司帕沙星分散片的制备及质量控制

Preparation and quality control of Sparfloxacin dispersible taliets

目的制备司帕沙星分散片,并对其进行质量控制。方法以崩解时间为指标,采用正交设计试验确定最佳处方,并与普通片进行了体外溶出度的比较。结果最佳处方在1min内全部崩解,溶出速度远大于普通片,符合分散片的各项质量指标。结论司帕沙星分散片工艺简单,质量可控。

Objective To assess the technology in preparation of sparfloxaein dispersible tablets and establish the methods for control its quality. Methods The prescription of sparfloxaein dispersible tablets were optimized in terms of disintegrating time by the orthogonal design test and compared vitro dissolution with common tablet. Results Full disintegration was observed in the dispersible tablets within one minute with a dissolution speed of much faster than that of the common tablet, and the quality of the dispersible tablets met the criterion. Conclusion The technology for preparation of sparfloxaein dispersible tablets is simple and the method of determination is suitable for eontroling the quality of the product.