Toxicological, Histopathological and Purity Evaluation of Polyherbal Drug Katoka Mixtures in Rodents

Aim: To conduct toxicological, histopathological and purity evaluation on Katoka® an herbal mixture in rodents.

Materials and Methods: Microbial purity was evaluated on some bacterial and fungal organisms. Toxicity of the drug was on Swiss mice administered with graded doses of the formulation from 1.0 to 15.0 g/kg body weight (bwt). Wistar rats were fed different doses of the formulation for 30 days to evaluate their biochemical profiles while vital organs histology was conducted.

Results: LD50 of the poly-herbal medicine was 7.2 g/kg bwt. Cytotoxic effect was not observed because median lethal concentration (LC50) of the formulation calculated to be 300 μgml-1 was higher than 0.288 μgml-1 of reference drug, vincristine. Except for little growth of E. coli (0.5x102 cfu/ml) that were within acceptable official limit no growth of other coli forms. Hepatic histology of treated animals at highest dose exhibited diffuse presence of lymphocytic cells with onset of edematous changes and focal necro-inflammation. Aspartate aminotransferases (AST) exhibited significant (p≤0.05) increase while alanine aminotransferases (ALT) decreased markedly compared to the control.

Conclusion: Katoka® is safe for consumption because no cytotoxic effect observed but must be within recommended dose to avoid hepatic inflammation.