美、日溶出曲线数据库对比研究及我国溶出曲线数据库建设进展

Comparative Study of the Dissolution Profile Database in United States and Japan and the Progress of Its Establishment in China

目的:比较各国溶出曲线数据库,介绍我国溶出曲线数据库建设进展。方法:文献分析法,对比溶出度与溶出曲线差异,介绍美国和日本溶出曲线数据库的建立过程和经验,详细阐述溶出曲线的价值、意义和特点以及其在药品研发领域的作用。结果与结论:建议药品监管部门将溶出曲线作为已上市化学口服固体制剂日常监管中的一种重要技术手段,并通过相关数据库的建立,为上市药品的监管提供技术支持和服务。

Objective: To introduce the progress of the establishment of the dissolution profile database in China by comparing that in different countries. Methods: The differences in dissolution tests and the dissolution profiles were compared by combination with its history and experience in the United States and Japan. Detailed descriptions were elaborated on the value, significance and characteristics of the dissolution profile and its role in pharmaceutical research. Results and Conclusion: It is recommended that regulatory authority take the dissolution profile as the daily regulation technology for marketed solid oral dosage. Through the establishment of related database, it can provide technical supports and services for the regulation of marketed chemical medicines.