布洛伪麻自微乳化制剂的处方筛选及体外溶出的评价  

Formulation study of ibuprofen and pseudoephedrine hydrochloride SMEDDS and the investigation of its dissolution

作　　者：桑艳双[1] 刘薇[1] 王安娜[1] 宋洪涛[1] 何仲贵[1] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《沈阳药科大学学报》2008年第8期598-602,共5页Journal of Shenyang Pharmaceutical University

摘　　要：目的筛选布洛伪麻自微乳化释药系统处方,并考察其溶出度。方法通过绘制假三元相图、乳化后的外观及粒径的测定筛选最佳处方;以市售软胶囊为参比制剂测定自微乳化胶囊在不同溶出介质中的溶出度;考察自微乳化后药液的稳定性。结果最优处方为1,2-丙二醇、Tween80、油酸乙酯3种物质的质量比为15∶40∶45。自微乳化制剂中布洛芬在3种溶出介质中溶出无差异,45 min时溶出度均达80%以上,而市售软胶囊在蒸馏水、0.1 mol.L-1盐酸中,60 min布洛芬的溶出度不到40%。结论自微乳化制剂中布洛芬的溶出不受介质的影响。Objective To study the self-microemulsifying drug delivery system（SMEDDS） of ibuprofen and pseudoephedrine hydrochloride;and investigate its dissolution property. Methods The optimum formulation was screened through the drawing of phase diagram, the appearance after emulsifying, and measurement of droplet size. Taking the commercial soft capsules as the reference, the dissolution of SMEDDS in three mediums was determined. The stability after emulsifying was investigated. Results The proportion of optimum formulation was m ： m： m = 15 ： 40 ： 45, composed of 1,2-propanediol/Tween80/ethyloleate. The dissolution of SMEDDS for ibuprofen in three medium had no significant difference, all more than 80% in 45 minute; however, those of the commercial soft capsules in distilled water and 0.1 mol·L^-1HCl were no more than 40 %. Conclusions The dissolution of ibuprofen is not influenced by the medium in the SMEDDS.

关 键 词：布洛芬 盐酸伪麻黄碱 自微乳化 溶出 

分 类 号：R94[医药卫生—药剂学]