山海丹牌野菊花注射液特征图谱分析

Specific chromatograms of shanhaidan yejuhua injection by HPLC

目的建立山海丹牌野菊花注射液中有效成分的含量测定及特征图谱研究方法,对其质量进行控制。方法采用高效液相色谱法(HPLC)梯度洗脱,流动相:乙腈-0.5%磷酸溶液,梯度洗脱,流速:1.0 m L·min^(-1),检测波长326 nm,以木犀草苷为参照峰计算其共有峰的相对保留时间。结果标记8个吸收值较大的共有峰,9批供试品中S峰与标准对照品峰相对应,其余特征峰的相对保留时间RSD均小于0.6%。结论该特征图谱方法可行,可用于该厂家野菊花注射液的质量控制。

Objective To establish a method for the determination of the content and the study on the feature map of the active ingredients in Shanhaidan Yejuhua Injection,and to study its quality control. Methods HPLC Gradient elution was used with the mobile phase of acetonitrile-0. 5% phosphate. The flow rate was set at 1. 0 m L·min- 1and the detection wavelength was 326 nm. The relative retention time was calculated with galuteolin as the reference peak. Results A total of 8 larger absorption values were marked,and the S peak of the 9 batches was correspondent to the standard control. The relative retention time of the other characteristic peaks was less than 0. 6%. Conclusions The method is feasible,and can be used for the quality control of shanhaidan yejuhua injection in the factory.