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中药曲剂沉香曲的质量标准研究
邹琳1, 宋露莹1, 冶雅琳1, 王向东2, 杨静1,2, 窦志英3, 王跃飞1,2, 柴欣1,2
1.天津中医药大学中医药研究院, 现代中药创制全国重点实验室, 天津 301617;2.现代中医药海河实验室, 天津 301617;3.天津中医药大学中药学院, 国家中医药管理局中药炮制技术传承基地(天津), 全国老药工传承工作室, 天津 301617
摘要:
[目的] 本研究旨在建立沉香曲的质量标准,并结合网络药理学方法对其薄层鉴别与含量测定指标成分进行预测,为其规范化应用提供科学依据。[方法] 采用网络药理学构建沉香曲的“成分-靶点-通路”网络;以8批沉香曲为研究对象,以其活性成分紫花前胡苷为指标,采用薄层色谱法进行定性鉴别;运用高效液相色谱法测定葛根素含量,并依据《中华人民共和国药典》方法测定水分、总灰分等常规检查项目。[结果] 网络药理学分析提示,葛根素和紫花前胡苷为沉香曲的潜在质量标志物;薄层色谱分析结果显示,各批次沉香曲样品在紫花前胡苷对照品相应位置上均显示清晰、分离良好的蓝色荧光斑点。研究确定了水分不得超过11.0%、总灰分不得超过4.0%的限量范围,并制定了沉香曲中的葛根素含量不得少于0.2%的限度标准。[结论] 通过系统分析沉香曲的质量特征,结合网络药理学预测,建立了涵盖理化检查、薄层鉴别和含量测定的综合评价体系,为沉香曲的质量控制提供了可靠方法。
关键词:  沉香曲  质量标准  薄层鉴别  含量测定  检查项  网络药理学
DOI:10.11656/j.issn.1672-1519.2026.04.12
分类号:R284.1
基金项目:天津市科技计划项目(25ZYCGCG00390);现代中药新质生产力科技创新工程专项(24ZXZKSY00010);现代中医药海河实验室科技项目(25HHZYSS00006);国家中医药管理局科技项目(GZY-KJS-2025-063)。
Study on the quality standard of traditional Chinese medicine fermented preparation: Chenxiangqu
ZOU Lin1, SONG Luying1, YE Yalin1, WANG Xiangdong2, YANG Jing1,2, DOU Zhiying3, WANG Yuefei1,2, CHAI Xin1,2
1.Institute of Traditional Chinese Medicine, State Key Laboratory of Chinese Medicine Modernization, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China;2.Haihe Laboratory of Modern Chinese Medicine, Tianjin 301617, China;3.School of Chinese Materia Medica, Tianjin University of Traditional Chinese Medicine, National Administration of Traditional Chinese Medicine Heritage Base for Traditional Chinese Medicine Processing Technology(Tianjin), National Inheritance Studio of Veteran Pharmacists, Tianjin 301617, China
Abstract:
[Objective] This study aims to establish a quality standard for Chenxiangqu and to predict components for TLC identification and content determination by integrating network pharmacology,thereby providing a scientific basis for its standardized application. [Methods] A “Component-Target-Pathway” network of Chenxiangqu was constructed using network pharmacology. Eight batches of Chenxiangqu were analyzed,with nodakenin selected as the main active ingredient for qualitative identification by thin-layer chromatography(TLC). The content of puerarin was determined by high-performance liquid chromatography(HPLC). In addition,routine test items including moisture and total ash were carried out according to the methods specified in the Chinese Pharmacopoeia. [Results] Network analysis indicated that puerarin and nodakenin may serve as potential quality markers for Chenxiangqu. TLC results revealed clear blue fluorescent spots at the positions corresponding to the nodakenin reference,with good separation. The study established that the moisture content should not be more than 11.0% and the total ash not more than 4.0%,along with setting the content standard requiring that the puerarin content in Chenxiangqu shall not be less than 0.2%. [Conclusion] By systematically characterizing the quality attributes of Chenxiangqu combined with network pharmacology,a comprehensive quality evaluation system was developed incorporating physicochemical tests,TLC identification and content determination,thus providing a reliable approach for quality control of Chenxiangqu.
Key words:  Chenxiangqu  quality standard  TCL identification  content determination  test items  network pharmacology
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