甲磺酸培氟沙星分散片的处方研究和体外溶出度考察

目的:优选甲磺酸培氟沙星分散片处方并考察其体外溶出度。方法:对处方中选用的微晶纤维素、交联聚乙烯吡咯烷酮、羧甲基淀粉钠和聚乙烯吡咯烷酮用量进行正交试验;采用紫外分光光度法考察甲磺酸培氟沙星分散片与普通片的溶出度。结果:优选的最佳处方为微晶纤维素20%、交联聚乙烯吡咯烷酮6%、羧甲基淀粉钠5.5%和聚乙烯吡咯烷酮8%。所制分散片在30s内完全崩解,15min时溶出度明显高于普通片。结论:采用本处方及工艺制得的甲磺酸培氟沙星分散片质量可靠,崩解时限短,体外释放度优于普通片。

Study on the Formulation of Pefloxacin Mesylate Dispersible Tablets and In Vitro Dissolution Characteristics

OBJECTIVE:To optimize the formulation of pefloxacin mesylate dispersible tablets by orthogonal design,and to evaluate its dissolution characteristics in vitro.METHODS:An orthogonal experiment was conducted to identify the amounts of microcrystalline cellulose,cross-link polyvinyl pyrrolidone,sodium carboxymethyl starch and polyvinyl pyrrolidone selected for the formulation of pefloxacin mesylate dispersible tablets.UV spectrophotometric method was used to examine the dissolutions of pefloxacin mesylate dispersible tablets and common tablets.RESULTS:The optimized formulation was composed of microcrystalline cellulose 20%,cross-link polyvinyl pyrrolidone 6%,sodium carboxymethyl starch 5.5% and polyvinyl pyrrolidone 8%.The dispersible tablets was completely disintegrated in 30 seconds,with its dissolution obviously higher than that of common tablets at 15min.CONCLUSIONS:Pefloxacin mesylate dispersible tablets prepared with this formulation process has controllable quality,shorter disintegration duration and better in vitro release rate than the common tablets.