肾宝合剂HPLC指纹图谱的研究  

HPLC fingerprinting of Shen-Bao Heji

作　　者：赵陆华[1] 屠颖[1] 吴孟华[1] 谭喜莹[1] 梅玲华 

机构地区：[1]中国药科大学分析测试中心,南京210009 [2]江西汇仁药业有限公司,南昌330201

出　　处：《中国药科大学学报》2005年第2期134-136,共3页Journal of China Pharmaceutical University

基　　金：国家高科技研究发展计划 ("八六三"计划 )资助项目 (No .2 0 0 2AA2Z3 2 14 )~~

摘　　要：目的:研究肾宝合剂的高效液相指纹图谱,为科学评价及有效控制合剂的质量提供了有效可靠的方法。方法:利用高效液相色谱法,梯度洗脱,测定了10批肾宝合剂样品。色谱条件为:AlltechC18柱(2 5 0mm×4 . 6mm ,5 μm) ,流动相A为乙腈;流动相B为0 . 1%醋酸水溶液,B相浓度梯度为0min ,76 % ;15min ,70 % ;4 0min ,5 3% ;5 0min ,30 % ;6 0min ,停止。结果:10批肾宝合剂样品得到的色谱指纹图谱有8个共有峰,体现了淫羊藿、补骨脂和蛇床子3种药材的特征。方法精密度、稳定性、重复性均符合有关规定。结论:肾宝合剂的指纹图谱特征性及专属性强,可用于全面控制肾宝合剂的质量,确保每一批产品的均一性。AIM:To establish a sensitive and special HPLC met hod for controlling the quality of Shen-Bao Heji.METHOD:HPLC analysis was performed on Alltech C 18 column(250 mm×4.6 mm,5 μm)with a mixture of acetonitrile (A) and 0.1% acetic acid-water (B) as mobile phase in gradient mode. The concentrations of solvent B in the mode were 76%(0 min);7 0%(15 min);53%(40 min);30%(50 min);stop(60 min).The column temperature was set at 25 ℃ and the flow rate was 1 mL/min.RESULT:The HPLC fingerp rinting of Shen-Bao Heji shows 8 common peaks.Based on the comparison of the r etention time and the on-line UV spectra of chemical standard, peaks 1,2,3,4 an d 5 come from Epimedium brevicomum;peaks 6 and 7 come from Maxim Psoralea ;peak 8 comes from Corylifolia Cnidium monnieri (L.) Cuss.. CONCLUSION:The chromatographic fingerprinting of Shen-Bao Heji with h igh sp ecificity can be used as a quality control method.

关 键 词：肾宝合剂 高效液相色谱 指纹图谱 

分 类 号：TQ461[化学工程—制药化工]