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  

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

作　　者：邹奇 聂蔚 侯凤飞 ZOU Qi;NIE Wei;HOU Feng-fei(Hunan utian Pharmaceutical Co.LTD,Hunan Tuckahoe Engineering Technology Research Center,Hunan Huaihua 418000,China)

机构地区：[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

出　　处：《中国药物评价》2023年第1期46-53,共8页Chinese Journal of Drug Evaluation

基　　金：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)。

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20μL。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0.41~2.07μg(R2=1);0.49μg~2.43μg(R2=1);0.47μg~2.35μg(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。Objective:Estalish the fingerprint and Three active Content Determination of Compound Yinxing Tongmai Oral Liquid. Methods:Waters xterra C18column(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(R~2=1);0.49 μg-2.43 μg(R~2=1);0.47 μg-2.35 μg(R~2=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.

关 键 词：复方银杏通脉口服液 HPLC 指纹图谱 含量测定 

分 类 号：R917[医药卫生—药物分析学]