摘要
目的:监测外科植入常规热塑性聚氨酯输尿管支架在模拟尿液中的钙、镁离子结晶情况,为常规热塑性聚氨酯材料的安全评估提供技术支持。方法:建立了一种电感耦合等离子体质谱(ICP-MS)法测定输尿管支架模拟体液释放量方法,研究其过程中结晶物的释放情况。结果:镁元素的检出限为0.02617 ng/mL,定量限为0.08723ng/mL,测量值RSD(n=6)为0.5%;钙元素的检出限为0.91980ng/mL,定量限为3.066ng/mL,测量值RSD(n=6)为0.9%。测定镁元素的平均回收率为102.3%~105.6%,钙元素的平均回收率为103.9%~109.0%。随着输尿管支架浸提时间的延长,结晶物含量增加,1个月后钙、镁离子的最大浓度分别达到62.565mg/L和298.333mg/L。结论:该方法操作简单,检出限低,可为输尿管支架类产品的临床前安全性评价提供方法和数据支持。
Objective:Study of ureteral stents surgically implanted with conventional thermoplastic polyurethane materials for monitoring of crystalline calcium and magnesium ions in simulated urine to provide technical support for safety assessment of conventional thermoplastic polyurethane materials.Methods:An inductively coupled plasma mass spectrometry(ICP-MS)method was developed to determine the release of simulated body fluids from ureteral stents and to study the release of crystalline material in the process.Results:The limit of detection(LOD)for magnesium was 0.02617 ng/mL,the limit of quantification(LOQ)was 0.08723 ng/mL,and the RSD,n=6,was 0.5%;The LOD for calcium was 0.91980 ng/mL,and the LOQ was 3.066 ng/mL.The RSD,n=6,was 0.9%.The average recoveries of elemental magnesium ranged from 102.3%to 105.6%,and the average recoveries of elemental calcium ranged from 103.9%to 109.0%.With the increase of ureteral stent leaching time the crystalline matter increased,and the maximum concentrations of calcium and magnesium ions in the crystalline matter at 1 month were 62.565mg/L and 298.333 mg/L,respectively.Conclusion:The method is simple to operate,has a low detection limit,and provides methodological and data support for the preclinical safety evaluation of ureter-based products.
作者
李晨
杨艳丽
LI Chen;YANG Yan-li(Gansu Medical Device Inspection and Testing Institute,Gansu Lanzhou 730070)
出处
《中国医疗器械信息》
2026年第1期44-46,共3页
China Medical Device Information
基金
甘肃省药品科研项目(项目名称:两种聚氨酯材料输尿管支架在人工尿液中腐蚀行为的研究,项目编号:2024GSMPA021)。
关键词
医疗器械
钙、镁离子含量
输尿管支架
medical devices
calcium and magnesium ion content
ureteral stents
