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UPLC指纹图谱结合多成分含量测定评价金刚藤胶囊质量                                                               Δ



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          沈 丽 ,沈 月 ,杨玉莹 ,张丹丹 ,吴雨希 ,周旭香 ,杨敬宇 ,胡 鹏 ,王 磊 ,吴和鸣 ,刘 丹 ,叶晓川                                        1, 4 #
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         (1.湖北中医药大学药学院中药资源与中药化学湖北省重点实验室,武汉 430065;2.湖北科技学院药学院
          糖尿病心脑血管病变湖北省重点实验室,湖北 咸宁 437099;3.湖北福人药业有限公司,湖北 咸宁 437400;
          4.湖北时珍实验室,武汉 430065)
          中图分类号  R284.1;R917      文献标志码  A      文章编号  1001-0408(2026)10-1290-05
          DOI  10.6039/j.issn.1001-0408.2026.10.09
          摘   要  目的  建立金刚藤胶囊超高效液相色谱(UPLC)指纹图谱及多成分含量测定方法,同时进行化学模式识别分析,以评价其
          质量。方法  建立UPLC法,采用Zorbax SB-C18 Rapid Resolution HD色谱柱,以乙腈-0.1%甲酸为流动相进行梯度洗脱。采用《中
          药色谱指纹图谱相似度评价系统(2012 版)》建立 10 批金刚藤胶囊的 UPLC 指纹图谱并进行相似度评价;采用 SPSS 22.0 软件及
          SIMCA 14.1 软件分别进行系统聚类分析和正交偏最小二乘-判别分析(OPLS-DA)。采用同样的 UPLC 法测定 10 批样品中绿原
          酸、3,5-二羟基-2-甲基苯甲酸-3-O-葡萄糖苷(M1)、咖啡酸、落新妇苷、氧化白藜芦醇、槲皮苷、白藜芦醇的含量。结果  10批样品
          的 UPLC 指纹图谱中共标定出 17 个共有峰,指认出其中 7 个色谱峰,分别为绿原酸、M1、咖啡酸、落新妇苷、氧化白藜芦醇、槲皮
          苷、白藜芦醇;10 批样品的相似度为 0.820~0.985。系统聚类分析与 OPLS-DA 结果均显示,10 批样品聚为 4 类,S1~S4 为一类,
          S5、S6为一类,S7、S8、S10为一类,S9为一类;7、10、2、16(白藜芦醇)、13(氧化白藜芦醇)、11、6(咖啡酸)、5(M1)、15(槲皮苷)号峰
          的变量重要性投影值>1。含量测定结果显示,绿原酸、M1、咖啡酸、落新妇苷、氧化白藜芦醇、槲皮苷、白藜芦醇含量分别为1.650 8~
          4.213 7、0.636 2~2.161 7、0.031 0~0.086 5、0.239 1~1.069 3、0.211 9~1.104 0、0.488 8~2.399 2、0.164 0~0.699 8 mg/g。结论  所
          建UPLC指纹图谱及含量测定方法操作简便、准确可靠、重复性好,结合化学模式识别分析可用于评价金刚藤胶囊的质量;白藜芦
          醇、氧化白藜芦醇、咖啡酸、M1、槲皮苷等9个成分可能是影响其质量的差异标志物。
          关键词  金刚藤胶囊;指纹图谱;含量测定;超高效液相色谱;化学模式识别分析

          Evaluation  of  the  quality  of  Jingangteng  capsules  based  on  UPLC  fingerprinting  combined  with  multi-
          component content determination
          SHEN Li ,SHEN Yue ,YANG Yuying ,ZHANG Dandan ,WU Yuxi ,ZHOU Xuxiang ,YANG Jingyu ,HU Peng ,
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          WANG Lei ,WU Heming ,LIU Dan ,YE Xiaochuan (1.  Hubei  Key  Laboratory  of  Resources  and  Chemistry
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          of  Chinese  Medicine,  School  of  Pharmacy,  Hubei  University  of  Chinese  Medicine,  Wuhan  430065,  China;
          2.  Hubei  Key  Laboratory  of  Diabetes  and  Angiopathy,  School  of  Pharmacy,  Hubei  University  of  Science  and
          Technology,  Hubei  Xianning  437099,  China;3.  Hubei  Furen  Pharmaceutical  Co.,  Ltd.,  Hubei  Xianning
          437400, China;4. Hubei Shizhen Laboratory, Wuhan 430065, China)
          ABSTRACT    OBJECTIVE  To  establish  the  UPLC  fingerprint  and  the  method  for  multi-component  content  determination  in
          Jingangteng  capsules,  and  to  evaluate  its  quality  by  combining  chemical  pattern  recognition  analysis.  METHODS  An  UPLC
          method was established. Separation was performed on a Zorbax SB-C18 Rapid Resolution HD column, with acetonitrile-0.1% formic
          acid  as  the  mobile  phase  for  gradient  elution. Using  the  Similarity  Evaluation  System  for  Chromatographic  Fingerprints  of
          Traditional  Chinese  Medicines (2012  edition),  UPLC  fingerprints  were  established  for  10  batches  of  Jingangteng  capsules,  and
          similarity  was  evaluated.  SPSS  22.0  and  SIMCA  14.1  software  were  used  to  perform  hierarchial-cluster  analysis  and  orthogonal
          partial  least  squares  discriminant  analysis (OPLS-DA),  respectively.  The  same  UPLC  method  was  employed  to  determine  the
          contents  of  chlorogenic  acid,  3,5-dihydroxy-2-methylbenzoic  acid-3-O-glucoside (M1),  caffeic  acid,  astilbin,  oxyresveratrol,
          quercitrin  and  resveratrol  in  the  10  batches  of  samples.  RESULTS  A  total  of  17  common  peaks  were  identified  in  UPLC
                                                              fingerprints  of  the  10  batches  of  samples,  of  which  7  were
              Δ 基金项目 湖北省自然科学基金(No.2023AFB513);金刚藤制剂
                                                              identified  as  chlorogenic  acid,  M1,  caffeic  acid,  astilbin,
         (胶囊、糖浆)质量标准提升研究项目(No.H2025103)
             *第一作者 硕士研究生。研究方向:中药药效物质基础及作用机                    oxyresveratrol,  quercitrin,  and  resveratrol.  The  similarities  of
          制。E-mail:1393908549@qq.com                          10  batches  of  samples  ranged  from  0.820  to  0.985. The  results
              # 通信作者 教授,博士生导师,博士。研究方向:中药药效物质基                 of  hierarchial-cluster  analysis  showed  that  10  batches  of
          础及作用机制。E-mail:yxxcc1965@163.com                     samples  were  grouped  into  four  categories:  S1-S4  formed  one


          · 1290 ·    China Pharmacy  2026 Vol. 37  No. 10                            中国药房  2026年第37卷第10期
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