RESUMO
Background: Rhuflex-F is a proprietary Ayurvedic herbo-mineral formulation clinically used to combat and relieve stiffness in joints and muscles, reduce edema, restore mobility, and also effective in relieving the symptoms of other autoimmune illnesses that lead to rheumatism. Aims: The aim and objective of the research study is to evaluate the efficacy of Rhuflex-F against in vitro protein denaturation and in vivo Freund's adjuvant-induced arthritis in albino rats. Materials and methods: In vitro inhibition of protein denaturation activity was carried out using bovine serum albumin. For in vivo activity, arthritis was induced by complete Freund's adjuvant in albino rats. Rhuflex-F (135-270 mg/kg, po) was administered for 30th days in arthritic rats, and effects were assessed on primary and secondary paw edema, on pain response, hematological, serum biochemical parameters (serum transaminases, alkaline phosphatase, urea, uric acid, and orosomucoid), and serum anti-oxidant parameters and adrenal ascorbic acid. Results: Aqueous extract of Rhuflex-F showed in vitro protein denaturation inhibitory activity in a dose-dependent manner. Rhuflex-F showed nonsignificant decrease in primary and secondary paw edema with reduced pain response, some reversal effects on hematological parameters such as white blood cell and red blood cell related parameters and serum orosomucoid and adrenal ascorbic acid in comparison to Fruend's adjuvant control group. Further, Rhuflex-F reversed Freund's adjuvant-induced adverse effects on oxidant status in the serum of albino rats. Conclusion: Result of the present study suggested that Rhuflex-F formulation has anti-inflammatory activity, may be due to the inhibition of protein denaturation in vitro and in vivo anti-arthritic activity against complete Freund's adjuvant-induced arthritis in albino rats.
RESUMO
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.