Abstract

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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