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鎳鈦形狀記憶合金骨植入物鎳離子釋放的體外測試方法 In vitro test methods for nickel ion release of Ni-Ti shape memory alloy bone implants |
| 作者： 鄭亞亞 呂原原 楊英 楊艷麗 閆鵬偉 李景元 宋麗霞 繆祥文 湯京龍 |
| 單位：蘭州西脈記憶合金股份有限公司(蘭州 730010)<br />甘肅省醫(yī)療器械檢驗檢測所(蘭州 730101) <br />中國食品藥品檢定研究院(北京 100050)<br />通信作者：李景元，E-mail：[email protected]；湯京龍， E-mail：[email protected] |
| 關(guān)鍵詞： 鎳鈦形狀記憶合金骨植入物；鎳離子釋放；測試方法 |
| 分類號：R318.04；TG139.6 |
| 出版年·卷·期（頁碼）：2023·42·1（57-60） |
| 摘要： |
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目的 鎳鈦形狀記憶合金骨植入物臨床使用過程中存在鎳離子析出的風(fēng)險，植入物鎳離子釋放在體內(nèi)很難直接測試，為此本文建立一種鎳鈦形狀記憶合金骨植入物鎳離子釋放的體外測試方法。方法 選用磷酸鹽緩沖鹽溶液（phosphate buffer salt solution ,PBS）作為測試液，用于植入物鎳離子的浸提，將植入物置于帶蓋容器中，容器中裝有PBS，將容器靜置在溫度穩(wěn)定控制的恒溫培養(yǎng)箱內(nèi)（37±1）℃下，靜置相應(yīng)設(shè)置的時間點，每個時間點設(shè)1組空白試驗和3個相同平行試樣進(jìn)行含鎳量測定，測試溶液中鎳離子濃度分別用石墨爐原子吸收光譜儀(atomic absorption spectrometer,AAS)和電感耦合等離子體質(zhì)譜儀(inductively coupled plasma mass spectrometry ,ICP-MS)設(shè)備進(jìn)行測試。結(jié)果 隨時間推移從器械中釋放出來的鎳離子濃度整體呈下降趨勢，鎳離子釋放時點為4周時，釋放周期結(jié)束，AAS測得單位面積每日釋放量平均值為0.37×10-3μg/（cm2·d）。單位面積測得的累計釋放量平均值為10.22×10-3μg/cm2。ICP-MS 測得單位面積每日釋放量為平均值：0.29×10-3μg/(cm2·d)。單位面積測得的累計釋放量平均值為7.9×10-3μg/cm2。AAS和ICP-MS兩種測試方法測試結(jié)果差異性不大，結(jié)果數(shù)據(jù)的走勢相同說明試驗可重復(fù)性高。結(jié)論 此方法可為鎳鈦形狀記憶合金骨植入物的風(fēng)險評估提供依據(jù)，確保植入物在臨床使用過程中鎳離子的析出不會對人體造成傷害，保證其臨床使用的安全性。 |
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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. |
| 參考文獻(xiàn)： |
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[1] 《中國組織工程研究與臨床康復(fù)》雜志社學(xué)術(shù)部.醫(yī)用TiNi形狀記憶合金在中國臨床醫(yī)學(xué)領(lǐng)域的應(yīng)用[J]. 中國組織工程研究與臨床康復(fù)，2011,15（25）：4565-4566. |
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地址：北京安定門外安貞醫(yī)院內(nèi)北京生物醫(yī)學(xué)工程編輯部 電話：010-64456508 傳真：010-64456661 電子郵箱：[email protected] |