College of Pharmaceutical Science, Institute of Drug Development & Chemical Biology, Zhejiang University of Technology, Hangzhou 310014, Zhejiang, People\'s Republic of China.
Curr Pharm Des. 2022;28(18):1445-1456. doi: 10.2174/1381612828666220518145635.
The analytical investigation of the pharmaceutical process monitors the critical process parameters of the drug, beginning from its development until marketing and post-marketing, and appropriate corrective action can be taken to change the pharmaceutical design at any stage of the process. Advanced analytical methods, such as Raman spectroscopy, are particularly suitable for use in the field of drug analysis, especially for qualitative and quantitative work, due to the advantages of simple sample preparation, fast, non-destructive analysis speed and effective avoidance of moisture interference. Advanced Raman imaging techniques have gradually become a powerful alternative method for monitoring changes in polymorph distribution and active pharmaceutical ingredient distribution in drug processing and pharmacokinetics. Surface-enhanced Raman spectroscopy (SERS) has also solved the inherent insensitivity and fluorescence problems of Raman, which has made good progress in the field of illegal drug analysis. This review summarizes the application of Raman spectroscopy and imaging technology, which are used in the qualitative and quantitative analysis of solid tablets, quality control of the production process, drug crystal analysis, illegal drug analysis, and monitoring of drug dissolution and release in the field of drug analysis in recent years.
药物分析中的分析研究从药物的开发到上市后监测，监控药物的关键工艺参数，并在工艺的任何阶段采取适当的纠正措施来改变药物设计。先进的分析方法，如拉曼光谱法，由于具有样品制备简单、快速、无损分析速度以及有效避免水分干扰等优点，特别适合用于药物分析领域，特别是定性和定量工作。先进的拉曼成像技术已逐渐成为监测药物加工和药代动力学中多晶型分布和活性药物成分分布变化的有力替代方法。表面增强拉曼光谱（SERS）也解决了拉曼固有的灵敏度和荧光问题，在非法药物分析领域取得了良好的进展。本综述总结了近年来拉曼光谱和成像技术在药物分析领域中用于固体片剂的定性和定量分析、生产过程的质量控制、药物晶体分析、非法药物分析以及药物溶解和释放监测等方面的应用。
