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目的:优选由硝苯地平缓释层与缬沙坦速释层组成的双层片处方。方法:先制备硝苯地平固体分散体,以丙烯酸树脂Eudragit NE30D为缓释骨架材料,采用正交试验设计优选处方;然后以缬沙坦在30 min的释放度为评价指标优化速释层的处方。结果:硝苯地平缓释层的最佳处方为Eudragit NE30D(以聚合物干重计)3.0%,乳糖为40%,磷酸氢钙为35%;缬沙坦速释层的最佳处方为乳糖18%、微晶纤维素40%、羧甲基淀粉钠6%、十二烷基硫酸钠10%。结论:正交试验优化的双层片处方良好,达到了设计要求。
OBJECTIVE: To optimize a two-layer tablet formulation consisting of a nifedipine sustained-release layer and a valsartan immediate-release layer. Methods: Nifedipine solid dispersion was prepared. Eudragit NE30D was used as the sustained-release matrix material. Orthogonal test was used to design the optimal prescription. Then, the release rate of valsartan at 30 min was used as the evaluation index to optimize the formulation of immediate- . RESULTS: The best prescription for sustained-release nifedipine was 3.0% of Eudragit NE30D (polymer dry weight), 40% of lactose and 35% of dicalcium phosphate. The optimal formulation of valsartan immediate-release layer was lactose 18%, microcrystalline cellulose 40%, sodium carboxymethyl starch 6%, sodium lauryl sulfate 10%. Conclusion: Orthogonal test optimized double-layer tablets prescription, to meet the design requirements.