Fangji Huangqi Decoction (FHD) is a classic prescription of traditional Chinese medicine which is recorded in “Jin Gui Yao Lue”. The purpose of this study is to develop a method for simultaneous determination multicomponent in FHD. The separation of the 19 compounds that included calycosin, calycosin-7-O-β-D-glucoside, formononetin, ononin, methylnissolin, methylnissolin-3-O-glucoside, isomucronulatol, tetrandrine, fangchinoline, atractylenolide-I, atractylenolide-III, liquiritigenin, liquiritin, isomucronulatol-7-O-β-D-glucoside, astragaloside-I, astragaloside-II, astragaloside-III, astragaloside-IV and glycyrrhetinic acid were achieved by linear gradient elution. The 19 components were identified by comparing the chromatographic peaks with the reference compounds and were quantitatively analyzed by multiple reaction monitoring. This method was strict validated with recovery (96.10–101.70%), precision [relative standard deviation (RSD), 1.34–3.34%], stability (RSD, 1.49–3.80%) and repeatability (RSD, 1.60–3.49%), respectively. All the compounds showed good linearities (R2 > 0.999). The limit of detection (LOD) and limit of quantitation (LOQ) for the 19 compounds were in the range of 0.03–0.27 μg/mL (LODs) and 0.05–1.23 μg/mL (LOQs). The correlation analysis indicated that astragalus flavonoids were negatively correlated with astragalosides, tetrandrine and their corresponding flavonoid glycosides, and atractylenolides were positively correlated with astragalosides and fangchinoline. This method proved to be reliable and effective, which would give a helpful basis for the quality control, pharmacological and pharmacokinetic of FHD.

中文翻译：

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基于UHPLC-MS/MS快速定量分析防己黄芪汤中19种生物活性成分

防己黄芪汤（FHD）是《金匮要略》中记载的中医经典方剂。本研究的目的是开发一种同时测定 FHD 中多组分的方法。毛蕊异黄酮、毛蕊异黄酮-7-O-β-D-葡萄糖苷、芒柄花素、ononin、甲基尼松林、甲基尼松林-3-O-葡萄糖苷、异粘连醇、粉防己碱、防己林、白术内酯-I、白术内酯-III等19种化合物的分离。通过线性梯度洗脱获得甘草苷元、甘草苷、异糖醇-7-O-β-D-葡萄糖苷、黄芪甲苷-I、黄芪甲苷-II、黄芪甲苷-III、黄芪甲苷-IV和甘草次酸。通过与对照品的色谱峰比较来鉴定19种成分，并通过多反应监测进行定量分析。该方法经过严格验证，回收率（96.10-101.70%）、精密度[相对标准偏差（RSD），1.34-3.34%]、稳定性（RSD，1.49-3.80%）和重复性（RSD，1.60-3.49%）分别。所有化合物均表现出良好的线性(R2＞0.999)。19 种化合物的检测限 (LOD) 和定量限 (LOQ) 范围为 0.03–0.27 μg/mL (LOD) 和 0.05–1.23 μg/mL (LOQ)。相关分析表明，黄芪总黄酮与黄芪甲苷、粉防己碱及其相应黄酮苷呈负相关，白术内酯与黄芪甲苷、防己诺林呈正相关。该方法可靠、有效，为FHD的质量控制、药理和药代动力学提供了有益的依据。