溶液介导的晶型转化研究及在线技术的应用

Progress on Transformation of Drug Polymorphism in Solution and on-line Application

药品晶型严重影响药品安全、药品质量及生物利用度.有关药物晶型的研究已经列入了国家"医药工业十二五发展规划",作为提升药物质量安全的主要任务和重点技术.该文以溶液介导晶型转化研究为对象,重点阐述了溶液体系中,工艺参数、添加剂对晶型转化的影响、在线技术如FBRM/PVM、在线拉曼等、分子模拟如MS、NAMD、Mercury等软件在多晶型研究中的应用.

The drug polymorphism has a profound effect on the quality, the safety and bioavailability. It was said that The Twelfth Five Year Development Plan of China＇s Pharmaceutical puts forward one of the major development tasks and technologies focused on drug polymorphism, which was considered as a method to enhance the quality and safety of the drugs. In this paper, Research on transformation in solution was summarized, and then, on the basis, the effects of the process parameters, additives on crystaltransfor mation were investigated, online technique such as FBRM/PVM,on line Raman spectroscopy, molecular sire ulation such as MS,NAMD,Mercury were applied during the study of the polymorphism.