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目的:参附口崩片的处方筛选和制备工艺的优化。方法:以口崩片的崩解时限、粉末的休止角和口感为指标,采用正交试验设计对参附口崩片的处方进行优选。结果:口崩片的最佳处方主药(参附提取物干燥粉末)含量为40%、微晶纤维素(MCC)用量为36%、交联聚乙烯吡咯烷酮(PVPP)用量为4%、交联羧甲基纤维素钠(CMC-Na)用量为5%、微粉硅胶用量为1.5%、阿斯巴甜用量为4%、甘露醇为填充剂和辅助矫味剂。结论:按优选处方制备的参附口崩片崩解迅速,口感良好,质量检查各指标均符合用药要求。
OBJECTIVE: Prescription screening and optimization of preparation process of Shenfu Orally Disintegrating Tablets. Methods: According to the disintegration time of the orally disintegrating tablet, the angle of repose of the oily powder and the mouthfeel, the orthogonal design was adopted to optimize the prescription of the ginseng orally disintegrating tablet. Results: The content of 40% microcrystalline cellulose (MCC), 36% PVP and 4% PVP were the best prescriptions for oral disintegrating tablets 5% sodium carboxymethylcellulose (CMC-Na), 1.5% powdered silica gel, 4% aspartame and mannitol as filler and auxiliary flavoring. Conclusion: Shenfukou disintegration tablet prepared according to the preferred prescription has rapid disintegration and good taste. The indexes of quality inspection meet the requirements of medication.