摘要
低分子量肝素(LMWH)在临床上广泛应用于防治血栓栓塞性疾病。由于其来源的特殊性和结构的复杂性,仿制LMWH类产品的研究和评价存在很多难点。近年来,欧美药品监管机构对LMWH仿制产品的技术要求不断完善,中国的监管理念也逐步与国际接轨。本文综述了近期国内外LMWH的技术评价进展情况,总结了目前存在的问题,为后续LMWH类仿制品的质量和疗效一致性评价提供理论的支持。
Low-molecular-weight heparin(LMWH)has been widely used in the prevention and treatment of thromboembolic diseases.There are many difficulties in the research and evaluation of the generic LMWH products because of the particularity of their source and the complexity of their structure.In recent years,the technical requirements of the European and American drug regulatory agencies for the generic LMWH products have been continuously improved and become gradually clear,and Chinese regulatory concept has gradually been in line with international standards.This paper reviews the recent progress in the evaluation of LMWH at home and abroad,summarizes the current problems,and provides theoretical support for the evaluation of the quality and efficacy of LMWH.
作者
石靖
陈思
SHI Jing;CHEN Si(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《国际药学研究杂志》
CAS
CSCD
北大核心
2018年第11期852-857,共6页
Journal of International Pharmaceutical Research
关键词
低分子量肝素
安全性
等效性
质量一致性
low-molecular-weight heparin
safety
bioequivalence
quality consistency
