重组C因子法在医疗器械细菌内毒素检测中的应用前景  

The Application Prospect of Recombinant Factor C Method in Bacterial Endotoxin Detection of Medical Devices

作　　者：许朝生 吴少海[1,2] Xu Chaosheng;Wu Shaohai(Guangdong Medical Device Quality Supervision and Inspection Institute,Guangzhou Guangdong 510663,China;Key Laboratory of Extracorporeal Circulation Devices,National Medical Products Administration,Guangzhou Guangdong 510663,China)

机构地区：[1]广东省医疗器械质量监督检验所,广东广州510663 [2]国家药品监督管理局体外循环器械重点实验室,广东广州510663

出　　处：《医疗装备》2024年第19期35-39,47,共6页Medical Equipment

基　　金：广东省药品监督管理局科技创新项目(2023ZDZ09)。

摘　　要：细菌内毒素是主要的致热原,进入人体血液循环会引起体温升高和炎性反应。临床上偶尔会发生因医疗器械内毒素不合格而引起的不良事件,故对医疗器械进行严格的细菌内毒素检测是保障患者安全的关键。然而,传统的细菌内毒素检测方法存在局限性,因此需要探索更科学有效的检测方法。为了保障医疗器械的安全性,该研究深入探讨了重组C因子法(rFC)在细菌内毒素检测中的优势,分析其在医疗器械检测领域的应用前景,并为该方法的顺利推广和应用提出可行性建议。As the main pyrogens,bacterial endotoxin can cause body temperature increase and inflammatory reaction when it enters the human blood circulation.Due to occasional adverse events caused by unqualified endotoxins in medical devices in clinical practice,strict bacterial endotoxin testing of medical devices is key to ensuring patient safety.However,traditional bacterial endotoxin detection methods have many limitations,so it is necessary to explore more scientific and effective detection methods.In order to ensure the safety of medical devices,the advantages of recombinant factor C(rFC)method in bacterial endotoxin detection were deeply explored in this study.In addition,with the analysis of its application prospects in the field of medical device testing,feasibility suggestions were proposed for the smooth promotion and application of this method.

关 键 词：医疗器械 细菌内毒素检查法 中国药典 鲎试剂 重组C因子法 

分 类 号：TH772[机械工程—仪器科学与技术]