Guchang Zhixie Pill: A Comprehensive Review of the Clinical Applications, Toxicological Profile, and Quality Markers

Objective: This study systematically reviews the clinical applications, toxicological profile, and quality markers of Guchang Zhixie Pill, offering a reference for its rational clinical use, as well as its quality and safety assessment. Methods: Relevant literature on the historical development, clinical applications, toxicology, and molecular characteristics of Guchang Zhixie Pill was retrieved from CNKI (https://www. cnki.net/), VIP (https://www.cqvip.com/), Sci-Hub (https://sci-hub.hkvisa.net/), TCMSP (https://old.tcmsp-e.com/tcmsp.php), Google Scholar (https://scholar.google.cz/schhp?hl=zh-CN), and PubMed (https://pubmed.ncbi.nlm.nih.gov/). Quality markers were predicted and analyzed based on established criteria to provide a scientific basis for ensuring clinical safety and efficacy. Results: Formulated based on Wumei Pill, Guchang Zhixie Pill is widely used in the treatment of ulcerative colitis and irritable bowel syndrome. Quality marker prediction and analysis, conducted in accordance with the "five principles" of quality marker identification, indicated that ursolic acid, oleanolic acid, chlorogenic acid, neochlorogenic acid, citric acid, 5-hydroxymethylfurfural, coptisine, berberine hydrochloride, (+)-magnoflorine, 6-shogaol, 10-gingerol, dehydrocostus lactone, papaverine, noscapine, palmatine, and corydaline serve as potential Q-markers for this formulation. Conclusion: As a classical prescription for intestinal astringency and antidiarrheal therapy, ensuring its rational clinical application is essential. The identification of 16 quality markers provides a scientific reference for quality control in future research.