目的研究使用新型无明胶稳定剂生产水痘减毒活疫苗(Varicella attenuated live vaccine,VarV)的分装冻干工艺对于产品品质的影响。方法采用柱塞式分装泵灌封机对VarV半成品进行分装,对冻干机进行板层温度均匀性测试,按照实验设计的不同冻干程序进行冻干,对冻干疫苗的水分、外观、病毒滴度等指标进行检定。结果柱塞式分装泵灌封后的VarV半成品较均一、稳定;板层温度较均匀;在保证产品品质的前提下,合适的干燥温度可减少能耗开支,掺气可缩短冻干周期。结论改进后的冻干工艺可以提高VarV质量,减少能耗。 Aim To study the effect of varietal freeze-dried vaccine (VarVella attenuated live vaccine, VarV) on the product quality by using the new gelatin-free stabilizer. Methods The plunger-type filling machine was used to divide the VarV semi-finished products. The temperature uniformity of the freeze-drying machine was tested. The freeze-dried process was designed according to the experimental design. The moisture, appearance , Virus titer and other indicators for testing. Results The VarV semi-finished product after potting was more uniform and stable. The temperature of the slab was more uniform. With the premise of ensuring product quality, suitable drying temperature could reduce the energy consumption, and the aeration could shorten the period of freeze-drying. Conclusion The improved lyophilization process can improve the quality of VarV and reduce energy consumption.