药物连续结晶技术研究进展  

Research Progress on Continuous Crystallization Technology of Drugs

作　　者：经梦倩 周嘉第 JING Mengqian;ZHOU Jiadi(Collaborative Innovation Center of Green Pharmaceuticals,Zhejiang University of Technology,Key Laboratory for Green Pharmaceutical Technologies and Related Equipment of Ministry of Education,National Engineering Research Centre for Process Development of Active Pharmaceutical Ingredients,Hangzhou 310014)

机构地区：[1]浙江工业大学绿色制药协同创新中心,绿色制药技术与装备教育部重点实验室,国家化学原料药合成工程技术研究中心,杭州310014

出　　处：《化工生产与技术》2025年第1期22-26,36,I0003,I0004,共8页Chemical Production and Technology

基　　金：国家自然科学基金(22408332)。

摘　　要：近年来药物连续结晶技术受到业界广泛重视,分析了药物的结晶机理,涵盖经典成核、非经典成核等多种理论,并阐述统一结晶模型对理解结晶过程的重要意义。归纳了连续结晶器类型,重点剖析连续管式结晶器的结构与优势。总结了连续结晶过程的控制方法,对比基于模型与非模型控制的特点与应用效果。经研究认为,连续结晶技术开发有利于优化药物结晶工艺,可显著提升生产效率、降低能源消耗,精准控制晶体成核与结晶过程,有效改善产品的一致性,最大程度提高药物晶体品质,在制药领域具有广阔的应用前景。In recent years,the continuous crystallization technology for pharmaceuticals has received extensive attention.In this paper,the crystallization mechanisms of drugs are analyzed,covering various theories such as classical nucleation and non-classical nucleation,and the significance of the unified crystallization model for understanding the crystallization process is elaborated.The types of continuous crystallizers are summarized,with a focus on analyzing the structures and advantages of continuous tubular crystallizers.Additionally,the control methods of the continuous crystallization process are summarized,and the characteristics and application effects of model-based and non-model-based controls are compared.It is believed that the development of continuous crystallization technology is conducive to optimizing the drug crystallization process,which can not only significantly improve the production efficiency and reduce energy consumption,but also precisely control the crystal nucleation and crystallization process,effectively improve the consistency of products,and maximize the quality of drug crystals.It has broad application prospects in the pharmaceutical field.

关 键 词：药物连续结晶 结晶机理 连续结晶器 过程控制 

分 类 号：TQ460.6[化学工程—制药化工]