目的 建立鸢都感冒颗粒HPLC指纹图谱和同时测定8种成分(新绿原酸、绿原酸、葛根素、3′-甲氧基葛根素、大豆苷、甘草苷、大豆苷元、牛蒡苷)的方法,并根据8种成分和指纹图谱数据进行分析和评价。方法 采用高效液相色谱仪、DAD检测器,Phenomenex C18柱,乙腈-0.1%磷酸水溶液梯度洗脱,建立了同时测定鸢都感冒颗粒8种成分和23批样品指纹图谱的方法。结果 8种成分的分离度、线性关系良好,加样回收率在97.86%~100.1%之间,RSD均小于2.0%;在指纹图谱研究中,以葛根素为参照峰,共标定了25个共有峰,采用指纹图谱相似度评价系统(2012年版)进行相似度分析,23批鸢都感冒颗粒有22批在0.90以上,1批(样品22)为0.501。去除样品22后,标定了31个共有峰,相似度均在0.90以上。在主成分分析和聚类分析中样品22与其他样品存在较大差异,23号样品虽然跟1~21号样品不一个厂家,含量分析上存在一定差异,但是差异不大。1~21号样品来自同一厂家,不同批次样品8种成分含量波动较小,质量相对比较稳定。结论 该方法准确,稳定可靠,为鸢都感冒颗粒的质量分析控制提供参考。
Abstract
OBJECTIVE To develop a method of high performance liquid chromatography for simultaneous determination of eight components (neochlorogenic acid, chlorogenic acid, puerarin, 3′-methoxypuerarin, daidzein, glycyrrhizin, daidzin and arctiin) of Yuandu Ganmao granules and establish the fingerprints. METHODS The contents of eight components and fingerprints of 23 batches of of Yuandu Ganmao granules samples were analyzed by high performance liquid chromatography coupled with diode array detector (HPLC-DAD), using Phenomenex C18 column and gradient elution of acetonitrile and 0.1%(V/V) phosphoric acid. RESULTS The assay showed good separation degree and linear relationship for the eight components. The spiked recovery ranged between 97.86% and 100.1% with RSD less than 2.0%. For chromatographic fingerprint, puerarin was chosen as reference peak and 25 common characteristic peaks were assigned. According to the fingerprint similarity evaluation system (2012 version), the similarity factors of 22 batches of Yuandu Ganmao granules were above 0.90, while that of sample 22 was 0.501. After removing sample 22, 31 common peaks were calibrated, and the similarity was above 0.90. Based on principal component analysis and hierarchical clustering analysis, sample 22 was significantly different from other samples. Although sample 23 and samples 1-21 were not from different manufactories, they showed slight different in content analysis. The contents of eight components of sample 1-21 produced by the same manufactory fluctuated slightly and the quality was relatively stable. CONCLUSION The established method is accurate, stable and reliable. It can provide reference for the quality analysis and control of Yuandu Ganmao granules.
关键词
鸢都感冒颗粒 /
高效液相色谱法 /
含量测定 /
指纹图谱 /
质量分析
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Key words
Yuandu Ganmao granules /
HPLC /
content determination /
fingerprint /
quality analysis
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中图分类号：
R917
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参考文献
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脚注
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基金
山东省自然科学基金项目资助(ZR2020MH385);国家“重大新药创制”科技重大专项资助(2018ZX09201010);淄博市科技发展计划资助(2017kj010043,2018kj010047)
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