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细菌内毒素检查法常见问题 被引量:15

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作者 周素文 李波
出处 《中国药学杂志》 CAS CSCD 北大核心 2006年第19期1516-1518,共3页 Chinese Pharmaceutical Journal
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参考文献15

  • 1Department of Health and Human Services,U.S.Food and Drug Administration.Guideline On Validation of The Limulus Amebocyte Lysate Test As An End-Product Endotoxin Test For Human and Animal Parenteral Drugs,Biological Produc ts,And Medical Devices.U.S.[S].1987:1-25.
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  • 5李波,蔡彤,张国来.细菌内毒素检查法的国内外发展概况和存在的问题[J].中国药学杂志,2002,37(12):954-957. 被引量:19
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二级参考文献40

  • 1李冠民,黄清泉.热原检查的研究进展及有关问题的探讨[J].中国实验动物学杂志,2002,12(4):232-235. 被引量:20
  • 2丁友玲 小川义之.细菌内毒素参考标准品化学组成与生物活性的研究.第一届全国细菌内毒素检查法研究与应用学术会议论文及摘要汇编[M].,1997.28.
  • 3XIAZhen-min(夏振民).Discussion of pyrogens in pharmaceuticals(略谈药品注射剂之热原)[J].中华核医学杂志,1991,(11):273-273.
  • 4WANG Si - li(王思理), HU Guan - shi(胡冠时), GONG Li - qing(贡立青) Editor - in - chief (主编). LAL Method and Its Apphcations(细菌内毒素检查法及其应用). Beijing(北京) : China Meteorological Press(气象出版社出版) ,2003.35
  • 5ZHOU Hal - jun (周海钧 ), XIA Zhen - rain (夏振民). Abstracts international symposium on pyrogen(国际热原研讨会论文汇编).1987. 109
  • 6Yamamoto A, Ochiai M, Kataoka M. Development of a highly sensitive in vitro assay method for biological activity of endotoxin contamination in biological products. Biologicals ,2002,30 (2) :85
  • 7Poole EJ,Johaar G, James S,et al. Differentiation between endotoxin and non- endotoxin pyrogens in human albumin solutions using an ex vivo whole blood culture assay. J Immunoassay, 1999,20 ( 1 - 2 ) :79
  • 8Kirchner H, Kleinieke C, Digel W. A whole - blood technique for testing production of human interferon by leukocytes. J Immunol Methods, 1982,48(2) :213
  • 9Dinarello CA,OConnor JV,LoPreste G,et al. H.man leukocytic pyrogen test for detection of pyrogen material in growth hormone produced by recombinant Escherichia coli, J Clin Microbiol, 1984,20(3) :323
  • 10Poole S,Thorpe R, Meager A, et cd. Assay of pyrogenic contamination in pharmaceuticals by cytokine release from monocytes. Dev Biol Stand, 1988,69 : 121

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引证文献15

二级引证文献60

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