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Optimization of a floating osmotic pump system of ambroxol hydrochloride using central composite design-response surface methodology and its pharmacokinetics in Beagle dogs

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Author:: No author available

Journal Title:: Acta Pharmaceutica Sinica

Issue:: 12

DOI:: No doi available

Key Word:: 渗透泵;漂浮;盐酸氨溴索;星点设计;效应面法;药动学

Abstract：本文设计了具有漂浮特性的盐酸氨溴索渗透泵胶囊.采用中国药典(2010版)附录XD释放度测定法第三法装置同时评价制剂的体外释放和漂浮性能.以葡萄糖用量、致孔剂用量和包衣增重为自变量,自制处方释放曲线与目标释放曲线相比而得的相似因子(f2)为应变量,采用星点设计-效应面法优化系统.优化处方:葡萄糖100.99 mg,致孔剂用量11.70％,包衣增重4.21％.f2为89.14,高于市售胶囊(69.02)和自制片(72.15).优化后零级释药明显(r=0.994 4),释药完全(＞90％).Beagle犬体内实验证明,自制胶囊Cmax、tmax低于市售胶囊、自制片,体内外相关性好(r=0.985 1),且生物利用度高(110.77％),说明自制胶囊有明显的控释特征.

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