盐酸川丁特罗片的制备及其处方优化

Studies on Preparation of Tranditerol Hydrochloride Tablets

目的制备盐酸川丁特罗薄膜衣片,优化其制备工艺。方法采用正交实验设计,以溶出度为指标,进行处方筛选。结果按优化后的处方得到的片剂达到实验设计要求,优化工艺各参数分别是:喷雾压力0·3MPa,喷浆速度8mL·min-1,包衣温度约45℃,包衣锅转速50r·min-1。结论该片剂处方合理,制备工艺简单易行,适合工业化生产。

OBJECTIVE To study the preparation of film-coated tratinterol hydrochloride tablets and optimize the technology. METHODS The orthogonal design method was used to optimize the formulation. The optimum technique parameters were shown as follows： The spray air pressure was 0.3 MPa, the rotating rate of spray solution was 8 mL·min^-1, the coating temperature was 45 ℃ and the rotation speed of coating pan was 50 r· min^-1. RESULTS The tablets prepared by optimized preparation fulfilled the design requirement. CONCLUSION The preparation is practical and reasonable, it is suitable for manufacturing industry.