单纯形网格法优选柿叶总黄酮自微乳处方

目的:采用单纯形网格法优选柿叶总黄酮自微乳的处方,为该制剂的后续研究奠定基础。方法:在制备工艺初步筛选基础上,以油相、乳化剂、助乳化剂的比例为考察因素,粒径、多分散指数及载药量为评价指标,采用单纯形网格法优选柿叶总黄酮自微乳的处方,并测定该自微乳的黏度、溶出度等基本理化性质。结果:柿叶总黄酮自微乳最佳处方为中链甘油三酸酯-聚氧乙烯氢化蓖麻油-二乙二醇乙基醚(10∶30∶60);平均粒径、多分散指数、载药量分别为32.7 nm,0.163,22.42 mg·g-1,黏度低,性质稳定,20 min累积溶出度达89.09%。结论:单纯形网格法所建数学模型预测性好,分析准确客观,为自微乳处方的优选提供了新方法。

Optimization of Formulation of Self-microemulsion Containing Total Flavonoids from Folium Kaki by Simplex Lattice Method

Objective: To optimize the formulation of self-microemulsion containing total flavonoids from Folium Kaki by simplex lattice method. Method: Based on screening of preparation process,taking rates of oil phase,emulsifier and co-emulsifier as factors,simplex lattice method was adopted to optimize formulation with particle size,polydispersity index and drug loading as indexes.Physicochemical properties of this self-microemulsion were determined,such as viscosity,dissolution and so on. Result: Optimum formulation was 10% of median chain triglyceride oil,30% of polyoxyethylene hydrogenated castor oil,60% of diethylene glycol ethyl ether.Average particle size,polydispersity index and drug loading of self-microemulsion containing total flavonoids from Folium Kaki were 32.7 nm,0.163 and 22.42 mg·g^-1;physicochemical properties was stable,cumulative dissolution at 20 min was 89.09%. Conclusion: Simplex lattice method can build a mathematical models with good prediction and objective analysis,and it can provide a new idea for optimization of self-croemusion formulation.