跌打活血散HPLC-DAD-ELSD双通道指纹图谱分析  

HPLC-DAD-ELSD Dual-channel Fingerprints of Dieda Huoxue Powder

作　　者：刘静[1] 刘燕[1] 于健东[1] 戴忠[1] 马双成[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2016年第9期924-931,共8页Chinese Pharmaceutical Affairs

基　　金：国家重点基础研究发展计划(编号2014ZX0930437-002)

摘　　要：目的:建立跌打活血散双通道指纹图谱分析方法以评价该制剂质量。方法:以C18(4.6 mm×250 mm,5μm)为色谱柱,乙腈-0.1%甲酸为流动相梯度洗脱;柱温:30℃;流速:1.0 m L·min-1;蒸发光散射检测器漂移管温度:115℃;氮气流速:2.7 L·min-1;进样量:20μL,采用HPLC-DADELSD联用法建立UV 254 nm与ELSD双通道指纹图谱,对7家生产企业的14批跌打活血散进行相似度评价。结果:在上述色谱条件下,相似度评价结果表明不同企业产品间存在一定差异,经对照品比对确认了指纹图谱中14个色谱峰(儿茶素、表儿茶素、羟基红花黄色素A、阿魏酸、三七皂苷R1、人参皂苷Rg1/Re、川续断皂苷VI、血竭素、芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚、11-羰基-β-乙酰乳香酸)。结论:建立的跌打活血散HPLC-DAD-ELSD双通道指纹图谱分析方法简便、可靠,可更为全面有效地控制该产品质量。Objective： To establish the dual-channel fingerprint analysis method for Dieda Huoxue Powder by HPLC-DAD-ELSD and to evaluate the quality of this drug. Methods： C18（4.6 mm × 250 mm, 5 μm） column was used with acetonitrile-0.1% formic acid at a flow rate of 1.0 m L·min-1 as the mobile phase. The column temperature was set at 30 ℃. The drift tube temperature for ELSD was 115 ℃, and nitrogen was used as the nebulizing gas at a flow rate of 2.7 L·min-1, and the injection volume was 20 μL. Dual-channel fingerprints in UV 254 nm and ELSD were established by HPLC-DAD-ELSD method. And 14 batches of samples from 7 enterprises were analyzed for similarity evaluation. Results： The results showed great diversity among different samples from different enterprises. And fourteen components [（＋）-catechin, epicatechin, hydroxysafflor yellow A, ferullic acid, notoginsenoside R1, ginsenoside Rg1/Re, asperosaponin VI, dracohodin, aloe-emodin, rhein, emodin, chrysophanol, physcion, acetyl-11-keto-β-boswellic acid] in the fingerprints were identified by comparing with reference standards. Conclusion： The method is simple and accurate, which can be used for the quality control of Dieda Huoxue Powder.

关 键 词：中药复方制剂 跌打活血散 双通道指纹图谱 儿茶素 表儿茶素 羟基红花黄色素A 阿魏酸 三七皂苷R1 人参皂苷Rg1/Re 川续断皂苷VI 血竭素 芦荟大黄素 大黄酸 大黄素 大黄酚 大黄素甲醚 11-羰基-Β-乙酰乳香酸 

分 类 号：R284.1[医药卫生—中药学]