水蛭素冻干粉急性毒性和致突变性研究

Study of acute toxicity and mutagenicity of lyophilizing hirudin powder

目的:检测水蛭素冻干粉的急性经口毒性和致突变性。方法:以水蛭素冻干粉(50AT_U/g)给小鼠灌胃检测急性经口毒性,用Ames试验、小鼠骨髓细胞微核试验和精子畸形试验检测其遗传毒性。结果:水蛭素冻干粉对小鼠经口LD50>10.0g/kg;Ames试验显示在加与不加S9混合液的各剂量组回变菌落数与自发回变对照组无明显差别;小鼠骨髓细胞微核试验和精子畸形试验结果显示,各剂量组的微核率和精子畸形率与阴性对照组比较差别无统计学意义。结论:在本实验条件下,水蛭素冻干粉的经口LD50>10.0g/kg,属实际无毒级,未见有致突变作用。

OBJECTIVE：To study acute oral toxicity and mutagenicity of lyophilizing hirudin powder.METHODS：Lyophilizing hirudin powder（50 AT-U/g）was given orally to mice to determine its acute oral toxicity,and mutagenicity was studied using Ames test,micronucleus test and sperm shape abnormality test.RESULTS：The oral LD50 of lyophilizing hirudin power in mice was more than 10.0 g/kg.No increase in the number of revertant colonies was found in the Ames test with and without S9 mixture.The micronucleus rates and sperm abnormality rates in all doses were not significantly different from the negative control.CONCLUSION：Lyophilizing hirudin powder showed no acute oral toxicity and mutagenicity.