乌梅酸枣仁口服液的质量标准研究

Quality Control of Fructus Mume & Semen Ziziphi Spinosae Oral Liquid

目的建立乌梅酸枣仁口服液的定性鉴别和含量测定的方法,为乌梅酸枣仁口服液制定质量标准提供参考依据。方法用薄层色谱(Thin Layer Chromatography)法鉴别乌梅酸枣仁口服液中熊果酸、柠檬酸以及酸枣仁皂苷A;高效液相色谱法(High Performance Liquid Chromatography)测定乌梅酸枣仁口服液中的有效成分柠檬酸、酸枣仁皂苷A的含量。结果薄层色谱方法简便、专属性强、重复性好。HPLC法测定结果表明柠檬酸、酸枣仁皂苷A分别在0.2～2.4 mg/ml,50～250μg/ml范围内线性关系良好(r=0.999 8,r=0.999 5),平均加样回收率分别为99.53%、99.88%,RSD分别为0.76%,0.71%。结论建立的特征图谱能够准确、快速进行定性、定量检测,可有效的监测该制剂的质量。

Objective To seek a serial quality control measurement of Fructus Mume & Semen Ziziphi Spinosae oral liquid by thin layer chromatography and high performance liquid chromatography.Methods The Ursolic acid,Citric acid and Jujuboside A were identified by TLC.The concentration of Citric acid was determined by HPLC method.Results The existence of Ursolic acid,Citric acid and Jujuboside A in oral liquid were examined by TLC method and the detective method was proved to be highly specififc,reliable and repeatable.The linear range of Citric acid was 0.2～2.4 mg/ml while the analysis estimation of Jujuboside A was 50～250μg/ml.Moreover,the average recovery of citric acid and jujuboside A were 99.53% and 99.88%,respectively.The relative standard deviation were 0.76% and 0.71%,respectively in HPLC.Conclusion The method is simple,reliable,accurate and efficient for quality control of Fructus Mume & Semen Ziziphi Spinosae oral liquid.