三七粉及三七伤药片质量评价方法研究  

Quality Evaluation Method of Notoginseng Radix et Rhizoma Powder and Sanqi Shangyao Tablets

作　　者：赵振霞 耿莲 安丽康 孔亚萍 刘永利 ZHAO Zhenxia;GENG Lian;AN Likang;KONG Yaping;LIU Yongli(Hebei Key Laboratory of Traditional Chinese Medicine Quality Evaluation and Standard Research,Hebei Institute for Drug and Medical Device Control,Shijiazhuang 050227,China)

机构地区：[1]河北省药品医疗器械检验研究院、河北省中药质量评价与标准研究重点实验室,河北石家庄050227

出　　处：《中国现代中药》2025年第4期742-749,共8页Modern Chinese Medicine

基　　金：河北特色中药饮片炮制规范化研究及应用示范项目(22372503D)。

摘　　要：目的:研究建立三七粉及三七伤药片质量评价方法。方法:采用显微鉴别法、薄层鉴别法、超高效液相色谱法、超高效液相色谱-质谱法分别对三七粉及三七伤药片中主要皂苷类成分进行定性、定量研究。结果:分别建立了三七粉及三七伤药片中三七皂苷R_(1)、人参皂苷Rg_(1)、人参皂苷Re、人参皂苷Rb_(1)、人参皂苷Rd 5个成分的薄层色谱鉴别与含量测定方法,鉴别特征明显,薄层斑点清晰、分离度良好,含量测定线性关系良好。三七粉中三七皂苷R_(1)、人参皂苷Rg_(1)、人参皂苷Re、人参皂苷Rb_(1)、人参皂苷Rd平均加样回收率分别为99.0%、99.3%、100.6%、101.5%、98.8%,RSD分别为1.4%、1.3%、1.6%、0.7%、1.6%;三七伤药片中三七皂苷R_(1)、人参皂苷Rg_(1)、人参皂苷Re、人参皂苷Rb_(1)、人参皂苷Rd平均加样回收率分别为95.5%、99.8%、102.0%、98.5%、97.0%,RSD分别为7.3%、2.9%、3.8%、3.3%、4.1%。结论:建立的方法专属性强、重复性好,适用于三七粉及三七伤药片中三七的质量评价。Objective:To establish a quality evaluation method for Notoginseng Radix et Rhizoma powder and Sanqi Shangyao Tablets.Methods:Microscopic observation,thin-layer chromatography(TLC),ultra-high performance liquid chromatography(UPLC),and UPLC-tandem mass spectrometry(MS/MS)were used for qualitative and quantitative analyses of saponins in Notoginseng Radix et Rhizoma powder and Sanqi Shangyao Tablets.Results:The TLC method for identification and determination of notoginsenoside R1,ginsenoside Rg1,ginsenoside Re,ginsenoside Rb1,and ginsenoside Rd in Notoginseng Radix et Rhizoma powder and Sanqi Shangyao Tablets was established.The established method showed clear spots with good separation in the identification and favorable linear relationships in the determination of key components.The recovery of notoginsenoside R1,ginsenoside Rg1,ginsenoside Re,ginsenoside Rb1,and ginsenoside Rd in Notoginseng Radix et Rhizoma powder was 99.0%,99.3%,100.6%,101.5%,and 98.8%,with the relative standard deviation(RSD)of 1.4%,1.3%,1.6%,0.7%,and 1.6%,respectively.The recovery of above-mentioned components in Sanqi Shangyao tablets was 95.5%,99.8%,102.0%,98.5%,and 97.0%,with the RSD of 7.3%,2.9%,3.8%,3.3%,and 4.1%,respectively.Conclusion:The established method demonstrated high specificity and reproducibility and can be used for the quality evaluation of Notoginseng Radix et Rhizoma powder and Sanqi Shangyao Tablets.

关 键 词：三七 三七粉 薄层鉴别 超高效液相色谱法 超高效液相色谱-质谱法 

分 类 号：R282[医药卫生—中药学]