摘要
目的以不同厂家复方酮康唑乳膏释放度的比较数据为例,论证建立释放度的重要性。方法采用流通池法进行体外释放度实验,以HPLC法测定酮康唑含量,计算累计释放百分率,并以威布尔方程拟合释放参数,用方差分析对组间溶出参数进行统计学分析。比较5个厂家复方酮康唑乳膏的体外释放度。结果5个厂家复方酮康唑乳膏体外释放度拟合参数m,T50,Td和T80均存在显著性差异(P<0.01)。结论说明不同厂家复方酮康唑乳膏的释放度存在差异,乳膏的体外释放度能够评价其质量。
Objective By the example for comparative data of dissolution of Compound Ketoconazole Cream from different manufacturers, the importance of establishing the dissolution test was argued. Methods The dissolution test was applied with flow-through cell method and a HPLC method was used to determine the concentration of ketoconazole. The accumulative release percentage （Q） was obtained and the Weibull＇s equation was used to model the dissolution parameters. The difference between different groups was statistically evaluated by variance analysis. To compare the dissolution amounts in vitro of Compound Ketoconazole Creams from 5 different manufactories. Results The significant difference was found among the dissolution of Compound Ketoconazole Creams from five different pharmaceutical factories in dissolution parameter m, T50, Td and T80 （P〈0.01）. Conclusions There was significant difference in dissolution parameters among the Compound Ketoconale Creams from five different pharmaceutical factories. It is indicated that the dissolution test could be used for quality control of Compound Ketoconazole Cream.
出处
《中国药事》
CAS
2009年第5期474-476,共3页
Chinese Pharmaceutical Affairs
关键词
复方酮康唑乳膏
释放度
流通池法
Compound Ketoconazole Cream
dissolution
flow-through cell method
