食物影响研究中高脂餐的配制与改良  

Formulation and modification of high-fat meals in food impact studies

作　　者：蒋倩倩 张薇 项笑娜 黄珺 江波[3] 杨丹丹[1] JIANG Qian-qian;ZHANG Wei;XIANG Xiao-na;HUANG Jun;JIANG Bo;YANG Dan-dan(Nursing Department,The Second Affiliated Hospital Zhejiang University School of Medicine,Hangzhou 310009,Zhejiang Province,China;Nutriology Department,The Second Affiliated Hospital Zhejiang University School of Medicine,Hangzhou 310009,Zhejiang Province,China;Center of Clinical Pharmacology,The Second Affiliated Hospital Zhejiang University School of Medicine,Hangzhou 310009,Zhejiang Province,China)

机构地区：[1]浙江大学医学院附属第二医院,护理部,浙江杭州310009 [2]浙江大学医学院附属第二医院营养科,浙江杭州310009 [3]浙江大学医学院附属第二医院临床药理中心,浙江杭州310009

出　　处：《中国临床药理学杂志》2024年第2期273-275,共3页The Chinese Journal of Clinical Pharmacology

基　　金：国家卫生健康委重大新药创制国家科技重大专项基金资助项目(2020ZX09201022)。

摘　　要：食物对药物吸收影响研究是新药临床药理研究的重要内容。虽然美国食品药品监督管理局《食物对生物利用的影响以及餐后生物等效性研究技术指导原则》以及我国《新药研发过程中食物影响研究技术指导原则》对高脂餐各成分的热量配比均有规定,但国内外各临床研究中心的高脂餐餐谱各异,各种餐谱各有优缺点。本中心调查了国内多家中心的高脂餐状况,结合多年的配餐经验,推出一款中西方结合、制作简便、易精准定量且符合中国人口味的改良版高脂餐餐谱。满意度调查显示,改良版高脂餐餐谱大幅提升了受试者满意度,提高依从性,从而更好地保障试验质量。The food effect(FE)on drug absorption is an important part of clinical pharmacological studies of new drugs.The caloric ratios for each component of a high-fat meal are specified in the“Technical Guidelines for Food Bioavailability and Postprandial Bioequivalence Studies”approved by the US Food and Drug Administration(FDA)and the“Technical Guidelines for Food Effect Studies in New Drug Development”approved by the National Medical Products Administration.However,the recipes for high-fat meals vary among clinical research centers,showing their advantages and disadvantages.Thus,we present a modified version of high-fat meal recipes with easy-to-quantify calories,which is a combination of Western and Chinese flavors,easy to prepare,and meets Chinese tastes.The center satisfaction surveys showed that our modified version of the high-fat meal recipe greatly improved subject satisfaction and compliance,thus better safeguarding the quality of the trial.

关 键 词：食物影响 高热量高脂肪 高脂餐 生物利用度 

分 类 号：R97[医药卫生—药品]