热分析技术在药品检验中的应用  

Application of thermal analysis for drug control

作　　者：林兰[1] 宁保明[1] 杨腊虎[1] 刘毅[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国新药杂志》2014年第15期1734-1737,共4页Chinese Journal of New Drugs

基　　金：国家质量监督检验检疫总局公益性行业科研专项(20124244008-10)

摘　　要：本文介绍了目前我国药品检验中差示扫描量热法和热重分析法的应用、发展和前景。结合近年来化学药品检验和化学药品对照品研制工作情况,对这两种热分析技术在药物的熔点、纯度和多晶型等多个药品质量分析研究方面进行介绍和展望,这对加快推进热分析技术在药品检验领域的应用及发展具有积极作用。随着热分析法在国内外药学领域的不断完善和推进,这一技术将成为新药研究、药品生产工艺控制和质量控制应用中的常规必备技术。The application, development and prospects of differential scanning calorimetry （DSC） and thermogravimetric analysis （TGA） in the area for drug control currently were introduced in this paper. Based on the work for chemical drug control and chemical reference substance studies, the characterization and prospects of DSC and TGA in pharmaceutical quality analysis, such as melting point, purity and polymorphs, were described. The establishment of database will be an active way to accelerate the application and development of thermal analysis techniques in the field of drug control. Thus, it will be an important and necessary method for the new drug research and drug control.

关 键 词：热分析 差示扫描量热法 热重分析法 化学药品对照品 

分 类 号：R927.1[医药卫生—药学]