麻疹-腮腺炎-风疹联合减毒活疫苗生产场地变更的质量可比性研究

Quality comparability study on manufacturing site change of live attenuated measles, mumps and rubella combined vaccine

目的比较生产场地变更前后生产的麻疹-腮腺炎-风疹联合减毒活疫苗（麻腮风疫苗）的关键质量指标及其变化趋势。方法新老车间同步各生产3批麻腮风疫苗，比较新老车间生产的疫苗的关键指标及其变化趋势，同时对新老车间生产的疫苗进行稳定性和安全性比较研究。结果新老车间生产的疫苗成品的关键质量指标均符合相关规定的要求，其中新车间生产的疫苗的水分为1.6％～1．8％，其麻疹、腮腺炎和风疹病毒滴度分别为4．1～4．3、4．8～5．0和3.9～4.1 lgCCIDs／ml，与老车间生产的疫苗（水分为1．6％～2．1％，麻疹、腮腺炎和风疹病毒滴度分别4．0～4．3、4．8～5．0和4．1～4．2 lgCCID50／ml）相似。新老车间生产的疫苗成品的稳定性和安全性实验结果均符合相关规定的要求，且新老车间生产的疫苗的稳定性实验结果相似，新老车间生产的疫苗的抗生素残留量（t=3．46，P〉O．05）和牛血清白蛋白残留量（t=2.00，P〉0．05）间的差异无统计学意义。结论麻腮风疫苗生产场地变更未对其制品质量产生影响。

Objective To compare the key quality indicators （KQIs） of live attenuated measles, mumps and rubella combined vaccine （MMR） and their changing trends between before and after manufacturing site change. Methods Three batches of MMR per site were prepared in new and old workshops simultaneously. KQIs of MMR and their changing trends were compared between new and old workshops. The stability and safety of MMR prepared in new and old workshops were compared. Results KQIs of MMR prepared in new and old workshops were both in compliance with related requirements. The residual moisture contents of 3 batches of MMR prepared in new workshop were 1.6%-1.8%, and viral titers of measles, mumps and rubella vaccine were 4. 1-4. 3, 4. 8-5.0 and 3. 9-4. 1 lgCCID50/ml, respectively, similar to those in old workshop （residual moisture contents were 1.6%-2. 1%, and viral titers were 4. 0-4. 3, 4. 8-5.0 and 4. 1-4. 2 lgCCID50/ml, respectively）. The results of stability and safety studies for MMR prepared in new workshop were similar to those in old workshop, and both were in compliance with related requirements. The contents of residual antibiotics and bovine serum albumin had no significant difference between MMR prepared in new and old workshops （residual antibiotics： t=3.46, P〉0. 05; residual bovine serum albumin： t=2. 00, P〉0.05）. Conclusion Manufacturing site change of MMR has no effect on the quality of MMR.