一次性使用无菌注射器及注射器用活塞体外细胞毒性研究  

Study on Cytotoxicity of Disposable Sterile Syringe and Syringe Piston in Vitro

作　　者：郝钢 李宜铮 武星 斯琴 张莉芳 颜皓 韩峰 HAO Gang;LI Yi-zheng;WU Xin;SI Qin;ZHANG Li-fang;HAN Feng(Inner Mongolia Autonomous Region Institute of Pharmaceutical Inspection and Research,Inner Mongolia Hohhot 010020;Center for Drug Inspection of Inner Mongolia,Inner Mongolia Hohhot 010020)

机构地区：[1]内蒙古自治区药品检验研究院,内蒙古呼和浩特010020 [2]内蒙古自治区药品检查中心,内蒙古呼和浩特010020

出　　处：《中国医疗器械信息》2022年第9期33-35,47,共4页China Medical Device Information

摘　　要：目的:探讨目前市场上一次性使用注射器及注射器用活塞的细胞毒性是否符合GB15810-2001《一次性使用无菌注射器》、YY/T0243-2016《一次性使用注射器用活塞》的要求。方法:使用含10%胎牛血清的DMEM培养基(DMEM)作为浸提介质,供试品分为两组,一组取注射器采用公称容量法浸提;另一组取注射器活塞,按重量法浸提,浸提液分别与L929细胞接触培养,采用四唑盐比色法(MTT法)进行吸光度检测,计算细胞的相对增殖率。结果:部分注射器用活塞细胞毒性较大。结论:需要加强对一次性使用无菌注射器的细胞毒性评价。Objective:To investigate whether the cytotoxicity of syringes and syringe pistons on the market meets the requirements of GB15810-2001 Disposable sterile syringes and YY/T0243-2016 Disposable syringe pistons.Methods:DMEM medium(DMEM)containing 10%fetal bovine serum was used as the extraction medium.The test articles were divided into two groups.One group was extracted with syringe by nominal volume method;The other group took the syringe piston and extracted it by gravimetric method.The extract was contacted with L929 cells and cultured respectively.The absorbance was detected by tetrazolium salt Colorimetry(MTT method)to calculate the relative proliferation rate of cells.Results:Some syringe pistons have high cytotoxicity.Conclusion:It is necessary to strengthen the cytotoxicity evaluation of disposable sterile syringes.

关 键 词：一次性使用无菌注射器 一次性使用注射器用活塞 细胞毒性 

分 类 号：TH789[机械工程—仪器科学与技术]