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杨馨玥1△,李红2,班辰婧1△,黄能听3,刘军3,夏忠庭2▲.参葛颗粒HPLC特征图谱及含量测定研究[J].中国医药科学,2024,14(11):55-59        基金项目:
参葛颗粒HPLC特征图谱及含量测定研究
Study on HPLC specific chromatogram and content determination of Shenge Granules
  
DOI:
中文关键词:  特征图谱;高效液相色谱法;参葛颗粒;相对保留时间;葛根素
英文关键词:Specific chromatogram; High-performance liquid chromatography; Shenge Granules; Relative retention time; Puerarin
作者单位
杨馨玥1△,李红2,班辰婧1△,黄能听3,刘军3,夏忠庭2▲ 1.天津中医药大学研究生院,天津 301617;2.盈科瑞 (天津)创新医药研究有限公司,天津 300382;3.北京盈科瑞创新医药股份有限公司,北京 102200 
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中文摘要:
      [摘要] 目的 采用高效液相色谱(HPLC)法创建参葛颗粒特征图谱及含量测定方法。 方法 色谱柱Kromasil 100-5-C18(4.6 mm×250.0 mm,5 μm);流动相乙腈-水;柱温30℃;流速为1.0 ml/min;进样量10 μl;检测波长为220 nm,采用对照品比对、超高压液相色谱串联四级杆飞行时间质谱联用技术对特征峰进行化学成分指认及药味归属,并检测10批参葛颗粒的特征图谱和含量。 结果 建立了参葛颗粒的HPLC图谱,标记8个特征峰并进行了指认,10批颗粒批间一致性良好,10批颗粒葛根素的含量范围为10.6611~11.9936 mg/g。 结论 建立的参葛颗粒特征图谱及含量测定方法操作简单,具有良好的稳定性、重现性,对参葛颗粒中所含的化学成分进行了较全面的展示,也可为其他相关中药复方制剂的质量控制研究提供参考。
英文摘要:
      [Abstract] Objective To create a specific chromatogram and content determination method for Shenge Granules using high-performance liquid chromatography (HPLC). Methods The determination was performed on a chromatographic column-Kromasil 100-5-C18 (4.6 mm × 250.0 mm, 5 μm), mobile phase acetonitrile - water; column temperature-30℃, flow rate - 1.0 ml/min; injection volume - 10 μl, detection wavelength - 220 nm, and the characteristic peaks were identified for chemical composition and medicinal flavor classification using reference standard comparison, UPLC-Q-TOF-MS technology. The specific chromatogram and content of 10 batches of Shenge Granules were also determined. Results An HPLC spectrum of Shenge Granules was established, with a total of 8 characteristic peaks marked and identified. The consistency between 10 batches of granules was good, and the content range of puerarin in 10 batches of granules was 10.6611-11.9936 mg/g. Conclusion The establishing method for specific chromatogram and content determination method of Shenge Granules are easy to operate, with good stability and reproducibility, which comprehensively display the chemical components contained in Shenge Granules. It can also provide a reference for the quality control research of other related traditional Chinese medicine compound formulations.
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