中成药中药物和药用辅料“质控对称”(QC-Symmetry)的探讨  

Discussion on“quality control symmetry”(QC-Symmetry)of drugs and pharmaceutical excipients in Chinese patent medicine

作　　者：徐杨 周伟俊 郑伟然 杨键 王艺欣 刘涛[3] XU Yang;ZHOU Weijun;ZHENG Weiran;YANG Jian;WANG Yixin;LIU Tao(College of Pharmacy,Chengdu University,Chengdu 610100,China;Zhanglan College,Chengdu University,Chengdu 610100,China;College of Food and Bioengineering,Chengdu University,Chengdu 610100,China;Heilongjiang Agricultural Engineering Vocational College,Harbin 150025,China)

机构地区：[1]成都大学药学院,四川成都610100 [2]成都大学张澜学院,四川成都610100 [3]成都大学食品与生物工程学院,四川成都610100 [4]黑龙江农业工程职业学院,黑龙江哈尔滨150025

出　　处：《中草药》2025年第4期1385-1393,共9页Chinese Traditional and Herbal Drugs

基　　金：成都大学2024年国家级大学生创新训练计划项目(202411079023)。

摘　　要：药用辅料是制剂处方中不可或缺的组成部分,在药物质量标准不断提升的背景下,药用辅料成药过程和成药后质量变化和对药物整体安全和药效影响的研究相对较少,在中成药研究中尤为突出。基于中药质量标准对所用药用辅料的质量控制重视不足,提出药物与药用辅料间“质控对称(quality control symmetry,QC-Symmetry)”及“质控不对称(quality control asymmetry,QC-Asymmetry)”的概念,并对中成药和药用辅料的QC-Asymmetry问题进行探讨,为药用辅料相关质量评价纳入中成药质量和工艺评价过程、使二者在质量和工艺控制中达到对称和相适应提供参考,以期进一步完善中成药等药物制剂研究的质量控制策略。Pharmaceutical excipients are an indispensable part of preparation prescriptions.Under the background of continuous improvement of drug quality standards,relatively few studies focus on the quality changes of pharmaceutical excipients during and after drug formation and their effects on the overall safety and efficacy of drugs,especially in the research of Chinese patent medicines.Based on the quality standard of traditional Chinese medicine,insufficient attention has been paid to the quality control of pharmaceutical excipients,in this paper,the concepts of“quality control symmetry(QC-Symmetry)”and“quality control asymmetry(QC-Asymmetry)”between drugs and pharmaceutical excipients are proposed,and the QC-Asymmetry problems of Chinese patent medicines and pharmaceutical excipients are discussed.It provides a reference for the quality evaluation of pharmaceutical excipients to be included in the quality and process evaluation process of Chinese patent medicines,aiming to achieve symmetry and adaptation in quality and process control,thereby improving the quality control strategy of Chinese patent medicine and other pharmaceutical preparations.

关 键 词：药用辅料 质控对称 中成药 质量标准 随药延长 生产工艺 有效期 

分 类 号：R283[医药卫生—中药学]