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[盐酸坦索罗辛缓释微丸单丸及多丸系统的释放动力学]

[Release kinetics of single pellets and the multi-pellet system of tamsulosin hydrochloride sustained release pellets].

作者信息

Yang Shuo, Wang Cai-Fen, Li Xue, Li Ying, Yin Xian-Zhen, Guo Tao, Zhang Ji-Wen, He Jun, Sun Li-Xin

出版信息

Yao Xue Xue Bao. 2014 Apr;49(4):535-42.

Abstract

The release behavior of single pellet was investigated by LC/MS/MS method with tamsulosin hydrochloride (TSH) as the model drug of the research and then the pellets were divided into four groups according to the drug loading. Comparison of dissolution profiles of each group and capsule were performed using f1 and f2 factor methods to study the difference and similarity. The release profiles of single pellet, each group and capsule were analyzed using principle component analysis (PCA). The particle system was built through Matlab to get the target release profile. The result of this research demonstrated the release behavior of single pellet correlated well with the drug loading. While the dissolution profile of capsule as a reference, the similarity factor of dissolution profiles of the lower drug loading groups were 62.2, 67.1, 53.9, respectively and, 43.3 for highest drug loading group. The particle systems with different pellet distribution and same release profiles were built through release behavior of single pellet. It is of significance to investigate the release behavior of single pellets for studying the release regularity of multiple-unit drug delivery system.

摘要

以盐酸坦索罗辛(TSH)为研究的模型药物,采用LC/MS/MS方法研究了单丸剂的释放行为,然后根据载药量将丸剂分为四组。使用f1和f2因子法比较每组与胶囊的溶出曲线,以研究差异和相似性。采用主成分分析(PCA)对单丸剂、每组和胶囊的释放曲线进行分析。通过Matlab构建颗粒系统以获得目标释放曲线。本研究结果表明,单丸剂的释放行为与载药量密切相关。以胶囊的溶出曲线为参考,低载药量组溶出曲线的相似因子分别为62.2、67.1、53.9,高载药量组为43.3。通过单丸剂的释放行为构建了具有不同丸剂分布和相同释放曲线的颗粒系统。研究单丸剂的释放行为对于研究多单元给药系统的释放规律具有重要意义。

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