非晶态给药体系的结构分析与鉴别方法的研究进展  

Research progress on structure analysis and identification methods of amorphous drug delivery system

作　　者：王频[1,2] 尹东东[2] 王杏林[2] 吴成杨[2] 张芳[2] 

机构地区：[1]河南大学药学院,开封475001 [2]天津药物研究院释药技术与药代动力学国家重点实验室,天津300193

出　　处：《药物分析杂志》2013年第4期531-535,543,共6页Chinese Journal of Pharmaceutical Analysis

基　　金：国家重点基础研究发展计划(973计划)课题(2010CB735602;2012CB724002)

摘　　要：非晶态给药体系在外形上虽与晶态无异,但其内部微观特征却与晶体药物有着本质区别。该体系内部分子的无序性和较高的自由能,均对增加水难溶性药物的水溶性有利。非晶态体系虽能在动力学上表现出较好的稳定性,但其热力学稳定性并不理想,常常会向低能态的晶态转变。为了探知非晶态形成的机理和提高非晶态的稳定性,对该体系进行深入的微观研究是很有必要的。本文将对近年来非晶态给药体系的鉴别和分析方法进行综述。Amorphous drug delivery system is of the same appearance as the crystalline state drug delivery system,but it is essentially different with crystalline drug due to its internal microscopic characteristics.Disorder of internal molecular and high free energy of the system are beneficial to increase the water-solubility of poorly water-soluble drugs.Although the amorphous system could show good dynamic stability,it is thermodynamically unstable,and is easy to shift to a crystal state of low-energy.In order to investigate the amorphization mechanism and improve the stability of amorphous,microcosmic study of the system is necessary.The article reviewed the methods that were used in recent years to identify and analyze the amorphous drug delivery system.

关 键 词：非晶态制剂 分析 鉴别 热分析 波谱分析 联用技术 显微镜技术 力学分析法 

分 类 号：R917[医药卫生—药物分析学]