托西酸舒他西林胶囊的制备工艺优化

目的优化托西酸舒他西林胶囊制备工艺,使其溶出度提高。方法将托西酸舒他西林原料微粉化,以超级羧甲淀粉钠为崩解剂,微粉硅胶为助流剂,湿法制粒制备托西酸舒他西林胶囊,以溶出度为指标进行综合评分,采用正交设计优化托西酸舒他西林的生产工艺。结果最佳处方为粉碎筛网目数200目、超级羧甲淀粉钠用量15%、二氧化硅用量4%。托西酸舒他西林胶囊溶出度平均达98.15%,加速试验考察6个月后溶出度仍在90%以上。结论托西酸舒他西林胶囊的制备工艺方便、科学,溶出度显著提高。

Optimization of the preparation procedure of sultamicillin tosilate capsules

Objective To optimize the preparation procedure of sultamicillin tosilate capsules and to improve the dissolution.Methods Sultamicillin tosilate was pulverized into tiny powder, the super Carboxymethyl Starch Sodium was used as the disintegrants,and the Gum Arabic was used as the glidants.Sultamicillin tosilate capsules were prepared by wet granulation.Experiments were conducted by orthogonal design and the formulations were evaluated by dissolution rate.Results The optimum procedure condition was:The shatter screen mesh was 200 meshes,that of super Carboxymethyl Starch Sodium was 15%,and Silicon Dioxide was 4%.The average value of capsule dissolution rate reached 98.15%.After 6 months,accelerated testing,its dissolution rate was kept at more than 90%.Conclusion The preparation of sultamicillin tosilate capsules is convenient and feasible.The dissolution rate of sultamicillin tosilate capsules has been improved.