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.
Biol Trace Elem Res. 2022 Jun;200(6):2963-2969. doi: 10.1007/s12011-021-02861-5. Epub 2021 Aug 10.
Plantago lanceolata L., folium (ribwort plantain) is an active pharmaceutical ingredient in traditional herbal medicinal products (THMP) available in pharmacies as a demulcent for the symptomatic treatment of oral or pharyngeal irritations and associated dry cough. This kind of THMP is widely applied among the European population; however, recently, voices have been heard in the public about alleged cadmium impurities. The idea of our study was a comprehensive risk assessment of the Cd impurity exposure and its effect on human health. Our assessment strategy was based on regulatory aspects (raw results versus limits set by FAO/WHO for herbal medicines) and toxicological risk assessment approach based on ICH Q3D guideline for elemental impurities in final pharmaceutical products. The cadmium was determined by electrothermal atomization atomic absorption spectrometry based on our previously described methodology. Obtained results show that all analysed THMP with P. lanceolata L., folium available in the Polish pharmacies contain cadmium impurities, but at a very low level (ranged 0.73 - 20.6 μg/L). The content of Cd in a single dose (ng/single dose) is also very low and is not a threat to patients. The estimated maximum daily exposure (ng/day) of Cd based on the 'worst-case scenario' (maximum concentrations by oral administration) meets the standards of ICH Q3D guideline (all results were below oral permitted daily exposure; PDE for Cd, i.e. < 5.0 µg/day). It can be concluded that all analysed samples of THMP with P. lanceolata L., folium should not represent any health hazard to the patients due to cadmium levels. To the best of our knowledge, this is the first study about Cd impurity level in THMP with P. lanceolata L., folium (ribwort plantain leaves) available in European pharmacies.
车前草（Plantago lanceolata L.，folium）是一种草药，作为一种黏液抑制剂，在药房中被广泛应用于治疗口腔或咽部刺激和相关干咳等症状。这种草药在欧洲人群中应用广泛，但最近公众中出现了有关其镉杂质的声音。我们研究的目的是对镉杂质暴露及其对人类健康的影响进行全面的风险评估。我们的评估策略基于监管方面（原始结果与草药设定的 FAO/WHO 限量进行对比）和基于 ICH Q3D 指导原则的毒理学风险评估方法，该指导原则针对最终药物产品中的元素杂质。镉是通过电热原子化原子吸收光谱法根据我们之前描述的方法来测定的。研究结果表明，波兰药房中所有含车前草的草药产品均含有镉杂质，但含量非常低（范围为 0.73-20.6μg/L）。单次剂量（ng/单次剂量）的 Cd 含量也非常低，不会对患者构成威胁。基于“最坏情况”（口服最大浓度）估算的最大日接触量（ng/天）符合 ICH Q3D 指南的标准（所有结果均低于口服允许日接触量；即 Cd 的 PDE 为 <5.0μg/天）。因此，可得出结论，由于 Cd 含量低，所有分析的含车前草的草药产品不应对患者的健康构成任何危害。据我们所知，这是第一份关于欧洲药房中含车前草的草药产品中 Cd 杂质水平的研究。
