复方岩白菜素缓释片释放度与稳定性考察  

Investigation on the Release Property and Stability of Compound Bergeninum Sustained Release Tablet

作　　者：刘祖祥[1] 何旭[2] 赵翠云[2] 刘健康 王成军[2] 

机构地区：[1]云南省第一人民医院,昆明650034 [2]大理学院药学与化学学院,云南大理671000 [3]云南白药集团大理药业有限公司,云南大理671000

出　　处：《大理学院学报（综合版）》2013年第6期8-11,共4页Journal of Dali University

基　　金：大理州科学技术局科研基金资助项目(KY414740)

摘　　要：目的:考察复方岩白菜素缓释片的稳定性。方法:根据中华人民共和国药典2010年版(二部)附录"原料与药物制剂稳定性试验指导原则"对供试品进行影响因素试验和加速试验及长期试验,并考察外观、含量、释放度、降解产物的变化。结果:在考察期内,复方岩白菜素缓释片外观无变化,含量、释放度基本不变,无降解产物。结论:本品稳定性较好。Objective： To investigate the release property and stability of compound Bergeninum sustained release tablet. Methods： According to the ＂Guidelines of raw materials and pharmaceutical preparations stability test＂ in Pharmacopoeia of the People＇s Republic of China （2010 edition, II, appendix）, we conducted influencing factors test, accelerated test and long term test on compound Bergeninum sustained release tablet. The indexes of sample appearance, content, release property and the change of degradation products were tested. Results： The results showed that compound Bergeninum sustained release tablets has good stability with no change in sample appearance, little change in content and release property and no degradation products in the test period. Conclusion： Compound Bergeninum sustained release tablet is stable.

关 键 词：复方岩白菜素缓释片 释放度 稳定性 含量 

分 类 号：R927.11[医药卫生—药学]