参芪益气口服液质量标准研究

目的 建立参芪益气口服液的质量标准.方法 采用薄层色谱(TLC)法对黄芪、党参、当归、山银花进行定性鉴别;采用高效液相色谱(HPLC)波长切换法测定方中主要药效成分毛蕊异黄酮葡萄糖苷、阿魏酸、绿原酸的含量,色谱柱为Agilent HC-C18柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1％磷酸溶液(1:...

Quality Standard of Shenqi Yiqi Oral Liquid

Objective To establish the quality standard of Shenqi Yiqi Oral Liquid.Methods Astragali Radix,Codonopsis Radix,Angelicae Sinensis Radix and Lonicerae Flos were qualitatively identified by the thin-layer chromatography(TLC)method.The contents of calycosin-7-glucoside,ferulic acid and chlorogenic acid were determined by the high-performance liquid chromatography(HPLC)wavelength switching method.The chromatographic column was Agilent HC-C₁₈ column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.1%phosphoric acid solution(1∶999,V/V)with gradient elution(10%A at 0-10 min,10%A-18%A at 10-60 min),the flow rate was 1.0 mL/min,the detection wavelength was 260 nm(0-25 min,45-60 min)for chlorogenic acid and calycosin-7-glucoside,315 nm(25-45 min)for ferulic acid,the column temperature was 30℃,the injection volume was 20μL,and the detection time was 60 min.Results TLC spots showed clear color and good resolution,and the negative samples had no interference.The linear ranges of chlorogenic acid,ferulic acid and calycosin-7-glucoside were 70.40-704.00μg,1.36-13.60μg and 1.28-12.80μg,respectively.The average recoveries of chlorogenic acid,ferulic acid and calycosin-7-glucoside were 99.44%,101.04%,97.97%with RSDs of 2.54%,1.57%,2.09%(n=6),respectively.The RSDs of precision,repeatability and stability tests were less than 2%(n=6).Conclusion The method is simple,accurate,stable and reproducible,which can be used for the quality control of Shenqi Yiqi Oral Liquid.