Safety profile of Ayurvedic poly­herbomineral formulation - Bacnil capsule in albino rats.

INTRODUCTION: Bacnil capsule is a poly­herbomineral formulation used to treat gastroenteritis. It contains many potential drugs derived from plant sources and Bhasma (calcined fine powder) preparations. AIMS: The study was designed to ascertain the safety of bacnil capsule orally in Charle's Foster albino rats. MATERIALS AND METHODS: As per the Organization for Economic Cooperation and Development (OECD) 425 protocol oral acute toxicity study, bacnil capsule was administered orally once only at the dose of 2000 mg/kg in rats. For repeated dose toxicity study, AYUSH 170 and OECD 407, it was administered at three dose levels, Therapeutic doses (TED) (196.2), TED × 5 (981) and TED × 10 (1962) mg/kg/day orally for 28 days in albino rats followed by a 15­day recovery period only on TED × 10 dose level. OBSERVATION AND RESULTS: Bacnil at the oral dose of 2000 mg/kg did not produce any toxicity or mortality in albino rats. Repeated dose 28­day oral toxicity revealed that test formulation did not produce any significant change in serum biochemical, hematological, and histopathological parameters at therapeutic dose level. Mild­to­moderate pathological changes were observed in the various serum biochemical and cytoarchitecture of the liver, heart, kidney, and stomach at a dose of 10 TEDs; however, the same was reversed after discontinuation in the recovery test. CONCLUSION: Bacnil at 196.2 mg/kg/day is safe at the therapeutic dose level in albino rats.