正心降脂片多指标成分的含量测定及聚类热图分析
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篇名: 正心降脂片多指标成分的含量测定及聚类热图分析
TITLE: Content Determination of Multiple Indexes in Zhengxin Jiangzhi Tablets and Cluster Heatmap Analysis
摘要: 目的:建立同时测定正心降脂片中葛根素、3′-甲氧基葛根素、大豆苷、芦丁、橙皮苷、丹酚酸A、槲皮素等7种成分含量的方法,并进行聚类热图分析。方法:采用高效液相色谱法。色谱柱为KromasilC18,流动相为乙腈-0.1%甲酸溶液(梯度洗脱),流速为0.8mL/min,检测波长为280nm,柱温为25℃,进样量为10μL。以含量数据为对象,采用Hiplot科研绘图平台绘制聚类热图。结果:葛根素、3′-甲氧基葛根素、大豆苷、芦丁、橙皮苷、丹酚酸A、槲皮素检测质量浓度的线性范围分别为17.00~170.00(r=0.9999)、5.14~51.40(r=0.9998)、3.00~30.00(r=0.9998)、153.00~1530.00(r=0.9999)、7.88~78.75(r=0.9998)、2.85~28.50(r=0.9999)、11.34~113.40μg/mL(r=0.9998)。精密度、稳定性(24h)、重复性试验的RSD均小于2%;平均加样回收率分别为99.58%(RSD=0.83%,n=6)、100.31%(RSD=1.17%,n=6)、100.61%(RSD=1.08%,n=6)、100.05%(RSD=0.82%,n=6)、100.31%(RSD=1.38%,n=6)、100.31%(RSD=0.85%,n=6)、99.85%(RSD=1.01%,n=6)。10批样品中上述成分的含量分别为7.2625~8.9415、2.4649~3.0689、1.4789~1.8834、58.6328~79.4083、3.5694~4.5006、1.0776~1.3415、1.1397~5.9570mg/g。聚类热图分析结果显示,10批样品可聚为4类,其中S1~S3聚为一类、S4聚为一类、S5~S6聚为一类、S7~S10聚为一类。结论:所建含量测定方法操作简便、准确性高、专属性强,结合聚类热图分析可用于正心降脂片的质量控制;不同批次样品的质量存在一定差异。
ABSTRACT: OBJECTIVE:To establish the method for the content determination of 7 components,such as puerarin , 3′-methoxypuerarin,daidzein,rutin,hesperidin,salvianolic acid A and quercetin ,in Zhengxin jiangzhi tablets ,and conduct cluster heatmap analysis. METHODS :HPLC method was adopted. The separation was performed on Kromasil C 18 column with mobile phase consisted of acetonitrile- 0.1% formic acid solution (gradient elution )at the flow rate of 0.8 mL/min. The detection wavelength was set at 280 nm,and the column temperature was 25 ℃. The sample size was 10 μL. Taking the content data as the object,the cluster heatmap was drawn by Hiplot scientific research mapping platform. RESULTS :The linear range of puerarin , 3′-methoxypuerarin,daidzein,rutin,hesperidin,salvianolic acid A and quercetin were 17.00-170.00(r=0.999 9),5.14-51.40(r= 0.999 8),3.00-30.00(r=0.999 8),153.00-1 530.00(r=0.999 9),7.88-78.75(r=0.999 8),2.85-28.50(r=0.999 9)and 11.34-113.40 μg/mL(r=0.999 8),respectively. RSDs of precision ,stability(24 h)and repeatability tests were all less than 2%; the average recoveries were 99.58%(RSD=0.83%,n=6),100.31%(RSD=1.17%,n=6),100.61%(RSD=1.08%,n=6), 100.05%(RSD=0.82%,n=6),100.31%(RSD=1.38%,n=6),100.31%(RSD=0.85%,n=6),99.85%(RSD=1.01%, n=6),respectively. The contents of above components in 10 batches of samples were 7.262 5-8.941 5,2.464 9-3.068 9,1.478 9- 1.883 4,58.632 8-79.408 3,3.569 4-4.500 6,1.077 6-1.341 5,1.139 7-5.957 0 mg/g,respectively. Results of cluster heatmap analysis showed that 10 batches of samples could be divided into 4 categories,including S 1-S3 as one category ,S4 as one category,S5-S6 as one category and S 7-S10 as one category. CONCLUSIONS :The established method is simple ,accurate and specific,which can be used for the quality control of Zhengxin jiangzhi tablets ,combined with cluster heatmap analysis. There are some differences in the quality of different batches of samples.
期刊: 2021年第32卷第22期
作者: 崔小敏,晋玥媞,任慧,胡静,董明芝,何芳,李宁,曲彤,陈志永
AUTHORS: CUI Xiaomin ,JIN Yueti,REN Hui,HU Jing,DONG Mingzhi ,HE Fang,LI Ning,QU Tong,CHEN Zhiyong
关键字: 正心降脂片;高效液相色谱法;含量测定;聚类热图分析
KEYWORDS: Zhengxin jiangzhi tablets ;HPLC;Content determination ;Cluster heatmap analysis
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