良附丸的HPLC指纹图谱研究

Research of HPLC fingerprints of Liangfu pills

目的:建立良附丸HPLC指纹图谱评价体系,为进一步完善其质量控制标准提供参考。方法:采用Diamonsil C_(18)(250×4.6 mm,5μm)色谱柱,乙腈-0.2%磷酸溶液为流动相梯度洗脱,流速1.0 mL﹒min^(-1),检测波长242 nm,柱温30℃。测定10个不同批次良附丸的指纹图谱,采用《中药色谱指纹图谱相似度评价系统》(2012.130723版)计算相似度,并用对照品对共有色谱峰进行指认。结果:建立了中药成方制剂良附丸指纹图谱共有模式,10批制剂指纹图谱相似度均在0.956以上,标定了8个共有色谱峰,指认了其中3个共有峰,即其中第2、6、7三个峰分别为高良姜素、香附烯酮和α-香附酮。结论:本法简便、可行、重复性好,可为全面控制良附丸的质量以及其产品的二次开发奠定基础。

Objective:To establish the HPLC fingerprints evaluation system of Liangfu pills,which could provide a reference for further research of improving its quality control standard.Method:A Diamonsil C18 column(250 mm×4.6 mm,5 μm) was used.The mobile phase was acetonitrile-0.2% phosphoric acid solution in gradient elution at a flow of 1.0 mL﹒min^-1.The detection wavelength was 242 nm and column temperature was 30℃.HPLC fingerprints of ten batches of Liangfu pills were detected,and "similarity evaluation" system for chromatographic fingerprint of Traditional Chinese Medicine(Version 2012.130723) was used to obtain their similarity.The control products were used to identify the common peaks.Result:Common pattern of HPLC fingerprints of Liangfu pills were established.The similarity of ten batches preparations were all above 0.956.Eight common peaks were obtained,and three of them were identified as galangin(the second peak),cyperotundone(the sixth peak),and ɑ-cyperone(the seventh peak).Conclusion:The method is simple,feasible and reproducible,which provides a good reference for further improvement of quality control and secondary development of Liangfu pills.