Monographs of plant extracts by APC

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As one step ahead to keep quality standard norms for Ayurveda products in tune with the present trends in the Indian ayurvedic medicines industry, the Ayurvedic Pharmacopoeial Committee (APC) is coming up with the new volume of Ayurveda Pharmacopoeia of India (API), Part I, exclusively comprising monographs of plant extracts for the first time.

The Committee has lately published the draft copy of the new edition, the eighth volume of API, Part-I, with 60 monographs based on upgraded monographs on 15 source plants, their powders, their aqueous and hydro-alcoholic extracts, to ensure quality of these traditionally well known medicinal plants for use as drug ingredients, according to sources from APC.

The monographs included in the draft are Amalaki, Arjuna, Asvagandha, Bibhitaka, Bhrngaraja, Brahmi, Haridra, Haritaki, Kalamegha, Kantakari, Mandukaparni, Satavari, Tamalaki, Vasa and Yasti. The Part I of API consists of monographs of single drugs even as the Part II consist monographs of compound formulations in Ayurveda.

The committee explains that the present trend of more manufacturers shifting their traditional preparation like Vatis and Gutikas to compressed tablets and capsules and attempts to adopt newer techniques of extraction, chemical preservation and application of modern principles to achieve greater shelf life for ayurvedic products has increased the importance of plant extracts.

“A recent trend in ayurvedic manufacturing pharmacy aims at (1) enhancement of potency and reduction in bulk of dosage form (2) convenience in administering doses and (3) acceptability by improving palatability,” says the draft volume. “The trend, an outcome of significant gains is knowledge in phyto-chemical contents of the source plant and improved methods of assessing the pharmacological and therapeutic actions of such phytochemical contents, has directly resulted in introduction of extracts of plants as a more effective means of obtaining desirable results”, it added.

The latest amendment in Drugs and Cosmetics Rule, 2010 under 158 (B) clause IV issuing guidelines with respect to medicinal plant extracts obtained from plants mentioned in books of First Schedule of the Act including aqueous, hydro-alcoholic and other than aqueous and hydro-alcoholic extracts, also lead the committee to conclude that it is appropriate to prepare monographs on plant extracts and the standards for aqueous and hydro-alcoholic extracts are presented for the first time, according to this, says the APC in the draft.

The work of preparing extracts using identical standard operating procedures was allotted to three extract manufacturers – the Bangalore-based Natural Remedies, Sami Labs and the Vijayawada-based Chemeloids – and coordinated by Natural Remedies.

Monographs on the fifteen plant drugs have been already included in earlier volumes of API Part I and they have now been upgraded to addition of Thin Layer Chromatography finger print profiling using Phyto-Chemical Reference Standard (PRS). New addition of assay for the PRS has been also added to make the monograph comparable to international standards.

Monograph of an extract in the pharmacopoeia is to provide qualitative and quantitative standards of quality for the extract for its use as a food item or a food supplement, dietary supplement or nutraceutical, as a drug or as an ingredient in cosmetics.

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