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[在片剂孔隙结构研究中使用压汞法并辅以氮吸附法]

[Use of mercury porosimetry, assisted by nitrogen adsorption in the investigation of the pore structure of tablets].

作者信息

Szepes Anikó, Kovács József, Szabóné Revész Piroska

机构信息

Szegedi Tudományegyetem Gyógyszertechnológiai Intézet, Szeged.

出版信息

Acta Pharm Hung. 2006;76(3):119-25.

Abstract

The microstructure of pharmaceutical solid dosage forms (porosity, pore volume-size distribution, specific surface area) can be investigated by different methods. Mercury porosimetry and nitrogen gas adsorption have been widely used to characterize the pore structure of tablets because these methods enable the determination of porosity and pore size distribution in one step. The two techniques are based on different physical interactions and cover specific ranges of pore size. Mercury porosimetry determines mesopores and macropores, whereas gas adsorption covers the micropore range. The aim of this study was to investigate the relationship between the compression force and the structure of tablets containing theophylline. The porosity parameters determined with mercury porosimetry and nitrogen adsorption were compared. The results indicated a good correlation between the applied compression forces and the porosity parameters of the tablets. The pore volume-size distributions, the pore size frequencies and the specific surface areas obtained with mercury porosimetry and nitrogen adsorption were not equal, which can be attributed to the different measurement ranges and to the complexity of the pore structures. Our results allow the conclusion that mercury porosimetry, assisted by nitrogen adsorption as a complementary technique, is an acceptable method to achieve a proper characterization of the internal structure of tablets.

摘要

药物固体剂型的微观结构(孔隙率、孔体积-尺寸分布、比表面积)可以通过不同方法进行研究。压汞法和氮气吸附法已被广泛用于表征片剂的孔隙结构,因为这些方法能够一步测定孔隙率和孔径分布。这两种技术基于不同的物理相互作用,覆盖特定的孔径范围。压汞法测定中孔和大孔,而气体吸附法覆盖微孔范围。本研究的目的是研究含茶碱片剂的压缩力与结构之间的关系。比较了用压汞法和氮气吸附法测定的孔隙率参数。结果表明,施加的压缩力与片剂的孔隙率参数之间存在良好的相关性。用压汞法和氮气吸附法获得的孔体积-尺寸分布、孔径频率和比表面积不相等,这可归因于不同的测量范围和孔隙结构的复杂性。我们的结果表明,以氮气吸附作为补充技术辅助的压汞法是一种能够对片剂内部结构进行适当表征的可接受方法。

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