三維（3D）重組皮膚模型已證實在模擬體內(nèi)代謝條件、給藥濃度及反應靶器官毒性特點方面具有突出優(yōu)勢。近年來已有多家公司構(gòu)建3D重組人工皮膚模型，且一些制藥公司已將3D細胞模型應用于藥物的早期毒性篩選。我國動物實驗替代方法的研究仍處于起步階段，利用3D重組皮膚模型進行體外安全性評價成為目前替代方法的研究熱點之一。綜述人3D重組皮膚模型在遺傳毒性評價中體外微核試驗和彗星試驗的研究進展，并對該模型在外用藥物體外替代遺傳毒性評價中的應用前景進行探討。

The three-dimensional (3D) reconstructed human skin model has been proved to have promising advantages in simulating the metabolic conditions in vivo, the concentration of administration and the toxicity characteristics on the targeted organs. In recent years, the 3D reconstructed skin models have been developed by many companies, and some pharmaceutical companies have launched research on the application of 3D cell model in the early toxicity screening of drugs. However, the research on alternative methods of animal test in China is still in its infancy, and in vitro safety evaluation using 3D reconstructed epidermis has become one of the research hotspots. In this article, the research progress of 3D reconstructed human epidermis in vitro micronucleus test and comet assay in genotoxicity evaluation was reviewed, and its application prospect in in vitro alternative genotoxicity evaluation of drugs was discussed.

R965.1

國家自然科學基金資助項目（81503347，81503068）；國家“十三五”重大新藥創(chuàng)制專項（2018ZX09201017）