摘要
肺吸入制剂是近年来发展较快的一种新兴剂型,因其无首过效应、可降低毒副作用等特点受到青睐。肺吸入制剂的非临床药代动力学(PK)研究主要包括整体动物PK研究和体外PK研究。在进行整体动物PK研究时需对动物种属的选择、给药准确性的监测、体内暴露量的检测等多加关注;体外PK研究主要包括离体脏器、酶系、细胞试验等研究。本文就国内外对肺吸入制剂非临床PK研究评价方法进行简要综述。
As a rapidly developing new dosage form in recent years,lung inhalation preparations,owing to almost non-first-pass effect,fewer toxic and side effects,have been increasingly favored.The non-clinical pharmacokinetic(PK)studies of lung inhalation preparations mainly include in vivo and in vitro studies.In the vivo PK studies,more attention should be paid to the selection of animal species,monitoring of doses,and determination of drug exposure.In vitro PK mainly includes isolated organs,metabolic enzymes,and cell experiments.This article briefly reviewed the non-clinical PK studies of lung inhalation preparations home and abroad.
作者
陈美玲
黄亚军
姜德建
王小青
CHEN Mei-ling;HUANG Ya-jun;JIANG De-jian;WANG Xiao-qing(Hunan Research Center for Safety Evaluation of Drugs,Hunan Key Laboratory of Pharmacodynamics and Safety Evaluation of New Drugs,Hunan Prima Drug Research Center Co.,Ltd,Changsha 410331)
出处
《中南药学》
CAS
2021年第8期1685-1689,共5页
Central South Pharmacy
关键词
肺吸入制剂
非临床
药代动力学研究
lung inhalation preparation
non-clinical
pharmacokinetic study
