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交联透明质酸钠凝胶重金属总量检测方法比较与探讨
引用本文:刘叶,彭健,赵长帅,孙兴霞,亓晓庆. 交联透明质酸钠凝胶重金属总量检测方法比较与探讨[J]. 药学研究, 2021, 40(2): 84-86
作者姓名:刘叶  彭健  赵长帅  孙兴霞  亓晓庆
作者单位:山东省医疗器械产品质量检验中心,山东 济南250101;山东省医疗器械产品质量检验中心,山东 济南250101;山东省医疗器械产品质量检验中心,山东 济南250101;山东省医疗器械产品质量检验中心,山东 济南250101;山东省医疗器械产品质量检验中心,山东 济南250101
基金项目:国家重点研发计划项目(No.2016YFC1103205)
摘    要:
目的 探究交联透明质酸钠凝胶重金属总量的检测方法.方法 按照《中国药典》2020年版0821重金属检测法第三法(硫化钠法)和第二法(炽灼残渣法)进行重金属限量检测,追踪实验过程并进行试验结果分析.结果 发现在对交联透明质酸钠凝胶进行重金属限量检测时第三法(硫化钠法)无法正确反映出产品中重金属的限量值,第二法(炽灼残渣法...

关 键 词:交联透明质酸钠凝胶  重金属限量  《中国药典》  硫化钠法  炽灼残渣法

Comparison and discussion on the detection methods of heavy metals in crosslinked sodium hyaluronate gel
LIU Ye,PENG Jian,ZHAO Changshuai,SUN Xingxi,QI Xiaoqing. Comparison and discussion on the detection methods of heavy metals in crosslinked sodium hyaluronate gel[J]. Journal of Pharmaceutical Research, 2021, 40(2): 84-86
Authors:LIU Ye  PENG Jian  ZHAO Changshuai  SUN Xingxi  QI Xiaoqing
Affiliation:Shandong Quality Inspection Center for Medical Devices,Jinan 250101,China
Abstract:
Objective To explore the method of detecting the total amount of heavy metals in crosslinked sodium hyaluronate gel.Methods In this study, two representative sodium hyaluronate gel products from different manufacturers were selected. According to the heavy metal detection method of Pharmacopoeia of the People''s Republic of China (2020 edition) 0821, heavy metal limit detection was carried out by the third method (sodium sulfide method) and the second method (ignition residue method), track the experimental process and analyze the experimental results.Results The experimental phenomena showed that the third method (sodium sulfide method) could not correctly reflect the limit value of heavy metals in the product, the second method (ignition residue method) is more appropriate.Conclusion The crosslinked sodium hyaluronate gel after cauterization and acidification can be used to investigate the total amount of heavy metals in the products.
Keywords:Cross-linked sodium hyaluronate gel  Heavy metal limit  Pharmacopoeia of the People''s Republic of China   sodium sulfide method    ignition residue method
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