摘要
目的探讨甲苯磺酸妥舒沙星分散片的制备工艺及其质量控制方法。方法以颗粒流动性以及分散片的外观光洁度、崩解时限为综合指标，选择L9（3^4）进行正交试验筛选出甲苯磺酸妥舒沙星分散片的最佳处方．同时对制备工艺中原辅料微粉化、崩解剂的加入方法、硬度等进行了研究。结果确定优选处方和制备工艺；所制备的分散片脆碎度、分散均匀性、溶出度均符合要求。结论本分散片制备工艺合理。具有溶散快、分散均匀、有效成分溶出量高的特性。
OBJECTIVE To study the preparation and quality control of Tosufloxaein Tosylate dispersible tablets. METHODS L9 （3^4）orthogonal design was used to obtain the optimal prescription with the grain flowing, the appearance and disintegration time limit of tablets as composite index. And the micronization of materials, the adding methods of disintegrating agents and hardness of tablets were studied. RESULTS The optimal prescription and preparation method were selected. The friability,Dispersible uniformity,dissolution of Dispersible Tablets fit the requirements. CONCLUSION The Dispersible Tablets have a optimal prescription, and a good dissolution, unif-rmity.
出处
《海峡药学》
2010年第7期72-75,共4页
Strait Pharmaceutical Journal
关键词
甲苯磺酸妥舒沙星
分散片
制备
质量控制
Tosufloxaein Tosylate
Dispersible Tablets
Preparation
Quality Control
