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UPLC-Q-Orbitrap HRMS结合主成分分析的丹灯通脑软胶囊质量评价研究
引用本文:周霖,周珮珮,王肖辉,薛文华,孙志,张俊,左莉华,梁淑红,薛连平,惠洁,刘克锋,王松,张晓坚,赵杰.UPLC-Q-Orbitrap HRMS结合主成分分析的丹灯通脑软胶囊质量评价研究[J].中草药,2018,49(18):4311-4318.
作者姓名:周霖  周珮珮  王肖辉  薛文华  孙志  张俊  左莉华  梁淑红  薛连平  惠洁  刘克锋  王松  张晓坚  赵杰
作者单位:郑州大学第一附属医院药学部;河南省精准临床药学重点实验室;郑州大学第一附属医院超声科;河南理工大学医学院
基金项目:河南省高等学校重点科研项目资助(19A320070);常州四药临床药学科研基金资助(CZSYJJ6015);河南省科技计划项目资助(182102310243)
摘    要:目的建立基于UPLC-Q-Orbitrap HRMS的丹灯通脑软胶囊(DTSC)中多种活性成分定量分析方法,并采用主成分分析(PCA)法对其质量进行综合评价。方法采用Acquity UPLC?BEH C18色谱柱(50 mm×2.1 mm,1.7μm),以乙腈-0.1%甲酸水溶液为流动相进行梯度洗脱,以实现化合物的前期分离;然后通过Q-Orbitrap MS正负离子同时监测、一级全扫描及自动触发二级质谱扫描的模式捕捉目标成分的精确相对分子质量及碎片离子信息,以实现对待测物的准确定性和定量;最后将定量结果与PCA法相结合对不同批次药物进行科学的质量评价分析。结果在优化的色谱、质谱条件下,甜菜碱、丹参素、绿原酸、原儿茶醛、葛根素、咖啡酸、木犀草苷、迷迭香酸、丹酚酸A、丹酚酸B、槲皮素、芹菜素、洋川芎内脂A、二氢丹参酮Ⅰ、丹参酮Ⅰ、隐丹参酮和丹参酮Ⅱ_A分别在0.018 1~0.578 4、5.555 7~177.782 0、0.018 1~0.580 3、0.002 8~0.089 2、0.787 2~25.191 3、0.000 5~0.016 7、0.007 2~0.228 9、0.065 8~2.105 3、0.304 6~9.747 1、3.888 1~124.417 6、0.000 5~0.016 0、0.000 6~0.018 1、0.002 5~0.080 1、0.019 8~0.632 8、0.032 2~1.031 7、0.102 8~3.290 0、0.044 5~1.422 9μg/mL线性关系良好(r≥0.999 2);精密度、重复性及稳定性良好(RSD≤5%);加样回收率在98%~102%,RSD均小于3%;定量分析结果表明大多数批次药物质量较为稳定,其中丹参酮Ⅰ、隐丹参酮、二氢丹参酮Ⅰ和丹参酮Ⅱ_A对药物质量具有较大影响,可对其进行重点监控以保证药物批次质量。结论建立的定量方法灵敏度高且准确性好,方法学考察结果符合测定要求,可用于DTSC中多种活性成分的快速测定;并为其质量评价提供新的科学依据和参考。

关 键 词:UPLC-Q-Orbitrap  HRMS  丹灯通脑软胶囊  主成分分析  质量评价  甜菜碱  丹参素  绿原酸  原儿茶醛  葛根素  咖啡酸  木犀草苷  迷迭香酸  丹酚酸A  丹酚酸B  槲皮素  芹菜素  洋川芎内脂A  二氢丹参酮I  丹参酮I  隐丹参酮  丹参酮IIA
收稿时间:2018/4/25 0:00:00

Quality assessment of Dandeng Tongnao Soft Capsule based on UPLC-Q-Orbitrap HRMS combined with principal component analysis
ZHOU Lin,ZHOU Pei-pei,WANG Xiao-hui,XUE Wen-hu,SUN Zhi,ZHANG Jun,ZUO Li-hu,LIANG Shu-hong,XUE Lian-ping,HUI Jie,LIU Ke-feng,WANG Song,ZHANG Xiao-jian and ZHAO Jie.Quality assessment of Dandeng Tongnao Soft Capsule based on UPLC-Q-Orbitrap HRMS combined with principal component analysis[J].Chinese Traditional and Herbal Drugs,2018,49(18):4311-4318.
Authors:ZHOU Lin  ZHOU Pei-pei  WANG Xiao-hui  XUE Wen-hu  SUN Zhi  ZHANG Jun  ZUO Li-hu  LIANG Shu-hong  XUE Lian-ping  HUI Jie  LIU Ke-feng  WANG Song  ZHANG Xiao-jian and ZHAO Jie
Institution:Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China;Henan Key Laboratory of Precision Clinical Pharmacy, Zhengzhou 450052, China,Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China;Henan Key Laboratory of Precision Clinical Pharmacy, Zhengzhou 450052, China,Department of Ultrasonography, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China,Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China;Henan Key Laboratory of Precision Clinical Pharmacy, Zhengzhou 450052, China,Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China;Henan Key Laboratory of Precision Clinical Pharmacy, Zhengzhou 450052, China,Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China;Henan Key Laboratory of Precision Clinical Pharmacy, Zhengzhou 450052, China,Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China;Henan Key Laboratory of Precision Clinical Pharmacy, Zhengzhou 450052, China,Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China;Henan Key Laboratory of Precision Clinical Pharmacy, Zhengzhou 450052, China,Medical college, Henan Polytechnic University, Jiaozuo 454000, China,Medical college, Henan Polytechnic University, Jiaozuo 454000, China,Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China;Henan Key Laboratory of Precision Clinical Pharmacy, Zhengzhou 450052, China,Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China;Henan Key Laboratory of Precision Clinical Pharmacy, Zhengzhou 450052, China,Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China;Henan Key Laboratory of Precision Clinical Pharmacy, Zhengzhou 450052, China and Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China;Henan Key Laboratory of Precision Clinical Pharmacy, Zhengzhou 450052, China
Abstract:
Keywords:UPLC-Q-Orbitrap HRMS  Dandeng Tongnao Soft Capsule  principal component analysis  quality assessment  betaine  danshensu  chlorogenic acid  protocatechuic aldehyde  puerarin  caffeic acid  galuteolin  rosmarinic acid  salvianolic acid A  salvianolic acid B  quercetin  apigenin  senkyunolide A  dihydrotanshinone I  tanshinone I  cryptotanshinone  tanshinon IIA
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