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中国医药导刊 ›› 2023, Vol. 25 ›› Issue (6): 575-579.

• 检验检测 • 上一篇    下一篇

人参益元颗粒质量控制方法研究

赵昱玮1, 司英奇2, 李锦锦3, 吴荻4, 南敏伦5, 赫玉芳1*, 刘一1, 曲元1   

  1. 1.长春中医药大学, 吉林 长春 130117;  2.吉林省奥普金钻技术检测服务有限公司, 吉林 长春 130507; 3.吉林农业大学, 吉林 长春 130118; 4.吉林大学第一医院, 吉林 长春 130021; 5.吉林省中医药科学院, 吉林 长春 130012
  • 收稿日期:2023-04-25 修回日期:2023-05-25 出版日期:2023-06-28 发布日期:2023-06-28
  • 基金资助:
    吉林省科技发展计划项目(项目编号:20210204037YY;项目名称:基于中医验方的创新中药——人参益元颗粒的临床前研究)

Study on Quality Control Method of Renshen Yiyuan Granules

  1. 1.Changchun University of Traditional Chinese Medicine,Jilin Changchun 130117, China;
    2.Jilin Aopu Jinzuan Technology Testing Service Co., Ltd., Jilin Changchun 130507, China;
    3.Jilin Agricultural University, Jilin Changchun 130118, China;
    4.The First Hospital of Jilin University,Jilin Changchun 130021, China;
    5.Academy of Chinese Medical Sciences of Jilin Province, Jilin Changchun 130012, China
  • Received:2023-04-25 Revised:2023-05-25 Online:2023-06-28 Published:2023-06-28

摘要: 目的:采用薄层色谱法和高效液相色谱法建立人参益元颗粒的质量控制方法。方法:采用薄层色谱法定性鉴别人参益元颗粒中人参、黄芪、炙甘草、白术;高效液相色谱法(HPLC)对人参益元颗粒中芍药苷进行含量测定。结果:采用薄层色谱法建立了益元颗粒中人参、黄芪、炙甘草、白术的定性鉴别方法,斑点清晰,阴性无干扰。采用高效液相色谱法建立了益元颗粒中芍药苷含量测定的方法,具体为采用Alphasil VC-C18(4.6 mm×250 mm,5 μm)色谱柱,以乙腈-0.2%磷酸溶液(17∶83)为流动相,检测波长230 nm,流速1.0 mL·min-1,柱温25 ℃,进样量10 μL。该方法专属性强,芍药苷在23.35~116.74 μg·mL-1(r=0.999 8)范围内线性关系良好,平均回收率为99.56%,RSD为1.40%。结论:本研究所建立的薄层色谱法鉴别及HPLC含量测定方法专属性强、重现性好,可用于人参益元颗粒的质量控制。

关键词: font-size:medium, ">人参益元颗粒;薄层色谱法;高效液相色谱法;质量标准

Abstract: Objective: The quality control method of renshen yiyuan granules was established by TLC and HPLC. Methods: TLC was used to qualitatively identify the components of Panax ginseng, Astragali radix,baked licorice and Atractylodes macrocephala in renshen yiyuan granules,and the content of paeoniflorin in renshen yiyuan granules was determined by HPLC. Results: The qualitative identification methods of the components of Panax ginseng,Astragali radix,baked licorice and Atractylodes macrocephala in renshen yiyuan granules were established by TLC. The TLC chromatography showed the same color spots in the same position of the corresponding control drugs,and the negative samples showed no interference.A HPLC method for determination the content of paeoniflorin in renshen yiyuan granules was established.The Alphasil VC-C18(4.6 mm×250 mm,5 μm)column was used with acetonitrile-0.2% phosphate solution(17∶83)as the mobile phase.The detection wavelength was 230 nm. The flow rate was 1.0 mL·min-1. The column temperature was 25 ℃ and the injection volume was 10 μL.The method established has strong specific, and paeoniflorin had a good linear relationship in the range of 23.35-116.74 μg·mL-1 (r=0.999 8). The average recovery rate was 99.56%, and RSD was 1.40%. Conclusion: The TLC identification method and the HPLC method for the content determination established in this study have strong specificity and good reproducibility, which can be used for the quality control of renshen yiyuan granules.

Key words: font-size:medium, ">Renshen yiyuan granules; TLC; HPLC; Quality standard

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