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USP compendial methods for analysis of heparin: chromatographic determination of molecular weight distributions for heparin sodium

机译:Usp药典分析肝素的方法:色谱法测定肝素钠的分子量分布

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摘要

Heparin is a polysaccharide product isolated from glycosaminoglycans of porcine mucosa (or occasionally other tissues and species). It is a linear non-uniform polymer consisting of alternating glucosamine and uronic acid monosaccharide residues and is highly sulfated. Heparin sodium drug product (HP) used in medicine consists of chains with molecular weight (MW) ranging from under 5,000 to over 50,000. Although HP has been used as an injectable antithrombotic medicine for more than 70 years, many aspects of its structure and purity, including its MW, have not been specified by public standards until recent years. In 2008, a number of HP lots associated with severe adverse effects, including fatalities, were found to have been contaminated with oversulfated chondroitin sulfate. This incident led to thorough revision of compendial standards worldwide. In the USA, the Food and Drug Administration (FDA) encouraged the inclusion of enhanced standards for purity and identity in the relevant monographs of the United States Pharmacopeia (USP) including acceptance criteria for MW distribution.
机译:肝素是从猪粘膜(或其他组织和种)的糖胺聚糖中分离出来的多糖产品。它是由交替的氨基葡萄糖和糖醛酸单糖残基组成的线性不均匀聚合物,并且高度硫酸化。用于医学的肝素钠药物产品(HP)由分子量(MW)在5,000以下至50,000以上的链组成。尽管HP已被用作注射用抗血栓药物已有70多年的历史,但直到最近几年,公共标准才对其结构和纯度的许多方面(包括分子量)进行了规定。 2008年,发现许多与严重不良影响(包括死亡)相关的HP批次都被过度硫酸化的软骨素硫酸盐污染。该事件导致了全球范围内的药典标准的彻底修订。在美国,美国食品药品监督管理局(FDA)鼓励在美国药典(USP)的相关专着中纳入有关纯度和特性的增强标准,包括分子量分布的接受标准。

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