依诺肝素钠的质量控制思路  

Strategies for quality control of enoxaparin sodium

作　　者：张筱红[1] 任连杰[2] 余立[2] 黄晓龙[3] 赵慧玲[3] 

机构地区：[1]国家药典委员会,北京100061 [2]北京市药品检验所,北京100035 [3]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国新药杂志》2012年第11期1200-1202,共3页Chinese Journal of New Drugs

摘　　要：依诺肝素钠具有抗凝血活性,可抑制血栓的形成。作为低分子肝素类产品的主要品种,其制剂在临床上广泛用于预防静脉血栓栓塞性疾病。依诺肝素钠是一类来源于猪肠黏膜的多组分生化药,本文结合其结构特点和生产工艺,对其产品质量控制提出思路,并主要针对产品的终端控制进行讨论,为质量标准的起草提供参考。Enoxaparin sodium has anticoagulant activity,and it can inhibit thrombosis formation.Enoxaparin sodium is the sodium salt of a low-molecular-weight heparin that is an anticoagulation agent widely used in preventing venous thrombus embolism（VTE）.Enoxaparin sodium is obtained by alkaline depolymerisation of the benzyl ester derivative of heparin from porcine intestinal mucosa.The goal of this article is to provide research strategies for the quality control based on the structure and production process of enoxaparin sodium.Terminal control of the product was discussed in this article,which can provide a suggestion for the drafting of quality specifications.

关 键 词：低分子肝素 依诺肝素钠 质量控制 质量标准 

分 类 号：R973.2[医药卫生—药品]