江苏大学学报（医学版）2012，Vol.22Issue(2)：162-166,5.
星点设计-效应面法优化依托贝特缓释胶囊的制备
Optimized preparation of etofibrate sustained release capsule by central composite design and response surface method
摘要
Abstract
Objective; Prepare Etofibrate sustained release capsule ;To optimize the formulation of Etofi-brate sustained release capsule by Central Composite Design-Response Surface Method Ology ( CCD-RSM ). Methods; Etofibrate pellets were prepared by centrifugal granulation equipment , then they were coated by solution of PEG4000 and Etofibrate dissolute in Acetone. Aqueous dispersion of Acrylic Resins ( Eudragit ROOD)was used for the sustained release layer coating. In the formulation design using CCD-RSM, independent variables were the mass ratio of solubilize layer , the mass ratio of PEG4000 in the solubilize layer, and the weight gain percentage of sustained release layer . The percentage of in vitro cumulative releases at 4 h, 8 h and 24 h were dependent variables. Multilinear and quadratic models were used to estimate the rela -tionship between the dependent and the independent variables , and to delineate RSM and overlay contour plots in order to select the optimal formulation. Results; The optimized formulation parameter was: weight ratio of solubilize layer was between 0. 7 - 1. 2; the mass ratio of PEG4000 in the solubilize layer was between 3.5% -12. 8% ;the weight gain percentage of sustained release layer was between 8.0% - 13. 5 %. Quadratic model showed better prediction capability than multilinear model. The quantitative relationships between three factors and three evaluation indexes were characterized . Moreover, in vitro release test of the selected optimal formulation indicated thigh approximation between the observed and estimated values . Conclusion: The CCD-RSM can be applied to optimize the formulation of Etofibrate sustained release cap -sule and the established model is of satisfactory predictive value .关键词
依托贝特/缓释胶囊/星点设计/效应面法Key words
etofibrate/sustained-release capsule/central composite design/response surface methodology分类
医药卫生引用本文复制引用
曹升,张朝晖,吴小涛,何红燕,霍苙茹..星点设计-效应面法优化依托贝特缓释胶囊的制备[J].江苏大学学报（医学版）,2012,22(2):162-166,5.基金项目
国家自然科学基金资助项目(81001319) （81001319）
镇江市社会发展基金资助项目(SH2011028) （SH2011028）
江苏大学临床医学科技发展基金资助项目(JLY2010135) （JLY2010135）
