酮康唑乳膏的研制与临床应用  

Studies on Preparation of Ketoconazole Cream and Clinical Application

作　　者：张圣雨[1] 肖明[1] 高银花[2] 

机构地区：[1]安徽省立医院药剂科,合肥230001 [2]安徽省立医院皮肤科,合肥230001

出　　处：《医药导报》2000年第5期470-471,共2页Herald of Medicine

摘　　要：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.

关 键 词：酮康唑乳膏 研制 临床应用 抗真菌药 

分 类 号：R986[医药卫生—药品] R978.5[医药卫生—药学]