中国甲型H1N1流感疫苗质量分析  

Quality analysis of 2009 pandemic influenza A （ H1N1 ） vaccines

作　　者：刘书珍[1] 邵铭[1] 陈震[1] 袁力勇[1] 邱平[1] 王剑锋[1] 英志芳[1] 胡忠玉[1] 裴宇盛[1] 李长贵[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中华微生物学和免疫学杂志》2011年第7期653-656,共4页Chinese Journal of Microbiology and Immunology

摘　　要：目的通过对甲型H1N1流感疫苗批签发中的检测数据进行分析和比较，了解我国甲型H1N1流感疫苗的总体质量状况。方法按照各企业注册标准对甲型H1N1流感疫苗进行资料审查和全项检定，对关键项目检测结果进行分析和比较。结果甲型H1N1流感疫苗批签发总体合格率为99．8％，有效成分血凝素含量在标示量的90％～103％范围内，甲醛、卵清蛋白和内毒素含量等安全性指标均符合规定。结论我国甲型H1N1流感疫苗各项检测总体情况良好，能充分保证疫苗的安全性和有效性，中国食品药品检定研究院的独立检验和批签发对保证上市疫苗的质量发挥了重要作用。Objective To analyze the laboratory testing data of 2009 pandemic influenza A （H1N1） vaccines during lot release procedure, thus to know the overall quality status of this vaccines. Methods National Institutes for Food and Drug Control（NIFDC） carried out the laboratory test according to the specifications of each manufacture, and the results was analyzed and compared between manufacturer and NIFDC. Results 99.8% of vaccines batches were released by NIFDC, haemagglutinin contents were between 90% to 103 % of labeled values, and testing results slightly differ between manufactures and NIFDC, other items related to safety were all meet specifications. Conclusion The quality of H1N1 vaccines in China were satisfying, the lot release and independent test by NIFDC play important roles to ensure the vaccines＇ quality.

关 键 词：甲型H1N1流感疫苗 批签发 独立检验 

分 类 号：R979.5[医药卫生—药品]