阿莫西林胶囊国内外现状比较分析

Compare and Analysis of the Situation of Amoxicillin Capsules at Home and Abroad

本文对常用β-内酰胺类口服抗生素制剂—阿莫西林胶囊的基本信息、国内外上市情况、参比制剂、国内质量研究、体外溶出评价等信息进行了梳理,并对国内外制剂的处方工艺和质量标准等进行了分析比较,为该品种的仿制药质量与疗效一致性评价工作提供技术信息、意见和建议。

Amoxicillin capsule is a commonly used oral preparation of β-lactam antibiotics. In this paper, the basic information, the market satiation at home and abroad, reference preparations, domestic quality studies and in vitro dissolution evaluation of amoxicillin capsules were sorted out. The formulation technology, quality standards of the preparations at home and abroad were compared and analyzed , which provided technical information, suggestions for the consistency evaluation of this variety.