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目的:初步建立以人二倍体细胞KMBn 17为培养基质的F基因型腮腺炎减毒活疫苗细胞工厂工艺。n 方法:分别使用细胞工厂和细胞培养瓶，以含体积分数5%和10%牛血清的培养基将KMBn 17细胞培养至单层后计数，并按不同感染复数(multiplicity of infection, MOI)接种F基因型腮腺炎病毒，观察细胞病变情况，初步确定细胞工厂工艺最适MOI和病毒收获时间。在无血清培养基条件下，对两种生产工艺制备的腮腺炎减毒活疫苗半成品和成品进行病毒滴度检测、热稳定性试验及其他相关质量指标的检测。n 结果:在细胞工厂中获得了生长状态良好的KMBn 17细胞，经洗涤后，在MOI为0.020时，培养7～9 d后可获得滴度较高的病毒收获液，经过滤、冻干，成品病毒滴度较稳定，其他质量指标经检测均符合中国药典2015年版三部的要求。n 结论:初步建立了细胞工厂制备F基因型腮腺炎减毒活疫苗的生产工艺。“,”Objective:To preliminarily establish the cell factory production process of F-genotype attenuated mumps vaccine in human diploid cell KMBn 17.n Methods:Cell factory and cell culture bottle were used to culture KMBn 17 cells to monolayer with 5% and 10% bovine serum, respectively. Cells were counted, inoculated with F-genotype mumps virus at different multiplicities of infection (MOIs) in serum-free culture medium. The cytopathic effect was observed after virus inoculation to determine the most suitable MOI and harvest time. The virus titer, thermal stability and other related quality items of bulk and final products were tested for 2 different production processes in serum-free culture medium.n Results:KMBn 17 cells obtained from cell factory were in good growth condition. After cell wash, with MOI of 0.020, virus harvests with high virus titer were obtained after 7-9 d of culture. After filtration and freeze-drying, virus titer of the final product was stable, and other quality items were in line with the requirements of Chinese pharmacopoeia 2015 (Volume Ⅲ).n Conclusion:The production process of F-genotype attenuated mumps vaccine in human diploid cell KMBn 17 is preliminarily established.n