热重和差示扫描量热分析技术在药物分析中的应用进展  

Applications of TGA and DSC in pharmaceutical analysis

作　　者：刘毅 覃玲 郭贤辉 陈华 裴宇盛 LIU Yi;QIN Ling;GUO Xianhui;CHEN Hua;PEI Yusheng(Institute for Chemical Drug Control,National Institutes for Food and Drug Control‚NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing 102629‚China)

机构地区：[1]中国食品药品检定研究院化学药品检定所,化学药品质量研究与评价重点实验室,北京102629

出　　处：《中国药物警戒》2024年第3期283-289,共7页Chinese Journal of Pharmacovigilance

基　　金：中国食品药品检定研究院化学药品检定所重点实验室学科建设项目(2023HYZX25);北京市自然科学基金资助项目(L222010)。

摘　　要：目的 探讨热重分析(TGA)和差示扫描量热分析(DSC)在药物分析中的应用,为药品质量控制奠定基础。方法 通过文献综述着重报道了这2种技术方法在水分含量分析、热稳定性研究、熔点测量、纯度分析、晶型分析等药物研究中的多方面应用研究情况。结果与结论 热重和差示扫描量热分析技术在药物的水分、熔点、纯度、晶型以及稳定性等相关分析中发挥重要作用,满足药品检验检测工作的更高分析需求。Objective To explore the application of thermogravimetric analysis(TGA) and Differential scanning calorimetry(DSC) in drug analysis to lay the foundation for pharmaceutical quality control.Methods a short overview of the applicative research on the water content,thermal stability,melting-point,purity,polymorphism and others in recent years,had been reported.The future development prospect was also discussed.Results and Conclusion TGA and DSC played an important role in the analysis of moisture,melting point,purity,crystallinity and stability of drugs to meet the higher analytical demands of pharmaceutical inspection and testing.It was looking forward to providing methods and ideas for the further research on drug quality and safety.

关 键 词：热重分析 差示扫描量热分析 水分含量 热稳定性 熔点 纯度 晶型 安全性 

分 类 号：R917[医药卫生—药物分析学]