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实验设计在自微乳化给药系统处方优化中的应用

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自微乳化给药系统(SMEDDS)是提高难溶性药物溶解度和生物利用度的有效方法之一.处方筛选以及优化是开发该类制剂的关键.实验设计(DoE)可以评估自变量及其相互作用对因变量的主要影响,因而被广泛应用于处方优化.文章主要概述了几种实验设计方法的原理、优缺点及其在SMEDDS处方优化中的应用,着重介绍了 D-最优混合物设计,以期为SMEDDS的处方优化方法选择提供参考.
Application of Design of Experiment in Formulation Optimization of Self-microemulsifying Drug Delivery System
Self-microemulsifying drug delivery system(SMEDDS)is one of the effective approaches to improve the solubility and bioavailability of poorly soluble drugs.The formulation screening and optimization is the key steps in the development of SMEDDS products.Design of experiment(DoE)methods are employed to evaluate the main effects of independent variables and their interactions on response variables in formulations,therefore they are widely used in formulation optimization.This review summarizes the principles,advantages and disadvantages of several experimental design methods and their application in SMEDDS products development,focusing on the D-optimal mixtures design,in order to provide some references for the selection of SMEDDS formulation optimization methods.

self-microemulsifying drug delivery systemformulation optimizationdesign of experimentD-optimal mixture design

史春爽、张宁、刘玥、李蕾、李春雷

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河北医科大学药学院,河北石家庄 050017

石药集团中奇制药技术(石家庄)有限公司,河北石家庄 050035

河北医科大学第二医院药学部,河北石家庄 050004

自微乳化给药系统 处方优化 实验设计 D-最优混合物设计

2024

中国医药工业杂志
上海医药工业研究院,中国化学制药工业协会

中国医药工业杂志

CSTPCD
影响因子:0.487
ISSN:1001-8255
年,卷(期):2024.55(10)
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