雌二醇透皮控释制剂的溶出度测定方法研究  

Dissolution method of estradiol transdermal delivery system

作　　者：龚赛君[1] 徐岚 陈国神[1] 

机构地区：[1]浙江省医学科学院药物研究所

出　　处：《中国药学杂志》1993年第3期153-155,共3页Chinese Pharmaceutical Journal

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(E_2-TDS)的72h累积释放量,溶出液用HPLC分析含量。结果表明:E_2-TDS 的溶出度曲线符合Hiquchi方程;累积释放量与E_2-TDS面积(剂量)有良好线性关系;不同规格及批号E_2-TDS 溶出曲线几乎重叠,说明本法用于E_2-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。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(E_2-TDS). Samples were analyzed byHPLC. The results showed that the dissolution pro-file of E_2-TDS fitted the Hiquchi equation, a goodlinear relation was noted between the accumulativeamount and area(dosage)of E_2-TDS. The dissolu-tion profiles were found to be virtually superimpos-able for different sizes and batches of E_2-TDS. It isindicated that this method is reproducible and reli-able for determination of dissolution of E_2-TDS,and it can also be used as a quality control tool fortransdermal delivery system.

关 键 词：雌二醇 溶出度 高效液相色谱 

分 类 号：R927.11[医药卫生—药学]