纯镁接骨螺钉在不同浸泡液中降解行为的研究  

Study on degradation behavior of magnesium bone screw in different immersion solution

作　　者：刘莉莉[1,2,3] 沈永 施燕平[1,2,3] 陈方 秦洋[1,2,3] 彭健 Liu Lili;Shen Yong;Shi Yanping;Chen Fang;Qin Yang;Peng Jian(Shandong Quality Inspection Center for Medical Devices,Jinan 250101,China;NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices,Jinan 250101,China;Shandong Key Laboratory of Biological Evaluation for Medical Devices,Jinan 250101,China)

机构地区：[1]山东省医疗器械产品质量检验中心,山东济南250101 [2]国家药品监督管理局生物材料器械安全性评价重点实验室,山东济南250101 [3]山东省医疗器械生物学评价重点实验室,山东济南250101

出　　处：《轻金属》2020年第12期40-46,共7页Light Metals

基　　金：国家重点研发计划项目(2016YFC1103205)。

摘　　要：以纯镁接骨螺钉作为实验模型,采用PBS、Earle、Hanks三种溶液作为体外降解浸泡介质,通过对浸泡溶液pH值、失重率、镁离子释放速度、表面降解形貌变化的测试,对纯镁接骨螺钉的降解行为进行研究。结合检测手段的要求,综合评价体外降解测试方法的可行性,为建立标准化的评价模型提供依据。结果表明:纯镁接骨螺钉在Earle溶液中的降解速度最大,在PBS溶液中的降解速度最小。在Earle溶液中,螺钉初期降解速度可为10 mg/d,7d螺纹边界已不明显,40 d螺钉颈部断裂且完全降解。在Hanks和PBS溶液中,螺钉的降解速度最终均在0.10 mg/d趋于平稳。在PBS溶液中浸泡,96 d螺纹清晰可见。在Hanks溶液中浸泡,28 d螺钉尖端已钝化,96 d螺纹边缘已经部分降解。The in vitro degradation behavior of magnesium bone screw was studied using immersion tests in PBS,Earle and Hanks solutions,by measuring the changes of pH value in immersion solution,weight loss rate,release rate of Mg 2+and surface degradation morphology.Combined with the detection method,the feasibility of in vitro degradation test was comprehensively evaluated,thus providing a basis for the establishment of standardized evaluation model.The results showed that the degradation rate of magnesium bone screw in Earle solution was the fastest,which was the slowest in PBS solution.The preliminary degradation rate of screw in Earle solution reached 10 mg/day,and the thread boundary was not obvious in 7 days,which broken from the neck and degraded completely in 40 days.The degradation rate of the screw in both Hanks and PBS solutions settled at 0.10 mg/day eventually.The thread of the 96-day screw in PBS solution was still clearly visible.In the Hanks solution,the tip of the 28-day screw became rounded and the thread of the 96-day screw was partially degraded.

关 键 词：纯镁接骨螺钉 降解 失重 Mg^2+的释放速度 

分 类 号：R318.08[医药卫生—生物医学工程]