Pro-inflammatory and toxicological evaluation of Hepacare® in mice

Abstract Objectives Hepacare ® is a widely marketed herbal formulation in Nigeria for treating chronic liver ailments. This study evaluated the safety, as well as pro-inflammatory and genotoxicity effects, of Hepacare ® in mice. Methods The effect of the formulation was estimated in a 28-day study where 25 mice were divided into five groups, and Hepacare ® was orally administered at 250, 500, 750 and 2500 mg/kg body weight. The biochemical and haematological parameters were determined, organ weights were estimated and histopathology was also conducted. mRNA expression of the pro-inflammatory cytokines, TNF-α and IL-6 was estimated by RT-PCR in acute toxicity experiments. Results The LD 50 was calculated at 3807.89 mg/kg body weight in mice. There was a significant increase (p   0.05) in TNF-α and IL-6 mRNA expression in the genotoxicity studies in all of the treatment groups compared with the control. However, several hepatic and nephro-pathological derangements were observed in the groups treated with higher doses of the formulation. Conclusions The study established that the herbal formulation may not induce significant pro-inflammatory toxic responses and genotoxic effects, but prolonged intake of higher doses may cause severe biochemical and clinical abnormalities.