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机构地区:[1]南京工业大学江苏省药物研究所有限公司,南京210009
出 处:《药学与临床研究》2012年第2期109-111,共3页Pharmaceutical and Clinical Research
摘 要:以进口的琥珀酸美托洛尔缓释片为参比制剂,采用f2相似因子法评价自研制剂和参比制剂在不同pH值的释放介质中体外释放行为的相似性,结果显示f2值均大于50,两种制剂体外释放行为相似。运用药物释放动力学模型拟合琥珀酸美托洛尔的释放过程,释放动力学特征以Higuchi模型拟合较好,根据Peppas方程,其释放机制是药物扩散和骨架溶蚀的共同作用。Metoprolol succinate sustained-release tablets were used as reference preparation,which have been imported from overseas.The release behavior similarity was investigated between the reference and self-prepared tablets in release mediums at different pH.Similar factors(f2) were used to evaluate the similarity of release curves.The values of f2 were all more than 50.The release behaviors were similar.Appling the release kinetic models to the tablets at different release mediums,the release of metoprolol succinate was basically in conformity with the Higuchi model.According to the Peppas equation,the release of metoprolol succinate was affected by drug diffusion and matrix erosion.
关 键 词:琥珀酸美托洛尔缓释片 释放曲线 f2相似因子 释药机制
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