氧氟沙星耳用滴丸的制备及临床应用  

The preparation and clinical effects of ofloxacin otic pills

作　　者：杨继章[1] 蒋伯良 姜秋芬[3] 

机构地区：[1]河北医科大学第五医院,石家庄050031 [2]河北邢台矿业集团总医院,邢台054000 [3]河北医科大学基础医学研究所,石家庄050017

出　　处：《上海医药》2001年第11期509-510,共2页Shanghai Medical & Pharmaceutical Journal

摘　　要：目的 :探讨氧氟沙星耳用滴丸的制备及质量控制方法 ,证实临床应用效果 ,为深入研究药效提供依据。方法 :以PEG等为基质制备氧氟沙星耳用滴丸 ,并建立质量标准 ;所制滴丸应用于化脓性中耳炎的治疗 ,设对照组 ,观察用药效果。结果 :本品制备工艺可行 ,质控方法可靠 ;本品治疗化脓性中耳炎 15 3例 ,总有效率达 98.6 9%;复方利福平滴耳液对照组 80例 ,总有效率为 84.6 2 %,结果显示P <0 .0 5。结论 :本剂型具有局部用药浓度高、作用持久、用药次数少、不流淌、携带方便等优点 ,可试用于临床。Objective: To study a method for the preparation and quality control of ofloxacin otic pills(OP)and the clinical effects were observed. Method:The OP was prepared with PEG etc.as the stroma.Its quality control was established.Purulent otitis midia patient group taken OP were compared with reference group.Results:The preparation was practicable,the method for quality control was convenient.One hundred and fifty-three patients with acute and chronic purulent otitis midia were treated with OP,the total effective rate was 98.69%.The total effective rate of reference group included 80 cases was 84.62%.There is a significant difference between the two groups(P<0.05). Conclusion: The advantages of these pills included high localconcentration, prolonged effect and no shedding etc.It may be used in clinical practice.

关 键 词：氧氟沙星 耳用滴丸 制备 质量控制 化脓性中耳炎 

分 类 号：R944[医药卫生—药剂学]