逍遙散出自《太平惠民和劑局方》，具有廣泛的臨床應(yīng)用，已有多種成方制劑上市，主要包括逍遙丸、逍遙片、逍遙顆粒以及逍遙膠囊等。目前對逍遙散類制劑主要采用高效液相色譜法、薄層色譜法、反相色譜法對其進行質(zhì)量控制，但這些方法的測定指標單一、藥效關(guān)聯(lián)性不強，不能準確反映逍遙散復(fù)方的物質(zhì)基礎(chǔ)、療效及作用機制。將藥效學(xué)、藥動學(xué)、中藥分析學(xué)、光譜學(xué)等多學(xué)科交叉融合，提出了從質(zhì)量標志物、一測多評法、譜效整合指紋譜及過程分析技術(shù)等方面著手實現(xiàn)逍遙散復(fù)方制劑質(zhì)量控制的研究策略，有助于闡釋該類復(fù)方制劑的內(nèi)在質(zhì)量及其作用機制。

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.

R286.01

國家科技重大專項（2017ZX0931047）；山西省應(yīng)用基礎(chǔ)研究計劃項目（201901D211138）