冷冻干燥法在乳剂固体化中的应用研究  

Application of Freeze-drying to Solidification of Emulsion

作　　者：王冠茹[1] 卞玮[1] 倪美萍[1] 杨亚妮[1] 何军[1] 

机构地区：[1]中国医药工业研究总院药物制剂国家工程研究中心,上海201203

出　　处：《中国医药工业杂志》2016年第2期217-224,共8页Chinese Journal of Pharmaceuticals

基　　金：国家重点基础研究发展计划(973项目;2013CB932504);上海市科委2012年度"科技创新行动计划"纳米科技专项(12nm0502500)

摘　　要：乳剂在贮存过程中存在诸多稳定性问题,如降解(水解)、奥斯瓦尔德熟化效应、粒径增大等。近年来,冷冻干燥技术在提高制剂稳定性方面得到广泛应用。但该法用于提高乳剂稳定性的研究尚不多见。本文综述了用冷冻干燥法制备冻干乳剂的处方因素(如乳化剂、冻干保护剂、辅料组成和配比)和冻干过程工艺条件的影响,以及冻干乳剂的几个重要考察指标。The instable phenomena of emulsion during storage are degradation（hydrolyzation）, Ostwald ripening and increasing of particle sizes, etc. In recent years, the lyophilization technique has been widely employed in the field of pharmaceutical preparation to improve stability. However, the usage of lyophilization technique in emulsion preparation is less common. The effects of pharmaceutical factors（such as emulsifiers, lyoprotectants and weight ratio of excipients） and process parameters of lyophilization on the solidification of emulsion are reviewed in this paper. Moreover, serval important evaluation parameters are briefly introduced.

关 键 词：乳剂 冷冻干燥法 处方组成 冻干工艺 考察指标 综述 

分 类 号：R944.9[医药卫生—药剂学]