摘要
目的：建立养心安神口服液的质量标准，以控制药品质量和临床疗效。方法：应用薄层色谱法对酸枣仁皂苷A、B进行定性鉴别；应用高效液相色谱法对养心安神口服液中的主药酸枣仁进行含量测定。检测器为：二极管阵列紫外检测器（HPLC-PAD）；色谱柱：安捷伦C18；流动相为：甲醇-水-冰醋酸（70：30：1）；流速：1.0mL/min；柱温：35℃；检测波长：204nm。结果：酸枣仁皂苷A、B的线性范围和线性方程分别为2.4785～12.3925μg，y=0.9997x-5.5975（R=0.999）；1.4335～7.1675μg，y=0.9945x-5.3352（R=0.9995）；重现性实验中，酸枣仁皂苷A、B的平均含量和RSD分别为45.16μg/mL、27.19μg/mL，1.69%、1.97%；精密度实验中，酸枣仁皂苷A、B的RSD分别为0.57%和0.82%。结论：采用薄层色谱法对酸枣仁皂苷A、B进行定性鉴别，同时采用高效液相色谱法对养心安神口服液中酸枣仁进行含量测定，可作为养心安神口服液的质量标准。
Objective：To establish the quality standards of Yangxin Anshen oral liguid, in order to control the quality and efficacy of the drug. Meth-ods：Used thin-layer chromatography （TLC） to qualitative identify jujuboside A and B, and test the content of semen zizyphi spinosae in the oral liq-uid by high performance liquid chromatography （HPLC）. Detector：HPLC-PAD;chromatographic column：Agilent C18;mobile phase：methanol-wa-ter-glacial acetic acid （70：30：1）;current speed：1.0mL/min;column temperature：35;detection wavelength：204nm. Results：The linearity range and linear equation of jujuboside A and B were 2.4785～12.3925μg, y=0.9997x-5.5975（R=0.999）;1.4335～7.1675μg, y=0.9945x-5.3352（R=0.9995）;in re-producibility experiment, the average content and RSD of jujuboside A and B were 45.16μg/mL, 27.19μg/mL, 1.69%, 1.97%;in precision experi-ment, the RSD of jujuboside A and B were 0.57%and 0.82%. Conclusion：The method of using TLC to qualitative identify jujuboside A and B, at the same time test the content of semen zizyphi spinosae in the oral liquid by HPLC, can be used as the quality standards of Yangxin Anshen oral liquid.
出处
《按摩与康复医学》
2015年第13期69-72,共4页
Chinese Manipulation and Rehabilitation Medicine
