国产水痘减毒活疫苗质量分析

Quality analysis of domestic attenuated varicella vaccine

目的对国产水痘减毒活疫苗进行质量分析,判断疫苗的安全性和有效性。方法取2019年生产的102批水痘减毒活疫苗,进行鉴别试验、外观、pH值、渗透压摩尔浓度、水分、病毒滴定、热稳定性、牛血清白蛋白残留量、抗生素残留量、无菌、异常毒性、细菌内毒素含量的检查。结果各项检查结果均符合《水痘减毒活疫苗制造与检定规程》和中国药典2015年版三部相关要求,病毒滴定和热稳定性试验结果均在3.4 lg噬斑形成单位/0.5 ml以上。结论国产水痘减毒活疫苗是安全有效的。

Objective To analyze the quality of domestic attenuated varicella vaccine to determine its safety and effectiveness.Methods Tests of identification,appearance,pH,osmolarity,moisture,virus titration,thermal stability,residual bovine serum albumin content,residual antibiotic content,sterility,abnormal toxicity and bacterial endotoxin content were performed on 102 batches of domestic attenuated varicella vaccines produced in 2019.Results All test results were in comply with Attenuated Varicella Vaccine Manufacturing and Verification Procedure and the requirements of Chinese pharmacopoeia 2015(VolumeⅢ).Virus titration and thermal stability test results were all above 3.4 lg plaque-forming unit/0.5 ml.Conclusion The domestic attenuated varicella vaccine tested is safe and effective.