中国、欧洲、美国药典中天然药物质量控制技术比较  

Comparison of quality control standards of natural crude drugs in Chinese,European and American pharmacopoeia

作　　者：王赵[1] 李海亮 金红宇[1] 马双成[1] WANG Zhao;LI Hai-liang;JIN Hong-yu;MA Shuang-cheng(National Institutes for Food and Drug Control,Bejing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国新药杂志》2024年第4期313-322,共10页Chinese Journal of New Drugs

基　　金：国家重点研发计划项目(2022YFC3501505)。

摘　　要：通过系统分析《中华人民共和国药典》、《美国药典/国家处方集》和《欧洲药典》对天然药物的质量控制标准,发现基于对照提取物全成分检测的整体质量控制理念仍是目前最有效的天然药物质量控制方法。本文旨在秉持兼容并蓄、博采众长的原则,分析上述国际通行的药典标准和规范中值得借鉴的经验和关键技术,提出科学建议,力求将各个国家和地区目前最科学合理的标准纳入到天然药物的整体质量控制,为创建和完善现代化、国际化的天然药物质量控制标准提供理论参考。Through comparison and analysis of the quality control standards of natural crude drugs in the Pharmacopoeia of the People's Republic of China,the European Pharmacopoeia,and the United States Pharmacopoeia,it was found that the overall quality control concept based on extractive reference substance was still the most effective quality control method for natural crude drugs.Adhering to the principle of inclusiveness and learning from others,this paper clarified the experience and key technologies worth learning from the above standards and strived to incorporate the most scientific and reasonable standards in various countries and regions into the quality control of natural crude drugs,so as to provide references for the establishment and improvement of modern and international quality standards for natural crude drugs in China.

关 键 词：天然药物 整体质量控制 对照提取物 《中华人民共和国药典》 《欧洲药典》 《美国药典/国家处方集》 

分 类 号：R95[医药卫生—药学]