重组C因子法检测医疗器械中细菌内毒素的方法学研究

Methodological Study of Recombinant Factor C Method for Detection of Bacterial Endotoxins in Medical Devices

目的 探究重组C因子法检测不同医疗器械中细菌内毒素的适用性,为重组C因子法在医疗器械检验中的使用提供依据。方法 以2020年版《中国药典》四部9251细菌内毒素检查法应用指导原则为依据,对重组C因子检测法的准确度进行验证,并按GB/T 16886.1-2011中对医疗器械的分类,选取不同医疗器械样品,使用重组C因子试剂盒进行检测,与凝胶法及动态浊度法进行比对。结果 高、中、低浓度内毒素标准品采用重组C因子法的实测值与理论值具有良好的相关性,说明方法具有较好的准确度,且不同医疗器械产品使用重组C因子法和动态浊度法检测结果的比值在50%~200%范围内,回收率在50%~200%之间,与凝胶法检测结果也一致。结论 重组C因子法对于医疗器械中细菌内毒素的检测具有良好的适用性。

Objective To explore the applicability of recombinant factor C method in the detection of bacterial endotoxin in different medical devices,in order to provide basis for the use of recombinant factor C method in medical device testing.Methods Based on 9251 Application Guidelines of Bacterial Endotoxin Detection listed in the Fourth Part of Chinese Pharmacopoeia(2020 Edition),the accuracy of the recombinant factor C detection method was verified.And according to the classification of medical devices in GB/T 16886.1-2011,different medical device samples were selected.The recombinant factor C kit was used for detection,compared with the gel colt method and dynamic turbidity method.Results The measured values of the high,medium and low concentrations of endotoxin standards by recombinant factor C method were well correlated with the theoretical values,indicating that the method had good accuracy.The ratios of the detection values of different medical device products using recombinant factor C method and dynamic turbidity method were in the range of 50 %-200 %,and the recoveries were in the range of 50 %-200 %,which were also consistent with the test results of the gel colt method.Conclusion The recombinant factor C method has good applicability for the detection of bacterial endotoxin in medical devices.