复方盐酸环丙沙星耳用滴丸的制备及质量控制  

Preparation and Quality Control of Ciprofloxacin Hydrochloride Compound Ear Drop Pill

作　　者：张香菊 龚子东 

机构地区：[1]河南开封陇海医院,开封市475003 [2]河南省医药学校,开封市475001

出　　处：《中国药房》2006年第9期670-671,共2页China Pharmacy

摘　　要：目的:制备复方环丙沙星耳用滴丸,并建立其质量控制方法。方法:以聚乙二醇为基质制备复方环丙沙星耳用滴丸,高效液相色谱法测定主药含量。结果:所制滴丸平均粒径0.45mm,粒重40mg;主药盐酸环丙沙星、醋酸地塞米松检测浓度线性范围分别为20～120、4～24μg/ml(r=0.9999),平均回收率分别为100.5%(RSD=0.36%)、99.5%(RSD=0.27%)。结论:该制剂制备工艺简单易行,质量稳定可靠。OBJECTIVE： To preparation ciprofloxacin hydrochloride compound ear drop pill and establish a method for its quality control. METHODS： PEG was used as matrix and the HPLC method was established for determination the content of main components . RESULTS： The pill＇s average particle size and weight was 0.45mm and 40mg; The liner range of main components ciprofloxacin hydrochloride and examethasone acetate were 20-120 μg/ml and 4-24μg/ml（r = 0.9 999） respectively, the average recovery rate were 100.5% （RSD = 0.36%） and 99.5% （RSD = 0.27%） respectively. CONCLUSIONS. The preparation procedure was simple and feasible,its quality was stable and reliable.

关 键 词：盐酸环丙沙星 醋酸地塞米松 耳用滴丸 制备 质量控制 

分 类 号：R927.2[医药卫生—药学] R987