药物稳定性研究,包括从有效物质的反应速度和机制的基础研究,评价处方和生产工艺对药物和成品的影响,以至容器的作用,及成品贮存和销售对产品完整性所产生的影响。在制药工业中,稳定性所涉及的学科首先是药物分析和产品试制,但物理化学、有机化学、数学、物理学、微生物学、毒物学、生产工艺、包装、管理、质量控制及销售也都包括在内。主要是物理有机化学——反应速度和机制的评价、动力学和热力学,而更重要的是有机分析。没有分析手段,不可能检测稳定性、测定反应速度或研究反应机制。因此,在稳定 The study of drug stability includes basic research on the reaction rate and mechanism of effective substances, the impact of prescriptions and manufacturing processes on pharmaceuticals and finished products, the role of containers, and the impact of finished product storage and marketing on product integrity. In the pharmaceutical industry, the subjects involved in stability are, above all, drug analysis and product trials, but also in the fields of physical chemistry, organic chemistry, mathematics, physics, microbiology, toxicology, production technology, packaging, management, quality control and marketing included. It is mainly physical organic chemistry - evaluation of reaction rates and mechanisms, dynamics and thermodynamics, and more importantly, organic analysis. Without analysis, it is not possible to detect stability, determine reaction rates, or study reaction mechanisms. Therefore, stable