药物元素杂质研究进展

Progress in the Study of Elemental Impurities in Drugs

在过去的几十年中,“重金属”一词被广泛使用,它常被理解为与污染或者毒性有关的金属或类金属。这一笼统的概念意味这一类物质可能具有相同的毒理学、化学或者生物特性,然而事实并非如此。近年来随着人们对药学研究的不断深入,对各类杂质研究的不断细化,“元素杂质”的概念被引入到药学领域。

The term “heavy metals” has been widely used over the past decades and is often understood to mean metals or metalloids associated with pollution or toxicity. This generalization implies that this group of substances may have the same toxicological, chemical or biological properties, which is not the case. In recent years, the concept of “elemental impurities” has been introduced into the field of pharmacology as the study of pharmacology has become more advanced and the study of various types of impurities has been refined.