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HPLC combined with chemometrics for quality control of Huamoyan Granules or Capsules

摘要:

Objective:Huamaoyan Granules(HMYG)and Huamaoyan Capsules(HMYC)are Chinese patent medici-nes with different dosage forms of the same prescription.Due to the different preparation process,the chemical composition of these Chinese patent medicines varies greatly among different forms,but there were few studies on the difference comparison and quality control of them.In order to improve the effec-tiveness and safety in its clinical application,an idea combining high performance liquid chromatography(HPLC)and chemometrics was put forward to study the quality control of Chinese patent medicines in different dosage forms of the same prescription.Methods:The differential markers of HMYG and HMYC were explored based on HPLC fingerprint and chemometrics including orthogonal projections to latent structures-discriminant analysis(OPLS-DA),principal component analysis(PCA),and hierarchical cluster analysis(HCA).Finally,the quantitative analysis method of related components was established by HPLC.Results:A quality control method for HMYG and HMYC was established.Firstly,the chemical compo-nents of HMYG and HMYC were systematically analyzed by HPLC fingerprinting.Further exploration showed that there were 20 characteristic peaks and 57 common peaks.Then,the potential differential markers between HMYG and HMYC were explored by chemometrics,and the differential markers were screened after intersection with the 20 characteristic peaks.Finally,HPLC quantitative analysis methods for nine components were established,including seven differential markers(neochlorogenic acid,proto-catechualdehyde,chlorogenic acid,cryptochlorogenic acid,caffeic acid,rosmarinic acid and salvianolic acid A).The results of HPLC quantitative analysis showed that the contents of eight components in HMYG and HMYC samples were significantly different.According to the above results,the differential markers between HMYG and HMYC screened based on HPLC fingerprint and chemometrics can effec-tively characterize the differences between the two dosage forms.Conclusion:The present work provides a rapid and effective method for routine quality evaluation and control of HMYG and HMYC.This work also provides feasible methods for the quality evaluation and con-trol of Chinese patent medicines with different dosage forms of the same prescription.

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作者: Minhang Dou [1] Jiayi Huang [1] Mimi Yu [2] Huahua Li [1] Yang Song [1] Ziwei Peng [1] Shouying Du [1] Jie Bai [1]
作者单位: School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 100029,China [1] Beijing Institute for Drug Control,NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine(Traditional Chinese Patent Medicine),Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 102206,China [2]
期刊: 《中草药(英文版)》2024年16卷3期 449-456页 MEDLINEISTIC
栏目名称: Original Articles
DOI: 10.1016/j.chmed.2023.03.005
发布时间: 2024-08-20
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