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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 study the fingerprint of Yiqi Fumai (freeze-dried) by HPLC. Methods: A gradient of acetonitrile-0.05% phosphoric acid was used on a Waters Symmetry C18 column (4.6 mm × 250 mm, 5 μm) with a flow rate of 1.0 mL · min-1 and a detection wavelength of 203 nm. Results: According to the “Code of Practice for the Similarity Evaluation System of Chromatographic Fingerprints of Traditional Chinese Medicine (Version 2004B)”, the similarity of 10 doses of Yiqi Fumai (lyophilized) for injection was above 0.90, 23 common peaks were identified, The HPLC fingerprinting of the preparation was established. Conclusion: The method is simple and feasible, which can effectively control the quality of Yiqi Fumai.