临床前药物安全性评价中大小鼠组织取材标准化的探讨  

Standardization of tissue sampling and trimming from rats and mice in preclinical safety evaluation study

作　　者：张頔[1] 林志[1] 李珊珊[1] 李波[1] 

机构地区：[1]中国药品生物制品检定所国家药物安全评价监测中心,北京100176

出　　处：《中国新药杂志》2009年第3期202-205,共4页Chinese Journal of New Drugs

摘　　要：临床前药物安全性评价中组织取材的标准化操作是毒性病理学评价的关键环节。通常在毒性研究方案中仅规定常规进行病理学检查的组织,但对于每一组织具体应该取材的详细准确部位没有相应的描述,并且各个实验室相关的标准操作规程(SOP)内容也不尽相同。这就使得不同实验室以及不同试验研究中所获得的病理学数据无法进行有效的比较分析。笔者根据国外相关指导原则及文献报道,对大小鼠常规毒性研究中的40余种脏器的标准化取材操作规范作一详细介绍。The standardization of tissue sampling and trimming from rats and mice is the more important part in preelinical safety evaluation study. Although the routine processes for sampling organs in different studies are defined in various guidelines, there is no any mention which parts of an organ should be examined histopathologically. This may result in poor comparability of pathological data obtained from different studies in different laboratories. In this paper, we comprehensively reviewed the standardization of tissue sampling and trimming from primary organs of rats and mice in general toxicity studies following the guideline and documents of standardization of tissue sampling and trimming.

关 键 词：临床前药物安全评价 组织取材 标准化 

分 类 号：R994.2[医药卫生—毒理学] R965.3[医药卫生—药学]