参枣滴丸质量标准研究

Study on the quality standard of Shenzao dripping pills

目的建立参枣滴丸的薄层定性鉴别方法及没食子酸的定量分析方法。方法采用TLC法鉴别参枣滴丸中广枣、丹参、人参、苏合香、冰片等主要药味,采用HPLC法测定参枣滴丸中没食子酸的质量分数。结果广枣、丹参、人参、苏合香、冰片的薄层色谱图条带、斑点均清晰,分离度较好,阴性无干扰;没食子酸在0.4375~12.4080μg范围内线性良好,精密度、稳定性、重复性试验RSD值均小于3%,平均加样回收率为96.48%,RSD值为1.08%。结论本研究制定的方法简单可行,专属性、准确性、耐用性、重复性均符合方法学测定要求,可用于新药参枣滴丸的质量控制。

Objective To establish a thin-layer qualitative identification method and a quantitative analysis method of gallic acid in Shenzao dripping pills.Methods The main medicinal flavors of Choerospondiatis Fructus,Salviae miltiorrhizae Radix et Rhizome,Ginseng Radix et Rhizoma,Styrax and Borneol in Shenzao dripping pills were identified by thin-layer chromatography,and the content of gallic acid in Shenzao dripping pills was determined by high performance liquid chromatography.Results The thin-layer chromatographic bands and spots of Choerospondiatis Fructus,Salviae miltiorrhizae Radix et Rhizome,Ginseng Radix et Rhizoma,Styrax and Borneol were clear with good resolution and no interference.Gallic acid showed good linearity in the range of 0.4375-12.4080μg.The RSD value of the precision,the stability and the repeatability test was less than 3%,and the average sample recovery was 96.48%with the RSD value of 1.08%.Conclusion The method developed in this study is simple and feasible,and its specificity,accuracy,durability and repeatability meet the requirements of methodological determination,which can be used for the quality control of the new drug Shenzao dripping pills.