咪康唑莫米松成膜凝胶的制备及其质量控制  

Preparation and Quality Control of Miconazole/Mometason in Skin Membrane Gel

作　　者：张丹霞[1] 赖东梅[1] 陈惠英[1] 廖朝峰[1] 张吕钊[1] 

机构地区：[1]广东省深圳市宝安人民医院药剂科,广东深圳518101

出　　处：《中国药业》2013年第5期53-55,共3页China Pharmaceuticals

基　　金：深圳市宝安区科技计划社会公益项目;项目编号:深宝科[2012]24号

摘　　要：目的制备咪康唑莫米松皮肤成膜凝胶并建立其质量控制方法。方法选用泊洛沙姆407和泊洛沙姆188为混合基质,冷溶法制备咪康唑莫米松皮肤成膜凝胶,用高效液相色谱法测定咪康唑莫米松含量。结果所制凝胶室温下为液体,涂布皮肤即变为成膜凝胶。咪康唑、莫米松的进样质量浓度分别为10.0～800μg/mL和1.0～80.0μg/mL时与各自峰面积积分值呈良好线性关系,r值分别为0.998 9(n=6)和0.998 1(n=6),咪康唑与莫米松的平均回收率和RSD分别为98.58%,1.46%和97.99%,2.8%(n=6),符合含量测定要求。结论该制剂处方合理,制备工艺简便、质量可控,是一种较为理想的皮肤成膜凝胶。Objective To prepare miconazole/mometason in skin membrane gel, and to establish a quality control meathod for it. Methods That in skin membrane gel were prepared by cold- solving method with p407 and p188 as mixed base. The content of miconazole and mometason was determined by HPLC- DAD. Results Prepared gels were liguid at room temperature and turned into skin membrane gel at body skin,The linear ranges of miconazole and mometason were in the range of 10.0-800 μg/mL（r=0.998 9）, l. 0 - 80. 0 μg/mL（ r = 0. 998 1, n = 6） respectively. The average recoveries and RSD of two active ingredients were 98.58% , 1.46% and 98.81%, 2.08% （n = 6）. Conclusion The preparation method is reasonable, simple and controllable, and it is an ideal skin membrane gel.

关 键 词：咪康唑 莫米松 皮肤成膜凝胶 制备 质量控制 

分 类 号：R944.1[医药卫生—药剂学] R978.5[医药卫生—药学]