六味地黄胶囊的质量标准研究.docxVIP

六味地黄胶囊的质量标准研究 　　【摘要】目的：建立六味地黄胶囊中酒萸肉的薄层色谱鉴别及莫诺苷和马钱苷的总量与丹皮酚含量的测定方法。方法：采用薄层色谱法对六味地黄胶囊中酒萸肉进行定性鉴别，采用高效液相色谱法同时测定方中酒萸肉里莫诺苷和马钱苷的总量及牡丹皮中丹皮酚的含量；色谱柱为Thermo-C18，流动相：以乙腈为流动相A，以%磷酸为流动相B，采用梯度洗脱，流速1mL/min，柱温35℃，马钱苷和莫诺苷的检测波长为240nm，丹皮酚的检测波长为270nm。结果：薄层色谱鉴别斑点清晰，阴性对照无干扰；莫诺苷在～μg范围中线性关系良好，平均回收率为%，RSD为%；马钱苷在～μg范围中线性关系良好，平均回收率为%，RSD为%；丹皮酚在～μg范围中线性关系良好。平均回收率为%，RSD为%。结论：所建立的方法简便、准确、重复性好，可用于六味地黄胶囊中酒萸肉的鉴别和酒萸肉里莫诺苷和马钱苷的总量及牡丹皮中丹皮酚的含量测定。　　【关键词】 六味地黄胶囊；酒萸肉；莫诺苷；马钱苷；丹皮酚　　【中图分类号】R284 【文献标志码】 A 【文章编号】1007--0029-04　　Abstract：Objective to establish a method for the determination of Liuwei Dihuang capsule in Fructus Corni by TLC and morroniside and loganin total quantity and the content of paeonol. Methods the TLC method of Liuwei Dihuang capsule in Fructus Corni were identified， by high performance liquid chromatography method for the simultaneous determination of party in Fructus Corni in morroniside and loganin content and cortex moutan in paeonol content； column chromatography Thermo-C18 ， flow phase： with acetonitrile as mobile phase a， with % phosphoric acid as the mobile phase B， the gradient elution， flow rate of 1mL / min， column temperature 35 degrees Celsius， detection wavelength of loganin and morroniside was 240nm， paeonol detection wavelength 270nm. Results TLC spots were clear， without the interference of negative control； morroniside in ～ μg range linear relationship is good. The average recovery rate was %， RSD = % ； loganin in ～ μg range linear relationship is good. The average recovery rate was %， RSD was % ； paeonol in ～ μg range linear relationship good. the average recovery was %， RSD was % . Conclusion the established method is simple， accurate and with good reproducibility and can be used for the determination of the content of morroniside and loganin total and tree peony bark of Paeonol in Liuweidihuang capsule liquor Cornus and the identification of Fructus Corni.　　Keywords： Six Dihuang Capsules； Fructus Corni； Monod Glycosides； Loganin； Paeono　　六味地黄胶囊收载于《中国药典》XX年版一部，原标准有茯