复方洛美沙星缓释凝胶滴耳剂的制备及其质量控制  

Preparation and Quality Control of Compound Lomefloxacin Sustained-release Gel Eardrops

作　　者：谢燕贤 陈丽娜[2] 温中明 李东 

机构地区：[1]深圳市宝安区石岩人民医院,深圳市518108 [2]深圳市宝安区人民医院,深圳市518101 [3]深圳市光明新区公明人民医院,深圳市518106 [4]深圳市人民医院,深圳市518020

出　　处：《中国药房》2011年第21期1985-1987,共3页China Pharmacy

摘　　要：目的:制备复方洛美沙星缓释凝胶滴耳剂并建立其质量控制方法。方法:以卡波姆-940作为凝胶基质制备复方洛美沙星缓释凝胶滴耳剂,采用高效液相色谱(HPLC)法测定盐酸洛美沙星和地塞米松含量,考察其体外释放情况和稳定性。结果:制备的滴耳剂均匀细腻、分散性好、含量稳定;1h时盐酸洛美沙星和地塞米松累积释药百分率均小于30%,36h时分别为53%、52%,72h时均大于80%;稳定性试验表明2种成分对光不稳定。结论:该制剂制备工艺简单,质量可控,具有明显的缓释作用,宜避光放置。OBJECTIVE：To prepare Compound lomefloxacin sustained-release gel eardrops and to establish the quality control methods.METHODS：The eardrops was prepared by taking carbomer-940 as a base in the gel.The contents of lomefloxacin hydrochloride and dexamethasone were determined by HPLC,and in vitro drug release and stability of gels were investigated.RESULTS：Prepared eardrops were well-distributed,delicate,stable with good dispersity.Accumulative release rates of lomefloxacin hydrochloride and dexamethasone were both lower than 30% at 1 h,53% and 52% at 36 h,more than 80 % at 72 h.Results of stability tests indicated 2 kinds of components were unstable under sunlight.CONCLUSION：The preparation of eardrops is simple,and the gel is controllable in quality with sustained-release effect.Prepared eardrops should be kept in dark place.

关 键 词：复方洛美沙星缓释凝胶滴耳剂 制备 质量控制 地塞米松 高效液相色谱法 稳定性 

分 类 号：R943[医药卫生—药剂学] R977.1[医药卫生—药学]