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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 formulation of self-microemulsifying drug delivery system of baridipine hydrochloride by the combination of star point design and response surface methodology. Methods: Taking the ratio of oil phase to the amount of emulsifier and co-emulsifier as variables, particle size, saturated drug loading and self-emulsification time as dependent variables, linear equations and quadratic and cubic polynomials were used to describe the three dependent variables and two The mathematical relationship between variables, according to the best mathematical model depicting the effect surface, select the best prescription. Results: The best fit between the three dependent variables and the two variables was the triad formula. The correlation coefficients were 0.9918, 0.9960 and 0.9825 (P <0.05), respectively, with high reliability. The preferred optimal formulation consists of medium chain triglyceride (MCT): Cremophor RH40: glycerol = 32.9: 42.9: 23.2 (w: w: w), wherein the mass fraction of the drug content 1%. Variables of the best prescription deviation from the predicted value ≤5%. Conclusion: The established model has good predictability.