Current Regulations for Standardization of Crude Drugs

Current Regulations for Standardization of Crude Drugs
In India a great deal of bulk knowledge exists among ordinary people about the traditional use of herbal medicine. It is difficult to quantify the market size of the traditional Indian system. Since most practitioners formulate and dispense their own recipes. The present annual turnover of product manufactured by large companies is estimated at approximately US $ 300 million compared to a turnover of approximately US $ 2.5 billions for modern drugs. According to the study on the attitude of modern medicine practitioners are relatively unfamiliar with Ayurvedic product even though some are practiced. They are willing to try an Ayurvedic product if it efficiency is scientifically proven and would try aliment such as cough, cold, diarrhea, stomach problem, reproductive disease, liver and skin disease.4
Patent proprietary Ayurvedic medicines are sold over the counter in pharmacies. These products appear to represent a major share of branded traditional medicine in India. Nevertheless systems like Ayurveda still need to gain an empirical support of modern medical sciences to make them credible and acceptable for all. An innovative research effort to define the advantage of traditional system of medicine with respect to their safety and efficacy could result in a better utilization of these complementary systems of medicine. Internationally several pharmacopoeias have provided monographs stating parameter and standard of many herbs and some product 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 (API)
Lay down monograph for herbs and herbal products to maintain their quality in their respective nations. Government of India too has brought out Ayurvedic Pharmacopoeia India, which recommends basic quality parameters for eighty common Ayurvedic herbal drugs.
Standardization and Quality Control of Herbal Crude Drugs7
Accounting to WHO it is the process involving the physicochemical evaluation of crude drug covering the aspects, 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.
Macro and Microscopic Examination: For Identification of right variety and search of adulterants.
Foreign Organic Matter: Remove of matter other than source plant to get the drug in pure form.
Ash Values: It is criteria to judge the identity and purity of crude drug – Total ash, sulfated ash, water soluble ash and acid insoluble ash etc.
Moisture Content: To check moisture content helps prevent degradation of product.
Extractive Values: These are indicating the approximate measure of chemical constituents of crude drug.
Crude Fiber: To determine excessive woody material Criteria for judging purity.
Qualitative Chemical Evaluation: It covers identification and characterization of crude drug with respect to phytochemicals Constituent.
Chromatographic Examination: Include identification of crude drug based on use of major chemical constituent as marker.
Qualitative Chemical Evaluation: Criteria to estimate amount the major class of constituents.
Toxicological Studies: Pesticide residue, potentially toxic elements, and Microbial count approach to minimize their effect in final product.
Physical evaluation:
Each monograph contains detailed botanical, macroscopic and microscopic descriptions of the physical characteristics of each plant that can be used to insure both identity and purity. Each description is accompanied by detailed illustrations and photographic images which provide visual documentation of accurately identified material.
Microscopic evaluation
Full and accurate characterization of plant material requires a combination of physical and chemical tests. Microscopic analyses of plants are invaluable for assuring the identity of the material and as an initial screening test for impurities. Most manufacturers of herbal products lack the quality control personnel to accurately assess plant identity and purity microscopically. The Ayurvedic Herbal Pharmacopoeia (AHP) fully characterize herbal products against the literature and AHP. Verified trade mark authenticated materials to assure identity of test materials. Ideally, submitted materials should be in their whole or semi-whole (cut) form for microscopic assessment. However, much information can be discerned from microscopic evaluation of powders as well.
Chemical evaluation
A chemical method for evaluation covers the isolation, identification and purification. Chemical analysis of the drug is done to assess the potency of vegetable and animal source material in terms of their active principles. The chemical tests include colour reaction test, these tests help to determine the identity of the drug substance and possible adultration.
Biological evaluation
Pharmacological activity of certain drugs has been applied to evaluate and standardize them. The assays on living animal and on their intact or isolated organs can indicate the strength of the drug or their preparations. All living organism are used, these assays are known as Biological assays or Bioassay.
Analytical Methods
Critical to compliance with any monograph standard is the need for appropriate analytical methods for determining identity, quality, and relative potency. There are a plethora of analytical methods available. However, it is often difficult to know which is the most appropriate to use. The primary goal of AHP is to provide multiple methods of identification and testing by which all aspects of the botanical can be appropriately assayed.
Chromatographic Characterization
Chromatography
Chromatography is the science which is studies the separation of molecules based on differences in their structure and/or composition. In general, chromatography involves moving a preparation of the materials to be separated the "test preparation” over a stationary support. The molecules in the test preparation will have different interactions with the stationary support leading to separation of similar molecules. Test molecules which display tighter interactions with the support will tend to move more slowly through the support than those molecules with weaker interactions. In this way, different types of molecules can be separated from each other as they move over the support material. Chromatographic separations can be carried out using a variety of supports, including immobilized silica on glass plates (thin layer chromatography), very sensitive High Performance Thin Layer Chromatography (HPTLC), volatile gases (gas chromatography), paper (paper chromatography), and liquids which may incorporate hydrophilic, insoluble molecules (liquid chromatography).
Purity Determination
Each monograph includes standards of purity and other qualitative assessments which include when appropriate: foreign matter, ash, acid-insoluble ash, moisture content, loss of moisture on drying, and extractives.
High performance thin layer chromatography (HPTLC) is valuable quality assessment tool for the evaluation of botanical materials. It allows for the analysis of a broad number of compounds both efficiently and cost effectively. Additionally, numerous samples can be run in a single analysis thereby dramatically reducing analytical time. With HPTLC, the same analysis can be viewed sing different wavelengths of light thereby providing a more complete profile of the plant than is typically observed with more specific types of analyses.
Quantitative Analysis
When applicable, the most appropriate quantitative analytical method with accompanying chromatograms shall be provided. The primary goal of the method(s) is to provide validated methods to be used for the quantization of the compound(s) most correlated with pharmacological activity or qualitative markers as determined by the primary pharmacological literature, constituent declaration in product labeling, and a survey of experts. The method(s) will be selected from the primary analytical literature by a Methods Selection Committee with priority given to compendial methods when available. In this context, validation consists minimally of a two-lab validation using the same procedures, samples, and reference standards.
Primary factors for considering a method as appropriate include accuracy of the findings, speed, basic ruggedness, applicability to a large segment of the manufacturing community, and avoidance of the use of toxic reagents and solvents. In an attempt to promote harmonization, primary consideration is given to those methods which are already accepted in official pharmacopoeias or by AOAC International. When necessary, comparative tests shall be conducted to determine which of the available method(s) is most appropriate. The validation process minimally includes: standard precision, linearity, sample precision using replicate samples, sample linearity, selectivity (co-elution, sensitivity to analyte degradation), retention times, and limits of detection. Other methods which may be of value to the industry may be included or cited in the monograph but are not required for compliance with the monograph.