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茶碱在亲水性和疏水性基质中的体外溶出动力学研究。

In vitro dissolution kinetic study of theophylline from hydrophilic and hydrophobic matrices.

作者信息

Maswadeh Hamzah M, Semreen Mohammad H, Abdulhalim Abdulatif A

机构信息

School of Pharmacy, Dep. of Pharmaceutical Technology, Al-Isra University, P.O. Box 961582, Code No. 11196 Amman, Jordan.

出版信息

Acta Pol Pharm. 2006 Jan-Feb;63(1):63-7.

PMID:17515331
Abstract

Oral dosage forms containing 300 mg theophylline in matrix type tablets, were prepared by direct compression method using two kinds of matrices, glycerylbehenate (hydrophobic), and (hydroxypropyl)methyl cellulose (hydrophilic). The in vitro release kinetics of these formulations were studied at pH 6.8 using the USP dissolution apparatus with the paddle assemble. The kinetics of the dissolution process were studied by analyzing the dissolution data using four kinetic equations, the zero-order equation, the first-order equation, the Higuchi square root equation and the Hixson-Crowell cube root law. The analysis of the dissolution kinetic data for the theophylline preparations in this study shows that it follows the first order kinetics and the release process involves erosion / diffusion and an alteration in the surface area and diameter of the matrix system, as well as in the diffusion path length from the matrix drug load during the dissolution process. This relation is best described by the use of both the first-order equation and the Hixson-Crowell cube root law.

摘要

采用直接压片法,使用两种基质(山嵛酸甘油酯(疏水性)和(羟丙基)甲基纤维素(亲水性))制备了含300mg茶碱的口服基质型片剂。使用桨板装置的美国药典溶出度测定仪,在pH 6.8条件下研究了这些制剂的体外释放动力学。通过使用四个动力学方程(零级方程、一级方程、Higuchi平方根方程和Hixson-Crowell立方根定律)分析溶出数据,研究了溶出过程的动力学。本研究中茶碱制剂溶出动力学数据的分析表明,其遵循一级动力学,释放过程涉及溶蚀/扩散以及基质系统表面积和直径的变化,以及溶出过程中从基质药物负载处的扩散路径长度的变化。使用一级方程和Hixson-Crowell立方根定律可以最好地描述这种关系。

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