中华微生物学和免疫学杂志
中華微生物學和免疫學雜誌
중화미생물학화면역학잡지
CHINESE JOURNAL OF MICROBIOLOGY AND IMMUNOLOGY
2011年
7期
653-656
,共4页
刘书珍%邵铭%陈震%袁力勇%邱平%王剑锋%英志芳%胡忠玉%裴宇盛%李长贵
劉書珍%邵銘%陳震%袁力勇%邱平%王劍鋒%英誌芳%鬍忠玉%裴宇盛%李長貴
류서진%소명%진진%원력용%구평%왕검봉%영지방%호충옥%배우성%리장귀
甲型H1N1流感疫苗%批签发%独立检验
甲型H1N1流感疫苗%批籤髮%獨立檢驗
갑형H1N1류감역묘%비첨발%독립검험
H1N1 iInfluenza vaccines%Lot release%Independent testing
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.
目的 通過對甲型H1N1流感疫苗批籤髮中的檢測數據進行分析和比較,瞭解我國甲型H1N1流感疫苗的總體質量狀況.方法 按照各企業註冊標準對甲型H1N1流感疫苗進行資料審查和全項檢定,對關鍵項目檢測結果進行分析和比較.結果 甲型H1N1流感疫苗批籤髮總體閤格率為99.8%,有效成分血凝素含量在標示量的90%～103%範圍內,甲醛、卵清蛋白和內毒素含量等安全性指標均符閤規定.結論 我國甲型H1N1流感疫苗各項檢測總體情況良好,能充分保證疫苗的安全性和有效性,中國食品藥品檢定研究院的獨立檢驗和批籤髮對保證上市疫苗的質量髮揮瞭重要作用.
목적 통과대갑형H1N1류감역묘비첨발중적검측수거진행분석화비교,료해아국갑형H1N1류감역묘적총체질량상황.방법 안조각기업주책표준대갑형H1N1류감역묘진행자료심사화전항검정,대관건항목검측결과진행분석화비교.결과 갑형H1N1류감역묘비첨발총체합격솔위99.8%,유효성분혈응소함량재표시량적90%～103%범위내,갑철、란청단백화내독소함량등안전성지표균부합규정.결론 아국갑형H1N1류감역묘각항검측총체정황량호,능충분보증역묘적안전성화유효성,중국식품약품검정연구원적독립검험화비첨발대보증상시역묘적질량발휘료중요작용.
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.
