生物大分子药物的药代动力学研究进展  

Progress in Pharmacokinetics of Bio-macromolecules

作　　者：赵娣[1] 陈西敬[1] ZHAO Di;CHEN Xijin(Clinical Pharmacokinetics Laboratory,China Pharmaceutical University,Nanjing 211198,China)

机构地区：[1]中国药科大学临床药代动力学研究室,江苏南京211198

出　　处：《药学进展》2018年第8期592-598,共7页Progress in Pharmaceutical Sciences

基　　金：国家自然科学基金(No.81503148;No.81473272)

摘　　要：近年来,生物大分子药物发展迅猛,受到的关注也越来越多。与传统小分子药物相比,生物大分子药物具有相对分子质量大、不易透过生物膜、给药剂量低、易在体内降解等特点,这导致其具有与小分子药物不同的药代动力学特征。以蛋白多肽药物、单克隆抗体药物、抗体药物偶联物和核酸药物4类生物大分子药物为例,综述近年来生物大分子药物的药代动力学研究进展,旨在为生物大分子药物及生物类似药的研发提供参考。Bio-macromolecular drugs have developed rapidly in recent years and attracted more and more attention. Compared with traditional small molecule drugs, bio-macromolecules are characterized by large molecular mass, poor permeation across biological membranes, low dosage and easy degradation in vivo, which leads to different pharmacokinetics from traditional small molecule drugs. This paper reviewed the pharmacokinetic characteristics of bio-macromolecular drugs including protein and polypeptide drugs, monoclonal antibody drugs, antibody-drug conjugates and nucleic acid drugs, so as to provide reference for the development of bio-macromolecular drugs and biosimilars.

关 键 词：生物大分子药物 蛋白多肽药物 单克隆抗体药物 抗体药物偶联物 核酸药物 药代动力学 

分 类 号：R977[医药卫生—药品] R969.1[医药卫生—药学]