CAJ | 학술논문

中药标准进入《美国药典》与《欧洲药典》是实现“中药标准主导国际标准制订”目标的前提与基础。通过对中、美、欧3个国家与地区的药典以及质量标准制订的关键问题进行比较分析，对如何完成中药国际质量标准的构建提出了建议。同时，为目前国际大环境重压下的中药国际化进程如何艰难破局提供借鉴与参考。
중약표준진입《미국약전》여《구주약전》시실현“중약표준주도국제표준제정”목표적전제여기출。통과대중、미、구3개국가여지구적약전이급질량표준제정적관건문제진행비교분석，대여하완성중약국제질량표준적구건제출료건의。동시，위목전국제대배경중압하적중약국제화진정여하간난파국제공차감여삼고。
Monographs of Chinese medicine into the United States Pharmacopeia and the European Pharmacopoeia is the prerequisite and foundation for the aim of "Chinese medicine standards leading the international standard-set-ting". By comparative analysis of the key issues of quality standards among Chinese, American and European Phar-macopoeia, thoughts and suggestions are proposed on how to implement the construction of international quality stan-dard of traditional Chinese medicine. Meanwhile, under the pressure of the present international environment, the pa-per can also provide some reference and advices which can help to break down the difficult situation for the process of internationalization of traditional Chinese medicine.