基于“成分-药效”关联分析的六味地黄丸质量控制方法

Study on quality control of Liu Wei Di Huang Wan based on components & efficacy relationship

本文以中药复方制剂六味地黄丸为研究示例,分别进行六味地黄丸药效成分明确化鉴别、典型药理模型的药效实验、成分与药效的关联分析,共鉴别出六味地黄丸中16个成分.通过成分与药效的关联性分析,得出4个与典型药理模型药效相关的成分.建立了指标性成分的含量测定方法学,通过"成分与药效"的关联性分析所得出指标性成分的含量测定方法,可实现对中药复方制剂六味地黄丸的质量控制.

Study on Liu Wei Di Huang Wan was carried about clear identification of Efficacy components,typical experimental pharmacological model of efficacy and Components Efficacy relationship.A total of 16 components was identified through HPLC-TOF/MS analysis.By analyzing Components Efficacy relationship through 11 samples,four components were determined with relationship to Pharmacological effects.The determination method was established to assay the contents of 5-HMF,Loganin,Paeonol and gallic acid in 11 samples.The fingerprint of Liu Wei Di Huang Wan was also established.The methods can achieve the quality control of TCM Liu Wei Di Huang Wan preparation.