毒性病理學(xué)在藥物安全評價中占有重要地位，其檢查結(jié)果可以回答藥物造成病理性損傷部位、程度、性質(zhì)和預(yù)后等基本問題。動物解剖及大體病理學(xué)檢查是毒性病理學(xué)評價的重要內(nèi)容，程序通常包括動物剖檢前的準(zhǔn)備、安樂死程序、確定和記錄所有肉眼觀察病變，收集實驗方案中列出的所有組織，臟器稱質(zhì)量及組織固定，以便進行后續(xù)病理制片及組織病理學(xué)檢查，上述程序必須以一致的方式進行并且符合標(biāo)準(zhǔn)操作規(guī)程（SOPs）。簡要介紹了毒性病理學(xué)評價中動物剖檢及大體病理學(xué)檢查應(yīng)遵循的一般原則，以期規(guī)范檢查程序，為提高我國臨床前藥物安全性評價的組織病理學(xué)檢查水平奠定基礎(chǔ)。

Toxicologic pathology plays an important role in the safety evaluation of drugs. The results of toxicologic pathology can answer the basic problems of pathological lesions such as location, severity grading, nature and prognosis, etc. Necropsy and gross pathology examination are important aspects of toxicologic pathology assessment. Procedures typically include preparation for the necropsy, euthanasia procedures, identification and recording all gross lesions, collection of tissues listed in the study protocol, determination of organ weight, as well as tissue fixation so as to be ready for the subsequent tissue processing and histopathology examination. All the procedures must be done in a consistent manner and in accordance with standard operating procedures (SOPs). The present paper briefly introduced the principles of necropsy and gross pathology examination for toxicologic pathology in order to standardize the procedures and to lay foundation for the improvement of the histopathology examination in the field of preclinical safety evaluation of drugs of China.

“十二五”國家科技重大專項課題（2015ZX09501004-002，2015ZX09501007-004）