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基于波兰药店可获得的草药,用 ET AAS 对局部麻醉剂(出牙凝胶)中的 Pb 和 Cd 进行毒理学分析。

Toxicological analysis of Pb and Cd by ET AAS in local anaesthetics for teething (teething gels) based on herbs available in Polish pharmacies.

机构信息

Independent Researcher, Poland; Faculty of Health Promotion, Kraków Higher School of Health Promotion, Krowoderska 73, 31-158 Kraków, Poland.

Department of Food Chemistry and Nutrition, Medical College, Jagiellonian University, Medyczna 9, 30-688 Kraków, Poland.

出版信息

J Trace Elem Med Biol. 2019 Mar;52:18-21. doi: 10.1016/j.jtemb.2018.11.005. Epub 2018 Nov 10.

Abstract

Studies related to the toxicological analyses of metallic impurities in pharmaceuticals (drugs) is an important issue but there is a lack of refereed literature around the safety of teething remedies from herbal origin related to toxic metals impurities. In this article, the levels of Pb and Cd were measured in samples of local anaesthetics for teething (gels) based on herbs. This article was motivated by the fact that Pb and Cd are relevant toxic metals that may cause an adverse effect in babies even at low levels. Additional justifications were (1) the insufficient control of metal impurities in teething gels, (2) the lack of sufficient validation steps and (3) the inadequate sensitivity of applied analytical techniques. The aim of this article was a qualitative and quantitative analysis of Pb and Cd in the most popular and available local anaesthetic for teething (teething gels) based on herbs (n = 5) available in Poland. Metals were determined by ET AAS (electrothermal atomization atomic absorption spectrometry), after digestion in a microwave unit using concentrated nitric acid. It was observed that all samples contained Pb and Cd. The levels of Pb and Cd as impurities (independently of the producer and declared composition) are similar. The concentrations of Pb and Cd, at ng/day levels, to which the user is exposed at daily doses meet the standards of the directive ICH Q3D.

摘要

关于药品(药物)中金属杂质毒理学分析的研究是一个重要问题,但关于草药出牙缓解剂中与有毒金属杂质有关的安全性,却缺乏参考文献。本文测量了基于草药的局部麻醉用出牙(凝胶)样本中 Pb 和 Cd 的水平。这篇文章的动机是 Pb 和 Cd 是相关的有毒金属,即使在低水平下也可能对婴儿造成不良影响。其他原因包括:(1)出牙凝胶中金属杂质的控制不足,(2)缺乏足够的验证步骤,(3)应用分析技术的灵敏度不足。本文的目的是对波兰市场上最受欢迎和可用的基于草药的局部麻醉用出牙(凝胶)(n=5)中 Pb 和 Cd 进行定性和定量分析。金属通过 ET AAS(电热原子化原子吸收光谱法)测定,在微波单元中使用浓硝酸消解后进行。结果表明,所有样本均含有 Pb 和 Cd。Pb 和 Cd 杂质的水平(与生产商和申报成分无关)相似。用户每日剂量下暴露的 Pb 和 Cd 浓度(ng/天)达到 ICH Q3D 指令的标准。

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