新型高性能生物醫(yī)用鎂合金(JDBM)安全性和有效性的實(shí)驗(yàn)研究
發(fā)布時(shí)間:2018-06-24 16:53
本文選題:鎂合金 + 安全性; 參考:《上海交通大學(xué)》2015年碩士論文
【摘要】:目的:1.探討新型高性能生物醫(yī)用鎂合金(JDBM)的體內(nèi)安全性,評(píng)估該材料對(duì)動(dòng)物重要臟器功能的影響及局部反應(yīng);2.探討新型高性能生物醫(yī)用鎂合金(JDBM)的體內(nèi)有效性,評(píng)估該材料在體內(nèi)的降解速率及成骨能力。方法:1.體內(nèi)安全性研究:建立新西蘭兔JDBM鎂合金植入模型,定時(shí)觀察傷口愈合及一般狀況。收集血液,檢測(cè)血常規(guī)、凝血功能、肝腎功能、心功能及鈣磷鎂并觀察材料植入后上述指標(biāo)的變化。收集心、肝、脾、肺、腎及螺釘周圍肌肉軟組織標(biāo)本,行HE染色,對(duì)各臟器進(jìn)行組織學(xué)觀察。通過X線攝片觀察螺釘周圍骨質(zhì)密度的變化,對(duì)螺釘?shù)某晒切阅苓M(jìn)行初步分析。2.體內(nèi)有效性研究:建立山羊股骨外側(cè)髁骨折JDBM螺釘內(nèi)固定模型。首先對(duì)傷口愈合及一般狀況進(jìn)行評(píng)估。CT掃描觀察骨折愈合程度及螺釘?shù)慕到馑俾?而后通過掃描電鏡對(duì)螺釘表面的微觀變化進(jìn)行觀察。應(yīng)用ELISA法檢測(cè)螺釘周圍局部環(huán)境中成骨相關(guān)因子含量的變化,通過硬組織切片+苦味酸/品紅染色觀察螺釘周圍新骨的形成并進(jìn)行評(píng)估。結(jié)果:1.體內(nèi)安全性研究證實(shí)JDBM材料具有良好的生物安全性。血液學(xué)檢測(cè)結(jié)果顯示該新型材料對(duì)血常規(guī)各項(xiàng)指標(biāo)、凝血功能、肝腎功能及心功能等均無明顯影響,同時(shí)也不會(huì)引起局部肌肉軟組織的炎癥異物反應(yīng)。X線片顯示,螺釘周圍未見明顯氣體積聚,且降解速度較為緩慢,至6個(gè)月時(shí),螺釘依然清晰可見,而在靠近骨皮質(zhì)區(qū)則可看到明顯的密度增高的表現(xiàn),表明此處骨形成較為活躍。2.體內(nèi)有效性研究證實(shí)JDBM具有較強(qiáng)的耐腐蝕效果及較好的促成骨能力。該材料在CT掃描及三維重建中可清晰顯像,其體內(nèi)降解速率較為緩慢,添加鈣磷涂層后,可進(jìn)一步降低其降解速率。掃描電鏡顯示螺釘表面微觀上已出現(xiàn)明顯的被腐蝕跡象。ELISA檢測(cè)顯示JDBM螺釘可在植入早期促進(jìn)周圍局部環(huán)境中BMP2和BALP的含量升高。硬組織切片檢測(cè)顯示,JDBM具有良好的促成骨性能。結(jié)論:1.JDBM是一種生物安全性良好的新型醫(yī)用鎂合金材料;2.JDBM具有良好的體內(nèi)耐腐蝕性能和體內(nèi)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.
【學(xué)位授予單位】:上海交通大學(xué)
【學(xué)位級(jí)別】:碩士
【學(xué)位授予年份】:2015
【分類號(hào)】:R683;R318.08
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