新型高性能生物医用镁合金（JDBM）安全性和有效性的实验研究

发布时间：2018-06-24 16:53

本文选题：镁合金 + 安全性　；参考：《上海交通大学》2015年硕士论文

【摘要】：目的:1.探讨新型高性能生物医用镁合金(JDBM)的体内安全性,评估该材料对动物重要脏器功能的影响及局部反应;2.探讨新型高性能生物医用镁合金(JDBM)的体内有效性,评估该材料在体内的降解速率及成骨能力。方法:1.体内安全性研究:建立新西兰兔JDBM镁合金植入模型,定时观察伤口愈合及一般状况。收集血液,检测血常规、凝血功能、肝肾功能、心功能及钙磷镁并观察材料植入后上述指标的变化。收集心、肝、脾、肺、肾及螺钉周围肌肉软组织标本,行HE染色,对各脏器进行组织学观察。通过X线摄片观察螺钉周围骨质密度的变化,对螺钉的成骨性能进行初步分析。2.体内有效性研究:建立山羊股骨外侧髁骨折JDBM螺钉内固定模型。首先对伤口愈合及一般状况进行评估。CT扫描观察骨折愈合程度及螺钉的降解速率,而后通过扫描电镜对螺钉表面的微观变化进行观察。应用ELISA法检测螺钉周围局部环境中成骨相关因子含量的变化,通过硬组织切片+苦味酸/品红染色观察螺钉周围新骨的形成并进行评估。结果:1.体内安全性研究证实JDBM材料具有良好的生物安全性。血液学检测结果显示该新型材料对血常规各项指标、凝血功能、肝肾功能及心功能等均无明显影响,同时也不会引起局部肌肉软组织的炎症异物反应。X线片显示,螺钉周围未见明显气体积聚,且降解速度较为缓慢,至6个月时,螺钉依然清晰可见,而在靠近骨皮质区则可看到明显的密度增高的表现,表明此处骨形成较为活跃。2.体内有效性研究证实JDBM具有较强的耐腐蚀效果及较好的促成骨能力。该材料在CT扫描及三维重建中可清晰显像,其体内降解速率较为缓慢,添加钙磷涂层后,可进一步降低其降解速率。扫描电镜显示螺钉表面微观上已出现明显的被腐蚀迹象。ELISA检测显示JDBM螺钉可在植入早期促进周围局部环境中BMP2和BALP的含量升高。硬组织切片检测显示,JDBM具有良好的促成骨性能。结论:1.JDBM是一种生物安全性良好的新型医用镁合金材料;2.JDBM具有良好的体内耐腐蚀性能和体内促成骨性能。
[Abstract]:Purpose 1. To study the safety in vivo of a new type of high performance biomedical magnesium alloy (JDBM), to evaluate the effect of the material on the function of important organs in animals and to evaluate the local reaction of JDBM. To evaluate the biodegradation rate and osteogenic ability of a novel high performance biomedical magnesium alloy (JDBM) in vivo. Method 1: 1. Safety study in vivo: a new Zealand rabbit model of JDBM magnesium alloy implantation was established to observe wound healing and general condition. Blood was collected, blood routine test, coagulation function, liver and kidney function, cardiac function and calcium, phosphorus and magnesium were measured. The specimens of heart, liver, spleen, lung, kidney and muscle and soft tissue around screws were collected and stained with HE. The bone density around the screw was observed by X-ray film, and the osteogenic property of the screw was preliminarily analyzed. 2. In vivo efficacy study: the model of JDBM screw fixation for lateral femoral condylar fracture in goats was established. The healing degree of fracture and the degradation rate of screw were observed by CT scanning, then the microcosmic changes of screw surface were observed by scanning electron microscope. The changes of osteoblast-related factors in local environment around screws were detected by Elisa. The formation of new bone around screws was observed and evaluated by picric acid / fuchsin staining in hard tissue sections. The result is 1: 1. In vivo safety studies confirmed that JDBM has good biological safety. The results of hematological examination showed that the new material had no significant effect on the indexes of blood routine, coagulation function, liver and kidney function and cardiac function, nor did it cause inflammatory foreign body reaction in local muscle and soft tissue. There was no obvious gas accumulation around the screw, and the degradation rate was slow. At 6 months, the screw was still clearly visible, but the density increased obviously near the cortical area of bone, indicating that the bone formation was active in this area. In vivo effectiveness study confirmed that JDBM has strong corrosion resistance and good bone promoting ability. The material can be clearly visualized in CT scan and 3D reconstruction, and its degradation rate in vivo is relatively slow, and the degradation rate can be further reduced after the addition of calcium and phosphorus coating. SEM showed that the surface of the screw had been corroded obviously. Elisa showed that JDBM screw could promote the increase of BMP2 and BALP in the local environment in the early stage of implantation. The results of hard tissue biopsy showed that JDBM had good bone promoting properties. Conclusion: 1. JDBM is a new medical magnesium alloy material with good biological safety. Secondly, JDBM has good corrosion resistance in vivo and bone promoting property in vivo.
【学位授予单位】：上海交通大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R683;R318.08

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