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配制麻疹-腮腺炎-风疹-水痘联合减毒活疫苗的各病毒原液最适滴度研究
引用本文:陈晓梅,于立芹,史晓莉,李瓯,刘晓琳,李淑云,张建军,赵炜炜,张安宁.配制麻疹-腮腺炎-风疹-水痘联合减毒活疫苗的各病毒原液最适滴度研究[J].国际生物制品学杂志,2016(4):157-161.
作者姓名:陈晓梅  于立芹  史晓莉  李瓯  刘晓琳  李淑云  张建军  赵炜炜  张安宁
作者单位:100176,北京天坛生物制品股份有限公司疫苗研究一室
基金项目:国家高技术研究发展计划(863计划)(2012AA02A400),National High-tech R&D Program of China (863 Program)(2012AA02A400)
摘    要:目的 研究配制麻疹-腮腺炎-风疹-水痘联合减毒活疫苗(measles-mumps-rubella-varicellacombined attenuated live vaccine,MMRV)的各病毒原液最适滴度.方法 将麻疹、腮腺炎、风疹和水痘病毒原液分别冻干,检测各冻干单价疫苗的滴度和热稳定性,观察病毒滴度的下降幅度.将4种病毒原液按不同配比配制MMRV,检测配制前后的各病毒滴度,摸索配制MMRV的最佳配比.按确认的最佳配比配制MMRV并冻干,检测冻干MMRV的各病毒滴度和热稳定性,确定配制MMRV的各病毒原液最适滴度.结果 各病毒原液冻干后,麻疹、腮腺炎、风疹和水痘病毒滴度分别下降约0.6、0.6、0.4 lgCCID50/ml和0.5 lgPFU/ml;各冻干单价疫苗37℃放置1周后,麻疹、腮腺炎、风疹和水痘病毒的滴度分别下降约0.6、0.5、0.5 lgCCID50/ml和0.5 lgPFU/ml.在配制MMRV过程中,仅腮腺炎病毒可能在一定程度上受到其他病毒的干扰.按确认的最佳配比配制的MMRV冻干后,麻疹、腮腺炎、风疹和水痘病毒滴度分别下降约0.5、0.6、0.5 lgCCID50/ml和0.6 lgPFU/ml;冻干MMRV于37℃放置1周后,麻疹、腮腺炎、风疹和水痘病毒滴度分别下降约0.6、0.6、0.5 lgCCID50/ml和0.5 lgPFU/ml.结论 在按确认的最佳配比配制MMRV时,麻疹、腮腺炎、风疹和水痘病毒原液的滴度需分别≥6.0、≥6.5、≥6.0 lgCCID50/ml和≥5.3 lgPFU/ml.

关 键 词:麻疹-腮腺炎-风疹疫苗  水痘疫苗  疫苗  联合  冷冻干燥法  滴度

Optimal virus bulk titers for measles-mumps-rubella-varicella combined attenuated live vaccine preparation
Abstract:Objective To study the optimal titer of each virus bulk for measles-mumps-rubellavaricella combined attenuated live vaccine (MMRV) preparation.Methods Measles,mumps,rubella,and varicella virus bulks were lyophilized separately.The titers and thermostability of each monovalent vaccine were detected to monitor the decline of virual titers.MMRVs were prepared with these 4 virus bulks at different ratios.The titer of each virus before and after MMRV preparation was detected to explore the optimal proportior.MMRVs were then prepared with the optimal proportion and lyophilized.The titer and thermostability of each virus in freeze-dried MMRVs were detected to determine the optimal titer of each virus bulk.Results After freeze-drying each virus bulk,the titers of measles,mumps,rubella,and varicella viruses decreased about 0.6,0.6,0.4 lgCCID50/ml and 0.5 lgPFU/ml,respectively.After storing each monovalent vaccine at 37 ℃ for a week,the titers of measles,mumps,rubella,and varicella viruses decreased about 0.6,0.5,0.5 lgCCI50/ml and 0.5 lgPFU/ml,respectively.During MMRV preparation,only mumps virus might be interfered by other viruses to some level.After freeze-drying MMRV prepared with optimal proportion,the titers of measles,mumps,rubella,and varicella viruses decreased about 0.5,0.6,0.5 lgCCID50/ml and 0.6 lgPFU/ml,respectively.After storing MMRV at 37 ℃ for a week,the titers of measles,mumps,rubella,and varicella viruses decreased about 0.6,0.6,0.5 lgCCI50/ml and 0.5 lgPFU/ml,respectively.Conclusion When MMRV is prepared with confirmed optimal proportion,the titers of measles,mumps,rubella,and varicella virus bulks need to reach ≥6.0,≥6.5,≥6.0 lgCCID50/ml and ≥5.3 lgPFU/ml,respectively.
Keywords:Measles-mumps-rubella vaccine  Chickenpox vaccine  Vaccine  combined  Freeze drying  Titer
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