(1. 上海工程技術(shù)大學(xué) 材料工程學(xué)院，上海 201620；
2. 西北有色金屬研究院，西安 710016)
摘 要: 制備一種新型外科植入用鈦合金Ti12.5Zr2.5Nb2.5Ta(TZNT)，通過溶血試驗、細胞毒性試驗和皮下埋植試驗系統(tǒng)評價該合金的生物相容性，并與3種標準外科植入用鈦合金Ti6Al4V、Ti6Al7Nb以及TA2進行對比。該合金經(jīng)完全退火工藝處理后(700 ℃，45 min，AC)，主要由大量位向不同的片層狀α相簇和少量位于α片間的β相組成。溶血試驗結(jié)果表明：TZNT的溶血率為0.683%(遠低于5%)，因此不會引起急性溶血。細胞毒性試驗結(jié)果表明：TZNT、Ti6Al4V和Ti6Al7Nb在3個時間組(2、4和6 d)的相對細胞增殖率均不低于100%，細胞毒性等級評定為0級，即對細胞不產(chǎn)生毒性。皮下埋植試驗結(jié)果表明：與Ti6Al4V和Ti6Al7Nb相比，TZNT和TA2植入白鼠體內(nèi)4周和8周后，無論是炎細胞密度還是植入物周圍的纖維膜厚度均有所降低，TZNT合金植入4周后，組織良好，包繞材料的纖維膜較疏松且與組織間的界限不清；隨著植入時間延長至8周，炎細胞密度進一步減少，纖維膜也變得更薄，更致密。綜合評價結(jié)果表明該新型合金具有良好的生物相容性。
關(guān)鍵字: 生物材料；鈦合金；醫(yī)用鈦合金；生物相容性；溶血；細胞毒性；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
