[Research status and comprehensive evaluation strategies for quality uniformity of Chinese patent medicines]

The quality uniformity of Chinese patent medicines is a core factor ensuring the stability of clinical efficacy and a key driver to promoting the high-quality and international development of traditional Chinese medicine(TCM). Due to the influence of multiple factors, such as geographical origin and processing methods of Chinese herbal pieces, their chemical composition inherently fluctuates. Moreover, it is difficult to control batch-to-batch variations during production, which easily leads to fluctuations in the quality of the final products. Traditional evaluation methods, primarily based on chemical components, only reflect compositional uniformity, but struggle to comprehensively assess consistency in therapeutic efficacy. Therefore, it is crucial to develop an evaluation strategy that integrates multi-dimensional indicators and strongly correlates with pharmacological outcomes. This study systematically reviewed the current landscape of quality uniformity evaluation for Chinese patent medicines, highlighting the limitations of existing systems in integrating chemical, formulation, and biological dimensions. Furthermore, it proposed the establishment of a comprehensive multi-dimensional evaluation system centered on "chemical uniformity-formulation parameter uniformity-biological uniformity-efficacy uniformity". By employing a combined weighting method integrating the Analytic Hierarchy Process(AHP) and the CRITIC method, a "Uniformity Index " was established as a comprehensive evaluation metric, facilitating the scientific transition from "compositional uniformity" to "efficacy uniformity". This work ultimately aims to provide a scientific pathway for evaluating the quality uniformity of Chinese patent medicines, thereby supporting the standardization and internationalization of the TCM industry.