[1]刘莉莉△,骆红宇,施燕平,等.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*[J].生物医学工程研究,2017,02:183-186.
LIU Lili,LUO Hongyu,SHI Yanping,et al.The Analysis and Safety Evaluation of Tungsten Content in ?Medical Sodium Hyaluronate Gel[J].Journal of Biomedical Engineering Research,2017,02:183-186.
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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*(PDF)
《生物医学工程研究》[ISSN:1006-6977/CN:61-1281/TN]
- 期数:
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2017年02期
- 页码:
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183-186
- 栏目:
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- 出版日期:
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2017-06-25
文章信息/Info
- Title:
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The Analysis and Safety Evaluation of Tungsten Content in ?Medical Sodium Hyaluronate Gel
- 文章编号:
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1672-6278 (2017)02-0183 -04
- 作者:
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刘莉莉1; 2△; 骆红宇1; 2; 施燕平1; 2; 潘华先1; 2; 秦洋2; 3
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1. 山东省医疗器械产品质量检验中心,济南 250101 2.山东省医疗器械生物学评价重点实验室,济南 250101 3. 山东恒信检测技术开发中心,济南 250101
- Author(s):
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LIU Lili1; 2; LUO Hongyu1; 2; SHI Yanping1; 2; PAN Huaxian1; 2; QIN Yang2; 3
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1. Shandong Inspection Center for Medical Devices, Jinan 250101,China;2.ShangDong Biology evaluation key laboratories for Medical Devices,Jinan 250101;3. Shandong Heng Xin Inspection Technique Exploiture Center, Jinan 250101
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- 关键词:
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医用透明质酸钠凝胶; 预灌封注射器; 钨含量; 电感耦合等离子体质谱; 安全性评价
- Keywords:
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Medical sodium hyaluronate gel; Prefilled syringes; Tungsten content; ICP-MS; Safety evaluation
- 分类号:
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R318
- DOI:
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10.19529/j.cnki.1672-6278.2017.02.18
- 文献标识码:
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A
- 摘要:
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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。
- Abstract:
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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.
备注/Memo
- 备注/Memo:
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(收稿日期:2016-10-08) 山东省重点研发计划项目(2015GSF118165)。△通信作者Email:liulili0728@163.com
更新日期/Last Update:
2017-07-10