硝酸益康唑滴耳液的制备及质量控制  

Preparation and Quality Contorl of Econazole Nitrate Ear-drops

作　　者：刘韵琪[1] 罗凤琴[1] 赵春景[1] 黄朝武[1] 

机构地区：[1]重庆医科大学附属第二医院,重庆市400010

出　　处：《中国药房》2002年第5期278-279,共2页China Pharmacy

摘　　要：目的 :建立硝酸益康唑滴耳液的制备及质量控制方法。方法 :以甘油、75 %乙醇为混合溶媒进行配制 ,采用紫外分光光度法测定益康唑含量 ,并进行稳定性考察、刺激性试验、体外抑菌试验。结果 :硝酸益康唑线性范围为200～600μg/ml,r=0.9999 ;平均回收率为100.76 % ,RSD=0.82 % (n=5)。硝酸益康唑滴耳液对标准和临床分离白色念珠菌的MIC为2μg/ml和4μg/ml。结论 :该滴耳液抗真菌作用强 ,制备工艺简单 ,稳定性好 ,刺激性小 ,质控方法简便、快速。OBJECTIVE:To establish the preparation process and method of quality control of econazole nitrate ear-drops.METHODS:With mixture of glycerin and 75% alcohol as solvent,econazole nitrate ear-drops was prepared and the content of econazole was determined by ultraviolet spectrophotometry.The stability,irritation and in vitro antimicrobial tests were carried out.RESULTS:There was a good linearity of calibration curve of econazole in range of 200～600μg/ml,r=0.9 999,the average recovery was 100.76%,RSD=0.82%(n=5).The in vitro antimycotic MICs of econazole nitrate in ear-drops were 2μg/ml and 4μg/ml against standard and clinically isolated strains of Candida albicans respectively.CONCLUSION:The ear-drops is simple in preparation,effective in antimycotic action,good in stability and slight in irritability,and the method of quality control is simple,rapid and accurate.

关 键 词：硝酸益康唑 滴耳液 质量控制 制备 

分 类 号：R987[医药卫生—药品]