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纤维蛋白原制品病毒灭活方法研究进展 被引量：13

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作者 赵雄 尹惠琼 章金刚
机构地区 军事医学科学院野战输血研究所
出处 《中国输血杂志》 CAS CSCD 2008年第2期141-144,共4页 Chinese Journal of Blood Transfusion
基金 全军"十五"指令性研究项目资助课题(编号:01L042)
关键词 纤维蛋白原 病毒灭活方法 血液制品
分类号 R392.33 [医药卫生—免疫学] R457 [医药卫生—治疗学]
  • 相关文献

参考文献23

  • 1刘隽湘.纤维蛋白(原)制剂[M]//刘隽湘.输血疗法与血液制剂.北京:人民卫生出版社,1996,210-214
  • 2Kheirabadi BS, Acheson EM, Deguzman R, et al. The potential utility of fibrin sealant dressing in repair of vascular injury in swine[J].J Trauma. 2007. 62( 1 ) :94-103
  • 3Schenk WG 3rd, Burks SG, Gagne PJ, et al. Fibrin sealant improves hemostasis in peripheral vascular surgery: a randomized prospective trial[ J]. Ann Surg, 2003, 237(6) :871-876
  • 4Kubota M, Okuyama N, Hirayama Y. A new method to close an intestinal wall defect using fibrin glue and polyglycolic acid felt sealant[J], J Pediatr Surg, 2007, 42(7) :1225-1230
  • 5Terasaka S, Iwasaki Y, Shinya N, et al. Fibrin glue and polyglycolic Acid nonwoven fabric as a biocompatible dural substitute [J]. Neurosurgery, 2006, 58(Suppl 1 ):134-139
  • 6Shimada Y, Hongo M, Miyakoshi N, et al. Dural substitute with polyglycolic acid mesh and fibrin glue for dural repair: technical note and preliminary results[ J]. J Orthop Sei, 2006, 11(5) : 454-458
  • 7章金刚.生物技术产品的病毒安全性[J].中国医药生物技术,2007,2(2):81-84. 被引量：7
  • 8Brackmann HH, Egli H. Acute hepatitis B infection after treatment with heat-inactivated factor Ⅷ concentrate [ J ]. Lancet, 1988, 2(8617) :967
  • 9Dichtelmuller H, Rudnick D, Breuer B, et al. Improvement of virus safety of a S/D-treated factor Ⅷ concentrate by additional dry heat treatment at 100 degrees C[ J]. Biologicals, 1996, 24 (2) :125-130
  • 10Murphy P, Nowak T, Lemon SM, et al. Inactivation of hepatitis A virus by heat treatment in aqueous solution[ J]. J Med Virel, 1993, 41(1):61-64

二级参考文献10

  • 1[4]Zhang JG.Viral safety for animal-derived products//British Council.China-UK Workshop on food safety,Zhengzhou,2006.Beijing:British Council Beijing Branch,2006:27-28.
  • 2[7]WHO.Requirements for the use of animal cells as in vitro substrates for the production of biologicals.WHO Technical Report Series,No.927,2005[EB/OL].[2007-03-23].http://www.who.int/biologicals/areas/blood_products/ANNEX%204%20Animal%20cellsP135-137.pdf.
  • 3[8]Committee for Proprietary Medicinal Products NOTE for guidance on virus validation studies:the design,contribution and interpretation of studies validating the inactivation and removal of viruses[EB/OL].(1996-02-14)[2007-03-23].http://www.emea.eu.int/pdfs/human/bwp/026895en.pdf.
  • 4[9]Committee for Proprietary Medicinal Products.NOTE for guidance on plasma-derived medical products[EB/OL].(2001-01-25)[2007-03-24].http://www.emea.eu.int/pdfs/human/bwp/026995en.pdf.
  • 5[10]ICH.Note for guidance on quality of biotechnological products:viral safety evaluation of biotechnology products derived from cell lines of human or animal origin[EB/OL].(2001-01-25)[2007-03-24].http://www.tga.gov.au/docs/pdf/euguide/ich/29595en.pdf.
  • 6[11]U.S.Department of Health and Human Services,Food and Drug Administration,Center for Biologics Evaluation and Research.Characterization and qualification of cell substrates and other biological starting materials used in the production of viral vaccines for the prevention and treatment of infectious diseases[EB/OL].(2006-09-28)[2007-03-19].http://www.fda.gov/cber/gdlns/vaccsub strates.pdf.
  • 7[12]Center for Biologics Evaluation and Research,Food and Drug Administration.Points to consider in the characterization of cell lines used to produce biologicals[EB/OL].(1993-06-12)[2007-03-20].http://www.fda.gov/cber/gdlns/ptccell.pdf.
  • 8[13]U.S.Department of Health and Human Services,Food and Drug Administration,Center for Biologics Evaluation and Research,Food and Drug Administration.Points to consider in the manufacture and testing of monoclonal antibody products for human use[EB/0L].(1997-02-27)[2007-03-19].http://www.fda.gov/cber/gdlns/ptc_mab.txt.
  • 9[14]State Food and Drug Administration.Guideline for viral removal/inactivation techniques and validation of blood products[EB/OL].(2002-05-09)[2007-03-22].http://www.sda.gov.cn/cmsweb/webportal/W4244/A6319285.html.(in Chinese)国家食品药品监督管理局.血液制品去除/灭活病毒技术方法及验证指导原则[EB/OL].(2002-05-09)[2007-03-22].http://www.sda.gov.cn/cmsweb/webportal/W4244/A6319285.html
  • 10[16]U.S.Department of Health and Human Services.PHS Guideline on infectious disease issues in xenotransplantation[EB/OL].(2001-01-19)[2007-03-20].http://www.fda.gov/cber/gdlns/xenophs0101.pdf.

共引文献6

同被引文献222

引证文献13

二级引证文献80

中国输血杂志
2008年 第2期

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