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药物微量量热法:在长期稳定性研究中的应用。

Pharmaceutical microcalorimetry: applications to long-term stability studies.

作者信息

Beezer A E, Gaisford S, Hills A K, Willson R J, Mitchell J C

机构信息

Experimental Thermodynamics Group, School of Physical Sciences, The University, Canterbury, Kent CT2 7NH, UK.

出版信息

Int J Pharm. 1999 Mar 15;179(2):159-65. doi: 10.1016/s0378-5173(98)00336-6.

Abstract

Calorimetry has been a mainstay of stability analyses for some time in the form of differential scanning microcalorimetry (DSC). This technique exploits high (relatively) temperature studies of pure materials and of formulations to accelerate any degradation or interactions. The behaviour of the material at storage or ambient conditions is then estimated via extrapolation from the Arrhenius equation. Recent developments in isothermal microcalorimetry allow the direct determination of both kinetic and thermodynamic parameters for long, slow reactions from studies conducted at appropriate temperatures and under designated environmental control (pH, pO2, RH etc.). This review introduces the kinetic analysis of microcalorimetric data and, through selected examples, shows applications of the method.

摘要

量热法以差示扫描量热法(DSC)的形式一直是稳定性分析的主要手段。该技术利用对纯物质和制剂进行的高(相对)温度研究来加速任何降解或相互作用。然后通过从Arrhenius方程外推来估计材料在储存或环境条件下的行为。等温微量热法的最新进展使得能够通过在适当温度和指定环境控制(pH、pO2、RH等)下进行的研究,直接测定长时、缓慢反应的动力学和热力学参数。本文综述介绍了微量热数据的动力学分析,并通过选定的实例展示了该方法的应用。

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