State Key Laboratory of Southwestern Chinese Medicine Resources, School of Pharmacy，Chengdu University of Traditional Chinese Medicine, 1166 Liutai Avenue, Wenjiang District, Chengdu 611137, Sichuan, China.
State Key Laboratory of Southwestern Chinese Medicine Resources, School of Pharmacy，Chengdu University of Traditional Chinese Medicine, 1166 Liutai Avenue, Wenjiang District, Chengdu 611137, Sichuan, China.
J Pharm Biomed Anal. 2023 Apr 1;227:115277. doi: 10.1016/j.jpba.2023.115277. Epub 2023 Jan 31.
The quality of traditional Chinese medicine (TCM) guarantees its clinical efficacy. Although advanced analytical techniques and methods can accurately determine the content of chemical components in TCM, it is difficult to accurately determine its clinical efficacy. In addition, the current analytical methods and technologies are complex and have difficulty meeting the requirements of a rapid, accurate and convenient determination of TCM quality. In this study, we first propose the concept of "indistinct" evaluation of the quality of TCM, that is, combining biological potency with character evaluation, quantifying the character evaluation, and preparing the safflower quality grade evaluation card based on the character analysis, which provides research ideas and methods for the rapid and accurate evaluation of the quality of TCM. We determined the biological potency of different batches of safflower based on the in vitro antiplatelet aggregation model and divided the safflower samples into two grades based on the biological potency. We further collected the color information of different grades of safflower samples, quantified the color information of different grades of safflower, drew a quality grade evaluation card for the rapid judgment of safflower quality grade and verified its accuracy by pharmacodynamic evaluation. To further analyze the differences in the material basis of different grades of safflower, the LC-MS method was used to simultaneously determine the contents of 19 chemical components, such as myricetin, in different grades of safflower samples to analyze the differences in the material basis of different grades of safflower. The result shows that the different grades of safflower exhibited significant differences in color. The pharmacodynamic results show that the quality evaluation card prepared based on color information can accurately evaluate quality, and the effect of first-class safflower is significantly better than that of second-class safflower. The chemical analysis results of different grades of safflower show that there are also significant differences between them, among which hypericin, 6-hydroxyapin-6-O-glucose-7-O-glucuronide, 6-hydroxykaempferol-3,6-O-diglucoside-7-O-glucuronic acid glycoside, 6-hydroxykaempferol-3,6,7-tri-O-glucoside and hydroxysafflower yellow A exhibit significant differences, which may be the main differentiating components of different grades of safflower. This study preliminarily confirmed that the "indistinct" evaluation of the quality of TCM based on character analysis is accurate and scientific, and the quality evaluation card prepared can accurately judge the quality of TCM, providing a reference for the rapid application of TCM character evaluation.
中药（TCM）的质量保证了其临床疗效。虽然先进的分析技术和方法可以准确测定 TCM 中化学成分的含量，但很难准确测定其临床疗效。此外，目前的分析方法和技术复杂，难以满足 TCM 质量快速、准确、方便测定的要求。在本研究中，我们首先提出了“模糊”评价 TCM 质量的概念，即结合生物效价和性状评价，对性状评价进行量化，并基于性状分析制备红花质量等级评价卡，为 TCM 质量的快速准确评价提供了研究思路和方法。我们基于体外抗血小板聚集模型测定了不同批次红花的生物效价，并根据生物效价将红花样品分为两个等级。我们进一步收集了不同等级红花样品的颜色信息，对不同等级红花的颜色信息进行了量化，绘制了红花质量等级快速判断的质量等级评价卡，并通过药效学评价验证了其准确性。为了进一步分析不同等级红花物质基础的差异，采用 LC-MS 法同时测定不同等级红花样品中杨梅素等 19 种化学成分的含量，分析不同等级红花物质基础的差异。结果表明，不同等级的红花在颜色上有显著差异。药效学结果表明，基于颜色信息制备的质量评价卡能够准确评价质量，一级红花的效果明显优于二级红花。不同等级红花的化学分析结果表明，它们之间也存在显著差异，其中金丝桃苷、6-羟基阿魏酰基-6-O-葡萄糖-7-O-葡萄糖苷、6-羟基山柰酚-3,6-O-二葡萄糖苷-7-O-葡萄糖醛酸苷、6-羟基山柰酚-3,6,7-三-O-葡萄糖苷和羟基红花黄色素 A 表现出显著差异，可能是不同等级红花的主要区分成分。本研究初步证实了基于性状分析的 TCM“模糊”质量评价是准确和科学的，制备的质量评价卡能够准确判断 TCM 的质量，为 TCM 性状评价的快速应用提供了参考。
