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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。
Toxicology plays an important role in the evaluation of drug safety. The test results can answer the basic questions such as the location, degree, nature and prognosis of the pathological injury caused by the drug. Animal anatomy and gross pathology are important components of toxicological pathology. The procedures usually include animal pre-exam preparation, euthanasia procedures, identification and recording of all macroscopic lesions, collection of all tissues listed in the protocol, Quality and Tissue Fixation for Follow-Up Pathology and Histopathology, The procedures must be performed in a consistent manner and in compliance with SOPs. The general principles of animal biopsy and general pathological examination in toxicological pathology are briefly introduced in order to standardize the examination procedure and lay the foundation for improving the histopathological examination of preclinical drug safety in our country.