Division of Toxicology, Wageningen University, Tuinlaan 5, 6703 HE Wageningen, The Netherlands.
Division of Toxicology, Wageningen University, Tuinlaan 5, 6703 HE Wageningen, The Netherlands.
Food Chem Toxicol. 2014 Mar;65:147-54. doi: 10.1016/j.fct.2013.12.035. Epub 2013 Dec 30.
This study describes the analysis of estragole in dry fennel preparations and in infusions prepared from them and an associated safety assessment. A wide range of estragole levels of 0.15-13.3mg/g dry fennel preparation was found. The estragole content in infusions was considerably lower ranging between 0.4 and 133.4μg/25mL infusion prepared from 1g dry material. Infusions prepared from whole fennel fruits contained about 3-fold less estragole compared to infusions prepared from fine cut fennel material. Safety assessment was performed using the Margin of Exposure (MOE) approach comparing available tumour data to the estimated daily estragole intakes from the consumption of 1-3 cups fennel tea. MOEs obtained for adults generally point at a low priority for risk management, especially when one cup of fennel tea is used daily during lifetime. MOEs for use of fennel teas by children were generally <10,000 indicating a priority for risk management. However, limiting such uses to 1-2weeks, MOEs might be 3 orders of a magnitude higher and there would be no priority for risk management. These results indicate a low priority for risk management actions for use of fennel teas especially for short-term uses proposed for the symptomatic treatment of digestive disorders.
本研究描述了对干茴香制剂和从中制备的浸液中茴香脑的分析及其相关安全性评估。发现干茴香制剂中茴香脑的含量范围很广，为 0.15-13.3mg/g。从 1g 干材料制备的浸液中，茴香脑的含量要低得多，在 0.4 和 133.4μg/25mL 之间。与从细切茴香材料制备的浸液相比，整个茴香果制备的浸液中含有的茴香脑约少 3 倍。使用暴露量边际（MOE）方法进行安全性评估，将可用的肿瘤数据与从饮用 1-3 杯茴香茶估计的每日茴香脑摄入量进行比较。对于成年人获得的 MOE 通常表明管理风险的优先级较低，特别是在一生中每天使用一杯茴香茶时。儿童使用茴香茶的 MOE 通常<10,000，表明需要管理风险。然而，如果将此类用途限制在 1-2 周内，MOE 可能会高出 3 个数量级，并且管理风险的优先级将降低。这些结果表明，在管理风险方面，茴香茶的使用优先级较低，尤其是对于拟用于治疗消化紊乱的短期使用。
