欧洲和美国药品标准数据库设计对中国的启示

Enlightenment from the Practice of Drug Standard Database Construction in Europe and America to China

关键词:  国家药品标准  欧洲药典  美国药典  数据库

Key words:  national drug standards  European pharmacopoeia  United States pharmacopoeia  database

摘要:

目的 为中国构建统一、权威、规范的药品标准数据库提供参考。方法 通过查询欧洲药品质量管理局和美国药典委员会药品标准数据库应用建设情况，总结归纳其构建思路，功能设定与应用特点，并对中国药品标准数据库建设关键结构框架与功能设定进行简要分析。结果 欧洲与美国均构建了具有精准检索、知识辅助功能的药典数据库，并充分考虑了实际工作需要以及用户需求，建设了药典论坛、色谱图谱、药典培训等数据库，可以更好地满足药典编制工作需要和用户需求。结论 中国应当以《“十四五”国家药品安全及促进高质量发展规划》为契机，充分借鉴欧洲、美国药典数据库结构设计、功能设定、用户体验等特色与优势，尽快构建以国家药品标准为核心的数据库群，更好地满足国家药品标准智慧管理和公共服务需要。

Abstract:

OBJECTIVE To provide references for the construction of a unified, authoritative and normative drug standard database in China. METHODS By referring to the application and construction of drug standard database of European Directorate for the Quality of Medicines & Healthcare for the quality of medicine and healthcare and United States Pharmacopeial Convention, this paper summarized the construction ideas, implementation functions and application characteristics of drug standard database, and briefly analyzed the key structural framework and design considerations for the construction of Chinese drug standard database. RESULTS Both European and American had built pharmacopoeia databases with accurate retrieval and knowledge assistance functions, and fully considered the actual work needs and user needs, and built pharmacopoeia forums, chromatographic maps, pharmacopoeia training databases, which could well meet the needs of pharmacopoeia compilation work and user needs. CONCLUSION China should take the “14th Five-year Plan for National Drug Safety and Promotion of High-quality Development” as an opportunity to fully learn from the characteristics and advantages of European and United States pharmacopoeia database structure design, function realization, user experience and other characteristics, as soon as possible for building a database cluster with national drug standards database as the core, to better meet the needs of national drug standards intelligent management and public service.