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作 者:段和祥 罗文艳 鄢雷娜 章红 陈希 DUAN Hexiang;LUO Wenyan;YAN Leina;ZHANG Hong;CHEN Xi(Jiangxi Institute For Drug Control,NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine,Jiangxi Provincial Engineering Research Center for Drug and Medical Device Quality,Nanchang 330029,China;Affiliated Rehabilitation Hospital of Nanchang University,Nanchang 330003,China)
机构地区:[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029 [2]南昌大学附属康复医院,江西南昌330003
出 处:《南昌大学学报(理科版)》2025年第2期157-164,共8页Journal of Nanchang University(Natural Science)
基 金:江西省自然科学基金资助项目(20224BAB206108);江西省药品监督管理局科研项目(2021KY35)。
摘 要:为建立清心莲子饮HPLC指纹图谱和多成分定量分析方法,采用waters XSelect^(R)HSS T3 C18(4.6×250 mm,5μm)色谱柱,以甲醇-0.5%甲酸水为流动相进行梯度洗脱。实验结果表明,木犀草苷、灯盏花乙素、黄芩苷、蒙花苷、汉黄芩苷、山柰酚、芹菜素、黄芩素、芒柄花素、汉黄芩素10种成分在进样浓度为4.951~247.6、2.594~129.7、5.209~260.5、1.882~94.1、7.678~383.9、5.238~261.9、2.798~139.9、4.998~249.9、10.22~510.8、5.270~263.5μg·mL^(-1)之间线性关系良好,相关系数均大于0.999,平均加样回收率在97.9%~101.7%之间,相对标准偏差均在1.5%以内。采用相似度评价、聚类分析和主成分分析,对15批自制的清心莲子饮样品进行统计分析,结果显示,15批样品生成的对照图谱共标记包含10种成分在内的17个共有峰,相似度在0.965以上,聚类分析和主成分分析结果一致,15批样品可明显分为2类。该方法准确高效,可用于经典名方清心莲子饮中10种成分的定量分析。In order to establish a method for HPLC fingerprints and multi-component quantitative analysis of Qingxin Lianzi Decoction.A waters XSelect^(R)HSS T3 C18 chromatographic column(4.6×250 mm,5μm)was used,with methanol and 0.5%formic acid water solution as the mobile phase for gradient elution.The experimental results showed that there were good linear relationship between the 10 components of luteolin-7-O-glucoside,scutellarin,baicalin,buddleoside,wogonoside,kaempferol,apigenin,baicalein,formononetin,wogonin were 4.951~247.6,2.594~129.7,5.209~260.5,1.882~94.1,7.678~383.9,5.238~261.9,2.798~139.9,4.998~249.9,10.22~510.8,5.270~263.5μg·mL^(-1),respectively,and the correlation coefficients were greater than 0.999.The average recoveries were 97.87%~101.73%,and the relative standard deviations were within 1.5%.Similarity evaluation,cluster analysis and principal component analysis were used for the statistically analysis on 15 batches of Qingxin Lianzi Decoction samples.Results showed that 17 common peaks were defined by the control fingerprint,including ten flavonoids,and the similarities were more than 0.965.The results of HCA and PCA were consistent.The 15 batches of samples were divided into two categories.The method is accurate and efficient,and can be used for the quantitative analysis of ten ingredients in Qingxin Lianzi Decoction.
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