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天麻头风灵胶囊质量标准提升研究
刘正清,郭元满,杨 华
0
(湖南汉森制药股份有限公司,湖南 益阳,413000)
摘要:
目的:提升天麻头风灵胶囊质量标准,有效控制其制剂质量。方法:采用薄层色谱法,以紫丁香苷和哈巴俄苷为对照,定性鉴别槲寄生和玄参;采用HPLC法对阿魏酸进行含量测定,C18柱(Inertsil ODS-2;4.6mm×250mm,5μm);流动相:乙腈-0.05%磷酸溶液(16∶84);检测波长:321nm;流速:1ml/min;柱温:30℃。结果:薄层色谱定性鉴别方法灵敏,专属性强;阿魏酸在9.97~997ng范围内线性良好,r=0.9999;加样回收率为97.52%。结论:本方法简便、重复性好,为天麻头风灵胶囊质量标准提升奠定了基础。
关键词:  天麻头风灵胶囊  HPLC  阿魏酸  紫丁香苷  哈巴俄苷
DOI:
Improvement of the quality standard for Tianmatoufengling capsules
LIU Zhengqing,GUO Yuanman,YANG Hua
(Hunan Hansen Pharmaceutical Co.,Ltd.,Yiyang 413000,Hunan,China)
Abstract:
Objective:To improve the quality standard for Tianmatoufengling capsules,and to effectively control the quality of this prescription.Methods:With syringin and harpagoside as controls,thin-layer chromatography was used for qualitative identification of mistletoe and Radix Scrophulariae.High-performance liquid chromatography was used for the content determination of ferulic acid and was performed on an Inertsil ODS-2 C18column (4.6mm×250mm,5μm) with a mobile phase of acetonitrile-0.05% phosphoric acid (16∶84) at a detection wavelength of 321nm,a flow rate of 1ml/min,and a column temperature of 30℃.Results:Thin-layer chromatography was sensitive and highly specific in qualitative identification.Ferulic acid showed a good linear relationship within the range of 9.97~997ng (r=0.9999),with an average recovery rate of 97.52%.Conclusion:This method is simple and convenient and has good reproducibility,which lays a foundation for improving the quality standard for Tianmatoufengling capsules.
Key words:  Tianmatoufengling capsule  high-performance liquid chromatography  ferulic acid  syringin  harpagoside

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