ACUTE AND SUBACUTE TOXICITY STUDIES OF POLYHERBAL FORMULATION: SHATGANDHA
*Amol A.Rasal, Vaishali R. Undale, Ashok V. Bhosale, Rakesh H.Nikam
Abstract
International regulations relating to human health require that all new
pharmaceutical drugs are tested for their safety prior to their use in
human being. Though the Herbal formulation thought to be safe, their
toxicity study is necessary. Also the World Health Organization
(WHO) has indicated assessment of the safety, efficacy and quality of
herbal medicines. In this project Shatgandha, the herbal formulation
manufactured by Indu Pharma is evaluated for toxicity acute and
subacute toxicity as per OECD Guidelines 425. The present finding
suggests that Shatgandha is non toxic at dose of 100 mg/kg & 200
mg/kg since no any marked changes in the Hematological, biochemical
and histopathological parameters were observed, but at 400 mg/kg it
has shown significant increase in AST, ALT, Creatinine & Urea as
well as marked Pathological changes in Histopathology of liver. In this study dose of 400
mg/kg has shown toxicity in mice.
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