硫酸吗啡口腔崩解片的稳定性研究  

Study on the Stability of Morphine Sulfate Orally Disintegrating Tablets

作　　者：胡蕾[1,2] 戴青[1] 刘芳[1] 刘松青[1] 

机构地区：[1]第三军医大学第一附属医院药学部,重庆400038 [2]重庆市第三人民医院药学部,重庆400014

出　　处：《中国药房》2015年第4期515-518,共4页China Pharmacy

基　　金：国家科技重大专项课题资助项目--重大新药创制(No.2008ZXJ09004-042)

摘　　要：目的:考察硫酸吗啡口腔崩解片制剂的稳定性,确定其贮藏条件和有效期。方法:以性状、崩解时限、主药含量和有关物质为考察指标,根据《中国药典》相关方法要求对硫酸吗啡口腔崩解片模拟上市包装样品进行影响因素试验(强光4500 lx,高温60℃,25℃、相对湿度75%,10 d)、加速试验(40℃、相对湿度75%、6个月)及长期试验(24个月)。结果:3种试验中,各指标与0天(0月)比较未见明显变化;本品对光、热、湿均较稳定,但有一定吸湿性。结论:建议硫酸吗啡口腔崩解片于阴凉处密闭保存,保质期为2年。OBJECTIVE： To study the stability of morphine sulfate orally disintegrating tablets and determine the storage condi- tions and the period of validity. METHODS： According to Chinese Pharmacopoeia requirements and related methods, morphine sul- fate oral disintegrating tablet sample were tested by influential factors test（glare of 4 500 lx, high temperature of 60℃ , 25 ℃ and relative humidity of 75%, 10 d）, accelerated test （40 ℃, relative humidity of 75%, 6 months） and long-term test （24 months）, with the index of characters, disintegration, the main drug content and related substances. RESULTS： The index has no significant changes compared with 0 day （0 month） and it is relatively stable with light, temperature and humidity, but it has certain mois- ture. CONCLUSIONS ： Morphine sulfate orally disintegrating tablets should be kept in the shade airtight with 2-year shelf life.

关 键 词：硫酸吗啡口腔崩解片 高效液相色谱法 含量测定 稳定性 

分 类 号：R927.11[医药卫生—药学]