目的:建立糖肾方的高效液相指纹图谱分析方法,为该药的质量控制提供依据.方法:采用Aglient C18色谱柱(250 mm×4.6 mm,5μm)、二极管阵列检测器,以甲醇-0.2％甲酸水溶液作为流动相进行梯度洗脱,流速为1.0 ml/min,检测波长为260 nm.采用"中药色谱指纹图谱相似度评价系统研究版(2004A)"对指纹图谱进行相似度评价.结果:建立了糖肾方的指纹图谱,确认了22个共有峰.经相似度评价,10批糖肾方的相似度均>0.99.结论:本研究建立的方法稳定可靠、重复性好,可为糖肾方的质量控制提供依据.%OBJECTIVE: To establish the method of high performance liquid chromatography ( HPLC ) fingerprinting of Tangshen formula , so as to provide basis for the quality control .METHODS:Aglient C18 (250 mm × 4.6 mm,5 μm) column and diode-array detector were adopted, methanol-0.2％ formic acid aqueous solution was set as mobile phase to conduct gradient elute.The flow rate was 1.0 ml/min, detection wavelength was 260 nm.Similarity evaluation was conducted according to "Similarity Evaluation System for Chromatographic Fingerprint of TCM (Version 2004A)".RESULTS: HPLC fingerprinting of Tangshen formula was established, 22 characteristic peaks were determined.After similarity evaluation, the similarity of 10 batches of Tangshen formula were >0.99 .CONCLUSIONS: The method is stable and reliable with a good reproducibility and can provide basis for the quality control.
展开▼
