畲药山里黄根的质量标准研究

Study on quality standard of traditional She medicine—Gardeniae Radix

目的：研究山里黄根的质量标准,为制定合理的质控方法提供科学依据。方法：运用薄层色谱法、高效液相色谱法分别对齐墩果酸、竹节参皂苷Ⅳa进行定性、定量测定;参照中国药典2010年版附录相关方法对山里黄根的醇溶性浸出物、水分和总灰分进行测定。结果：山里黄根薄层色谱鉴别特征性明显;竹节参皂苷Ⅳa质量浓度在12.61-252.2μg·m L-1范围内呈线性,回归方程为Y=2.016X＋1.372（r=1.000）,平均回收率为98.4%（RSD=1.3%）。18批山里黄根样品的测定结果表明,竹节参皂苷Ⅳa的含量为0.013%-0.086%,醇溶性浸出物的结果为7.7%-13.6%,水分为4.1%-9.7%,总灰分为1.3%-4.6%。结论：研究所得方法简便、准确、重现性好,可用于山里黄根的质量控制。

Objective：To study the quality standard of Gardeniae Radix,and to provide the scientific basis for establishing a reasonable method of quality control.Methods：The method of thin-laver chromatography and high performance liquid chromatography was used for qualitative and quantitative determination of oleanolic acid and cikusetsu saponin Ⅳ a.The ethanol soluble extractives,the water content,and the total ash of Gardeniae Radix were determined according to the method in the appendix of Chinese pharmacopoeia.Results：Characteristics of thin layer chromatography of Gardeniae Radix were obvious.A good linearity of chikusetsu saponin Ⅳ a was shown in ranges of 12.61-252.2 μg·m L-1,and the calibration curve was Y = 2.016 X ＋ 1.372,r = 1.000.The average recovery rate was 98.40%（RSD = 1.3%）.The content of chikusetsu saponin Ⅳa was 0.013%-0.086%,and the result of ethanol-soluble extractives,the moisture content,and the total ash were 7.7%-13.6%,4.1%-9.7%,and 1.3%-4.6% in 18 batches of Gardeniae Radix,respectively.Conclusion：This method is simple,accurate and reproducible,which can be used for the quality control of Gardeniae Radix.