银杏酮酯口服自微乳化给药系统的制备Preparationoftheoralself.PDF

药学学报 Acta Pharmaceutica Sinica 2009, 44 (7) : 803808 ·803 · 银杏酮酯口服自微乳化给药系统的制备 1, 2 3 1 1* 颖 , 刘启德 , 赖 乐 , 陈建海 ( 1. 南方医科大学南方医院, 广东 广州 510515; 2. 广州中医药大学附属骨伤科医院, 广东 广州 510240; 3. 广州中医 大学, 广东 广州 510006) 摘要: 研究制备银杏酮酯口服自微乳化给药系统。采用平衡溶解度方法筛选乳化剂与助乳化剂; 采用伪三元 相图法制备微乳; 采用正交法优化处方组成; 并考察自微乳化制剂的乳化效率、溶出度、稳定性与 动学研究等。 结果表明, 由肉豆蔻酸异丙酯IPM 、聚氧乙烯蓖麻油Cremophor EL、丙二醇与银杏酮酯组成的自微乳化给药系 统遇水可自发形成粒径为20～50 nm 的稳定微乳。自微乳化给药系统的乳化效率与溶出快, 且制剂稳定性高, 能 提高生物利用度。制备的银杏酮酯口服自微乳化给药系统稳定有效。 关键词: 银杏酮酯; 自微乳化给 系统; 制备工艺; 生物利用度 中图分类号: R943 文献标识码:A 文章编号: 05 13-4870 (2009) 07-0803-06 Preparation of the oral self-microemulsifying drug delivery system of GBE50 1, 2 3 1 1* XIONG Ying , LIU Qi-de , LAI Le , CHEN Jian-hai (1. Nanf ang Hosp ital, Southern M edical University, Guangzhou 510515, China; 2. The Affili ated Orthopa edics and Traumatology Hosp ital, Guangzhou University of Chinese M edicine, Guangzhou 510240, China; 3. Guangzhou University of Chinese M edicine, Guangzhou 510006, China) Abstract: To prepare the oral self-microemulsifying drug delivery system (SMEDDS) of GBE50, balance solubility method was used to screen emulsifier and assistant emulsifier; a pseudo-temary phase diagram was used to prepare microemulsion; and orthogonal design was used to optimize formulation. Self-microemulsifying efficiency, dissolution, stability and pharmacokinetics