麻腮风水痘联合减毒活疫苗的稳定性观察  

Stability of live attenuated measles, mumps, rubella and varicella combined vaccine

作　　者：张安宁 于立芹 陈晓梅 史晓莉 李瓯 李磊 张建军 付永其 

机构地区：[1]北京天坛生物制品股份有限公司,北京100176

出　　处：《中国生物制品学杂志》2016年第12期1238-1241,1245,共5页Chinese Journal of Biologicals

基　　金：863计划(2012AA02A400)

摘　　要：目的观察中试阶段制备的麻腮风水痘（measles,mumps,rubella and varicella,MMRV）联合减毒活疫苗的稳定性。方法将检定合格的3批中试阶段制备的MMRV联合减毒活疫苗分别置-20℃、2-8℃、室温（25℃）和37℃,定期对其病毒滴度进行检测;在0和18月进行鉴别试验、物理检查、水分检测、无菌检查、异常毒性检查、牛血清白蛋白残留量检测、抗生素残留量检测。结果 -20℃放置18个月,MMRV联合减毒活疫苗中麻疹、腮腺炎、风疹及水痘病毒滴度分别不低于4.55 lg CCID（50）/ml、5.05 lg CCID（50）/ml、3.80 lg CCID（50）/ml和4.65 lg PFU/ml;2-8℃放置18个月,MMRV联合减毒活疫苗中麻疹、腮腺炎、风疹及水痘病毒滴度分别不低于4.05 lg CCID（50）/ml、4.93 lg CCID（50）/ml、3.80 lg CCID（50）/ml和4.32 lg PFU/ml;25℃放置6周,MMRV联合减毒活疫苗中麻疹、腮腺炎、风疹及水痘病毒滴度分别不低于3.80 lg CCID（50）/ml、4.43 lg CCID（50）/ml、3.93 lg CCID（50）/ml和3.87 lg PFU/ml;37℃放置4周,MMRV联合减毒活疫苗中麻疹、腮腺炎、风疹及水痘病毒滴度分别不低于3.80 lg CCID（50）/ml、4.43 lg CCID（50）/ml、3.93 lg CCID（50）/ml和3.84 lg PFU/ml。其他各项指标检测结果均符合制造及检定规程要求。结论冻干MMRV联合减毒活疫苗稳定性良好。Objective To observe the stability of live attenuated measles, mumps, rubella and varicella（MMRV）combined vaccine in pilot phase. Methods Three batches of live attenuated MMRV vaccine in pilot phase, qualified in control tests, were stored at-20, 2 - 8, 25（room temperature）and 37 ℃ respectively, and determined for titer regularly.The vaccine was subjected to identity test, physical examination, determination of moisture, sterility test, abnormal toxicity test as well as determination of residual bovine serum albumin（BSA）and residual antibiotic contents at months 0 and 18 after storage. Results The titers of measles, mumps, rubella and varicella viruses in MMRV vaccine were not less than4. 55 lg / ml, not less than 5. 05 lg CCID（50）/ ml, not less than 3. 80 lg CCID（50）/ ml and not less than 4. 65 lg PFU / ml after storage at-20 ℃ for 18 months, while were not less than 4. 05 lg CCID（50）/ ml, not less than 4. 93 lg CCID（50）/ ml, not less than 3. 80 lg CCID（50）/ ml and not less than 4. 32 lg PFU / ml after storage at 2 - 8 ℃ for 18 months, not less than3. 80 lg CCID（50）/ ml, not less than 4. 43 lg CCID（50）/ ml, not less than 3. 93 lg CCID（50）/ ml and not less than 3. 87 lg PFU / ml after storage at 25 ℃ for 6 weeks, and not less than 3. 80 lg CCID（50）/ ml, not less than 4. 43 lg CCID（50）/ ml, not less than3. 93 lg CCID（50）/ ml and not less than 3. 84 lg PFU / ml after storage at 37 ℃ for 4 weeks, respectively. All the quality indexes of MMRV vaccine met the requirements for manufacturing and quality control. Conclusion Freeze-dried live attenuated MMRV vaccine showed high stability.

关 键 词：麻腮风水痘联合减毒活疫苗 滴度 稳定性 

分 类 号：R373.1[医药卫生—病原生物学] R392.33[医药卫生—基础医学]