Study on a non-pharmacopeial formulation for its hepatoprotective activity against drug induced hepatotoxicity in animal model

Objectives This study assessed the hepatoprotective efficacy of a non-pharmacopeial formulation (NPF) against rifampicin-induced hepatotoxicity, aiming to expand the repertoire of hepatoprotective agents in Unani medicine. Methods An acute toxicity study and HPTLC analysis were performed. The experiment utilized 42 Wistar rats, each weighing between 150 and 200 g. The rats were systematically allocated into seven distinct groups, each containing six animals, identified as negative, positive, standard, and test groups A, B, C, and D. Liver damage was induced by oral administration of rifampicin at a dose of 500 mg/kg daily for 30 days, following a 2-hour interval after the administration of standard and test drugs. The standard and test groups received Silymarin (100 mg/kg), NPF, Afsanteen , Kasni , and Asaroon at doses of 167, 117, 167, and 217 mg/kg, respectively, orally once daily for 30 days. Serum levels of marker enzymes (SGOT, SGPT, and ALP), total protein (TP), and albumin (S. Alb) were evaluated. All groups underwent biochemical and histopathological analysis. Results The formulation was deemed safe at a dose of up to 2000 mg/kg. Compared to the standard drug, test groups A and D demonstrated potential protective effects on the liver enzymes. Test groups B and C exhibited normal liver architecture. Conclusions Asaroon (test group D) demonstrated greater efficacy than NPF. Histopathologically, Afsanteen and Kasni were found to be effective. The study indicated that formulations by Unani scholars were more effective than non-pharmacopeial formulations, although the tested NPF remained effective and safe in this study.