本文選題：醫(yī)用透明質(zhì)酸鈉凝膠　切入點：預(yù)灌封注射器　出處：《生物醫(yī)學(xué)工程研究》2017年02期 　論文類型：期刊論文

【摘要】：鎢元素在預(yù)灌封注射器包裝組件的加工工藝中引入,隨著醫(yī)用透明質(zhì)酸鈉凝膠的使用直接進入人體。為了實現(xiàn)產(chǎn)品中鎢的準確定量,建立了微波消解-電感耦合等離子體質(zhì)譜測定醫(yī)用透明質(zhì)酸鈉凝膠中鎢元素的含量的方法。此方法準確簡便,檢出限為0.0006 mg/kg,定量限為0.002 mg/kg;回收率為95.2%~104.5%。使用該方法對12家市售產(chǎn)品進行測定,鎢的含量在0.03~4.56 ug/g之間。通過毒理學(xué)分析計算,得到每日攝入的鎢元素的量應(yīng)小于75 mg/d。此類產(chǎn)品可滿足人體的安全性評價要求,但可繼續(xù)通過工藝革新等措施減少人體鎢的攝入量。
[Abstract]:The tungsten element is introduced into the processing process of the packing assembly of the pre-filled injector. With the use of the medical sodium hyaluronate gel, it is directly introduced into the human body. In order to realize the accurate quantification of tungsten in the product, A microwave digestion-inductively coupled plasma mass spectrometry (ICP-MS) method for the determination of tungsten in medical sodium hyaluronate gel was established. The detection limit was 0.0006 mg / kg and the quantitative limit was 0.002 mg / kg. The recovery rate was 95.2 mg / kg. The content of tungsten was 0.034.56 ug/g. The daily intake of tungsten should be less than 75 mg / d. This kind of product can meet the safety evaluation requirements of human body, but it can continue to reduce the intake of tungsten through technological innovation and other measures.
【作者單位】： 山東省醫(yī)療器械產(chǎn)品質(zhì)量檢驗中心;山東省醫(yī)療器械生物學(xué)評價重點實驗室;山東恒信檢測技術(shù)開發(fā)中心;
【基金】：山東省重點研發(fā)計劃項目(2015GSF118165)
【分類號】：R318.08

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