参芪扶正注射液中黄芪药材HPLC指纹图谱研究

Studies on HPLC Fingerprint of Huangqi in Shenqifuzheng Injection

目的:建立参芪扶正注射液中黄芪药材的HPLC指纹图谱。方法:Waters 717型高效液相色谱仪,Waters 2996二极管阵列检测器,低压四元泵,自动进样器;KR100-5C18色谱柱,体积250mm×4.6mm;流动相为乙腈-水,线性梯度洗脱;柱温30℃;流速0.8mL/min;检测波长270nm;记录时间为90min。结果:10批样品与对照用黄芪药材(批号031124)HPLC指纹图谱的相似度都在90%以上,精密度、稳定性、重复性试验中各共有峰相对保留时间和相对峰面积的RSD均<3%。结论:本方法操作简便,结果稳定可靠,该法可以作为参芪扶正注射液中黄芪药材的一种质量控制方法。

Objective： To establish the fingerprint of Huangqi material in the Shenqifuzheng Injection by HPLC. Methods： Waters 717 high performance liquid chromatogram, Waters 2996 diode array detector,low pressure quaternionic pump, autosampler; KR100 - 5C18 Column ,250mm × 4.6mm ; acetonitrile - water as mobile phase, linear gradient elution, column temperature at 30℃ ; flow rate is 0.8 mL/min, detector wave is 270nm, proceeding time 90 minutes. Results：All the similarity of the 10 samples are more than 90% compared with the control group （ NO. 031124）. The RSD of the retention time and relative peak area of the shared peak is lower than 3% in the precision, stability and repetitiveness experiments. Conclusion： The practice is very simple and the result obtained is always stable. Therefore, this method can be used to control the quality of the Shenqifuzheng Injection.