TOXICOLOGICAL EVALUATION OF HEPACARE® – A NIGERIAN HERBAL FORMULATION

Hepacare® is a widely marketed herbal drug in Nigeria which is used for treating chronic liver ailments¹ and in this study, it is evaluated for its safety as well as pro-inflammatory and genotoxicity effects in mice. The effect of the drug was estimated in a 28-day study in which twenty five mice were randomly divided into five groups and administered orally at 250, 500, 750 and 2500 mg/kg body weight. Biochemical and haematological parameters were determined. The relative organ weights were estimated and histopathology of the liver and kidney tissues were also conducted. Furthermore, mRNA expression of pro-inflammatory cytokines, TNF-α and IL-6 were also estimated by RT-PCR in acute toxicity experiment.² There was a significant increase (p < 0.05) in the activity of ALP in the group treated with 750 mg/kg b.w.; while mice treated with 2500 mg/kg showed significant increase in the levels of AST, ALT, ALP, total bilirubin and total protein as compared to the control group. However, there was a significant dose related increase in monocytes counts in the groups treated with 750 and 2500 mg/kg. There was no significant difference (p > 0.05) in mRNA expression of TNF-α, IL-6 and genotoxicity studies in all the treatment groups as compared to the control. However, some hepatic and nephro-pathological derangements were observed in the groups treated with higher doses of the drugs. In conclusion, the study established that the herbal drug may not induce significant pro inflammatory toxic responses and genotoxic effects but prolonged intake may cause severe biochemical and clinical abnormalities especially at higher doses.

[1] Ishola IO, Akinyede AA, Robert AK, Omilabu SA. Drug Research. 2014; 65: 30 – 39.

[2] Schneider CA, Rasband WS, Eliceiri KW. Nature Methods. 2012; 9: 671 – 675