目的 建立注射用益气复脉(冻干)的HPLC指纹图谱,并建立评价其质量的指纹图谱分析方法。方法 采用HPLC法,色谱柱为Waters Symmetry^® C₁₈柱(250 mm×4.6 mm,5 μm);流动相为乙腈-0.01%磷酸水溶液梯度洗脱;检测波长203 nm;柱温32 ℃。结果 建立了注射用益气复脉(冻干)中人参皂苷类、五味子木质素类的指纹图谱,并建立了3种指纹图谱分析评价方法。结论 建立的注射用益气复脉(冻干)指纹图谱的重复性、稳定性好,采用夹角余弦法与相关系数法从两个不同的角度评价指纹图谱,可以有效地反映益气复脉的质量,两者差异不大,而采用欧氏距离法却无法获得两张图谱的真实相似程度,无法给出直观的综合质量评价结果。

Objective To establish an HPLC method for determining the fingerprint of Yiqifumai Injection. Methods The HPLC analysis was performed on a Waters Symmetry C₁₈ column (250 mm × 4.6 mm, 5 μm) and the mobile phase consisted of acetonitrile-0.01% phosphoric acid. The detective wavelength was set at 203 nm and the column temperature maintained at 32 ℃. Results Two kinds of components in Yiqifumai for Injection were identified as ginsenosides and lignins by fingerprints. Three evaluation methods for fingerprints of Yiqifumai Injection were established. Conclusion The HPLC fingerprints of Yiqifumai Injection is stable and reproducible. The included angle cosine did not differ much from correlation coefficient, they can evaluate the quality of Yiqifumai Injection effectively while Euclidean distance can not give a direct visual evaluation on Yiqifumai Injection.