盐酸阿夫唑嗪缓释片的初步研制

Primary Preparation of Sustained-release Tablet of Alfuzosin Hydrochloride

目的:完成盐酸阿夫唑嗪缓释片的处方设计及其制剂。方法:正交设计优选速释层处方,缓释层以溶出百分率为考察指标。结果:经统计学分析,确定每片速释层含主药1mg、乳糖35mg、羧甲基淀粉钠1mg、淀粉8mg;缓释层含主药4mg、羟丙基甲基纤维素50mg、甲基纤维素70mg。结论:确定的缓释片处方合理,工艺简便,质量可靠。

Objective: To study the prescription design of Alfuzosin sustained-release tablet and its preparation, method: The formulation of normal-layer was selected by orthogonal design and the composition of sustaining-layer were explored according to its dissolution, result: The prescription of normal-layer was consisted of alfuzosin Img, lactose 35 mg, sodium carboxylmethyl starch 1 mg, starch 8 mg, the prescription of sustaining-layer was consisted of alfuzosin 4 mg, HPMC 50 mg, MC 70 mg. conclusion: The prescription of the tablet is reasonable, and the technique is simple.