盐酸非索非那定盐酸伪麻黄碱缓释片处方工艺研究  

Study on Formulation and Process of Fexofenadine HCl and Pseudoephedrine HCl Extended-Release Tablets

作　　者：胡功允 彭俊清 余慧 

机构地区：[1]浙江华海药业股份有限公司,浙江临海317024

出　　处：《中国现代应用药学》2011年第9期846-849,共4页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的对盐酸非索非那定盐酸伪麻黄碱缓释片的处方及工艺进行研究。方法采用单因素和正交设计法分别考察盐酸非索非那定层和盐酸伪麻黄碱层处方。结果确定盐酸非索非那定层中崩解剂的量,盐酸伪麻黄碱层中羟丙甲纤维素,卡波姆的量为影响片剂质量的关键因素,筛选出最佳处方。结论采用本工艺进行放大生产的产品质量符合要求。OBJECTIVE To develop the formulation and process of fexofenadine HCl and pseudoephedrine HCl extended-release tablets.METHODS Using single factor and orthogonal experiment design to study formulation of fexofenadine HCl layer and pseudoephedrine HCl layer,respectively.RESULTS The amount of disintegrant in the fexofenadine HCl layer,and the amounts of HPMC and Carbomer in the pseudopehedrine HCl layer are the key factors which have influences on the quality of tablets.The optimized formulation and process have been determined.CONCLUSION The quality of scale-up product which manufactured as per to the process meets the specification.

关 键 词：盐酸非索非那定 盐酸伪麻黄碱 HPMC骨架 双层片 缓释 

分 类 号：R943.41[医药卫生—药剂学]