复方醋酸甲地孕酮片的溶出度研究

Study on the Dissolution of Compound Megestrol Acetate Tablets

目的:建立测定复方醋酸甲地孕酮片溶出度的方法。方法:对溶出介质、转速、取样时间等进行考察确定桨法试验的溶出条件,采用高效液相色谱法分别用紫外(288nm)和荧光检测器(激发波长为285nm,发射波长为310nm)测定醋酸甲地孕酮和炔雌醇2种组分的含量并计算累积溶出率。结果:确定以0.5%十二烷基硫酸钠为溶出介质,转速为75r·min-1,取样时间为60min。醋酸甲地孕酮和炔雌醇的检测浓度线性范围分别为0.3941～3.941μg·mL-1(r=1.0000)、0.01432～0.1432μg·mL-1(r=0.9999),平均回收率分别为98.8%、99.6%,RSD分别为0.4%、0.3%(n=9)。结论:所建立的溶出度测定方法专属、灵敏、快速、准确,可用于复方醋酸甲地孕酮片的溶出度测定。

OBJECTIVE：To establish the method for dissolution test of Compound megestrol acetate tablets.METHODS：Dissolution method was set up by investigating the dissolution medium,rotation speed,dissolution time,etc.The contents of megestrol acetate and ethinyloestradiol in samples were determined by HPLC using UV detector（288 nm） and fluorescence detector（excition wavelength of 285 nm,emission wavelength of 310 nm）.Accumulative drug release rate was calculated.RESULTS：0.5% sodiumdoecylsulfate was used as the dissolution medium and the rotation speed was 75 r·min-1.The sampling time was 60 min.The linear range of megestrol acetate and ethinyloestradiol were 0.394 1～3.941 μg·mL-1（r=1.000 0） and 0.014 32～0.143 2 μg·mL-1（r=0.999 9）.The average recovery was 98.8% and 99.6%（RSD=0.4% and 0.3%,n=9）,respectively.CONCLUSION：The established method for dissolution test is specific,sensitive,rapid and accurate,which can be used for dissolution test of Compound megestrol acetate tablets.