高分辨三维X射线显微成像在药物制剂结构分析中的应用  

Application of High-resolution Three-dimensional X-ray Microscopic Imaging in the Structural Analysis of Pharmaceutical Preparations

作　　者：昝孟晴 黄韩韩 南楠[1] 牛剑钊[1] 马玲云[1] 许鸣镝[1] 刘倩[1] ZAN Mengqing;HUANG Hanhan;NAN Nan;NIU Jianzhao;MA Lingyun;XU Mingdi;LIU Qian(Key Laboratory for Research and Evaluation of Chemical Drug Quality,National Medical Products Administration,National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,国家药品监督管理局化学药品质量研究与评价重点实验室,北京100050

出　　处：《中国现代应用药学》2022年第24期3316-3321,共6页Chinese Journal of Modern Applied Pharmacy

基　　金：国家重点研发计划项目(2020YFE0201700)。

摘　　要：药物制剂的结构研究能够帮助更加全面地评价药物制剂的质量,也有助于新型药物制剂的设计和创新。高分辨三维X射线显微成像技术能够在微米级甚至纳米级空间分辨率上原位、无损地展示粉末、颗粒、片剂、胶囊等固体制剂的三维结构信息,为新型制剂的创新和质量控制提供新方法。本文在介绍高分辨三维X射线显微成像技术的原理、发展及其研究药物制剂结构的基本流程的基础上,综述了其在药物制剂结构研究方面的国内外进展,为相关研究提供参考。Research on the structure of pharmaceutical preparations can help to evaluate the quality of pharmaceutical preparations more comprehensively, as well as the design and innovation of new pharmaceutical preparations. High-resolution three-dimensional X-ray microscopy imaging technology can display the three-dimensional structure information of solid preparations such as powders, granules, tablets, capsules, etc. in situ and non-destructively at the spatial resolution of micrometers or even nanometers, which provides new methods for the innovation and quality control of new preparations. Based on the introduction of the principle and development of high-resolution 3D X-ray microscopy imaging technology and the basic process of studying the structure of pharmaceutical preparations, this article reviewed its domestic and foreign progress in the study of pharmaceutical preparations structure, and provided references for related research.

关 键 词：药物制剂结构 高分辨三维X射线显微成像技术 三维结构表征 质量控制 微米级空间分辨率 

分 类 号：R943[医药卫生—药剂学]