On the production of CONAVIRĀ® immune-booster by good manufacturing practice: Development of specifications for the herbal component.

Abstract


S. J. Ameh*, O. O. Obodozie, U. S. Inyang, M. S. Abubakar and M. Garba

CONAVIR ® is an immunostimulant phytomedicine developed at the National Institute for Pharmaceutical Research and Development, Abuja. The paper describes the steps taken and the results obtained in the attempt to develop specifications for the herbal component – the aerial parts of Andrographis paniculata Ness (Family: Acanthaceae), grown in the Institute’s gardens. The said steps are vital for production as per good manufacturing practice. Qualitative and quantitative tests on the fresh and air-dried materials were carried out as prescribed in standard texts. Quantitative results on the dried herb included: bitterness value, 2.86 ± 1.74 x 103 units per g; loss on drying, 10.64 ± 0.36 %w/w; total ash, 14.10 ± 4.49 %w/w; acid insoluble ash, 1.00 ± 0.06 %w/w; and water extractable matter, 30.37 ± 2.63 %w/w. Tests for phytochemicals revealed the presence of glycosides, saponins, tannins and alkaloids, but not of anthraquinones. Normal phase thin layer chromatography of the aqueous or ethanolic extract gave 5 spots, while the reverse phase of the same extracts gave 6. These results, including macroscopic and sensory examinations of the fresh herb, provided the quantitative and descriptive data needed for identifying and characterizing the herbal component of CONAVIR® .

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