目的筛选银黄口腔崩解片的处方和制备工艺。方法以Eudragit E100为包衣材料.对金银花提取物进行包衣,掩盖其苦涩味。处方筛选中采用正交试验设计,以颗粒收率、抗张强度和崩解时间为指标.优选出银黄口腔崩解片的处方。在制备工艺中分别对搅拌制粒和流化床制粒工艺进行了考察。结果最佳制备工艺为:金银花提取物包衣增重10%.以交联PVPP为崩解剂用量10%。内外各加50%,流化床制粒后压片。结论按优选处方和工艺制得的银黄口腔崩解片,具有一定硬度,在口腔内能迅速崩解,且口感良好,达到了设计要求。

Objective To optimize the formulation and process development of Yinhuang orally disin- tegrating tablets.Methods Powder of Flos Lonicerae has unpleasant taste,so fluid-bed coating method with Eudragit El00 as coating material was applied to masking the bitter and astringent taste of the pow- der.The orthogonal design was adopted to optimize the tablet formulation.The yield of granulea,tensile strength,and disintegration time were determined as the index.The high stirring and fluid-bed granula- tion processes were studied.Results The optimal conditions were:The powder of Flos Lonicerae had pleasant taste with 10% weight getting after coating.Crosspovidone PVPP was used as disintegratant, making up 10% of the weight in the total prescription,of which 50% was added outside and inside of the tablets,respectively.After granulated by fluidized bed,Yinhuang bulk powder was granulated and then tableted.Conclusion The disintegration time and tensile strength of Yinhuang buccal disintegrating tablet are better and the taste is satisfactory.Yinhuang buccal disintegrating tablets reach the design stan- dard.

上海市教委课题