超微结构病理学在药物非临床安全性评价毒理学研究中的应用现状和关注点  

Current practices and points to consider for use of ultrastructural pathology in toxicology studies during nonclinical safety evaluation of drugs

作　　者：王娅 郑少秋 钱庄 闫振龙 胡文元 钟小群 胡静 李一昊 陈晓俊 彭瑞楠 李慧 葛建雅 缪成贤 邵薇 张亚群 吕建军 WANG Ya;ZHENG Shaoqiu;QIAN Zhuang;YAN Zhenlong;HU Wenyuan;ZHONG Xiaoqun;HU Jing;LI Yihao;CHEN Xiaojun;PENG Ruinan;LI Hui;GE Jianya;MIAO Chengxian;SHAO Wei;ZHANG Yaqun;LYU Jianjun(Innostar Biotechnology Nantong Co.,Ltd,Nantong 226133,China;Jiangxi University of Traditional Chinese Medicine,Nanchang 330103,China;Yangtze Delta Advanced Research Institute,Yangtze Delta Pharmaceutical College,Nantong 226133,China)

机构地区：[1]益诺思生物技术南通有限公司,江苏南通226133 [2]江西中医药大学,江西南昌330103 [3]长三角药物高等研究院,长三角药学高等工程学院,江苏南通226133

出　　处：《药物评价研究》2022年第8期1487-1492,共6页Drug Evaluation Research

基　　金：江苏省新药一站式高效非临床评价公共服务平台建设项目(BM2021002)。

摘　　要：超微结构病理学是药物非临床毒理学研究中毒性病理学评估的重要辅助工具。简要介绍了超微结构病理学在药物非临床安全性评价毒理学研究中的应用现状和关注点,并举例说明了透射电子显微镜等超微结构病理学技术在药物非临床安全性评价中的应用。目前,超微结构病理学技术在药物非临床毒理研究中虽然使用率不高,却是非临床毒理学研究中毒性病理学评估的重要辅助工具,可用于对光学显微镜检查结果的进一步研究,以作为早期药物发现和非临床安全性评价毒理学研究的有益补充。在使用超微结构病理学技术进行药物非临床毒理学研究时,应关注其使用的必要性、良好实验室规范(GLP)依从性、专业性、科学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.

关 键 词：超微结构病理学 毒性病理学 透射电子显微镜 非临床毒理学研究 药物安全性评价 

分 类 号：R965.3[医药卫生—药理学]