石伟;李家春;杨素德;李云;靳瑞婷;孙仙玲;王振中;毕宇安;萧伟;
SHI Wei;LI Jia-chun;YANG Su-de;LI Yun;JIN Rui-ting;SUN Xian-ling;WANG Zhen-zhong;BI Yu-an;XIAO Wei;Nanjing University of Chinese Medicine;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process;Jangsu Kanion Pharmaceutical Co. ,Ltd.;

• 1:南京中医药大学
• 2:中药制药过程新技术国家重点实验室
• 3:江苏康缘药业股份有限公司

摘要(Abstract)：

建立六味地黄软胶囊的HPLC指纹图谱,为六味地黄软胶囊质量控制提供参考。采用HPLC,Agilent C18(4.6mm×250 mm,5μm)色谱柱,以乙腈-0.02%三氟乙酸为流动相,梯度洗脱,流速1.0 m L·min-1,柱温30℃;检测波长0~60min,238 nm;60~70 min,210 nm,对不同批次六味地黄软胶囊的指纹图谱进行测定,采用中药指纹图谱相似度评价系统(2004A版)软件分析,以马钱苷为参照峰,从中选择了16个分离较好的共有峰,并根据共有峰对12批样品进行聚类分析(HCA)和相似度分析(SA)。聚类分析将12批样品划分为2类,其中7号为第一类,其他均为第二类;相似度结果表明,12批六味地黄软胶囊指纹图谱与共有模式之间相似性良好,相似度均大于0.92,SA分析结果与HCA分析结果基本一致。该方法简便易行,有较好的精密度、重复性及稳定性,可以作为六味地黄软胶囊质量的评价方法。
In order to establish HPLC fingerprint of Liuwei Dihuang soft capsule,and to provide certain reference for an quality control of it,the HPLC method was performed on an Agilent C18( 4. 6 mm × 250 mm,5 μm) column with acetonitrile-0. 02% trifluoroacetic acid as mobile phase,gradient elution volume flow of 1. 0 m L·min- 1,column temperature was 30 ℃,detection wavelength:0-60 min,238 nm,60-70 min,210 nm. The software for chromatographic fingerprint was applied to analysis different batches of Liuwei Dihuang soft capsule samples. Sixteen mutual peaks were selected as the fingerprint peaks in 12 samples with loganin as the reference peak,and all of the detected peaks were separated effectively. Cluster analysis( HCA) and similarity analysis( SA) were done based on data of 12 samples clustering analysis of 12 batches of samples were divided into 2 categories. Including 7 for the first class,the rest was second,similarities calculated by SA were all above 0. 92,indicating a good similarity between the reference and twelve batches of samples,also,the analysis results of HCA and SA basically the same. This method is simple with good precision,repeatability and stability,and provides the basis for Liuwei Dihuang soft capsule quality control.

关键词(KeyWords)： 六味地黄软胶囊;高效液相色谱法;系统聚类分析;指纹图谱
Liuwei Dihuang soft capsule;HPLC;hierarchical cluster analysis;fingerprint

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 石伟;李家春;杨素德;李云;靳瑞婷;孙仙玲;王振中;毕宇安;萧伟;
SHI Wei;LI Jia-chun;YANG Su-de;LI Yun;JIN Rui-ting;SUN Xian-ling;WANG Zhen-zhong;BI Yu-an;XIAO Wei;Nanjing University of Chinese Medicine;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process;Jangsu Kanion Pharmaceutical Co. ,Ltd.;

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DOI:

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