超微结构病理学是药物非临床毒理学研究中毒性病理学评估的重要辅助工具。简要介绍了超微结构病理学在药物非临床安全性评价毒理学研究中的应用现状和关注点，并举例说明了透射电子显微镜等超微结构病理学技术在药物非临床安全性评价中的应用。目前，超微结构病理学技术在药物非临床毒理研究中虽然使用率不高，却是非临床毒理学研究中毒性病理学评估的重要辅助工具，可用于对光学显微镜检查结果的进一步研究，以作为早期药物发现和非临床安全性评价毒理学研究的有益补充。在使用超微结构病理学技术进行药物非临床毒理学研究时，应关注其使用的必要性、良好实验室规范（GLP）依从性、专业性、科学性和使用局限性等方面。

Ultrastructural pathology is an essential auxiliary tool for the assessment of toxicologic pathology in nonclinical toxicology studies of drugs. This paper briefly introduces the current application status and points to consider of ultrastructural pathology in toxicology studies during nonclinical safety evaluation of drugs, and exemplifies the application of ultrastructural pathology techniques such as transmission electron microscope (TEM) in nonclinical safety evaluation of drugs. At present, although the ultrastructural pathology technology has a low usage rate in nonclinical toxicology studies, it is an essential auxiliary tool for the evaluation of toxicologic pathology in toxicology studies of drugs. As a useful complement to drug discovery and nonclinical safety evaluation of drugs, it can be used for the further research on the results of light microscopy. Attention should be paid to the necessity of use, compliance with good laboratory practice (GLP), professionalism, scientific nature and the limitations when using ultrastructural pathology techniques for nonclinical toxicology studies of drugs.

江苏省新药一站式高效非临床评价公共服务平台建设项目（BM2021002）