动态浊度法检测Sabin株脊髓灰质炎灭活疫苗及其中间产品中细菌内毒素含量  

Content Determination of Bacterial Endotoxin in Sabin Strain Inactivated Polio Vaccine and Its Intermediate Products by Kinetic Turbidimetric Method

作　　者：宋天扬 唐军 王璇 罗正辉 雷银瓶 何芯雯 吴长伟 刘杰 SONG Tian-yang;TANG Jun;WANG Xuan;LUO Zheng-hui;LEI Yin-ping;HE Xin-wen;WU Chang-wei;LIU Jie(Department of Quality Control,Institute of Medical Biology,Chinese Academy of Medical Sciences;Key Laboratory for Quality Control and Evaluation of Vaccines and Biological Products,National Medical Products Administration)

机构地区：[1]中国医学科学院医学生物学研究所质量检定室 [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

出　　处：《中国食品药品监管》2023年第2期82-89,共8页China Food & Drug Administration Magazine

摘　　要：目的:建立一种用于检测Sabin株脊髓灰质炎灭活疫苗及其中间产品中细菌内毒素含量的方法。方法:应用细菌内毒素动态试管检测仪检测Sabin株脊髓灰质炎灭活疫苗及其中间产品中细菌内毒素含量,并对方法的标准曲线可靠性、准确度、精密度和耐用性进行验证。结果:细菌内毒素含量在0.125~2EU/ml范围内,标准曲线回归方程为LgTg=2.918-0.2760LgC(∣r∣=0.9964);干扰试验中,供试品细菌内毒素含量回收率为62.82%~101.04%;准确度试验中,供试品细菌内毒素含量回收率为64.54%~93.74%;精密度试验中,3名实验人员测试的平均反应时间相对标准偏差(RSD)均小于4%,18次测试的平均反应时间总RSD小于8%,供试品细菌内毒素含量回收率为76.66%~149.65%;使用不同厂家鲎试剂时,供试品细菌内毒素含量回收率为76.66%~112.68%。结论:动态浊度法可用于Sabin株脊髓灰质炎灭活疫苗及其中间产品中细菌内毒素的定量检测。Objective:To establish a method for the determination of bacterial endotoxin in Sabin strain inactivated polio vaccine and its intermediate products.Methods:The bacterial endotoxin dynamic test tube detector was used to quantitatively detect the bacterial endotoxin content in the Sabin strain inactivated polio vaccine and its intermediate products,and the reliability,accuracy,precision and applicability of the standard curve of the method were verified.Results:In the range of 0.125~2EU/ml,the standard curve regression equation was LgTg=2.918-0.2760LgC(∣r∣=0.9964).The recovery rate of the bacterial endotoxin content of the test product in the interference test was 62.82%~101.04%and that in the accuracy test was 64.54%~93.74%.In the repeatability test,the average response time RSD of the 3 experimenters was less than 4%,and the average response time RSD of the 18 reactions was less than 8%.The recovery rate of endotoxin content in the test solution was 76.66%~149.65%,and the recovery rate of bacterial endotoxin content was 76.66%~112.68%when tested with different manufacturers of horseshoe crabs.Conclusion:The kinetic turbidimetric method can be used for the quantitative detection of bacterial endotoxin content in Sabin strain inactivated polio vaccine and its intermediate products.

关 键 词：动态浊度法 Sabin株脊髓灰质炎灭活疫苗 中间产品 干扰试验 准确度试验 精密度试验 

分 类 号：R927.2[医药卫生—药学]