Study on Quality Standard of Shiwuwei Sai'erdou Pill

OBJECTIVE To establish a method for the qualitative and quantitative determination of Shiwuwei Sai'erdou pill, and to provide the basis for the improvement of its quality standard. METHODS TLC was used to identify Chebulae Fructus, Berberis Bark and Chrysanthemum Morifolium. The contents of gallic acid, magnolia alkaloid, mangiferin, ellagic acid and berberine hydrochloride were determined by HPLC. RESULTS TLC identification method had good specificity, clear spots and good resolution, negative control had no interference. The content determination results showed the linear relationship was good within 0.054 64-0.437 12 μg of gallic acid, 0.090 12-0.720 96 μg of magnolia alkaloid, 0.012 64-0.102 72 μg of mangiferin, 0.040 56-0.324 48 μg of ellagic acid, 0.034 68-0.277 44 μg of berberine hydrochloride. The RSD of instrument precision, repeatability, stability and recovery all met the requirements. CONCLUSION The method is simple and reproducible, and can be used for the quality control of Shiwuwei Sai'erdou pill.