药物和医药产品的长期稳定性或降解:最新技术

Tomáš Lener, Karel Nesměrák
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摘要

药物和医药产品的基本参数之一除了其生理作用外,还有其保质期。即使是药品也会受到时间的影响,逐渐降解和变质。这会导致药效降低,甚至发生严重变化,或产生毒性。因此,确定任何药物或药品的保质期至关重要。过期未使用的药物或药品必须以昂贵的方式进行处理,这意味着经济损失,同时也对环境造成不必要的负担。最近,关于延长药品保质期的可能性进行了大量讨论。对药品历史残留物的分析结果在这一讨论中起着重要作用。因此,本文概述了这一领域的最新成果。在第一部分中,综述的重点是历史药物制剂(从古代到 19 世纪早期),这些药物制剂是研究药物长期稳定性的有趣、有价值且往往是独一无二的材料(尽管我们对其初始成分并不确定)。综述的第二部分概述了有关现代医药产品稳定性的文章,这些产品大多已实现工业化生产。 图文摘要
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Long-term stability or degradation of drugs and pharmaceutical products: state-of-the-art

One of the fundamental parameters of drugs and pharmaceutical products is, in addition to their physiological effects, also their shelf-life. Even pharmaceuticals are subject to the effects of time, which gradually degrades and deteriorates them. This results in a reduction or even a serious change in the effects, or the development of toxicity. Therefore, the determination of the shelf-life of any drug or pharmaceutical product is of paramount importance. Unused drugs or pharmaceutical products after the expiry date have to be disposed of in a costly manner, which means financial losses and also imposes an unnecessary burden on the environment. There has recently been considerable discussion about the possible extension of the shelf-life of pharmaceuticals. The results of analyses of the historical remains of pharmaceuticals play an important role in this discussion. Therefore, an overview of recent results in this field is given here. In the first part, the review focuses on historical medicinal preparations (from antiquity to the early 19th century), which represent interesting, valuable, and often unique material for the study of the stability of medicinal substances over a long period (despite the uncertainty we have about their initial composition). The second part of the review gives an overview of articles on the stability of modern medicinal products, mostly already industrially produced.

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