Jurowski Kamil, Krośniak Mirosław
Institute of Medical Studies, Medical College, University of Rzeszów, Rzeszów, Poland.
Department of Food Chemistry and Nutrition, Medical College, Jagiellonian University, Kraków, Poland.
Nat Prod Res. 2023 Aug-Sep;37(16):2765-2769. doi: 10.1080/14786419.2022.2128345. Epub 2022 Sep 29.
Traditional herbal medicinal products (THMP) with L., folium (Ribwort Plantain Leaves) are well-known and very popular among the European population. The aim of our study was the toxicological risk assessment for adults of Pb impurities in THMP with L. obtained from pharmacies in Poland. The estimations of Pb impurities in the single dose (22.1 - 50.7 ng/single dose) and in the daily dose (ng/day) were based on the worst-case scenario (WCS), i.e. based on the posology recommended by manufacturers. The estimated daily exposure (ng/day) meets the standards of the ICH Q3D (R1) guideline on elemental impurities (5.0 µg/day) according to the Pb levels (all results were below 250 ng/day). It can be concluded that all investigated THMPs with L., folium available in pharmacies from Poland should not represent any health risk to the adults.
含大车前叶（L.，folium，即车前草叶）的传统草药产品（THMP）在欧洲人群中广为人知且非常受欢迎。我们研究的目的是对从波兰药店获取的含大车前叶的THMP中铅杂质对成年人的毒理学风险进行评估。单剂量（22.1 - 50.7纳克/单剂量）和日剂量（纳克/天）中铅杂质的估计基于最坏情况设想（WCS），即基于制造商推荐的剂量学。根据铅含量，估计的每日暴露量（纳克/天）符合国际人用药品注册技术协调会（ICH）Q3D（R1）关于元素杂质的指南标准（5.0微克/天）（所有结果均低于250纳克/天）。可以得出结论，波兰药店中所有被调查的含大车前叶的THMP对成年人不应构成任何健康风险。
