【摘要】 目的 建立综合评价红金消结胶囊质量的高效液相色谱（HPLC）多组分定量联合化学计量学及灰色关联度分析（GRA）法。方法 色谱柱为Symmetry C₁₈柱（250 mm×4.6 mm,5μm），流动相为乙腈-0.4%磷酸溶液（梯度洗脱），流速为1.0 mL/min，检测波长为210 nm（三七皂苷R₁、柴胡皂苷a、柴胡皂苷d）和250 nm（原花青素B₂、表儿茶素、鸡矢藤苷酸、鸡矢藤苷、鸡矢藤苷酸甲酯、车叶草苷、香附烯酮、圆柚酮、α-香附酮），柱温为30℃，进样量为10μL。参照2020年版《中国药典（四部）》通则方法，检测崩解时限、水分和含氮量。采用主成分分析（PCA）法和正交偏最小二乘法-判别分析（OPLS-DA）法挖掘影响制剂质量的差异标志物。采用GRA法分析不同批次制剂中各成分的含量数据，以相对关联度为测度，对其进行综合质量评价。结果 15批红金消结胶囊中上述12种成分的含量分别为0.296～1.065 mg/g、1.224～2.094 mg/g、0.886～1.502 mg/g、0.385～0.662 mg/g、0.281～0.446 mg/g、5.142～8.713 mg/g、1.452～2.435 mg/g、0.997～1.689 mg/g、0.155～0.416 mg/g、0.149～0.294 mg/g、0.039～0.066 mg/g 、0.067～0.150 mg/g；崩解时限均不超过19 min，水分均不超过4.32%，含氮量均不超过22.0 mg/g。化学计量学分析结果显示，鸡矢藤苷酸、表儿茶素、鸡矢藤苷、柴胡皂苷a、三七皂苷R₁、α-香附酮的含量是影响红金消结胶囊质量的主要潜在标志物。GRA结果显示，相对关联度为0.336 6～0.662 0。结论 红金消结胶囊的质量存在一定批间差异。所建立的方法可操作性强，结果准确，评价结果科学、直观，可用于红金消结胶囊的综合质量评价。更多还原

【Abstract】 Objective To establish a high-performance liquid chromatography（HPLC） multi-component quantitative combined chemometrics and grey relational analysis（GRA） method for comprehensive evaluation of the quality of Hongjin Xiaojie Capsules.Methods The chromatographic column was Symmetry C₁₈column（250 mm × 4. 6 mm,5 μm）,the mobile phase was acetonitrile-0. 4% phosphoric acid solution（gradient elution）,the flow rate was 1. 0 mL/min,the detection wavelength was 210 nm（notoginsenoside R₁,saikosaponin a,and saikosaponin d） and 250 nm（procyanidin B₂,epicatechin,paederosidic acid,paederoside,paederosidic acid methyl ester,asperuloside,cyperenone,nootkatone,and α-cyperone）,the column temperature was 30 ℃,and the injection volume was 10 μL. Referring to the general rules of the Chinese Pharmacopoeia（2020 Edition,Volume Ⅳ）, the disintegration time,moisture,and nitrogen content were detected. Principal component analysis（PCA） and orthogonal partial least squares discriminant analysis（OPLS-DA） were used to identify differential biomarkers affecting the quality of the perparation.The GRA method was used to analyze the content data of each component in different batches of perparation,and the relative correlation was used as a measure to conduct a comprehensive quality evaluation of the perparation.Results The contents of the12 components mentioned above in 15 batches of Hongjin Xiaojie Capsules were 0. 296-1. 065 mg/g,1. 224-2. 094 mg/g,0. 886-1. 502 mg/g,0. 385-0. 662 mg/g,0. 281-0. 446 mg/g,5. 142-8. 713 mg/g,1. 452-2. 435 mg/g,0. 997-1. 689 mg/g,0. 155-0. 416 mg/g,0. 149-0. 294 mg/g,0. 039-0. 066 mg/g,and 0. 067-0. 150 mg/g,respectively.The limit of disintegration time was ≤ 19 min,the moisture content was ≤ 4. 32%,and the nitrogen content was ≤ 22. 0 mg/g.The results of chemometric analysis showed that the contents of paederosidic acid,epicatechin,paederoside,saikosaponin a,notoginsenoside R₁,and α-cyperone were the main potential biomarkers affecting the quality of Hongjin Xiaojie Capsules. The GRA results showed the relative correlation was in the range of 0. 336 6-0. 662 0.Conclusion There are certain batch differences in the quality of Hongjin Xiaojie Capsules. The established method is feasible,accurate,and scientific with intuitive evaluation results,which can be used for the comprehensive quality evaluation of Hongjin Xiaojie Capsules.更多还原