论文部分内容阅读
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。
Objective: To study the preparation of rufloxacin hydrochloride ear drops. Methods: Prescription and preparation technology were prepared. The content of rufloxacin hydrochloride was determined by spectrophotometry, and the stability and irritation test were carried out. This product will be used in 108 patients and observe the effect. Results: The prescription was reasonable and the preparation process was feasible. The regression equation of rufloxacin hydrochloride was C = 26.553 4A + 1.692 8, r = 0.999 8. The average recovery was 100.3% with RSD = 0.9%. The cure rate of 108 patients was 98.2%. Conclusion: The preparation prescription is reasonable, quality control method is reliable, the clinical effect is better.