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风湿灵片质量标准研究 被引量:1

Study on Quality Standard of Fengshiling Tablets
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摘要 目的:建立风湿灵片的质量标准。方法:建立防己、续断的TLC鉴别方法,乌头碱的TLC检查方法及粉防己碱的HPLC含量测定方法。色谱柱为Kromasil ODS C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.3%二乙胺溶液(75:25),检测波长:280 nm。柱温:室温;流速:1.0 ml·min^(-1)。结果:在TLC色谱中能够检出防己、续断,阴性对照无干扰;乌头碱在与对照品色谱相应位置不出现斑点。粉防己碱在0.178~1.776μg范围内线性关系良好(r=0.999 9),平均加样回收率为97.47%,RSD为0.68%(n=6)。结论:该方法简便、可靠,重复性好,可用于风湿灵片的质量控制。 Objective:To establish the quality standard of Fengshiling tablets.Method:Radix Stephaniae Tetrandrae and Radix Dipsaci in the tablets were identified by TLC.The content of aconitine was detected by TLC and that of tetrandrine was determined by HPLC.The Kromasil ODS C_(18) column(250 mm×4.6 mm,5μm) was used and a mixure of acetonitrile-0.3%diethylamine solution (75:25) as mobile phase and detection wavelengh was 280 nm.The column temperature was at room temperature and the flow rate was 1.0 ml·min^(-1).Result:Radix Stephaniae Tetrandrae and Radix Dipsaci could be identified by TLC without any interference.There was no aconitine spot at the relative site of standard substance.The linear range of tetrandrine was 0.178-1.776μg(r =0.999 9), and the average recovery was 97.47%with RSD of 0.68%(n =6).Conclusion:The method is simple,rapid and reproducible,and can be used in the quality control of Fengshiling tablets.
出处 《中国药师》 CAS 2013年第3期365-368,共4页 China Pharmacist
关键词 风湿灵片 粉防己碱 薄层色谱法 高效液相色谱法 质量标准 Fengshiling tablets Tetrandrine TLC HPLC Quality standard
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