摘要
科学合理的溶出度试验质量标准能体现出口服固体制剂的内在品质。本文详尽阐述了如何科学、客观地拟定质量标准中溶出度试验各参数,如溶出介质、取样时间点、装置、转速、限度及试验方法等。
Scientific and reasonable quality criteria of dissolution test can reflect the inner quality of the oral solid preparation. How to scientifically and objectively develop and validate the parameters of dissolution test, such as medium, agitation rate, sampling time and determining method are reviewed in this paper.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2012年第3期I0003-I0012,共10页
Chinese Journal of Pharmaceuticals
关键词
溶出度试验法
质量标准
参数
dissolution test
quality criteria
parameter
