Sun X, Cao Z Y, Liu J G, Feng C
Department of Materials Science and Engineering, Jilin University, Changchun 130025, China.
Joint Surgery Department, Norman Bethune No.1 Hospital, Jilin University, Changchun 130000, China.
Biomed Mater Eng. 2015;26 Suppl 1:S119-27. doi: 10.3233/BME-151297.
The security risk of magnesium alloys used as biodegradable implant material was evaluated in this study. Dose-response assessment was conducted by using toxicological data from authoritative public health agencies (World Health Organization) and assuming 1~3 years of uniform corrosion. Through modification calculation, the tolerable corrosion rate of biodegradable magnesium alloys in vivo was proposed, which theoretically ensured the bio-safety of the degradation products. The tolerable limits corresponding to various component elements in magnesium alloys were considered separately, although there are deficits in the toxicological data of some component elements. The influence of corrosion on the strength of magnesium alloys was evaluated, which would contribute to the rationally utilization of magnesium alloys as degradable implant materials. This study illustrates that not only toxicological calculations but also mechanical performance should be taken into consideration when developing novel degradable metallic implant.
本研究评估了用作可生物降解植入材料的镁合金的安全风险。通过使用权威公共卫生机构（世界卫生组织）的毒理学数据并假设1至3年的均匀腐蚀来进行剂量反应评估。通过修正计算，提出了可生物降解镁合金在体内的可耐受腐蚀速率，这在理论上确保了降解产物的生物安全性。尽管某些组成元素的毒理学数据存在不足，但分别考虑了镁合金中各种组成元素的耐受限度。评估了腐蚀对镁合金强度的影响，这将有助于合理利用镁合金作为可降解植入材料。本研究表明，在开发新型可降解金属植入物时，不仅应考虑毒理学计算，还应考虑机械性能。
