星点设计-效应面法优化沙棘黄酮提取物分散片处方

目的:优化沙棘黄酮提取物分散片的处方.方法:以崩解时间、混悬系数和抗张强度为指标,交联聚维酮(PVPP)、羟丙基纤维素(HPC)、聚维酮(PVP-K30)用量为自变量,采用星点设计试验优化处方,数据进行多元线性和二项式非线性方程拟合,通过效应面法确定最佳处方.结果:最佳成型工艺为PVPP 50.0 mg/片,HPC 9.2 mg/片,PVP-K30 7.0 mg/片.预测值和测定值非常接近,偏差0.32％.结论:星点设计-效应面法可用于优选沙棘黄酮提取物分散片的处方工艺,优选的成型工艺稳定可行.

Optimization of Formulation of Seabuckthorn Flavonoids Extract Dispersible Tablets by Central Composite Design/Response Surface Methodology

Objective: To optimize formulation of seabuckthorn flavonoids extract dispersible tablets by central composite design-response surface methodology. Method: With disintegration time,suspension coefficient and tensile strength as dependent variables,the amounts of PVPP,HPC and PVP-K30 as independent variables,formulation was optimized by central composite design,data was fitted by multiple linear and binomial nonlinear equations,response surface methodology was adopted to determine optimum formulation. Result: Optimal formulation was proposed to contain PVPP 50.0 mg/table,HPC 9.2 mg/table and PVP-K30 7.0 mg/table.Dissolution test of optimal formulation indicated that there was low deviation (0.32%) between the predicted value and the measured value. Conclusion: Central composite design-response surface methodology was convenient to optimize molding technology of seabuckthorn flavonoids extract dispersible tablets,optimized molding technology was stable and feasible.