实验室细菌内毒素定量检测方法建立与验证  

Establishment and validation of laboratory bacterial endotoxin quantitative detection method

作　　者：李辉 汤曼莉 杨玉玲 吴愫青 LI Hui;TANG Manli;YANG Yuling;WU Suqing(Zhuhai Institute for Food and Drug Control,Zhuhai Guangdong,519000,China)

机构地区：[1]珠海市食品药品检验所,广东珠海519000

出　　处：《质量安全与检验检测》2023年第6期14-18,共5页QUALITY SAFETY INSPECTION AND TESTING

摘　　要：建立细菌内毒素动态浊度定量检测方法,比较不同厂家鲎试剂对细菌内毒素定量检测的影响。根据《中国药典》2020年版四部《细菌内毒素检查法》和《分析方法验证指导原则》,建立细菌内毒素动态浊度定量检测方法,进行线性、适用性、重复性等方法学验证,运用该方法对我所常见检品氯化钠注射液和维生素C注射液共3批进行检测,并比较3个不同厂家鲎试剂对检测结果的影响。结果显示,本次实验建立的细菌内毒素动态浊度法线性、适用性、重复性验证结果良好,氯化钠注射液和维生素C注射液在湛江安度斯鲎试剂、厦门鲎试剂和福州新北鲎试剂条件下检测结果一致,符合规定。本实验建立的细菌内毒素动态浊度定量检测方法能满足日常检测需求,不受鲎试剂种类的影响,结果灵敏、准确。To establish a quantitative method for dynamic turbidimetric determination of bacterial endotoxin,and compare the effects of limulus reagent from different manufacturers on the quantitative detection of bacterial endotoxin.According to the Bacterial Endotoxin Test Method and The Guiding Principles for The Verification of Analytical Methods in the Fourth Part of The Chinese Pharmacopoeia(2020 edition),the dynamic turbidity quantitative detection method for bacterial endotoxin was established,and the linearity,applicability and repeatability of the methodology were verified.Three batches of sodium chloride injection and vitamin C injection were tested by this method,and the effects of limulus lysate from three different manufacturers on the test results were compared.The results showed that the linear,applicability and repeatability of the dynamic turbidimetric method for bacterial endotoxin established in this experiment were verified well.The detection results of sodium chloride injection and vitamin C injection were consistent under the conditions of Andus limulus reagent,Xiamen limulus reagent and Fuzhou xinbei limulus reagent,which met the requirements.The dynamic turbidimetric quantitative detection method of bacterial endotoxin established in this experiment can meet the needs of daily detection,is not affected by the type of limulus lysate,and the results are sensitive and accurate.

关 键 词：鲎试剂 细菌内毒素 定量检测 氯化钠注射液 维生素C注射液 动态浊度法 

分 类 号：R95[医药卫生—药学]