BMJ:当我用一个词。药品管理-二甘醇

2024-02-13 来源:BMJ

本文由小咖机器人翻译整理

期刊来源:BMJ

原文链接:https://doi.org/10.1136/bmj.q356

摘要内容如下:

1937年,当二甘醇被用作一种医药产品(磺胺的一种药剂)的溶剂时,导致了死亡,公众的强烈抗议加速了一项法案的颁布,该法案在美国已经准备了几年,但遭到了制药公司的反对。众所周知,1938年的《食品、药品和化妆品法案》(Food,Drug,and Cosmetics Act)赋予了当时刚刚成立的食品和药品管理局(FDA)更大的权力来监管药物配方的内容。然而,尽管此后在世界各地建立了类似的监管制度,但仍有报告称,无论是故意掺假还是作为污染物,药物制剂中的二甘醇中毒事件仍在发生,通常发生在发展中国家,通常影响到儿童,并经常造成死亡。

英文原文如下:

Abstracts

In 1937, when diethylene glycol was used as a solvent in the preparation of a medicinal product, an elixir of sulfanilamide, resulting in deaths, public outcry hastened the promulgation of an act that had been in preparation in the USA for several years, but which had met with opposition from pharmaceutical companies. The 1938 Food, Drug, and Cosmetics Act, as it was known, gave greater powers to the then recently formed Food and Drug Administration (FDA) in regulating the contents of medicinal formulations. Nevertheless, although similar regulatory systems have since been established around the world, episodes of poisoning with diethylene glycol in pharmaceutical formulations, whether deliberately included adulteration or as a contaminant, continue to be reported, generally in developing countries, usually affecting children, and often causing deaths.

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