九味熄风颗粒生物碱类成分指纹图谱建立及其多指标成分定量分析  

Fingerprint and Multi-components Determination of Alkaloid in Jiuwei Xifeng Granules

作　　者：付娟[1] 李家春[1] 张海弢[1] 胡军华[1] 黄文哲[1] 王振中[1] 萧伟[1] 

机构地区：[1]江苏康缘药业股份有限公司中药制药过程新技术国家重点实验室,江苏连云港222001

出　　处：《中国实验方剂学杂志》2016年第19期43-47,共5页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家"重大新药创制"科技重大专项(2013ZX09402203)

摘　　要：目的:建立九味熄风颗粒的指纹图谱,并同时测定其中钩藤碱、异钩藤碱、去氢钩藤碱、异去氢钩藤碱。方法:采用Phenomenex Gemini C18色谱柱,以甲醇-0.1%三乙胺为流动相进行梯度洗脱,流速1.0 m L·min^(-1),柱温35℃,检测波长246nm。对10批九味熄风颗粒进行了指纹图谱及含量测定研究,采用"中药色谱指纹图谱相似度评价软件"(2004A)进行分析。结果:得到分离度、重复性均较好的九味熄风颗粒指纹图谱,共标示出13个共有峰,各批次样品相似度>0.96;通过对照品比对,确定了4个成分,分别为钩藤碱、异钩藤碱、去氢钩藤碱、异去氢钩藤碱,并对其进行定量分析。结论:该方法快速、简便、准确,可作为全面评价该制剂质量的有效方法之一。Objective： To study the HPLC fingerprint of the Jiuwei Xifeng granules,and establish a method for the content determination of rhyncholphylline,isorhynchophylline,corynoxeine and isocorynoxeine.Method： Phenomenex Gemini C18 column was used with methyl alcohol-0. 1% triethylamine as the mobile phase for gradient elution. The flow rate was 1. 0 m L · min-1; the column temperature was 35 ℃,and the detection wavelength was 246 nm. Ten batches of Jiuwei Xifeng granules were analyzed by HPLC fingerprints and content determination methods. Data were analyzed by using Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine（ Version 2004A）. Result： In the fingerprints of well separated and repeated Jiuwei Xifeng granules,13 common peaks were identified. The similarity among different batches was more than0. 96. Based on the comparison with reference products,four components,rhyncholphylline,isorhynchophylline,corynoxeine and isocorynoxeine were identified; quantitative analysis was conducted for the above components.Conclusion： The method is rapid,simple and accurate,it can be used for the quality control of Jiuwei Xifeng granules.

关 键 词：九味熄风颗粒 指纹图谱 钩藤碱 异钩藤碱 去氢钩藤碱 异去氢钩藤碱 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学]