摘要
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 was260 nm. Similarity evaluation was conducted according to ＂Similarity Evaluation System for Chromatographic Fingerprint of TCM（ Version 2004 A） ＂. 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.
出处
《中国医院用药评价与分析》
2017年第11期1464-1467,1470,共5页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
广东省科技计划项目(No.2011A080504005)
