纳米药物非临床药代动力学的研究策略及关注要点  

Research strategies and considerations on non-clinical pharmacokinetics of nanomedicine

作　　者：付淑军 黄芳华 顾景凯[2] 吴伟[3] 孙涛 王庆利 FU Shujun;HUANG Fanghua;GU Jingkai;WU Wei;SUN Tao;WANG Qingli(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China;College of Life Science,Jilin University,Changchun 130012,Jilin,China;School of Pharmacy,Fudan University,Shanghai 201203,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022 [2]吉林大学生命科学学院,吉林长春130012 [3]复旦大学药学院,上海201203

出　　处：《中国临床药理学与治疗学》2021年第8期842-850,共9页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：随着纳米技术的迅速发展,纳米药物的研发已成为目前药物创新的发展方向之一。纳米药物具有基于纳米结构的尺度效应,其药代动力学特征与普通药物相比存在明显差异,其药代动力学研究与普通药物相比也有其特殊性。本文着重探讨纳米药物的非临床药代动力学的研究策略及关注要点,包括受试物、体内/外试验、生物样本分析、数据评价分析等,期望为研发者提供参考。With the rapid development of nanotechnology,the research and development of nanomedicine has become one of the current development directions of drug innovation.The pharmacokinetic characteristics of nanomedicine are significantly different from general drugs because of the scale effect based on nanostructures,and pharmacokinetics studies of nanomedicine may be different from the general drugs.This article focuses on the research strategies and considerations on non-clinical pharmacokinetics of nanomedicine,including test agents,in vivo/in vitro assays,biological sample analysis,data evaluation and analysis etc.,providing references for developers.

关 键 词：纳米药物 非临床药代动力学 载体材料 游离型药物 负载型药物 

分 类 号：R969.1[医药卫生—药理学]