甲型H1N1流感疫苗生产用工作毒种的质量控制 |
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引用本文: | 方捍华,袁力勇,邵铭,刘书珍,李长贵.甲型H1N1流感疫苗生产用工作毒种的质量控制[J].微生物学免疫学进展,2009,37(4):8-10. |
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作者姓名: | 方捍华 袁力勇 邵铭 刘书珍 李长贵 |
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作者单位: | 中国药品生物制品检定所,北京,100050 |
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摘 要: | 根据中国药典2005年版三部和WHO"人用大流行流感疫苗制备的指导原则"相关要求,以及各企业的申报规程,对全国10家甲型H1N1流感疫苗生产企业工作毒种A/Californ ia/07/2009 NYMC X-179A进行毒种检定,结果均符合中国药典2005年版三部和各企业申报规程的要求。
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关 键 词: | 甲型H1N1流感疫苗 工作毒种 鉴别 |
Quality control of H1Nl influenza vaccine seed virus |
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Abstract: | To develop fast identification method for H1N1 influenza vaccines seed virus,and test seed virus A/California/07/2009 NYMC X-179A of all influenza vaccine manufacturer of China according 2005 edition CP Vol.III,WHO guidelines and the requirements of different influenza vaccine manufacturers.The seed virus A/California/07/2009 NYMC X-179A from 10 influenza vaccine manufacturers of China were all complied with the requirements of 2005 edition CP Vol.III,could be used for H1N1 influenza vaccine production. |
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Keywords: | H1N1 influenza vaccine Seed virus Identity test |
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