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超高效液相色谱指纹图谱结合一测多评法对一清颗粒进行质量评价

UPLC fingerprinting combined with quantitative analysis of multicomponents by a single marker for quality evaluation of YiQing granules.

作者信息

Li YangHong, Yu Bao, Zhao Wei, Pu Xiyu, Zhong Xue, Tao Xingbao, Wang Yunhong, Cao Weiguo, Zhang Dan

机构信息

College of Traditional Chinese Medicine, Chongqing Medical University, Chongqing, China.

College of Chinese Materia Medica, Chongqing University of Chinese Medicine, Chongqing, China.

出版信息

Front Chem. 2025 Jul 28;13:1632033. doi: 10.3389/fchem.2025.1632033. eCollection 2025.

DOI:10.3389/fchem.2025.1632033
PMID:40791300
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12336232/
Abstract

RESEARCH BACKGROUND

YiQing granules (YQGs) are a patented drug commonly used in clinics in China. However, the quality control index of this preparation is relatively limited, which does not effectively ensure the quality of the product. Thus, a comprehensive quality evaluation of YQGs is lacking.

OBJECTIVE

The aim of this study was to establish a method for quantitative and qualitative analysis of YQGs based on ultra-high performance liquid chromatography-photodiode array detector (UPLC-PAD) fingerprint combined with quantitative analysis of multicomponents by a single marker (QAMS).

METHODS

We established and verified the comprehensive evaluation method that UPLC fingerprint combined with QAMS and stoichiometric method, to assess the overall quality of YQGs produced by different manufacturers. Berberine was selected as an internal reference, and the relative correction factors of coptisine, epiberberine, baicalin, berberine, palmatine, wogonoside, baicalein, wogonin, aloe-emodin, rhein, emodin, and chrysophanol were established.

STUDY RESULTS

Results showed that the experimental time of the fingerprint was significantly reduced to approximately 0.5 h using the UPLC-PAD method. A total of 32 common peaks with similarity greater than 0.9 were identified. The accuracy of QAMS was compared with the external standard method, with no significant difference between the two methods.

CONCLUSION

The UPLC fingerprint combined with QAMS method established in this study is feasible and reliable; it can be used for the comprehensive quality evaluation of YQGs and can provide a reference for the quality evaluation of other traditional Chinese medicine preparations.

摘要

研究背景

一清颗粒是中国临床上常用的一种专利药物。然而，该制剂的质量控制指标相对有限，无法有效保证产品质量。因此，缺乏对一清颗粒的全面质量评价。

目的

本研究旨在建立一种基于超高效液相色谱-光电二极管阵列检测器（UPLC-PAD）指纹图谱结合一测多评法（QAMS）对一清颗粒进行定量和定性分析的方法。

方法

建立并验证UPLC指纹图谱结合QAMS和化学计量学方法的综合评价方法，以评估不同厂家生产的一清颗粒的整体质量。选择盐酸小檗碱作为内参，建立黄连碱、表小檗碱、黄芩苷、盐酸小檗碱、巴马汀、汉黄芩苷、黄芩素、汉黄芩素、芦荟大黄素、大黄酸、大黄素和大黄酚的相对校正因子。

研究结果

结果表明，采用UPLC-PAD法，指纹图谱的实验时间显著缩短至约0.5小时。共鉴定出32个相似度大于0.9的共有峰。将QAMS的准确性与外标法进行比较，两种方法之间无显著差异。

结论

本研究建立的UPLC指纹图谱结合QAMS法可行、可靠；可用于一清颗粒的全面质量评价，为其他中药制剂的质量评价提供参考。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/379b/12336232/f5ad9b186f3a/fchem-13-1632033-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/379b/12336232/313da962fe20/fchem-13-1632033-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/379b/12336232/8f2815e6090c/fchem-13-1632033-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/379b/12336232/d9391397b73b/fchem-13-1632033-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/379b/12336232/5eb649c750b2/fchem-13-1632033-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/379b/12336232/f5ad9b186f3a/fchem-13-1632033-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/379b/12336232/313da962fe20/fchem-13-1632033-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/379b/12336232/8f2815e6090c/fchem-13-1632033-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/379b/12336232/d9391397b73b/fchem-13-1632033-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/379b/12336232/5eb649c750b2/fchem-13-1632033-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/379b/12336232/f5ad9b186f3a/fchem-13-1632033-g005.jpg

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