| 引用本文: | 胡功允,彭俊清,余慧.盐酸非索非那定盐酸伪麻黄碱缓释片处方工艺研究[J].中国现代应用药学,2011,28(9):846-849. |
| HU Gongyun,PENG Junqing,YU Hui.Study on Formulation and Process of Fexofenadine HCl and Pseudoephedrine HCl Extended-Release Tablets[J].Chin J Mod Appl Pharm(中国现代应用药学),2011,28(9):846-849. |
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| 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。 |
| 关键词: 盐酸非索非那定 盐酸伪麻黄碱 HPMC骨架 双层片 缓释 |
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| Study on Formulation and Process of Fexofenadine HCl and Pseudoephedrine HCl Extended-Release Tablets |
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HU Gongyun, PENG Junqing, YU Hui
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Zhejiang Huahai Pharmaceuticals Co., Ltd., Linhai 317024, China
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| Abstract: |
| 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. |
| Key words: fexofenadine HCl pseudoephedrine HCl HPMC matrix bi-layer tablets extended-release |
