柳氮磺吡啶控释胶囊稳定性及释放稳定性实验  

Stability experiment of the Controled-release capsules of Salazosulfapyridine and its releasing in vitro

作　　者：古丽萍[1] 罗玫[1] 盛杰[1] 王晓文[1] 

机构地区：[1]中国人民解放军第473医院,甘肃兰州730070

出　　处：《解放军药学学报》2000年第3期165-167,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的 :考察自制柳氮磺吡啶控释药胶囊剂的稳定性和释放稳定性 ,制订药品有效期限。方法 :UV法测定室温及加速试验条件下不同存贮时间胶囊的含量及释放百分率 ,并进行统计学处理。结果 :胶囊剂含量在各贮存条件下无明显变化。释放百分率 :室温放置 0月的释放度为T30 2 6 .83± 5 .14、T50 32 .0 3± 3 .92、TD35 .77± 3 .10、T80 41.89± 2 .86 ,室温放置 3月的释放度为T30 32 .36± 5 .0 2、T50 37.13± 4.97、TD40 .35± 4.99、T80 45 .6 5± 5 .44 ,加速试验 3月的释放度为T30 34.6 6± 5 .96、T50 40 .18± 7.0 1、TD45 .2 9± 8.99、T80 5 5 .71± 15 .2 7。结论 :本制剂工艺稳定可靠 ,释放稳定 ,有效期暂订二年。加速试验对胶囊的释放有一定影响 ,但释药曲线形状变化不大 ,只是初始释放时间推迟 10min 。Aim To inspect the stability of the Controledrelease taking orally capsules of salazosulfa-pyridine.Worked out the valid time.Methods The content and release percentage of the capsules were determined at 40℃,RH 75% and room temperature for three months by UV,and analyse it by statistics.Results The capsules content had no obvious change in each store condition.Release percent were compared with room temperature,quicken test for three months and original capsules had no obvious change (P>0.05),and original capsules were compared with quicken test for three months had happened (P<0.05).Conclusion The technology of preparation is stable and reliable.The drug release is stable,valid for two years.The quicken test had some influence on release of capsules,but shape of release curve had no change.Only release time was postponed for ten minute.The quicken test may have influence on capsuleshelles.

关 键 词：柳氮磺吡啶 释放稳定性 控释胶囊 

分 类 号：R944.9[医药卫生—药剂学] R927.1[医药卫生—药学]