叶下珠饮片质量标准研究

Quality Standard of Phyllanthus Urinaria

目的建立叶下珠饮片的质量标准,提高其质量控制水平。方法采用薄层色谱(TLC)法对叶下珠饮片中的没食子酸进行定性鉴别;以没食子酸和柯里拉京为指标成分,采用高效液相色谱(HPLC)法测定含量。结果叶下珠饮片没食子酸薄层色谱中,在与对照品溶液同一位置显相同颜色的斑点。HPLC定量分析结果中,没食子酸的线性回归方程为Y=30.715 X-0.172 9,质量浓度线性范围为0.66~26.40μg/mL(r=1.000 0),平均回收率为97.99%,RSD=1.44%(n=6);柯里拉京的线性回归方程为Y=13.192 X+1.494 6,质量浓度线性范围为1.79~71.84μg/mL(r=0.999 8),平均回收率为95.68%,RSD=1.04%(n=6)。结论该方法简单易行,专属性强,重复性好,可作为叶下珠饮片的质量控制方法。

Objective To establish the quality standard of Phyllanthus Urinaria and improve its quality control level. Methods Gallic acid and corilagin were selected as index ingredients. The qualitative and quantitative analyses were performed by TLC and HPLC meth- ods. Results The TLC spots of gallic acid had similar color with the reference solution at the same position. The results of quantitative analyses showed that the linear equation of gallic acid is Y=30. 715X-0. 172 9,the liner range was 0. 66-26.40 Ixg/mL（r=l. 000 0） and the average recovery was 97.99% , RSD = 1.44% （n = 6） ; the linear equation of corilagin is Y= 13. 192X ＋ 1. 494 6, the liner range was 1.79-71.84 μg/mL（r=0.999 8）,and average recovery was 95.68 %,RSD=1.04%（n=6）.Conclusion The method is convenient,accurate,repeatable and specific,which can be used for the quality control of Phyllanthus Urinaria.