注射用益气复脉（冻干）的HPLC指纹图谱研究___

目的：采用HPLC方法对注射用益气复脉（冻干）指纹图谱进行研究。方法：采用Waters Symmetry C18柱 (4.6 mm×250 mm, 5μm)，乙腈-0.05%磷酸梯度洗脱，流速为1.0 mL·min-1，检测波长203 nm。结果：按“中药色谱指纹图谱相似度评价系统的操作规范 (版本2004B)”计算，10批注射用益气复脉（冻干）的相似度均在0.90以上，确定了23个共有峰，建立了该制剂的HPLC指纹图谱。结论：方法简单可行，可以有效地控制益气复脉的质量。

Objective: To establish the HPLC fingerprint for the quality control of Yiqifumai injections. Method: A Waters Symmetry C₁₈ column (4.6 mm×250 mm, 5µm) by stepwise gradient elution with water (0.05% Phosphoric acid, v/v) and acetonitrile as the mobile phase was used. The flow rate was 1.0 mL·min^-1, and the detection wavelength was at 203 nm. Results: The operating standard of similarty evaluation system for chromatographic fingerprint of Chinese Materia Medica (Version 2004B) was used to calculate. Similarity of 10 batches of injections was higher than 0.90, the fingerprint of Yiqifumai injections was established, and 23 common peaks were indicated. Conclusion: This method is simple, accurate, and can be applied to the quality control of Yiqifumai injections.

1XIA Jing (夏晶), WANG Gang-li (王钢力), JI Shen (季申)，et al. Fingerprint chromatography of Shengmai injection by HPLC (生脉注射液HPLC指纹图谱的研究). Chin Tradit Pat Med(中成药),2006, 28 (8):1093
2XIA Jing (夏晶), WANG Ke (王柯), WANG Gang-li (王钢力). et al. Affirming marker peaks for fingerprint chromatography of Shengmai injection(LC-MS／MS法确认生脉注射液指纹图谱的特征峰). Chin Tradit Pat Med(中成药),2007, 29(3):313
3LIN Xiao (林晓), ZHOU Qiang-feng (周强峰), XU De-sheng (徐德生). Research progress of the pharmacological actions of ophiopogon root (麦冬药理作用研究进展). Shanghai J Tradit Chin Med(上海中医药杂志),2004, 38 (6):59
4ZHOU Yi-feng (周一峰), QI Jin (戚进), ZHU Dan-ni (朱丹妮),et al. Homoisoflavonoids from Ophiopogon japonicus and its oxygen free radicals (OFRs) scavenging effects(麦冬须根高异黄酮类成分及其清除氧自由基作用). Chin J Nat Med(中国天然药物),2008, 6 (3):201
5MO Zheng-ji (莫正纪), JIANG Guang-chi (江光池), RAN Lan (冉兰)，et al.Pharmacological studies on the active constituents of Ophiopogon japonicus(麦冬有效成分的药理研究). West China J Pharm Sci(华西药学杂志), 1991, 6 (1):13