艾可合剂质量标准研究

Study on the quality standards of Aike mixture

目的建立艾可合剂的质量标准。方法采用TLC法定性鉴别艾可合剂中白芍、赤芍及枳壳;采用HPLC法,以乙腈-水为流动相梯度洗脱,对艾可合剂中柴胡皂苷a进行定量分析。结果定性鉴别分离度好,专属性强;柴胡皂苷a在0.513～3.078μg范围内线性关系良好(r=0.9999),平均回收率为99.5%(RSD=0.95%)。结论所建立的方法准确可靠、重复性好,可有效控制艾可合剂的质量。

OBJECTIVE To establish the quality standards of Aike mixture.METHODS We identified the ingredient of Root of Herbaceous peony,Chishao and Citrus aurantium in Aike mixture by TLC;we detected the content of Saikosaponin-A in Aike mixture by HPLC,used gradient elution and the mobile phase was Acetonitrile-water.RESULTS The way of TLC had a good separation and specificity and Saikosaponin-A had a good linear relationship in 0.513～3.078μg（r=0.9999）,the average recovery was 99.5%（RSD=0.95%）.CONCLUSION the way of identification is accurate,reproducible and can be used in the quality control of Aike mixture.