β型钛合金材料的生物相容性评价  

Biocompatibility evaluation of β-type titanium alloys

作　　者：张明华[1] 于振涛[2] 张殿忠[1] 井文森[1] 龙华[1] 

机构地区：[1]解放军第四军医大学唐都医院全军骨肿瘤研究所,陕西省西安市710038 [2]西北有色金属研究院,陕西省西安市710016

出　　处：《中国组织工程研究与临床康复》2010年第42期7849-7853,共5页Journal of Clinical Rehabilitative Tissue Engineering Research

基　　金：国家高技术研究发展计划(863计划)(2002AA326070)项目;与硬组织生物力学相容的新型钛合金及其生物涂层技术开发~~

摘　　要：背景:前期大量研究证实钛及钛合金具有良好的生物相容性和较强的耐腐蚀性,β钛合金以其高机械强度、低弹性模量,使其成为目前最具有吸引力的金属生物医学应用材料。目的:评价两种新型β型钛合金材料TLE(Ti-(3～6)Zr-(2～4)Mo-(24～27)Nb),TLM2(Ti-(1.5～4.5)Zr-(0.5～5.5)Sn-(1.5～4.4)Mo-(23.5～26.5)Nb)的生物相容性。方法:取健康成年新西兰兔30只,随机抽签法分为皮下植入组和肌肉植入组。将2种新型钛合金TLE、TLM2加工成圆柱形实验试件,分别植入家兔大腿皮下和背侧肌肉内。对照材料(Ti-6Al-4V)同法植入同一动物的对侧相同部位。依据GB/T16886.6-1997标准,在1,2,6,12,24周取标本大体观察纤维包膜的形态,光学显微镜下观察皮下和肌肉组试件与周围组织界面反应情况,苏木精-伊红染色进行组织学观察。结果与结论:植入2,6,12,24周后,试件周围均形成了血管化的包膜,随着植入时间的延长包膜逐渐变薄、透明度增高,包膜内毛细血管的数量增加。肌肉植入组包膜厚度在6,12周时比皮下植入组薄,炎细胞主要是中性粒细胞、巨噬细胞、多核巨细胞、淋巴细胞和浆细胞,随着时间的延长,各类炎细胞的数量逐渐减少,12周后中性粒细胞数量明显减少,淋巴细胞和浆细胞随时间延长数量逐渐变少,24周时均未见中性粒细胞。说明TLE,TLM2新型医用钛合金生物相容性好,具有良好的临床应用前景。BACKGROUND： Previous studies have validated the good biocompatibility and strong corrosion resistance of titanium and titanium alloys, β titanium alloy has become the most attractive metal biomedical materials due to high mechanical strength and low elastic modulus. OBJECTIVE： To evaluate the biocompatibility of two new β-type titanium alloys： TLE （Ti-（3-6） Zr-（2-4） Mo-（24-27） Nb） and TLM 2 （Ti-（1.5-4.5） Zr-（0. 5-5.5） Sn-（1.5-4.4） Mo-（23.5-26.5） Nb）. METHODS： Thirty healthy adult New Zealand rabbits were involved in this study and randomly divided into two groups： subcutaneous implant group and intramuscular implant group. The two new β-type titanium alloys （TLE, TLM 2） were made into cylindrical test pieces, and implanted into thigh subcutaneous tissue and back muscles in rabbit respectively. The contrast materials （Ti-6Al-4V） were implanted into the opposite side in the same animals. According to GB/T16886.6-1997 standard, the samples were taken at 1, 2, 6, 12 and 24 weeks after the implantation to observe fibrous capsule morphology. Interfacial condition between test pieces and surrounding tissues was observed in light microscope, and histological examinations were carried out through hematoxylin-eosin staining. RESULTS AND CONCLUSION： At 2, 6, 12, 24 weeks, vascularized capsules formed around specimens, and became thinner and transparent along with the implantation time prolonged, the number of capillaries in the capsules was also increased. The capsule thickness of the intramuscular implant group was less than subcutaneous implant group in 6, 12 weeks. Inflammatory cells included mainly neutrophils, macrophages, multinucleated giant cells, lymphocytes and plasma cells. With the time went, the number of inflammatory cells decreased, the number of neutrophils was significantly reduced at 12 weeks, lymphocytes and plasma cells gradually decreased with time, there was no neutrophil at 24 weeks. The two new β-type titanium alloys （TLE, TLM 2） have go

关 键 词：生物相容性 Β型钛合金 植入试验 材料生物相容性 生物材料 

分 类 号：R318[医药卫生—生物医学工程]