大环内酯类抗生素杂质谱研究进展_黄珊.pdfVIP

中国医药工业杂志 Chinese Journal of Pharmaceuticals 2015, 46(3) · 299 · 综述与专论 大环内酯类抗生素杂质谱研究进展 黄 珊1，李 悦1*，朱红激2 (1. 中国医药工业研究总院上海医药工业研究院，创新药物与制药工艺国家重点实验室，上海 200040； 2. 国药集团化学试剂有限公司，上海 200002) 摘要：药物中杂质控制是保证用药安全的重要环节。大环内酯类抗生素是临床应用最为广泛的抗菌药物之一，主要由微 生物发酵或半合成过程生产，组分复杂且杂质较多。为有效控制药物质量，必须控制其中的杂质。现代仪器和分析技术 的快速发展为药物杂质谱的建立提供了快速灵敏的方法。本文综述了大环内酯类药物杂质来源、分类及杂质谱的建立。 关键词：大环内酯类抗生素；有关物质；杂质谱；综述 中图分类号：R978.1+5 文献标志码：A 文章编号：1001-8255(2015)03-0299-07 Research Progress of Impurity Pro? les in Macrolide Antibiotics HUANG Shan1, LI Yue1*, ZHU Hongji2 (1. State Key Lab. of New Drug and Pharmaceutical Process, Shanghai Institute of Pharmaceutical Industry, China State Institute of Pharmaceutical Industry, Shanghai 200040; 2. Sinopharm Chemical Reagent Co., Ltd., Shanghai 200002) ABSTRACT: Controlling impurities in drugs is important to ensure drug safety. Macrolide antibiotic is one of the most widely used antibiotics in clinical, which are mainly produced by fermentation and then modified by chemical derivation. Macrolide antibiotics are consist of various components. Their related substances are multipled and diverse. The impurities should be controlled, which is crucial for the effective control of the product quality. With the rapid development of modern instruments and analysis techniques, many sensitive methods for impurity pro? les are provided. This article reviews the sources and classi? cations of related substances in macrolide antibiotics, as well as the establishment of impurity pro? les. Key Words: macrolide antibiotic; related subatance; impurity pro? les; review 大环内酯类抗生素因其抗菌活性强、抗菌谱 霉素 (telithromycin) 也已上市。这类抗生素主要通 广、疗效显著且不易产生耐药性等优点而被广泛用