标准研讨

基于HPLC指纹图谱和多成分含量测定的苏合香丸质量评价研究*

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  • 1.成都大学药学院 四川省药物制剂及装备工程技术研究中心,成都 610050;
    2.成都九芝堂金鼎药业有限公司,成都 610100
第一作者 Tel:(028)84216071;E-mail:645980201@qq.com
**Tel:(028)84216070;E-mail:renjing98@tom.com

收稿日期: 2024-04-05

  网络出版日期: 2024-10-17

基金资助

*青藏高原民族药用资源保护与利用实验室开放基金项目(QTPEM2301)

Quality evaluation of Suhexiang pills by HPLC fingerprint and multi-component quantitative analysis*

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  • 1. School of Pharmacy, Chengdu University, Sichuan Pharmaceutical Preparation and Equipment Engineering Technology Research Center, Chengdu 610050, China;
    2. Chengdu Jiuzhitang Jinding Pharmaceutical Co., Ltd., Chengdu 610100, China

Received date: 2024-04-05

  Online published: 2024-10-17

摘要

目的: 建立温通开窍药苏合香丸高效液相色谱指纹图谱以及同时测定没食子酸、胡椒碱、木香烃内酯、丁香酚和肉桂酸5个成分含量的方法,为苏合香丸质量控制方法提供参考。方法: 采用Swell Chromplus C18色谱柱(250 mm×4.6 mm,5 μm),以甲醇(A)-0.05%磷酸水溶液(B)为流动相,梯度洗脱,流速 1.0 mL·min-1,检测波长220 nm,柱温30 ℃,对15批苏合香丸进样分析;采用“中药指纹图谱相似度评价系统”生成对照指纹图谱,并进行相似度分析,结合聚类分析、主成分分析进行评价。结果: 建立苏合香丸指纹图谱,15 批样品的相似度均大于0.9。共标定了13个共有峰,并指认了没食子酸、肉桂酸、丁香酚、胡椒碱、木香烃内酯5个成分,并建立5个成分的含量测定方法,测定其含量分别为2.506~3.652 mg·g-1、0.666~0.876 mg·g-1、3.834~5.140 mg·g-1、0.884~1.306 mg·g-1和19.908~55.704 mg·g-1。采用聚类分析将15 批苏合香丸分为4 类,主成分分析筛选出3个主成分,累计方差贡献率为76.102%,说明主成分可包含原有数据的绝大部分信息。结论: 建立的苏合香丸指纹图谱及多成分含量测定方法稳定、可靠,可为苏合香丸的质量控制及临床应用提供参考。

本文引用格式

易静, 刘德慧, 杨蓉, 杜彭飞, 孙文霞, 任静 . 基于HPLC指纹图谱和多成分含量测定的苏合香丸质量评价研究*[J]. 药物分析杂志, 2024 , 44(9) : 1551 -1559 . DOI: 10.16155/j.0254-1793.2024-0224

Abstract

Objective: To establish the HPLC fingerprint of Suhexiang pills and determine the contents of gallic acid, piperine, costunolide, eugenol and cinnamic acid simultaneously, and to provide reference for the quality control method of Suhexiang pills. Methods: The separation was performed on a Swell Chromplus C18 column (250 mm×4.6 mm, 5 μm) with methanol (A)-0.05% phosphoric acid solution (B) as the mobile phase at a flow rate of 1.0 mL·min-1. The detection wavelength was 220 nm and the column temperature was 30 ℃. Fifteen batches of Suhexiang pills were analyzed. The “Traditional Chinese Medicine Fingerprint Similarity Evalution System” was used to establish the reference fingerprint and the similarity analysis was evaluated in combination with cluster analysis and principal component analysis. Results: The fingerprint of Suhexiang pills was established, and the similarities of 15 batches of samples were above 0.9. Thirteen common peaks were identified, and five components including galliic acid, cinnamic acid, eugenol, piperine and costunolide were identified. The contents of the five components were 2.506-3.652 mg·g-1, 0.666-0.876 mg·g-1, 3.834-5.140 mg·g-1, 0.884-1.306 mg·g-1 and 19.908-55.704 mg·g-1, respectively. Using cluster analysis, 15 batches of Suhexiang pills were divided into four categories. Three principal components were selected, and the cumulative variance contribution rate was 76.102%, indicating that the principal components could contain most of the information of the original data. Conclusion: The fingerprint and multi-component content determination method of Suhexiang pills are stable and reliable, which can provide reference for the quality control and clinical application of Suhexiang pills.

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