两种工艺制备的麻疹减毒活疫苗加速稳定性可比性研究  

Comparability study on accelerated stability of live attenuated measles vaccine prepared by two processes

作　　者：许晚 沈谊清 周锋 张芹 丁文正 杨文震 郁佳俊 Xu Wan;Shen Yiqing;Zhou Feng;Zhang Qin;Ding Wenzheng;Yang Wenzhen;Yu Jiajun(Vaccine DivisionⅡ,Shanghai Institute of Biological Products Co.,Ltd.,Shanghai 201403,China)

机构地区：[1]上海生物制品研究所有限责任公司疫苗二室,201403

出　　处：《国际生物制品学杂志》2020年第6期276-281,共6页International Journal of Biologicals

基　　金：国家科技重大专项 (2018ZX09738003-005)。

摘　　要：目的:通过强制降解试验,对细胞工厂与转瓶培养两种工艺制备的麻疹减毒活疫苗进行加速稳定性可比性研究。方法:取细胞工厂与转瓶培养工艺制备的麻疹减毒活疫苗单次收获液和原液各3批于25℃保存10 d,疫苗成品3批于37℃保存10 d。按照中国药典2015年版三部和企业标准进行病毒滴度检定。利用Minitab 19软件比较两种工艺产品的病毒滴度降解曲线。结果:所有样品的降解曲线均符合麻疹病毒的热敏感性。细胞工厂和转瓶工艺制备的疫苗单次收获液第1组病毒滴度分别下降1.51和1.56 lg半数细胞培养感染量(50%cell culture infective dose,CCID 50)/ml,第2组均下降1.33 lgCCID 50/ml,第3组均下降1.54 lgCCID 50/ml,原液分别下降1.20和1.43 lgCCID 50/ml,成品分别下降1.33和1.30 lgCCID 50/ml。2种工艺产品的降解曲线相似。结论:细胞工厂与转瓶培养工艺生产的麻疹减毒活疫苗具有相似的加速稳定性。Objective To study the comparability of accelerated stability between cell factory and rotary bottle culture processes of live attenuated measles vaccine by forced degradation test.Methods Measles vaccine single harvests and bulks produced by cell factory and rotary bottle culture processes,3 lots each,were kept at 25℃for 10 d.Final products produced by 2 processes,3 lots each,were kept at 37℃for 10 d.Virus titers were tested according to Chinese pharmacopoeia 2015(VolumeⅢ)and enterprise quality standard.Virus degradation curves of products by 2 processes were compared by Minitab 19.Results All degradation curves showed heat sensitivity consistent with measles virus.Decrease in virus titers of single harvests produced by cell factory and rotary bottle processes were 1.51 lg 50%cell culture infective dose(CCID50)/ml vs.1.56 lgCCID50/ml for group 1,both 1.33 lgCCID50/ml for group 2,and both 1.54 lgCCID50/ml for group 3.Decrease in virus titers of bulks were 1.20 lgCCID50/ml vs.1.43 lgCCID50/ml and in titers of final products were 1.33 lgCCID50/ml vs.1.30 lgCCID50/ml.Virus degradation curves of products by 2 processes were similar.Conclusion Measles vaccines produced by cell factory culture and rotary bottle culture have similar accelerated stability.

关 键 词：麻疹疫苗 病毒培养 细胞工厂 转瓶 强制降解试验 稳定性分析 

分 类 号：R392-33[医药卫生—免疫学] R511.1[医药卫生—基础医学]