防逆流纳米Ag-CHA-SiO_2抗菌型导尿管体外生物安全性研究  

Study on biosafety of antireflux nano Ag-CHA-SiO_2 antibacterial catheters in vitro

作　　者：孙欣[1] 赵吟[1] 裴泽军[1] SUN Xin;ZHAO Yin;PEI Ze-jun(The Wuxi No.2 People's Hospital,Nanjing Medical University,Wuxi 214002,Jiangsu Province,China)

机构地区：[1]无锡市第二人民医院,江苏无锡214002

出　　处：《医疗卫生装备》2019年第3期41-44,共4页Chinese Medical Equipment Journal

基　　金：无锡市医院管理中心重点项目(YGZXZ1510)

摘　　要：目的:研究防逆流纳米Ag-CHA-SiO_2抗菌型导尿管(简称"抗菌型导尿管")的体外生物安全性,为后期的产品开发提供实验依据。方法:依据GB/T 16886.5—2017《医疗器械生物学评价第5部分:体外细胞毒性试验》进行细胞形态观察与MTT试验以评判抗菌型导尿管细胞毒性,0级和1级判定为无毒性材料;依据WS/T 367—2012《医疗机构消毒技术规范》中的抑菌环操作规范进行抑菌环试验以评价抗菌型导尿管的抑菌性能,抑菌环直径≥7 mm时即判定具有抑菌、抗菌作用。结果:根据细胞形态观察与MTT试验结果,抗菌型导尿管细胞毒性分级为1级,为无毒性材料;抗菌型导尿管对大肠杆菌和金黄色葡萄球菌的抑菌圈直径分别为(11.24±0.54)、(7.63±0.34)mm,均≥7 mm,具有抑菌、抗菌性能。结论:防逆流纳米Ag-CHA-SiO_2抗菌型导尿管无细胞毒性、抑菌性能良好,体外生物安全性能符合要求,是良好的升级换代产品,值得深入研究并推广。Objective To study the biosafety in vitro of antireflux nano Ag-CHA-SiO2 antibacterial catheters,and to provide experimental basis for product development in the later stage.Methods Cell morphology observation and MTT assay were executed to determine the cytotoxicity of the catheter according to GB/T 16886.5-2017 Biological evaluation of medical devices-Part 5:Test for in vitro cytotoxicity,and Class 0 and 1 were regarded as nontoxic materials.Inhibition ring test was carried out to evaluate the bacteriostatic activity of the catheter according to WS/T 367-2012 Regulation of disinfection technique in healthcare settings,and the catheter was considered being bacteriostatic in case the inhibition ring had a diameter not less than 7 mm.Results Cell morphology observation and MTT assay showed the catheter was graded as Class 1 cytotoxicity,that is,the catheter was nontoxic.The inhibition ring diameters was(11.24±0.54)mm for escherichia coli and(7.63±0.34)mm for staphylococcus aureus,so the catheter proved to gain bacteriostatic activity.Conclusion The antireflux Ag-CHA-SiO2 antibacterial catheter behaves well in cytotoxicity,bacteriostatic activity,biosafety in vitro,and thus is worthy promoting practically.[Chinese Medical Equipment Journal,2019,40(3):41-44]

关 键 词：纳米Ag-CHA-SiO2 导尿管 细胞毒性 抑菌圈 MTT法 

分 类 号：R318[医药卫生—生物医学工程] TB383[医药卫生—基础医学]