纯镁膜体外腐蚀及体内的生物安全性  

In vitro corrosion and in vivo biosafety of pure magnesium film

作　　者：孙溪饶 王程越 赵远 张振保 Sun Xirao;Wang Chengyue;Zhao Yuan;Zhang Zhenbao(Second Affiliated Hospital of Jinzhou Medical University,Jinzhou 121000,Liaoning Province,China;Jinzhou Stomatological Hospital,Jinzhou 121000,Liaoning Province,China)

机构地区：[1]锦州医科大学附属第二医院,辽宁省锦州市121000 [2]锦州市口腔医院,辽宁省锦州市121000

出　　处：《中国组织工程研究》2020年第16期2578-2584,共7页Chinese Journal of Tissue Engineering Research

基　　金：辽宁省自然科学基金计划重点项目(20180530071)，项目负责人：王程越;辽宁省自然科学基金资助计划(2019-MS-141)，项目负责人：孙溪饶~~

摘　　要：背景:镁及其合金具有良好的机械性能、生物相容性及可降解性等,有望在引导骨再生技术中作为引导骨再生膜应用于临床。目的:分析可降解高纯镁膜的体外腐蚀规律及体内生物安全性。方法:将纯镁样品、纯钛样品分别浸泡于人工唾液中,7,14 d后取出样品,观察样品表面腐蚀情况,检测样品失重率、平均腐蚀速率与人工唾液内的pH值。取6只健康杂种犬(由锦州医科大学实验动物中心提供),建立双侧下颌骨缺损模型,左侧植入纯镁膜,右侧植入纯钛膜,术后12周取下颌骨实验区标本,分别进行大体观察、X射线显微镜检测,同时进行主要脏器病理组织学观察。实验方案经锦州医科大学伦理委员会批准。结果与结论:①体外浸泡实验:纯镁样品表面先是出现点腐蚀,随着浸泡时间的延长腐蚀降解越来越严重,浸泡14 d后表现为面腐蚀;纯钛膜无明显腐蚀现象。浸泡纯镁膜溶液的pH值不断升高,在7 d后基本趋于平衡,保持在10左右;纯钛膜pH值相对稳定,且略低于纯镁膜,维持在8.6左右。纯镁膜浸泡14 d的失重率较7 d时增加(P<0.05),平均腐蚀速率较7 d时降低(P<0.05);纯钛膜并无明显降解行为出现,各时间点基本无质量损失。②体内植入实验:纯镁膜组膜材料全部降解,骨小梁排列较紧密,形成立体网状结构,部分骨组织已改建为成熟骨,但仍有骨缺损;纯钛组植骨区新生骨组织充满缺损区,新生骨小梁数量增多,骨小梁较为粗大,排列尚为有序、紧密;纯镁膜组骨缺损区骨体积分数与骨孔隙体积分数均高于纯钛膜组(P<0.05)。实验犬的肝、肾结构均未见异常,未见炎细胞浸润。③结果表明:纯镁膜可促进犬下颌骨骨缺损区的骨愈合,并且生物安全性良好,但其耐腐蚀性有待进一步提高。BACKGROUND: Magnesium and its alloys hold good mechanical properties, biocompatibility and degradability, which can be clinically used as the membrane guiding bone regeneration in guided bone regeneration technology. OBJECTIVVE: To explore the in vitro corrosion and in vivo biosafety of biodegradable high-purity magnesium film. METHODS: The pure magnesium sample and the pure titanium sample were respectively immersed in artificial saliva. After 7 and 14 days, the sample was taken out to observe the surface corrosion, the weight loss rate and the average corrosion rate of the sample, and the pH value in the artificial saliva were determined. Six healthy mongrel dogs(provided by the Experimental Animal Center of Jinzhou Medical University) were selected to establish a bilateral mandibular defect model. The left side was implanted with pure magnesium film an d the right side was implanted with titanium film. At 12 weeks postoperatively, specimens of the mandibular experimental area were removed for gross observation and X-ray examination. The histopathological observation of major organs was performed at the same time. The study was approved by the Ethics Committee of Jinzhou Medical University. RESULTS AND CONCLUSION:(1) In vitro immersion test: pitting corrosion occurred on the surface of pure magnesium sample. Corrosion degradation became more and more serious with the immersion time. After 14 days of immersion, it showed surface corrosion. Pure titanium film showed no obvious corrosion. The pH value of the soaked pure magnesium film solution increased continuously, and it basically became balanced after 7 days, and remained at about 10. The pH value of pure titanium film was relatively stable, and slightly lower than that of pure magnesium film, and maintained at about 8.6. The weight loss rate of pure magnesium film immersed for 14 days was higher than that at 7 days(P < 0.05), and the average corrosion rate was lower than that of 7 days(P < 0.05). There was no obvious degradation behavior of pure titanium film

关 键 词：纯镁膜 纯钛膜 生物安全性 体外腐蚀 引导骨再生技术 下颌骨缺损 生物相容性 体内实验 骨缺损修复 

分 类 号：R459.9[医药卫生—治疗学] R781[医药卫生—临床医学]