目的 建立注射用益氣復(fù)脈(凍干)的HPLC指紋圖譜,并建立評價其質(zhì)量的指紋圖譜分析方法。方法 采用HPLC法,色譜柱為Waters Symmetry^® C₁₈柱(250 mm×4.6 mm,5 μm);流動相為乙腈-0.01%磷酸水溶液梯度洗脫;檢測波長203 nm;柱溫32 ℃。結(jié)果 建立了注射用益氣復(fù)脈(凍干)中人參皂苷類、五味子木質(zhì)素類的指紋圖譜,并建立了3種指紋圖譜分析評價方法。結(jié)論 建立的注射用益氣復(fù)脈(凍干)指紋圖譜的重復(fù)性、穩(wěn)定性好,采用夾角余弦法與相關(guān)系數(shù)法從兩個不同的角度評價指紋圖譜,可以有效地反映益氣復(fù)脈的質(zhì)量,兩者差異不大,而采用歐氏距離法卻無法獲得兩張圖譜的真實相似程度,無法給出直觀的綜合質(zhì)量評價結(jié)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.