星点设计-效应面优化法在国内制剂处方优化中的应用进展

星点设计(central composite design, CCD)是效应面优化法(response surface methodology, RSM)中最常用的一种设计方法,在药剂学领域制剂处方优化方面获得了广泛的使用。值此引入国内20周年之际,本文回顾了CCD在国内药剂学研究中的应用情况。在简述其基本原理与使用步骤基础上,总结了使用历程中的常见错误,并对因素与效应的选择问题进行了讨论,以促使研究者系统了解CCD,在研究中进行合理使用。

Progress on application of central composite design-response surface methodology in optimization of preparations in China

Central composite design(CCD)is one of the most commonly used design methods in response surface optimization and has been widely applied in the field of pharmaceutics to optimize preparations.On the 20th anniversary of the introduction of CCD into China,the paper reviews its application in domestic pharmaceutical researches.Based on the brief introduction of basic principle and operation steps of CCD,the mistakes emerging in the application of CCD are summarized,including conceptual confusion with Box-Behnken design and facecentered CCD as well as wrong designs.Besides,the issues concerning the selection of factors and responses are discussed.The article is helpful for researchers to comprehensively understand the CCD and facilitates the rational application of this method.