多参数反馈调控结晶系统的开发及应用  

Development and application of multi-parameter feedback control system for crystallization

作　　者：刘诗苑 李炳辉 唐凯[1] 孙良杰 韦桂璇 江燕斌[1] LIU Shiyuan;LI Binghui;TANG Kai;SUN Liangjie;WEI Guixuan;JIANG Yanbin(School of Chemistry and Chemical Engineering,South China University of Technology,Guangzhou 510641,China)

机构地区：[1]华南理工大学化学与化工学院,广州510641

出　　处：《化学工业与工程》2023年第1期60-71,共12页Chemical Industry and Engineering

基　　金：国家自然科学基金(22178121)。

摘　　要：结晶是一种重要的分离纯化单元操作,晶体的性质决定了医药产品的价值和用途。随着化工行业和医药行业的快速发展,传统的Trial-and-error结晶研究思路已不能满足其高效性、灵活性和经济性的需要。针对这一现状,结合多种过程分析技术,基于“质量来源于设计(Quality by design,QbD)”的新思路,自主开发了多参数反馈控制结晶系统,并分别以5′-核苷酸二钠和β-蒿甲醚为模型药物,考察了多参数反馈控制结晶系统在结晶过程动力学研究和建模中的应用。结果表明,研制的多参数反馈控制结晶系统对结晶过程的控制和机理描述具有指导意义,在制药领域具有良好的应用前景。Crystallization is an important separation and purification unit operation,and the nature of crystals determines the value and use of pharmaceutical products.With the rapid development of the chemical industry and the pharmaceutical industry,the traditional trial-and-error crystallization research ideas can no longer meet the needs of efficiency,flexibility and economy.In view of this situation,based on the new idea of"Quality by Design(QbD)"and combined with a variety of process analysis techniques,this study independently developed a multi-parameter feedback control system for crystallization.Disodium 5’-ribonucleotide andβ-artemether were used as model respectively.The application of the multi-parameter feedback control system in the kinetic study and modeling of the crystallization process has been investigated.The results show that the multi-parameter feedback control system not only has guiding significance for the control of crystallization process and the elaboration of crystallization mechanism,but also has good application prospects in the pharmaceutical field.

关 键 词：药物结晶 反馈调节 过程分析技术 结晶动力学 

分 类 号：TQ420.61[化学工程]