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[中药指纹图谱(特征图谱)在《中国药典》(2010 - 2020年)中的应用进展与展望]

[Progress and prospect of application of traditional Chinese medicine fingerprint (specific chromatogram) in Chinese Pharmacopoeia (2010-2020)].

作者信息

Yan H, Zou C

机构信息

Pharmacy School of Wannan Medical College, Wuhu 241002, China.

出版信息

Nan Fang Yi Ke Da Xue Xue Bao. 2022 Jan 20;42(1):150-155. doi: 10.12122/j.issn.1673-4254.2022.01.19.

Abstract

The Chinese Pharmacopoeia began to apply fingerprints (specific chromatogram) to quality control of traditional Chinese medicine in its 2010 edition, and in its 2015 and 2020 editions, new fingerprints (specific chromatogram) were added for improvement of the Pharmacopoeia-based national standards for drugs. This review analyzes the traditional Chinese medicine fingerprints (specific chromatogram) in Chinese Pharmacopoeia (2010-2020) in terms of the number of varieties listed, application of fingerprints (specific chromatogram), selection of evaluation method, determination method, the selection of extraction or preparation solvents of the test samples. With the expansion of the application of fingerprints (specific chromatogram), the evaluation indicators are constantly improving. The future development of the fingerprints (specific chromatogram) is also discussed in light of the selection of appropriate extraction or preparation solvents to obtain effective substances, which is the basis for the establishment of the fingerprints; multiple fingerprints for one drug based on different functional indications or basic sources, which expands the application of the fingerprints; addition of technical guidelines for traditional Chinese medicine fingerprints to standardize the use of the fingerprints; and the regular revision, update and application expansion of the fingerprints to ensure its essential role in quality control of traditional Chinese medicine.

摘要

《中国药典》在其2010年版中开始将指纹图谱(特征图谱)应用于中药质量控制,在2015年版和2020年版中,又增加了新的指纹图谱(特征图谱)以完善基于药典的国家药品标准。本综述从收载品种数量、指纹图谱(特征图谱)应用情况、评价方法选择、测定方法、供试品提取或制备溶剂选择等方面,对《中国药典》(2010 - 2020年)中的中药指纹图谱(特征图谱)进行分析。随着指纹图谱(特征图谱)应用范围的扩大,评价指标也在不断完善。还结合选择合适的提取或制备溶剂以获取有效成分(这是建立指纹图谱的基础)、基于不同功能主治或基源对一种药物采用多个指纹图谱(这扩大了指纹图谱的应用)、增加中药指纹图谱技术指导原则以规范指纹图谱的使用、以及对指纹图谱进行定期修订、更新和扩大应用以确保其在中药质量控制中的关键作用等方面,探讨了指纹图谱(特征图谱)的未来发展。

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