基于生物药剂学分类系统的口服固体速释制剂生物豁免  

Biowaiver for immediate-release solid oral dosage forms based on biopharmaceutics classification system

作　　者：刘曼[1] 张文萍[2] 张丽娜[1] 刘会臣[1] 

机构地区：[1]航天中心医院临床药理室,北京100049 [2]宁夏医科大学总医院药剂科临床药理研究室,银川750004

出　　处：《中国新药杂志》2016年第5期532-542,588,共12页Chinese Journal of New Drugs

摘　　要：生物药剂学分类系统将药物按溶解度和渗透性分为4类,在指导新药研发和剂型设计、预测药物体内体外相关性、进行生物豁免研究等方面发挥了非常重要的作用。本文综述了基于生物药剂学分类系统的口服固体速释制剂生物豁免所需溶解度、渗透性和溶出度的接受标准和测定方法,并分类描述了进行过生物豁免研究的药物及其有关资料;建议我国尽快开展和接受生物豁免。The biopharmaceutics classification system（ BCS） is a framework for classifying drug substances based on their solubility and permeability. According to the BCS,drug substances are classified into four categories. The BCS can be used as a very important tool to guide the development of new drug substances,design pharmaceutical dosage forms,predict in vitro-in vivo correlation,and research biowaiver. In this paper,the acceptance criteria and determination methods of solubility,permeability and in vitro dissolution were reviewed,which were necessary for the biowaiver of immediate-release solid oral dosage forms based on the BCS. The drug substances which had been conducted the biowaiver studies were described in this paper according to the four categories. It is recommended that the biowaiver policy be developed and accepted in our country as soon as possible.

关 键 词：生物药剂学分类系统 生物豁免 生物等效性 速释制剂 溶解度 渗透性 

分 类 号：R951[医药卫生—药学]