注射用辛芍(冻干粉针)指纹图谱研究

Study on RP-HPLC fingerprint of Xinshao injection

目的:采用RP-HPLC建立注射用辛芍(冻干粉针)的指纹图谱测定方法。方法:采用Diamonsil C18色谱柱,80%乙腈-0.1%磷酸溶液为流动相进行梯度洗脱,流速1.0 mL.min-1,柱温40℃,检测波长为230 nm。结果:在相同色谱条件下获得药材、中间体和制剂的各色谱峰分离较好,建立了注射用辛芍的HPLC对照指纹图谱,标注了制剂中的8个共有指纹峰,制剂与药材、中间体的指纹图谱有良好的相关性,10批样品相似度大于0.97,达到指纹图谱的技术要求。结论:该方法准确、重复性好,可作为注射用辛芍(冻干粉针)质量控制的重要依据之一。

Objective： To establish the fingerprint detecting standard of Xinshao Injection by reversed phase high performance liquid chromatography. Method： The chromatographic conditions were as follows： an Diamonsil C18 column was used, the mobile phase was composed of 80% acetontrile and 0. 1% phosphoric acid with gradient elution, the flow rate 1.0 mL min^-1 , column temperature was 40 ℃ and the UV absorbance detection was set at 230 nm. Result： A standard HPLC fingerprint procedure was developed for Xinshao Injection, with 8 common peaks. Under the same selected chromatographic conditions, the HPLC fingerprints of raw drugs and their intermediate, finished products were obtained with good separation and correlation （no less than 0.97） according to the technical requirements of fingerprint on Injection of Chinese traditional medicine. Conclusion： This method was accurate, repeatable and can be used as the important parameters of the quality control for Xinshao Injection.