高效液相色谱法同时测定参芪扶正注射液中党参炔苷和毛蕊异黄酮葡萄糖苷的含量

Simultaneous Determination of Dangshenol and Calycosine Glycosides in Shenqifuzheng Injection by High Performance Liquid Chromatography

目的:建立高效液相色谱法同时测定参芪扶正注射液中党参炔苷和毛蕊异黄酮葡萄糖苷的含量。方法:色谱柱为Dikema C_(18)柱(4.6 mm×250 mm,5μm);以乙腈为流动相A,0.1%磷酸水溶液为流动相B,梯度洗脱;流速为1.0 ml/min,柱温30℃,进样量10μl,检测波长203 nm。结果:党参炔苷在10~500μg/ml范围内线性关系良好,毛蕊异黄酮葡萄糖苷在10~500μg/ml范围内线性关系良好。10批样品中,党参炔苷、毛蕊异黄酮葡萄糖苷的平均含量分别为(0.001 8±0.000 4)、(0.004 7±0.001 0)mg/ml,达到文献报道的治疗剂量。结论:本研究方法快速、准确、科学且合理,能够为参芪扶正注射液质量控制提供依据。

OBJECTIVE： To establish the method for simultaneous determination of dangshenol and calycosine glycosides in shenqifuzheng injection by high performance liquid chromatography（ HPLC）. METHODS： The column was Dikema C_（18） column（ 4. 6 mm × 250 mm,5 μm）; the mobile phase A was acetonitrile,and the mobile phase B was 0. 1% phosphoric acid solution,with gradient elution. The flow rate was 1. 0 ml/min,the column temperature was 30 ℃,the sample size was 10 μl,and the detective wavelength was 203 nm. RESULTS： The dangshenol had good linear relationship within range of 10-500 μg/ml,and calycosine glycosides had good linear relation within range of 10-500 μg/ml. In terms of the 10 batches of samples,the average content of dangshenol and calycosine glycosides were respectively（ 0. 001 8 ± 0. 000 4） and（ 0. 004 7 ± 0. 001 0） mg/ml,which reached therapeutic concentration as literatures reported. CONCLUSIONS： This method used in this study is fast,accurate,scientific and suitable,which can provide important reference for evaluation of active components in Shenqifuzheng injection.