益母草注射液指纹图谱的研究  

Fingerprint analysis of Yimucao injection

作　　者：杨超 包小红 耿昭[2] 周娟 

机构地区：[1]四川省食品药品检验检测院,成都611731 [2]成都中医药大学,成都611137

出　　处：《药物分析杂志》2016年第7期1219-1224,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立益母草注射液指纹图谱测定方法。方法:采用高效液相色谱-蒸发光散射检测法测定益母草注射液指纹图谱。使用阳离子交换色谱柱(4.6 mm×250 mm,5μm),以甲醇-[0.3%醋酸铵-冰醋酸(500∶277),pH 2.20](35∶65)为流动相,流速0.8 m L·min^(-1),柱温30℃,ELSD漂移管温度80℃,载气流速2.0 L·min^(-1)。并进行方法学验证。结果:本方法重复性、稳定性良好;采用中药指纹图谱相似度评价软件,建立了益母草注射液标准指纹图谱,确定其成分有Cl-、5-羟甲基-2糠酸、水苏碱、Na+、K+、胆碱;对31批样品进行测定,相似度范围为0.957~1.000。结论:方法学验证结果表明,本文建立的HPLC-ELSD指纹图谱分析法稳定可行,可用于益母草注射液指纹图谱的测定。Objective：To establish a method for fingerprint analysis of Yimucao injection.Methods：HPLC-ELSD was used to analyze the fingerprint of Yimucao injection.The conditions were set as follows：Cation exchange chromatography column（4.6 mm×250 mm,5 μm）,mobile phase of methanol-[0.3% ammonium acetate-acetic acid（500∶277）,pH 2.20]（35∶65）,flow rate at 0.8 m L·min（-1）,column temperature at 30 ℃,ELSD drift tube temperature at 80 ℃,flow rate of carrier gas at 2.0 L·min（-1）.In addition,the methodology was validated.Results：The repeatability and stability of this method were good.With special software,the standard fingerprint of Yimucao injection was established,including the contents of Cl-,5-hydroxymethyl-2-furoic acid,stachydrine,Na＋,K＋ and choline.Moreover,31 additional samples were tested and the similarity was from 0.957 to 1.000.Conclusion：The result of methodology validation indicated that the analysis of fingerprint by HPLC-ELSD which is stable and reliable,can be used to analyze the fingerprint of Yimucao injection.

关 键 词：益母草注射液 中药指纹图谱 盐酸水苏碱 氯化胆碱 胆碱 葫芦巴碱 5-羟甲基-2-糠酸 高效液相色谱法 蒸发光散射检测 

分 类 号：R917[医药卫生—药物分析学]