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目的建立双鱼颗粒(SG)指纹图谱,并进行多成分定量分析,为评价SG提供依据。方法采用Kromasil C18(250mm×4.6 mm,3.5μm)色谱柱,以乙腈-0.05%三氟乙酸水溶液梯度洗脱,体积流量0.8 m L/min,柱温30℃,检测波长为230、327 nm。采用Q-TOF/MS对指纹图谱中共有峰进行指认。结果得到分离度、重现性均较好的SG指纹图谱,标示出17个共有峰,10批样品相似度均大于0.95;采用LC/Q-TOF/MS方法指认了14个共有峰,其中7个共有峰经对照品比对,分别为芍药苷、绿原酸、隐绿原酸、异绿原酸A、异绿原酸B、异绿原酸C和新绿原酸,并对这7个成分进行了定量分析,平均回收率在97.8%~101.8%,RSD均小于2%。结论本方法能够快速、简便、准确地对SG指纹图谱及7个指标成分同时进行分析,可作为全面评价该制剂质量的有效方法。
Objective To establish the fingerprints of Pisces (SG) and conduct multi-component quantitative analysis to provide a basis for the evaluation of SG. Methods The chromatographic column was Kromasil C18 (250 mm × 4.6 mm, 3.5 μm) with a gradient of acetonitrile-0.05% trifluoroacetic acid. The volume flow rate was 0.8 mL / min and the column temperature was 30 ℃. The detection wavelength was 230 and 327 nm. The common peaks in fingerprints were identified by Q-TOF / MS. The results showed that there were 17 common peaks with good resolution and reproducibility. The similarity of 10 batches of samples was greater than 0.95. 14 common peaks were identified by LC / Q-TOF / MS method, of which 7 A total peak by the comparison of the control, respectively, paeoniflorin, chlorogenic acid, latent chlorogenic acid, iso-chlorogenic acid A, iso-chlorogenic acid B, iso-chlorogenic acid C and chlorogenic acid, and these 7 Quantitative analysis of the components, the average recovery was 97.8% ~ 101.8%, RSD were less than 2%. Conclusion This method can be used to analyze the fingerprint of SG and the seven index components simultaneously, quickly and easily, and can be used as an effective method to evaluate the quality of the preparation.