隨著藥品及化妝品新原料和新劑型的不斷出現(xiàn)，亟需能夠滿足當(dāng)代藥品及化妝品新原料測(cè)試需求的新模型新方法。介紹了藥品及化妝品原料毒性測(cè)試中的體外皮膚模型發(fā)展現(xiàn)狀，列舉了皮膚類器官和皮膚芯片在藥品、化妝品原料毒性測(cè)試中的應(yīng)用實(shí)例，并結(jié)合我國(guó)法規(guī)和監(jiān)管現(xiàn)狀對(duì)類器官與器官芯片模型的驗(yàn)證及標(biāo)準(zhǔn)化提出了建議，最后對(duì)皮膚類器官和皮膚芯片作為原料毒性測(cè)試工具可能在監(jiān)管決策中發(fā)揮的作用進(jìn)行了展望，以期為此類新型復(fù)雜體外模型的研發(fā)和應(yīng)用提供建議。

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

國(guó)家重點(diǎn)研發(fā)計(jì)劃項(xiàng)目（2022YFF0711100）；中國(guó)食品藥品檢定研究院中青年發(fā)展研究基金資助項(xiàng)目（2022C1）