SAFETY ASSESSMENT OF DIABECON: AN AYURVEDIC FORMULATION IN RATS

Abstract

Diabecon an ayurvedic formulation was tested for safety by estimation of heavy metal contents and also for acute and sub chronic toxicity. Heavy metal content in formulation were tested and found to be within limit as prescribed by WHO. In acute toxicity no toxic symptoms were seen at single oral dose of 2000 mg/kg, observed up to 14 days in rats. In sub chronic toxicity study, Diabecon was tested at the doses of 50, 250 and 500 mg/kg p.o. once daily for 90 days in rats. The results did not show evidence of any treatment related changes in body weight, food and water intake and ill health or behavioral changes, when compared with the control animals. Some significant changes were observed in high dose treatment group (500 mg/kg) in hematological and serum chemistry parameters compared to control group but were within the normal laboratory limit and were considered as incidental.