心神宁片中酸枣仁成分的质量控制研究

Quality control study of Semen ziziphi spinosae components in Xinshen Ning tablet

目的对心神宁片中酸枣仁所含的酸枣仁皂苷A、B（皂苷类）及斯皮诺素（黄酮类）两大类成分进行研究,建立心神宁片中酸枣仁成分的含量测定方法。方法采用高效液相色谱法（HPLC）对心神宁片中的酸枣仁成分进行研究;建立心神宁片中斯皮诺素的含量测定方法,采用Perkin Elmer C18色谱柱（4.6 mm×250 mm,5μm）,以乙腈-水（0.1%冰乙酸）为流动相进行梯度洗脱;检测波长为335 nm;柱温为25℃;流速为1.0 ml/min;进样体积为10μl。结果所建立的斯皮诺素含量测定方法可行,斯皮诺素的线性范围为3.339-53.424μg/ml（r=0.9999）,平均加样回收率为100.91%,RSD（n=9）为1.63%。结论酸枣仁皂苷A和B含量测定的色谱图不理想,所建立的斯皮诺素含量测定方法可行,且准确、简便、稳定性和重现性良好、专属性强,可作为心神宁片质量标准的控制方法。

Objective To study the two kinds components of jujubosides A and B（saponins） and spinosin（flavonoid） of Semen ziziphi spinosae in Xinshen Ning tablet and to establish the method for quantitative determination of Semen ziziphi spinosae in Xinshen Ning tablet. Methods High performance liquid chromatography（HPLC） was used to study the components of Semen ziziphi spinosae in Xinshen Ning tablet.Perkin Elmer C18 chromatographic column（4.6 mm×250 mm,5 μm） was used for establishing the method for quantitative determination of spinosin in Xinshen Ning tablet.Acetonitrile-water（0.1% glacial acetic acid） was used as mobile phase for gradient elution.The determine wavelength was 335 nm,the column temperature was 25℃,the flow velocity was 1.0 ml/min and injection volume was 10 μl. Results The established spinosin content determination method was feasible.The linear range of spinosin was 3.339-53.424 μg/ml（r=0.9999）,average recovery rate was 100.91%,and RSD（n=9） was 1.36%. Conclusion The quantitative determination chromatograms of jujubosides A and B is not ideal.The established spinosin content determination method is feasible,accuracy,easy,good stability and reproducibility and strong specificity,which can be used as standard quality control method of Xinshen Ning tablet.