中国组织工程研究

中国组织工程研究 ›› 2010, Vol. 14 ›› Issue (42): 7849-7853.doi: 10.3969/j.issn.1673-8225.2010.42.014

• 材料生物相容性 material biocompatibility • 上一篇    下一篇

β型钛合金材料的生物相容性评价

张明华1，于振涛2，张殿忠1，井文森1，龙  华1   

  1. 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
  • 出版日期:2010-10-15 发布日期:2010-10-15
  • 作者简介:张明华，男，1961年生，江苏省高淳县人，1985年解放军第四军医大学毕业，副主任医师，副教授，主要从事骨科生物材料研究。 zmhua@fmmu.edu.cn
  • 基金资助:

    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。

Biocompatibility evaluation of β-type titanium alloys

Zhang Ming-hua1, Yu Zhen-tao2, Zhang Dian-zhong1, Jing Wen-sen1, Long Hua1   

  1. 1 Institute of Orthopedics Oncology of Chinese PLA, Tangdu Hospital, Fourth Military Medical University of Chinese PLA, Xi’an   710038, Shaanxi Province, China; 2 Northwest Institute for Nonferrous Metal Research, Xi’an   710016, Shaanxi Province, China
  • Online:2010-10-15 Published:2010-10-15
  • About author:Zhang Ming-hua, Associate chief physician, Associate professor, Institute of Orthopedics Oncology of Chinese PLA, Tangdu Hospital, Fourth Military Medical University of Chinese PLA, Xi’an 710038, Shaanxi Province, China zmhua@fmmu.edu.cn
  • Supported by:

    National High-tech Research & Development Program of China (863 Program), No. 2002AA326070*

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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，TLM 2新型医用钛合金生物相容性好，具有良好的临床应用前景。

关键词: 生物相容性, &beta, 型钛合金, 植入试验, 材料生物相容性, 生物材料

Abstract:

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 good biocompatibility and extensive clinical application outlook in medicine.

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