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生物可降解封堵器中锡残留量的检测方法

Determination Method of Tin Residue in Biodegradable Occluder
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摘要 为准确测定生物可降解封堵器中微量残留的锡,采用石墨炉原子吸收法(GFAAS)和电感耦合等离子体原子发射光谱法(ICP-AES)对生物可降解封堵器产品中锡残留量进行测定,最后就两种检测方法进行对比分析。测定结果表明:两种检测方法均能达到准确测定的条件要求,测试值接近分别为27和31μg·g^(-1),显著低于行业标准限量值150μg·g^(-1);相比于ICP-AES法,GFAAS法具有更低的检出限、定量限,以及更高的精密度,因而更加适用于生物可降解封堵器产品中锡残留量的测定。两种检测方法均具有分析快速、准确、便捷和准确性好等特点,可为相关标准方法研究及方法精密度和准确度评定提供参考。 In order to accurately determine trace residual tin in biodegradable occluders,graphite furnace atomic absorption spectrometry(GFAAS) and inductively coupled plasma atomic emission spectrometry(ICP-AES)were used to determine the residual tin content in biodegradable occluder products. Finally,the two detection methods were compared and analyzed. The measurement results show that the two detection methods can meet the requirements for accurate determination,and the test values are close to 27 μg·g;and 31 μg·g^(-1),which are significant lower than the industry standard limit value of 150 μg·g^(-1). Compared with the ICP-AES method,the GFAAS method has lower detection limits,quantification limits and higher precision,so it is more suitable for the determination of tin residues in biodegradable occluder products.Both of the two detection methods have the characteristics of rapid analysis,accuracy,convenience and good accuracy,which can provide reference for the research of relevant standard methods and the evaluation of method precision and accuracy.
作者 向有缘 王书晗 彭俊 柯浩奇 XIANG Youyuan;WANG Shuhan;PENG Jun;KE Haoqi(Shenzhen Institute of Drug Inspection(Shenzhen Medical Device Testing Center),Shenzhen 518052,China)
出处 《材料研究与应用》 CAS 2022年第3期455-459,共5页 Materials Research and Application
基金 深圳市战略性新兴产业和未来产业发展专项资金项目(201908161544) 高风险医疗器械可沥滤物研究及标准化科技创新团队项目(2021TDB29)。
关键词 生物可降解封堵器 锡残留量 检测 石墨炉原子吸收法 电感耦合等离子体原子发射光谱法 biodegradable occluder tin residue detection graphite furnace atomic absorption spectrometry inductively coupled plasma-atomic emission spectrometry
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