INDUSTRIAL PREPARATIONS AND STANDARDIZATION OF HERBAL MEDICINES
WHO Guidelines for Quality Standardized Herbal Formulations
a.Quality control of crude drugs material, plant preparations and finished products.
b.Stability assessment and shelf life.
c.Safety assessment; documentation of safety based on experience or toxicological studies.
d. Assessment of efficacy by ethnomedical informations and biological activity evaluations.
The bioactive extract should be standardized on the basis of active principles or major compounds along with the chromatographic fingerprints (TLC, HPTLC, HPLC and GC). The standardization of crude drug materials include the following steps:
1.Authentication (Stage of collection, parts of the plant collected, regional status, botanical identity like phytomorphology, microscopical and histological analysis, taxonomical identity, etc.)
2.Foreign matter (herbs collected should be free from soil, insect parts or animal excreta, etc.)
3.Organoleptic evaluation (sensory characters – taste, appearance, odor, feel of the drug, etc.)
4.Tissues of diagnostic importance present in the drug powder.
5. Ash values and extractive values.
7.Moisture content determination
8. Chromatographic and spectroscopic evaluation. TLC, HPTLC, HPLC methods will provide qualitative and semi quantitative information about the main active constituents present in the crude drug as chemical markers in the TLC fingerprint evaluation of herbals (FEH). The quality of the drug can also be assessed on the basis of the chromatographic fingerprint.
9.Determination of heavy metals – e.g. cadmium, lead, arsenic, etc.
10.Pesticide residue – WHO and FAO (Food and Agricultural Organization) set limits of pesticides, which are usually present in the herbs. These pesticides are mixed with the herbs during the time of cultivation. Mainly pesticides like DDT, BHC, toxaphene, aldrin cause serious side-effects in human beings if the crude drugs are mixed with these agents.
11.Microbial contamination – usually medicinal plants containing bacteria and molds are coming from soil and atmosphere. Analysis of the limits of E. coli and molds clearly throws light towards the harvesting and production practices. The substance known as afflatoxins will produce serious side-effects if consumed along with the crude