Institute of Medical Studies, Medical College, Rzeszów University, Al. Mjr. W. Kopisto 2a, 35-959, Rzeszów, Poland.
Department of Food Chemistry and Nutrition, Medical College, Jagiellonian University, Medyczna 9, 30-688, Kraków, Poland.
Regul Toxicol Pharmacol. 2021 Jul;123:104945. doi: 10.1016/j.yrtph.2021.104945. Epub 2021 May 13.
Elemental impurities (EIs) profiling in final pharmaceutical products is often not adequately treated, however it is crucial problem in pharmaceutical analysis by reason of the various regulatory authorities (like ICH Q3D guideline). EIs in pharmaceuticals may arise from numerous sources of which the herbal ingredients are not a frequent subject of pharmaceutical analyses. However, based on number of traditional use registrations per year for herbal medicinal products (HMPs) in the EU, it can be stated that monocomponent HMPs are still very popular for use. Due to the high frequency of use, exposure to EIs from HMPs may be high during long-term use. The aim of our article was Ni and Cr impurities profiling of Valeriana officinalis L., radix (Valerian root) as an example of the HMP available in Polish pharmacies for the relief of mild nervous tension and sleep disorders. The choice of metals was justified by: (1) a single dose of Ni administered via oral route can induce dermatitis in nickel-sensitised individuals; (2) Cr is a very problematic element from toxicological point of view. Our results indicate that the standards of the ICH Q3D guideline are met for all EIs.
元素杂质（EIs）在最终药品中的分析往往得不到充分处理，但鉴于各监管机构（如 ICH Q3D 指南）的要求，这是药品分析中一个至关重要的问题。药品中的 EIs 可能来自许多来源，其中草药成分并不是药品分析的常见对象。然而，基于每年在欧盟进行传统用途注册的草药药品（HMP）数量，可以说单一组分的 HMP 仍然非常受欢迎。由于使用频率高，长期使用 HMP 可能会导致 EIs 暴露量增加。我们的文章旨在分析缬草根（缬草根）中 Ni 和 Cr 杂质的情况，以作为波兰药店中可用于缓解轻度神经紧张和睡眠障碍的 HMP 为例。选择这些金属的原因是：（1）通过口服途径给予单次剂量的 Ni 可在镍敏感个体中引起皮炎；（2）从毒理学角度来看，Cr 是一个非常成问题的元素。我们的研究结果表明，所有 EIs 均符合 ICH Q3D 指南的标准。
