微量动态显色法定量检测EV71灭活疫苗内毒素含量的可行性  

Feasibility on micro-dynamic chromogenic assay for quantitative detection of bacterial endotoxin in inactivated EV71 vaccine

作　　者：常亚军[1,2] 赵王丽 葛绕玲 乔燕 杨宝嘉 段男 易力 宋杰[1,2] Chang Yajun;Zhao Wangli;Ge Raoling;Qiao Yan;Yang Baojia;Duan Nan;Yi Li;Song Jie(Institute of Medical Biology,Chinese Academy of Medical Sciences&Peking Union Medical College,Kunming 650118,China;NMPA Key Laboratory for Quality Control and Evaluation of Vaccines and Biological Products,Chengdu 611731,China)

机构地区：[1]中国医学科学院&北京协和医学院医学生物学研究所,昆明650118 [2]国家药品监督管理局疫苗及生物制品质量控制与评价重点实验室,成都611731

出　　处：《国际生物制品学杂志》2023年第5期268-272,共5页International Journal of Biologicals

基　　金：云南省万人计划“青年拔尖人才”(YNWR-QNBJ-2019-143)。

摘　　要：目的研究微量鲎试剂动态显色法定量检测肠道病毒71型灭活疫苗(inactivated enterovirus 71 vaccine,iEV71)内毒素含量的可行性。方法使用微量鲎试剂动态显色法,进行标准曲线可靠性验证、干扰试验及3批成品测定,同时与凝胶法检测结果比对。结果标准曲线可靠性验证线性范围为0.0050~5.0000内毒素单位(endotoxin unit,EU)/ml,标准曲线决定系数为0.999,线性良好;干扰试验结果显示,供试品稀释10倍加入0.5 EU/ml标准内毒素测定回收率,回收率为94.4%,满足回收率50%~200%的要求。说明该稀释倍数下供试品对反应无干扰。另外,3批成品检测结果均符合标准限要求,且与凝胶法检测结果一致。结论微量鲎试剂动态显色法可用于iEV71成品内毒素含量的定量检测。Objective To study the feasibility of quantitative detection of endotoxin content in inactivated enterovirus 71 vaccine(iEV71)by micro-dynamic chromogenic assay.Methods The reliability verification of standard curve,interference test and detection of 3 batches of final product were carried out by micro-dynamic chromogenic assay.The results were compared with those of gel method.Results In the reliability verification of the standard curve,the linear range was 0.0050-5.0000 endotoxin unit(EU)/ml,and the standard curve had good linearity with coefficient of determination at 0.999.The interference test result showed that the recovery rate was 94.4%when the test sample was diluted 10 times and 0.5 EU/ml standard endotoxin was added.The recovery rate met the requirement of 50%-200%indicating that the test sample did not interfere with the reaction at this dilution ratio.In addition,the results for 3 batches of final product met the requirements of the standard limit and were consistent with the gel method test results.Conclusion The micro-dynamic chromogenic assay can be used for quantitative detection of endotoxin in the final product of iEV71.

关 键 词：细菌内毒素 微量动态显色法 肠道病毒71型灭活疫苗 定量检测 

分 类 号：R392.7[医药卫生—免疫学]