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A new strategy for quality evaluation and control of Chinese patent medicine based on chiral isomer ratio analysis: With Yuanhuzhitong tablet as an example
Gou, Yan1,2; Geng, Zhao2,3; Zhong, Lian1,2; Wei, Jinchao3; Liu, Juanru1; Deng, Xiaohong2; Li, Min1; Yuan, Jun2; Wang, Yitao3; Guo, Li1
2021-08
Source PublicationBiomedical Chromatography
ISSN0269-3879
Volume35Issue:12
Abstract

Chiral compounds commonly exist in traditional Chinese medicine (TCM), but little research on the quality control of TCM has been conducted. In this study, a new strategy is proposed, taking Yuanhuzhitong tablet [YHZT, consisting of Radix Angelicae Dahuricae and Rhizoma Corydalis (Yan Hu Suo, YHS)] for example, which is based on chiral isomer ratio analysis to monitor the production process of Chinese patent medicine companies. In the process of content determination for tetrahydropalmatine (THP) in YHZT from different companies, noticeable differences were observed in their chromatographic behaviors. It is known that THP has two enantiomers, naturally coexisting in YHS as a racemic mixture, so we prepared THP twice and subsequently performed chiral separation analysis using supercritical fluid chromatography. As a result, the peak area ratios of two enantiomers from different companies varied remarkably, demonstrating that some companies did not probably manufacture YHZT products in accordance with the prescription proportion, used inferior or extracted YSH crude materials in the production process, and added raw chemical medicine in the production to reach the standard and lower the costs. In conclusion, the peak area ratio of chiral isomers could be taken as a key quality index.

KeywordChinese Patent Medicine Chiral Quality Supercritical Fluid Chromatography Tetrahydropalmatine
DOI10.1002/bmc.5211
URLView the original
Indexed BySCIE
Language英語English
WOS Research AreaBiochemistry & Molecular Biology ; Pharmacology & Pharmacy ; Chemistry
WOS SubjectBiochemical Research Methods ; Biochemistry & Molecular Biology ; Chemistry, Analytical ; Pharmacology & Pharmacy
WOS IDWOS:000681007600001
Scopus ID2-s2.0-85111739354
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Citation statistics
Document TypeJournal article
CollectionInstitute of Chinese Medical Sciences
THE STATE KEY LABORATORY OF QUALITY RESEARCH IN CHINESE MEDICINE (UNIVERSITY OF MACAU)
Corresponding AuthorGeng, Zhao; Li, Min
Affiliation1.College of Pharmacy, Chengdu University of Traditional Chinese Medicine, Chengdu, China
2.National Medical Products Administration Key Laboratory for Quality Evaluation of Traditional Chinese Medicine (Traditional Chinese Patent Medicine), Sichuan Institute for Drug Control (Sichuan Testing Center of Medical Devices), Chengdu, China
3.State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, Macao
Corresponding Author AffilicationInstitute of Chinese Medical Sciences
Recommended Citation
GB/T 7714
Gou, Yan,Geng, Zhao,Zhong, Lian,et al. A new strategy for quality evaluation and control of Chinese patent medicine based on chiral isomer ratio analysis: With Yuanhuzhitong tablet as an example[J]. Biomedical Chromatography, 2021, 35(12).
APA Gou, Yan., Geng, Zhao., Zhong, Lian., Wei, Jinchao., Liu, Juanru., Deng, Xiaohong., Li, Min., Yuan, Jun., Wang, Yitao., & Guo, Li (2021). A new strategy for quality evaluation and control of Chinese patent medicine based on chiral isomer ratio analysis: With Yuanhuzhitong tablet as an example. Biomedical Chromatography, 35(12).
MLA Gou, Yan,et al."A new strategy for quality evaluation and control of Chinese patent medicine based on chiral isomer ratio analysis: With Yuanhuzhitong tablet as an example".Biomedical Chromatography 35.12(2021).
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