南方医科大学学报 ›› 2022, Vol. 42 ›› Issue (1): 150-155.doi: 10.12122/j.issn.1673-4254.2022.01.19

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《中国药典》(2010年版~2020年版)中药指纹(特征)图谱应用进展与展望

鄢海燕,邹纯才   

  1. 皖南医学院药学院,安徽 芜湖 241002
  • 出版日期:2022-01-20 发布日期:2022-03-02

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

YAN Haiyan, ZOU Chuncai   

  1. Pharmacy School of Wannan Medical College, Wuhu 241002, China
  • Online:2022-01-20 Published:2022-03-02

摘要: 《中国药典》2010年版开始将指纹(特征)图谱用于中药的质量控制,《中国药典》2015年版和《中国药典》2020年版均新增了指纹(特征)图谱,完善了以《中国药典》为核心的国家药品标准。本文从收载品种数及指纹(特征)图谱应用情况、评价方法、测定方法的选择、供试品提取或制备溶剂的选择等几个方面对《中国药典》(2010年版~2020年版)中药指纹(特征)图谱进行了归纳、整理与分析,发现指纹(特征)图谱在得到更广泛应用的同时,评价指标也在不断完善。同时,从选择合适的提取或制备溶剂获得药效物质是指纹(特征)图谱建立的基础、基于不同功能主治或基源建立一药多谱是指纹(特征)图谱的有效拓展、增加中药指纹(特征)图谱技术指导原则是规范指纹(特征)图谱使用的保障、指纹(特征)图谱的修订更新与应用延伸是指纹图谱活力体现等几个方面对指纹(特征)图谱进行了展望,以期推动中药指纹(特征)图谱在中药质量控制中发挥更大作用。

关键词: 中国药典;中药指纹(特征)图谱;质量控制

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.

Key words: Chinese Pharmacopoeia; traditional Chinese medicine fingerprint (specific chromatogram); quality control