评价口服药物动态溶出的体外模型  

In vitro dynamic dissolution models for oral drugs

作　　者：张雅琦 屠露萍 饶泽鹏 金鹤翔 王文喜[1] ZHANG Ya-qi;TU Lu-ping;RAO Ze-peng;JIN He-xiang;WANG Wen-xi(College of Pharmaceutical Science,Zhejiang University of Technology,Hangzhou 310014,China)

机构地区：[1]浙江工业大学药学院,杭州310014

出　　处：《药物分析杂志》2023年第3期366-374,共9页Chinese Journal of Pharmaceutical Analysis

摘　　要：溶出度试验是评价口服固体制剂质量的重要手段。药物在胃肠道的溶出和吸收是1个连续、动态的过程,传统溶出试验由于缺乏与体内相似的化学成分、流体动力学等条件,对药物的体内评价作用十分有限。为此,研究人员构建了一些基于人体生理状态的非生物学动态体外溶出方法,包括多室溶出模型、溶出-吸收模型和体外消化模型等。这些新型的体外溶出模型可以作为传统溶出的补充或替代,使研究人员更加全面地了解药物在体内的溶出表现。本文对近年来该领域的最新进展进行简要的综述,并对各模型的适用范围及优缺点进行概括,为口服药物的溶出度评价提供参考。Dissolution test is an important way to evaluate the quality of oral solid dosage forms.The dissolution and absorption of drugs in gastrointestinal tract are continuous and dynamic progress.Due to the lack of chemical components and fluid dynamics conditions which are similar to in vivo enviroment,the traditional dissolution meth-ods are extremely limited in the evaluation of drug in vivo.Therefore,in vitro non-biological dynamic dissolution methods based on physiological state of gastrointestinal tract have been constructed,including multi-compartment dissolution models,dissolution-absorption systems,and in vitro digestion models.These novel in vitro dissolution models could be supplements or substitutes of traditional dissolution models,so that researchers can comprehen-sively understand the drug dissolution behavior in vivo.This paper reviewed recent advances of non-compendial dissolution models,and summarized the applicable scopes and relative merits,aiming to provide a reference for the evaluation of dissolution degree of oral drugs.

关 键 词：动态溶出 人工胃-十二指肠模型 胃肠模拟器 溶出-渗透系统 动态胃模型 压力溶出装置 体内外相关性 口服给药 

分 类 号：R917[医药卫生—药物分析学]