| 摘要: |
| [目的] 建立清热利胆片高效液相色谱（HPLC）指纹图谱并测定清热利胆片中14个成分的含量，以评价清热利胆片的整体质量。[方法] 采用Eclipse XDB-C18色谱柱（5 μm，4.6 mm×250.0 mm），以0.1%磷酸水-乙腈为流动相进行梯度洗脱，柱温35℃，流速1.0 mL/min，检测波长294 nm，建立15批清热利胆片的HPLC指纹图谱，经中药色谱指纹图谱相似度评价系统（2012版）进行相似度分析，标定共有峰并进行指认，在此基础上，对指认出的成分进行含量测定。[结果] 不同批次清热利胆片相似度均在0.983以上，共标定62个共有峰，并指认出14个成分，为绿原酸、金丝桃苷、槲皮素、山奈酚、芦丁、迷迭香酸、芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚、黄芩苷、厚朴酚、和厚朴酚，其14个成分的平均含量分别为（0.31±0.04）（0.04±0.01）（0.25±0.02）（0.20±0.06）（0.10±0.02）（0.23±0.05）（0.17±0.01）（0.19±0.02）（0.18±0.03）（0.56±0.08）（0.14±0.02）（1.98±0.17）（1.03±0.12）（0.65±0.04） mg/片。[结论] 建立清热利胆片HPLC指纹图谱结合多成分含量测定分析方法，其方法灵敏、稳定，可用于清热利胆片的质量评价。 |
| 关键词: 清热利胆片 高效液相色谱 指纹图谱 含量测定 |
| DOI：10.11656/j.issn.1672-1519.2023.11.18 |
| 分类号:R284.1 |
| 基金项目:国家自然科学基金项目（81973557）；释药技术与药代动力学国家重点实验室（天津药物研究院）开发课题（010162001）。 |
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| Establishment of HPLC fingerprint and determination of multi-componentsof Qingre Lidan Tablet |
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QIAO Xiaoli1, CAO Ningning2, WANG Qingguo3, LIU Xiaojun1, ZHANG Haifang4, XIAO Xuefeng3
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1.Tianjin Nankai Hospital, Tianjin 300100, China;2.Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300250, China;3.School of Chinese Materia Medica, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China;4.Graduate School, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
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| Abstract: |
| [Objective] To establish ahigh performance liquid chromatography(HPLC) fingerprint and a determination method of 14 components in Qingre Lidan Tablets, so as toevaluate the quality of Qingre Lidan Tablets. [Methods] Eclipse XDB-C18(5 μm, 4.6 mm×250 mm) was used for gradient elution with 0.1% phosphoric acid in water and acetonitrileas mobile phase. The column temperature was 35℃, the flow rate was 1.0 mL/min, and the detection wavelength was 294 nm. HPLC fingerprints of 15 batches of Qingre Lidan Tablets were established, and similarity analysis was conducted by using similarity evaluation software of Chinese medicine chromatographic fingerprint(2012), afterwords, calibrated the common peak and identified it, and on this basis, determined the content of the identified components. [Results] The similarity of different batches of Qingre Lidan Tablets was above 0.983. There were 62 common peaks in the fingerprints of 15 batches of samples, among which 14 components were identified, including Chlorogenic acid, Hyperoside, Quercetin, Kaempferol, Rutinum, Rosmarinic acid, Baicalin, Aloeemodin, Rhein, Emodin, Chrysophanic acid, Physcion, Magnolol, and Honokiol. The average content of them was (0.31±0.04)(0.04±0.01)(0.25±0.02)(0.20±0.06)(0.10±0.02)(0.23±0.05)(0.17±0.01)(0.19±0.02)(0.18±0.03)(0.56±0.08)(0.14±0.02)(1.98±0.17)(1.03±0.12)(0.65±0.04) mg/tablet, respectively. [Conclusion] The established HPLC fingerprint combined with multi-component content determination method for Qingre Lidan Tablets is sensitive and stable, and can be used for quality evaluation of Qingre Lidan Tablets. |
| Key words: Qingre Lidan Tablet HPLC fingerprint content determination |
