伪麻非索缓释胶囊与原研缓释片体外释放行为一致性评价  

Evaluation on the Consistency of the Release Behavior in vitro between Pseudoephedrine/Fexofenadine Sustained-release Capsules and Original Sustained-release Tablets

作　　者：袁春平[1,2] 梁华娟[2] 林碧珊[2] 黄掌欣[2] 

机构地区：[1]中国医药工业研究总院药物制剂国家工程研究中心,上海201203 [2]国药集团广东环球制药有限公司,广东佛山528305

出　　处：《中国医药工业杂志》2016年第6期755-760,共6页Chinese Journal of Pharmaceuticals

摘　　要：评价伪麻非索缓释胶囊与原研缓释片（商品名Allegra-D？）体外释放行为的一致性。分别考察了伪麻非索缓释胶囊与原研缓释片在不同释放介质（p H 1.0盐酸、p H 3.0盐酸、p H 4.5磷酸盐缓冲液、p H 6.8磷酸盐缓冲液和水）、不同转速（50和75 r/min）、不同装置（桨法、桨法加沉降篮和篮法）的条件下,盐酸伪麻黄碱（1）和盐酸非索非那定（2）体外释放曲线的相似性。并考察3批工业放大样品释放曲线的均一性和重现性。结果伪麻非索缓释胶囊与原研缓释片的1在上述条件下的释放曲线均相似。采用桨法加沉降篮法,75 r/min,2在p H 3.0盐酸、p H 6.8磷酸盐缓冲液和水3种介质中的释放曲线相似;而在其他条件下释放曲线不相似。工业放大样品均一性和重现性均符合技术法规要求。The consistency of the in vitro release behavior between pseudoephedrine/fexofenadine sustained-release capsules and original sustained-release tablets （Allegra-D） was evaluated. The release behavior of pseudoephedrine/fexofenadine in the capsules and the original tablets was investigated in pH 1.0 hydrocloric acid, pH 3.0 hydrochloric acid, pH 4.5 phosphate buffer solution, pH 6.8 phosphate buffer solution, and water, under different rotation speeds （50 and 75 r/min） with different devices （paddle, paddle stirring with rotating basket, and basket）, respectively. The uniformity and reproducibility on the release curves of three batches of industrial products were also investigated. The release curves of pseudoephedrine hydrochloride in the capsules were similar to that of the original tablets under the above conditions. The release curves of fexofenadine hydrochloride in the capsules were similar to that of the original tablets in pH 3.0 hydrochloric acid, pH 6.8 phosphate buffer solution and water at the speed of 75 r/min inpaddle stirring with rotating basket, but not silimar under the other conditions. The uniformity and reproducibility of the industrial products met the technical requirements.

关 键 词：伪麻非索缓释胶囊 释放曲线 F2因子 一致性评价 

分 类 号：R917[医药卫生—药物分析学]