成人剂量型流行性感冒病毒裂解疫苗的稳定性研究  

A study on stability of adult-dose split influenza virus vaccine

作　　者：周健[1] 高菁霞[1] 马磊[1] 刘婧[1] 廖国阳[1] 戴宗祥[1] 

机构地区：[1]中国医学科学院/北京协和医学院医学生物学研究所,云南省重大传染病疫苗研发重点实验室,云南昆明650118

出　　处：《国际检验医学杂志》2013年第12期1497-1499,1502,共4页International Journal of Laboratory Medicine

基　　金：北京协和医学院/中国医学科学院医学生物学研究所国家国际合作项目(2011DFR30420);云南省自然科学基金资助项目(2004C070M;2006YX29)

摘　　要：目的了解疫苗在不同温度和不同时间存放的质量变化,为研制安全有效的流感疫苗提供依据。方法将流感疫苗放置在4℃和37℃进行长期稳定性和加速稳定性试验,不同存放时间点测定流感病毒血凝素(HA)含量及各项质量指标。结果疫苗经4℃保存18个月和37℃保存2周,HA含量和其他质量指标都符合药典要求。结论成品流感疫苗在1年有效期内均合格。Objective To understand the changes of vaccinal qualities stored in different temperatures and at different times and provide basis for developing safe and effective influenza vaccines.Methods Influenza vaccines were stored at 4 ℃ and 37 ℃ to perform long-term stability and accelerated stability test.Influenza virus hemagglutinin（HA） content and various quality indicators were determined at different storage time point.Results HA content and other quality indicators of vaccines were all in line with requirements of the pharmacopoeia after storage at 4 ℃ for 18 months and at 37 ℃ for 2 weeks.Conclusion Finished products of influenza vaccine are all qualified in the validity period of one year.

关 键 词：流行性感冒病毒裂解疫苗 血凝素 稳定性 

分 类 号：R392[医药卫生—免疫学]