| HPLC多组分定量结合化学计量学及灰色关联度的葆宫止血颗粒质量评价 |
| 投稿时间：2023-06-14 点此下载全文
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| 引用本文：田红女,张晓冬,王海燕.HPLC多组分定量结合化学计量学及灰色关联度的葆宫止血颗粒质量评价[J].中国现代中药,2024,26(3):518-527 |
| DOI：10.13313/j.issn.1673-4890.20230614001 |
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| 基金项目:河南省高等学校重点科研指导计划项目（20B460010） |
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| 中文摘要:目的 建立一种分析葆宫止血颗粒中13个成分的高效液相色谱法，并结合化学计量学及灰色关联度分析对葆宫止血颗粒进行质量评价。方法 采用50%甲醇超声提取样品，CAPCELL PAK C18色谱柱，乙腈-0.2%磷酸水溶液为流动相梯度洗脱，同时测定葆宫止血颗粒中梓醇、地黄苷D、地黄苷A、益母草苷、三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1、柴胡皂苷a、柴胡皂苷d、芍药内酯苷、芍药苷、苯甲酰芍药苷和鹤草酚的含量。采用化学计量学挖掘影响葆宫止血颗粒产品质量的差异标志物，结合灰色关联度法计算各指标的关联度并对13批葆宫止血颗粒的质量进行排序。结果 13个成分的线性范围分别为2.68~134.00、1.64~82.00、0.88~44.00、0.57~28.50、2.35~117.50、11.93~596.50、9.71~485.50、2.05~102.50、1.86~93.00、9.62~481.00、19.05~952.50、1.78~89.00、0.66~33.00 μg·mL–1（r>0.999），3个质量浓度水平加样回收率为96.78%~100.12%（RSD<2.0%）。化学计量学分析显示，芍药苷、人参皂苷Rg1、芍药内酯苷、人参皂苷Rb1、梓醇、柴胡皂苷a和三七皂苷R1是影响葆宫止血颗粒产品质量的主要标志物。灰色关联度分析相对关联度为0.344 6~0.574 2。结论 该方法揭示了影响葆宫止血颗粒质量的主要潜在标志物，综合评价了葆宫止血颗粒的质量，可为其内在整体质量控制提供参考。 |
| 中文关键词:葆宫止血颗粒 高效液相色谱法 多组分 化学计量学 灰色关联度分析 质量控制 |
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| Quality Evaluation of Baogong Zhixue Granule by HPLC Multi-component Quantitative Combined with Chemometrics and Grey Relational Analysis |
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| Abstract:Objective To develop an High Performance Liquid Chromatography (HPLC) method for the simultaneous determination of 13 components in Baogong Zhixue Granule, and to comprehensively evaluate the quality of Baogong Zhixue Granule by chemometrics and grey relational analysis (GRA).Methods The Baogong Zhixue Granule samples were extracted with 50% methanol solution under ultrasonic condition. The chromatographic separation was performed on a CAPCELL PAK C18 column and gradient elution was carried out with acetonitrile-0.2% phosphoric acid aqueous solution as the mobile phase. The contents of catalpol, rehmannioside D, rehmannioside A, leonuride, notoginsenoside R1, ginsenoside Rg1, ginsenoside Rb1, saikosaponin a, saikosaponin d, albiflorin, paeoniflorin, benzoylpaeoniflorin and agrimophol in Baogong Zhixue Granule were determined. Chemometrics was used to explorethe potential markers affecting the product quality of Baogong Zhixue Granule. The relative correlation degree of each index was calculated by GRA method, and the quality of 13 batches of Baogong Zhixue Granule was sorted.Results The linear ranges of 13 components were 2.68-134.00, 1.64-82.00, 0.88-44.00, 0.57-28.50, 2.35-117.50, 11.93-596.50, 9.71-485.50, 2.05-102.50, 1.86-93.00, 9.62-481.00, 19.05-952.50, 1.78-89.00 and 0.66-33.00 μg·mL–1 (r>0.999), respectively, and the average recoveries of three mass concentration ranged from 96.78%-100.12% with RSD<2.0%. Chemometric analysis showed that paeoniflorin, ginsenoside Rg1, albiflorin, ginsenoside Rb1, catalpol, saikosaponin a and notoginsenoside R1 were the main potential markers affecting the quality of Baogong Zhixue Granule. The relative correlation degree was 0.344 6-0.574 2.Conclusion This method revealed the main potential markers affecting the quality of Baogong Zhixue Granules, comprehensively evaluated the quality of Baogong Zhixue Granules, and provided a reference for its internal and overall quality control. |
| keywords:Baogong Zhixue Granule HPLC multi-component chemometrics GRA quality control |
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