黄豆苷元自微乳化半固体骨架胶囊的制备及处方优化  

Preparation and formulation optimization of self-microemulsifying semi-solid matrix hard capsules of daidzein

作　　者：崔文奇[1] 王东凯[1] 韩晓[1] 

机构地区：[1]沈阳药科大学药学院

出　　处：《中国药剂学杂志（网络版）》2010年第2期56-63,共8页Chinese Journal of Pharmaceutics：Online Edition

摘　　要：目的考察黄豆苷元自微乳化半固体骨架胶囊的处方。方法制备药物的过饱和溶液以测定药物在各种油、表面活性剂及助表面活性剂中的溶解度,采用配伍实验、伪三元相图法筛选表面活性剂的种类及其与助表面活性剂的比例;通过正交设计优化处方并制备黄豆苷元自微乳化半固体骨架胶囊。结果优化后的处方各组分组成为:黄豆苷元1.5g、LM1944CS10g、EL-35-Transcutol(质量比4∶1)50g、S-4020g。自制胶囊乳化后平均粒径小于40nm,45min累积溶出度达90%以上。结论按优化后处方可制得黄豆苷元自微乳化半固体骨架释药系统。Objective To develop the formulation of daidzein self-microemulsifying semi-solid matrix hard capsules. Methods The solubility of daidzein in different oil phase,surfactants and cosurfactants was investigated. The type of surfactants and its ratio with cosurfactants were selected based on compatibility tests and pseudo-ternary phase diagrams. The optimal formulations of daidzein self-microemulsifying hard capsules were screened by orthogonal experimental design. Results The optimized daidzein self-microemulsifying hard capsules were composed of daidzein 1.5 g,LM1944CS 10 g,EL-35-Transcutol (m:m = 4∶1) 50 g,S-40 20 g. Microemulsion droplets with a mean droplet size less than 40 nm were formed by using this formulation. The accumulated dissolution of this formulation was more than 90% in 45 min. Conclusions Daidzein self-microemulsifying hard capsules can be prepared according to the optimized formulation.

关 键 词：药剂学 自微乳化 半固体 黄豆苷元 

分 类 号：R94[医药卫生—药剂学]