摘要
背景:镁及镁合金因诸多优质特性有很大潜力可成为骨科使用的可降解材料,其是否有良好的生物相容性及适宜此类新型材料的溶血实验评价方法亟待研究。目的:探讨使用不同溶血实验方法测定镁及镁合金材料的溶血率。方法:参考现行国家标准GB/T 16886.4及GB/T 16175制备镁及常用镁合金样品并进行溶血实验(直接接触法),同时将测试介质由生理盐水更换为D-PBS缓冲液作为改良实验,分别计算溶血率。其后测定上清液pH值,并用电感耦合等离子体原子发射光谱法(ICP-AES)测定镁离子浓度。利用统计学方法分析镁及常用镁合金溶血率的影响因素。结果:本研究中的镁及常用镁合金在国标评价方法下溶血率很高(34.0%±2.7%~75.5%±4.4%),而利用D-PBS缓冲液作为测试介质进行改进后,各组溶血率出现了显著下降(1.1%±0.8%~5.3%±3.5%)。同一材料中D-PBS组上清液pH值、镁离子浓度相对生理盐水组显著降低。生理盐水组中溶血率与pH值、镁离子浓度呈显著正相关。结论:采用国标法测试时镁合金与生理盐水反应造成测试液pH升高引起溶血率增高,使用D-PBS缓冲液作为测试介质可消除此干扰因素。适合新型可降解材料的溶血实验标准亟待推出。
Background: Magnesium and its alloys have great potential to be degradable materials for orthopedics because of their good properties. It is urgent to study whether they have good biocompatibility and the hemolysis test evaluation method suitable for these new materials. Objective: To explore the different hemolysis test methods to determine the hemolysis rate of magnesium and magnesium alloy materials. Methods: According to the current national standards GB/T 16886.4 and GB/T16175, the magnesium and magnesium alloy samples were prepared and the hemolysis test(direct contact method) was carried out. Meanwhile, the test medium was changed from normal saline to D-PBS buffer as the modified test, and the hemolysis rate was calculated respectively. Then the pH value of the supernatant was determined, and the concentration of magnesium ion was determined by ICP-AES. The influencing factors of the hemolysis rate of magnesium and magnesium alloys were analyzed by statistical method. Results: The hemolysis rates of magnesium and magnesium alloys were high(34.0%±2.7%-75.5%±4.4%) under the national standard evaluation method. However, the hemolysis rates of all materials decreased significantly(1.1%±0.8%-5.3%±3.5%) after using D-PBS buffer as the test medium. In the same material, the pH value and magnesium isoisn rcaotne cewnatsr aptioosint iovfe lsyu pceorrnrealtaatnet di nw iDth-PthBeS pg rHo uvpa lwuee rae nsdig nmiafigcnaenstiluy mlo iwoenr tchoannc etnhtorsaet iionn.N CS ognrcoluups.i oInn st: heW hNeSn g trhoeu pn, atthioe nhael mstoalyn--dard method is applied to test, the reaction between magnesium alloys and normal saline results in the increase of pH value which causes the increase of hemolysis rate. Using D-PBS buffer as the test medium can eliminate this interference factor. The hemolysis test standard suitable for new degradable materials needs to be introduced urgently.
作者
李政垚
刘洁颖
赵宇
高鹏
王以朋
LI Zhengyao;LIU Jieying;ZHAO Yu;GAO Peng;WANG Yipeng(Department of Orthopaedics,Peking Union Medical College Hospital,CAMS&PUMC,Beijing 100730,China)
出处
《中华骨与关节外科杂志》
2020年第4期319-324,共6页
Chinese Journal of Bone and Joint Surgery
