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健脾化瘀方的HPLC指纹图谱建立及8种成分含量测定
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          陈小凯 ,李 勇 ,谭 为 ,余榕键 ,黄建江 ,刘芷欣 ,林举择 ,王昌俊 [1.南方医科大学附属广东省人
                                             3, 4
                           2 #
          民医院(广东省医学科学院)药学部,广州 510080;2.广东药科大学广东省药物新剂型重点实验室和广东省局
          部精准药物递药制剂工程技术研究中心,广州 510006;3.南方医科大学附属广东省人民医院(广东省医学科
          学院)中医科,广州 510080;4.广东省老年医学研究所中医科,广州 510080;5.南方医科大学附属广东省人
          民医院(广东省医学科学院)病理科,广州 510080]
          中图分类号  R927.1;R284.1      文献标志码  A      文章编号  1001-0408(2023)23-2874-06
          DOI  10.6039/j.issn.1001-0408.2023.23.10

          摘   要  目的  建立健脾化瘀方的高效液相色谱(HPLC)指纹图谱,并测定方中 8 种成分的含量。方法  采用 Thermo Hypersil
          Gold C18色谱柱,以甲醇-0.05%磷酸溶液为流动相进行梯度洗脱,流速为1.0 mL/min,柱温为30 ℃,进样量为5 μL,苦参碱的检测
          波长为211 nm,其他成分的检测波长为283 nm。采用《中药色谱指纹图谱相似度评价系统(2012版)》对获得的10批健脾化瘀方
          HPLC指纹图谱进行相似度评价。采用HPLC法测定样品中绿原酸、香草酸、对香豆酸、阿魏酸、橙皮苷、槲皮素、佛手柑内酯、苦参
          碱8种成分的含量。结果  建立了健脾化瘀方的HPLC指纹图谱,共标定出27个共有峰,指认了8个化学成分。10批样品与对照
          指纹图谱的相似度为0.942~0.999。精密度、重复性、稳定性试验的RSD均小于3%(n=6)。绿原酸、香草酸、对香豆酸、阿魏酸、
          橙皮苷、槲皮素、佛手柑内酯、苦参碱的平均加样回收率分别为 99.48%、101.32%、101.18%、100.79%、101.12%、99.19%、99.81%、
          102.46%,RSD 分别为 1.34%、0.93%、1.90%、1.84%、0.54%、1.53%、1.33%、1.01%(n=6);含量分别为 0.021~0.061、0.025~0.034、
          0.116~0.295、0.006~0.062、0.014~0.053、0.017~0.026、0.014~0.027、14.05~24.11 mg/g。结论  所建立的指纹图谱和含量测定
          方法可为健脾化瘀方的质量控制以及后续的制剂开发提供参考依据。
          关键词  健脾化瘀方;指纹图谱;含量测定;高效液相色谱法;质量标准

          Establishment of HPLC fingerprint and content determination of 8 components in Jianpi huayu decoction
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          CHEN Xiaokai ,LI Yong ,TAN Wei ,YU Rongjian ,HUANG Jianjiang ,LIU Zhixin ,LIN Junze ,WANG
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          Changjun [1.  Dept.  of  Pharmacy,  Guangdong  Provincial  People’s  Hospital (Guangdong Academy  of  Medical
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          Sciences),  Southern  Medical  University,  Guangzhou  510080,  China;2.  Guangdong  Provincial  Key  Laboratory
          of  Advanced  Drug  Delivery  and  Guangdong  Provincial  Engineering  Center  of  Topical  Precise  Drug  Delivery
          System,  Guangdong  Pharmaceutical  University,  Guangzhou  510006,  China;3.  Dept.  of  Traditional  Chinese
          Medicine,  Guangdong  Provincial  People’s  Hospital (Guangdong  Academy  of  Medical  Sciences),  Southern
          Medical  University,  Guangzhou  510080,  China;4.  Dept.  of Traditional  Chinese  Medicine,  Guangdong  Institute
          of  Geriatrics,  Guangzhou  510080,  China;5.  Dept.  of  Pathology,  Guangdong  Provincial  People’s  Hospital
         (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou 510080, China]

          ABSTRACT      OBJECTIVE  To  establish  the  HPLC  fingerprint  of  Jianpi  huayu  decoction,  and  to  determine  the  contents  of  8
          components.  METHODS  Thermo  Hypersil  Gold  C18 column  was  used  with  mobile  phase  consisted  of  methanol-0.05%  phosphoric
          acid aqueous solution (gradient elution) at the flow rate of 1.0 mL/min. The column temperature was 30 ℃, the injection volume
          was  5  μL.  The  detection  wavelength  of  matrine  was  211  nm,  and  the  other  components’  detection  wavelength  was  283  nm.  The
          similarity  evaluation  of  HPLC  fingerprints  for  10  batches  of  Jianpi  huayu  decoction  was  performed  by  using  the  Similarity
          Evaluation  System  of  Chromatographic  Fingerprint  of  Traditional  Chinese  Medicine (2012  edition).  The  contents  of  chlorogenic
                                                              acid,  vanillic  acid,  p-coumaric  acid,  ferulic  acid,  hesperidin,
              Δ  基金项目 广 东 省 基 础 与 应 用 基 础 研 究 基 金 项 目(No.     quercetin,  bergapten  and  matrine  in  the  samples  were
          2022A1515011260);广东省中医药局科研项目(No.20221004)           determined  by  HPLC.  RESULTS  HPLC  fingerprint  of  Jianpi
             *第一作者 主管中药师,硕士。研究方向:中药制剂研发。
                                                              huayu  decoction  was  established. A  total  of  27  common  peaks
          E-mail:chenxiaokay2008@163.com
              # 通信作者 助理研究员,硕士。研究方向:中药新制剂研发。电                  were  identified,  and  8  components  were  identified.  The
          话:020-39352508。E-mail:ly598@126.com                 similarity  between  10  batches  of  samples  and  the  control  map


          · 2874 ·    China Pharmacy  2023 Vol. 34  No. 23                            中国药房  2023年第34卷第23期
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