目的 建立一種同時(shí)測定注射用益氣復(fù)脈（凍干）（YQFM）中4種皂苷（人參皂苷Rf、人參皂苷Rc、人參皂苷Ro和人參皂苷Rg₅）含量的HPLC法。方法 用Pro Elut PLS固相萃取柱預(yù)先處理樣品，然后采用Waters Symmetry C₁₈色譜柱（250 mm×4.6 mm，5 μm），以乙腈-0.05%磷酸水溶液為流動(dòng)相進(jìn)行梯度洗脫，體積流量1.0 mL/min，柱溫26℃，檢測波長203 nm，進(jìn)樣量10 μL。結(jié)果 人參皂苷Rf（0.008 96~0.224 mg/mL），人參皂苷Rc（0.009 84~0.246 mg/mL），人參皂苷Ro（0.010 06~0.251 5 mg/mL），人參皂苷Rg₅（0.002 61~0.026 1 mg/mL）線性良好；準(zhǔn)確度試驗(yàn)（n=6）中，人參皂苷Rf、人參皂苷Rc、人參皂苷Ro和人參皂苷Rg₅的平均回收率分別為93.9%、91.8%、97.4%和87.8%；20批YQFM中人參皂苷Rf、人參皂苷Rc、人參皂苷Ro和人參皂苷Rg₅平均含量分別為0.233 3（0.195 2~0.271 1 mg/g）、0.438 4（0.325 8~0.497 1 mg/g）、0.739 6（0.615 8~0.910 8 mg/g）、0.066 1 mg/g（0.038 2~0.087 8 mg/g）。結(jié)論 所建立的方法簡單可靠，可用于測定YQFM中人參皂苷Rf、人參皂苷Rc、人參皂苷Ro和人參皂苷Rg₅ 4種皂苷的含量測定。

Objective To establish a method for simultaneous determination of four saponins (ginsenoside Rf, ginsenoside Rc ginsenoside Ro and ginsenoside Rg₅) in Yiqi Fumai Lyophilized Injection (YQFM) by HPLC. Methods The samples were pretreated with the Pro Elut PLS SPE column. Waters symmetry C₁₈ column (250 mm×4.6 mm, 5 μm) was used as the chromatographic column; acetonitrile-0.05% phosphoric acid aqueous solution was used as the mobile phase for gradient elution; the flow rate was 1.0 mL/min; the column temperature was 26℃; the detection wavelength was 203 nm; and the injection volume was 10 μL. Results The linearity of ginsenoside Rf (0.008 96-0.224 mg/mL), ginsenoside Rc (0.009 84-0.246 mg/mL), ginsenoside Ro (0.010 06-0.251 5 mg/mL), ginsenoside Rg₅ (0.002 61-0.026 1 mg/mL) was good; in the accuracy test (n=6), the average recoveries of ginsenoside Rf, ginsenoside Rc, ginsenoside Ro and ginsenoside Rg₅ were 93.9%, 91.8%, 97.4% and 87.8% respectively. The average contents of ginsenoside Rf, ginsenoside Rc, ginsenoside Ro and ginsenoside Rg₅ for 20 batches of YQFM were 0.233 3 mg/g(0.195 2-0.271 1 mg/g), 0.438 4 mg/g (0.32 58-0.497 1 mg/g), 0.739 6 mg/g (0.615 8-0.910 8 mg/g) and 0.066 1 mg/g (0.038 2-0.087 8 mg/g), respectively. Conclusion The method is simple and reliable, and can be used for the determination of four saponins in YQFM.

R285.6

天津市科技計(jì)劃項(xiàng)目（18YFCZZC00430）