健胃消食泡腾片的成型工艺研究

Optimization of the preparation process for Jianweixiaoshi Effervescent Tablets

目的对健胃消食泡腾片的处方配比及制备工艺进行研究。方法以泡腾片的崩解时间、pH值、脆碎度、口感及颗粒的硬度、流动性、压片难易为指标,采用单因素实验优选成型工艺条件,对健胃消食泡腾片的制备工艺进行筛选。结果取太子参半量与山药混合粉碎成细粉,其余药物加水10倍量煎煮2次制成细粉,与上述细粉合并,将合并所得药物细粉460g、碳酸氢钠240g、甜蜜素5g、蔗糖20g,用质量分数10%PVP的乙醇溶液制粒;然后取无水枸橼酸250g与聚乙二醇6000 25g,与上述颗粒混合均匀,压制成1 000片。结论健胃消食泡腾片的制备工艺简单可行,各项指标符合《中国药典》标准,工艺重复性好。

Objective To optimize the formulation and preparation process of Jianweixiaoshi Effervescent Tablets .Methods Several indicators such as the disintegration time ,the pH value ,the breakage ,the taste and the hardness were selected to evaluate and optimize the preparation process with experiments of single factor analysis .Results Half of Radix Pseudostellariae mixed with Rhizoma Dioscoreae was ground into fine powder .The rest of ingredients were extacted with 10 folds of water for 2 twice of de-coction .The extraction was dried and grinded into fine powder and then mixed with above powders .The granules were prepared with 10% （g/g） PVP in ethanol .Conclusion The proposed preparation conditions for Jianweixiaoshi Effervescent Tablets were demonstrated with the propertis of simple ,feasible and reproducible .All indicators met the requirements of Chinese Pharmaco-poeia .