Astragali radix (AR) is not only a traditional Chinese medicine, but also a good tonic that is often consumed by people and has good disease prevention and health care effects. Due to the complex composition of AR and the interaction of different chemical components, it presents challenges in quality control. In this study, a gradient elution tower plate theory suitable for gradient elution was firstly established, followed by HPLC analysis combined with quantitative analysis of multi-components by single marker (QAMS) and multi-markers assay by monolinear method (MAML) for accurate content determination of the indicator components (calycosin-7-O-β-D-glucoside and formononetin) in AR. FTIR and DSC are also used to collect the fingerprints of AR and quantize them to obtain the structural information inside the substance. The established fingerprints were evaluated qualitatively and quantitatively using the systematic quantitative fingerprint method (SQFM) and chemometrics, and the characteristic parameters of the three fingerprints were investigated in relation to the macro-quantitative similarity (P_m) using the Pearson correlation analysis. Finally, the coefficient of variation weighted mean method (CVWMM) was used to synthesize the evaluation results and establish the HPLC–FTIR–DSC quality control system, which is more objective and reasonable. The results showed that the calculated results of QAMS and MAML were basically consistent with those of an external standard method. P_m had the function of representing the overall fingerprint information of the samples for quantitative evaluation. SQFM combined with CVWMM successfully differentiated the quality grades of 35 batches of AR samples. The combination of the three analytical methods resulted in the effective improvement of the quality evaluation of AR compared with a single method in terms of accuracy and completeness. This study provides a novel and comprehensive strategy for quality consistency evaluation of AR.

中文翻译：

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多维谱结合化学计量分析评价黄芪质量一致性


黄芪（AR）不仅是一味中药，也是人们经常食用的良好滋补品，具有良好的防病保健作用。由于AR成分复杂以及不同化学成分之间的相互作用，给质量控制带来了挑战。本研究首先建立了适合梯度洗脱的梯度洗脱塔板理论，然后通过HPLC分析结合单标记多组分定量分析（QAMS）和单线性法多标记测定（MAML）来获得准确的含量AR中指示剂成分（毛蕊花苷-7-O-β-D-葡萄糖苷和芒柄花素）的测定。 FTIR和DSC还用于收集AR指纹并对其进行量化以获得物质内部的结构信息。采用系统定量指纹法（SQFM）和化学计量学对建立的指纹图谱进行定性和定量评价，并利用皮尔逊相关分析。最后采用变异系数加权平均法（CVWMM）综合评价结果，建立了HPLC-FTIR-DSC质量控制体系，更加客观合理。结果表明，QAMS和MAML的计算结果与外标法的计算结果基本一致。 P _m 具有代表样品整体指纹信息的功能，可用于定量评价。 SQFM结合CVWMM成功区分了35批次AR样品的质量等级。 三种分析方法的结合使得AR质量评价较单一方法在准确性和完整性方面得到有效提高。本研究为AR质量一致性评价提供了一种新颖且全面的策略。