体外微核试验在一次性使用结扎夹遗传毒性评价中的应用  

Application of In Vitro Micronucleus Assay in Genotoxicity Evaluation of Ligation Clips for Single Use

作　　者：王鸾鸾[1] 孙晓霞[1] 王国伟 孙令骁 车国喜 刘香东 刘成虎[1] WANG Luan-luan;SUN Xiao-xia;WANG Guo-wei;SUN Ling-xiao;CHE Guo-xi;LIU Xiang-dong;LIU Cheng-hu(NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices,NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging,Shandong Key Laboratory of Biological Evaluation for Medical Devices,Shandong Quality Inspection Center for Medical Devices,Jinan 250101,China)

机构地区：[1]山东省医疗器械产品质量检验中心,国家药品监督管理局生物材料器械安全性评价重点实验室,国家药品监督管理局药品包装材料质量控制重点实验室,山东省医疗器械生物学评价重点实验室,山东济南250101

出　　处：《食品与药品》2021年第2期116-120,共5页Food and Drug

基　　金：山东省医疗器械产品质量检验中心项目(编号:ZX201804)。

摘　　要：目的探讨流式细胞术体外微核试验在医疗器械早期遗传毒性筛选和遗传毒性评价中的应用。方法CHL细胞分为无代谢活化系统短期接触组(-S9/6 h组)、无代谢活化系统长期接触组(-S9/24 h组)和有代谢活化系统短期接触组(+S9/6 h组)。EMA和SYTOX Green双荧光标记,流式细胞术分析微核率,并与细胞分裂阻滞法的双核微核结果进行比较。结果与阴性对照相比,环磷酰胺、丝裂霉素C可诱导CHL细胞产生畸变,供试品溶液处理组的CHL细胞无畸变,流式细胞术与细胞分裂阻滞法结果一致。结论流式细胞术体外微核法快速、准确,在医疗器械早期遗传毒性筛选和遗传毒性评价中有良好的应用前景。Objective To explore the application of flow cytometry in early genotoxicity screening and genotoxicity evaluation of medical devices.Methods CHL cells were divided into three groups:no metabolic activation and shortterm exposure group(-S9/6 h group),no metabolic activation and continuous exposure group(-S9/24 h group)and metabolic activation and short-term exposure group(+S9/6 h group).After double fluorescent labeling with EMA and SYTOX Green,the micronucleus rate was analyzed by flow cytometry,and the results were compared with those of cytokinesis-block method.Results Compared with the negative control group,cyclophosphamide and mitomycin C could induce the aberration of CHL cells,and there was no aberration in the test solution treated group.The results of flow cytometry and cytokinesis-block method were consistent.Conclusion In vitro micronucleus assay by flow cytometry is rapid and accurate,which has a good prospect in early screening and genotoxicity evaluation of medical devices.

关 键 词：医疗器械 CHL细胞 流式细胞术 体外微核试验 

分 类 号：R955[医药卫生—药学]