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《工程(英文)》 >> 2019年 第5卷 第5期 doi: 10.1016/j.eng.2019.01.015

中药的质量标准——概念、进展与展望

a State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China
b State Key Laboratory of Quality Research of Chinese Medicines, Macau University of Science and Technology, Macao, China
c School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China

收稿日期: 2018-06-21 修回日期: 2018-12-27 录用日期: 2019-01-07 发布日期: 2019-06-26

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摘要

数千年来,中药作为一种重要的补充药物,被广泛应用于各种疾病的治疗中。然而,人们始终未能就其质量控制问题达成一致。中药不同于化学药品,后者往往具有明确且有效的质量标准。现行做法是评估众多草药和制剂中的一种(或几种)化合物的含量,以此用作质量标志物。但所评估的化合物可能既不与药物疗效密切相关,也不具有整体代表性。本文基于临床用途、复方配伍以及中药的生产工艺,对之前提出的中药质量标志物的新概念进行了进一步讨论。同时,还阐述了用于中药(包括草药、炮制品和制剂)定性和定量分析的实用技术方法,以促进发现和鉴定用作质量标志物的特定化学物质,由此形成新的质量控制模式。此外,本文还描述了目前中药质量控制领域所取得的进展。这些进展为中药质量控制的前景提供了有用信息。

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