倍他米松乳膏的稳定性及有效期预测  

Stability and Expiration Date Prediction of Betamethasone Cream

作　　者：钱美英[1] 缪丽燕[1] 石建[1] 王金花[1] 张华[1] 

机构地区：[1]苏州大学附属第一医院临床药学研究室,苏州市215006

出　　处：《中国药房》2006年第11期852-853,共2页China Pharmacy

摘　　要：目的：研究及预测倍他米松乳膏的稳定性与有效期.方法：以高效液相色谱法测定倍他米松的含量,分别用初均速法和强光照射法对倍他米松乳膏进行稳定性试验.结果：倍他米松检测浓度线性范围为0.25～8μg/ml（r=0.9 991）,平均回收率为98.56%（RSD=0.78%）;其含量与温度相关性较大,光照的影响不明显.结论：倍他米松乳膏宜于常温阴凉处保存,预测有效期为1y.OBJECTIVE：To study the stability and to predicate the expiration date of betamethasone cream. METHODS： The HPLC method was used to determination the content of betamethasone, the stability test of cream was done by initial mean velocity method and strong light exposure experiment, respectively.RESULTS： The linear concentration range for betamethasone cream was 0.25-8μg/ml（ r = 0.9 991）, the average recovery rate was 98.56%, RSD = 0.78% ; The content was highly correlated to temperature,whereas on which the light exposure did little effect .CONCLUSIONS：Betamethasone cream should be stored under room temperature and in a cool place,it is predicted that the expiration date of betamethasone cream is 1 year.

关 键 词：高效液相色谱法 倍他米松乳膏 初均速法 含量 稳定性 有效期 

分 类 号：R927.2[医药卫生—药学]