中国药物警戒 ›› 2022, Vol. 19 ›› Issue (9): 982-986.
DOI: 10.19803/j.1672-8629.2022.09.11

• 基础与临床研究 • 上一篇    下一篇

一测多评法测定血塞通注射液中5种皂苷类成分

王冰1, 李冬梅1,Δ, 王常顺2, 冯亚楠1, 刘永利2,*   

  1. 1河北省药物警戒中心,河北 石家庄 050090;
    2河北省药品医疗器械检验研究院,河北 石家庄,050090
  • 收稿日期:2022-05-24 出版日期:2022-09-15 发布日期:2022-09-16
  • 通讯作者: *刘永利,男,硕士,主任药师,中药质量控制方法与标准研究。E-mail: liuyongli2008@126.com
  • 作者简介:王冰,女,硕士,药物警戒。Δ为并列第一作者。
  • 基金资助:
    河北省中医药管理局科研计划项目（2021218）

Determination of 5 saponins in Xuesaitong injection by quantitative analysis of multi-components by single marker

WANG Bing1, LI Dongmei1,Δ, WANG Changshun2, FENG Yanan1, LIU Yongli2,*   

  1. 1Hebei Pharmacovigilance Center, Shijiazhuang Hebei 050090,China;
    2Hebei Institute for Drug and Medical Device Control, Shijiazhuang Hebei 050090,China
  • Received:2022-05-24 Online:2022-09-15 Published:2022-09-16

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摘要： 目的 建立血塞通注射液中5种皂苷成分的一测多评含量测定方法（简称“一测多评法”）,并对影响校正因子的因素进行考察。方法 采用超高效液相色谱法：色谱柱为Waters HSS T3（2.1 mm×100 mm, 1.7 µm）,流动相为乙腈与水梯度洗脱,检测波长为203 nm,以人参皂苷Rg1为对照,建立其与三七皂苷R1及人参皂苷Re、Rb1、Rd的校正因子,利用该校正因子计算三七皂苷R1及人参皂苷Re、Rb1、Rd的含量,实现一测多评,同时利用外标法测定这4种成分的含量,比较两者的差异,验证一测多评法的准确性和科学性。结果 采用校正因子计算的含量值与外标法实测值之间没有明显差异。结论 用一测多评法对血塞通注射液进行质量控制是可行、准确的。

关键词: 一测多评法, 血塞通, 注射液, 校正因子, 超高效液相色谱法, 皂苷

Abstract: Objective To establish a method for simultaneous assay of 5 kinds of saponins in Xuesaitong injection by quantitative analysis of multi-components by single marker (QAMS),and to investigate the factors influencing the correction factors. Methods Ultra high performance liquid chromatography（UPLC）was used,the determination was performed on Waters HSS T3 (2.1 mm×100 mm, 1.7 µm) column with mobile phase consisted of acetonitrile and water gradient elution. The detection wavelength was set at 203nm. Ginsenoside Rg1 was used as control to establish the relative correction factors（RCF）with panax notoginseng R1, ginsenoside Re, Rb1 and Rd. The contents of notoginseng saponin R1, ginsenoside Re, Rb1 and Rd were calculated by using the correction factor, and the contents of these four components were determined by external standard method. The difference between them was compared to verify the accuracy and scientificity of the method. Results There was no obvious difference between the content value calculated by correction factor and the measured value by external standard method. Conclusion It is feasible and accurate to control the quality of Xuesaitong injection with one test and multiple evaluation.

Key words: quantitative analysis of multi-components by single marker (QAMS), Xuesaitong, injection, relative correction factor (RCF), UPLC, saponins

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