目的  考察水痘减毒活疫苗（水痘疫苗）的稳定性。方法  取32批由上海生物制品研究所有限责任公司（上海公司）于2013—2019年生产的水痘疫苗，按照水痘疫苗注册标准和中国药典2015年版三部的要求进行各项检定；在0个月进行热稳定性试验，在0和24个月分别进行鉴别试验、外观检查、异常毒性检查、无菌检查和细菌内毒素含量、牛血清白蛋白残留量、抗生素残留量、渗透压摩尔浓度、pH值、病毒滴度、水分检测。结果  2013—2019年水痘疫苗在有效期内各项指标检定结果均符合注册标准和中国药典要求。疫苗水分不高于3.0%。病毒滴度在每0.5毫升 3.3～4.5 lg噬斑形成单位。结论  上海公司生产的水痘疫苗安全、有效、稳定。

Objective  To study the stability of live-attenuated varicella vaccine (varicella vaccine). Methods  Thirty-two batches of varicella vaccine manufactured by Shanghai Institute of Biological Products Co., Ltd (SIBP) from 2013 to 2019 were tested following the varicella vaccine registration standards and related regulations in Chinese pharmacopoeia(version 2015). The thermal stability was performed in month 0. The tests of identification, appearance, abnormal toxicity, sterility, bacterial endotoxin content, bovine serum albumin residue, antibiotic residue, molar concentration of osmotic pressure, pH, virus titer and moisture were performed in month 0 and 24. Results The results of varicella vaccine met the registration standards and Chinese pharmacopoeia requirements in the period of validity. The vaccine moisture was no higher than 3.0%, and the virus titer in the range of 3.3-4.5 lg plaque-forming unit per 0.5 ml. Conclusion  The varicella vaccines manufactured by SIBP are safe, effective and stable.