Safety profile of Ayurvedic poly‑herbomineral formulation - Bacnil capsule in albino rats.

INTRODUCTION: Bacnil capsule is a poly‑herbomineral 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 15‑day 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 28‑day oral toxicity revealed that test formulation did not produce any significant change in serum biochemical, hematological, and histopathological parameters at therapeutic dose level. Mild‑to‑moderate 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.