我国晶型药物研究现状与发展方向

The present situation and development direction of the research for polymorphic drugs in China

固体药物晶型可影响药物的临床疗效和安全性,也影响着药物的质量稳定性,对固体药物晶型的研究是进行药物质量控制和管理的重要内容。因此,药物多晶型研究日益受到国际医药研发与管理领域的重视。现就我国晶型药物研究和管理现状进行总结和分析,结合晶型药物最新研究成果和西方发达国家晶型药物管理经验,从科学的角度,为我国晶型药物研究和管理的发展方向提供参考和建议。

Solid drug polymorphism can affect the clinical efficacy and safety, as well as quality and stability. The research of solid drug polymorphism is of importance in the quality control and management of drugs. Therefore, the polymorphism research is strongly emphasized in the field of international drug R＆D and management. In this review, the present situation of research and management of polymorphic drugs in China is summarized and analyzed. The development direction of the research and management of polymorphic drugs in China will be suggested scientifically on the basis of the latest research achievements and the management experiences in western developed countries.