应用效应面法优化薄膜包衣预混料的处方研究

目的应用星点设计-效应面法优化制备一种薄膜包衣预混料的处方。方法以成膜材料羟丙基甲基纤维素和聚乙烯醇及增塑剂聚乙二醇的用量为考察因素,薄膜衣溶液的黏度以及薄膜的抗张强度和渗透性为考察指标,采用数学模型描述考察指标和考察因素之间的关系,根据模型绘制效应面和等高线图,再依据设定的考察指标目标值,通过重叠等高线图确定优化处方。结果按最佳模型处方制备的薄膜包衣预混料,其考察指标的预测值与实测值偏差较小,模型具有良好的预测性。结论星点设计-效应面法,能够实现薄膜包衣预混料处方多指标的同步优化,所建立的模型具有较好的预测能力和实用性。

Study on the Formulation Optimization of a Premixed Film Coating Powders by the Response Surface Methodology

OBJECTIVE To optimize the formulation of a premixed film coating powders by the central composite design-response surface methodology(RSM plus CCD). METHODS In the formulation design, independent variables were the amount of the film coating powders HPMC, PVA and plasticizer PEG, and viscosity of the premixed film coating solution, permerbility and tensile stress of the film coating as indexes were dependent variables. Mathematic models were used to estimate the relationship between them, and to delineate RSM and overlay contour plots in order to select the optimal formulation with the application of hypothesized indexes. RESULTS The quantitative relationships between dependent and independent variables were characterized. The best-fitted mathematic models were selected. Bias between observed and predicted values of the film coating indexes were negligible indicating the high predictability of the fit models. CONCLUSION The multi-objective simultaneous optimization of the formulation of a film coating powders could be achieved by RSM plus CCD. The models developed in this study are proved to be predictable and feasible.