抗菌增敏药药效学非临床研究技术指南  

Technical guidelines for preclinical pharmacodynamic investigation of antibacterial sensitizer

作　　者：周红 覃容欣[2] Zhou Hong;Qin Rong-xin(Key Laboratory of Basic Pharmacology,Ministry of Education and Joint Laboratory of International Cooperation,Ministry of Education of Characteristic Ethnic Medicine,College of Pharmacy,Zunyi Medical University,Chemotherapy Pharmacology Professional Committee of Chinese Pharmacological Society,Zunyi 563003;Department of Pharmacy and Laboratory Medicine,Army Medical University(the Third Military Medical University),Chongqing 400038)

机构地区：[1]遵义医科大学基础药理教育部重点实验室暨特色民族药教育部国际合作联合实验室,中国药理学会化疗药理专业委员会,遵义563003 [2]陆军军医大学(第三军医大学)药学与检验医学系,重庆400038

出　　处：《中国抗生素杂志》2023年第1期8-12,共5页Chinese Journal of Antibiotics

基　　金：国家自然科学基金委员会-贵州省人民政府联合基金项目(No.U1812403-4-1)。

摘　　要：抗菌增敏药是一类本身并不具有抗菌作用的药物,但是其与抗菌药物联合应用后可增加抗菌药物的抗菌活性。抗菌增敏药是抗菌药物研究领域的新的研究方向,它的非临床研究的药效学内容同样包括体内和体外两个方面。在体外研究中,评价指标除包括与其他单一抗菌药物评价相同的指标如MIC、MBC、KCs、PAE和ED50,还需要做联合用药后联合抑菌指数(FICI)和联合时间-杀菌曲线的研究。在体内研究中,评价指标同单一抗菌药物评价指标,但是需要特别注意联合用药药物的配伍剂量的选择。本技术指南对抗菌增敏药非临床研究药效学的内容及方法进行论述,旨在为抗菌增敏药的临床前药效学研究提供参考。Antimicrobial sensitizers refer to the drugs that do not have antibacterial effect by themselves,but can increase the antibacterial activity of the antibacterial drugs after combined application.The investigation of antimicrobial sensitizers is a new research direction in the field of antibacterial drugs,and its pharmacodynamics of non-clinical research content also includes in vivo and in vitro experiments.In addition to the evaluation indexes including MIC,MBC,KCs,PAE,and ED50,which are the same as those of other single antibacterial drugs,in vitro studies on fractional inhibitory concentration index(FICI)and combined time-killing curve after combination therapy are also required.As for in vivo studies,the evaluation criteria are the same as those for single antimicrobial drugs,but special attention needs to be paid to the selection of compatible doses for drugs combinations.The technical guidelines discuss the contents and methods of pharmacodynamics of non-clinical research study of antimicrobial sensitizers,aiming to provide a reference for preclinical pharmacodynamics study of antimicrobial sensitizers.

关 键 词：抗菌药物增敏药 药效学 技术指南 抗菌活性 联合抑菌指数 

分 类 号：R9[医药卫生—药学]