十五味赛尔斗丸的质量标准研究

Study on Quality Standard of Shiwuwei Sai’erdou Pill

目的建立十五味赛尔斗丸定性定量检测方法,为其质量标准提高提供依据。方法采用薄层色谱法,对制剂中诃子、小檗皮、风毛菊进行定性鉴别。通过HPLC同时测定没食子酸、木兰花碱、芒果苷、鞣花酸、盐酸小檗碱的含量。结果TLC鉴别方法专属性好,斑点清晰且分离度好,阴性对照无干扰;含量测定结果显示,没食子酸在0.05464~0.43712μg,木兰花碱在0.09012~0.72096μg,芒果苷在0.01264~0.10272μg,鞣花酸0.04056~0.32448μg,盐酸小檗碱在0.03468~0.27744μg,线性关系良好。仪器精密度、重复性、稳定性、加样回收率的RSD值均符合要求。结论所建立的方法操作简单,重复性较好,可用于十五味赛尔斗丸的质量控制研究。

OBJECTIVE To establish a method for the qualitative and quantitative determination of Shiwuwei Sai’erdou pill,and to provide the basis for the improvement of its quality standard.METHODS TLC was used to identify Chebulae Fructus,Berberis Bark and Chrysanthemum Morifolium.The contents of gallic acid,magnolia alkaloid,mangiferin,ellagic acid and berberine hydrochloride were determined by HPLC.RESULTS TLC identification method had good specificity,clear spots and good resolution,negative control had no interference.The content determination results showed the linear relationship was good within 0.05464-0.43712μg of gallic acid,0.09012-0.72096μg of magnolia alkaloid,0.01264-0.10272μg of mangiferin,0.04056-0.32448μg of ellagic acid,0.03468-0.27744μg of berberine hydrochloride.The RSD of instrument precision,repeatability,stability and recovery all met the requirements.CONCLUSION The method is simple and reproducible,and can be used for the quality control of Shiwuwei Sai’erdou pill.