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中国药物评价 ›› 2023, Vol. 40 ›› Issue (1): 46-53.

• 评价技术与方法 • 上一篇    下一篇

复方银杏通脉口服液指纹图谱建立及3种成分含量测定研究

邹奇, 聂蔚, 侯凤飞   

  1. 湖南补天药业股份有限公司,湖南省茯苓工程技术研究中心, 湖南 怀化 418400
  • 收稿日期:2022-10-17 修回日期:2023-02-08 出版日期:2023-02-28 发布日期:2023-02-28
  • 基金资助:
    高新技术产业科技创新引领计划(科技攻关类)(编号:2020SK2051)、科技创新与成果转化项目(编号:2019zh010602)

Study on HPLC Fingerprint and Three Active Content Determination of Compound Yinxingtongmai Oral Liquid

  1. Hunan utian Pharmaceutical Co. LTD, Hunan Tuckahoe Engineering Technology Research Center, Hunan Huaihua 418000, China
  • Received:2022-10-17 Revised:2023-02-08 Online:2023-02-28 Published:2023-02-28

摘要: 目的:建立复方银杏通脉口服液的指纹图谱和3种成分的含量测定方法。方法:采用Waters xterra C18色谱柱(250 mm×4.6 mm,5μm)紫外检测器;流动相为乙腈(A)-0.1%磷酸水(B),梯度洗脱,检测波长224 nm及286 nm,进样量20 μL。结果:10批复方银杏通脉口服液指纹图谱确定27个共有峰,确认了4种成分分别是二苯乙烯苷、特女贞苷、丹酚酸B、松脂醇二葡萄糖苷。10批样品与对照图谱的相似度均大于0.985。3种成分的含量测定中二苯乙烯苷、特女贞苷、丹酚酸B分别在0.41~2.07 μg(R2=1);0.49 μg~2.43 μg(R2=1);0.47 μg~2.35 μg(R2=0.999)范围内呈良好的线性关系。二苯乙烯苷,特女贞苷,丹酚酸B平均回收率为96.76%、94.52% 和111.66%(n=9),RSD分别为2.97%、 2.27%和3.29%(n=9)。结论:该研究建立的指纹图谱和含量测定方法稳定可靠,可为复方银杏通脉口服液后续质量提升提供依据。

关键词: font-size:medium, ">复方银杏通脉口服液;HPLC;指纹图谱;含量测定

Abstract: Objective:Estalish the fingerprint and Three active Content Determination of Compound Yinxing Tongmai Oral Liquid. Methods:Waters xterra C18 column(250 mm×4.6 mm, 5 μm) UV detector was used; the moile phase was acetonitrile(A)-0.1% phosphoric acid water(B), gradient elution, detection wavelength 224 nm, and the injection volume was 20 μL. Results: The fingerprints of 10 atches of Compound Yinxingtongmai Oral Liquid identified 27 common peaks and identified 4 components. The similarity of 10 atches of samples and the control map were all greater than 0.985. Stilene glycosides, secretinosidesand salvianolic acid, linear relationshipwere shown at 0.41 μg-2.07 μg(R2=1); 0.49 μg-2.43 μg(R2=1); 0.47 μg-2.35 μg(R2=0.999), respectively. The average recovery rates of stilbeneside, Privet Glycoside, and Danphenolic Acid B were 96.76%, 94.52%, and 111.66%(n=9), and the RSDs were 2.97%, 2.27%, and 3.29%, respectively. Conclusion: The method estalished in this study is stale and reliale, and can provide a asis for the susequent quality improvement of Compound Yinxingtongmai Oral Liquid.

Key words: font-size:medium, ">Compound yinxingtongmai oral liquid; High performance liquid chromatography(HPLC); Fingerprint;Content determination

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