水飞蓟胶囊的急性毒性和遗传毒性研究  

Research on the acute toxicity and genetic toxicity of silybum marianum gaertn capsules

作　　者：王晓丹[1] 杨鸿武[1] 范会弟[1] 于淼[1] 

机构地区：[1]辽宁省疾病预防控制中心毒理检测所辽宁省公共卫生安全评价重点实验室,辽宁沈阳110005

出　　处：《中国卫生检验杂志》2016年第2期192-194,共3页Chinese Journal of Health Laboratory Technology

摘　　要：目的研究水飞蓟胶囊的急性毒性和遗传毒性。方法采用最大耐受剂量法进行小鼠急性毒性试验,通过Ames试验、小鼠骨髓嗜多染红细胞微核试验和小鼠精子畸形试验检测水飞蓟胶囊的遗传毒性。结果雌、雄两性小鼠对水飞蓟胶囊的最大耐受量(MTD)均>24.00 g/(kg·bw),属于无毒级物质;各剂量组的TA97、TA98、TA100、TA102菌株的回变菌落数与溶剂对照组比较,回变菌落数均未超过自发回变菌落数的1倍以上,亦无剂量-反应关系,结果为阴性;小鼠骨髓嗜多染红细胞微核试验和小鼠精子畸形试验中各剂量组微核率、精子畸形率与阴性对照组之间差异无统计学意义(P>0.05),而环磷酰胺阳性对照组与阴性对照组之间差异有统计学意义(P<0.01),证明试验结果均为阴性。结论在该试验条件下,水飞蓟胶囊属于无毒级物质,亦不具有遗传毒性。Objective To study the acute toxicity and genetic toxicity of silybum marianum gaertn capsules. Methods Acute toxicity test for mice was done by maximum dose method. Genetic toxicity were detected by Ames test,micronucleus test of bone marrow PCE cell in mice and sperm shape abnormality test on mice. Results The maximum tolerated dose（ MTD） of silybum marianum gaertn for male and female mice were both more than 24. 00 g /（ kg·bw）,so silybum marianum gaertn capsules was a substance with no toxicity. The variable number of colonies of TA97,TA98,TA100 and TA102 strains in each dose group were compared with the solvent control group,and that was not more than 1 times of the spontaneous colony count. Nor dose-response relationship was found with the negative result; Comparing with the negative control group,there were no statistical significance on the differences in the micronucleus rate of micronucleus test of bone marrow PCE cell in mice and the teratospermia rate of sperm shape abnormality test of mice（ P〉 0. 05）,but there were statistical significance on the differences between the positive control groups of cyclophosphamide and negative control groups（ P〈 0. 01）,which demonstrated that test results were all negative. Conclusion Under this experimental condition,for silybum marianum gaertn capsules,there was proved to be a substance with no toxicity and were not any genetic toxicity.

关 键 词：水飞蓟胶囊 急性毒性 遗传毒性 安全性评价 

分 类 号：R285[医药卫生—中药学]