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药物材料的差示扫描量热法和扫描热显微镜分析

Differential scanning calorimetry and scanning thermal microscopy analysis of pharmaceutical materials.

作者信息

Bond Laura, Allen Stephanie, Davies Martyn C, Roberts Clive J, Shivji Arif P, Tendler Saul J B, Williams Phillip M, Zhang Jianxin

机构信息

Laboratory of Biophysics and Surface Analysis, School of Pharmaceutical Sciences, University of Nottingham, University Park, NG7 2RD Nottingham, UK.

出版信息

Int J Pharm. 2002 Aug 28;243(1-2):71-82. doi: 10.1016/s0378-5173(02)00239-9.

Abstract

Micro-thermal analysis (microTA) by scanning thermal microscopy is being used increasingly for the analysis of pharmaceutical dosage forms. However, there is currently little evidence to show that microTA data can compare directly with that from the established approach of differential scanning calorimetry (DSC). This work compares DSC and microTA data from an active vitamin B6 analogue, pyridoxal hydrochloride, and two commonly used pharmaceutical excipients, Mannitol and Avicel which are used in its formulation. It is found that microTA provides precise and accurate micro-thermal analytical data with 0.1 K thermal sensitivity, which is comparable to that obtained by DSC measurements of bulk samples. It is also shown that microTA offers the opportunity to study single particles and the interfacial region between particles, data which is currently inaccessible through the DSC technique.

摘要

通过扫描热显微镜进行的微热分析(microTA)越来越多地用于药物剂型分析。然而,目前几乎没有证据表明microTA数据能与差示扫描量热法(DSC)这种既定方法的数据直接比较。这项工作比较了活性维生素B6类似物盐酸吡哆醛以及其制剂中常用的两种药用辅料甘露醇和微晶纤维素的DSC和microTA数据。结果发现,microTA能提供精确且准确的微热分析数据,热灵敏度为0.1 K,这与对大量样品进行DSC测量得到的数据相当。还表明,microTA提供了研究单个颗粒以及颗粒间界面区域的机会,而这些数据是目前DSC技术无法获取的。

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