摘要
体外释放度是固体制剂质量控制的重要指标之一。它是生物等效性评价的重要指标,也是缓控释制剂处方优化、稳定性考察、生产过程的质量控制等方面的重要参数。本研究对近年来国内缓控释制剂处方优化的指标,包括相似因子和偏离度的应用进行了比较。
Release in vitro is one of the indexes for quality control of solid dosage forms. It is not only the important indexes for evaluation of bioequivalence, also the important parameter of formulation optimization, study of the stability and quality control within producing of sustained or controlled release dosage forms. The review is the study on index for formulation optimization of sustained or controlled released dosege forms in China since 1999, including the application of similarity factor and deviation.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2006年第1期15-17,共3页
China Journal of Chinese Materia Medica
关键词
缓控释制剂
处方优化
体外释放度
相似因子
偏离度
sustained or continUed release dosage forms
form ulation optimization
release in vitro
similarity factor
deviation
