摘要
目的 建立附子汤物质基准特征图谱及多指标成分含量测定方法,阐明附子汤的关键质量属性.方法 制备15 批附子汤基准样品,建立附子汤高效液相色谱(HPLC)特征图谱,并进行特征峰归属和相似度分析;以人参皂苷Rg1、人参皂苷Re、人参皂苷Rf、人参皂苷Rb1 为指标性成分建立附子汤人参含量测定方法,以均值的 70%～130%为界限设定各质量控制指标的量值范围,并进行量值传递分析.结果 15 批附子汤基准样品特征图谱有 12 个共有峰,并指认没食子酸、儿茶素、芍药苷、人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1 和白术内酯Ⅲ 7 个特征峰,相似度均在0.98 以上;15 批基准样品中指标性成分含量范围及转移率分别为人参皂苷Rg1 含量0.51～0.94 mg/g,人参皂苷Re含量0.34～0.62 mg/g,人参皂苷Rg1 与人参皂苷Re之和转移率 12.05%～26.91%;人参皂苷Rf含量0.14～0.27 mg/g,转移率 11.15%～43.71%;人参皂苷Rb1 含量 0.41～0.76 mg/g,转移率 10.53%～33.23%.结论 本研究建立的附子汤基准样品HPLC特征图谱及人参含量测定方法精密准确,重复性和稳定性良好,为经典名方附子汤基准样品及其制剂关键化学属性的质量评价奠定了基础.
Abstract
Objective We aimed to establish the benchmark characteristic map of Fuzi decoction and the determination method of multi-index components,and to clarify the key quality attributes of Fuzi decoction.Methods Fifteen batches of Fuzi decoction substance benchmarks samples were prepared;the high-performance liquid chromatography(HPLC)characteristic spectrum of Fuzi decoction was established;and characteristic peak attribution and similarity analysis were performed.Ginsenosides Rg1,Re,Rf,and Rb1 were used as the index components to establish a method to determine ginseng content in Fuzi decoction.The value range of each quality control index was set at a limit of 70%-130%of the average value,and the quantity transfer analysis was performed on the material basis of 15 Fuzi decoction batches.Results The characteristic spectra of the 15 Fuzi decoction batches had 12 common peaks,and seven characteristic peaks of gallic acid,catechin,paeoniflorin,ginsenosides Rg1,Re,and Rb1,and atractylenolide Ⅲ were identified,with a similarity of more than 0.98.Ginsenosides Rg1,Re,Rf,and Rb1 content ranges were 0.51-0.94,0.34-0.62,0.14-0.27,and 0.41-0.76 mg/g,respectively.The transfer rates of ginsenosides Rg1 and Re,Rf,and Rb1 were 12.05%-26.91%,11.15%-43.71%,and 10.53%-33.23%,respectively.Conclusion The characteristic HPLC of Fuzi decoction and the determination method of Fuzi decoction ginseng content established in this study are accurate,reproducible,and stable,laying the foundation for the quality evaluation of the key chemical properties of Fuzi decoction and its preparation.
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