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.
出处
《中国药房》
CAS
CSCD
北大核心
2006年第9期670-671,共2页
China Pharmacy
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
Ciprofloxacin hydrochloride
Dexamethasone acetate
Ear drop pill
Preparation
Quality control
