{"title":"中药质量一致性评价:现状与未来展望》。","authors":"Chun-Lu Liu, Yan Jiang, Hui-Jun Li","doi":"10.1080/10408347.2024.2305267","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":10744,"journal":{"name":"Critical reviews in analytical chemistry","volume":" ","pages":"1-18"},"PeriodicalIF":4.2000,"publicationDate":"2024-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Quality Consistency Evaluation of Traditional Chinese Medicines: Current Status and Future Perspectives.\",\"authors\":\"Chun-Lu Liu, Yan Jiang, Hui-Jun Li\",\"doi\":\"10.1080/10408347.2024.2305267\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":10744,\"journal\":{\"name\":\"Critical reviews in analytical chemistry\",\"volume\":\" \",\"pages\":\"1-18\"},\"PeriodicalIF\":4.2000,\"publicationDate\":\"2024-01-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Critical reviews in analytical chemistry\",\"FirstCategoryId\":\"92\",\"ListUrlMain\":\"https://doi.org/10.1080/10408347.2024.2305267\",\"RegionNum\":2,\"RegionCategory\":\"化学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CHEMISTRY, ANALYTICAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Critical reviews in analytical chemistry","FirstCategoryId":"92","ListUrlMain":"https://doi.org/10.1080/10408347.2024.2305267","RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CHEMISTRY, ANALYTICAL","Score":null,"Total":0}
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.
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.