTLC
After spray with
At 254nm At 366nm 10% FeCl3

T1 T2 T3 T1 T2 T3 T1 T2 T3

T1 – Spot of Group-A (7Bhavana)

T2 – Spot of Group-B (21Bhavana)
T3 – Gallic Acid Standard
 Stability study

Real time – 1 year -at interval of 0,1,3,6,12 months

Accelerated – 6 months - at the end of 6 months

Storage conditions
Real time – Temperature : 25 ∘ C ⩲ 2
Relative Humidity : 60% ⩲ 5

Accelerated – Temperature : 40 ∘ C ⩲ 2
Relative Humidity : 75% ⩲ 5

Evaluation – Organoleptic parameters, Physico-chemical parameters,

Microbial load etc
 Dosage Form Parameters to be evaluated
Churna / Powder/ Lepa LOD, Ash Value, Acid insoluble Ash, pH, Water Soluble Extractives, Alcohol
Soluble Extractives, Particle Size determination, Microscopic Studies,
Chromatography

Gutika / Tablet / Guggulu LOD, Ash Value, Acid insoluble Ash, pH, Water Soluble Extractives, Alcohol
/Ghana / Lepa Guti Soluble Extractives, Chromatography, Hardness, Disintegration time, Weight
variation, Friability Test

Avaleha LOD, Ash Value, Acid insoluble Ash, pH, Water Soluble Extractives, Alcohol
Soluble Extractives, Chromatography, Sugar content
Sneha LOD, pH, Water Soluble Extractives, Alcohol Soluble Extractives,
Chromatography, Solid Content, Specific Gravity, Refractive Index,
Saponification Value, Acid Value, Fatty Acid (saturated/unsaturated)

Aasav-Arishta / Pravahi Solid Content, Specific Gravity, LOD, pH, Water Soluble Extractives, Sugar
Kwatha content, Alcohol Content, Chromatography
Bhasma, Kupipakva, Rasa LOD, Ash Value, Acid insoluble Ash, Atomic Emission Spectroscopy, XRD,
Kalpa XRF, Particle Size determination, Qualitative test for particular
Metal/Mineral.

Malhara / Ointment / pH, Saponification Value

Shatdhaut Ghrita
Kshaara / Lavan LOD, Ash Value, Acid insoluble Ash, pH, Sodium-Potassium-Iron content

Kshaarasutra LOD, Sulphated Ash, pH, Water Soluble Extractives, Hexane Soluble
Extractives, Total Alkalies, Sodium, Potassium, Curcumin, Length, Weight,
Diameter, Tensile Strength
PROBLEMS IN SETTING STANDARDS FOR
AYURVEDIC DRUGS

o Variation in quality of raw material acc to season and region.

o No regulation over raw material suppliers.

o Variation in formula of compound drug.

o Process modification i.e. Shatdhaut Ghrita

o In single drug we can compare for active principles but in

compound formulations, it is tough task.

o Concepts of ayurved are different.

o क िं चित ् रसेन ु रुते र्म…. Not by chemical compound

o ऩुरुषिं ऩुरुषिं वीक्ष्य…… cannot have uniformity like in modern medicine

AYURVED CONCEPT FOR DRUG STANDARDIZATION
o एविं प्र ृ तत एविं गण
ु िं एविं प्रभाविं अस्मर्न दे शे जातिं अस्मर्न ् ऋतो एविं गहृ हतिं एविं तनहहतिं
एविं उऩम ृ तिं अनया र्ात्रया युक्तिं अस्मर्न व्याधौ एविंववधमय ऩुरुषमय तावन्तिं दोषिं
उऩ षमयतत वा उऩशर्यतत
o Prakruti
o Guna
o Prabhava
o Collection – Place, Time, Method
o Preservation - Place, Method
o Sanskara
o Matra, Vyadhi, Indication, Anupaana, Dosha Shodhana / Shamana
 बहुता तत्र योग्यत्वं ऄनेकववधकल्पना संपतः च आवत चतुष्कः ऄयं द्रव्याणां
गुण उच्यते॥

बहुता - Availability – no chances of adulteration/substitution

योग्य - not damaged by any factors e.g. ककट्ट, सविि, अतप, जन्तु
etc.

