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.
J Trace Elem Med Biol. 2019 May;53:109-112. doi: 10.1016/j.jtemb.2019.02.011. Epub 2019 Feb 26.
The monitoring of elemental impurities (EIs) in pharmaceutical materials is often not adequately treated, although it is a very important topic because the directive ICH Q3D requires a wide range of elements, often at low concentrations, to be monitored. This article describes the quantitative toxicological analysis of copper, manganese and zinc as EIs in the pharmaceutical gels for teething containing herbs available in Poland. The levels of EIs were measured to evaluate whether the intake of these metals through the gels was within recommended levels. The flame absorption spectrometry (FAAS) following microwave induced digestion (concentrated nitric acid) was applied to determine the levels of Cu, Mn and Zn in the products. This article was motivated especially by the facts that: (i) herbs can be a potential source of EIs; (ii) Cu, Mn and Zn are essential trace elements in the infancy period; (iii) there is a general lack of data around the risk assessment associated with exposure to these EIs in this kind of pharmaceutical. Our safety assessment is based on triple approach including: (1) profile of EIs in gels; (2) the actual amount of EIs in the appropriate amount of gel applied with a single administration (one drop) and (3) the daily exposure of EIs in analysed teething pharmaceuticals due to the maximum daily dose. Our results show that all EI levels meet the standards of directive ICH Q3D. It can be concluded that all of the teething gels investigated, based on herbs, available in Polish pharmacies do not represents a health hazard to babies.
药物原料中元素杂质（EIs）的监测通常得不到充分处理，尽管这是一个非常重要的话题，因为 ICH Q3D 指令要求广泛监测多种元素，这些元素通常浓度较低。本文描述了定量毒理学分析铜、锰和锌作为波兰市售草药出牙凝胶中的 EIs。测量 EIs 的水平以评估通过凝胶摄入这些金属是否在推荐水平内。采用微波诱导消解（浓硝酸）后的火焰吸收光谱法（FAAS）测定产品中 Cu、Mn 和 Zn 的水平。本文的动机主要有以下几点：（i）草药可能是 EIs 的潜在来源；（ii）Cu、Mn 和 Zn 是婴儿期必需的痕量元素；（iii）在这种药物中，与接触这些 EIs 相关的风险评估缺乏普遍的数据。我们的安全评估基于三重方法，包括：（1）凝胶中 EIs 的概况；（2）在单次给药（一滴）中使用适量凝胶时 EIs 的实际含量；（3）由于最大日剂量，分析出牙药物中 EIs 的每日暴露量。我们的结果表明，所有 EIs 水平均符合 ICH Q3D 指令的标准。可以得出结论，波兰药店中所有基于草药的出牙凝胶都不会对婴儿构成健康危害。
