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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, CCIDn 50)/ml,第2组均下降1.33 lgCCIDn 50/ml,第3组均下降1.54 lgCCIDn 50/ml,原液分别下降1.20和1.43 lgCCIDn 50/ml,成品分别下降1.33和1.30 lgCCIDn 50/ml。2种工艺产品的降解曲线相似。n 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 (Volume Ⅲ) 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 (CCIDn 50)/ml vs. 1.56 lgCCIDn 50/ml for group 1, both 1.33 lgCCIDn 50/ml for group 2, and both 1.54 lgCCIDn 50/ml for group 3. Decrease in virus titers of bulks were 1.20 lgCCIDn 50/ml vs. 1.43 lgCCIDn 50/ml and in titers of final products were 1.33 lgCCIDn 50/ml vs. 1.30 lgCCIDn 50/ml. Virus degradation curves of products by 2 processes were similar.n Conclusion:Measles vaccines produced by cell factory culture and rotary bottle culture have similar accelerated stability.