随着药品及化妆品新原料和新剂型的不断出现，亟需能够满足当代药品及化妆品新原料测试需求的新模型新方法。介绍了药品及化妆品原料毒性测试中的体外皮肤模型发展现状，列举了皮肤类器官和皮肤芯片在药品、化妆品原料毒性测试中的应用实例，并结合我国法规和监管现状对类器官与器官芯片模型的验证及标准化提出了建议，最后对皮肤类器官和皮肤芯片作为原料毒性测试工具可能在监管决策中发挥的作用进行了展望，以期为此类新型复杂体外模型的研发和应用提供建议。

With the continuous emergence of new ingredients and dosage forms, novel models and methods are urgently needed to meet the requirements of assessing new ingredients of contemporary cosmetics and drugs. This review introduces the current status of in vitro skin models for toxicity testing of new ingredients of cosmetics and drugs, and then giving several examples of the application of skin organoids and skin-on-chips in toxicity testing of novel ingredients of cosmetics and drugs. The following section puts forward suggestions for validation and standardization of organoids and organ-on-chips based on the current regulations and supervision in China. Finally, the potential role of skin organoids and skin-on-chips as the toxicity testing tools of new ingredients in regulatory decision-making is prospected, with a view to providing suggestions for the development and application of such novel complex in vitro models.

R965.3

国家重点研发计划项目（2022YFF0711100）；中国食品药品检定研究院中青年发展研究基金资助项目（2022C1）