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| 通脉养心丸的研究进展及质量标志物（Q-marker）预测分析 |
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张燕燕1,2, 秦灏学1,2, 叶麟晰1,2, 乐楠茜1,2, 林佳美慧1,2, 唐毅1,2, 陈思璇1,2, 何睿宁1,2, 陈婷1,2,3,4, 张伟1,2
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1.湖南中医药大学中西医结合学院, 长沙 410208;2.中西医结合心脑疾病防治湖南省重点实验室, 长沙 410208;3.湖南省中药粉体与创新药物研究省部共建国家重点实验室培育基地, 长沙 410208;4.省部共建组分中药国家重点实验室, 天津中医药大学, 天津 301617
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| 摘要: |
| 通脉养心丸是一种基于传统中医方剂“炙甘草汤”和“生脉散”加减而成的现代中成药，主要成分包括地黄、甘草、党参等11味中药，具有益气养阴、通脉止痛的功效。现代药理学研究表明，通脉养心丸具有舒张血管、抗炎、保护血管内皮、抑制钙离子超载等多种药理作用，广泛应用于冠心病、心律失常、经皮冠状动脉介入治疗（PCI）术后不良反应等心脏疾病的治疗。通过搜集国内外相关文献，总结了近年来关于通脉养心丸的化学成分、药理作用及临床应用的研究进展，并基于中药质量标志物（Q-marker）的“五原则”，对通脉养心丸的Q-marker进行了预测分析。结果提示地黄苷D、甘草苷、甘草次酸、甘草酸、二苯乙烯苷、大黄素、五味子醇甲、五味子醇乙、五味子乙素、麦冬皂苷D、鲁斯可皂苷元、没食子酸、芒柄花黄素，可作为通脉养心丸的质量标志物，后续可选择以上成分作为通脉养心丸的质量评估指标。文章旨在为完善通脉养心丸制剂过程中质量溯源体系及其质量评价与控制体系提供参考，以期为通脉养心丸的临床应用提供理论支撑。 |
| 关键词: 通脉养心丸 质量标志物 化学成分 药理作用 |
| DOI：10.11656/j.issn.1672-1519.2025.03.18 |
| 分类号:R285.5 |
| 基金项目:国家自然科学基金项目（82405131）；2023年中药粉体与创新药物省部共建国家重点实验室培育基地开放基金项目（23PTKF1019）；组分中药国家重点实验室资助课题（CBCM2024103）；湖南中医药大学校级研究生创新课题（2023CX168）；湖南中医药大学2024年大学生创新创业训练计划课题（X202410541235）。 |
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| Research progress of Tongmai Yangxin Pill and prediction analysis of quality marker（Q-marker） |
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ZHANG Yanyan1,2, QIN Haoxue1,2, YE Linxi1,2, LE Nanxi1,2, LIN Jiamei Hui1,2, TANG Yi1,2, CHEN Sixuan1,2, HE Ruining1,2, CHEN Ting1,2,3,4, ZHANG Wei1,2
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1.College of Integrated Traditional Chinese and Western Medicine, Hunan University of Chinese Medicine, Changsha 410208, China;2.Hunan Key Laboratory of Integrated Chinese and Western Medicine for Prevention and Treatment of Heart and Brain Diseases, Changsha 410208, China;3.Hunan Provincial Ministry of Traditional Chinese Medicine Powder and Innovative Drug Research Co-built National Key Laboratory Cultivation Base, Changsha 410208, China;4.State Key Laboratory of Component-based Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
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| Abstract: |
| Tongmai Yangxin Pill is a modern Chinese herbal medicine based on the addition and subtraction of traditional Chinese medicine prescriptions “Zhigancao Decoction” and “Shengmai Powder”，The main ingredients include Rehmannia glutinosa，licorice root，Codonopsis pilosula and other 11 traditional Chinese medicines. It is known for its effects in replenishing qi，nourishing yin，promoting blood circulation，and alleviating pain. Modern pharmacological studies have demonstrated that Tongmai Yangxin Pill has various pharmacological effects，including vasodilation，anti-inflammatory effects，protection of vascular endothelium，and inhibition of calcium overload. These properties make it widely applicable in the treatment of cardiovascular diseases，such as coronary artery disease，arrhythmias，and adverse reactions after percutaneous coronary intervention（PCI）. This review collected and summarized recent domestic and international research on the chemical composition，pharmacological effects，and clinical applications of Tongmai Yangxin Pill. Additionally，based on the “Five Principles” of traditional Chinese medicine quality markers（Q-markers），this paper predicted and analyzed the Q-markers of Tongmai Yangxin Pill. The results suggested that components such as Rehmannia glutinosa D，glycyrrhizin，glycyrrhetinic acid，glycyrrhizic acid，stilbene glycoside，emodin，schizandrin A，schizandrin B，schisandrin，ophiopogonin D，ruscogenin，gallic acid，and formononetin could serve as quality markers for Tongmai Yangxin Pill. These components can be selected for quality evaluation in future studies. This review aims to provide reference for improving the quality traceability system and quality evaluation and control system in the preparation process of Tongmai Yangxin Pill，in order to provide theoretical support for the clinical application of Tongmai Yangxin Pill. |
| Key words: Tongmai Yangxin Pill quality markers chemical constituent pharmacological effect |
