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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 complete the formulation and preparation of alfuzosin hydrochloride sustained-release tablets. Methods: Orthogonal design of immediate-release layer prescription, sustained-release layer dissolution rate as the index. Results: According to the statistical analysis, 1 mg of main drug, 35 mg of lactose, 1 mg of sodium carboxymethyl starch and 8 mg of starch were determined in each immediate-release layer. The sustained-release layer contained 4 mg of main drug, 50 mg of hydroxypropyl methylcellulose, 70mg of cellulose. Conclusion: The prescription of sustained-release tablets is reasonable, the process is simple and the quality is reliable.