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基于指纹图谱和多成分含量测定的清瘟护肺颗粒质量评价
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          周慧英 ,王 园 ,王亚妮 ,杨 允 ,王 博 ,杨栓柱 ,曹利平 ,张 红 ,龙凯花 (1.陕西省中医药研究院中
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          药研究所,西安 710003;2.西北大学生命科学学院,西安 710069;3.陕西省中医医院肺病科,西安 710003)
          中图分类号  R284      文献标志码  A      文章编号  1001-0408(2026)03-0338-06
          DOI  10.6039/j.issn.1001-0408.2026.03.11
          摘   要  目的  为清瘟护肺颗粒质量评价及临床应用提供科学依据。方法  以14批清瘟护肺颗粒为样品,采用《中药色谱指纹图
          谱相似度评价系统(2012版)》建立其高效液相色谱(HPLC)指纹图谱,并进行色谱峰指认和相似度评价。应用聚类分析(CA)、主
          成分分析(PCA)和正交偏最小二乘-判别分析(OPLS-DA)对14批样品进行化学模式识别分析。同时,采用HPLC法测定样品中新
          绿原酸(NGA)、绿原酸(CHA)、隐绿原酸(CGA)、连翘酯苷A(FTA)、3,5-O-二咖啡酰奎宁酸(3,5-O-DA)、4,5-O-二咖啡酰奎宁酸
         (4,5-O-DA)及安格洛苷C(AGC)的含量。结果  指纹图谱和含量测定的方法学考察结果均符合相关要求。14批样品的HPLC指
          纹图谱中共标示出14个共有峰,并指认出其中7个共有峰[NGA(峰2)、CHA(峰3)、CGA(峰5)、FTA(峰11)、3,5-O-DA(峰12)、4,
          5-O-DA(峰13)和AGC(峰14)];各样品的相似度均大于0.94。CA、PCA结果显示,样品可被分为3类;OPLS-DA结果显示,4号峰
         (未知)、11号峰(FTA)、8号峰(未知)、9号峰(未知)、1号峰(未知)为差异性成分。14批样品中NGA、CHA、CGA、3,5-O-DA、FTA、
          4,5-O-DA、AGC的含量范围分别为0.210 4~0.458 7、0.269 1~0.506 3、0.228 1~0.461 1、0.443 9~1.044 6、0.066 7~0.155 7、0.062 8~
          0.143 8、0.057 4~0.105 7 mg/g。结论  本研究建立的HPLC指纹图谱及多成分含量测定方法高效、可靠,可用于清瘟护肺颗粒的质
          量评价。
          关键词  清瘟护肺颗粒;高效液相色谱法;指纹图谱;聚类分析;主成分分析;正交偏最小二乘-判别分析;含量测定

          Quality  evaluation  of  Qingwen  hufei  granules  based  on  fingerprints  combined  with  multi-component
          content determination
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          ZHOU Huiying ,WANG Yuan ,WANG Yani ,YANG Yun ,WANG Bo ,YANG Shuanzhu ,CAO Liping ,
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          ZHANG Hong ,LONG Kaihua (1.  Institute  of  Chinese  Materia  Medica,  Shaanxi  Academy  of  Traditional
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          Chinese  Medicine,  Xi’an  710003,  China;2.  College  of  Life  Sciences,  Northwest  University,  Xi’an  710069,
          China;3. Dept. of Pulmonary Disease, Shaanxi Provincial Hospital of Chinese Medicine, Xi’an 710003, China)
          ABSTRACT    OBJECTIVE  To  provide  a  scientific  basis  for  the  quality  evaluation  and  clinical  application  of  Qingwen  hufei
          granules.  METHODS  Fourteen  batches  of  Qingwen  hufei  granules  were  used  as  samples  to  establish  high-performance  liquid
          chromatography (HPLC)  fingerprints  using  the  Similarity  Evaluation  System  for  Chromatographic  Fingerprint  of  Traditional
          Chinese  Medicine (2012  Edition).  The  chromatographic  peaks  were  identified  and  the  similarity  was  evaluated.  Cluster  analysis
         (CA),  principal  component  analysis (PCA),  and  orthogonal  partial  least  squares-discriminant  analysis (OPLS-DA)  were  used  to
          conduct  chemical  pattern  recognition  analysis  on  the  14  batches  of  samples.  Meanwhile,  the  contents  of  neochlorogenic  acid
         (NGA),  chlorogenic  acid (CHA),  cryptochlorogenic  acid (CGA),  forsythoside A (FTA),  3,5-O-dicaffeoylquinic  acid (3,5-O-
          DA), 4,5-O-dicaffeoylquinic acid (4,5-O-DA), and angoroside C (AGC) in the samples were determined by HPLC. RESULTS
          The  methodological  investigation  results  of  both  the  fingerprint  and  the  content  determination  complied  with  the  relevant
          requirements.  Fourteen  common  peaks  were  indicated  in  the  HPLC  fingerprints  of  the  14  batches  of  samples,  and  7  of  them  were
          identified [NGA (peak  2),  CHA (peak  3),  CGA (peak  5),  FTA (peak  11),  3,5-O-DA (peak  12),  4,5-O-DA (peak  13),  and
          AGC (peak  14)];  the  similarity of  each  sample  was  greater  than  0.94. The  results  of  CA  and  PCA  showed  that  the  samples  could
                                                              be  classified  into  3  categories;  the  results  of  OPLS-DA
              Δ 基金项目 陕西省重点研发计划项目(No.2024SF-YBXM-489);         indicated  that  peak  4 (unknown),  peak  11 (FTA),  peak  8
          陕西省科协青年人才托举计划项目(No.20230321);陕西省中医药管               (unknown),  peak  9 (unknown),  and  peak  1 (unknown)
          理局委托项目(No.SZY-KJCYC-2025-ZY-006);国家中医药管理局曹
                                                              were  the  differential  components.  The  content  ranges  of
          利平全国名中医传承工作室建设项目(No. 国中医药办人教函〔2022〕
                                                              NGA,  CHA,  CGA,  3,5-O-DA,  FTA,  4,5-O-DA  and  AGC
          245号)                                               in  the  14  batches  of  samples  were  0.210  4-0.458  7,  0.269  1-
             *第一作者 研究实习员,硕士。研究方向:中药药效物质基础。
          E-mail:zhying617@163.com                            0.506 3, 0.228 1-0.461 1, 0.443 9-1.044 6, 0.066 7-0.155 7,
              # 通信作者 副研究员,硕士。研究方向:中药药效物质基础。                   0.062  8-0.143  8,  and  0.057  4-0.105  7  mg/g,  respectively.
          E-mail:longkaihua@126.com                           CONCLUSIONS  The  HPLC  fingerprint  and  multi-component


          · 338 ·    China Pharmacy  2026 Vol. 37  No. 3                               中国药房  2026年第37卷第3期
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