逍遥蒌贝胶囊的质量标准研究

目的建立逍遥蒌贝胶囊的质量控制方法。方法采用薄层色谱法（TLC）对处方中白术、当归、浙贝母和柴胡进行定性鉴别;采用高效液相色谱法（HPLC）测定处方中芍药苷的含量,色谱柱：Diamonsil C18色谱柱（4.6 mm×200 mm,5μm）;流动相：甲醇-0.1%磷酸水溶液（30∶70,v/v）;流速：1.00 mL.min-1;检测波长：232 nm;进样量10μL。结果薄层鉴别的色谱斑点清晰,特征斑点对应性强,阴性对照无干扰;芍药苷进样量在65～1 300 ng范围内与峰面积具有良好的线性关系,r=0.999 9,平均回收率为99.43%（n=6）,RSD为1.97%。结论所建立的方法简便、准确、重现性好,可作为逍遥蒌贝胶囊的质量控制标准。

Research on Quality Standard of Xiaoyao Loubei Capsule Effect

Objective To establish the qualify control method of xiaoyao loubei capsule.Methods The thin layer chromatography（TLC）was adopted to have a qualitative identification of rhizome atractylodis macrocephalae,angelica sinensis,thunberg fritillary bulb and radix bupleuri in the ingredients of the formula.The high performance liquid chromatography（HPLC）was used to determine the content of paeoniflorin.Color column：Diamonsil C18 color column（4.6 mm×200 mm,5 m）;mobile phase：methanol-0.1% phosphoric acid solution（30∶ 70,v/v）;flow rate：1.00 mL·min-1;wavelength：232 nm;sample size：10 μL.Results It was indicated in TLC identification that the color spectrum dots were clear,the characteristic dots were correspondent strongly among each other,and the negative control was not interfered.The good linear relationship presented between the sample size ranged from 65 to 1 300 ng and peak area for paeoniflorin,r=0.999 9,average recovery rate was 99.43%（n=6）and RSD was 1.97%.Conclusion The established method is sample and accurate in operation and good in repeatability.It can be used as the quality control standard of xiaoyao loubei capsule.