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天麻健脑颗粒的综合质量评价
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          杜锦顔 ,莫静媛 ,谢 询 ,黄小玲 ,伍小玲 ,王利胜 (1.广州中医药大学中药学院,广州 510006;2.东莞市
                 1*
          中医院内三科,广东 东莞 523000)
          中图分类号  R917;R284      文献标志码  A      文章编号  1001-0408(2024)20-2482-06
          DOI  10.6039/j.issn.1001-0408.2024.20.07

          摘   要  目的  建立天麻健脑颗粒(TJG)的指纹图谱及测定含量的方法,结合化学计量学分析综合评价TJG的质量。方法  采用
          高效液相色谱(HPLC)法建立13批(S1~S13)TJG的指纹图谱,测定肌苷、天麻素、巴利森苷B、巴利森苷E的含量;采用SPSS 20.0
          和SIMCA 18软件进行聚类分析、主成分分析和正交偏最小二乘法-判别分析,以变量重要性投影(VIP)值大于1为标准,筛选影响
          质量的标志性成分。结果  13批TJG共标定28个共有峰,其相似度均大于0.9;共指认了7个共有峰,分别为天麻素、对羟基苯甲
          醇、巴利森苷B、巴利森苷E、钩藤碱、肌苷、红景天苷。13批TJG聚为3类,其中S1~S2、S8~S10、S12为一类,S3、S7为一类,S4~
          S6、S11、S13为一类;肌苷的VIP值大于1。肌苷、天麻素、巴利森苷B、巴利森苷E的含量分别为62.637~176.677、17.821~37.642、
          5.748~16.077、5.660~13.510 μg/g。结论  所建HPLC指纹图谱及含量测定方法稳定可靠、重复性高,结合化学计量学分析可用于
          评价TJG的质量;肌苷可能是影响TJG质量的标志性成分;13批TJG质量存在差异。
          关键词  天麻健脑颗粒;指纹图谱;含量测定;聚类分析;主成分分析;正交偏最小二乘法判别分析

          Comprehensive quality evaluation of Tianma jiannao granules
          DU Jinyan ,MO Jingyuan ,XIE Xun ,HUANG Xiaoling ,WU Xiaoling ,WANG Lisheng (1.  College  of
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          Traditional Chinese Medicine, Guangzhou University of Chinese Medicine, Guangzhou 510006, China;2. Dept.
          Three  of  Internal  Medicine,  Dongguan  Hospital  of  Traditional  Chinese  Medicine,  Guangdong  Dongguan
          523000, China)
          ABSTRACT    OBJECTIVE  To  establish  the  fingerprints  of  Tianma  jiannao  granules (TJG)  and  the  method  for  content
          determination to evaluate the quality of TJG comprehensively combined with chemometric analysis. METHODS  High-performance
          liquid chromatography (HPLC) was used to establish the fingerprints of 13 batches (S1-S3) of TJG and determine the contents of
          inosine, gastrodin, parishin B and parishin E. Cluster analysis, principal component analysis, and orthogonal partial least squares-
          discriminant  analysis  were  performed  using  SPSS  20.0  and  SIMCA  18  software;  using  variable  importance  projection (VIP)  value
          greater than 1 as a criterion, marker components that affected quality were screened. RESULTS A total of 28 common peaks were
          identified in the 13 batches of TJG with similarities greater than 0.9, and 7 common peaks were identified, which were gastrodin,
          p-hydroxybenzyl  alcohol,  parishin  B,  parishin  E,  rhynchophylline,  inosine  and  salidroside. The  13  batches  of TJG  were  clustered
          into  3  categories,  S1-S2,  S8-S10  and  S12  were  clustered  into  one  category;  S3  and  S7  were  clustered  into  one  category;  S4-S6,
          S11 and S13 were clustered into one category. VIP of inosine was greater than 1. The contents of inosine, gastrodin, parishin B and
          parishin  E  were  62.637-176.677,  17.821-37.642,  5.748-16.077  and  5.660-13.510  μg/g.  CONCLUSIONS  The  established  HPLC
          fingerprints  and  content  determination  method  are  stable,  reliable  and  highly  reproducible,  which  can  be  used  to  evaluate  the
          quality of TJG in combination with chemometric analysis. Inosine may be a marker component that affects the quality of TJG. There
          are differences in the quality of 13 batches of TJG.
          KEYWORDS     Tianma  jiannao  granules;  fingerprint;  content  determination;  cluster  analysis;  principal  component  analysis;
          orthogonal partial least squares-discriminant analysis

              Δ 基金项目 广东省普通高校重点领域专项;东莞市高水平医院
          建设专项;东莞市社会发展科技项目(No.20231800903722)                     天麻健脑颗粒(Tianma jiannao granules,TJG)是由
             *第一作者 硕士研究生。研究方向:中药药效物质基础。E-mail:                东莞市中医院脑病科宁为民主任中医师根据临床治疗
          1729458053@qq.com
                                                              眩晕症的经验方研制而成的中药颗粒剂。该方以清代
              # 通信作者 教授,博士生导师。研究方向:药物制剂新技术与新
          剂型。E-mail:wlis68@126.com                            医家程钟龄治疗眩晕的半夏白术天麻汤为基础,调整白


          · 2482 ·    China Pharmacy  2024 Vol. 35  No. 20                            中国药房  2024年第35卷第20期
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