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基于多种内参物的一测多评法测定金莲清热颗粒中6种成分含量
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          和 敏 ,毛 姗 ,李 琳 ,倪海峰 ,都青钰 ,于永杰                       1, 3, 4 ,张 霞  1, 3, 4 # (1. 宁 夏 医 科 大 学 药 学 院 ,银 川
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          750004;2.宁夏启元药业有限公司,银川 750011;3.宁夏药物创制与仿制药研究重点实验室,银川 750004;
          4.宁夏少数民族医药现代化教育部重点实验室,银川 750004)
          中图分类号  R917      文献标志码  A      文章编号  1001-0408(2023)17-2069-05
          DOI  10.6039/j.issn.1001-0408.2023.17.04

          摘  要  目的  建立基于多种内参物的一测多评法测定金莲清热颗粒中芒果苷、荭草素-2″-O-β-L-半乳糖苷、荭草苷、藜芦酸、牡荆
          苷和哈巴俄苷6个成分的含量。方法  以Agilent Eclipse Plus C18为色谱柱,以乙腈-0.1%磷酸溶液为流动相(梯度洗脱),流速为1
          mL/min,柱温为30 ℃,检测波长为270 nm。分别以荭草苷、牡荆苷、荭草素-2″-O-β-L-半乳糖苷为内参物,采用一测多评法建立另
          外5个待测成分与内参物的相对校正因子,然后计算21批金莲清热颗粒样品中6个成分的含量,并与外标法测定结果进行比较。
          结果  一测多评法测得21批金莲清热颗粒样品中芒果苷、荭草素-2″-O-β-L-半乳糖苷、荭草苷、藜芦酸、牡荆苷和哈巴俄苷的含量
          范围分别为 0.234~0.516、1.804~2.270、2.143~2.606、0.190~0.223、0.594~0.782、0.080~0.152 mg/g,外标法测定结果分别为
          0.235~0.523、1.798~2.265、2.137~2.599、0.190~0.224、0.597~0.786、0.077~0.151 mg/g,2种方法所测结果的差异百分比不大于
          4.00%。结论  建立了基于多种内参物同时测定金莲清热颗粒中6种成分含量的一测多评法,该方法与外标法所得结果无明显差
          异,可用于金莲清热颗粒的质量控制。
          关键词  金莲清热颗粒;一测多评法;芒果苷;荭草素-2″-O-β-L-半乳糖苷;荭草苷;藜芦酸;牡荆苷;哈巴俄苷;含量测定


          Content determination of 6 components in Jinlian qingre granules by QAMS method based on a variety of
          internal reference substances
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          HE Min ,MAO Shan ,LI Lin ,NI Haifeng ,DU Qingyu ,YU Yongjie       1, 3, 4 ,ZHANG Xia 1, 3, 4 (1.  School  of
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          Pharmacy,  Ningxia  Medical  University, Yinchuan  750004,  China;2.  Ningxia  Qiyuan  Pharmaceutical  Co.  Ltd.,
          Yinchuan  750011,  China;3.  Ningxia  Key  Laboratory  of  Drug  Development  and  Generic  Drug  Research,
          Yinchuan  750004,  China;4.  Key  Laboratory  of  Ningxia  Minority  Medicine  Modernization,  Ministry  of
          Education, Yinchuan 750004, China)
          ABSTRACT   OBJECTIVE To establish a quantitative analysis of multi-components by single marker (QAMS) method based on
          a  variety  of  internal  reference  substances  for  the  content  determination  of  6  components  in  Jinlian  qingre  granules,  such  as
          mangiferin,  2″-O-β-L-galactopyranosylorientin,  orientin,  veratric  acid,  vitexin,  harpagoside.  METHODS  The  determination  was
          performed  on Agilent  Eclipse  Plus  C18   column  with  mobile  phase  consisted  of  acetonitrile-0.1%  phosphoric  acid  solution (gradient
          elution) at the flow rate of 1 mL/min. The column temperature was 30 ℃, and the detection wavelength was set at 270 nm. Taking
          orientin,  vitexin  and  2″-O-β-L-galactopyranosylorientin  as  internal  references,  the  relative  correction  factors (RCF)  of  the  other  5
          components  to  be  determined  and  internal  substances  were  determined  by  QAMS.  The  contents  of  6  components  in  21  batches  of
          Jinlian qingre granules were calculated and then compared with the results of the external standard method. RESULTS The contents
          of  mangiferin,  2″-O-β-L-galactopyranosylorientin,  orientin,  veratric  acid,  vitexin  and  harpagoside  in  21  batches  of  samples  were
          determined  by  QAMS  in  the  range  of  0.234-0.516,  1.804-2.270,  2.143-2.606,  0.190-0.223,  0.594-0.782,  0.080-0.152  mg/g;  the
          contents  of  them  determined  by  external  standard  method  were  0.235-0.523,  1.798-2.265,  2.137-2.599,  0.190-0.224,  0.597-0.786,
          0.077-0.151  mg/g,  respectively.  The  percentage  difference  between  the  results  measured  by  the  two  methods  should  not  exceed
          4.00%.  CONCLUSIONS  QAMS  has  been  constructed  for  the  simultaneous  determination  of  6  components  in  Jinlian  qingre
          granules based on a variety of internal reference substances. The results obtained by this method are not significantly different from
          those obtained by the external standard method, and can be used for the quality control of Jinlian qingre granules.
                                                             KEYWORDS     Jinlian  qingre  granules;  quantitative  analysis
             Δ 基金项目 国家自然科学基金项目(No.81960711)                  of  multi-components  by  single  marker;  mangiferin;  2″-O-β-L-
             *第一作者 硕士研究生。研究方向:药物分析。电话:0951-
                                                             galactopyranosylorientin;   orientin;   veratric   acid;   vitexin;
          6880693。E-mail:hemin981210@163.com
                                                             harpagoside; content determination
             # 通信作者 正高职高级工程师,硕士生导师,硕士。研究方向:中
          药质量控制。电话:0951-6980170。E-mail:ydzhx@126.com


          中国药房  2023年第34卷第17期                                              China Pharmacy  2023 Vol. 34  No. 17    · 2069 ·
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