仿制低分子肝素的免疫原性研究  

Immunogenicity Study of Low Molecular Weight Heparin

作　　者：王秀萍 崔慧斐[1] 陈少鹏 WANG Xiu-ping;CUI Hui-fei;CHEN Shao-peng(School of Pharmaceutical Sciences,Shandong University,Jinan 250012,China;Dongying Tiandong Pharmaceutical Co.,Ltd.,Dongying 257067,China)

机构地区：[1]山东大学药学院,山东济南250012 [2]东营天东制药有限公司,山东东营257067

出　　处：《食品与药品》2019年第3期247-252,共6页Food and Drug

摘　　要：低分子肝素(LMWH)是当前临床最常使用的抗凝剂,其应用中存在的重要不良反应为肝素诱导的血小板减少症。随着各种原研LMWH专利的到期,大量仿制LMWH涌现。为此,FDA发布指南要求各仿制LMWH厂家在进行注册申报时,需开展与此不良反应相关的免疫原性研究。本文介绍了LMWH免疫原性发生的背景及FDA指南中LMWH免疫原性研究的内容与方法,以冀为仿制LMWH的开发提供参考。Low-molecular-weight heparin(LMWH)is the most commonly used anticoagulant in clinic,heparininduced thrombocytopenia(HIT)is the most severe side effect of LMWH.With the expiration of all patents for LMWH,a large number of generic LMWH have emerged.Therefore,FDA issued Immunogenicity-Related Considerations for Low Molecular Weight Heparin Guidance for Industry for the evaluation of related potential risk in drug registration.In this review,the background of LMWH immunogenicity and the contents and methods of immunogenicity study of LMWH required by FDA in this guidance have been summarized to provide reference for the development of generic LMWH.

关 键 词：低分子肝素 仿制药 免疫原性 肝素诱导的血小板减少症 

分 类 号：R973.2[医药卫生—药品]