| 引用本文: |
刘晓慧, 彭江丽, 奉艳婷, 邓美玲, 钱敏, 王适, 彭求贤.基于HPLC指纹图谱和一测多评法的化瘀止痛贴膏质量评价[J].湖南中医药大学学报,2025,45(12):2307-2315[点击复制] |
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| 基于HPLC指纹图谱和一测多评法的化瘀止痛贴膏质量评价 |
| 刘晓慧,彭江丽,奉艳婷,邓美玲,钱敏,王适,彭求贤 |
| (湖南中医药大学药学院, 湖南 长沙 410208;湘产大宗药材品质评价湖南省重点实验室, 湖南 长沙 410208;湖南中医药大学第二附属医院药剂科, 湖南 长沙 410005) |
| 摘要: |
| 目的 建立化瘀止痛贴膏的高效液相色谱（HPLC）指纹图谱，并结合一测多评（QAMS）法测定其中10种成分的含量，为其质量评价提供参考。方法 采用Agilent HC C18色谱柱，以乙腈-1%甲酸、0.1%三乙胺为流动相进行梯度洗脱，柱温30 ℃，流速1 mL·min-1，构建HPLC指纹图谱，进行相似度评价，并采用化学计量学方法进行化学模式识别研究。利用相对校正因子来计算各成分的含量，同时将QAMS法计算结果和外标法实测值进行比较，计算其他相对校正因子，测定其含量。结果 14批指纹图谱共确定10个共有峰，相似度评价>0.9，以黄芩苷为内参物，儿茶素、羟基红花黄色素A、黄柏碱、龙胆苦苷、木兰花碱、药根碱、小檗碱、丹皮酚和大黄素甲醚的校正因子分别为0.922 9、1.148 7、1.171 6、1.532 7、1.113 5、0.316 8、0.200 6、0.389 4、0.594 4，与外标法计算结果无显著差异。结论 建立的HPLC指纹图谱与QAMS法，结果准确、方法可靠，能为化瘀止痛贴膏的质量控制与综合评价提供科学依据。 |
| 关键词: 化瘀止痛贴膏 质量评价 指纹图谱 一测多评 相似度评价 |
| DOI：10.3969/j.issn.1674-070X.2025.12.009 |
| 投稿时间：2025-09-19 |
| 基金项目:湖南省中医药管理局科研项目（B2023052）；湖南省自然科学基金-科药联合项目（2022JJ80087，2024JJ8175）。 |
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| Quality evaluation of Huayu Zhitong Plaster based on HPLC fingerprint and QAMS method |
| LIU Xiaohui, PENG Jiangli, FENG Yanting, DENG Meiling, QIAN Min, WANG Shi, PENG Qiuxian |
| (School of Pharmacy, Hunan University of Chinese Medicine, Changsha, Hunan 410208, China;Key Research Laboratory of Germplasm Resources and Standardized Planting of Genuine Regional Medicinal Materials produced in Hunan Province, Changsha, Hunan 410208, China;Pharmacy Department, the Second Hospital of Hunan University of Chinese Medicine, Changsha, Hunan 410005, China) |
| Abstract: |
| Objective To establish the HPLC fingerprint of Huayu Zhitong Plaster and to determine the content of its ten components using the quantitative analysis of multi-components by single-marker (QAMS) method, so as to provide a reference for quality assessment. Methods The HPLC fingerprint was developed using an Agilent HC-C18 column with a mobile phase of acetonitrile-1% formic acid 0.1% triethylamine under gradient elution conditions. The column temperature was maintained at 30 ℃ and the flow rate was set at 1 mL·min-1. Similarity evaluation was performed on the fingerprint, and chemometric methods were applied for chemical pattern recognition. The content of the components were calculated using relative correction factors (RCFs). The results obtained by the QAMS method were compared with those determined by the external standard method, and additional RCFs were calculated accordingly for content determination. Results A total of ten common peaks were identified in the fingerprints of the 14 batches, with similarity evaluations exceeding 0.9. Using baicalin as the internal reference substance, the correction factors for catechin, hydroxysafflor yellow A, phellodendrine, gentiopicroside, magnoflorine, jateorrhizine, berberine, paeonol, and physcion were determined as 0.922 9, 1.148 7, 1.171 6, 1.532 7, 1.113 5, 0.316 8, 0.200 6, 0.389 4, and 0.594 4, respectively. There was no significant difference between the results calculated by the QAMS method and those calculated by the external standard method. Conclusion The established HPLC fingerprint combined with the QAMS method demonstrates accuracy and reliability, thereby providing a scientific foundation for the quality control and comprehensive evaluation of Huayu Zhitong Plaster. |
| Key words: Huayu Zhitong Plaster quality evaluation HPLC fingerprint quantitative analysis of multi-components by single-marker similarity evaluation |
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