[关键词]
[摘要]
逍遥散出自《太平惠民和剂局方》,具有广泛的临床应用,已有多种成方制剂上市,主要包括逍遥丸、逍遥片、逍遥颗粒以及逍遥胶囊等。目前对逍遥散类制剂主要采用高效液相色谱法、薄层色谱法、反相色谱法对其进行质量控制,但这些方法的测定指标单一、药效关联性不强,不能准确反映逍遥散复方的物质基础、疗效及作用机制。将药效学、药动学、中药分析学、光谱学等多学科交叉融合,提出了从质量标志物、一测多评法、谱效整合指纹谱及过程分析技术等方面着手实现逍遥散复方制剂质量控制的研究策略,有助于阐释该类复方制剂的内在质量及其作用机制。
[Key word]
[Abstract]
Xiaoyaosan, a classical prescription originated from Taiping Huimin Heji Jufang, has a wide range of clinical applications. At present, a variety of prescriptions of Xiaoyaosan have been put on the market. The quality research of Xiaoyao prescriptions which have been listed in recent years was summarized, mainly includes Xiaoyao Pills, Xiaoyao Tablets, Xiaoyao Granules and Xiaoyao Capsules, their quality control methods include HPLC, TLC and, RP-HPLC. However, these quality control methods have single determination index and weak correlation with efficacy, which can not accurately reflect the material basis, efficacy and mechanism of Xiaoyaosan compound, and then novel strategies of quality control of Xiaoyaosan was put forward. This strategy integrates pharmacodynamics, pharmacokinetics, traditional Chinese medicine analysis, spectroscopy and other disciplines to achieve the quality control of Xiaoyaosan compound preparation from the aspects of quality markers, QAMS, spectrum effect integrated fingerprint spectrum and process analysis technology. which is helpful to explain the internal quality and mechanism of Xiaoyaosan compound preparation.
[中图分类号]
R286.01
[基金项目]
国家科技重大专项(2017ZX0931047);山西省应用基础研究计划项目(201901D211138)