医用透明质酸钠凝胶中钨含量的分析研究及其安全性评价

The Analysis and Safety Evaluation of Tungsten Content in Medical Sodium Hyaluronate Gel

钨元素在预灌封注射器包装组件的加工工艺中引入,随着医用透明质酸钠凝胶的使用直接进入人体。为了实现产品中钨的准确定量,建立了微波消解-电感耦合等离子体质谱测定医用透明质酸钠凝胶中钨元素的含量的方法。此方法准确简便,检出限为0.0006 mg/kg,定量限为0.002 mg/kg;回收率为95.2%~104.5%。使用该方法对12家市售产品进行测定,钨的含量在0.03~4.56 ug/g之间。通过毒理学分析计算,得到每日摄入的钨元素的量应小于75 mg/d。此类产品可满足人体的安全性评价要求,但可继续通过工艺革新等措施减少人体钨的摄入量。

Tungsten element was from the prefilled syringes＇ s manufacturing process,could directly enter into many organs in the body with the use of medical sodium hyaluronate gel. In order to achieve the accurate quantification of tungsten,a new method was established with microwave digestion-ICPMS to determination of tungsten content in medical sodium hyaluronate gel. The method was simple and accurate. The detection limit was 0. 0006 mg/kg and LOQ was 0. 002 mg/kg. The spike recovery results was 95. 2 % ~104. 5 %（ n = 3）. The tungsten content was between 0. 03 and 4. 56 ug/g in 12 commercial products. The daily dose of tungsten elements was less than 75 mg/day by toxicological analysis and calculation. Although the results of these products are satisfied the safety evaluation for the human body,while the intake of tungsten would be reduced through technological innovation and other measures.