Preclinical Toxicity Study of the phytomedicine - bee honey, propolis and Mikana glomerata extract in rodents

This study was designated to evaluate the preclinical toxicity of the phytomedicine - bee honey, propolis (1.8 %) and extract of Mikana glomerata Sprengel (3.7%), commonly used in Brazil in treatment of respiratory illnesses. In order to eavaluate the acute toxicity, groups of Swiss mice (n=10/group) received a single dose of the phytomedicine (7.5 to 35mL/kg; p.o.) or saline 0,9% (5ml/kg; p.o.). The acute toxicity data showed a low toxicity order for the phytomedicine. The absence or presence of toxicity by prolonged use of phytomedicine was also evaluated through biochemical and hematological analysis of Wistar rat blood samples using daily oral doses of 7.5 or 15 ml/Kg; during 90 days. The toxicity study did not show any treatment-related abnormalities in hematological (red blood cell, Hemoglobin, hematocrit, mean corpuscular hemoglobin, mean corpuscular volume, mean corpuscular hemoglobin concentration; leucocytes and platelets) or biochemical parameters (glucose, urea, cholesterol, HDL-cholesterol, triglycerides; alanine aminotranferase, aspartate aminotranferase, alkaline phosphatase and total proteins). No significant differences were found between the treated groups and the saline control group in regard to the rate of weight gain. The external apperance of several organs (heart, spleen, liver, kidney, suprarenal gland, stomach, lungs, testicles, ovaries and womb) were analysed, and any aparent and significant features or differences from control group were recorded. It was possible to verify significant differences (p <0.05) in relation to the weight of the liver and kidney and spleen; which presented higher in the male animal treated with the phytomedicine. However, such alterations were not dependent dose and they just limited to the males. Therefore, through preclinical assay, it appears that no toxicological hazard (acute and sub-chronic) is related to the use of test phytomedicine.