硝酸舍他康唑凝胶剂的制备及稳定性考察

Study on the preparation and stability of sertaconazole nitrate gel

制备硝酸舍他康唑凝胶剂并考察其稳定性.以卡波姆-940为凝胶基质制备硝酸舍他康唑凝胶剂,采用滴定法测定硝酸舍他康唑含量,通过初步稳定性实验考察硝酸舍他康唑凝胶剂的稳定性.制得的制剂均匀,分散性好;在光照、高温和离心条件下,制剂无沉积、合并和分层,药物含量也无明显变化.该制剂制备工艺简单,质量可控.

To study the preparation and the stability of sertaconazole nitrate gel.Carbopol-940 was used as gel matrix,the content of sertaconazole nitrate was determined with titration method and the preliminary stability experiments were carried out.The result of stability experiments showed that no flocculation,coalescence or breaking was not obviously changed.The preparation process was simple and quality controllable.