中、美、日、欧的法定溶出度测定法之比较  

Comparison in Dissolution Test of Chinese, American, Japanese and European Official Methods

作　　者：余仲平[1] 

机构地区：[1]沈阳第一制药厂,辽宁沈阳110023

出　　处：《药学进展》2007年第10期469-473,共5页Progress in Pharmaceutical Sciences

摘　　要：溶出度试验是一种体外检查方法。当体内外试验相关时,溶出度检查可用于药品的质量控制及评价药物处方工艺等影响因素。对我国、美国、日本和欧洲等国家和地区采用的溶出度检查方法,包括试验方法与装置、判定限度及研究设计进行比较。Dissolution test is an in vitro test method . When the correlation between experiments in vitro and in vivo has been established, the dissolution test may be used to control the quality of pharmaceutical products and to evaluate the influence of factors such as drug formulation and manufacturing process. In this paper is provided information about comparison in dissolution test of Chinese, American, Japanese and European official methods. The key points discussed were procedure and apparatus, acceptance criteria, and study design.

关 键 词：溶出度检查 方法与装置 判定限度 研究设计 差异比较 

分 类 号：R927[医药卫生—药学]