参芪扶正注射液中党参药材HPLC指纹图谱研究

Study on HPLC Fingerprint of Dangshen in Shenqifuzheng Injection

目的:建立参芪扶正注射液中党参药材的HPLC指纹图谱。方法:色谱条件为KR100-5C18色谱柱,体积250×4.6 mm;流动相为乙腈-水,线性梯度洗脱;柱温30℃;流速0.8 ml/min;检测波长270 nm;记录时间为70 min。结果:10批样品与对照用党参药材(批号030918)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党参药材的一种质量控制方法。

Objective： To establish the fingerprint of Dangshen material in the Shenqifuzheng Injection by HPLC. Methods： KR 100-5C18 Column, 250×4. 6 mm; acetonitrile-water as mobile phase, linear gradient elution; column temperature was at 30℃ ; flow rate was 0. 8 ml/min; detector wave was 270 nm; proceeding time was 70 minutes. Results： All the similarity of the 10 samples were more than 90% compared with the control group （NO. 030918）. The RSD of the relative retention time and relative peak area of the shared peak was lower than 3% in the precision, stability and repetitiveness experiments. Conclusion： The practice is simple and the result obtained is always stable. This method can be used to control the Dangshen quality of the Shenqifuzheng Injection.