Page 51 - 《中国药房》2023年23期
P. 51

心痛舒喷雾剂 HPLC 指纹图谱、含量测定及指标成分传递规律

          研究     Δ



          梁万徽 ,陶舒悦 ,左池靖 ,汪 杰 ,刘 艳 ,余卫东 ,彭 灿                        1, 2, 3, 4, 5 # ,王 茜 (1.安徽中医药大学药学院,
                 1*
                          1
                                  1
                                           1
                                                                                  1, 5
                                                   1
                                                           1
          合肥 230012;2.省部共建安徽道地中药材品质提升协同创新中心,合肥 230012;3.安徽省乡村振兴协同技
          术服务中心,合肥 230012;4.安徽省现代中药产业共性技术研究中心,合肥 230012;5.药物制剂技术与应用
          安徽省重点实验室,合肥 230012)
          中图分类号  R917      文献标志码  A      文章编号  1001-0408(2023)23-2861-07
          DOI  10.6039/j.issn.1001-0408.2023.23.08

          摘  要  目的  建立心痛舒喷雾剂高效液相色谱(HPLC)指纹图谱,对其指认成分进行含量测定,并探究饮片、中间体、喷雾剂中指
          标成分的传递规律,为心痛舒喷雾剂的工艺把关和质量控制提供参考。方法  采用《中药色谱指纹图谱相似度评价系统(2012
          版)》建立13批心痛舒喷雾剂的HPLC指纹图谱,并指认共有峰;采用HPLC法对指认成分进行含量测定;以牡丹皮中的丹皮酚和
          川芎中的阿魏酸为指标成分,考察两者在饮片、中间体、喷雾剂中的传递规律。结果  13批心痛舒喷雾剂中共有33个共有峰,相似
          度均≥0.994;共指认了8个成分,分别为没食子酸(5号峰)、氧化芍药苷(9号峰)、绿原酸(10号峰)、咖啡酸(14号峰)、芍药苷(17
          号峰)、阿魏酸(21号峰)、洋川芎内酯Ⅰ(27号峰)、丹皮酚(31号峰)。8个成分的含量分别为0.590 3~0.719 7、0.565 7~0.851 3、
          0.279 4~0.368 1、0.080 6~0.106 1、1.922 5~3.033 5、0.151 3~0.191 6、0.250 6~0.336 0、3.056 7~4.161 0 mg/mL。丹皮酚和阿魏
          酸从饮片→喷雾剂的平均转移率分别为63.76%、38.06%,其中在牡丹皮的渗漉提取和减压浓缩工艺中丹皮酚的损失超30%,在川
          芎的水蒸气蒸馏提取工艺中阿魏酸的损失超50%。结论  建立的心痛舒喷雾剂HPLC指纹图谱及含量测定方法重复性好、专属性
          强;牡丹皮的渗漉提取和减压浓缩及川芎的水蒸气蒸馏提取是引起指标成分转移率下降的关键工艺。
          关键词  心痛舒喷雾剂;高效液相色谱法;指纹图谱;含量测定;成分传递规律

          HPLC  fingerprint,  content  determination  and  transferring  patterns  of  index  components  of  Xintongshu
          spray
                                                  1
                                     1
          LIANG Wanhui ,TAO Shuyue ,ZUO Chijing ,WANG Jie ,LIU Yan ,YU Weidong ,PENG Can        1, 2, 3, 4, 5 ,WANG
                       1
                                                                                    1
                                                             1
                                                                       1
          Qian (1.  School  of  Pharmacy, Anhui  University  of  Chinese  Medicine,  Hefei  230012,  China;2.  MOE-Anhui
              1, 5
          Joint  Collaborative  Innovation  Center  for  Quality  Improvement  of Anhui  Genuine  Chinese  Medicinal  Materials,
          Hefei  230012,  China;3.  Rural  Revitalization  Collaborative  Technical  Service  Center  of Anhui  Province,  Hefei
          230012,  China;4.  Generic  Technology  Research  Center  for  Anhui  TCM  Industry,  Hefei  230012,  China;
          5. Anhui  Provincial  Key  Laboratory  of  Pharmaceutical  Preparation  Technology  and Application,  Hefei  230012,
          China)

          ABSTRACT   OBJECTIVE  To  establish  the  HPLC  fingerprint  of  Xintongshu  spray,  determine  the  contents  of  identified
          components,  and  investigate  the  transferring  patterns  of  the  index  components  of  decoction  pieces,  intermediates  and  spray,  so  as
          to provide scientific reference for technology management and quality control of Xintongshu spray. METHODS  HPLC fingerprints
          of 13 batches of Xintongshu spray were established by the Similarity Evaluation System for Chromatographic Fingerprints of TCM
         (2012 edition), and common peaks were identified; the contents of identified components were determined by HPLC. The paeonol
          in Moutan Cortex and ferulic acid in Chuanxiong Rhizoma were used as index components to investigate the transferring patterns of
                                                             them  in  decoction  pieces,  intermediates  and  spray.  RESULTS
             Δ 基金项目 安徽省科技重大专项(No.202103a07020001);亳州市        There  were  a  total  of  33  common  peaks  in  the  fingerprints  of
          科技重大专项揭榜挂帅项目(No.bzzd2021002)                       13  batches  of  Xintongshu  spray,  and  the  similarities  were
             *第一作者 硕士研究生。研究方向:中药复方药效物质基础。
                                                             more  than  0.994.  Eight  components  were  identified,  i.e.  gallic
          E-mail:1551457923@qq.com
             # 通信作者 副教授,硕士生导师,博士。研究方向:中药制剂与分                 acid (peak  5),  oxypaeoniflorin (peak  9),  chlorogenic  acid
          析。E-mail:pengcanking@hotmail.com                  (peak  10),  caffeic  acid (peak  14),  paeoniflorin (peak  17),


          中国药房  2023年第34卷第23期                                              China Pharmacy  2023 Vol. 34  No. 23    · 2861 ·
   46   47   48   49   50   51   52   53   54   55   56