【摘要】 本文用FDA桨法溶出装置（USP装置2）,测定不同规格及不同批号雌二醇透皮控释制剂（E₂-TDS）的72h累积释放量,溶出液用HPLC分析含量。结果表明:E₂-TDS 的溶出度曲线符合Hiquchi方程;累积释放量与E₂-TDS面积（剂量）有良好线性关系;不同规格及批号E₂-TDS 溶出曲线几乎重叠,说明本法用于E₂-TDS的溶出度测定重现性好,方法可靠。本法也可作为其它透皮控释制剂（TDS）的溶出度质量控制方法。更多还原

【Abstract】 A dissolution test procedure using the FDApaddle method（USPapparatus 2）was developed fordetermining the in vitro release profile of differentsizes and batches of estradiol transdermal deliverysystem（E₂-TDS）. Samples were analyzed byHPLC. The results showed that the dissolution pro-file of E₂-TDS fitted the Hiquchi equation, a goodlinear relation was noted between the accumulativeamount and area（dosage）of E₂-TDS. The dissolu-tion profiles were found to be virtually superimpos-able for different sizes and batches of E₂-TDS. It isindicated that this method is reproducible and reli-able for determination of dissolution of E₂-TDS,and it can also be used as a quality control tool fortransdermal delivery system.更多还原