目的 对比不同冻干稳定剂配方对麻疹-腮腺炎-风疹-水痘联合减毒活疫苗(measles，mumps，rubella and vericella combined live attenuated vaccine，MMRV)稳定性的影响，初步筛选出最佳配方。方法 对比2种含明胶（配方1、2）和1种无明胶冻干稳定剂配方（配方3）对MMRV在37、25及2～8 ℃保存后关键质量指标的影响。结果 37 ℃加速稳定性试验中，仅配方3产品4种病毒滴度均在合格范围内。25 ℃加速稳定性试验中，配方1产品1个月时腮腺炎和水痘病毒滴度即全部低于质量标准下限，配方2、3产品放置6个月，所有4种病毒滴度均在质量标准范围内，但配方2腮腺炎及水痘病毒滴度均处于标准下限。2~8 ℃长期稳定性试验中，配方1产品放置6个月，腮腺炎及水痘病毒滴度均低于质量标准下限，配方2、3产品的病毒滴度稳定性可分别保持18和24个月。结论 针对MMRV开发的无明胶冻干稳定剂配方3在冻干和保存过程中对4种病毒的活性保护效果最佳，其产品有效期至少为2年，并有进一步延长的潜力。研究结果也为日后研发降低明胶使用含量的麻疹系列疫苗冻干稳定剂配方提供了支持。

Objective  To compare the stability of measles, mumps, rubella and varicella combined live attenuated vaccine (MMRV) using different lyophilization stabilizer formulations, and to select the optimal formulation. Method  The effects of 2 lyophilization stabilizers with gelatin (formulas 1, 2) and 1 without (formula 3) on key quality indicators of MMRV stored at 37, 25 and 2-8 ℃ were compared. Results  In the 37 ℃ accelerated stability test, only formula 3 MMRV had all 4 viruses titers within the required range. In the 25 ℃ accelerated stability test, at 1 month, the mumps and varicella virus titers in formula 1 MMRV were below requirement. All virus titers in both formulas 2 and 3 MMRV at 6 months were within the required range, although mumps and varicella virus titers in formula 2 MMRV were at the lower limit. In 2-8 °C long-term stability test, the mumps and vericella virus titers in formula 1 MMRV at 6 months were all below the required range. The stabilities of formulas 2 and 3 MMRV were qualified for up to 18 and 24 months, respectively. Conclusion  The formula 3 gelatin-free lyophilization stabilizer developed for MMRV has the best protective effect on all 4 viruses during lyophilization and preservation processes. The period of validity for formula 3 MMRV is at least 2 years and has the potential for further extension. This study also supports the future development of reduced gelatin stabilizer for measles series vaccines.