应用效应面法优化薄膜包衣预混料的处方研究-中国现代应用药学.pdf

·药 剂 · 应用效应面法优化薄膜包衣预混料的处方研究 1 2* 3 4 4 张纪兴 ，何雯 ，冯炳林 ，陈小坚 ，刘瑞驹 (1.广东药学院，广州 510006 ；2.上海医药工业研究院，上海 200040 ；3.武汉 大学，武汉 430072 ；4.广州固志医药科技有限公司，广州 510663) 摘要：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。 关键词：薄膜包衣预混料；处方优化；星点设计-效应面法；重叠等高线 中图分类号：R943.5 文献标志码：A 文章编号：1007-7693(2010)10-0921-05 Study on the Formulation Optimization of a Premixed Film Coating Powders by the Response Surface Methodology 1 2* 3 4 4 ZHANG Jixing , HE Wen , FENG Binglin , CHEN Xiaojian , LIU Ruiju (1.Guangdong Pharmaceutical University, Guangzhou 510006, China; 2. Shanghai Institute of Pharmaceutical Industry, Shanghai 200040, China; 3. Wuhan University, Wuhan 430072, China; 4. Guangzhou Guzhi Pharmaceuticals Technology Co.,Ltd. , Guangzhou 510663, China) ABSTRACT: 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 c