星点设计-效应面法优化盐酸巴尼地平自微乳化释药系统  

Optimization of Barnidipine Selfmicroemulsifying Drug Delivery System by Central Composite Design-Response Surface Methodology

作　　者：何艳[1] 李高[2] 吴笑春[1] 辛华雯[1] 李罄[1] 余爱荣[1] 

机构地区：[1]广州军区武汉总医院临床药理科,武汉430070 [2]华中科技大学同济医学院药剂教研室

出　　处：《中国药师》2010年第1期11-13,共3页China Pharmacist

摘　　要：目的:星点设计-效应面法优化盐酸巴尼地平自微乳化释药系统的处方。方法:以油相用量和乳化剂及助乳化剂用量之比为变量,粒径、饱和载药量、自乳化时间为因变量,采用线性方程和二次及三次多项式描述三个因变量和两个变量之间的数学关系,根据最佳数学模型描绘效应面,选择最佳处方。结果:三个因变量和两个变量之间以三项式拟合最佳,相关系数分别为:0.9918,0.9960,0.9825(P<0.05),具有较高的可信度。优选的最佳处方组成为:中链甘油三酸酯(MCT):聚氧乙烯氢化蓖麻油(Cremophor RH40):甘油=32.9:42.9:23.2(w:w:w),其中药物含量的质量分数为1%。最佳处方的变量理论值与预测值的偏差≤5%。结论:所建立的模型预测性良好。Objective： To optimize the formulations of Barnidipine selfemulsifying drug delivery system by a central composite design-response surface methodology. Method： Independent variables were oil content, the ratio of emulsifier and co-emulsifier. Particle size, drug content and self-emulsifying time were three dependent variables. Linear or nonlinear mathematic models were used to estimate the relationship between independent and dependent vailables. Response surfaces were delineated according to the best-fit mathematic models, and optimum formulations were selected. Result： The relation between the three dependent variable and two variables fitted best to the trinomial model. Regression coefficients of trinomial model were as high as 0.991 8,0. 996 0 and 0.982 5 ,respectively. The optimized formulation of self-emulsifying of Barnidipine were Barnidipine, Medium chain triglycerides （ MCT）, Cremophor RH40 and Glycerine. The proportion of them were （w： w： w： w = 10： 329： 429： 232）. Bias between observed and predicted values were all less than 5%. Conelusion： The optimum mathematic model is highly predictive.

关 键 词：盐酸巴尼地平 星点设计 效应面 自微乳化 优化 

分 类 号：R944.9[医药卫生—药剂学]