Oketch-Rabah Hellen A, Roe Amy L, Rider Cynthia V, Bonkovsky Herbert L, Giancaspro Gabriel I, Navarro Victor, Paine Mary F, Betz Joseph M, Marles Robin J, Casper Steven, Gurley Bill, Jordan Scott A, He Kan, Kapoor Mahendra P, Rao Theertham P, Sherker Averell H, Fontana Robert J, Rossi Simona, Vuppalanchi Raj, Seeff Leonard B, Stolz Andrew, Ahmad Jawad, Koh Christopher, Serrano Jose, Low Dog Tieraona, Ko Richard
U.S. Pharmacopeial Convention, Rockville, MD, USA.
United States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USA.
Toxicol Rep. 2020 Feb 15;7:386-402. doi: 10.1016/j.toxrep.2020.02.008. eCollection 2020.
As part of the United States Pharmacopeia's ongoing review of dietary supplement safety data, a new comprehensive systematic review on green tea extracts (GTE) has been completed. GTEs may contain hepatotoxic solvent residues, pesticide residues, pyrrolizidine alkaloids and elemental impurities, but no evidence of their involvement in GTE-induced liver injury was found during this review. GTE catechin profiles vary significantly with manufacturing processes. Animal and human data indicate that repeated oral administration of bolus doses of GTE during fasting significantly increases bioavailability of catechins, specifically EGCG, possibly involving saturation of first-pass elimination mechanisms. Toxicological studies show a hepatocellular pattern of liver injury. Published adverse event case reports associate hepatotoxicity with EGCG intake amounts from 140 mg to ∼1000 mg/day and substantial inter-individual variability in susceptibility, possibly due to genetic factors. Based on these findings, USP included a cautionary labeling requirement in its Powdered Decaffeinated Green Tea Extract monograph that reads as follows: ")."
作为美国药典对膳食补充剂安全数据持续审查的一部分，一项关于绿茶提取物（GTE）的新的全面系统评价已完成。GTE可能含有肝毒性溶剂残留、农药残留、吡咯里西啶生物碱和元素杂质，但在本次评价中未发现它们与GTE引起的肝损伤有关的证据。GTE的儿茶素谱因生产工艺而异。动物和人体数据表明，禁食期间重复口服大剂量GTE可显著提高儿茶素（特别是表没食子儿茶素没食子酸酯）的生物利用度，这可能涉及首过消除机制的饱和。毒理学研究显示出肝细胞型肝损伤。已发表的不良事件病例报告将肝毒性与每天140毫克至约1000毫克的表没食子儿茶素没食子酸酯摄入量相关联，并且个体易感性存在很大差异，这可能是由于遗传因素。基于这些发现，美国药典在其脱咖啡因绿茶提取物粉末专论中纳入了一项警示标签要求，内容如下：“）” 。
