差示扫描量热法在化学药品对照品纯度分析中的应用  

Application of differential scanning calorimetry in the purity analysis of chemical reference substances

作　　者：刘毅[1] 吴建敏[1] 鲁涓[2] 李玉巍 宁保明[1] 林兰[1] 

机构地区：[1]中国食品药品检定研究院,北京100050 [2]江苏省常州市药品检验所,常州213002 [3]青海省食品药品检验所,西宁810016

出　　处：《中国新药杂志》2017年第10期1115-1118,共4页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项资助项目(2015ZX09303001);中国食品药品检定研究院学科带头人培养基金(2015X3)

摘　　要：目的:重点介绍差示扫描量热法(differential scanning calorimetry,DSC)在安替比林、异丙安替比林等化学药品对照品纯度分析中的应用性研究。方法:结合DSC、高效液相色谱法和容量法等分析化学药品对照品的量值情况,同时进行DSC纯度分析的适用性研究。结果:安替比林和异丙安替比林的DSC纯度分析、高效液相色谱纯度分析和容量分析结果分别为99.9%和99.7%,100.0%和100.0%,100.2%和100.2%,无明显差异。结论:DSC特别适用于化学药品对照品的纯度分析,积极推进了热分析技术在药品检验领域的应用和发展。Objective ： To introduce the application of differential scanning calorimetry （DSC） in the purity analysis of chemical reference substances such as phenazone and propyphenazone. Methods： The DSC method, high performance liquid chromatography （HPLC） and volumetric method were used to analyze the values of chemical reference substances, and the applicability of DSC was also studied by means of thermogravimetrie analysis （TGA）. Results： The purities of phenazone and propyphenazone determined by DSC analysis, HPLC analysis and volumetric analysis were 99.9% and 99.7% , 100.0% and 100.0% , 100.2% and 100.2% , respectively, without significant differences. Conclusion： Differential scanning calorimetry is particularly suitable for purity analysis of chemical reference substances, and this study would actively promote the application of thermal analysis technology in the field of drug control.

关 键 词：差示扫描量热法 热重分析法 化学药品对照品 热分析 

分 类 号：R917[医药卫生—药物分析学]