金莲花颗粒的高效液相指纹图谱研究

HPLC Characteristic Spectrum of Jinlianhua Granules

目的建立金莲花颗粒的高效液相色谱(HPLC)特征图谱分析方法,控制不同批次金莲花颗粒的质量。方法以10批次金莲花颗粒为研究对象,采用HPLC法,色谱柱为Agilent C18柱(250 mm×4.6 mm,4.0μm),流动相为0.1%HAc水-乙腈(梯度洗脱),检测波长为254 nm,流速为0.6 mL/min,柱温为30℃,进样量为10μL。采用中药色谱指纹图谱相似度评价软件系统(2004 A版)对10批次样品的指纹图谱进行相似度评价。结果金莲花颗粒HPLC特征图谱共标示出21个特征共有峰,10批次金莲花颗粒的特征图谱与对照图谱相似度均超过0.994。结论建立了金莲花颗粒的HPLC特征图谱,该方法稳定,重复性好,可用于金莲花颗粒的质量控制。

Objective To establish a high performance liquid chromatography(HPLC)method for the analysis of Jinlianhua Granules,and to control the quality of Jinlianhua Granules in different batches.Methods Ten batches of Jinlianhua Granules with different batches were used in this study.HPLC method was applied,and the chromatographic column was Agilent-C18 column(250 mm×4.6 mm,4.0μm),the mobile phase was 0.1%HAc water-acetonitrile solution by gradient elution.The detection wavelength was 254 nm,t he flow rate was 0.6 mL/min,the column temperature was 30℃,and the injection volume was 10μL.The similarity of fingerprints was evaluated according to the software system 2004A issued by the State Pharmacopoeia Committee.Results The characteristic spectrum of Jinlianhua Granules was established,and a total of 21 common characteristic peaks were identified.The similarities between the characteristic spectrums and the control spectrum of 10 batches of Jinlianhua granules was all above 0.994.Conclusion The established method of the HPLC characteristic spectrum of Jinlianhua Granules is stable and reproducible,which can be used for the quality evaluation of Jinlianhua Granules.