从化妆品监管科学角度探讨类器官及器官芯片的发展现状、趋势与启示  

Discussion of the development status,trend and enlightenment of organoids and organ-on-chips from the perspective of regulatory science of cosmetics

作　　者：林铌 张凤兰[1] 余振喜[1] 王钢力[1] 路勇[1] LIN Ni;ZHANG Fenglan;YU Zhenxi;WANG Gangli;LU Yong(Center of Safety&Technology Evaluation for Cosmetics,National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院化妆品安全技术评价中心,北京100050

出　　处：《药学研究》2024年第4期352-358,共7页Journal of Pharmaceutical Research

基　　金：国家重点研发计划项目(No.2022YFF0711100);中国食品药品检定研究院中青年发展研究基金(No.2022C1)。

摘　　要：类器官和器官芯片等新型体外替代模型是近年国际前沿技术和研究热点,并被逐渐应用于药品、化妆品领域的研发和监管中,使该类技术备受关注。本文首先简要阐释了类器官和器官芯片的基本概念、发展历程及技术特点,然后列举了该类技术在化妆品原料安全性、功效性测试中的应用场景。最后,结合国内外化妆品技术法规,对类器官和器官芯片在提升我国化妆品原料研发效能、支持监管决策方面的未来趋势进行了展望,并从监管科学角度提出了应用该类新技术时的监管建议,以期为符合我国国情的化妆品监管提供技术储备,促进创新性科学研究成果转化为实用性监管科学工具。In recent years,new complex in vitro models such as organoids and organ-on-chips have emerged at the forefront of international technology and research,gradually being applied to drug and cosmetic research,development,and supervision while attracting considerable attention.This article briefly explains the basic concepts,development history,and technical characteristics of organoids and organ-on-chips.It then provides examples of their application in safety and efficacy testing of cosmetic ingredients.Finally,combining domestic and international cosmetic regulations,it looks forward to future trends using organoids and organ-on-chips to improve the efficiency of cosmetic ingredient research and support regulatory decision-making.Additionally,it proposes regulatory suggestions for the application of this type of new technology from a perspective of regulatory science with an aim to provide technical reserves for cosmetic regulation that aligns with China′s situation and promote the transformation of innovative achievements in scientific research into practical regulatory tools.

关 键 词：类器官 器官芯片 化妆品 原料 安全性 功效性 监管科学 

分 类 号：R95[医药卫生—药学]