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中药质量标准:欧洲药典与中国药典的比较及最新进展

Quality standard of traditional Chinese medicines: comparison between European Pharmacopoeia and Chinese Pharmacopoeia and recent advances.

作者信息

Leong Fong, Hua Xue, Wang Mei, Chen Tongkai, Song Yuelin, Tu Pengfei, Chen Xiao-Jia

机构信息

State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Avenida da Universidade, Taipa, Macao People's Republic of China.

LU-European Center for Chinese Medicine and Natural Compounds, Institute of Biology, Leiden University, Sylviusweg72, 2333BE Leiden, The Netherlands.

出版信息

Chin Med. 2020 Jul 28;15:76. doi: 10.1186/s13020-020-00357-3. eCollection 2020.

Abstract

Traditional Chinese medicine (TCM) are becoming more and more popular all over the world. However, quality issues of TCM may lead to medical incidents in practice and therefore quality control is essential to TCM. In this review, the state of TCM in European Pharmacopoeia are compared with that in Chinese Pharmacopoeia, and herbal drugs that are not considered as TCM and not elaborated by TCM working party at European Directorate for the Quality of Medicines & Health Care (EDQM) but present in both European Pharmacopoeia and Chinese Pharmacopoeias are also discussed. Different aspects in quality control of TCM including origins, identification, tests and assays, as well as sample preparation, marker selection and TCM processing are covered to address the importance of establishing comprehensive quality standard of TCM. Furthermore, advanced analytical techniques for quality control and standard establishment of TCM are also reviewed.

摘要

传统中药在全球越来越受欢迎。然而,中药的质量问题可能会在实际应用中导致医疗事故,因此质量控制对中药至关重要。在本综述中,将欧洲药典中的中药情况与中国药典进行了比较,还讨论了那些不被视为中药且未在欧洲药品质量管理局(EDQM)的中药工作组中详细阐述,但同时存在于欧洲药典和中国药典中的草药。涵盖了中药质量控制的不同方面,包括来源、鉴别、检测和含量测定,以及样品制备、标志物选择和中药炮制,以强调建立全面中药质量标准的重要性。此外,还综述了用于中药质量控制和标准建立的先进分析技术。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a080/7388521/c1493b0eed5f/13020_2020_357_Fig1_HTML.jpg

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