藥用輔料是制劑處方中不可或缺的組成部分，在藥物質(zhì)量標(biāo)準(zhǔn)不斷提升的背景下，藥用輔料成藥過程和成藥后質(zhì)量變化和對藥物整體安全和藥效影響的研究相對較少，在中成藥研究中尤為突出?；谥兴庂|(zhì)量標(biāo)準(zhǔn)對所用藥用輔料的質(zhì)量控制重視不足，提出藥物與藥用輔料間“質(zhì)控對稱（quality control symmetry，QC-Symmetry）”及“質(zhì)控不對稱（quality control asymmetry，QC-Asymmetry）”的概念，并對中成藥和藥用輔料的QC-Asymmetry問題進(jìn)行探討，為藥用輔料相關(guān)質(zhì)量評價納入中成藥質(zhì)量和工藝評價過程、使二者在質(zhì)量和工藝控制中達(dá)到對稱和相適應(yīng)提供參考，以期進(jìn)一步完善中成藥等藥物制劑研究的質(zhì)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.

R283

成都大學(xué)2024年國家級大學(xué)生創(chuàng)新訓(xùn)練計劃項目（202411079023）