济生肾气丸的高效液相色谱法特定指纹图谱的研究

Fingerprint chromatograms and characteristic peaks of Jisheng Shenqi Pills by HPLC

目的建立济生肾气丸高效液相色谱法(HPLC)的指纹图谱方法,为其质量控制提供参考依据。方法流动相为乙腈-0.3%磷酸水溶液进行梯度洗脱,流速为1.0 ml/min,检测波长240 nm。采用《中药色谱指纹图谱相似度评价系统软件(2004A版)》对7批样品进行相似度评价。结果确定了9个特征峰,并在单位药材中找到归属。7批次样品指纹图谱相似度较好,均>0.797。结论结果表明该方法简便、准确,重现性好,可评价济生肾气丸的质量。

Objective To establish the chromatogrphic fingerprint of Jisheng Shenqi Pills by HPLC method for evaluating the quality of the preparation. Methods The mobile phase was acetonitrile-0.3% acetic acid solution in a gradient elution mode.The flow rate was 1.0 ml/min and the UV detection wavelength was 240 nm. The similarity of 7 batches of samples was evaluated by using Similarity Calculation Software of TCM Chromatogrphic Fingerprint （2004A edition）. Results Nine common peaks were identified in 7 batches of samples and found belonging to their single medicinal material. The similarity of fingerprint was all higher than 0.797. Conclusion The method is simple and accurate, reproducible for quality control of the preparation.