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The Use Of Quality Control Parameters In The Evaluation Of Vegetable Crude Drugs
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1.4 CONVENTIONAL METHOD FOR STANDARDIZATION OF HERBAL FORMULATION
Standardization
of herbal raw drugs include passport data of raw plant drugs, botanical
authentication, microscopic and molecular examination, identification
of chemical composition by various chromatographic techniques and
biological activity of the whole plant. Macroscopic and microscopic
evaluation and chemical profiling of the herbal materials for quality
control and standardization have been reported by various workers.
Macroscopic identity of medicinal plant materials is based on sensory
evaluation parameters like shape, size, colour, texture, odour and taste
while microscopy involves comparative microscopic inspection of
powdered herbal drug. Further, advances in microscope technology have
increased the accuracy and capabilities of microscopy as a mean of
herbal crude material identification due to the implication of light and
scanning electron microscopes (SEM) in herbal drug standardization.
Furthermore, various advanced methods such as chromatographic,
spectrophotometric and combination of these methods, electrophoresis,
polarography, and the use of molecular biomarkers in fingerprints are
currently employed in standardization of herbal drugs ( Choudhary and
Sekhon, 2011).
1.5 CURRENT REGULATIONS FOR STANDARDIZATION OF CRUDE DRUGS
Internationally,
several pharmacopoeias have provided monographs stating parameters and
standard of many herbs and some products made out of these herbs.
Several pharmacopoeias like:
Pharmacopoeia committee
Chinese Herbal Pharmacopoeia
United States Herbal Pharmacopoeia
British Herbal Pharmacopoeia
British Herbal Compendium
Japanese Standards for Herbal Medicine
The Ayurvedic Pharmacopoeia of India
Lay down monograph for herbs and herbal products to maintain their quality in their respective nations (Agarwal, 2005).
1.6 STANDARDIZATION AND QUALITY CONTROL PARAMETERS FOR EVALUATION OF HERBAL CRUDE DRUGS
According
to WHO (1996a and b), standardization and quality control of herbals is
the process involved in the physicochemical evaluation of crude drug
covering aspects, such as selection and handling of crude material,
safety, efficacy and stability assessment of finished product,
documentation of safety and risk based on experience, provision of
product information to consumer and product promotion. Attention is
normally paid to such quality indices such as:
Macroscopic
Examination: In case of whole drugs, the macroscopic and secondary
characters are sufficient for identification of right variety and search
of adulterants.
Microscopic Examination: These are valuable both for
powders and ungrounded drugs for identification of right variety and
search of adulterants.
Foreign organic matter: This involves removal of matter other than source plant to get the drug in pure form.
Ash
values: These are criteria to judge the identity and purity of crude
drug such as: Total ash, sulphated ash, water soluble ash and acid
insoluble ash etc.
Moisture content: Checking moisture content helps
reduce errors in the estimation of the actual weight of drug material.
Low moisture suggests better stability against degradation of product.
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