目的 建立經(jīng)典名方當(dāng)歸補(bǔ)血湯基準(zhǔn)樣品系統(tǒng)的質(zhì)量控制方法，為其質(zhì)量評價(jià)提供參考。方法 制備26批基準(zhǔn)樣品，在同一供試品溶液下，基于超高效液相色譜-二極管陣列檢測器（UPLC-PDA）、UPLC-蒸發(fā)光散射檢測器（ELSD）、親水相互作用色譜-二極管陣列檢測器（HILIC-PDA）法建立當(dāng)歸補(bǔ)血湯基準(zhǔn)樣品多維指紋圖譜，明確其指紋圖譜的峰歸屬和相似度范圍。對毛蕊異黃酮葡萄糖苷和毛蕊異黃酮、黃芪甲苷、阿魏酸、總多糖進(jìn)行定量分析，確定其含量限度范圍。結(jié)果 建立當(dāng)歸補(bǔ)血湯基準(zhǔn)樣品三維指紋圖譜方法，共標(biāo)定了32個(gè)共有峰，通過與對照品比對，指認(rèn)了其中17個(gè)共有峰，使用“中藥色譜指紋圖譜相似度評價(jià)系統(tǒng)（2012版）”計(jì)算相似度，其相似度均大于0.9。26批基準(zhǔn)樣品毛蕊異黃酮葡萄糖苷和毛蕊異黃酮、黃芪甲苷、阿魏酸、總多糖的含量均值±30%范圍分別為0.075%～0.140%、0.023%～0.043%、0.103%～0.191%、4.69%～8.70%。結(jié)論 建立經(jīng)典名方當(dāng)歸補(bǔ)血湯多維指紋圖譜及多成分含量測定方法，適用性強(qiáng)，重復(fù)性、穩(wěn)定性良好，可為當(dāng)歸補(bǔ)血湯基準(zhǔn)樣品及其制劑的質(zhì)量控制提供依據(jù)。

Objective A comprehensive and systematical quality control method was established to provide reference for quality control and evaluation of substance benchmarks for Danggui Buxue Decoction, in order to provide reference for establishing the quality control standard. Methods Twenty-six batches of substance benchmarks were prepared. Based on a same sample solution, a multidimensional fingerprint of substance benchmarks was established by UPLC-PDA, UPLV-ELSD and HILIC-PDA to definite the common peaks and the similarity range. Five quality markers, including calycosin-7-O-β-D-glucopyranoside and calycosin, astragaloside Ⅳ, ferulic acid, and total polysaccharides, were analyzed to determine the quantitative ranges. Results According to the three-dimensional fingerprint Spectrum, thirty-two common peaks could be demarcated, while seventeen of these could be identified by reference substances. Besides, their similarities were all more than 0.9 based on the Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System (2012). The ranges of mean content about calycosin-7-O-β-Dglucopyranoside plus calycosin, astragaloside Ⅳ, ferulic acid, and total polysaccharides from twenty-six batches of substance benchmarks were 0.075%-0.140%, 0.023%-0.043%, 0.103%-0.191%, and 4.69%-8.70%, respectively. Conclusion With high applicability, well repeatability and stability, the multidimensional fingerprint and multicomponent determination of DangguiBuxue Decoction can provide reference for establishing the quality control of substance benchmarks and preparations.

R284.1

2019年容桂街道戰(zhàn)略性新興產(chǎn)業(yè)項(xiàng)目（RG202004001）