盐酸芦氟沙星滴耳液的制备与临床应用

Preparation and Clincal Application of Rufloxacin Hydrochloride Ear Drops

目的:研制盐酸芦氟沙星滴耳液。方法:拟定处方与制备工艺,采用分光光度法测定盐酸芦氟沙星的含量,并进行了稳定性与刺激性试验。将本品用于108例患者并观察疗效。结果:处方设计合理,制备工艺可行;盐酸芦氟沙星的回归方程为C=26.553 4A+1.692 8,r=0.999 8。平均回收率为100.3％,RSD=0.9％;108例患者治愈率为98.2％。结论:该制剂处方合理,质控方法可靠,临床效果较好。

elective: To develop nifloxacin hydrcchloride ear drops. Method: The compcsition of recipe and manufacturing technique were desigened; the concentration of RFLX was determined by UV spectrophotometry; the stability and irritability test were carried out. 108 patients with eye infections were treated with nifloxacin hydrcchloride ear drops. Result: The designation of the recipe was reasonable and mannufactur-ing technique was feasible; the recovery to RFLX was 100.3% with RSD 0.9% of the 108 patients observed. 106 were cured;2 were effective. Conclusion: The preparation is ratinal in formula and reliable in method of quality cobol.