Quality Analysis Evaluation and Research of Berberine Hydrochloride Tablets
Expand
Deyang Food and Drug Safety Inspection and Testing Center； Key Laboratory of Chemical Drug Quality Research of Sichuan Provincial Drug Administration，Sichuan Deyang 618000， China
Objective： Based on provincial drug sampling inspections， this study evaluates and analyzes the quality of berberine hydrochloride tablets to clarify their current quality status， providing reference and suggestions for improving their quality standards and consistency evaluation. Methods： A total of 117 batches of berberine hydrochloride tablets were tested according to statutory standards， along with exploratory research. Results： The standard compliance rate of the tested tablets was 100%， with all indicators meeting current quality standards， indicating good safety and stability. Exploratory studies on dissolution， content determination， and elemental impurities revealed no abnormalities but identified areas for potential improvement. Conclusion： This study provides important reference for the consistency evaluation of berberine hydrochloride tablets， with subsequent recommendations to enhance quality standard refinement and regulatory oversight.
