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.
出处
《国际检验医学杂志》
CAS
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)
