银参胶囊遗传毒性研究  

Genotoxicity of Yinshen Capsule

作　　者：刘玉明 蒋定文 李珂娴 陈伟 侯登勇 LIU Yuming;JIANG Dingwen;LI Kexian;CHEN Wei;HOU Dengyong(Naval Characteristic Medical Center of PLA,Shanghai,China 200433)

机构地区：[1]中国人民解放军海军特色医学中心

出　　处：《中国药业》2020年第3期17-19,共3页China Pharmaceuticals

基　　金：中国人民解放军海军特色医学中心横向合作项目[12F201]

摘　　要：目的探讨银参胶囊的遗传毒性。方法选用SPF级健康ICR小鼠,通过Ames试验、小鼠骨髓细胞微核试验、小鼠睾丸染色体畸变试验等遗传毒性试验验证银参胶囊的安全性。结果 Ames试验中,银参胶囊在8~5 000μg/皿剂量范围内,无论是否加入哺乳动物肝脏微粒体酶(S9),鼠伤寒沙门菌TA97,TA98,TA100,TA102等4株菌的回复突变菌落数均未出现剂量依赖性增加;微核试验中,2 500,5 000,10 000 mg/kg剂量组均未见骨髓中含微核的嗜多染红细胞数增加;小鼠睾丸染色体畸变试验中,药物质量分数为2 500,5 000,10 000 mg/kg时,细胞的染色体畸变率均未出现剂量依赖性增加。结论银参胶囊未显示致突变作用,可初步判定其在遗传毒性方面是安全的。Objective To explore the genotoxicity of Yinshen Capsule. Methods Healthy mice of specific pathogen free SPF were chosen,and Ames test,bone marrow cell micronucleus test and testicular chromosome aberration test were adopted to verify the safety of Yinshen Capsule. Results In Ames tests,no dose-dependent increase was observed in the number of revertant colony of salmonella typhimurium TA97,TA98,TA100 and TA102 in the range of 8-5000 μg/plate dose of Yinshen Capsule,with or without S9. In micronucleus tests,in 2 500,5 000 and 10 000 mg/kg dose group,no increase in the number of polynuclear polyerythrocytes with micronucleus in the bone marrow was observed. In the chromosome aberration tests,no dose-dependent increase was observed in the chromosome aberration rate of cells when the drug concentrations were 2 500,5 000 and 10 000 mg/kg. Conclusion Yinshen Capsule does not show any mutagenic effect,and it can be preliminarily determined that it is safe in genotoxicity.

关 键 词：银参胶囊 遗传毒性 AMES试验 小鼠 骨髓细胞微核试验 睾丸染色体畸变试验 

分 类 号：R932[医药卫生—生药学] R285.5[医药卫生—药学]