赤苷脉通注射液的致突变研究

目的探讨中药制剂赤苷脉通注射液的致突变性。方法采用鼠伤寒沙门氏组氨酸营养缺陷型菌株回复突变实验(Ames实验)、中国仓鼠肺成纤维细胞(CHL)染色体畸变实验和小鼠骨髓微核实验来检测赤苷脉通注射液的致突变作用。结果 Ames实验中,赤苷脉通注射液在312.5～5 000μg.皿-1剂量范围内,无论加或不加S9,鼠伤寒沙门氏菌组氨酸缺陷型TA97,TA98,TA100,TA102和TA1535 5株菌的回复突变菌落数均未出现剂量依赖性的增加;染色体畸变实验中,非活化条件或代谢活化条件下,药物质量浓度为1 200,600和300μg.mL-1时,细胞的染色体畸变率均未出现剂量依赖性增加;微核实验中,在1 150,575和287.5mg.kg-1剂量组中均未见骨髓中含微核的嗜多染红细胞数增加。结论在该实验室条件下,Ames实验、CHL细胞染色体畸变实验和小鼠骨髓微核实验结果均为阴性,即中药制剂赤苷脉通注射液无潜在的遗传毒性。

Mutagenicity study of Chiganmaitong Injection

Objective To explore mutagenicity of Chiganmaitong Injection.Methods Three types of tests were performed：Salmonella typhimurium histidine auxotrophic strain reverse mutation assay（Ames test）,Chinese hamster lung fibroblasts（CHL） chromosomal aberration test and mouse bone marrow micronucleus test.Results In Ames test,for Chiganmaitong Injection in 312.5-5 000 μg·dish-1dose range,with S9 or not,the number of revertant colonies salmonella typhimurium histidine-deficient TA97,TA98,TA100,TA102 and TA1535 five bacteria had no dose-dependent increase;In chromosome aberration test,in the non-activation conditions or metabolic activation conditions,in 1 200,600,and 300 μg·mL-1 concentration,the cell chromosome aberration had no dose-dependent increased;In micronucleus test,in 1 150,575 and 287.5 mg·kg-1 dose group,there was no statistically significant difference between test sample group and blank control group.Conclusion In the experimental conditions,Ames test,CHL cell chromosome aberration test and mouse bone marrow micronucleus test results were negative,therefore,Chiganmaitong Injection has no mutagenic effect.