基于生物药剂学分类系统的口服固体速释制剂生物豁免

发布时间：2018-01-26 19:07

  本文关键词： 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　出处：《中国新药杂志》2016年05期 　论文类型：期刊论文

【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。
[Abstract]:The biopharmaceutical classification system divides the drugs into four categories according to their solubility and permeability, which are used to guide the development and formulation of new drugs, and to predict the correlation of drugs in vivo and in vitro. Biological immunity research has played a very important role in this paper. This review based on the biopharmaceutical classification system of oral solid rapid release formulations of biological immunity required solubility. Acceptance criteria and methods for determination of permeability and dissolution, and classification of drugs and their related information for studies of biological exemptions; It is suggested that our country should carry out and accept biological exemption as soon as possible.
【作者单位】： 航天中心医院临床药理室;宁夏医科大学总医院药剂科临床药理研究室;
【分类号】：R943
【正文快照】： 基于生物药剂学分类系统(biopharmaceuticalclassification system,BCS)的口服固体速释制剂生物豁免(biowaiver)已经陆续得到美国食品药品监督管理局(Food and Drug Administration,FDA)、世界卫生组织(World Health Organization,WHO)和欧洲药品监督管理局(European Medicine，

本文编号：1466364