(1. 上海工程技术大学 材料工程学院，上海 201620；
2. 西北有色金属研究院，西安 710016)
摘 要: 制备一种新型外科植入用钛合金Ti12.5Zr2.5Nb2.5Ta(TZNT)，通过溶血试验、细胞毒性试验和皮下埋植试验系统评价该合金的生物相容性，并与3种标准外科植入用钛合金Ti6Al4V、Ti6Al7Nb以及TA2进行对比。该合金经完全退火工艺处理后(700 ℃，45 min，AC)，主要由大量位向不同的片层状α相簇和少量位于α片间的β相组成。溶血试验结果表明：TZNT的溶血率为0.683%(远低于5%)，因此不会引起急性溶血。细胞毒性试验结果表明：TZNT、Ti6Al4V和Ti6Al7Nb在3个时间组(2、4和6 d)的相对细胞增殖率均不低于100%，细胞毒性等级评定为0级，即对细胞不产生毒性。皮下埋植试验结果表明：与Ti6Al4V和Ti6Al7Nb相比，TZNT和TA2植入白鼠体内4周和8周后，无论是炎细胞密度还是植入物周围的纤维膜厚度均有所降低，TZNT合金植入4周后，组织良好，包绕材料的纤维膜较疏松且与组织间的界限不清；随着植入时间延长至8周，炎细胞密度进一步减少，纤维膜也变得更薄，更致密。综合评价结果表明该新型合金具有良好的生物相容性。
关键字: 生物材料；钛合金；医用钛合金；生物相容性；溶血；细胞毒性；皮下埋植
surgical implant application
（1. School of Materials Engineering, Shanghai University of Engineering Science, Shanghai 201620, China;
2. Northwest Institute for Nonferrous Metal Research, Xi’an 710016, China）
Abstract:The biocompatibility of a new titanium alloy Ti12.5Zr2.5Nb2.5Ta (TZNT) for surgical implant application was investigated by hematolysis test, cytotoxic test and subcutaneous implantation test. The three standard titanium alloys Ti6Al4V, Ti6Al7Nb and TA2 for surgical implant application were taken as contrast materials. TZNT subjected to the full annealing treatment (700 ℃, 45 min, AC) is composed of a large number of lamellar α-phase clusters with different orientations and a small amount of β-phase between lamellar α-phase. The hematolysis test result shows that the hematolysis rate of TZNT is 0.683% (less than 5%), which indicates that the acute hematolysis cannot be induced by TZNT. The cytotoxic test result shows that the relative cell proliferation rates of TZNT, Ti6Al4V and Ti6Al7Nb are more than or equal to 100% at different cultivation periods (2, 4 and 6 d), the cytotoxicity is ranked as 0 grade, which indicates that three titanium alloys cannot induce the cytotoxic effect. The subcutaneous implantation test result shows that the density of inflammation cells and the thickness of fibrous membrane decrease in the TZNT and TA2 groups at different implantation periods (4 weeks and 8 weeks) to white mice when compared with those in the Ti6Al4V and Ti6Al7Nb groups. For TZNT implanted for 4 weeks, the tissues surrounding TZNT are good, the fibrous membrane is very loose and the interface between the fibrous membrane and the tissues is very obscure. When the implantation period increases to 8 weeks, the density of inflammation cells further decreases. Other than that, the fibrous membrane also gets compacter and thinner. The comprehensive evaluation results show that the new titanium alloy TZNT possesses good biocompatibility and is an ideal biomedical material.
Key words: biomaterial; titanium alloy; medical titanium alloy; biocompatibility; hematolysis test; cytotoxic test; subcutaneous implantation
