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.
Biol Trace Elem Res. 2019 Oct;191(2):517-521. doi: 10.1007/s12011-019-1643-8. Epub 2019 Jan 25.
Control of elemental impurities (EIs) in pharmaceutical herbal products is currently important but not a very popular topic in modern toxicological analysis. The occurrence and concentration of EIs in the pharmaceutical herbal products should be controlled and meet the standards of directive International Conference on Harmonisation's Q3D Guideline on Elemental Impurities. An interesting area of interest is measuring EIs including toxic and allergic metals in pharmaceutical herbal products for teething. The aim of this article was determination of Ni and Cr impurities in pharmaceutical herbal products for teething available in Polish pharmacies. Justifications were (1) herbs as an important source of EIs and (2) infants may be particularly sensitive to the toxic effects of metals because they tend to absorb a higher fraction of an oral dose. The analysis was carried out using microwave-assisted wet digestion with concentrated nitric acid and electrothermal atomisation atomic absorption spectrometry. The safety assessment involved a triple approach: (1) level of Ni and Cr impurities in pharmaceutical samples; (2) level of Ni and Cr impurities including one-time administration of teething gels and (3) daily intake of metals. In all three cases, the results indicate that the standards of directive ICH Q3D are met for Ni and Cr. Overall, it can be concluded that none of the teething gels represents a health hazard to infants.
药品草药中元素杂质（EIs）的控制目前在现代毒理学分析中很重要，但并不是一个非常热门的话题。药品草药中 EIs 的出现和浓度应得到控制，并符合指令国际协调会议（ICH）Q3D 元素杂质指导原则的标准。一个有趣的研究领域是测量药品草药中用于出牙的有毒和过敏性金属的 EIs。本文的目的是测定波兰药店出售的用于出牙的药品草药中的 Ni 和 Cr 杂质。理由是（1）草药是 EIs 的重要来源，（2）婴儿由于口服剂量的较高比例吸收，可能对金属的毒性作用特别敏感。分析使用微波辅助湿法消解，用浓硝酸进行消解，用电热原子化原子吸收光谱法进行分析。安全性评估采用三重方法进行：（1）药品样品中 Ni 和 Cr 杂质的水平；（2）包括一次使用出牙凝胶在内的 Ni 和 Cr 杂质水平；（3）金属的日摄入量。在所有三种情况下，结果均表明 Ni 和 Cr 符合 ICH Q3D 指令的标准。总体而言，可以得出结论，没有一种出牙凝胶对婴儿构成健康危害。
