丹参川芎嗪注射液及其丹参提取液的HPLC指纹图谱研究

HPLC Fingerprint Study of Danshen Chuanxiongqin Injection and Its Salvia miltiorrhiza Extract

目的:建立丹参川芎嗪注射液及丹参提取液的HPLC指纹图谱。方法:采用Unitary C_(18)(250 mm×4.6 mm,5μm)色谱柱;以甲醇-0.05%磷酸溶液为流动相,梯度洗脱;检测波长为254 nm;柱温为30℃;流速为1.0 mL/min,建立10批丹参川芎嗪注射液的HPLC指纹图谱;利用"中药色谱指纹图谱相似度评价系统(2004 A版)"软件对其进行相似度评价。结果:建立了丹参川芎嗪注射液HPLC指纹图谱,共确定8个共有峰,指认了6个成分;10批样品相似度均为0.999,且方法可靠。结论:该分析方法分离效果好、可行性强,可为丹参川芎嗪注射液的质量控制提供可靠的依据。

Objective:To establish HPLC fingerprints of Danshen chuanxiongqin injection and Salvia miltiorrhiza extract.Methods:Using the Unitary C18(250 mm×4.6 mm,5 μm)column,the mobile phase was methanol-0.05% phosphoric acid solution with gradient elution,detection wavelength was 254 nm,column temperature was 30 ℃ and flow rate was 1.0 mL/min.The HPLC fingerprint of ten batches of Danshen chuanxiongqin injection was determined.The similarity evaluation was performed by the "Chinese Herbal Chromatographic Similarity Evaluation System(2004 A edition)" software.Results:The HPLC fingerprint of Danshen chuanxiongqin injection was established.A total of eight common peaks were determined and six peaks were identified.The similarities of ten samples were 0.999.The method was reliable.Conclusion:The analytical method has good separation effect and feasibility and can provide a reliable basis for the quality control of Danshen chuanxiongqin injection.