目的 建立UHPLC-UV測定注射用益氣復脈（凍干）（YQFM）中人參皂苷Rg₁、Re、Rb₁含量的方法。方法 采用Waters Xselect^® HSS C₁₈（3.0×150 mm，2.5 μm）色譜柱，以0.05%磷酸溶液-乙腈為流動相梯度洗脫，進樣量為5 μL，檢測波長為203 nm，柱溫28℃。進行線性關(guān)系考察，重復性、中間精密度、準確性、耐用性試驗。取10批YQFM，按照本研究建立的方法和YQFM國家藥品標準（YBZ07062006-2009Z-2015）中的HPLC含量測定法[5]進行測定。結(jié)果 人參皂苷Rg₁、人參皂苷Re、人參皂苷Rb₁分別在0.019 37~0.387 40、0.020 32~0.406 40、0.050 00~0.999 9 mg/mL線性關(guān)系良好（R>0.999 9），重復性、中間精密度、準確性、耐用性等均滿足定量分析要求。含量測定結(jié)果與國家標準方法比較無明顯差異。結(jié)論 研究建立的方法可用于人參皂苷Rg₁、Re、Rb₁含量的測定，與傳統(tǒng)的HPLC-UV法相比，本方法具有分析速度快、節(jié)約溶劑等特點，同時相較于UPLC-MS/MS法，具有經(jīng)濟、簡便的優(yōu)勢。

Objective To establish a UHPLC-UV method for the analysis of ginsenoside Rg₁, Re, and Rb₁ in Yiqi Fumai Lyophilized Injection. Methods The determination was achieved on a Waters Xselect^® HSS C₁₈ column (3.0 mm×150 mm, 2.5 μm) with a gradient elution system of 0.05% phosphoric acid solution-acetonitrile. The injection volume was 5 μL with detection wavelength of 203 nm, column temperature was maintained at 28℃. Linear relationship, repeatability, intermediate precision, accuracy and durability were tested. Ten batches of YQFM were selected and determined according to the method established in this study and the HPLC content determination method in YQFM national drug standard (YBZ07062006-2009Z-2015). Results Ginsenoside Rg₁, ginsenoside Re, Ginsenoside Rb₁ the linear relationship was good in the range of 0.019 37-0.387 40, 0.020 32-0.406 40, 0.050 00-0.999 90 mg/mL respectively (r > 0.999 9). Repeatability, intermediate precision, accuracy and durability meet the requirements of quantitative analysis. There was no significant difference between the content determination results and the national standard method. Conclusion The method can be used for the determination of Ginsenoside Rg₁, Re and Rb₁. Compared with HPLC-UV method, this method has the characteristics of fast analysis speed and solvent saving. At the same time, it has the advantages of economy and simplicity compared with UPLC-MS/MS method.

R285.6

天津市科技計劃項目（18YFCZZC00430）