黄芪皂苷注射液指纹图谱的研究  

Study on fingerprints of astragalosides injection by HPLC-ELSD

作　　者：管佳[1] 毕志明[1] 李萍[1] 

机构地区：[1]中国药科大学生药学教研室,江苏南京210038

出　　处：《中国中药杂志》2006年第10期807-809,共3页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金重大资助项目(90209045)

摘　　要：目的：建立黄芪皂苷类成分注射液（包括药材、中间体及注射液制剂）的HPIE-ELSD指纹图谱质量控制方法。方法：Agilent Zorbax SB-C18柱，流动相为A水-B乙腈，二元梯度洗脱：15％～60％B（0—65min），流速0．8mL·mi^-1，蒸发光散射检测器，漂移管温度105℃，载气流速2．7L·min^-1。结果：药材、中间体、注射液制剂中标定的各共有峰相对保留时间的RSD值均小于1．0％，单峰面积大于或等于10％峰的峰面积比值也比较稳定，三者的图谱间具有很好的相关性，10批样品间具有很高的相似度。结论：本方法可作为黄芪皂苷注射液质量控制的依据。Objective： To develop an HPLC method for fingerprint determination of the astragalosides injection. Method： Analyses were carried out at 25℃ on a Zorbax SB-C18 column （4.6 mm× 250 mm,5 μm）. Mobile phase A was water, and B was acetonitrile. The analysis followed a linear gradient program. Initial conditions were 15% B; 0 ～ 65 rain, changed to 60% B. The flow rate was 0.8 mL·min^-1 The drift tube temparature of the ELSD was 105℃, and gas flowrate was 2.7 L·min^-1. Result： The RSD of relative retention time of the common peaks in the plant material, the extract and the injection fingerprints was less than 0. 1%, and there was good similarity among 10 batches of samples. Condusion： The method was reliable and simple which could be used for quality control of the injection.

关 键 词：指纹图谱 黄芪皂苷 注射液 

分 类 号：R286[医药卫生—中药学]