Considerations and suggestions on"medicine and excipient homology"
SUN Hui-min
LI Jin
LI Dan-xi
WANG Jue
ZHAO Xia
NING Bao-ming
YAO Shang-chen
Abstract：With the increasing public concern over drug safety and the ongoing advancement of generic drug consistency evaluation in China,the critical role of pharmaceutical excipients has garnered heightened recognition.Based on an in-depth analysis of the definition and properties of pharmaceutical excipients,this study references international research on atypical active substances and reveals that certain excipients can directly function as active pharmaceutical ingredients in drug formulations.Building on this finding,the concept of"medicine and excipient homology"is proposed and comprehensively elaborated,supported by examples of common excipients exhibiting this dual characteristic.Furthermore,the current regulatory frameworks for such excipients in China and other countries are comparatively analyzed,highlighting existing challenges and actionable recommendations are proposed to refine the precision management of pharmaceutical excipient quality in China,aiming to enhance drug efficacy and safety through improved excipient governance.
Keywords：medicine and excipient homologypharmaceutical excipientsactive pharmaceutical ingredientsatypical activeadministration of pharmaceutical excipients
Publication Date：2025-08-03
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：9( 1688-1696 )