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PHARMACOLOGICAL
Year : 2019  |  Volume : 40  |  Issue : 3  |  Page : 185-191

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


Ph.D. Scholar, Pharmacology Laboratory, Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat, India

Correspondence Address:
Dr. Mukesh Nariya
Pharmacology Laboratory, Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar-361008, Gujarat
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ayu.AYU_64_18

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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.


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