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.

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成都大学2024年国家级大学生创新训练计划项目（202411079023）