基于基准剂量反应建模的食品中的大麻素的最新风险评估
Eva Wisotzki1,2, Heike Franke1, Constanze Sproll2
1Postgraduate Study of Toxicology and Environmental Protection, Rudolf-Boehm-Institut für Pharmakologie und Toxikologie, Universität Leipzig, Härtelstrasse 16-18, 04107 Leipzig, Germany.
Molecules (Basel, Switzerland)
|October 16, 2024
概括
大麻素 (CBD) 存在风险,动物研究表明安全剂量为每天15毫克,人类数据表明每天10毫克. 由于未受监管的CBD市场的安全问题,建议进行初步监管.
科学领域:
- 药理学和毒理学 药理学和毒理学
- 食品安全法规 食品安全法规
- 大麻素研究 研究 大麻素研究
背景情况:
- 卡纳比 (CBD) 是一种非精神活性大麻化合物,已获得药物批准 (Epidyolex),但作为食品成分面临监管障碍.
- 一个不断扩大的,不受监管的市场提供CBD产品与未经验证的健康声明和剂量.
- 人们对CBD潜在的肝毒性和对人类生殖健康的影响存在担忧.
研究的目的:
- 进行CBD作为食品成分的风险评估.
- 为人类安全消费建立基于健康的指导值 (HBGV).
- 评估是否需要对CBD市场进行初步监管.
主要方法:
- 确定和分析适用于基准剂量 (BMD) 计算的研究.
- 对动物研究数据的推断,以确定安全的人类剂量.
- 对人类数据的分析,以确定最低观察到的不良影响水平 (LOAEL).
主要成果:
- 动物研究确定了43 mg/kg bw/day的基准剂量下置信限值 (BMDL),这表明人体安全剂量约为15 mg/day.
- 人类数据给出了4.3毫克/公斤体重/天的LOAEL.
- 一个更新的风险评估证实了基于人体LOAEL的10毫克/天的HBGV.
结论:
- 已建立的每天10毫克的HBGV为消费者安全提供了基础.
- 目前不受监管的CBD市场给消费者带来了不可接受的风险.
- 建议采取初步监管措施,以解决安全差距并保护公众健康.
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