摘要
红霉素作为第一个药用的十四元环大环内酯类抗生素,属于国家和世界卫生组织的基本药物。本文介绍了红霉素口服片剂的基本信息、国内外上市情况、参比制剂等信息,并对国内外制剂的处方、工艺、质量标准和质量控制进行比较分析,为该品种的一致性评价工作提供参考。
Erythromycin, the first 14-membered macrolide antibiotics, belongs to the national essential drugs and WHO essential drugs. This article introduced the basic information of erythromycin oral tablet, the situation of listing at home and abroad, the situation of reference preparation and so on. The formulation, technology and quality standards of the preparations at home and abroad were compared and analyzed, providing reference for the consistency evaluation of this variety.
作者
武建卓
洪建文
Wu Jian-zhuo;Hong Jian-wen(Guangdong Institute for Drug Control, Guangzhou 510663)
出处
《国外医药（抗生素分册）》
CAS
2019年第2期144-149,共6页
World Notes on Antibiotics
关键词
红霉素口服片剂
国内外现状比较
一致性评价
erythromycin oral tablet
comparison of current situation at home and abroad
consistency evaluation
