Giron D
Sandoz Ltd, Pharmaceutical Analytical Research and Development, Basle, Switzerland.
J Pharm Biomed Anal. 1986;4(6):755-70. doi: 10.1016/0731-7085(86)80086-3.
Thermal analysis includes all methods measuring some parameter during the heating of a sample. Differential scanning calorimetry (or differential thermal analysis) where the parameter is heat flow into and out of the sample and thermogravimetry where the parameter is the weight change of the sample are of great value for the pharmaceutical industry. Characterisation of drug substance, excipients, and packaging material: identification, purity, polymorphism, solvation, stability, ..., may be routinely done. Further examples demonstrating the use of these methods for the development of the dosage form are given: choice of the salt form, phase-diagrams, drug substance-excipient interactions, physical changes on processing or during storage, and even analysis of the dosage form.
热分析包括在对样品加热过程中测量某些参数的所有方法。差示扫描量热法(或差示热分析)中,参数是流入和流出样品的热流;热重分析法中,参数是样品的重量变化,这两种方法对制药行业具有重要价值。药物原料、辅料和包装材料的表征:鉴定、纯度、多晶型、溶剂化、稳定性等,都可以常规进行。还给出了更多示例,展示了这些方法在剂型开发中的应用:盐型的选择、相图、药物原料与辅料的相互作用、加工过程或储存期间的物理变化,甚至剂型分析。