Laboratory of Innovative Toxicological Research and Analyses, Institute of Medical Studies, Medical College, Rzeszów University, Rzeszów, Poland.
Department of Regulatory and Forensic Toxicology, Institute of Medical Expertises, Łódź, Poland.
Nat Prod Res. 2024 Mar;38(6):1067-1072. doi: 10.1080/14786419.2023.2207136. Epub 2023 Apr 28.
Traditional herbal medicinal products (THMP) with ( L. and L.) are very popular among the European population. The idea of our study was the toxicological analysis of lead impurities in THMP with obtained from Polish pharmacies. For this purpose, we prepared the impurity profiles and comprehensive toxicological risk assessment. The Pb impurity profiles show lead impurities in all samples investigated (in the range: 2.15-6.99 μg/L). The estimations of Pb impurities in the single dose (32.25-105.01 ng/single dose) and in the daily dose (64.50-210.00 ng/day) were based on the posology recommended by the manufacturers. All the results obtained meet the standards of the ICH Q3D (R1) guideline on elemental impurities according to the levels of Pb. It can be concluded that all investigated THMPs with available in Poland should not represent any health risk to adults.
含 （L. 和 L.）的传统草药制品在欧洲人群中非常受欢迎。我们研究的想法是对从波兰药店获得的含 的草药制品进行铅杂质的毒理学分析。为此，我们准备了杂质概况和综合毒理学风险评估。Pb 杂质概况显示，在所研究的所有样品中都存在铅杂质（范围：2.15-6.99μg/L）。根据制造商推荐的剂量，对单剂量（32.25-105.01ng/单剂量）和日剂量（64.50-210.00ng/天）中的 Pb 杂质进行了估算。根据 Pb 的水平，所有获得的结果均符合 ICH Q3D（R1）指导原则关于元素杂质的标准。可以得出结论，波兰市售的所有含 的草药制品对成年人不应该构成任何健康风险。
