对中药仿制“同”的思考  

Simply Discussing the Consistency of Generic and Original Drug of TCM

作　　者：李鸿彬[1] 陆文亮[1] 

机构地区：[1]天津天士力集团研究院,天津300402

出　　处：《中国药事》2011年第7期674-677,共4页Chinese Pharmaceutical Affairs

摘　　要：目的讨论中成药仿制"同"的思想。方法从源头管理一致性、中间过程一致性、质量标准一致性探讨仿制要同,并对临床试验提出建议,保证中成药仿制的一致性。结果与结论应强化源头管理、中间过程结合质量标准等全过程一致性理念,以保障中药仿制和原研的一致性。Objective Discussing the consistency of generic and original drugs of TCM.Methods Ensuring consistency of source managemant,intermediate process,quality standards,so as to ensure consistency of generic of TCM and suggestions about clinical trials were made to ensure the consistency.Results and Conclusion Ensuring consistency of source management,intermediate process,with quality standards,to ensure consistency of generic and original drug of TCM.

关 键 词：中成药 仿制 

分 类 号：R288[医药卫生—中药学]