复方山楂颗粒的质量标准研究

目的建立复方山楂颗粒的质量标准。方法采用薄层色谱法对制剂中山楂进行定性鉴别;采用高效液相色谱法对齐墩果酸和熊果酸进行含量测定:色谱柱为Welchrom C18(250mm×4.6mm,5μm);流动相为甲醇-乙腈-10mmol·L-1乙酸铵(55∶27∶18);流速为1.0mL·min-1;检测波长为215nm。结果薄层鉴别斑点清晰、分离较好,阴性对照无干扰;齐墩果酸的质量浓度在2.5⁸0μg·mL-1范围内与峰面积呈良好的线性关系(r=0.999 6),熊果酸的质量浓度在1080μg·mL-1范围内与峰面积呈良好的线性关系(r=0.999 6),熊果酸的质量浓度在10³20μg·mL-1范围内与峰面积呈良好的线性关系(r=0.999 7);齐墩果酸的平均加样回收率为98.4%,RSD=2.1%(n=6),熊果酸的平均加样回收率为98.6%,RSD=1.9%(n=6)。结论所用定性与定量方法简便、专属性强,结果准确、可靠;所建标准可用于复方山楂颗粒的质量控制。

Study on the quality standard of Fufang Shanzha Granules

Objective To establish the quality standard of Fufang Shanzha Granules.Methods TLC method was used for the qualitative identification of Crataegus Fructus.HPLC was used to determine the content of oleanic acid and ursonic acid.The determination was performed on a Welchrom C18column（250mm×4.6mm,5μm）with a mobile phase consisted of methanol-acetonitrile-10mmol·L^-1 ammonium acetate（55∶27∶18）at the flow rate of 1.0mL·min^-1.The detection wavelength was set at 215nm.Results TLC spots were clear and well-separated without interference.The linear range of oleanic acid was 2.5-80μg·mL1（r=0.999 6）with an average recovery of 98.4%（RSD=2.1%,n=6）.The linear range of ursonic acid was 10-320μg·mL^-1（r=0.999 7）with an average recovery of 98.6%（RSD=1.9%,n=6）.Conclusion The method is simple,specific,accurate and reliable and could be used for the quality control of Fufang Shanzha Granules.