两种不同取样方式测定麻腮风类减毒活疫苗病毒滴度的评价  

Comparison of two different sampling methods of titrating the live attenuated measles,mumps and rubella vaccines

作　　者：李娟[1] 李薇[1] 权娅茹[1] 赵慧[1] 易敏[1] 李长贵[1] LI Juan;LI Wei;QUAN Yaru;ZHAO Hui;YI Min;LI Changgui(National Institutes for Food and Drug Control,NHC Key Laboratory of Research on Quality and Standardization of Biotech Products,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室,北京102629

出　　处：《中国药品标准》2022年第3期286-290,共5页Drug Standards of China

基　　金：国家药典委生物制品国家标准提高课题《减毒活疫苗病毒滴度测定方法的优化》。

摘　　要：目的:比较麻腮风类减毒活疫苗的两种取样方式测定疫苗各组分滴度是否存在差异。方法:采用多支疫苗混合滴定和单支疫苗滴定两种方法对国内上市的麻腮风类疫苗进行检测,对两种方法测定的结果平行比对。结果:单支疫苗滴定后的均值与多支疫苗混合后的检测结果基本一致;腮腺炎疫苗的支间滴度差异略高,麻疹、风疹疫苗的支间滴度差异较小。结论:目前使用的多支混合滴定的检测方法能够满足对麻腮风类疫苗质控的要求,但单支滴定法对工艺改进更有指导意义。Objective:To compare two different methods of virus titration of live attenuated measles,mumps and rubella(MMR)vaccines.Methods:Two different sampling methods were used to determine the titers of each component of live attenuated MMR vaccins.Results:The mean titers of the individual vial were comparable to the titers of mixed vials.In individual testing method,mumps vaccines varied among different vials.However,the measles and rubella components achieved good consistency among different vials.Conclusion:The method for determining the virus titer of MMR vaccine in the Chinese Pharmacopoeia can ensure the effectiveness of vaccines,however,the testing method by individual vials can facilitate the process improvements of MMR vaccines.

关 键 词：麻腮风减毒活疫苗 病毒滴定 

分 类 号：R921.2[医药卫生—药学]