复方司帕沙星滴耳液的稳定性考察及药效学试验

Stability and Pharmacodynamic Study of Compound Sparfloxacin Ear Drops

目的:评价复方司帕沙星滴耳液的产品稳定性及药效学。方法:以甘油和乙醇为溶剂制备滴耳液;采用双波长分光光度法,于263nm和360.0nm波长处测定益康唑含量,于297nm波长处测定司帕沙星含量,进行产品稳定性考察;对10只豚鼠进行药效学试验。结果:益康唑和司帕沙星的平均回收率分别为100.64%(RSD=0.98%)和100.34%(RSD=0.46%),产品在温度40℃、相对湿度(RH)75%,180d内稳定性好,有效期2年以上。豚鼠药效学试验结果,试验组与对照组的细菌清除率分别为90.00%和89.86%,疗效均明显。结论:该制剂处方工艺简单、稳定性好,疗效明显,可作为医院制剂在临床推广应用。

Objective:To investigate the stability and pharmacodynamics of compound sparfloxacin ear drops(CSED).Methods:The ear drops was prepared with glycerin and alcohol as vehicle.Dual wavelength spectrophotometry was used to determine the content of econazole at 263 nm and 360.0 nm,the content of sparfloxacin was determined at 297 nm,the stability test and 10 guinea pig's pharmacodynamics study of CSED were observed.Results:The average recovery of econazole and sparfloxacin was 100.64%(RSD=0.98%) and 100.34%(RSD=0.46%),respectively.The validity time were 2 years more to determination in 40℃ RH 75% 180 d.The bacterial eradication were 90.00% for CSED and 89.86% for compound ofloxacin ear drops,respectively in guinea pig's otitis and otitis media with bacterial infections.Conclusion:The ear drops is simple in preparation,good in stabilily,efficacy is well in guinea pig's pharmacodynamic test,so is an ideal hospital preparation and clinical using.