2017年版《英国药典》概述及启示
x

请在关注微信后,向客服人员索取文件

篇名: 2017年版《英国药典》概述及启示
TITLE:
摘要: 目的:对2017年版《英国药典》进行概述,为药品检验者使用药典提供便利。方法:通过对2017年版《英国药典》的主要内容和编排结构进行概览,运用文献研究并与2015年版《中国药典》进行比较,描述中、英两国药典的异同,并提出可供我国药典的借鉴之处。结果与结论:《英国药典》内容包括“介绍”“凡例”“正文品种”“红外对照图谱”等7部分,其分为“医药原料药”“配方制剂”“兽药”等6卷。与之前版本比较,2017年版新增了69个品种,删除了9个专论,技术修改91个品种;与《中国药典》比较,《英国药典》另纳入了兽药、顺势疗法制剂、手术材料和红外光谱图等。与《中国药典》5年修订1次比较,英国药典委员会每年都对《英国药典》进行更新和修订,为科学分析方法的建立及时提供了可靠的参考材料;同时,还建立了《英国药典》在线网站www.pharmacopoeia.com,为使用者提供了更加方便、快捷的平台;并特别注重与药品制造商、监管机构、欧洲药品管理局(EMA)以及EMA中的中草药产品委员会保持紧密的联系,以及时修订药品标准;由此为我国药典的修订提供启示和借鉴。
ABSTRACT: OBJECTIVE: To summarize 2017 edition of British Pharmacopoeia, and to facilitate the use of it by drug inspectors. METHODS: The main contents and layout of 2017 edition of British Pharmacopoeia were overviewed; the similarities and differences between Chinese Pharmacopoeia and British Pharmacopoeia were described by means of literature research and general comparison with the 2015 edition of Chinese Pharmacopoeia. The reference for Chinese Pharmacopoeia was put forward. RESULTS & CONCLUSIONS: British Pharmacopoeia includes 7 parts as “introduction” “explanatory notes” “text variety” “infrared control chromatogram”, and divided into 6 volumes, such as “pharmaceutical raw materials” “formulated preparations” “veterinary drugs”. Compared with the previous edition, 2017 edition added 69 new varieties, removed 9 monographs and modified 91 varieties technologically. Compared with Chinese Pharmacopoeia, British Pharmacopoeia additionally included veterinary drugs, homeopathic preparations, surgical materials, infrared spectrogram, etc. Compared with the update of Chinese Pharmacopoeia every 5 years, British Pharmacopoeia Commission updated and revised the British Pharmacopoeia every year, and provided reliable reference for the establishment of scientific analysis methods in time. At the same time, British Pharmacopoeia Commission established British Pharmacopoeia online website www.pharmacopoeia.com to provide a more convenient and fast platform for users; British Pharmacopoeia Commission paid special attention to maintaining close ties with drug manufacturers, regulators, the European Medicines Agency (EMA) and the Chinese Herbal Medicine Products Committee in EMA so as to revise drug standards timely. It provides enlightenment and reference for the revision of Chinese Pharmacopoeia.
期刊: 2018年第29卷第3期
作者: 谢茵,张静
AUTHORS: XIE Yin,ZHANG Jing
关键字: 2017年版;英国药典;中国药典;概述;启示
KEYWORDS: 2017 edition; British Pharmacopoeia; Chinese Pharmacopoeia; Outline; Inspiration
总下载数: 6 次
本日下载数: 0次
本月下载数: 2次
文件大小: 619.60Kb

* 注:未经本站明确许可,任何网站不得非法盗链资源下载连接及抄袭本站原创内容资源!在此感谢您的支持与合作!