STANDARDIZATION OF HERBAL DRUGS/PRODUCTS: BOON TO INDIAN PHARMA MARKET

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Efficient Standardisation and Quality control of  Herbal products  can be achieved by adopting a 6 point protocol consisting of:

Standardisation and authentification of ingredients
(Triple ‘P’ based screening)

SOP development for manufacturing process of Herbal Products
(Extraction, Distillation, Calcination, Fermentation etc)

Standardization of Formulations
(Triple ‘P’ based screening, especially Chemical and Chromatographic Profiling, Marker compounds,   Quantitative studies)

Stability (shelf life) studies
(Shelf life evaluation based on physic-chemical, microbial and HPTLC/HPLC     Fingerprints)

Efficacy
(Pharmacological screening data and documented traditional use)

Safety
(Toxicological data and documented experience) [17].

The European Medicines Agency(EMEA) defines marker compounds as “chemically defined constituents of a herbal drug which are of interest for control purposes, independent of whether they have any therapeutic activity or not”. Examples of markers are the valerenic acids in Valeriana officinalis and piperine in Piper longum etc. [16, 18, and 19].

Marker compounds are pure, single isolated compounds, secondary metabolites mostly with terpene, steroid, alkaloid, flavonoid, aromatic & heteroaromatic frameworks having alcoholic, carbonyl, olefinic, acid, ester & amide functionalities. Marker compounds of ingredients not necessarily the markers for formulations. Some undergo transformations and decompose, vanish or generate new markers. Marker compounds specific to Multiherbal Formulations need to be isolated. Formation of new markers depends on the various Manufacturing processes.

Marker compounds may be used to help identify herbal materials, set specifications for raw materials, standardize herbal formulations during all aspects of manufacturing processes and obtain stability profiles [20].

Generally three types of Markers:-
*  Chemical markers
*  Bio markers
*  Bio-active markers (Therapeutic markers)

Markers compounds new classification:-

*  Chemically modified markers generated by
-  Dealkylation
-  Deacetylation
-  Dehydration
-  Isomerisation

*  Hybrid markers generated by
-  Condensation
-  Esterification
-  Glycosilation

*  Pseudo markers generated by
-  Degradation
-  Decomposition
-  Polymerisation

*  Impurity markers - These are negative markers formed by
- Pyrolysis

Impurity markers-These are particularly useful for lavana, ksara, bhasma which are prepared by burning the plant ingredients.

* Markers generation by Isolation & spectroscopic techniques are used such as Gravity columns, Preparative layers; Flash / MPLC / HPLC; Liquid – Liquid Chromatography like DCCC / HSCSS; IR/UV/1D and 2D NMR, Mass and their quantification by chromatographic techniques like TLC; HPTLC / AMD; HPLC; GC & GC-MS; TLC – FID/FPD; Capillary Electrophoresis [17]

Fingerprint Analysis for Standardization-
It has potential to determine authenticity and reliability of chemical constituents of herbal drug and formulations [21]. It addresses the systematic and comprehensive nature of herbal medicines, so it has been internationally accepted as one of the efficient methods to control the quality of herbal medicines [22]. Chromatographic and Spectroscopic technologies are still two main methods for establishing the fingerprint, including TLC, HPLC, GC, CE, IR, NIR, NMR, as well as DNA fingerprinting. Nowadays, more and more hyphenated technologies are used such as GC-MS, HPLC-MS, HPLC-DAD-MS, and LC-NMR. Especially, the hyphenation of MS with HPLC or GC has been a very useful means to the chemical constituents’ analysis, quality control and metabolite studies, etc. [23-27]. Sometimes, a single fingerprint is inadequate for the effective analysis of complex herbal medicine, so multiple chromatographic fingerprints with different test conditions in the same or different separation principles have been proposed.

CONCLUSION:-
The pharmacopoeial standards in Ayurvedic Pharmacopoeia of India are not adequate enough to ensure the quality of plant materials. Herbal drugs/products standardization is massively wide and deep. The drugs are primarily dispensed as water decoction or ethanolic extract or in the form of fresh plant parts, juice or crude powder. Thus medicinal plant parts should be authentic and free from harmful materials like pesticides, heavy metals, microbial or radioactive contamination, etc. The extracts should then be checked for indicated biological activity in an experimental animal model(s) as polyherbal formulations contain more than 2 herbs so their combined effect should be studied. It should be then standardized on the basis of active principle or major compound(s) along with fingerprints using chromatographic and spectroscopic methods and stabilization with a minimum shelf-life of over a year, undergo regulatory or limited safety studies in animals. Determination of the probable mode of action will explain the therapeutic profile. The herbal medicines developed in this mode should be dispensed as prescription drugs or even OTC products depending upon disease consideration and under no circumstances as health foods or nutraceuticals.

Herbal medicine is making dramatic comeback and increasing number of patients are visiting alternative medicine clinics as the side effects of synthetic medicine are alarming. Under the prevailing circumstances futher investigations into the concept of polyherbal formulations should be undertaken. It can be concluded that polyherbal formulations should not be dismissed only on the basis that they do not withstand modern research. Ayurveda and herbal medicine has roots in medicinal herbs and they have been practiced for centuries.There is need for development of techniques which includes both traditional methods of evaluation and modern methods of evaluation. This will improve the quality of the drug and also motivates the practitioners to get more involved in the standardization process.

Since marketed polyherbal formulation(s) contains numbers of ingredients so by optimizing the formulation the no. of ingredients can be minimized and the no. of chemical constituents contained within it making Standardization process easier and there will be no need for unnecessary having so many drugs for an ailment and their adverse effects can be reduced. So by Standardization of Herbal drugs/products, their acceptance by the consumers will increase thereby increasing the Indian herbal market and the export of Indian Herbal  Products  to the world market making India the Pharma Power House till 2020.

REFERENCES:-
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