甲氧氯普胺速释层与萘普生钠缓释层双层片的处方筛选及优化

Formulation screening and optimization of bilayer tablet with metoclopramide rapid release layer and naproxen sodium sustained release layer

目的 制备由甲氧氯普胺速释层与萘普生钠缓释层组成的双层片。方法 以体外释放度为指标考察影响药物释放的因素 ,采用正交设计优化甲氧氯普胺速释层中崩解剂的种类与用量 ,采用中心复合设计优化萘普生钠缓释层中骨架材料用量。结果 当甲氧氯普胺速释层中羧甲基淀粉钠 (CMS Na)的用量为 30 % ,萘普生钠缓释层中优特奇 RLPO(Eudragit RLPO)与HPMCK4M的用量分别为 2 0 %和 15 %时 ,可以得到释放度符合要求的复方缓释片。结论 正交设计、中心复合设计优化片剂处方预测性良好 ,结果准确可靠。

OBJECTIVE: To prepare bilayer tablet, which consists of a metoclopramide rapid release layer and a naproxen sodium sustained release layer. METHODS: Orthogonal experiment design and central composite design were adopted to optimize the formulation of metoclopramide rapid release layer and naproxen sodium sustained release layer, respectively. The behaviors of compound naproxen sodium sustained release tablets were evaluated by release test in vitro. RESULTS: The cumulative release of the bilayer tablet was up to criteria, when the amount of CMS-Na was 30% in metoclopramide rapid release layer, Eudragit&reg RLPO and HPMC K4M were 20% and 15% in naproxen sodium sustained release layer. CONCLUSION: Orthogonal experiment design and central composite design were successful in optimizing the preparation of tablets with accurate and reliable results.