聚氯乙烯材质医疗器械细胞毒性检测方法的探究

Research on Cytotoxicity Detection Method of PVC Material Medical Devices

目的:对聚氯乙烯(Polyvinyl Chloride,PVC)材质医疗器械的浸提液制备方法进行探索,为其细胞毒性检测提供依据。方法:按照GB/T16886.12中规定的浸提比例(0.2g/mL),改变浸提温度(36℃、36.5℃、37℃、38℃)、时间(2h、4h、8h、12h、24h、48h)、湿度(100%、90%、80%、70%)和摇床速率(5000r/min、8000r/min、10000r/min),通过体外细胞毒性检测方法评价PVC材质医疗器械不同的浸提液对细胞毒性的影响。结果:细胞毒性与浸提样品的时间、温度及摇床转速呈正相关性,其中38℃、48h及摇床转速8000r/min细胞毒性最高,均<70%,按照GB/T16886.5-2017判定均具有细胞毒性;结论:PVC材质医疗器械的体外细胞毒性对样品浸提液制备过程中浸提时间和摇床速率要求严格,在制备浸提液时应该根据产品的临床使用情况合理选择浸提时间和摇床的速率。

Objective:To explore the preparation method of the extraction solution of PVC medical devices and provide the basis for its cytotoxicity test.Methods:According to the extraction ratio(0.2g/mL)specified in GB/T16886.12,the influence of different extraction solutions of PVC medical devices on cytotoxicity was evaluated by in vitro cytotoxicity test method by changing the extraction temperature(36℃,36.5℃,37℃,38℃),time(2h,4h,8h,12h,24h,48h),humidity(100%,90%,80%,70%)and shaking table rate(5000r/min,8000r/min,10000r/min).Results:The cytotoxicity was positively correlated with the time,temperature and rotation speed of the shaking table.The cytotoxicity was the highest at 38℃,48h and 8000r/min of the shaking table,which were less than 70%.According to GB/T16886.5-2017,they were all cytotoxic.Conclusion:The in vitro cytotoxicity of PVC medical devices has strict requirements on the extraction time and the shaking table speed during the preparation of the sample extraction solution.The extraction time and the shaking table speed should be reasonably selected according to the clinical use of the product.