细菌内毒素检查微量凝胶法的研究  

Study of a microgel method for the examination of bacterial endotoxins

作　　者：张晨雪 蔡彤 陈晨 刘涛[2] 李文龙 裴宇盛 ZHANG Chenxue;CAI Tong;CHEN Chen;LIU Tao;LI Wenlong;PEI Yusheng(Division of Pharmacology,Institute for Chemical Drug Control,National Institute for Food and Drug Control,Beijing 102629,China;Suzhou Institute of Biomedical Engineering and Technology,Chinese Academy of Sciences,Key Laboratory of Biomedical Testing Technology,Chinese Academy of Sciences,Suzhou Jiangsu 215163,China)

机构地区：[1]中国食品药品检定研究院化学药品检定所药理室,北京102629 [2]中国科学院苏州生物医学工程技术研究所,中国科学院生物医学检验技术重点实验室,江苏苏州215163

出　　处：《中国药物警戒》2024年第8期841-846,851,共7页Chinese Journal of Pharmacovigilance

基　　金：国家重点研发计划(2023YFC2606100)。

摘　　要：目的通过研究微量凝胶法确定其能否满足《中华人民共和国药典》(2020年版)(简称“《中国药典》”)要求,作为现有细菌内毒素检查法的补充。方法依据《中国药典》四部“9101药品质量分析方法验证指导原则”规定,按照其项下“杂质测定”中“限度”项目具体要求,对微量凝胶法(5μL样品+50μL鲎试剂)进行专属性、检测限、耐用度3项内容进行验证,并采用凝胶法和微量凝胶法对85批样品进行品种适用性比较研究,对384批样品进行一致性比对研究。结果经方法学验证,微量凝胶法符合《中国药典》对定性方法的要求,微量凝胶法与凝胶法相比,品种适用性与一致性比对具有等效结果。结论微量凝胶法可以作为凝胶法的补充方法在我国推广。Objective To determine whether the microgel method can meet the requirements of Chinese Pharmacopoeia,as a supplement to the existing bacterial endotoxin test method.Methods According to the provisions of“9101 Guidelines for the validation of pharmaceutical quality analysis methods”in Part IV of the Pharmacopoeia of the People’s Republic of China(2020 edition),the microgel method(5μL samples+50μL limulus ambocyte lysate)was analyzed for“specificity”,“limit of detection”and“durability”in the item of“Determination of impurities”.The gel method and microgel method were used to compare 85 batches of samples for variety applicability and 384 batches of samples for consistency comparison.Results The microgel method was methodologically validated and showed that it met the requirements of the Pharmacopoeia of the People’s Republic of China for the qualitative methods,and the microgel method was equivalent to the gel method for the comparison of the applicability and consistency of the varieties.Conclusion The microgel method can be promoted as a supplementary alternative to the gel method in China.

关 键 词：细菌内毒素 鲎试剂 微量凝胶法 方法学验证 品种适用性 一致性评价 补充方法 

分 类 号：R927.1[医药卫生—药学]