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 Mar;37(5):840-846. doi: 10.1080/14786419.2022.2089987. Epub 2022 Jun 23.
Traditional herbal medicinal products (THMP) with are very popular as OTC among the European population. The aim of this article was the toxicological risk assessment (TRA) of Cd impurities in THMP with from Polish pharmacies. The estimations of Cd impurities in the single dose (1.10-12.90 µg/single dose) and in the daily dose (ng/day) were based on the worst-case scenario (WC), i.e. based on the dosage indicated in the community herbal monograph on L. and L., herba by the European Medicines Agency (EMA). The estimated daily exposure (ng/day) meets the standards of the ICH Q3D (R1) guideline (5.0 µg/day) according to the Cd levels (all results were below 40 ng/day). It can be concluded that all THMPs analysed with from Polish pharmacies should not represent any health risk to the human health.
含 的传统草药药品 (THMP) 在欧洲人群中作为 OTC 非常受欢迎。本文的目的是对波兰药店中含 的 THMP 中的 Cd 杂质进行毒理学风险评估 (TRA)。根据最坏情况 (WC),即基于欧洲药品管理局 (EMA) 在社区草药专论中对 L. 和 L.,herba 的剂量指示,对单个剂量 (1.10-12.90 µg/单个剂量) 和每日剂量 (ng/天) 中的 Cd 杂质进行估计。根据 ICH Q3D (R1) 指南 (5.0 µg/天) 的标准,估计的每日暴露量 (ng/天) (所有结果均低于 40 ng/天)。可以得出结论,波兰药店中分析的所有含 的 THMP 都不应对人类健康构成任何健康风险。