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目的:建立同时测定参芪扶正注射液中黄芪皂苷Ⅰ、Ⅱ、Ⅲ、Ⅳ和党参炔苷、芒柄花素含量的方法。方法:采用高效液相色谱法。色谱柱为Ultimate XB-C18,检测器为蒸发光散射检测器,流动相为乙腈-0.5%甲酸(梯度洗脱),流速为1.2 ml/min,柱温为30 ℃,进样量为10 μl。结果:黄芪皂苷Ⅰ、Ⅱ、Ⅲ、Ⅳ、党参炔苷和芒柄花素检测进样量线性范围分别为0.62~5.67 μg(r=0.999 6)、0.78~6.31 μg(r=0.999 6)、0.36~3.48 μg(r=0.999 7)、0.81~6.72 μg(r=0.999 5)、0.82~7.03 μg(r=0.999 8)、0.58~6.62 μg(r=0.999 7);定量限分别为1.21、0.15、0.12、0.03、0.12、0.17 μg/ml;检测限分别为0.35、0.35、0.04、0.01、0.03、0.04 μg/ml;精密度、稳定性、重复性试验的RSD<2%;加样回收率分别为95.1%~101.1%(RSD=2.0%,n=9)、95.2%~100.7%(RSD=1.9%,n=9)、95.8%~100.2%(RSD=1.4%,n=9)、96.2%~100.6%(RSD=1.7%,n=9)、96.6%~101.2%(RSD=1.4%,n=9)、95.9%~99.5%(RSD=1.2%,n=9)。结论:该方法操作简便、结果准确,可用于同时测定参芪扶正注射液中黄芪皂苷Ⅰ、Ⅱ、Ⅲ、Ⅳ、党参炔苷和芒柄花素的含量。
OBJECTIVE:To establish a method for the contents determination of astragalosidesⅠ,Ⅱ,Ⅲ,Ⅳ,lobetyolin and formononetin in Shenqi fuzheng injection. METHODS: HPLC was performed. The detector was evaporative light scattering detector, column was Ultimate XB-C18 with mobile phase of acetonitrile-0.5% formic acid (gradient elution) at a flow rate of 1.2 ml/min, column temperature was 30 ℃, and injection volume was 10 μl. RESULTS: The linear range was 0.62-5.67 μg for astragalosidesⅠ(r=0.999 6), 0.78-6.31 μg for astragalosidesⅡ(r=0.999 6), 0.36-3.48 μg for astragalosidesⅢ(r=0.999 7), 0.81-6.72 μg for astragalosides Ⅳ(r=0.999 5), 0.82-7.03 μg for lobetyolin (r=0.999 8) and 0.58-6.62 μg (r=0.999 7) formononetin; limit of quantitation was 1.21,0.15,0.12,0.03,0.12,0.17 μg/ml; limit of detection was 0.35, 0.35, 0.04, 0.01, 0.03, 0.04 μg/ml; RSDs of precision, stability and reproducibility tests were lower than 2%;recoveries were 95.1%-101.1%(RSD=2.0%,n=9), 95.2%-100.7%(RSD=1.9%,n=9), 95.8%-100.2% (RSD=1.4%,n=9),96.2%-100.6%(RSD=1.7%,n=9),96.6%-101.2%(RSD=1.4%, n=9) and 95.9%-99.5%(RSD=1.2%,n=9), respectively. CONCLUSIONS: The method is simple and accurate, and can be used for the simultaneous determination of astragalosidesⅠ,Ⅱ,Ⅲ,Ⅳ, lobetyolin and formononetin in Shenqi fuzheng injection.
参芪扶正注射液高效液相色谱法黄芪皂苷Ⅰ黄芪皂苷Ⅱ黄芪皂苷Ⅲ黄芪皂苷Ⅳ党参炔苷芒柄花素
Shenqi fuzheng injectionHPLCAstragalosideⅠAstragalosideⅡAstragalosideⅢAstragalosideⅣLobetyolinFormononetin
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