基于中药质量标志物的人参、西洋参、三七及相关中成药质量控制方法研究

Research on Quality Control Methods of Panax ginseng,Panax quinquefolius,Panax notoginseng and Related Proprietary Chinese Medicines Based on Q-Marker

目的基于中药质量标志物( Q-marker)的理念及研究模式,对人参、西洋参、三七质量标志物进行研究,并建立质量控制方法。方法对人参、西洋参、三七的物质基础、生物合成途径等进行分析,用液相色谱-质谱联用法对三种药材中主要成分进行测定,探寻人参、西洋参、三七的质量标志物并建立含量测定方法。结果人参、西洋参、三七的质量标志物为其特有成分人参皂苷 Rf、拟人参皂苷F11 与三七皂苷R1及共有成分人参皂苷Rg1、 Re与 R b1的比例特征,分别采用超高效液相色谱法与超高效液相色谱-串联质谱联用法建立了人参、西洋参、三七药材及含人参、西洋参、三七的中成药中质量标志物的含量测定方法。结论选择的质量标志物科学合理,可反映三种药材的特性,建立的含量测定方法提高和完善了人参、西洋参、三七药材、饮片及相关中成药的质量控制水平。

OBJECTIVE To explore Q-markers of Panax ginseng,Panax quinquefolius,Panax notoginseng and establish the content determination method based on the concept and research model of Q-marker. METHODS The material basis and biosynthesis pathway of Panax ginseng,Panax quinquefolius,Panax notoginseng were analyzed. The main components of three medicinal materials were determined by liquid chromatography-mass spectrometry,and methods for determination of Q-markers in Panax ginseng,Panax quinquefolius,Panax notoginseng herbs and proprietary Chinese medicine were established. RESULTS The Q-markers of Panax ginseng,Panax quinquefolius,and Panax notoginseng were their specific constituents,including ginsenosides Rf,pseudo ginsenoside F11,notoginseng saponins R1,and the ratio feature of the common constituents,including ginsenosides Rg1,ginsenosides Re,and ginsenosides Rb1. Methods for determination of Q-markers in Panax ginseng,Panax quinquefolius,Panax notoginseng herbs and proprietary Chinese medicine were established by ultra-high performance liquid chromatography(UPLC) and ultra-high performance liquid chromatography-electrospray ionization quadruple mass spectrometry(UPLC/MS/MS). CONCLUSION The Q-markers which were selected are scientific and reasonable,also can reflect the characteristics of the three medicinal materials. The established methods would improved the quality control level of Panax ginseng,Panax quinquefolius,Panax notoginseng and related proprietary Chinese medicine.