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一种用于食品药品研究的新丹参酸A对照品的制备与标定

Preparation and Certification of a New Salvianolic Acid A Reference Material for Food and Drug Research.

作者信息

Yang Dezhi, Su Bin, Bi Yancai, Zhang Li, Zhang Baoxi, Song Junke, Lu Yang, Du Guanhua

机构信息

Beijing City Key Laboratory of Polymorphic Drugs, Center of Pharmaceutical Polymorphs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050, People's Republic of China.

Soteria Pharmaceutical Co., Ltd., Laiwu, 271100, People's Republic of China.

出版信息

Nat Prod Bioprospect. 2020 Apr;10(2):67-75. doi: 10.1007/s13659-020-00236-2. Epub 2020 Apr 18.

DOI:10.1007/s13659-020-00236-2
PMID:32306209
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7176770/
Abstract

Salvianolic acid A (Sal A), a water-soluble ingredient in Danshen, has various biological activities. Sal A and its impurities have similar physical and chemical properties, as well as strong reducibility; therefore, they are difficult to prepare and purify. In this study, high-purity Sal A was obtained by purification of sephadex chromatography and preparative chromatography. Furthermore, HPLC-DAD tandem ECD and HPLC-DAD tandem MS methods were used for non-volatile organic impurity analysis, ICP-MS method was used for non-volatile inorganic impurities and mass balance method and quantitative nuclear magnetic resonance were employed to certify the product. The structures of Sal A and its relative impurities were validated by nuclear magnetic resonance spectroscopy and mass spectrometry, and their contents were quantified as well. Following the principles of ISO Guides 34:2009 and 35:2005, a Sal A reference material was certified, covering homogeneity studies, stability studies, characterization, and uncertainty estimations.

摘要

丹参水溶性成分丹酚酸A（Sal A）具有多种生物活性。Sal A与其杂质具有相似的理化性质，且具有较强的还原性，因此难以制备和纯化。本研究通过葡聚糖凝胶柱色谱和制备色谱纯化获得了高纯度的Sal A。此外，采用高效液相色谱-二极管阵列检测器串联电化学检测器（HPLC-DAD tandem ECD）和高效液相色谱-二极管阵列检测器串联质谱（HPLC-DAD tandem MS）方法对非挥发性有机杂质进行分析，采用电感耦合等离子体质谱（ICP-MS）法对非挥发性无机杂质进行分析，并采用质量平衡法和定量核磁共振法对产品进行认证。通过核磁共振光谱和质谱对Sal A及其相关杂质的结构进行了验证，并对其含量进行了定量。按照ISO指南34:2009和35:2005的原则，对Sal A标准物质进行了认证，涵盖了均匀性研究、稳定性研究、特性表征和不确定度评估。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5630/7176770/683a9cc9bf30/13659_2020_236_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5630/7176770/f400923aad05/13659_2020_236_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5630/7176770/e9b5aaa77ebe/13659_2020_236_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5630/7176770/683a9cc9bf30/13659_2020_236_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5630/7176770/f400923aad05/13659_2020_236_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5630/7176770/e9b5aaa77ebe/13659_2020_236_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5630/7176770/683a9cc9bf30/13659_2020_236_Fig3_HTML.jpg

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本文引用的文献

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Anal Bioanal Chem. 2018 Oct;410(26):6719-6731. doi: 10.1007/s00216-018-1272-7. Epub 2018 Aug 24.
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Development of pure certified reference material of stevioside.甜菊糖苷纯标准物质的研制。
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Chemical purity using quantitative H-nuclear magnetic resonance: a hierarchical Bayesian approach for traceable calibrations.
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