醒脑静注射液HPLC特征图谱研究  

HPLC specific chromatograms of Xingnaojing injection

作　　者：杨立新[1,2] 冯伟红[1,2] 夏伯候[3] 林丽美[3] 刘薇薇 苗婉清 甘国锋 邹济高 李春[1,2] 

机构地区：[1]中国中医科学院中药研究所,北京100700 [2]中药质量控制技术国家工程实验室,北京100700 [3]湖南中医药大学,湖南长沙410208 [4]无锡济民可信山禾药业股份有限公司,江苏无锡214028 [5]山西省清徐县人民医院,山西太原030400

出　　处：《中国中药杂志》2016年第9期1640-1645,共6页China Journal of Chinese Materia Medica

基　　金：北京市自然科学基金项目(7132152);中央级公益性科研院所基本科研业务费专项(ZZ070828)

摘　　要：该研究采用高效液相色谱法建立并分析了不同厂家生产醒脑静注射液的特征图谱。采用Thermo BDS Hypersil C18色谱柱(4.6 mm×250 mm,5μm)进行分离,流动相为乙腈-0.02%甲酸水溶液,梯度洗脱,流速1.0 m L·min^(-1),检测波长254nm,柱温35℃,进样量20μL。通过对29批醒脑静注射液的HPLC特征图谱研究,共标定了11个特征峰。经与对照品对比,指认出其中7个特征峰的结构,分别为优香芹酮、樟脑、姜黄烯酮、莪术烯醇、莪术二酮、莪术酮和吉马酮。运用计算机辅助相似性评价系统及主成分分析对所建29批醒脑静注射液的HPLC特征图谱进行分析比较,结果显示不同厂家生产的醒脑静注射液能明显分为3类。该文所建立的HPLC特征图谱为科学评价和有效控制醒脑静注射液质量提供了依据。To establish and analyze the HPLC specific chromatograms of Xingnaojing injection manufactured by different factories.The separation was performed on a Thermo BDS Hypersil C_（18）column（ 4. 6 mm × 250 mm,5 μm）,with the mobile phase consisting of acetonitrile-0. 02% formic acid aqueous solution for gradient elution. The flow rate was 1. 0 m L·min-（-1）,and the column temperature was 35 ℃. The detection wavelength was set at 254 nm,and the sample size was 20 μL. Eleven chromatographic peaks were identified as characteristic peaks of HPLC specific chromatograms of Xingnaojing injection,after analyzing 29 batches of Xingnaojing injection samples. Compared with the reference substances,seven of them were identified as eucarvone,camphor,curcumenone,curcumenol,curdione,curzerenone and germacrone,respectively. HPLC specific chromatograms of Xingnaojing injection manufactured by three factories could be easily classified into three categories after investigation with computer-aided similarity evaluation system combined with principal component analysis. The established HPLC specific chromatograms provide a basis for scientific evaluation and effective con-trol of the quality of Xingnaojing injection.

关 键 词：醒脑静注射液 特征图谱 主成分分析 高效液相色谱法 

分 类 号：R286.0[医药卫生—中药学] O657.72[医药卫生—中医学]