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目的探讨蜂胶滴液的急性毒性和致突变性。方法急性毒性采用最大耐受剂量法设15 g/Kg.BW剂量,3次经口染毒大小鼠;Ames试验采用TA97、TA98、TA100、TA1024种菌株,设0.32、1.6、8、40、200μg/皿5个剂量组及溶剂对照组(二甲基亚砜)、自发对照组和阳性对照组,用平板掺入法重复两次;骨髓细胞微核试验和精子畸形试验均设1 250 mg/kg.BW、2 500 mg/kg.BW、5 000 mg/kg.BW3个剂量组,另设15%(v/v)基酒食用植物油对照组和环磷酰胺阳性对照组(CP,40 mg/kg.BW),统计微核细胞率和精子畸形率。结果大、小鼠急性经口MTD值均大于15 000 mg/kg.BW,属无毒级;受试物各剂量组4种菌株的回变菌落数均未超过未处理对照数的2倍;各剂量组的精子畸形率和微核细胞率均未见统计学意义。结论在本研究条件下,蜂胶滴液未见致突变作用,属无毒级保健食品。但是与受试物实际酒精度70%(v/v)之间存在差异,如要全面评价其安全性,尚需进行其它方面的研究。
Objective To investigate the acute toxicity and mutagenicity of propolis drops. Methods Acute toxicity was established by maximum tolerated dose of 15 g / Kg.BW dose, 3 times the size of rats exposed to oral; Ames test using TA97, TA98, TA100, TA1024 strains, set 0.32,1.6,8,40,200 g / Dish five dose group and the solvent control group (DMSO), spontaneous control group and positive control group, repeated by plate doping method; bone marrow micronucleus test and sperm abnormality test were set 1 250 mg / kg.BW, 2 500 mg / kg.BW, 5 000 mg / kg.BW and 15% (v / v) alcoholic vegetable oil control group and cyclophosphamide positive control group (CP, 40 mg / kg.BW), the rate of micronuclei cells and sperm deformity rate. Results The acute and oral MTD values of mice in both groups were all above 15 000 mg / kg.BW, which belonged to non-toxic grade. The number of colonies returned to the 4 strains in each dose group did not exceed 2 times of the untreated control. The sperm deformity rate and the rate of micronucleated cells in each dose group were not statistically significant. Conclusion Under the conditions of this study, propolis drops did not cause mutagenic effects, is a non-toxic grade health food. However, there is a discrepancy between the actual alcohol content of 70% (v / v) of the test substance and other aspects of the safety assessment.