基于UPLC的注射用活血通络指纹图谱研究及多成分定量测定  

Fingerprint and multi-components quantitative determination for Huoxuetongluo Injection by UPLC

作　　者：林夏[1,2,3] 崔培超 徐桂红[2,3] 李家春[2,3] 黄文哲[2,3] 王振中[1,2,3] 萧伟[1,2,3] 

机构地区：[1]南京中医药大学药学院,江苏南京210000 [2]江苏康缘药业股份有限公司,江苏连云港222001 [3]中药制药过程新技术国家重点实验室,江苏连云港222001 [4]江苏康缘生态农业发展有限公司,江苏连云港222001

出　　处：《中草药》2016年第2期262-266,共5页Chinese Traditional and Herbal Drugs

基　　金：国家科技部重大新药创制"脑血栓形成急性期治疗药物--注射用活血通络的临床研究"(2011ZX091012-122)

摘　　要：目的建立注射用活血通络的指纹图谱,并进行多成分定量分析,提升注射用活血通络质量标准。方法采用Thermo C18柱(100 mm×3 mm,1.7μm),以甲醇-0.05%甲酸水溶液梯度洗脱,体积流量0.4 m L/min,柱温20℃,检测波长为260nm。结果得到分离度和重现性良好的指纹图谱,确定21个共有峰,其中11个共有峰来自于赤芍药材,7个共有峰来自于川芎药材,3个共有峰来自桃仁药材。同时利用相似度软件对10批注射用活血通络指纹图谱进行分析,各批次样品相似度在0.98以上;通过对照品比对,指认了5个成分,分别为苦杏仁苷、羟基芍药苷、芍药内酯苷、芍药苷、阿魏酸,并对其进行定量分析。结论 UPLC建立的注射用活血通络指纹图谱检测和5个指标成分定量分析方法,快速、简便、准确,能有效评价该制剂的质量。Objective To establish a UPLC fingerprint of the compounds in Huoxuetongluo Injection, and to make a quantitative analysis. Methods The Thermo C18（100 mm × 3 mm, 1.7 μm） column was used with a mobile phase of methyl alcohol-0.05% formic acid gradient elution, the flow rate was 0.4 mL/min, the column temperature was 20 ℃, and the detection wavelength was 260 nm. Results The fingerprint chromatography included 21 mutual peaks, of which 11 mutual peaks from Paeoniae Radix Rubra, 7 mutual peaks from Chuanxiong Rhizoma, and 3 mutual peaks from Persicae semen. The similarity among the batches was more than 0.98. Based on the retention time, and UV absorption spectra of reference compounds, five components, amygdalin, oxypaeoniflorin, albiflorin, paeoniflorin, and ferulic acid, were identified and quantified. Conclusion The method is rapid, simple, and accurate, and can be used for the quality control of Huoxuetongluo Injection.

关 键 词：注射用活血通络 UPLC 指纹图谱 多成分定量测定 苦杏仁苷 羟基芍药苷 芍药内酯苷 芍药苷 阿魏酸 

分 类 号：R286.02[医药卫生—中药学]