酮康唑乳膏的研制与临床应用

Studies on Preparation of Ketoconazole Cream and Clinical Application

目的 :为满足临床需要研制一种酮康唑乳膏。方法 :将酮康唑制成 2 %乳膏 ,建立了酸碱度、卫生学、含量测定等质控方法 ,并进行了刺激性、稳定性和临床应用方面的考察。结果 :pH 6.5～ 7.5时 ,卫生学检查符合规定 ,含量测定平均回收率为 10 0 .63 % ,RSD =0 .42 %。结论 :本制剂制备工艺简便 ,质控方法准确可靠 ,性质稳定 ,适合临床应用。

Objective:To satisfy the clinical needs, a ketoconazole cream was prepared. Method:Ketoconazole was made into 2% cream. The quality controlled methods, including acidbase scale, hygienics, assaying, were established. Irritation test, stability, and clinical trial about the preparation were conducted. Results:The pH was 6.5～7.5, according with the standard of the hygienical test. The average recovery rate is 100.63% through the determination of content, RSD=0.42%. The irritation resulted by the preparation was less, and stability was better. Conclusion:This preparing method is simple, the quality control is accurate and dependable, the nature is stable, it is a useful preparation for the clinic.