摘要
目的:开展化学药品标准物质的热分析技术应用性研究,寻找DSC纯度分析法应用时物质内在性质与结构方面的规律特点。方法:DSC纯度分析以0.5℃·min^-1的升温速率扫描熔融区间,气氛为氮气,干燥气为50 mL·min^-1;开展了98种共106批次化学药品标准物质的DSC纯度分析,分别从熔融温度、化学结构和HPLC纯度比对等角度对其应用性规律进行了初步探讨。结果:熔点越高的物质出现熔融分解等热不稳定性的概率越大;含吡唑酮类、二氢吡啶类结构的标准物质研究可优先考虑DSC纯度分析法,而含有磺酸、氨基酸结构特征的需慎重选择。结论:DSC纯度分析法能有效、可靠地应用于化学药品标准物质的质量研究。
Objective:To carry out the applicable analysis of thermal analysis technology for chemical reference substances,and to find the characteristics in physical properties and chemical structures during differential scanning calorimetry(DSC) purity study. Methods:To scan the melting range at a heating rate of 0.5 ℃·min^-1 in DSC purity analysis,the atmosphere was nitrogen and the dry gas flow was 50 mL·min^-1. Ninety-eight kinds of chemical reference substances including 106 batches were studied in DSC purity analysis,and the application rules were preliminarily explored in the melting temperatures,chemical structures and comparative HPLC purity. Results:Compared to the low melting point substances, the probability of thermal instability such as melting decomposition would increase in the high melting point substances. The method of DSC purity analysis was suitable for the chemical reference substances with structures of pyrazolone or dihydropyridine,and was not recommended for those with sulfonic or amino acid structures. Conclusion:The method of DSC purity analysis is applied to the quality study of chemical reference substances effectively and reliably.
作者
吴锐
刘朝霞
黄海伟
严菁
刘毅
WU Rui;LIU Zhao-xia;HUANG Hai-wei;YAN Jing;LIU Yi(National Institutes for Food and Drug Control,Beijing 102629,China;School of Pharmacy,Yantai University,Yantai 264005,China)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2020年第8期1494-1502,共9页
Chinese Journal of Pharmaceutical Analysis
基金
中国食品药品检定研究院学科带头人培养基金(2015X3)。
关键词
化学药品标准物质
解热镇痛类药品
差示扫描量热法
纯度
化学结构
chemical reference substances
non-steroid anti-inflammatory drugs
differential scanning calorimetry(DSC)
purity
chemical structure
