普卢利沙星分散片处方筛选

摘要

目的：筛选及考察普卢利沙星分散片的最优处方。方法以片重差异、崩解时限和溶出度为指标，逐步调整辅料用量，最终获得普卢利沙星的优化处方。结果确定了以微晶纤维素为赋形剂、聚乙烯吡咯烷酮（PVP）为粘合剂、低取代羟丙纤维素（L-HPC）为崩解剂、滑石粉作为润滑剂的分散片处方；分散片溶出速度较普通片更快。结论研制的普卢利沙星分散片处方合理、工艺放大可行，符合药品质量标准的要求。%Objective To optimize formula of prulifloxacin dispersible tablets. Methods Tablet weight variation, disintegrate time and dissolution rate were used as the quality index, excipients were progressively adjusted to form optimizational for-mula for prulifloxacin dispersible tablets. Results MCC as an excipient, PVP as an adhesive, L-HPC as a disinte-grant and talc powder as a lubricant of the dispersible tablet formula. The dissolution rate of the dispersible tablet was faster than that of the conventional tablet. Conclusion The prepared prulifloxacin indispersible tablet is reasonable in formula, feasible in scale up to production and it meets the quality standards.