功能性辅料的发展和应用  

Development and Application of Functional Excipients

作　　者：于丽娜[1] 孙会敏[1] 杨锐[1] 金少鸿[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2013年第6期628-634,共7页Chinese Pharmaceutical Affairs

基　　金：国家"十二五"科技支撑计划:化学新药质量标准研究与评价技术平台(编号2011ZX09303-001)

摘　　要：目的综述功能性辅料的研究进展。方法通过查阅国内外文献,阐述了功能性辅料的概念以及各国药典的收录情况。以乳糖、微晶纤维素、滑石粉和吐温80为例,简要介绍了辅料的功能性对制剂的影响。结果与结论通过建立药用辅料的功能性评价平台,合理选择辅料及灵活的工艺,以质量源于设计的理念为指导,可以获得质量可控的产品。Objective To review the research progress of functional excipients. Methods In this paper, the concept of functional excipients was comprehensively expounded, as well as its embodiment in different pharmacopeias via reviewing literatures at home and abroad. Lactose, microcrystalline, talc and polysorbate 80 were taken as specific examples to introduce the influence on formulation exerted by the functionality of pharmaceutical excipients. Results and Conclusion It is indicated that the functionality evaluation platform for medicinal excipients should be established, and appropriate excipients and agile process should be chosen with the guidance of quality by design （QbD）, in order to obtain products with controllable quality.

关 键 词：药用辅料 功能性 乳糖 纤维素 滑石粉 吐温80 质量源于设计 

分 类 号：TQ460.4[化学工程—制药化工]