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Why Standardized Herbal Extracts?


It is a known fact that different botanical herbs of the same species offer variable pathological response in humans. This phenomenon occurs primarily because of the geographical area where the herb is grown, its harvesting period, its storage conditions etc. Each of these factors has an influence on the chemical constituents of the herb. In a world where different herbs are sourced from and stored at different places, for optimum quality & efficacy of the end product, standardization of herbs is a modern day requirement.

Nature has provided a precarious balance of each chemical constituent in a healthy plant. These balanced chemical constituents of an herb or plant are responsible for its therapeutic activity and its efficacy in a particular phyto-therapy. In its natural habitat these herbs / plants contain water / alcohol soluble chemical constituents. They may also contain volatile matters. These chemical constituents or volatile matter, as the case may be, are imbedded on a matrix which holds them together.

The matrixes in most of the cases are cellulosic in nature, which interweave all the chemical constituents therein. Scientific studies have shown that cellulosic matters have no particular role in disease management and therefore not strictly necessary to be part of disease management. This concept is very well described in Ayurveda, where hundreds of preparations are filtered concoction, either in water or in self generated alcoholic preparations.

Millennium Herbal Care Ltd. conceptualizes innovative all natural phyto-therapies consisting of synergistic herbs inspired by Ayurveda through in house R&D and verified by third party in-clinic evaluations. Each phyto-therapy / health supplement consists of authentic herbs which are ethno botanically verified using well laid out techniques involving macroscopic, microscopic identification of the plant as well as Thin Layer Chromatography (TLC).

After verification, these herbs / plants are extracted using modern technology to get a cellulose free product. The extracted material is further verified by HPTLC / GC for presence of various chemical constituents as it would exist in the parts (i.e. root, stem, leaf or fruit) of the herb / plant.

The entire process of extraction is carefully carried out in a controlled environment to retain the complete chemical constituents of the plant. Standardization involves an extraction technique whereby some of the active constituents can be quantified using modern day analytical instruments. This would essentially indicate that major chemical constituents of the herb / plant are in certain resonance to equilibrate the stability and therapeutic activity of the extract.

Hence, standardized extracts of whole herbs offer not only the active ingredient, but also contain several synergistic compounds, which although may not directly affect the pathological mechanism, but can influence the bioavailability of the active component, negate possible side effects, and prevent the body from becoming immune to respond to therapy.

Process of standardization
& quality control

For achieving standardized quality of a herb, the process of standardization and quality control test involves various parameters e.g. correct identification, botanical authentication, (right from the source of collection), ethno-botanical identification, macroscopic appearance of the drug, its odour, taste, foreign matter contamination, microbial load and residual toxic matter. Further it also requires drying, powdering, extraction process, in process quality control, preparation of formulations, standardization of the finished product, stability studies, packing and labeling.

Production of standardized herbal extracts involve modern sophisticated analytical techniques viz. TLC(Thin Layer Chromatography), HPTLC(High Performance Thin Layer Chromatography), HPLC(High Performance Liquid Chromatography), GC(Gas Chromatography), UV(Ultraviolet) spectroscopy for chemical identification & quantitative measurement of the active constituent in terms of percentage in the whole mass. The active constituents in the herbs are alkaloids, glycosides, saponins, tannins, oils, etc. of different entities.

The therapeutic activity of herb is determined by the chemical composition of these various components often referred to as the “Chemical Markers”. These markers are used as a reference to compare the quality of the product for standardizing the test material (extract) using HPTLC & HPLC. The standardized herbal extraction process ensures maximum possible extraction of the active constituent & removal of the inactive substances, such as water and cellulose.

This helps to ensure the conformity of quality and therapeutic efficacy of each product without seasonal or batch-to-batch variations. There is no change in the chemical composition of the herb. For example, Ashwagandha usually contains 2 to 4% Withanoloid A. Withanoloid A is the therapeutically active constituent in Ashwagandha. Our products contain this minimum percentage of Withanoloid A to make it therapeutically efficacious at the prescribed dose of a particular formulation.

Further, microbiology, chemical and free metal analysis is done at both raw material and finished product stages to adhere to the highest quality and safety standards. The above principles are employed in all the major ingredients used in different formulations marketed by Millennium Herbal Care making them relatively more efficacious and reliable.