中国药物警戒 ›› 2015, Vol. 12 ›› Issue (2): 86-88.

• 质量与工艺研究 • 上一篇    下一篇

普卢利沙星分散片处方筛选

唐洪娟1，2,陈大为1*   

  1. 1苏州大学医学部药学院，江苏 苏州 215123;
    2浙江省桐乡市卫生学校，浙江 桐乡 314500
  • 收稿日期:2014-10-14 出版日期:2015-02-08 发布日期:2015-07-28
  • 通讯作者: 陈大为，男，教授，博士生导师，新型靶向药物传释系统的研究、 功能性药用高分子材料的研究、中药新剂型设计与生物学评价。
  • 作者简介:唐洪娟，女，在读硕士，高级讲师，药剂及药品生产质量管理方面教学与研究。

Optimization of Formula for Prulifloxacin Dispersible Tablets

TANG Hong-juan1,2，CHENG Da-wei1*   

  1. 1Pharmaceutical College of Soochow University, Jiangsu Suzhou 215123, China;
    2Tongxiang Medical School of Zhejiang Province, Zhejiang Tongxiang 314500, China
  • Received:2014-10-14 Online:2015-02-08 Published:2015-07-28

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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。

关键词: 普卢利沙星, 分散片, 处方

Abstract: 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 formula for prulifloxacin dispersible tablets. Results MCC as an excipient, PVP as an adhesive, L-HPC as a disintegrant 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.

Key words: prulifloxacin, dispersible tablet, formula

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