心血管系统治疗药物的晶型研究进展.PDFVIP

·690 · 现代药物与临床 Drugs Clinic 第 29 卷 第 6 期 2014 年 6 月 • 综述 • 心血管系统治疗药物的晶型研究进展 1, 2 1 1 1* 2* 张 娜 ，黄海伟 ，林 兰 ，何 兰 ，吕 扬 1. 中国食品药品检定研究院，北京 100050 2. 中国医学科学院 北京协和医学院 药物研究所，北京 100050 摘 要：药物晶型问题直接关系到药物的质量和疗效，且众多固体药物的专利纠纷都涉及到晶型问题，药物的多晶型成为药 物研发中备受关注的课题。我国目前在药物晶型鉴别和检查的技术与方法方面与发达国家存在较大的差距，检验标准和检验 方法的缺失成为了晶型药物发展的一个瓶颈。以心血管系统药物为切入点，对目前临床常用且文献报道较多的几类心血管系 统治疗药物的晶型研究现状进行综述，为建立晶型标准检测方法提供依据，以保证其临床用药安全、有效。 关键词：心血管系统治疗药物；晶型；质量标准 中图分类号：R972 文献标志码：A 文章编号：1674 - 5515(2014)06 - 0690 - 06 DOI: 10.7501/j.issn.1674-5515.2014.06.026 Research progress on polymorphism of cardiovascular drugs 1, 2 1 1 1 2 ZHANG Na , HUANG Hai-wei , LIN Lan , HE Lan , LÜ Yang 1. National Institutes for Food and Drug Control, Beijing 100050, China 2. Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, China Abstract: Polymorphism is essential to the quality and effect of drugs and is involved in many patent disputes of solid dosage medicines. Polymorphism of drugs has drawn lots of attentions in drug research and development areas. It is important to improve the techniques and methods to characterize drug polymorphism. Meanwhile, the development of drug polymorphism is restricted by the lack of characterizing standards and methods. This paper reviewed the current polymorphism development of several cardiovascular drugs which are widely used in clinic and widely reported, so as to support the generation of standard polymorphism characterizing methods and ensure the safety and effectiveness of these drugs in clinic. Key words: cardiovascular drugs; polymorphism; quality standards 心血管疾病是危害人类健康的严重疾病，是造