国内抗生素药品的质量现状

摘要

Quality consistency evaluation for generic drugs is currently the most popular topic in China.In this paper,based on the results of the national quality evaluation of post-marketing drugs over the years,the quality of domestic antibiotics was objectively analyzed to find the main differences between generics and brand-name drugs at present.The results are considered to help for the quality consistency evaluation for generic antibiotics.%仿制药质量与疗效的一致性评价工作是当前国内医药界的最热门话题.本文基于历年国家评价性抽验的结果,客观分析国产抗生素药品的质量现状,探讨国产仿制药与原研药品的主要质量差距,为国内开展抗生素药品的质量与疗效的一致性评价工作提供参考.