Abstract
<p><strong>Objective: </strong>Pipaliasava is a commercially available traditionally fermented biomedicine containing self-generated alcohol. Pipaliasava was standardised for various physicochemical and toxicological parameters using relevant modern techniques.</p><p><strong>Methods: </strong>Pipaliasava was evaluated for organoleptic and various physicochemical properties. Alcohol content was determined by gas chromatography. The formulation was analysed for the presence of microbial contamination by microbial tests and for heavy metals by atomic emission spectroscopy. HPTLC studies were carried out for quantitative determination of gallic acid in ethyl acetate extract of the formulation.</p><p><strong>Results: </strong>The formulation was found to be mild acidic. The refractive index was found to be 1.37. The viscosity was found to be 29.2 cp. The solid content was found to be 22.05 % w/v. Water-soluble extractive value and alcohol-soluble extractive value were evaluated to be 31.664 % w/v and 30.424 % w/v. Reducing and non-reducing sugars were found to be 20.08 % w/v and 0.38 % w/v. The content of ethanol was found to be 8.29 % using GC technique. Different extracts of pipaliasava were evaluated for the presence of various phytoconstituents using respective chemical tests. The formulation showed the absence of lead and mercury and permissible levels of arsenic and cadmium. The formulation showed no presence of <em>E. coli, P. </em><em>aerugenosa</em> and<em> S. aureus</em> in the microbiological examination<em>.</em> Gallic acid content in the ethyl acetate extract of pipaliasava was found to be 0.0061 % by HPTLC.</p><p><strong>Conclusion: </strong>Marketed pipaliasava formulation was successfully standardized as per Ayurvedic Pharmacopoeia of India and WHO guidelines.</p>
Highlights
Ayurveda, the oldest and richest system of medicine practiced worldwide, uses medicinal plants in different forms for prevention and treatment of many diseases
According to a survey made by WHO, herbal medicines are used by 80 % of world population for primary health care [1]
Lack of rigid quality control procedures for herbal drugs and formulations is one of the major problems faced by the herbal industry [2,3]
Summary
The oldest and richest system of medicine practiced worldwide, uses medicinal plants in different forms for prevention and treatment of many diseases. For determination of solid content, pipaliasava (50 ml) was evaporated to a thick extract on a water bath. The alcohol extracts were pooled together, evaporated to dryness and weight was determined. For alcohol-soluble extractive value, Pipaliasava (5 ml) was macerated with 100 ml of alcohol, filtered and 25 ml of the filtrate was evaporated to dryness and weight was determined. The percentage of alcohol-soluble extractive with reference to pipaliasava was calculated.
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