高海燕丁恩峰陈军丽

    (1.石药集团恩必普药业有限公司，河北石家庄 050031；2.英国施达化学集团公司中国代表处，河北石家庄 050031；3.石家庄市第三医院制剂科，河北石家庄 050031)

    国际注册中抗生素杂质控制指南介绍

    高海燕1丁恩峰2陈军丽3

    (1.石药集团恩必普药业有限公司，河北石家庄 050031；2.英国施达化学集团公司中国代表处，河北石家庄 050031；3.石家庄市第三医院制剂科，河北石家庄 050031)

    对药品中的杂质进行分析和控制是确保药品安全使用，保护患者利益的重要问题。在药品研发、药品生产和药品国际注册中，对于杂质分析和控制日益成为困扰制药企业的难点、热点和关键点。在已经颁布的ICH关于杂质指南和FDA关于杂质的指南中，都没有涉及抗生素药品中如何控制杂质的问题。2010年7月，EMA发布了《Guideline on setting specifications for related impurities in antibiotics》，重点阐述了欧盟对于如何控制抗生素类药品杂质问题的观点。为了帮助中国制药企业更好的理解和应用这个指南，促进抗生素药品杂质控制的工作，作者对这个指南进行了编译。

    抗生素；杂质控制；杂质分布状况；报告限度；鉴定限度；确认限度；国际注册

    Abstract:It is important to analyze and control the impurities in drugs so as to ensure the safe use of drugs and to protect the bene fi t of patients. In medical research, pharmaceutical production and international registration of pharmacy, the analysis and control of impurity in drugs has become dif fi cult and hot point for pharmaceutical enterprises. But, in ICH guide and FDA guide related to impurity which has been issued, there is no content involving in how to control impurity in antibiotics. In July, 2010, “Guideline on Setting Speci fi cations for Related Impurities in Antibiotics” was issued by EMA, in which the viewpoints of how to control the impurities in antibiotics from EU were stated. In order to help Chinese enterprises to understand and apply this guide so as to promote the control of impurities in antibiotic drugs, this guide was interpreted and presented herein. ......