医用镁基金属植入器械的研究及应用进展

尤茗语; 张家振; 江珊; 曲春鸽; 田甜

doi:magtech-2025-07-11-00001

中国药物评价 >

2025 , Vol. 42 >Issue 5: 351 - 351-355

DOI: https://doi.org/magtech-2025-07-11-00001

药物研究

医用镁基金属植入器械的研究及应用进展

尤茗语 ,
张家振 ,
江珊 ,
曲春鸽 ,
田甜

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1.国家药品监督管理局医疗器械技术审评检查长三角分中心，上海 201210；
2.国家药品监督管理局医疗器械技术审评中心，北京 100076

尤茗语，女，博士，研究方向：无源医疗器械技术审评

收稿日期: 2025-07-11

修回日期: 2025-08-26

录用日期: 2025-11-27

网络出版日期: 2025-12-15

基金资助

上海市科学技术委员会项目（24692122800）

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Research and Application Progress of Medical Magnesium-Based Implantable Devices

Mingyu YOU ,
Jiazhen ZHANG ,
Shan JIANG ,
Chunge QU ,
Tian TIAN

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1.Yangtze River Delta Center for Medical Device Evaluation and Inspection of NMPA， Shanghai 201210， China；
2.Center for Medical Device Evaluation， NMPA， Beijing 100076， China

Received date: 2025-07-11

Revised date: 2025-08-26

Accepted date: 2025-11-27

Online published: 2025-12-15

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摘要

医用镁基金属植入器械凭借其良好的生物相容性、可降解性及与骨相匹配的力学性能，已成为目前生物可降解植入物方向的研究热点。近年来，随着材料科学和生物医学工程的快速发展，这类器械在骨科、心血管外科等多个临床领域展现出显著优势，其科研成果和产品上市情况备受关注。本研究综述了镁基金属的腐蚀特征和体内/体外降解规律，深入分析了该材料在不同医学领域的应用场景，重点探讨其在骨折内固定及骨修复材料、心血管支架、口腔修复膜、胆管支架等领域的临床应用现状与国内外代表性产品进展，以期为相关领域研究人员、医疗器械审评人员等提供参考依据，推动镁基金属植入器械的临床转化进程。

关键词： ; font-size:medium; ">镁；可降解；骨修复材料；心血管支架；医疗器械

本文引用格式

尤茗语 , 张家振 , 江珊 , 曲春鸽 , 田甜 . 医用镁基金属植入器械的研究及应用进展[J]. 中国药物评价, 2025 , 42(5) : 351 -351-355 . DOI: magtech-2025-07-11-00001

Abstract

Medical magnesium-based implant devices have emerged as a research hotspot in biodegradable implants due to their excellent mechanical properties， biodegradability， and biocompatibility. With rapid advancements in materials science and biomedical engineering in recent years， these devices have demonstrated significant advantages across clinical fields such as orthopedics and cardiovascular surgery， drawing widespread attention to both scientific achievements and commercialized products. This review systematically examines the corrosion characteristics and in vivo/in vitro degradation mechanisms of magnesium alloys， provides an in-depth analysis of their application scenarios in diverse medical domains， and focuses on clinical progress in fracture fixation， bone repair materials， cardiovascular stents， dental membranes， and biliary stents， highlighting representative domestic and international products. The findings aim to offer valuable references for researchers， medical device regulators， and industry stakeholders to accelerate the industrialization of magnesium-based implants.

Key words： ; font-size:medium; ">Magnesium； Biodegradable； Bone repair materials； Cardiovascular stents； Medical devices

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