布洛芬粉粒的溶出研究: 粒径大小的影响及二种不同粒径粉粒混合后溶出过程的模拟

布洛芬粉粒的溶出研究: 粒径大小的影响及二种不同粒径粉粒混合后溶出过程的模拟

马吉德, 朱家璧

中国药科大学药学院, 南京 210009

收稿日期:1997-04-29 修回日期:1997-12-12 出版日期:1998-03-15 发布日期:1998-03-15

Dissolution Studies of Ibuprofen Powders: Effect of Particle Size on Dissolution Rate and Simulation of Dissolution Process of Mixed Binary Systems

Gul Majid Khan, Jia-Bi Zhu

Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, China Pharmaceutical University, Nanjing 210009

Received:1997-04-29 Revised:1997-12-12 Online:1998-03-15 Published:1998-03-15

摘要/Abstract

摘要： 本文围绕粒径大小对布洛芬粉末溶出的影响进行了一系列实验研究。在非漏槽条件下比较了六种筛分粒径(<65, 65~74, 74~91, 91~125, 125~150, 和150~200 mm)的溶出速率。粒径大于74 mm的粉末溶出速度随粒径的减小而增加。另一方面, 粒径小于74 mm的粉末则呈不同的溶出曲线, 起始较慢。这可能是由研磨后形成的颗粒静电引起。本文还进行了两种粉末按不同比例混合后的溶出实验。用每一组分的溶出数据模拟了二组分混合体系的溶出过程。几乎在全部溶出过程中模拟曲线都能很好地与测定值吻合。对二组分混合体系的溶出进行评估和模拟有可能用在多粒径粉末混合体系的溶出速度的评估及预测中。

关键词: 布洛芬粉粒, 粒径大小, 溶出速率, 二组分混合体系, 溶出过程的模拟

Abstract: A series of experiments were performed to investigate the effect of particle size on the dissolution rate of ibuprofen (IBF) powders. Dissolution studies were conducted under nonsink conditions and dissolution rates of six sieved particle size fractions (<65, 65~74, 74~91, 91~125, 125~150, and 150~200 μm) were compared. Dissolution rates of the fractions with particle size >74 μm increased with reduction of particle size. On the other hand, fractions enclosing particles with a size <74 μm demonstrated different profiles and slower initial rates of dissolution. This could be due to the development of electrostatic charge on the particles during micronization. Dissolution measurements of binary systems mixed at various ratios of the sieved samples were also carried out. Simulation of the dissolution process of the mixed binary systems was performed using the dissolution values of the sieved fractions. The simulated dissolution curves coincided well with those measured over almost the whole dissolution process. The evaluation of the dissolution behavior of the mixed binary systems and their simulation appears to be useful in the estimation and prediction of dissolution rates of multiparticulate powder systems.

Key words: Ibuprofen powders, Particle size, Dissolution rate, Mixed binary systems, Simulation of dissolution process

Supporting:

马吉德, 朱家璧. 布洛芬粉粒的溶出研究: 粒径大小的影响及二种不同粒径粉粒混合后溶出过程的模拟[J]. .

Gul Majid Khan, Jia-Bi Zhu. Dissolution Studies of Ibuprofen Powders: Effect of Particle Size on Dissolution Rate and Simulation of Dissolution Process of Mixed Binary Systems[J]. .