Improvement of Quality Standard of Bufei Fanggan Mixture
Objective To establish the quality standard of Bufei Fanggan Mixture.Methods Thin-layer chromatography(TLC)method was used to qualitatively identify Astragali Radix,Glycyrrhizae Radix et Rhizoma,and Citri Reticulatae Pericarpium in the preparation.High-performance liquid chromatography(HPLC)method was used to determine the content of astragaloside Ⅳ.The chromatographic column was Waters Xbridge C18 column(250 mm × 4.6 mm,5 μm),the mobile phase was acetonitrile-water(32∶68,V/V),the flow rate was 1.0 mL/min,the column temperature was 35 ℃,the evaporative light scattering detector was adopted,the injection volume was 20 μL(test solution,negative reference solution)and 10 μL(reference solution).Results In the TLC chromatograms,the characteristic spots of Astragali Radix,Glycyrrhizae Radix et Rhizoma,and Citri Reticulatae Pericarpium showed clear color,good separation,and had no interference from the negative control.The linear range of astragaloside Ⅳ was 0.584 3-5.842 8 μg(r=0.999 7,n=7).The RSDs of precision,stability,and repeatability test results were all lower than 2％.The average recovery of astragaloside Ⅳ was 92.68％with an RSD of 5.13％(n=6).The average contents of astragaloside Ⅳin the three batches of samples were 44.22,42.31,and 41.01 μg/mL(n=4),respectively.Conclusion The established method is simple,accurate,and has good reproducibility,which can be used for quality control of Bufei Fanggan Mixture.The content of astragaloside Ⅳ in every 1 mL of Bufei Fanggan Mixture should not be lower than 29.76 μg.
万方数据
维普
