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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。
Objective To optimize the preparation of a film coating premix by the method of apices design-response surface method. Methods Taking the amount of hydroxypropyl methylcellulose, polyvinyl alcohol and plasticizer polyethylene glycol as film-forming materials, the viscosity of film-coat solution and the tensile strength and permeability of film as indexes, The model describes the relationship between the inspection index and the inspection factor, draws the effect surface and the contour map according to the model, and then determines the optimal prescription by overlapping contour maps according to the set target value of the inspection index. Results The film coating premix prepared according to the best model prescription showed a small deviation from the measured value of the observed index, and the model has good predictability. Conclusions The star-point design-response surface method can realize the simultaneous optimization of the multi-index of film coating premix prescription. The established model has good predictive ability and practicability.