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目的:建立六味地黄丸(水蜜丸)高效液相特征图谱分析方法,为科学评价其质量提供可靠方法。方法:采用Phenomenex Gemini C18柱(250mm×4.6mm,5μm)色谱柱,以乙腈(A)-0.1%磷酸溶液(B)为流动相梯度洗脱(0-130min,1%A→99%A),流速0.6mL/min,检测波长242nm,柱温35℃。运用中药色谱指纹图谱相似度评价系统2.0版(国家药典委员会)进行分析。结果:建立了六味地黄丸(水蜜丸)质量特征图谱。结论:该方法准确,重复性好,可用于六味地黄丸的质量控制。
Objective: To establish a high performance liquid chromatographic method for the analysis of Liuwei Dihuang Wan (Shuiwan Wan), providing a reliable method for scientifically evaluating its quality. METHODS: The mobile phase was eluted with Phenomenex Gemini C18 column (250 mm × 4.6 mm, 5 μm) using a mobile phase of acetonitrile (A) -0.1% phosphoric acid (B) (0-130 min, 1% A → 99% A) , Flow rate 0.6mL / min, detection wavelength 242nm, column temperature 35 ℃. Using Chinese medicine chromatographic fingerprint similarity evaluation system version 2.0 (State Pharmacopoeia Commission) for analysis. Results: The quality characteristic map of Liuwei Dihuang Wan (water pill) was established. Conclusion: The method is accurate, reproducible and can be used for quality control of Liuwei Dihuang Pill.