北京生物医学工程

镍钛形状记忆合金骨植入物镍离子释放的体外测试方法

In vitro test methods for nickel ion release of Ni-Ti shape memory alloy bone implants

作者：郑亚亚吕原原杨英杨艳丽闫鹏伟李景元宋丽霞缪祥文汤京龙

单位：兰州西脉记忆合金股份有限公司(兰州 730010)<br />甘肃省医疗器械检验检测所(兰州 730101) <br />中国食品药品检定研究院(北京 100050)<br />通信作者：李景元，E-mail：630831854@qq.com；汤京龙， E-mail：wys-xbs@nifdc.org.cn

关键词：镍钛形状记忆合金骨植入物；镍离子释放；测试方法

分类号：R318.04；TG139.6

出版年·卷·期（页码）：2023·42·1（57-60）

摘要：

目的镍钛形状记忆合金骨植入物临床使用过程中存在镍离子析出的风险，植入物镍离子释放在体内很难直接测试，为此本文建立一种镍钛形状记忆合金骨植入物镍离子释放的体外测试方法。方法选用磷酸盐缓冲盐溶液（phosphate buffer salt solution ,PBS）作为测试液，用于植入物镍离子的浸提，将植入物置于带盖容器中，容器中装有PBS，将容器静置在温度稳定控制的恒温培养箱内（37±1）℃下，静置相应设置的时间点，每个时间点设1组空白试验和3个相同平行试样进行含镍量测定，测试溶液中镍离子浓度分别用石墨炉原子吸收光谱仪(atomic absorption spectrometer,AAS)和电感耦合等离子体质谱仪(inductively coupled plasma mass spectrometry ,ICP-MS)设备进行测试。结果随时间推移从器械中释放出来的镍离子浓度整体呈下降趋势，镍离子释放时点为4周时，释放周期结束，AAS测得单位面积每日释放量平均值为0.37×10-3μg/（cm2·d）。单位面积测得的累计释放量平均值为10.22×10-3μg/cm2。ICP-MS 测得单位面积每日释放量为平均值：0.29×10-3μg/(cm2·d)。单位面积测得的累计释放量平均值为7.9×10-3μg/cm2。AAS和ICP-MS两种测试方法测试结果差异性不大，结果数据的走势相同说明试验可重复性高。结论此方法可为镍钛形状记忆合金骨植入物的风险评估提供依据，确保植入物在临床使用过程中镍离子的析出不会对人体造成伤害，保证其临床使用的安全性。

Objective The risk of nickel ion precipitation during the clinical use of nickel-titanium shape-memory alloy bone implants exists, and the release of nickel ions from implants is difficult to test directly in vivo.Methods Phosphate buffered salt solution（PBS） was chosen as the test solution for the leaching of nickel ions from implants. The implants were placed in a container with a lid containing PBS, and the container was left in a temperature-stable controlled thermostatic incubator at (37±1)℃ for the corresponding set time points, and one set of blank tests and three identical parallel specimens were set at each time point for the determination of nickel content, and the concentration of nickel ions in the test solution The tests were performed with a graphite furnace atomic absorption spectrometer(AAS) and an inductively coupled plasma mass spectrometer (ICP-MS)device, respectively.Results The overall decreasing trend of nickel ion concentration released from the apparatus over time was observed at the end of the release cycle at the time point of 4 weeks of nickel ion release, and the average daily release amount per unit area measured by AAS was 0.37×10-3μg/(cm2·d). The average value of the cumulative release per unit area was 10.22×10-3μg/cm2. The average value of the daily release per unit area measured by ICP-MS was 0.29×10-3μg/(cm2·d). The mean value of the cumulative release per unit area was 7.9×10-3μg/cm2. The variability of the test results between AAS and ICP-MS was not significant, and the same trend of the results indicated that the test was reproducible. Conclusion This method can provide a basis for risk assessment of nickel-titanium shape-memory alloy bone implants to ensure that the precipitation of nickel ions during the clinical use of the implants will not cause harm to humans and ensure the safety of their clinical use.

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