The US regulatory and pharmacopeia response to the global heparin contamination crisis.
The US regulatory and pharmacopeia response to the global heparin contamination crisis.
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DOI：
10.1038/nbt.3606
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发表时间：
2016-06-09
影响因子：
46.9
通讯作者：
Al-Hakim A
中科院分区：
文献类型：
--
作者：
Szajek AY;Chess E;Johansen K;Gratzl G;Gray E;Keire D;Linhardt RJ;Liu J;Morris T;Mulloy B;Nasr M;Shriver Z;Torralba P;Viskov C;Williams R;Woodcock J;Workman W;Al-Hakim A
2007 年广泛使用的救命抗凝药物肝素的污染再次引起人们对天然来源复杂生物药物的表征、质量控制和标准化相关挑战的关注。肝素是一种线性、高度硫酸化的多糖，由交替的葡萄糖胺和糖醛酸单糖残基组成。自 20 世纪 30 年代以来，肝素已成功用作注射抗血栓药物，其从动物来源（主要是猪肠）中的分离及其制造工艺自推出以来并未发生重大变化。 2007 年的肝素污染危机在美国造成数人死亡，并在全球范围内造成数百起不良反应，揭示了复杂的全球供应链对于复杂掺假的脆弱性。本视角讨论了美国食品和药物管理局 (FDA)、美国药典公约 (USP) 和国际利益相关者如何合作重新定义肝素的质量期望，从而使重要的天然产品得到更好的控制，并不易受到出于经济动机的掺假影响。
The contamination of the widely used lifesaving anticoagulant drug heparin in 2007 has drawn renewed attention to the challenges that are associated with the characterization, quality control and standardization of complex biological medicines from natural sources. Heparin is a linear, highly sulfated polysaccharide consisting of alternating glucosamine and uronic acid monosaccharide residues. Heparin has been used successfully as an injectable antithrombotic medicine since the 1930s, and its isolation from animal sources (primarily porcine intestine) as well as its manufacturing processes have not changed substantially since its introduction. The 2007 heparin contamination crisis resulted in several deaths in the United States and hundreds of adverse reactions worldwide, revealing the vulnerability of a complex global supply chain to sophisticated adulteration. This Perspective discusses how the US Food and Drug Administration (FDA), the United States Pharmacopeial Convention (USP) and international stakeholders collaborated to redefine quality expectations for heparin, thus making an important natural product better controlled and less susceptible to economically motivated adulteration.
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影响因子：
4.9
作者：
Raman K;Mencio C;Desai UR;Kuberan B
通讯作者：
Kuberan B
影响因子：
7.8
作者：
Laremore, Tatiana N.;Zhang, Fuming;Dordick, Jonathan S.;Liu, Jian;Linhardt, Robert J.
通讯作者：
Linhardt, Robert J.
影响因子：
46.9
作者：
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通讯作者：
Sasisekharan, Ram
DOI：
10.1016/j.jpba.2009.10.017
发表时间：
2010-03-11
影响因子：
3.4
作者：
Keire, David A.;Trehy, Michael L.;Buhse, Lucinda F.
通讯作者：
Buhse, Lucinda F.
影响因子：
4.3
作者：
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通讯作者：
Keire, David A.