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Quality Markers for Astragali Radix and Its Products Based on Process Analysis

Due to the complex nature of traditional medicines, quality control methods need to cover two aspects: compliance of raw materials with quality standards and process control. Astragali radix (AR), the roots of Astragalus mongholicus Bunge, was selected in this study as an example of a widely used tr...

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Autores principales: Dai, Yuntao, Wang, Dongbo, Zhao, Manjia, Yan, Lihua, Zhu, Chao, Li, Pengyue, Qin, Xuemei, Verpoorte, Rob, Chen, Shilin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7775524/
https://www.ncbi.nlm.nih.gov/pubmed/33390938
http://dx.doi.org/10.3389/fphar.2020.554777
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author Dai, Yuntao
Wang, Dongbo
Zhao, Manjia
Yan, Lihua
Zhu, Chao
Li, Pengyue
Qin, Xuemei
Verpoorte, Rob
Chen, Shilin
author_facet Dai, Yuntao
Wang, Dongbo
Zhao, Manjia
Yan, Lihua
Zhu, Chao
Li, Pengyue
Qin, Xuemei
Verpoorte, Rob
Chen, Shilin
author_sort Dai, Yuntao
collection PubMed
description Due to the complex nature of traditional medicines, quality control methods need to cover two aspects: compliance of raw materials with quality standards and process control. Astragali radix (AR), the roots of Astragalus mongholicus Bunge, was selected in this study as an example of a widely used traditional medicine in various formulations. Astragaloside IV (AG IV) and calycosin 7-O-β-D-glucoside (CG) are used as the markers for the quality control of AR and its products in the Chinese Pharmacopoeia. However, in the raw materials, malic acid esters of the CG and acetate esters of the astragaloside are easily decomposed into CG and AG IV during storage and processing of AR to make extracts for various preparations. The thermal stability of the isoflavonoids and astragalosides in decoction was studied. The level of CG and astragalosides (AG I/AG II/AG IV) was strongly affected by prolonged heat during processing, while calycosin was stable in the conditions. Also the major astragalosides in AR could fully converted into AG IV which eventually reaches a stable level under certain conditions. With calycosin and AG IV as marker components, practical, reproducible, and precise methods were established and applied to the quality analysis of AR from its raw materials to its intermediates and products. This study demonstrates that a full chemical profiles analysis of the whole manufacturing process (from “raw materials—intermediates/extracts—final product”) is important to identify quality markers (Q-markers) and even to establish proper analysis methods for traditional Chinese medicine products.
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spelling pubmed-77755242021-01-02 Quality Markers for Astragali Radix and Its Products Based on Process Analysis Dai, Yuntao Wang, Dongbo Zhao, Manjia Yan, Lihua Zhu, Chao Li, Pengyue Qin, Xuemei Verpoorte, Rob Chen, Shilin Front Pharmacol Pharmacology Due to the complex nature of traditional medicines, quality control methods need to cover two aspects: compliance of raw materials with quality standards and process control. Astragali radix (AR), the roots of Astragalus mongholicus Bunge, was selected in this study as an example of a widely used traditional medicine in various formulations. Astragaloside IV (AG IV) and calycosin 7-O-β-D-glucoside (CG) are used as the markers for the quality control of AR and its products in the Chinese Pharmacopoeia. However, in the raw materials, malic acid esters of the CG and acetate esters of the astragaloside are easily decomposed into CG and AG IV during storage and processing of AR to make extracts for various preparations. The thermal stability of the isoflavonoids and astragalosides in decoction was studied. The level of CG and astragalosides (AG I/AG II/AG IV) was strongly affected by prolonged heat during processing, while calycosin was stable in the conditions. Also the major astragalosides in AR could fully converted into AG IV which eventually reaches a stable level under certain conditions. With calycosin and AG IV as marker components, practical, reproducible, and precise methods were established and applied to the quality analysis of AR from its raw materials to its intermediates and products. This study demonstrates that a full chemical profiles analysis of the whole manufacturing process (from “raw materials—intermediates/extracts—final product”) is important to identify quality markers (Q-markers) and even to establish proper analysis methods for traditional Chinese medicine products. Frontiers Media S.A. 2020-12-18 /pmc/articles/PMC7775524/ /pubmed/33390938 http://dx.doi.org/10.3389/fphar.2020.554777 Text en Copyright © 2020 Dai, Wang, Zhao, Yan, Zhu, Li, Qin, Verpoorte and Chen http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Dai, Yuntao
Wang, Dongbo
Zhao, Manjia
Yan, Lihua
Zhu, Chao
Li, Pengyue
Qin, Xuemei
Verpoorte, Rob
Chen, Shilin
Quality Markers for Astragali Radix and Its Products Based on Process Analysis
title Quality Markers for Astragali Radix and Its Products Based on Process Analysis
title_full Quality Markers for Astragali Radix and Its Products Based on Process Analysis
title_fullStr Quality Markers for Astragali Radix and Its Products Based on Process Analysis
title_full_unstemmed Quality Markers for Astragali Radix and Its Products Based on Process Analysis
title_short Quality Markers for Astragali Radix and Its Products Based on Process Analysis
title_sort quality markers for astragali radix and its products based on process analysis
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7775524/
https://www.ncbi.nlm.nih.gov/pubmed/33390938
http://dx.doi.org/10.3389/fphar.2020.554777
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