麻疹风疹联合减毒活疫苗的稳定性观察

目的  观察麻疹风疹联合减毒活疫苗（麻风二联）的稳定性。方法  将17批北京生物制品研究所有限责任公司（北京公司）2012—2017年生产的麻风二联存放于（5±3）℃，分别在0、9、12、18和24个月按照企业注册标准和中国药典2010或2015年版三部要求进行相关检测。同时对新、旧车间生产的各3批疫苗进行主要质量指标比对。结果  随着存放时间延长，疫苗的病毒滴度呈逐渐下降趋势，麻疹病毒滴度波动于3.9~4.8 lg半数细胞培养感染量（CCID₅₀)/ml，风疹病毒滴度波动于4.0~4.8 lgCCID₅₀/ml，热稳定病毒滴度下降均不超过1.0 lg，疫苗水分不高于3.0%，疫苗的其余各项指标均符合企业注册标准和中国药典要求。新、旧车间生产的疫苗质量没有差别。结论  北京公司生产的麻风二联的质量稳定。

Stability observation of measles and rubella combined vaccine,live

 Objective  To observe the stability of measles and rubella combined vaccine, live (MR vaccine). Methods  Seventeen batches of MR vaccines produced by Beijing Institute of Biological Products Co., Ltd. (BIBP) in 2012-2017 were stored at (5±3) °C, and according to the enterprise registration standard and the requirements of Chinese pharmacopoeia (2010 or 2015 edition, volume Ⅲ), the related tests were carried out in 0, 9, 12, 18 and 24 months, respectively. At the same time, the main quality indicators of 3 batches each of MR vacccines produced in the new and old workshops were compared. Results  The virus titer decreased gradually with the extension of the storage time. The measles and rubella virus titers were 3.9-4.8 and 4.0-4.8 lg 50% cell culture infective dose (CCID₅₀)/ml, respectively, and all virus titer droping in thermal stability test was not higher than 1.0 lg. The moisture was all not higher than 3.0%. The results of the other indicators were in compliance with the registration standards and pharmacopoeia requirements. There was no difference between the quality of vaccines produced in new and old workshops. Conclusion  The quality of MR vaccine produced by BIBP is stable.