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Objective: The aim of the present study was to evaluate safety profile of Tamrabhasma (TMB), an Indian Ayurvedic preparation of copper found to possess significant ulcer protective activity both experimentally and clinically using some general, physiological, reproductive and laboratory parameters in rats and mice. Methods: Acute toxicity study was carried out in mice and rats of either sex treated orally with TMB (5, 20, 100 and 1000 mg/kg single oral dose). Subacute toxicity was carried out with 5, 20 and 100 mg/kg administered orally daily for 7 days while, 5mg/kg dose daily was used for 80 days for chronic toxicity study. In addition, teratological studies including both prenatal and postnatal studies were done in rats treated with TMB (5mg/kg single dose orally for 60 days plus during mating plus either upto 18 days of gestation or till delivery respectively to assess the safety profile of the drug. Results: TMB did not show any acute, subacute or chronic toxicity in terms of any change in general parameters (behaviour, mortality, weight gain, food and water intake). It did not produce any change in hematological profile, liver function tests and histopathological studies of major organs (liver, kidney, adrenals and testis) after 80 days study in rats. Teratological studies in rats showed no deleterious effect on organogenesis or intrauterine fetal development or any harmful effects on postnatal development of rat pups. Conclusion: The above observations are likely to strengthen the safe use of commonly used Ayruvedic medicine Tamrabhasma (TMB) in peptic ulcer diseases.

Keywords

Tamrabhasma, Toxicity, Physiological, Reproductive, Teratological Parameters

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