基于有效物质基础的枳实药材的质量控制体系研究

Quality control system of Zhishi(Fructus Aurantii Immaturus) based on effective substance basis

目的 建立基于有效物质基础研究的中药枳实的质量控制体系.方法 薄层色谱（TLC）定性鉴别枳实中二氢黄酮类、挥发油类,并采用HPLC法对其中有效指标性成分柚皮苷、橙皮苷、新橙皮苷进行含量测定.结果 枳实中二氢黄酮类和挥发油类在所建立的色谱条件下分离效果好,斑点清晰.柚皮苷在0.652 5～5.22μg范围内线性关系良好（r=0.999 9）,平均回收率为96.98％,RSD为1.74％;橙皮苷在0.037～0.296 μg范围内线性关系良好（r=0.999 5）,平均回收率为97.70％,RSD为1.89％;新橙皮苷在0.507 5～4.06 μg范围内线性关系良好（r=0.999 9）,平均回收率为98.22％,RSD为1.81％.结论 所用TLC法简便、可行,可用于枳实中二氢黄酮类、挥发油类的定性鉴别;对17批枳实药材进行含量测定,所建立的HPLC法简便、准确.所评价建立的质量控制体系可较好地应用于与表征枳实药材的自然药物属性关联的有效物质基础.

Objective To establish a quality control system of Zhishi （Fructus Aurantii Immaturus） based on effective substance basis.Methods Thin layer chromatography （TLC） was used to qualitatively identify dihydroflavone and volatile oils in Zhishi,and HPLC was used to quantitatively determine the effective index constituents including naringin,hesperidin and neogesperidin.Results The qualitative identification with TLC of dihydroflavone and volatile oils in Zhishi was specific.Naringin showed a good linear relationship at a range from 0.652 5 μg to 5.22 μg （r =0.999 9） and the average recovery was 96.98％ （RSD =1.74％）.Hesperidin showed a good linear relationship at a range from 0.037 μg to 0.296 μg （r =0.999 5） and the average recovery was 97.70％ （RSD =1.89％）.Neogesperidin showed a good linear relationship at a range from 0.507 5 μg to 4.06 μg （r =0.999 9） and the average recovery was 98.22％ （RSD =1.81％）.Conclusion The applied TLC is simple and feasible in the qualitative identification of dihydroflavone and volatile oils in Zhishi.The established HPLC quantitative determination of 17 batches of Zhishi material is easy and accurate.The quality control sgstem develop and evaluated in the paper canbe used as an effective substance basis related to natural properties of Zhishi.