摘要
杂质研究是β-内酰胺类抗生素的重要研究内容,与药物的安全性直接相关。β-内酰胺类抗生素一般由微生物发酵、纯化、精制以及化学修饰等过程制得。与一般化学合成药物相比生产过程更加复杂,其纯度一般也较化学药品低,而且该类抗生素对热、光和湿的稳定性一般不是很好,因此更应该对其杂质进行深入研究。本文主要对β-内酰胺类抗生素构造异构体以及立体异构体等杂质的产生途径,国内外对该类抗生素的质控情况等进行了介绍。
Impurity control is a very important part for β-lactam antibiotics research, which is related to safety directly. β-1actam antibiotics are usually obtained from fermentation, purification, chemical modification and refining process. The manufacturing process of β-lactam antibiotics is more complicated than that of other chemical synthetic products, the purity is lower than chemicals, and it may not be stable to heat, light and humidity. We mainly discuss the producing routes of isomers of β-lactam antibiotics, and introduce the quality control of β-lactam antibiotics.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2010年第8期561-566,共6页
Chinese Journal of Antibiotics
