不同厂家司帕沙星片体外溶出度比较

目的考察4厂家司帕沙星片的体外溶出度,为临床用药提供参考。方法采用转篮法进行体外溶出度实验,用紫外分光光度法进行含量测定,计算其累积溶出百分率,并以威布尔方程拟合溶出参数。结果不同厂家的司帕沙星片体外溶出度均符合2005年版《中国药典》相关规定,但各厂家T50,Td值间均有显著性差异。结论不同厂家司帕沙星片溶出参数存在差异,临床选用应加以注意。

Comparison of dissolution of sparfloxacin tablets in vitro from different pharmaceutical factories

OBJECTIVE To investigate the dissolution of sparfloxacin tablets in vitro from four different pharmaceutical factories and give suggestions for clinical use. METHODS The dissolution tests were carried out with rotating basket method and the content of sparfloxacin was determined by UV spectrophotometry. The accumulation dissolution percent was calculated and Weibull formula was used to fit the dissolution parameters. RESULTS The dissolution of sparfloxacin tablets in vitro from four factories were all up to the related standards specified in Chinese pharmacopoeia（2005 edition）.But significant differences of dissolution parameters T50 and Td were found among the sparfloxacin tablets. CONCLUSION There were significant differences in dissolution parame- ters of the sparfloxacin tablets from four factories, indicating that attention should be paid to their differences in clinical use.