ऄनेकववधकल्पना

संपत
 RAW MATERIAL - IDENTIFICATION
Factors to be taken into consideration for nomenclature of a drug

 रुहि

 मवभाव

 दे श

 ऱािंछन

 उऩर्ा

 वीयम

 इतर
ग्राह्य-अग्राह्यता
अभ्र -
स्मनग्धिं ऩथ
ृ द
ु ऱिं वणमसय
िं क्
ु तिं भारतो अचध र् ्
सख ु तनर्ोच्यऩत्रिं ि तत ् अभ्रिं शमतिं एररतर् ् ॥

वैक्रान्त –
ऄष्टास्त्र ऄष्टफिकः षट्कोणो मसृणो गुरः.
शुद्धवमवितवणणः च युक्तो वैक्रान्त उच्यते ॥
COLLECTION
Place

• अग्नेया ववन््यशैिाद्ाः सौम्यो वहमवगररः मतः॥

• पंचमहाभूत ऄनुसार

• ववल्मक कु वत्सत अनूप ऄश्म स्मशान उषरमागगजाः॥

जन्तु-ववनन-वहम व्याप्ता न औष्यः कायगवसवद्धदाः ॥
Time

• शाखा पिाशं ऄवचरप्ररढं – वषाग, वसन्त

 मूिावन – ग्रीष्मे
 शीणगप्ररढपणाग – वशवशरे
 त्वक् कन्द क्षीर – शरकद
 सार – हेमन्ते
 पुष्प फि – यथा ऋतु

 शरकद ऄवखिकायागथं ग्राह्यं सरसं औषधम् ॥

ववरे कवमनाथं च वसन्तान्ते समाहरे त्॥
PRESERVATION OF RAW MATERIAL
 गृहोत्वा च ऄनुरप गुणवत् भाजनस्थावन अगारे षु प्राक् -उदक् द्वारे षु वनवात प्रवात
देशेषु वनत्य पुष्पोपहारबविवत्कमगष,ु ऄवग्न-सविि-उपस्वेद-धूम-रजो-मूषक-चतुष्पद
ऄनवभगमयावन स्ववच्छन्नावन वशक्येषु असज्य स्थापयेत॥
्

 Place – Maintenance of Temperature, Humidity, Light

 No chances of contamination with water and insects etc.
 Proper sterilization and hygienic conditions
 Acharya said – Gandha, Dhoopa, Balikarma should be conducted
PROCESS
 Equipment
 Material
 Size
 Manual, Automatic

 Fuel

 Duration

 Siddhi lakshan
 Sneha – वततमवत ् मनेह ल् , शब्दहीनो अस्ग्नतनक्षऺप्त, पेनोद्गर् तैऱे,
पेनशािंतत सवऩमवष, गिंधवणमरसोद्भव.
 Avaleha – दवी प्रऱेऩ, तन्तर् ु त्व, अप्सु र्ज्जनर् ्, स्मथरत्विं, ऩीडिते र्ुद्रा,
गिंधवणमरसोद्भव
 Bhasma – वणम, रे खाऩण ू त्म व, वाररतर, उनर्, अऩन ु भमव, तनरुत्थ
POST-PROCESS
 Packing

 Preservation

 Use
Preservation
Containers – Well Closed, Air Tight, Hermetically Sealed, Light Resistant,
Aerosol Containers For Various Purpose.

Preservatives – Benzoic Acid & Sodium Benzoate, Salicylic Acid, Methyl

Paraben etc.

Antioxidants – Sodium Bisulphate, Ascorbic Acid etc.

Refrigerator and Other Temperature Regulatory Units

Radiation

Concentrated Sugar – Dip In Syrup Or Preparation Of Syrup

Oil Preservation - Pickles

Red Chilly – Wheat

Lime Powder - Shunthi

FINAL PRODUCT
 तत् एव युक्तं भैषज्यं यत् अरोग्याय् कल्पते॥