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过程分析技术在结晶过程中的应用研究进展
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作者单位
吴思俊,龙之祥,彭祖仁,仇萍,李正,李文龙 1.天津中医药大学中药制药工程学院
2.省部共建组分中药国家重点实验室
3.湖南正清制药集团股份有限公司 
基金项目:国家“重大新药创制”科技重大专项(2018ZX09201011)
中文摘要:结晶是一种传统的分离与纯化技术,目前在高纯度化合物的分离纯化过程中发挥着至关重要的作用,广泛应用于化工、制药等领域。基于质量源于设计理念的过程分析技术为结晶过程的监测、反馈及其控制提供了高效且可靠的支持。该文对衰减全反射傅里叶变换红外光谱技术、拉曼光谱技术、近红外光谱技术、聚光束反射测量技术等多种过程分析技术在结晶过程中的应用进行综述,系统总结上述技术的现状、优缺点,并对未来发展趋势进行展望,以期为结晶工艺的在线监控提供有效参考。
中文关键词:结晶  质量源于设计  过程分析技术  光谱  在线监控
 
Progress on Application of Process Analytical Technology in Crystallization Process
Abstract:Crystallization which plays an important role in the separation and purification of high purity compounds,is a traditional separation and purification technology widely used in chemical,pharmaceutical and other fields.The spectral process analysis technology based on the concept of quality by design provides an efficient and intelligent support for the monitoring,feedback and control of crystallization process.In this paper,applications of several process analysis technologies,such as attenuated total reflection Fourier transform infrared spectroscopy,Raman spectroscopy,near infrared spectroscopy and focused beam reflectance measurement are reviewed.The status,advantages and disadvantages of the above technologies are systematically summarized,and their future development trends are prospected,in order to provide an effective reference for the on line monitoring of crystallization process.
Key Words:crystallization  quality by design  process analytical technology  spectroscopy  on line monitoring
引用本文:吴思俊,龙之祥,彭祖仁,仇萍,李正,李文龙.过程分析技术在结晶过程中的应用研究进展[J].分析测试学报,2020,39(10):1209-1217.
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