两种工艺制备的麻疹减毒活疫苗加速稳定性可比性研究

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版三部和企业标准进行病毒滴度检定。利用Minitab 19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。2种工艺制备的麻疹减毒活疫苗单次收获液病毒滴度第1组分别下降1.51和1.56 lg细胞培养半数感染量（CCID₅₀）/ml，第2组均下降1.33 lg CCID₅₀/ml，第3组均下降1.54 lg，原液分别下降1.20和1.43 lg CCID₅₀/ml，成品分别下降1.33和1.30 lg CCID₅₀/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。

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

Objective  To study the comparability of accelerated stability between cell factory and rotary bottle culture processes of live attenuated measles vaccine cells by forced degradation test. Methods  Measles vaccine single harvests and bulks produced by cell factory and rotary bottle culture processes, 3 lots respectively, were kept at 25 ℃ for 10 d. Final products produced by 2 processes, 3 lots respectively, were kept at 37 ℃ for 10 d. Virus titers were tested according to China pharmacopoeia and enterprise quality standard. Virus degradation curves of products by 2 processes were compared by Minitab 19. Results  All degradation curves showed heat sensitivity. Virus titers of single harvests produced by 2 process were 1.51 vs, 1.56 lg 50% cell culture infective dose (CCID₅₀)/ml, 1.33 vs. 1.33 lg CCID₅₀/ml, and 1.54 vs. 1.54 lg CCID₅₀/ml; titers of bulks were 1.20 vs. 1.43 lg CCID₅₀/ml; titers of final products were 1.33 vs. 1.30 lg CCID₅₀/ml. Virus degradation curves of products by 2 processes were similar. Conclution  Measles vaccines processed by cell factory culture and rotary bottle culture have similar accelerated stability.