骨痨敌注射剂及其药味黄芪的HPLC指纹图谱  

HPLC fingerprint of Gu Laodi injection and astragalus

作　　者：王昭慧[1] 刘虹霞[2] 闫瑞[2] 赵桂云[2] 张扬[2] 张国刚[2] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016 [2]沈阳药科大学中药学院,辽宁沈阳110016

出　　处：《沈阳药科大学学报》2016年第8期632-636,共5页Journal of Shenyang Pharmaceutical University

基　　金：辽宁省2015年度大学生创新创业训练计划项目(201510163000039)

摘　　要：目的建立骨痨敌注射剂及其主要药味黄芪的HPLC指纹图谱分析方法,进行黄芪药材与制剂间的对比研究,为制剂的质量控制提供依据。方法采用Kromasil C_(18)柱(250 mm×4.6 mm,5μm),以乙腈-水为流动相,梯度洗脱,流速为1.0 m L·min^(-1),柱温为30℃,检测波长为260 nm,进样量为10μL。结果通过对16批黄芪药材及8批制剂进行指纹图谱分析,药材标定10个共有峰,制剂标定16个共有峰,并运用"中药指纹图谱计算机辅助相似度计算软件",计算出了药材和制剂的相似度,并且制剂中的6个色谱峰在黄芪药材中得到归属。结论该HPLC指纹图谱为骨痨敌注射剂的质量评价提供科学依据。Objective To establish an HPLC fingerprint analysis method of Gu Laodi injection and astragalus,the comparative study betw een medicine and injection can provide the basis for quality control of the injection. Methods A Kromasil C18column（ 250 mm × 4. 60 mm,5 μm） as adopted and the mobile phase as acetonitrile-w ater in a gradient mode,the flow rate as 1. 0 m L·min^-1,the column temperature as 30 ℃,the avelength as set at 260 nm,and the injection volume as 10 μL. Results By the analysis of 16 batches of astragalus and 8 batches of injection,medicine calibrated 10 common peaks and preparation calibrated 16 common peaks. The similarity of the medicine and the preparation ere got by using traditional Chinese medicine chromatographic fingerprint similarity calculation softw are. And 6 chromatographic peaks of the preparation belonged to astragalus. Conclusions The HPLC fingerprint can provide a scientific basis for quality evaluation of Gu Laodi injection.

关 键 词：骨痨敌注射剂 黄芪 指纹图谱 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]