司帕沙星分散片的研制及其质量控制  

Preparation and quality control of sparfloxacin dispersible tablets

作　　者：石庆平[1] 丁峰[1] 许善初[1] 朱锦秀[1] 程鹏[1] 

机构地区：[1]蚌埠医学院第一附属医院药剂科,233004

出　　处：《江苏医药》2010年第7期825-827,共3页Jiangsu Medical Journal

摘　　要：目的制备司帕沙星分散片,并进行质量控制。方法高效液相色谱法进行样品含量及有关物质测定;通过改变不同因素进行司帕沙星分散片的工艺筛选,并按中国药典2005年版二部附录进行分散均匀性检查、崩解时限检查和溶出度检查。结果优化处方为:司帕沙星200g,交联聚维酮(PVPP)80g,微晶纤维素(MCC)300g,羧甲基淀粉钠(CMS-Na)48g,甘露醇128g,微粉硅胶48g,10%聚维酮K30的50%乙醇溶液适量,共制成1000片。结论优化后分散片的片重差异、溶出度和崩解时间均符合中国药典的规定,有关物质和含量亦符合本品临床用药的质量标准(草案)。Objective To prepare the dispersal tablets of sparfloxacin and set up their quality control.Methods The concentration and relative substances of sparfloxacin were determined by HPLC method.The optimized technique was obtained by changing various factors,and the inspections of the tablet about dispersal uniformity,disintegration time limit and dissolution were made according to Chinese Pharmacopoeia.Results An optimal formula was sparfloxacin 100g,cross-linked povidone 40g,microcrystalline cellulose 150g,sodium carboxymethyl starch 24g,mannitol 64g,silica powder 24g,10% povidone K30（50% ethanol solution suitable）,and 1000 tablets were prepared.ConclusionThe tablet weight variation,dissolution and disintegration time of the optimized tablet are all accordant with Chinese pharmacopoeia.The detections of relative substances and contents are all accordant the quality criteria of clinical drugs as well.

关 键 词：司帕沙星 

分 类 号：R943[医药卫生—药剂学]