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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
                           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
                                             1
          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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                                 1, 2
          WANG Bo ,YU Xiaotao ,LIU Yuping ,HE Zhenyu ,WANG Rui        1, 2, 3 (1.  Dept.  of  Pharmacy,  Luohe  Central
                   1, 2
          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 ·
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