西他沙星薄膜衣片的制备及稳定性考察

Preparation and Stability Study of Sitafl oxacin Hydrate Film-coated Tablets

目的 采用湿法制粒制备西他沙星薄膜衣片,并对其进行影响因素考察.方法 以f2相似因子为考察指标,对处方中填充剂用量、崩解剂用量、原料粒径、片芯硬度及包衣增重为单因素进行处方工艺考察.对优化后处方所制制剂进行影响因素（高温、强光、高湿）考察.结果 最佳处方为填充剂用量每片90.75mg、崩解剂的用量每片11.27mg、原料过80目筛、片芯硬度为70～90N及包衣增重3.5％,制剂溶出度达90％以上,影响因素试验中制剂的稳定性均较好.结论 该制备工艺可行,可为工业化生产提供理论依据.

Objective Sitafloxacin Hydrate film-coated tablets were prepared using granulation method, the influencing factors were investigated as well. Methods The amount of the fillers, disintegrants, particle size of raw materials, hardness of tablet core as well as coating weight were investigated as single factor, using the similarity factor as the index. Then the influencing factors were performed as well. Results The optimized formulation of single sitafloxacin hydrate film-coated tablet was as follows： 90.75mg filler, 11.27mg disintegrants. The process parameters were the raw material through a 80 mesh sieve, hardness of tablet core between 70N and 90N, and coated weight 3.5%. The drug dissolution was above 90%. In the influencing factor test, the tablets were stable. Conclusion The process of preparation is feasible, and it provides basis for the industrialized production.