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药物溶出速率测定——旋转圆盘法的评估

Drug dissolution rate measurements--evaluation of the rotating disc method.

作者信息

Kaunisto Erik, Nilsson Bernt, Axelsson Anders

机构信息

Department of Chemical Engineering, Lund University, Lund, Sweden.

出版信息

Pharm Dev Technol. 2009;14(4):400-8. doi: 10.1080/10837450802712641.

Abstract

Dissolution rate measurements are important to understand the behaviour of drugs or drug formulations. Many methods for measuring dissolution rates are available and a good choice should be based on method limitations as well as drug characteristics. In the present study the rotating disc method was critically evaluated for dissolution rate measurements, using aspirin and benzoic acid as model substances. Existing theory for the rotating disc was compared with experiments and a computational fluid dynamics (CFD) model simulating the USP vessel. Simulations showed that it is possible to predict mass transfer controlled drug release rates within the laminar flow regime. Mass transfer coefficients obtained from the CFD model were in better agreement with experimental data than those obtained from existing theory. It was concluded that the hydrodynamic boundary layer controlling release rates was in reality thicker than existing theory would suggest.

摘要

溶出速率测定对于理解药物或药物制剂的行为很重要。有许多测量溶出速率的方法,一个好的选择应基于方法的局限性以及药物特性。在本研究中,以阿司匹林和苯甲酸作为模型物质,对旋转圆盘法进行溶出速率测定的关键评估。将旋转圆盘的现有理论与实验以及模拟美国药典容器的计算流体动力学(CFD)模型进行了比较。模拟表明,在层流状态下预测传质控制的药物释放速率是可能的。从CFD模型获得的传质系数比从现有理论获得的传质系数与实验数据的吻合度更好。得出的结论是,控制释放速率的流体动力学边界层实际上比现有理论所表明的更厚。

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