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本文研究了两种类型的氨茶碱控释片体内外试验的相关性。体外溶出试验表明骨架控释片和膜包衣控释片的溶出均属于表观一级释放过程,释放速度常数分别为0.1529h~(-1)和0.1510h~(-1)。体内试验表明,以单室模型拟合测得的血药浓度,其吸收速度常数分别为1.84h~(-1)和0.97h~(-1),二者有显著性差异,但其它动力学参数无显著性差异。体内外相关性研究表明,膜包衣控释片存在有一定相关性,而骨架片未见类似相关性。
This article studies the correlation of two types of aminophylline controlled release tablets in vitro and in vivo. In vitro dissolution tests showed that dissolution of the controlled release tablets and the coated tablets were both in the order of apparent first order release with release rates of 0.1529 h -1 and 0.1510 h -1, respectively. In vivo experiments showed that the single-chamber model fitted to the measured plasma concentration, the absorption rate constant were 1.84h ~ (-1) and 0.97h ~ (-1), both significant differences, but other kinetics No significant difference in parameters. In vitro and in vivo correlation studies have shown that there is a certain correlation between the film coated controlled release tablets, and no similar correlation between the matrix tablets.