Safety profile of Ayurvedic poly‑herbomineral formulation – Bacnil capsule in albino rats
| Autor: | Bhakti Sitapara, Subrata De, Swati Sharma, Mukesh B Nariya, Balaji Panigrahi |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: | |
| Zdroj: | Ayu |
| ISSN: | 0976-9382 0974-8520 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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