中药质量一致性评价:现状与未来展望》。

IF 4.2 2区 化学 Q1 CHEMISTRY, ANALYTICAL Critical reviews in analytical chemistry Pub Date : 2024-01-22 DOI:10.1080/10408347.2024.2305267
Chun-Lu Liu, Yan Jiang, Hui-Jun Li
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引用次数: 0

摘要

传统中药(TCMs)的质量一致性评价是决定其能否安全有效地应用于临床的关键因素。然而,中药的化学成分多样、异质、复杂、灵活,且制备工艺多变。与化学合成药物和生物药物相比,这些特点给中药的一致性研究带来了更大的挑战。因此,制定有效的中药质量一致性评价策略至关重要。本综述从质量特性出发,从基于化学的策略(化学一致性)和基于生物学的策略(生物等效性)两方面探讨了质量一致性的评价策略。其中,以化学为基础的策略是主流,以生物学为基础的策略与以化学为基础的策略相辅相成。此外,还讨论了新兴的化学-生物学策略(整体评价),包括单独结合策略和整合策略。最后,本综述对这一领域的挑战和未来前景进行了深入探讨。通过强调中药质量一致性的现状和趋势,本综述旨在为建立普遍适用的中药化学-生物学综合评价策略做出贡献。这将促进中药质量评价向更高阶段迈进。
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Quality Consistency Evaluation of Traditional Chinese Medicines: Current Status and Future Perspectives.

Quality consistency evaluation of traditional Chinese medicines (TCMs) is a crucial factor that determines the safe and effective application in clinical settings. However, TCMs exhibit diverse, heterogeneous, complex, and flexible chemical compositions, as well as variability in preparation processes. These characteristics pose greater challenges in researching the consistency of TCMs compared to chemically synthesized and biological drugs. Therefore, it is paramount to develop effective strategies for evaluating the quality consistency of TCMs. From the starting point of quality properties, this review explores the strategy used to evaluate quality consistency in terms of chemistry-based strategy (chemical consistency) and the biology-based strategy (bioequivalence). Among them, the chemistry-based strategy is the mainstream, and biology-based strategy complements the chemistry-based strategy each other. Furthermore, the emerging chemistry-biology strategies (overall evaluation) is discussed, including individually combining strategy and integration strategy. Finally, this review provides insights into the challenges and future perspectives in this field. By highlighting current status and trends in TCMs quality consistency, this review aims to contribute to establishment of generally applicable chemistry-biology integrated evaluation strategy for TCMs. This will facilitate the advancement toward a higher stage of overall quality evaluation.

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来源期刊
CiteScore
12.00
自引率
4.00%
发文量
137
审稿时长
6 months
期刊介绍: Critical Reviews in Analytical Chemistry continues to be a dependable resource for both the expert and the student by providing in-depth, scholarly, insightful reviews of important topics within the discipline of analytical chemistry and related measurement sciences. The journal exclusively publishes review articles that illuminate the underlying science, that evaluate the field''s status by putting recent developments into proper perspective and context, and that speculate on possible future developments. A limited number of articles are of a "tutorial" format written by experts for scientists seeking introduction or clarification in a new area. This journal serves as a forum for linking various underlying components in broad and interdisciplinary means, while maintaining balance between applied and fundamental research. Topics we are interested in receiving reviews on are the following: · chemical analysis; · instrumentation; · chemometrics; · analytical biochemistry; · medicinal analysis; · forensics; · environmental sciences; · applied physics; · and material science.
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