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复方洛美沙星缓释凝胶滴耳剂的制备及其质量控制
引用本文:谢燕贤,陈丽娜,温中明,李东.复方洛美沙星缓释凝胶滴耳剂的制备及其质量控制[J].中国药房,2011(21):1985-1987.
作者姓名:谢燕贤  陈丽娜  温中明  李东
作者单位:深圳市宝安区石岩人民医院;深圳市宝安区人民医院;深圳市光明新区公明人民医院;深圳市人民医院;
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。

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

Preparation and Quality Control of Compound Lomefloxacin Sustained-release Gel Eardrops
XIE Yan-xian CHEN Li-na WEN Zhong-ming LI Dong.Preparation and Quality Control of Compound Lomefloxacin Sustained-release Gel Eardrops[J].China Pharmacy,2011(21):1985-1987.
Authors:XIE Yan-xian CHEN Li-na WEN Zhong-ming LI Dong
Institution:XIE Yan-xian(Shenzhen Bao’an District Shiyan People's Hospital,Shenzhen 518108,China) CHEN Li-na(Shenzhen Bao’an District People's Hospital,Shenzhen 518101,China) WEN Zhong-ming(Shenzhen Guangmingxin District Gongming People's Hospital,Shenzhen 518106,China) LI Dong(Shenzhen People's Hospital,Shenzhen 518020,China)
Abstract: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...
Keywords:Compound lomefloxacin sustained-release gel eardrops  Preparation  Quality control  Dexamethasone  HPLC  Stability  
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