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不同产地皂角刺多指标定量检测及质量差异评价
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          梁美锋 ,万雄飞 ,廖 念 ,朱珊珊 ,王志坚(1.武汉科技大学附属华润武钢总医院药学部,武汉 430080;
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          2.湖北中医药大学药学院,武汉 430070)
          中图分类号  R917;R284      文献标志码  A      文章编号  1001-0408(2025)05-0568-06
          DOI  10.6039/j.issn.1001-0408.2025.05.11

          摘   要  目的  建立不同产地皂角刺的多指标定量检测方法,并评价其质量差异。方法  采用高效液相色谱-一测多评(HPLC-
          QAMS)法同时检测皂角刺中原儿茶酸、香草酸、异东莨菪内酯、滨蒿内酯、异牡荆素、黄颜木素、花旗松素、漆黄素、槲皮素、山柰
          酚、刺囊酸、白桦脂酸、β-谷甾醇、豆甾醇的含量,色谱柱为Kromasil C18,流动相为0.2%磷酸-乙腈溶液(梯度洗脱),检测波长针对
          不同指标成分分别为254、360、210 nm,柱温为30 ℃,流速为1.0 mL/min,进样量为10 μL;按照《中国药典》方法检测浸出物和总灰
          分含量;利用化学计量学、加权逼近理想解排序(TOPSIS)分析、Logistic回归模型对不同产地30批(编号S1~S30)皂角刺样品进
          行质量差异评价。结果  上述 14 种成分依次在 1.55~77.50、0.71~35.50、0.28~14.00、0.96~48.00、1.77~88.50、0.09~4.50、
          4.65~232.50、1.49~74.50、0.37~18.50、1.18~59.00、7.35~367.50、3.58~179.00、0.49~24.50、0.21~10.50 μg/mL 质量浓度范围
          内线性关系良好(r 均大于 0.999),精密度、稳定性(24 h)及重复性的 RSD 均小于 2.00%,平均加样回收率为 96.99%~100.13%
         (RSD均小于2.00%),相对校正因子重复性良好。浸出物和总灰分含量分别为4.2%~12.5%和0.5%~2.3%。QAMS法与外标法
          所测得的14种成分的含量差异无统计学意义(P>0.05)。化学计量学分析结果显示,30批皂角刺样品可聚为3类,其中S1~S11
          聚为一类,S12~S20聚为一类,S21~S30聚为一类;刺囊酸、白桦脂酸、花旗松素、山柰酚、异牡荆素、滨蒿内酯和原儿茶酸可能是
          影响不同产地皂角刺质量的差异成分。加权TOPSIS分析结果显示,30批皂角刺的相对贴近度(Jb )为0.144 5~0.721 8,其中样品
          S27 的质量最优(Jb值为 0.721 8)。Logistic 回归模型分析结果显示,样品 S21~S30 为优级,S1~S11 为中级,S12~S20 为差级。
          结论  所建立的HPLC-QAMS法操作简便、结果准确,综合评价方法客观、全面,可用于不同产地皂角刺的质量差异评价。
          关键词  皂角刺;高效液相色谱法;一测多评法;化学计量学;加权TOPSIS分析;Logistic回归模型;质量差异评价


          Multi-index  quantitative  detection  and  quality  difference  evaluation  of  Gleditsia  sinensis  from  different
          producing areas
          LIANG Meifeng ,WAN Xiongfei ,LIAO Nian ,ZHU Shanshan ,WANG Zhijian(1.  Dept.  of  Pharmacy,  CR  &
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          WISCO  General  Hospital  Affiliated  to  Wuhan  University  of  Science  and  Technology,  Wuhan  430080,  China;
          2. School of Pharmacy, Hubei University of Chinese Medicine, Wuhan 430070, China)
          ABSTRACT    OBJECTIVE  To  establish  a  multi-index  quantitative  detection  method,  and  to  evaluate  the  quality  difference  of
          Gleditsia  sinensis  from  different  producing  areas.  METHODS  The  contents  of  protocatechuic  acid,  vanillic  acid,  isoscopoletin,
          scoparone,  isovitexin,  fustin,  taxifolin,  fisetin,  quercetin,  kaempferol,  echinocystic  acid,  betulinic  acid,  β -sitosterol  and
          stigmasterol  were  detected  by  high  performance  liquid  chromatography-quantitative  analysis  of  multi-components  by  single  marker
         (HPLC-QAMS). The  chromatographic  column  was  Kromasil  C18,  the  mobile  phase  was  0.2%  phosphoric  acid-acetonitrile  solution
         (gradient elution), the detection wavelengths were 254, 360, 210 nm for different index components, the column temperature was
          30  ℃,  the  flow  rate  was  1.0  mL/min,  and  the  sample  injection  volume  was  10  μL.  The  contents  of  extract  and  total  ash  were
          detected  according  to  the  method  of  Chinese  Pharmacopoeia.  The  quality  differences  of  30  batches  of  G.  sinensis (No.  S1-S30)
          from  different  producing  areas  were  evaluated  by  chemometrics,  weighted  technique  for  order  preference  by  similarity  to  an  ideal
          solution (TOPSIS) analysis and Logistic regression model. RESULTS The linear ranges of 14 components were 1.55-77.50, 0.71-
          35.50,  0.28-14.00,  0.96-48.00,  1.77-88.50,  0.09-4.50,  4.65-232.50,  1.49-74.50,  0.37-18.50,  1.18-59.00,  7.35-367.50,  3.58-
          179.00,  0.49-24.50  and  0.21-10.50  μg/mL,  respectively (all  r>0.999). The  RSDs  of  precision,  stability (24  h)  and  repeatability
          were  less  than  2.00%;  the  average  recoveries  were  96.99%-100.13% (all  RSDs<2.00%),  and  the  relative  correction  factor  had
                                                              good  repeatability.  The  contents  of  extract  and  total  ash  were
              Δ  基金项目 湖 北 省 中 医 药 科 研 立 项 青 年 人 才 项 目(No.     4.2%-12.5%  and  0.5%-2.3%,  respectively.  There  was  no
          ZY2019Q014)                                         significant  difference  in  the  content  of  14  components
             *第一作者 副主任药师。研究方向:药物质控、临床药学。电话:
                                                              measured  by  QAMS  method  and  external  standard  method
          027-86212343
              # 通信作者 副主任药师,硕士。研究方向:药物质控、药事管理、                (P>0.05).  The  results  of  chemometrics  showed  that  30
          临床药学。E-mail:tpb011@163.com                          batches of samples were clustered into 3 categories: S1 to S11


          · 568 ·    China Pharmacy  2025 Vol. 36  No. 5                               中国药房  2025年第36卷第5期
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