药物共晶表征方法研究进展

doi:10.19803/j.1672-8629.2021.10.23

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (10): 995-999.
DOI: 10.19803/j.1672-8629.2021.10.23

药物共晶表征方法研究进展

熊婧¹, 戴霞林², 何兰^1,*, 武香香^3#

¹中国食品药品检定研究院,化学药品质量研究与评价重点实验室,北京 102629;
²天津理工大学化学化工学院,天津 300384;
³河南中医药大学中医药科学院,河南郑州 450046

收稿日期:2021-04-25 出版日期:2021-10-15 发布日期:2021-10-27
通讯作者: ^*何兰,女,博士,教授,药物质量分析研究。E-mail：helan1961@aliyun.com。^#为共同通信作者。
作者简介:熊婧,女,硕士,副研究员,药物质量分析研究。
基金资助:
国家重点研发计划（2016YFE0205400）; 国家自然基金青年科学基金项目（21801020）; 国家药典委员会药品标准制修订研究课题（2018Y002）

Research Progress in Characterization Methods of Pharmaceutical Cocrystals

XIONG Jing¹, DAI Xialin², HE Lan^1*, WU Xiangxiang^3#

¹National Institutes for Food and Drug Control, NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing 102629, China;
²School of Chemistry and Chemical Engineering, Tianjin University of Technology, Tianjin 300384, China;
³Academy of Chinese Medicine Sciences, Henan University of Traditional Chinese Medicine, Zhengzhou Henan 450046, China

Received:2021-04-25 Online:2021-10-15 Published:2021-10-27

摘要/Abstract

摘要： 药物共晶是一种可以改善活性药物成分诸多理化性质的新型固体形态,与单组分和复方药物相比具有一定的优势,是一种有潜力的新型药物开发技术。近几年已有药物共晶获批上市,针对药物共晶制定科学合理的质量控制方法,是我国药品监管部门面临的挑战。本文通过对药物共晶的表征方法进行综述,全面掌握可有效鉴别药物共晶的分析技术,为药物共晶质量标准的建立提供参考。

关键词: 共晶, 表征, X射线衍射法, 热分析法, 光谱法, 显微镜法, 核磁共振波谱法, 动态蒸气吸附法

Abstract: Pharmaceutical cocrystals are a new solid form which can improve many physical and chemical properties of active pharmaceutical ingredients. As a potential new drug development technology, pharmaceutical cocrystals have many advantages over single component and compound drugs. In recent years, some pharmaceutical cocrystals have been approved for marketing, so a challenge to regulatory departments of drugs in China is to establish effective quality control methods for pharmaceutical cocrystals. Through the review of characterization methods of pharmaceutical cocrystals, we can find out more about the analytical techniques that can effectively identify pharmaceutical cocrystals so as to provide reference for the establishment of quality standards for pharmaceutical cocrystals.

Key words: cocrystal, characterization, XRD, TA, spectrometry, microscope, NMR, DVS

中图分类号:

R917.799

熊婧, 戴霞林, 何兰, 武香香. 药物共晶表征方法研究进展[J]. 中国药物警戒, 2021, 18(10): 995-999.

XIONG Jing, DAI Xialin, HE Lan, WU Xiangxiang. Research Progress in Characterization Methods of Pharmaceutical Cocrystals[J]. Chinese Journal of Pharmacovigilance, 2021, 18(10): 995-999.

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药物共晶表征方法研究进展

Research Progress in Characterization Methods of Pharmaceutical Cocrystals

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