灯盏花素注射液HPLC特征图谱研究

目的: 采用HPLC法对灯盏花素注射液的特征图谱进行研究。 方法: 采用Zorbax SB C₁₈(4.6 mm×250 mm,5 μm)色谱柱,以0.5%甲酸溶液-甲醇-乙腈为流动相梯度洗脱,流速1.0 mL·min^-1,检测波长330 nm。 结果: 初步建立了由12个共有峰组成的灯盏花素注射液特征图谱,并对89批样品进行了相关系数比较,分析了造成特征图谱差异的可能原因。 结论: 生产工艺的不统一是导致特征图谱差异的主要原因。

Objective: To establish the HPLC specific chromatogram of Dengzhanhuasu injection. Method: A Zorbax SB C₁₈(4.6 mm×250 mm,5 μm) column was adopted by stepwise gradient elution with formic acid (0.5%,v/v)-methanol-acetonitrile as the mobile phase.The flow rate was 1.0 mL·min^-1,and detection wavelength was set at 330 nm. Results: The HPLC specific chromatogram of Dengzhanhuasu injection was constructed with 12 common specific chromatogram peaks.After calculating 89 different samples,the similarity of different samples was compared. Conclusion: The main causes for the different HPLC specific chromatogram were different manufacture technology.