毒性病理学评价中动物剖检及大体病理学检查原则

Principles of necropsy and gross pathology examination for toxicologic pathology assessment

毒性病理学在药物安全评价中占有重要地位,其检查结果可以回答药物造成病理性损伤部位、程度、性质和预后等基本问题。动物解剖及大体病理学检查是毒性病理学评价的重要内容,程序通常包括动物剖检前的准备、安乐死程序、确定和记录所有肉眼观察病变,收集实验方案中列出的所有组织,脏器称质量及组织固定,以便进行后续病理制片及组织病理学检查,上述程序必须以一致的方式进行并且符合标准操作规程(SOPs)。简要介绍了毒性病理学评价中动物剖检及大体病理学检查应遵循的一般原则,以期规范检查程序,为提高我国临床前药物安全性评价的组织病理学检查水平奠定基础。

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.