效应面法优化新型自微乳化口腔速溶膜Optimizationofnovelself.PDF

586 药学学报 Acta Pharmaceutica Sinica 20 11, 46 (5) : 586591 效应面法优化新型自微乳化口腔速溶膜 1 1, 2* 1 1 1 璐 , 易 涛 , 刘 颖 , 宦 娣 , 何吉奎 ( 1. 西南大学药学院, 重庆 400715; 2. 澳门科技大学澳门药物及健康应用研究所, 澳门 000853) 摘要: 本文研制了一种顺应性强且可提高水难溶性药物口服生物利用度的新剂型 自微乳化口腔速溶 膜。采用 Box-Behnken 设计效应面法对其处方进行优化, 考察处方中固体载体微晶纤维素、低取代羟丙基纤维 素、羟丙甲基纤维素的用量对体外崩解时间、体外释放度、形 微乳后的粒径及抗拉伸性的影响。筛选最优处 方制得的口腔速溶膜崩解时间为 ( 17.09 ± 0.72) s, 形 微乳粒径为 (28.81 ± 3.26) nm, 体外2 min 时释放率为 (66.18 ± 1.94)% 。本剂型服用方便, 口腔中迅速自微乳化, 药物释放快速, 抗拉伸性强, 具有广阔的应用前景。 关键词: 自微乳化给药系统; 口腔速溶膜; 效应面法; Box-Behnken; 吲哚美辛 中图分类号: R943 文献标识码:A 文章编号: 05 13-4870 (20 11) 05-0586-06 Optimization of novel self-microemulsifying mouth dissolving films by response surface methodology 1 1, 2* 1 1 1 XIAO Lu , YI Tao , LIU Ying , HUAN Di , HE Ji-kui (1. School of Pharmaceutical Sciences, Southwest University, Chongqing 400715, China; 2. Macau Institute for App lied Research in Medicine and Health, Macau University of Science and Technology, Macau 000853, China) Abstract: This paper report the development of a new dosage form self-microemulsifying mouth dissolving films, which can improve the oral bioavailability of water insoluble drugs and have good compliance. A three factor, three-level Box-Behnken design was used for optimizing formulation, investigated the effect of amounts of microcrystalline cellulose, low-substituted