星点设计-效应面法优化双嘧达莫漂浮渗透泵给药系统  

Optimization of a floating osmotic pump system of dipyridamole using central composite design-response surface methodology

作　　者：张志宏[1] 唐歆[1] 彭博[1] 聂淑芳[1] 李想[1] 潘卫三[1] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《药学学报》2009年第2期203-207,共5页Acta Pharmaceutica Sinica

摘　　要：本文设计了双嘧达莫气囊式漂浮渗透泵。采用中国药典(2005版)附录XD释放度测定法第三法装置同时评价制剂的体外释放和漂浮性能。以聚氧乙烯(PEOWSR303)用量(X1,mg)、NaCl用量(X2,mg)和致孔剂用量(PEG4000,X3,%)为自变量,自制处方溶出曲线与目标溶出曲线相比而得的相似因子(f2)为应变量,采用星点设计-效应面法优化系统。优化模型为f2=-29.3+2.35X3-0.123X12-0.046X22+0.145X1X2(R=0.996),当包衣增重8%～9%、X1:20～34、X2:30～57、X3:50时溶出曲线和目标溶出曲线相似,从优化模型可得致孔剂用量最小值为35.1%,所得优化模型在试验范围内预测效果良好。A new type of floating osmotic pump of dipyridamole was designed in this paper. Apparatus three （Chinese Pharmacopeia 2005, appendix XD） was employed for in vitro dissolution test in order to evaluate the release and floating behavior in a same experiment. The system was optimized using central composite design-response surface methodology; where similarity factor （f2） between the dissolution profile of prepared formulation and the target dissolution profile was taken as dependent factor, usage amount of polyoxyethylene （X1, mg）, NaC1 （X2, mg） and pore former （PEG4000, X3, %） were taken as independent factors. The optimization model was f2=-29.3＋2.35X3-0.123X1^2-0.0462^2＋0.145X1X2 （R= 0.996）. It was found that the dissolution profile could match the target dissolution profile under the condition of weight gain 8% - 9%, X1 （20 - 34）, X2 （30 - 57）, X3 = 50. It is also found that the minimum usage percentage of pore former is 35.1%. The prediction results of the optimization model were good in the experiments.

关 键 词：渗透泵 漂浮 双嘧达莫 星点设计 效应面法 

分 类 号：R943.4[医药卫生—药剂学]