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目的:建立灯盏花素分散片及灯盏花素原料的HPLC指纹图谱分析方法。方法:采用HPLC法测定,色谱柱为Agilent TC-C18(4.6 mm×250 mm,5μm),流动相乙腈-0.1 mol·L-1醋酸铵(磷酸调pH 3.0),梯度洗脱,检测波长335 nm,流速0.8 mL·min-1,柱温35℃。结果:应用“中药色谱指纹图谱相似度评价系统”对灯盏花素分散片及灯盏花素原料各批次进行了质量评价,相似度均≥0.99,方法精密度、稳定性和重复性良好。结论:所建立的液相色谱指纹图谱专属性和特征性强,可以有效地控制灯盏花素分散片及其原料的质量。
Objective: To establish a method for the HPLC fingerprint analysis of breviscapine dispersible tablets and breviscapine raw materials. Methods: The HPLC method was used. The mobile phase consisted of Agilent TC-C18 (4.6 mm × 250 mm, 5 μm), mobile phase acetonitrile-0.1 mol·L-1 ammonium acetate nm, flow rate 0.8 mL · min-1, column temperature 35 ℃. Results: The quality evaluation of Breviscapine Dispersible Tablets and Breviscapine raw materials was carried out using the “similarity evaluation system of chromatographic fingerprints of traditional Chinese medicines”, the similarities were all ≥0.99, and the method was good in precision, stability and repeatability. . Conclusion: The HPLC fingerprints established by this method are unique and characteristic, which can effectively control the quality of breviscapin dispersible tablets and their raw materials.