安神补脑液高效液相色谱指纹图谱的研究

Studies on the HPLC Fingerprint of Anshen Bunao Liquid

目的:建立安神补脑液的HPLC指纹图谱,为科学评价及有效控制制剂的质量提供有效可靠的方法。方法:采用Phenomenex Luna 5 u C18(2)100R(4.6 mm×250 mm,5μm)色谱柱,以乙腈-水梯度洗脱,检测波长320 nm,柱温25℃,确定安神补脑液的HPLC指纹图谱条件,对两个企业共18批样品进行测定。结果:18批样品得到的色谱指纹图谱有17个共有峰,体现了淫羊藿、制何首乌和甘草3种药材的特征。方法精密度、稳定性、重复性良好。结论:本方法为安神补脑液的质量评价提供了依据。

Objective： To establish a sensitive HPLC fingerprint method for controlling the quality of Anshen Bunao Liquid. Methods： HPLC analysis was performed on Column Phenomenex Luna 5u C18（2） 100R （4.6 mm × 250 mm,5 μm）, with a mixture of acetonitrile and water as mobile phase in gradient mode. The wavelength was set at 320 nm, and column temperature was 25 ℃. Samples of 18 batches, which was produced by two enterprises, were analyzed. Results： The HPLC fingerprint of Anshen Bunao Liquid showed 17 common peaks, which indicated that the components were originated primarily from Radix Polygoni Multiflori Preparata, Herba Epimedii, and Radix et Rhizoma Glycyrrhizae. Good precision, stability and repetition were showed. Conclusions： The method provides an evidence to quality evaluation of Anshen Bunao Liquid.