X-射线粉末衍射技术在多晶型药物定量分析中的应用

梅梅; 李煜; 杨伟峰<sup>*</sup>

引用本文:	梅梅,李煜,杨伟峰.X-射线粉末衍射技术在多晶型药物定量分析中的应用[J].中国现代应用药学,2017,34(9):1356-1360.
	MEI Mei,LI Yu,YANG Weifeng.Application of X-ray Powder Diffraction to Quantitative Analysis of Pharmaceutical Polymorphism[J].Chin J Mod Appl Pharm(中国现代应用药学),2017,34(9):1356-1360.

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X-射线粉末衍射技术在多晶型药物定量分析中的应用
梅梅¹, 李煜², 杨伟峰^1,2
1.浙江工业大学化学工程学院, 杭州 310014;2.浙江省食品药品检验研究院, 杭州 310052

摘要:

X-射线粉末衍射技术（X-ray powder diffraction，PXRD）是研究药物多晶型的主要手段之一。药物在生产过程中有时会发生晶型的转变，只进行晶型的定性分析已经不能满足现代药物的质量控制要求。本文通过查阅中外文献，对PXRD在多晶型药物定量分析中的具体应用进行了综述。采用PXRD定量分析药物的多晶型状态，将使实际工艺中药物的多晶型现象得到更明确的阐述和更合理的控制，从而建立科学的质量控制体系和严格的药物质量标准。

关键词: X-射线粉末衍射药物多晶型定量分析

DOI：10.13748/j.cnki.issn1007-7693.2017.09.032

分类号:R944.2

基金项目:浙江省食品药品监管系统科技计划项目（2014004）

Application of X-ray Powder Diffraction to Quantitative Analysis of Pharmaceutical Polymorphism

MEI Mei¹, LI Yu², YANG Weifeng^1,2

1.College of Chemical Engineering of Zhejiang University of Technology, Hangzhou 310014, China;2.Zhejiang Institute for Food and Drug Control, Hangzhou 310052, China

Abstract:

X-ray powder diffraction technique is one of the main methods to study drug polymorphs. In the process of drug production, there would be a change of crystal type, only the qualitative analysis of the crystalline form has not satisfied the quality control requirements of modern medicine. In this paper, the application of X-ray powder diffraction technique in the quantitative analysis of polymorphic drugs is reviewed by consulting domestic and foreign literature. The crystalline state analysis of the drug by X-ray diffraction quantitative technology, will enable the drug polymorphism in the practical process more clearly elaborated and more reasonable control, so as to establish a scientific quality control system and strict quality standard of drugs.

Key words: X-ray powder diffraction pharmaceutical polymorphism quantitative analysis