冰黄肤乐软膏中24种机元素含量测定及重金属限量标准的建立
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公益性行业科研专项(201507004-2)——10种含矿物药的外用制剂安全性与可控性研究


Determination of 24 Organic Elements in Binghuang Fule Ointment and Establishment of Heavy Metal Limit Standards
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    摘要:

    目的:测定冰黄肤乐软膏中无机元素的含量,提出重金属元素的限量标准,为冰黄肤乐软膏的质量标准的完善和中医临床用药安全提供参考。方法:通过采用微波消解-电感耦合等离子体质谱法对冰黄肤乐软膏的无机元素进行测定和分析。结果:建立了冰黄肤乐软膏中24种无机元素的含量测定方法,精密度、稳定性、重复性、加样回收实验结果均符合药典相关规定。结论:建立的冰黄肤乐软膏无机元素检测方法可行,为冰黄肤乐软膏的质量标准的完善和临床用药安全提供参考。

    Abstract:

    The content of inorganic elements in Binghuang Fule Ointment was determined,and a limit standard for heavy metal elements was proposed,which provided a reference for the improvement of the quality standard of Binghuang Fule Ointment and the safety of clinical medicine in traditional Chinese medicine.Methods:The inorganic elements of Binghuang Fule Ointment were determined and analyzed by microwave digestion-inductively coupled plasma mass spectrometry.Results:A method for determining the content of 24 inorganic elements in Binghuang Fule Ointment was established.The precision,stability,repeatability,and sample recovery test results all met the relevant provisions of the Pharmacopoeia.Conclusion:The established detection method for inorganic elements of Binghuang Fule Ointment is feasible,and it can provide a reference for the improvement of the quality standards of Binghuang Fule Ointment and the safety of clinical medication.

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赵霞,李芝奇,徐玥,于梦圆,张文婷,王昭懿,李朝峰,林瑞超,赵崇军.冰黄肤乐软膏中24种机元素含量测定及重金属限量标准的建立[J].世界中医药,2020,(13).

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  • 收稿日期:2020-06-10
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  • 在线发布日期: 2020-07-30
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