摘要
目的建立一种同时测定注射用益气复脉(冻干)(YQFM)中4种皂苷(人参皂苷Rf、人参皂苷Rc、人参皂苷Ro和人参皂苷Rg5)含量的HPLC法。方法用Pro Elut PLS固相萃取柱预先处理样品,然后采用Waters Symmetry C18色谱柱(250 mm×4.6 mm,5μm),以乙腈-0.05%磷酸水溶液为流动相进行梯度洗脱,体积流量1.0 mL/min,柱温26℃,检测波长203 nm,进样量10μL。结果人参皂苷Rf(0.008 96~0.224 mg/mL),人参皂苷Rc(0.009 84~0.246 mg/mL),人参皂苷Ro(0.010 06~0.251 5 mg/mL),人参皂苷Rg5(0.002 61~0.026 1 mg/mL)线性良好;准确度试验(n=6)中,人参皂苷Rf、人参皂苷Rc、人参皂苷Ro和人参皂苷Rg5的平均回收率分别为93.9%、91.8%、97.4%和87.8%;20批YQFM中人参皂苷Rf、人参皂苷Rc、人参皂苷Ro和人参皂苷Rg5平均含量分别为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)。结论所建立的方法简单可靠,可用于测定YQFM中人参皂苷Rf、人参皂苷Rc、人参皂苷Ro和人参皂苷Rg54种皂苷的含量测定。
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,5μm)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 was10μL.Results The linearity of ginsenoside Rf(0.00896—0.224 mg/mL),ginsenoside Rc(0.00984—0.246 mg/mL),ginsenoside Ro(0.01006—0.2515 mg/mL),ginsenoside Rg5(0.00261—0.0261 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%and87.8%respectively.The average contents of ginsenoside Rf,ginsenoside Rc,ginsenoside Ro and ginsenoside Rg5 for 20 batches of YQFM were 0.2333 mg/g(0.1952—0.2711 mg/g),0.4384 mg/g(0.3258—0.4971 mg/g),0.7396 mg/g(0.6158—0.9108 mg/g)and 0.0661 mg/g(0.0382—0.0878 mg/g),respectively.Conclusion The method is simple and reliable,and can be used for the determination of four saponins in YQFM.
作者
李莉
周垚垚
李红艳
李海燕
张磊
岳洪水
李德坤
鞠爱春
LI Li;ZHOU Yaoyao;LI Hongyan;LI Haiyan;ZHANG Lei;YUE Hongshui;LI Dekun;JU Aichun(Tianjin Tasly Pride Pharmaceutical Co.,Ltd.,Tianjin 300410,China;Tianjin Key Laboratory of Safety Evaluation Enterprise of TCM Injections,Tianjin 300410,China)
出处
《药物评价研究》
CAS
2020年第8期1581-1586,共6页
Drug Evaluation Research
基金
天津市科技计划项目(18YFCZZC00430)。
