Evaluation of drugs, WHO and

ICH guidelines for assessment

for herbal drugs stability.
Class : T.Y.B.Pharm
By : Rajani Bhati
Subject : Herbal Drug Technology
Guided by: Dr. (Mrs.) Shubhangi Pharande
CONTENT
ØIntroduction
ØEvaluation methods
• Organoleptic evaluation
• Microscopic evaluation
• Physical evaluation
• Chemical evaluation
• Biological evaluation
ØWHO and ICH guidelines for the assessment of herbal drugs
ØStability testing of herbal drugs
ØReference
•
INTRODUCTION

• Evaluation of a drug means confirmation of its identity and

determination of its quality and purity and detection of nature of
adulteration.
• The evaluation of crude drugs is necessary because of :
1) Biochemical variation
2) Deterioration due to treatment and storage
3) Substitution and adulteration due to carelessness, ignorance
• The crude drugs can be identified on the basis of their morphological,
histological, chemical, physical and biological studies.
Evaluation methods of drugs
• a crude drug can be evaluated by following 5 methods :
1) Organoleptic evaluation : it means study of drug using organ senses. It refers
to the methods of analysis like colour, odour, taste, size, shape and
special features , such as touch, texture. The study of form of a crude
drug is morphology while description of the form is morphography.
Ex. : fractured surfaces in cinchona, cascara barks ; odour and taste of spice-
drugs like black pepper, cumin, asafoetida.
2) Microscopic evaluation : this methos allows detailed examination of a drug
and it can be used to identify then organised drugs by their known histological
characters. Structural details of the drugs from plant origin are confirmed by
using various reagents or stains which distinguishes cellular structures.
Ex. : determination of leaf constants, presences of calcium oxalate crystals or
sclereids or the type of trichomes present .
3) Chemical evaluation : The chemical evaluation includes qualitative chemical tests,
quantitative chemical tests, chemical assays and instrumental analysis. The isolation,
purification and identification of active constituents are chemical methods of evaluation.
Qualitative chemical tests include identification tests for various phytoconstituents like
alkaloids, glycosides, tannins, etc.
Ex. : Quantitative chemical tests such as acid value, saponification value, etc; chemical
assay include assays for alkaloid, resin, volatile oils, etc .
4) Physical evaluation : Physical standards are to be determined for the drugs, wherever
possible. These are rarely constant for crude drugs, but may help in evaluation, specifically
with reference to moisture content, specific gravity, density, optical rotation, refractive
index, melting point, viscosity, and solubility in different solvents.
Ex. : moisture content for digitalis and ergot should NMT 5% w/w ; M.P. of beeswax- 62-
65%, etc.
5) Biological evaluation : this method is generally used when standardization is not
adequately done by chemical or physical means and also for conformity of therapeutic
activity of raw material and finished product. This evaluation is performed using whole
animals, animal preparations, isolated living tissues or microorgnisms.
WHO Guidelines
• World health organization (WHO) is a specialized agency of the untied nations
responsible for internation public health and its headquarter is in Geneva,
Switzerland and was established on 7th April, 1948.
• The first ever director general of WHO after its establishment was G. Brock
Chisholm and Andrija Stampar was the assembly’s first president . The
present director head of WHO is Tedros Adhanom Ghebreyesus.
• The WHO country office in india is headquartered in Delhi with country-wide
presence.
•
References
• https://jiwaji.edu/pdf/ecourse/pharmaceutical/Evaluation%20of
%20crude%20drugs.pdf