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蒲蓝利咽合剂的指纹图谱建立及含量测定
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1, 2
王 博 1, 2* ,于晓涛 ,刘玉萍 ,赫振玉 ,王 瑞 1, 2, 3 # (1.漯河市中心医院药学部,河南 漯河 462000;2.河南省
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中药制剂与加工中医药重点实验室,河南 漯河 462000;3.河南省中药制剂现代化技术研发与临床应用工程研
究中心,河南 漯河 462000)
中图分类号 R917;R284 文献标志码 A 文章编号 1001-0408(2022)22-2753-05
DOI 10.6039/j.issn.1001-0408.2022.22.13
摘 要 目的 建立蒲蓝利咽合剂的指纹图谱和绿原酸等8种成分的含量测定方法,以评价蒲蓝利咽合剂的质量。方法 以黄芩
苷为参照峰,采用《中药色谱指纹图谱相似度评价系统(2012版)》建立11批蒲蓝利咽合剂的高效液相色谱(HPLC)指纹图谱,指认
共有峰并进行相似度评价,采用SPSS 20.0、SIMCA 14.1软件进行聚类分析、主成分分析、正交偏最小二乘法-判别分析,以变量重
要性投影(VIP)值大于1为指标筛选影响蒲蓝利咽合剂质量的标志物;采用相同的HPLC法测定绿原酸等8种成分的含量。结果
11批蒲蓝利咽合剂指纹图谱共有20个共有峰,相似度在0.973~0.994之间;指认了8个共有峰,分别为绿原酸、咖啡酸、马钱苷、菊
苣酸、木蝴蝶苷B、黄芩苷、千层纸素A-7-O-β-D-葡萄糖醛酸、汉黄芩苷。聚类分析结果显示,11批样品分为2大类,其中S3、S10~
S11为一类,其余为一类。主成分分析结果显示,前4个主成分的累计方差贡献率为95.546%,其分类结果与聚类分析结果一致。
正交偏最小二乘法-判别分析结果显示,15、14(黄芩苷)、10、18(汉黄芩苷)、11、17(千层纸素A-7-O-β-D-葡萄糖醛酸)、4、20、16、
12、7、19号峰的VIP值大于1。11批样品中绿原酸、咖啡酸、马钱苷、菊苣酸、木蝴蝶苷B、黄芩苷、千层纸素A-7-O-β-D-葡萄糖醛
酸 、汉 黄 芩 苷 的 含 量 分 别 为 0.287~1.021、0.163~0.485、0.735~3.641、0.587~4.012、1.920~9.063、37.443~115.974、3.623~
13.942、7.135~18.736 mg/g。结论 建立的蒲蓝利咽合剂HPLC指纹图谱及绿原酸等8种成分的含量测定方法,可用于该制剂的质
量评价;黄芩苷、汉黄芩苷、千层纸素A-7-O-β-D-葡萄糖醛酸等12种成分可能是影响蒲蓝利咽合剂质量的标志物。
关键词 蒲蓝利咽合剂;指纹图谱;含量测定;高效液相色谱法;化学模式识别分析
Fingerprint establishment and content determination of Pulan liyan mixture
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WANG Bo ,YU Xiaotao ,LIU Yuping ,HE Zhenyu ,WANG Rui 1, 2, 3 (1. Dept. of Pharmacy, Luohe Central
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Hospital, Henan Luohe 462000, China;2. Henan Provincial Key Laboratory of TCM Preparations and
Processing, Henan Luohe 462000, China;3. Henan Engineering Research Center of TCM Preparation
Modernization Technology R&D and Clinical Application, Henan Luohe 462000, China)
ABSTRACT OBJECTIVE To establish the fingerprint of Pulan liyan mixture, and content determination method of 8
components such as chlorogenic acid so as to evaluate the quality of Pulan liyan mixture. METHODS Using baicalin as reference
peak, high-performance liquid chromatography (HPLC) fingerprints of 11 batches of Pulan liyan mixture were established by the
Chromatographic Fingerprint Similarity Evaluation System of TCM (2012 edition) for similarity evaluation and identifying the
common peaks. Cluster analysis, principal component analysis and orthogonal partial least squares-discriminant analysis of those
samples were performed with SPSS 20.0 software and SIMCA 14.1 software. The variable importance projection (VIP) value
greater than 1 was used as the index to screen the markers affecting the quality of Pulan liyan mixture; the contents of 8
components such as chlorogenic acid were determined by the same HPLC method. RESULTS Totally 20 common peaks in the
fingerprints of 11 batches of Pulan liyan mixture was established, and the similarities were 0.973-0.994. The 8 peaks were
identified, which were chlorogenic acid, caffeic acid, loganin, cichoric acid, styroside B, baicalin, melaleucalycin A-7-O-β-D-
glucuronic acid and wogonin. The results of cluster analysis showed that the 11 batches of samples were divided into two
categories, S3, S10 and S11 were grouped into one category, and the other batches of samples were grouped into one category.
The results of principal component analysis showed that the cumulative variance contribution rate of the first four principal
components was 95.546%, and the classification results were
Δ 基金项目 河南省工程研究中心资助项目(No. 豫发改高技
consistent with the cluster analysis results. The results of
〔2019〕569 号);中央引导地方科技发展专项(No. 漯财预指〔2020〕
orthogonal partial least squares-discriminant analysis showed
309号)
that 15, 14 (baicalin), 10, 18 (wogonin), 11, 17 (laminarin
*第一作者 主管药师,硕士。研究方向:中药质量评价。电话:
0395-3385705。E-mail:496690274@qq.com A-7-O-β-D-glucuronic acid), 4, 20, 16, 12, 7 and 19 peaks
# 通信作者 主任药师,硕士。研究方向:中药制剂研发。电话: had VIP values greater than 1. The contents of chlorogenic
0395-3356116。E-mail:wangrui56116@163.com acid, caffeic acid, loganin, cichoric acid, styroside B,
中国药房 2022年第33卷第22期 China Pharmacy 2022 Vol. 33 No. 22 · 2753 ·