中药组方优化试验设计方法概述

Summary of Experimental Design Methods for Optimization of Complex Prescription of Chinese Medicine

组方优化研究是中药方剂研究的重要环节,是中兽药产业化推广的关键步骤。本文介绍了中药组方的概念、组方优化的原则、目的、意义及指导思想等,总结了近年来基于中医传统理论和现代数理模型的两类中药组方优化方法,进一步对其中基于现代数理模型的试验设计方法,包括正交设计、均匀设计、基线等比设计、Plackett-Burman筛选试验设计、星点设计、中心组合设计、Doehlert设计等进行比较,并分析了不同方法在试验安排、数据分析和拟合模型等方面的优缺点、在组方优化领域的适用范围和实用性,并对未来的方法设计提出展望,为中兽药复方制剂的研发提供参考。

The study of optimization of prescription is an important link in the research of Chinese medicine prescription and a key step in the industrialization and promotion of Chinese medicine.This article introduces the concept of formulating traditional Chinese medicine,the principle,purpose,significance and guiding ideology of formulating formulas,and summarizes the methods used in formulating formulas in recent years are mainly divided into two categories,compared the experimental designs based on modern mathematical models(orthogonal design,homogeneous design,baseline proportional design,Plackett-Burman design,central composite design,Box-Behnken,Doehlert design),and analyzed the advantages and disadvantages in experimental arrangements,data analysis and fitting models,the scope of application and practicability in the field of formulation optimization,and put forward the prospect of future method design.