可吸收界面螺钉体外降解行为研究  

In Vitro Degradation Behavior of Absorbable Interface Screws

作　　者：朱雪真 刘威志 孙振龙 闫顺杰 刘华 王忠礼 ZHU Xuezhen;LIU Weizhi;SUN Zhenlong;YAN Shunjie;LIU Hua;WANG Zhongli(Weigao Group Co.Ltd.,National Engineering Research Center,Weihai,264210;Shandong Weigao Orthopedic Materials Co.Ltd.,Weihai,264200)

机构地区：[1]威高集团有限公司国家工程研究中心,威海市264210 [2]山东威高骨科材料股份有限公司,威海市264200

出　　处：《中国医疗器械杂志》2023年第6期598-601,611,共5页Chinese Journal of Medical Instrumentation

基　　金：科技部“十三五”重点研发计划(2017YFC1104800);山东省科技厅重点研发计划项目(2020CXGC010502);威海市国家区域创新中心专项(2017QYCX06)。

摘　　要：通过熔融共混方法制备了以乳酸-乙醇酸共聚物(PLGA)为基体填充β-磷酸三钙(β-TCP)无机填料的复合材料,采用注射成型工艺制备可吸收界面螺钉。配制模拟人体的PBS缓冲液,根据相关医疗器械产品检测标准的要求对界面螺钉进行体外降解实验,对降解不同时间节点的界面螺钉进行特性黏度、平均分子量分布、质量损失、力学性能和热性能等进行测试表征,根据降解性能-时间曲线,确定界面螺钉丧失力学性能的时间节点。详细研究了PLGA和β-TCP复合材料制备的界面螺钉体外降解行为,为PLGA和β-TCP复合材料制备的可吸收产品降解行为提供参考和依据。The composite material PLGA compounded withβ-tricalcium phosphate(β-TCP)was prepared by melt blending method,and the absorbable interface screw was prepared by injection molding process.Prepare PBS buffer that simulates human body,conduct in vitro degradation experiments on interface screws according to relevant national and industry standards,then test and characterize interface screws at different time points for degradation of intrinsic viscosity,average molecular weight distribution,mass loss,mechanical properties and thermal properties.According to the degradation performance-time curve,determine the time node at which the interface screw loses the mechanical properties.In this paper,the in vitro degradation behavior of interfacial screws prepared from PLGA andβ-TCP composites was studied in detail,providing a reference and basis for the degradation behavior of absorbable products prepared from PLGA andβ-TCP composites.

关 键 词：界面螺钉 可吸收 体外降解 性能研究 

分 类 号：R197.39[医药卫生—卫生事业管理] TH77[医药卫生—公共卫生与预防医学]