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甲型H1N1流感疫苗生产用工作毒种的质量控制 被引量:1

Quality control of H1N1 influenza vaccine seed virus
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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。 To develop fast identification method for H1N1 influenza vaccines seed virus, and test seed virus A/Callfornia/ 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/Califoruia/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.
出处 《微生物学免疫学进展》 2009年第4期8-10,共3页 Progress In Microbiology and Immunology
关键词 甲型H1N1流感疫苗 工作毒种 鉴别 H1N1 influenza vaccine Seed virus Identity test
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  • 1Proposed WHO recommendations for the production and control of influenza vaccines (human, live attenuated) [EB). http://www. who. int/vaceine-researoh/diseases/influenza/Draft -WHO -recs- LAIV-2627-Feb09. pdf.
  • 2WHO Guidelines on the use of vaccines and antivirals during influenza pandemics, [ EB]. http ://www. who. int/csr/resources/publications/influenza/11-29-01 A. pdf.
  • 3Influenza A virus ( A/reassortant/NYMC X-179A( California/07/ 2009 x NYMC X-157) (H1N1) ) segment 6 neuraminidase (NA) gene, complete cds [ EB]. http://www, ncbi. nlm. nih. gov/nuccore/238623305.
  • 4Influenza A virus ( A/reassortant/NYMC X-179A( California/07/ 2009 x NYMC X-157) ( H1N1 ) ) segment 4 hemagglutinin (HA) gene, complete eds[ EB]. http://www, nebi. rdm. nih. gov/nuccore/238623303.
  • 5Influenza A virus (A/NYMC X-157A( Puerto Rico/8/1934-New York/55/2004) ( H3N2 ) ) segment 7, complete sequence [ EB ]. http ://www. ncbi. nlm. nih. gov/nuceore/208343819.

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