超微結(jié)構(gòu)病理學(xué)是藥物非臨床毒理學(xué)研究中毒性病理學(xué)評估的重要輔助工具。簡要介紹了超微結(jié)構(gòu)病理學(xué)在藥物非臨床安全性評價毒理學(xué)研究中的應(yīng)用現(xiàn)狀和關(guān)注點，并舉例說明了透射電子顯微鏡等超微結(jié)構(gòu)病理學(xué)技術(shù)在藥物非臨床安全性評價中的應(yīng)用。目前，超微結(jié)構(gòu)病理學(xué)技術(shù)在藥物非臨床毒理研究中雖然使用率不高，卻是非臨床毒理學(xué)研究中毒性病理學(xué)評估的重要輔助工具，可用于對光學(xué)顯微鏡檢查結(jié)果的進(jìn)一步研究，以作為早期藥物發(fā)現(xiàn)和非臨床安全性評價毒理學(xué)研究的有益補(bǔ)充。在使用超微結(jié)構(gòu)病理學(xué)技術(shù)進(jìn)行藥物非臨床毒理學(xué)研究時，應(yīng)關(guān)注其使用的必要性、良好實驗室規(guī)范（GLP）依從性、專業(yè)性、科學(xué)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.

江蘇省新藥一站式高效非臨床評價公共服務(wù)平臺建設(shè)項目（BM2021002）