医用镁及其合金材料安全性评价研究进展  

Advances in Safety Evaluation of Medical Magnesium and Alloy Materials

作　　者：张梅玲[1,2] 陈虹[2] 赵丹妹[2] 王春仁[2] 

机构地区：[1]中国药科大学,南京211198 [2]中国食品药品检定研究院,北京100050

出　　处：《中国医疗器械信息》2016年第1期8-14,共7页China Medical Device Information

摘　　要：随着冶金技术的发展,应用最广的有不锈钢、钛及其合金、钴基合金、镍钛形状记忆合金等。现阶段这些传统医用金属材料依然存在着许多不足,如产生缝隙腐蚀、摩擦腐蚀;弹性模量与人骨的相差较大,产生应力遮挡效应,导致愈合迟缓,甚至植入失效;生物惰性材料,不可降解,需再次手术取出。而金属镁及其合金可以克服上述金属材料的缺点,具有可降解、密度和弹性模量与人骨相近、人体必需元素、地球含量丰富等优点,是理想的金属植入材料。但目前镁作为医用材料大多还处于研究阶段,其转化为临床产品仍需要大量的体内外安全评价数据。本文将从细胞毒性、血液相容性、体内植入长期毒性、体内降解吸收分布代谢、临床安全性评价等方面对镁及合金类金属材料作为医用材料的安全性进行了综述。With the development of metallurgical technology, more and more metallic materials begin to be used in clinical,the most used materials in clinical practice currently are stainless steel, titanium and its alloys, cobalt based alloys, nickel-titanium shape memory alloys. But many disadvantages still exist in these traditional medical metallic materials, such as crevice corrosion, friction corrosion; elastic modulus difference with human bones, which results in stress shielding effect, slow healing, and even implant failure. Biologically inert materials, which cannot degrade, and need surgery to remove them again. But the magnesium metal and its alloys can overcome the disadvantages of the metal materials above, which are biodegradable, whose density and modulus of elasticity are similar to human bones. Besides the magnesium is an essential element of human body, which is rich in the earth, etc., so the magnesium is an ideal metal implant material. But magnesium as medical materials is still in the research stage, so amounts of safety evaluation data in vitro and vivo is still required if used in a clinical practice. In this paper, we make a brief review of cytotoxicity, blood compatibility, long-term toxicity, degradation, absorption, distribution and metabolism in vivo, clinical safety evaluation and other aspects of the magnesium alloy material for medical use.

关 键 词：镁及其合金 安全性评价 细胞毒性 长期毒性 吸收分布 

分 类 号：R318.08[医药卫生—生物医学工程]