目的 观察国产流感病毒裂解疫苗（流感疫苗）的稳定性。方法 取58批上海生物制品研究所有限责任公司（上海公司）2011－2018年生产的流感疫苗，按照国家食品药品监督管理总局批准的流感疫苗注册标准和中国药典的要求进行各项检定，在0月和12个月做全项检定，在3、6、9个月进行血凝素含量检测。结果 流感疫苗在有效期内各项指标检定结果均符合注册标准和药典要求。各型流感病毒株血凝素含量均为配制量的80%~120%。结论 上海公司生产的流感疫苗质量稳定。

Objective  To observe the stability of a domestic influenza vaccine (split virion), inactivated (Flu-sp vaccine). Methods  Fifty-eight lots of Flu-sp produced by Shanghai Institute of Biological Product Co., Ltd., (SIBP) in 2011-2018 were tested according to Flu-sp vaccine registration standards approved by China Food and Drug Administration and related regulations in Chinese pharmacopoeia. The all tests were performed in months 0 and 12. The hemagglutinin content test was performed in months 3, 6 and 9. Results  All testing results of Flu-sp vaccine met registration standards and relevant regulations within the period of validity. The hemagglutinin content of all influenza virus strains were 80%-120% of the formulated amounts. Conclusion  The Flu-sp vaccine produced by SIBP has stable quality.