复方参芪五味咀嚼片的质量标准研究

Study on Quality Standard of Compound Shenqi Wuwei Chewable Tablets

[目的]研究控制复方参芪五味咀嚼片的质量标准的方法。[方法]采用薄层色谱法鉴别复方参芪五味咀嚼片中的人参皂苷Rg1(人参)、五味子醇甲(五味子)和黄芪甲苷(黄芪)、麦冬药材;采用高效液相色谱法样品中人参皂苷Rg1、五味子醇甲和黄芪甲苷含量进行测定。[结果]在选择的薄层色谱条件下,各样品斑点显色清晰;复方参芪五味咀嚼片中人参皂苷Rg1、五味子醇甲和黄芪甲苷分别在2.5～17.5、2.4～12.0、4.6～32.2μg/ml的线性范围内,与峰面积线性关系良好。人参皂苷Rg1、五味子醇甲和黄芪甲苷的平均加样回收率分别为98.1%、97.2%、97.7%,RSD值分别为2.0%、1.4%、1.2%。[结论]所建立的方法准确、重现性好,可以作为控制复方参芪五味咀嚼片的质量标准的方法。

[Objective]To establish the quality standard of compound Shenqi Wuwei chewable tablets.[Method] Ginsenoside Rgl（RADIX ET RHIZOMA GINSENG）,schizandrin（FRUCTUS SCHISANDRAE CHINENSIS）,astragaloside IV（RADIX ASTRAGALI） and RADIX LIRIOPES were identified by thin layer chromatography（TLC）,and contents of ginsenoside Rgl,schizandrin and astragaloside IV were determined by HPLC.[Results]The TLC spots were fairly clear.In the range of 2.5-17.5,2.4-12.0 and 4.6-32.2 μg/ml,ginsenoside Rgl,schizandrin and astragaloside IV showed a good linear relationship to peak area,respectively.The recovery rates of ginsenoside Rgl,schizandrin and astragaloside IV were 98.1%,97.2% and 97.7% respectively with RSD value of 2.0%,1.4% and 1.2%,individually.[Conclusion]This method is accurate,reproducible and sensitive,which can be used for the quality control of compound Shenqi Wuwei chewable tablets.