Abstract: Amlena is a branded mineralo-herbal drug used to treat peptic ulcers. Purpose of our study was to explore the acute and sub-acute oral toxicities of drug Amlena in experimental rats. In acute toxicity studies the drug Amlena 5000 mg/kg was administered orally, observed after 1hr dosing and also observed for 14 days. In sub-chronic oral toxicity study, evaluations were carried out after administering daily oral doses of 500 and 1000 mg/kg body wt., for 28 days to the rats. Biochemical and haematological assessments as well as body and relative organ weights of the rats, gross necropsy was carried out. Results were statistically analysed using Analysis of variance (ANOVA) with the level of significance set at P < 0.05. The limit dose of 5000 mg/kg did not cause any mortality or signs of acute toxicity in the rats tested during the observation period. In the sub-chronic tests, the results did not show any significant variations in terms of haematological and biochemical parameters. The weekly body and organ weight of the rats showed no statistically significant differences between the control and treated rats.
Keywords: Amlena, Peptic ulcer, Acute oral toxicity, Sub-acute oral toxicity