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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 vaccine combined with measles, mumps, rubella and varicella (MMRV) prepared in pilot phase. Methods The virus titer in MMRV live attenuated vaccine prepared in three batches during pilot phase was detected at -20 ℃, 2-8 ℃, room temperature (25 ℃) and 37 ℃ respectively. 18 months for identification test, physical examination, moisture test, sterile test, abnormal toxicity test, bovine serum albumin residue test, antibiotic residue test. Results The titer of measles, mumps, rubella and varicella virus in live attenuated MMRV vaccine was not less than 4.55 lg CCID 50 / ml and 0.055 CCL 50 / ml at the temperature of -20 ℃ for 18 months. lg CCID 50 / ml and 4.65 lg PFU / ml respectively; titers of measles, mumps, rubella and varicella virus in MMRV live attenuated vaccine are not less than 4.05 lg CCID 50 ) / ml, 4.93 lg CCID 50 / ml, 3.80 lg CCID 50 / ml and 4.32 lg PFU / ml respectively; measles, mumps, rubella and varicella virus in MMRV combined live attenuated vaccine for 6 weeks The titers were not lower than 3.80 lg CCID 50 / ml, 4.43 l CCID 50 / ml, 3.93 lg CCID 50 / ml and 3.87 lg PFU / ml, respectively; The measles, mumps, rubella and varicella virus titers in the vaccine were not lower than 3.80 lg CCID 50 / ml, 4.43 l CCID 50 / ml, 3.93 lg CCID 50 / ml and 3.84 lg PFU / ml, respectively. Other indicators test results are in line with manufacturing and testing procedures requirements. Conclusion The freeze-dried MMRV combined with attenuated live vaccine has good stability.