β-内酰胺类抗生素中高分子杂质的分离与检测方法进展

Review on Progresses of Isolation and Test Methods for High-molecular Weight Polymer Impurities in β-lactam Antibiotics

β-内酰胺类抗生素中的高分子杂质是导致不良反应的主要因素,关于用Sephadex G10凝胶色谱法控制β-内酰胺抗生素中高聚物的研究已有较多报道,但对其他质量控制方法的研究报道较少。本文主要对β-内酰胺抗生素中高分子杂质的检测方法包括高效凝胶色谱法、高效液相色谱法、LC-MS、柱切换技术等进行综述。

The high molecular weight impurities are the major cause for adverse reactions of antibiotics. Researches on polymers control in β-lactam antibiotics by using Sephadex G-10 gel filtration chromatography have been much reported, however, there are few reports on other methods for quality control of the polymers. This paper focuses on the test methods such as high performance gel filtration chromatography, high performance liquid chromatography, LC-MS, and HPLC-column-switching for the detection of high-molecular weight polymer impurities.