United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts.

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作者： Hellen A,Oketch-Rabah ^[1] ; Amy L,Roe ^[2] ; Cynthia V,Rider ^[2] ; Herbert L,Bonkovsky ^[3] ; Gabriel I,Giancaspro ^[2] ; Victor,Navarro ^[4] ; Mary F,Paine ^[5] ; Joseph M,Betz ^[1] ; Robin J,Marles ^[2] ; Steven,Casper ^[2] ; Bill,Gurley ^[6] ; Scott A,Jordan ^[2] ; Kan,He ^[7] ; Mahendra P,Kapoor ^[2] ; Theertham P,Rao ^[2] ; Averell H,Sherker ^[4] ; Robert J,Fontana ^[2] ; Simona,Rossi ^[2] ; Raj,Vuppalanchi ^[2] ; Leonard B,Seeff ^[2] ; Andrew,Stolz ^[2] ; Jawad,Ahmad ^[6] ; Christopher,Koh ^[8] ; Jose,Serrano ^[6] ; Tieraona,Low Dog ^[9] ; Richard,Ko ^[6]

作者单位： U.S. Pharmacopeial Convention, Rockville, MD, USA. ^[1] United States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USA. ^[2] Vice Chair, (USP GTEH EP, 2015-2020 cycle). ^[3] U.S. FDA Liaison to the USP GTEH EP (2015-2020 cycle). ^[4] Section on Gastroenterology & Hepatology, Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, NC, 27157, USA. ^[5] Expert Members of the Drug Induced Liver Injury Network (DILIN), USA. ^[6] Department of Pharmaceutical Sciences, College of Pharmacy and Pharmaceutical Sciences, Washington State University, Spokane, WA, USA. ^[7] Liver Diseases Research Branch National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 6707 Democracy Blvd., Bethesda, MD, USA. ^[8] Department of Internal Medicine, University of Michigan, Ann Arbor, MI, 48109, USA. ^[9] Liver Diseases Branch, Intramural Research Program, National Institute of Diabetes and Digestive and Kidney Diseases, 10 Center Drive, Building 10, Rm 9B-16, Bethesda, MD, 20892,USA. ^[10] Chair (USP GTEH EP, 2015-2020 cycle). ^[11]

关键词 ADME, Absorption, distribution, metabolism, and excretion ALP, alkaline phosphatase ALT, alanine aminotransferase AST, aspartate aminotransferase AUC, area under the curve Bw, body weight C, Catechin CAM, causality assessment method CG, (+)‐catechin‐3‐gallate CIH, Concanavalin A-induced hepatitis CMC, chemistry, manufacturing, and controls COMT, catechol‐O‐methyltransferase Camellia sinensis ConA, Concanavalin A DILI, drug‐induced liver injury DILIN, Drug‐Induced Liver Injury Network DO, Diversity Outbred DS, Dietary Supplement DSAE, JS3 USP Dietary Supplements Admission Evaluations Joint Standard-Setting Subcommittee Dietary supplements EC, (–)‐epicatechin ECG, (‐)‐epicatechin‐3‐gallate EFSA, European Food Safety Authority EGC, (–)‐epigallocatechin EGCG, (–)‐epigallocatechin‐3‐gallate FDA, United States Food and Drug Administration GC, (+)‐gallocatechin GCG, (–)‐gallocatechin‐3‐gallate GT(E), green tea or green tea extract GT, green tea GTE, green tea extract GTEH, EP Green Tea Extract Hepatotoxicity Expert Panel Green tea Green tea extract HDS, herbal dietary supplement HPMC, Hydroxypropyl methylcellulose Hepatotoxicity LD50, lethal dose, median LFT(s), liver function test(s)LT(s), Liver test(s)Liver injury MGTT, Minnesota Green Tea Trial MIDS, multi-ingredient dietary supplement MRL, maximum residue limit NAA, N-acetyl aspartate NIDDK, National Institute of Diabetes and Digestive and Kidney Diseases NIH, National Institutes of Health NOAEL, no observed adverse effect level NTP, National Toxicology Program OSM, online supplementary material PAs, Pyrrolizidine Alkaloids PD-1, Programmed death domain-1 PDGTE, powdered decaffeinated green tea extract PK/PD, pharmacokinetics and pharmacodynamics RUCAM, Roussel Uclaf Causality Assessment Method SIDS, single-ingredient dietary supplement TGF-beta, Transforming growth factor beta USP, United States Pharmacopeia γ-GT, Gamma-glutamyl transferase

DOI 10.1016/j.toxrep.2020.02.008

PMID 32140423

发布时间 2024-03-28

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United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts.

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United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts.

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