Antimicrobial evaluation, acute and subchronic toxicity studies of Leone Bitters, a Nigerian polyherbal formulation, in rodents

This study evaluated acute and sub-chronic toxicities in rodents and microbial purity of a polyherbal preparation, Leon Bitters, prepared with Gongronema latifolia (climbing stem), Cocos nucifera (coconut) roots and Parinari curatellifolia seeds. Microbial purity was evaluated on some bacterial and fungal organisms using appropriate diagnostic media. Toxicity of the polyherbal preparation was evaluated in Swiss albino mice by administering to the animals oral graded doses of the lyophilized drug in the ranges of 1.0 g/kg to 20.0 g/kg body weight and observed continuously for the first 4h and hourly for the next 12 h, then 6 hourly for 56 h (72 h, acute toxicity). Wistar rats were also fed with different doses of the lyophilized drug for 30 days and the effects of the drug on some tissues heart, liver, kidney and testes were microscopically examined. Also the effects on the biochemical and haematological parameters were evaluated (sub-chronic toxicity model). No zone of inhibition was observed on either the bacterial culture media or the fungal culture media. The median acute toxicity value (LD50) of the polyherbal medicine was determined to be 7.2 g/kg body weight. No significant increase in the body weight was observed in the groups treated with the drug compared to the control. There was significant increase (p≤ 0.05) in creatinine level while aspartate aminotransferases (AST) and alanine aminotransferases (ALT) showed no appreciable increase. The drug significantly reduced (p≤0.05) triglyceride (TG) level while low density lipoprotein (LDL)-cholesterol level was not altered, but led to increase in high density lipoprotein (HDL)–cholesterol in the treated groups compared to the control. There was no significant change in the mean corpuscular haemoglobin (MCH), mean corpuscular volume (MCV) and mean corpuscular haemoglobin concentration (MCHC) in all the treated animals compared to the control. The study showed that the drug exhibited hypolipidemic activity and good reducing effects on cardiovascular factors. However, a long term use may be harmful to the testes, a male reproductive organ.