经典名方附子汤物质基准特征图谱及多成分含量测定研究

Study on the Substance Benchmark Characteristic Chromatogram and Multi-Component Content Determination of Classical Formula Fuzi Decoction

【目的】建立附子汤物质基准的高效液相色谱(HPLC)特征图谱及多成分含量测定方法。【方法】建立附子汤物质基准特征图谱方法,并采用《中药色谱指纹图谱相似度评价系统》(2012版)对15批附子汤物质基准的特征图谱进行分析。分别建立附子汤物质基准中11个成分的HPLC含量测定方法,并测定15批附子汤物质基准对应实物的干膏率。【结果】15批附子汤物质基准特征图谱的相似度均大于0.9,遴选了12个共有峰,并指认其中8个。结果显示,附子汤物质基准样品中苯甲酰新乌头原碱、苯甲酰次乌头原碱、白术内酯Ⅲ、人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1、没食子酸、芍药内酯苷、芍药苷、1,2,3,4,6-五没食子酰葡萄糖、苯甲酰芍药苷的含量分别为:0.0503~0.1911、0.0267~0.0470、0.0430~0.1276、0.5546~1.0068、0.5687~0.9795、0.9299~1.7261、1.0589~2.1184、1.4303~4.9655、6.8829~9.5111、0.0561~0.2625、0.1606~0.3690 mg/g。15批附子汤物质基准对应实物的平均干膏率为29.54%。【结论】建立的特征图谱和多指标成分测定方法准确、稳定,可为经典名方附子汤物质基准及相关制剂的质量控制提供依据。

Objective To establish a high performance liquid chromatography(HPLC)characteristic chromatogram and multi-component content determination method for the substance benchmark of Fuzi Decoction.Methods The characteristic chromatogram method of Fuzi Decoction substance benchmark was established,and the Similarity Evaluation System of Chromatographic Fingerprint of Traditional Chinese Medicine(2012 Edition)was used to analyze the characteristic chromatograms of 15 batches of Fuzi Decoction substance benchmark samples.The HPLC content determination methods of 11 components in the Fuzi Decoction substance benchmark samples were established respectively,and the dry extract rate of 15 batches of Fuzi Decoction substance benchmark samples was determined.Results The similarity of characteristic chromatograms of 15 batches of Fuzi Decoction substance benchmark samples was greater than 0.9,and 12 common peaks were selected and eight of them were identified.The results showed that the contents of benzoylmesaconine,benzoylhypaconine,atractylenolideⅢ,ginsenoside Rg1,ginsenoside Re,ginsenoside Rb1,gallic acid,albiflorin,paeoniflorin,1,2,3,4,6-penta-galloyl glucose and benzoyl paeoniflorin were 0.0503-0.1911,0.0267-0.0470,0.0430-0.1276,0.5546-1.0068,0.5687-0.9795,0.9299-1.7261,1.0589-2.1184,1.4303-4.9655,6.8829-9.5111,0.0561-0.2625,0.1606-0.3690 mg/g,respectively.The average dry extract rate of the 15 batches of Fuzi Decoction substance benchmark samples was 29.54%.Conclusion The established characteristic chromatogram and multi-index content determination method are accurate and stable,which provides a basis for the quality control of the substance benchmark and related preparations of Fuzi Decoction.