微弧氧化钛基生物材料的制备及溶血率检测

背景:微弧氧化工艺是一种直接在金属表面原位生长陶瓷层的新型表面处理技术。而作为种植体材料的表面改性技术还处于实验阶段,有关其生物相容性的研究报道较少。目的:采用微弧氧化工艺对钛片进行表面改性,并检测这种改性后生物材料的溶血率。设计:设置阳性、阴性对照,对比观察,金标准对照。单位:武汉协和医院。材料:选用健康雄性成年新西兰大白兔1只,普通级,体质量2.5kg。纯钛棒TA1(宝鸡市英耐特有色金属有限公司);经过微弧氧化表面改性处理的钛试件;20g/L草酸钾。方法:实验于2006-05在华中科技大学同济医学院附属协和医院普外科实验市完成。①材料:按一定比例配置去离子水和磷酸氢二钠、乙酸钙成微弧氧化电解液,直径为10mm,厚度为2mm的钛片置于电解液中表面进行微弧氧化反应10min。②实验分组:实验组、阴性对照组及阳性对照组。实验组:微弧氧化-Ti试件,浸泡在10mL生理盐水的试管中;阳性对照组:每个试管加10mL去离子水;阴性对照组:每个试管加10mL生理盐水。③实验操作:抽取新西兰大白兔新鲜全血,抗凝后分别与实验组和阳性对照、阴性对照组接触,用紫外-可见光分光光度计比色,评价各组的溶血率。按国际化标准组织规定要求,以溶血率≤5%判定材料符合医用材料的溶血要求,溶血率>5%预示材料有溶血作用。主要观察指标:3组材料的溶血率。结果:实验组溶血率为0.90%,提示该种植材料无溶血作用。结论:微弧氧化钛基材料对红细胞无毒性作用,符合国内外溶血测试标准。

Preparation of titanium substrate biomaterials by using microarc oxidation and measurement of blood compatibility

BACKGROUND: Microarc oxidation (MAO) is a break-through anodyzing technology for forming oxide films on valve metal.Use of this technology allows thick, porous oxide layers to be formed on the surface of pure titanium. Few biocompatibility reports using this treatment have been found.OBJECTIVE: The blood compatibility of a novel surface modified titanium substrata biomaterial using MAO was investigated.DESIGN: Positive and negative control, contrast observation and gold standard control.SETTING: Wuhan Union Hospital.MATERIALS: A healthy male adult New-Zealand rabbit, weighing 2.5 kg and ordinary grade, was selected in this study.Pure titanium sticks TA1 (Baoji Yingnaite Non-ferrous Metal Co., Ltd.), MAO-Ti and 20 g/L potassium oxalate were also selected in this study.METHODS: The study was carried out in the Laboratory of General Surgery, Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology in May 2006. ① Materials: Titanium substrate of 10 mm in diameter and 2 mm in depth was put in an electrolyte which was quipped with deionized water, dibasic sodium phosphate, and ethanoic acid calcium for MAO treatment for 10 minutes. ② Groups: Three groups were analysed: test group, negative control group and positive control group. Test group: MAO-Ti was dipped in 10 mL saline; Positive control group: 10 mL deionized water was added in each tube; Negative control group: 10 mL saline was added in each tube. ③ Operation: Fresh whole blood was collected from rabbit and then mixed with the liquids in the three groups respectively after anti-coagulation. In addition, UV-Visible Spectrophotometer was used to evaluate the hemolytic ratio. A hemolytic ratio below or equal to 5% indicated that this novel material fitted the requirements. On the contrary, a hemolytic ratio higher than 5% proofed the existence of a hemolyzation.MAIN OUTCOME MEASURES: The hemolytic ratio of materials in three groups.RESULTS: The hemolytic ratio of the test group was 0.90%. The result indicated that this new material had no haemolysis effect.CONCLUSION: The material does not resolve red blood cells and is coincident with the international and governmental standard.