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芪丹颗粒的质量标准
引用本文:欧阳春华.芪丹颗粒的质量标准[J].中国药师,2011,14(7):980-982.
作者姓名:欧阳春华
作者单位:株洲市药品检验所,湖南株洲,412008
摘    要:目的:建立芪丹颗粒的质量标准。方法:采用TLC法鉴别方中黄芪、丹参、淫羊藿、五味子;采用HPLC-ELSD法测定黄芪甲苷的含量。结果:在TLC色谱中可检出黄芪、丹参、淫羊藿、五味子的特征斑点,且斑点清晰,易于观察;黄芪甲苷在0.458~4.122μg范围内线性关系良好(r=0.9992),平均回收率为96.0%,RSD=0.2%(n=6)。结论:方法简便、准确、可作为该制剂的质量控制方法。

关 键 词:芪丹颗粒  质量标准  高效液相色谱法

Study on Quality Standard for Qidan Granules
Ouyang Chunhua.Study on Quality Standard for Qidan Granules[J].China Pharmacist,2011,14(7):980-982.
Authors:Ouyang Chunhua
Institution:Ouyang Chunhua(Zhuzhou Institute for Drug Control,Hunan Zhuzhou 412008,China)
Abstract:To establish the quality standard for Qidan granules. Method: Radix astragali, Radix et rhlzome salvlae mlhiorrhlzae, Follum eplmedii and Fructus schisandrae chinensis were identified by TLC ; The content of Astragaloside IV was determined by HPLC-ELSD. Result: The spots in the TLC were clear and distinguished well. The linear range of Astragaloside IV was 0. 458-4. 122 tLg (r = 0. 999 2). The average recovery was 96.0% ,RSD = 0. 2% (n = 6). Conclusion: The method is simple, sensitive and stable, and can be used for the quality control of Qidan granules.
Keywords:Qidan granules  Quality standard  HPLC  
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