动态浊度法定量检测冻干甲型肝炎减毒活疫苗中细菌内毒素含量的方法验证  

Verification of dynamic turbidimetric method for quantitative detection of bacterial endotoxin content in freeze-dried live attenuated hepatitis A vaccine

作　　者：罗正辉 宋天扬 唐军 赵王丽 葛绕玲 杨东琼 何芯雯 常亚军 Luo Zhenghui;Song Tianyang;Tang Jun;Zhao Wangli;Ge Raoling;Yang Dongqiong;He Xinwen;Chang Yajun(Department of Quality Control,Institute of Medical Biology,Chinese Academy of Medical Sciences,Kunming 650000,China)

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,昆明650000

出　　处：《国际生物制品学杂志》2022年第3期149-153,共5页International Journal of Biologicals

基　　金：云南省科技创新人才计划(2019HC006)。

摘　　要：目的对定量检测冻干甲型肝炎减毒活疫苗中细菌内毒素含量的动态浊度法进行验证。方法采用动态浊度法定量检测冻干甲型肝炎减毒活疫苗中细菌内毒素含量,并对分析方法的线性、专属性、准确度、重复性、中间精密度和耐用性进行验证。结果动态浊度法的线性相关系数绝对值为0.996;最大有效稀释倍数下专属性回收率为68.81%~73.80%;准确度回收率为53.50%~77.77%;3名实验人员重复性相对标准偏差分别为2.0%、3.6%、2.0%;中间精密度相对标准偏差为7.6%;耐用性回收率为66.49%~108.34%。结论动态浊度法检测冻干甲型肝炎中的细菌内毒素含量的方法具有良好的专属性、准确度、线性、重复性、中间精密度和耐用性,符合定量检测和数据完整性的要求。Objective To verify the dynamic turbidimetric method for quantitative detection of bacterial endotoxin in freeze-dried live attenuated hepatitis A vaccine(f-HAV).Methods The bacterial content of endotoxin in f-HAV was quantitatively detected by dynamic turbidimetry,and the linearity,specificity,accuracy,repeatability,intermediate precision and durability of the analytical method were verified.Results The absolute value of the linear correlation coefficient was 0.996.The specificity recovery rates under maximum valid dilution were 68.81%-73.80%.The accuracy recovery rates were 53.50%-77.77%.The repeatability relative standard deviations(RSDs)of 3 experimenters were 2.0%,3.6%,2.0%,respectively.The RSD of intermediate precision was 7.6%,and the recovery rates of durability were 66.49%-108.34%.Conclusion The dynamic turbidimetric method for the determination of bacterial endotoxin content in f-HAV has good linearity,specificity,accuracy,repeatability,intermediate precision and durability,and meets the requirements of quantitative data integrity.

关 键 词：动态浊度法 细菌内毒素 冻干甲型肝炎减毒活疫苗 方法验证 

分 类 号：R392.7[医药卫生—免疫学]