【摘要】 目的制备复方司帕沙星滴耳液并考察其稳定性。方法以司帕沙星、益康唑为主药,以甘油和乙醇为溶剂制备滴耳液,采用双波长分光光度法测定两主药含量,并考察了3批样品的稳定性。结果司帕沙星和益康唑检测浓度线性范围分别为0．8-24μg／mL和4-120 μg／mL, 平均回收率分别为99．44％(RSD=0．71％)和100．36％(RSD=0．81％),3批市售包装样品经加速试验、室温留样考察,质量稳定有效期均在2年以上。结论该制荆制备工艺简单,含量测定方法结果准确,稳定性好。更多还原

【Abstract】 Objective To prepare compound sparfloxacin ear drops (CSED) and to study its stability. Methods Sparfloxacin and econazol were taken as the chief components for the preparation of CSED with glycerine and alcohol as solvent,the contents of 2 chief components were determined by the dual - wavelength spectrophotometric method. 3 batches of samples’ stability were investigated. Results The linear detection concentration ranges of sparfloxacin and econagol were 0. 8-24μg/mL and 4-120 μg/mL, respectively. The average recovery of sparfloxacin and econazole was 99. 44% (RSD=0.71%) and 100.36% (RSD=0.81%),respectively. 3batches of sample were found to be stable in quality with a validity time over 2 years in the accelerated, room temperature storage test under the condition of commercial packing. Conclusion CSED is simple in preparation, accurate in content determination and good in stability.更多还原