雷公藤多苷片的HPLC指纹图谱和模式识别研究

Fingerprint analysisi and chemical pattern recognition for tripterygium wilfordii glycosides tablets

目的:建立雷公藤多苷片的高效液相色谱法(HPLC)指纹图谱评价体系。方法:采用Agilent ZORBAX SBC18分析柱,以水-乙腈为流动相梯度洗脱,流速0.75 m L/min,检测波长218 nm,柱温35℃,测定6个厂家的15批雷公藤多苷片,运用"中药指纹图谱相似度评价系统"软件计算相似度,并用对照品指认部分色谱峰。结果:建立了雷公藤多苷片指纹图谱共有模式,确定了22个特征峰,指认了3个色谱峰,通过聚类分析和主成分分析将6个厂家的样品分为两大类。结论:HPLC指纹图谱结合模式识别可以较好地反映雷公藤多苷片的内在质量。

Objective：To establish the high performance liquid chromatography（HPLC） fingerprint and evaluation system for tripterygium wilfordii glycosides tablets. Methods：Agilent ZORBAX SB - C18 column was used with water and acetonitrile in gradient elution mode. The flow rate was 0.75 mL/min and the detective wavelength was 218 nm,and the column tempera- ture was 35℃. The fingerprints for tripterygium wilfordii glycosides tablets from 15 different manufacturers and batches were set up, the similarity assay was carried out by Chinese material medica fingerprint similarity evaluation system （2004A edition） ,and the peaks were identified by comparing the reference substance. Results ：The common mode of HPLC fingerprints for tripterygium wilfordii glycosides tablets were set up. There were 22 common peaks in the fingerprints and three peaks were identified. The whole batches were divided into two parts by cluster analysis and principal component analysis. Conclusion： HPLC fingerprint is an effective method for the quality control of tripterygium wilfordii glycosides tablets with chemical pattern recognition.