补肺活血胶囊UPLC指纹图谱建立及质量评价  

UPLC Fingerprint Establishment and Quality Evaluation of Bufei Huoxue Capsule

作　　者：任慧 郭盛[1] 许小雪 张祎盈 李全 王恒斌 耿婉丽 尚尔鑫[1] 钱大玮[1] 段金廒[1] REN Hui;GUO Sheng;XU Xiao-xue;ZHANG Yi-ying;LI Quan;WANG Heng-bin;GENG Wan-li;SHANG Er-xin;QIAN Da-wei;DUAN Jin-ao(National and Local Collaborative Engineering Center of Chinese Medicinal Resources Industrialization and Formulae Innovative Medicine/Jiangsu Collaborative Innovation Center of Chinese Medicinal Resources Industrialization/Jiangsu Key Laboratory for Traditional Chinese Medicine Formulae Research,Nanjing University of Chinese Medicine,Nanjing 210023,China;Lei Yunshang Group,Suzhou 215003,China;Guangdong Leiyunshang Pharmaceutical Co.,Ltd.,Yunfu 527300,China)

机构地区：[1]南京中医药大学中药资源产业化与方剂创新药物国家地方联合工程研究中心/江苏省中药资源产业化过程协同创新中心/江苏省方剂高技术研究重点实验室,江苏南京210023 [2]雷允上药业集团有限公司,江苏苏州215003 [3]广东雷允上药业有限公司,广东云浮527300

出　　处：《中国现代中药》2022年第11期2214-2221,共8页Modern Chinese Medicine

基　　金：国家自然科学基金项目(81873189);江苏省高校自然科学研究重大项目(18KJA360006);江苏省“六大人才”高峰项目(YY-026);江苏省研究生科研创新项目(KYCX21_1728)。

摘　　要：目的:建立补肺活血胶囊超高效液相色谱法(UPLC)指纹图谱。方法:采用ACQUITY UPLC BEH C_(18)色谱柱(100 mm×2.1 mm,1.7μm),乙腈(A)-0.1%甲酸水溶液(B)为流动相梯度洗脱,流速为0.4 mL·min^(-1),检测波长为246 nm,建立补肺活血胶囊指纹图谱;采用UPLC串联四极杆飞行时间质谱法结合对照品对所建立的指纹图谱共有峰进行定性分析;采用主成分分析(PCA)进一步对影响补肺活血胶囊质量均一性的差异性成分进行筛选。结果:依据11批样品建立的指纹图谱相似度评价均大于0.969;指纹图谱中共标定20个共有峰,对其中18个共有峰进行了化学成分鉴定。PCA显示,影响补肺活血胶囊批间质量均一性的主要化学组分为补骨脂苷和异补骨脂苷。结论:所建立的UPLC指纹图谱方法专属性强,可用于补肺活血胶囊的质量评价。Objective:To establish the ultra-high performance liquid chromatography(UPLC)fingerprint of Bufei Huoxue Capsule(BHC)and to provide a basis for its quality evaluation.Methods:The fingerprint of BHC was established by Acquity UPLC BEH C^(18) column(100 mm×2.1 mm,1.7μm)with acetonitrile(A)-0.1%formic acid aqueous solution(B)as mobile phase by gradient elution.The flow rate was 0.4 mL·min^(-1) and the detection wavelength was 246 nm.The common peaks of the established fingerprint were qualitatively analyzed by UPLC-quadrupole-time-of-flight mass spectrometry(UPLC-Q-TOF-MS)combined with standard solution.The differential components affecting the quality uniformity of BHC were further screened by principal component analysis(PCA).Results:The similarity of the fingerprints based on 11 batches of samples was all more than 0.969.A total of 20 common peaks were calibrated,of which 18 common peaks were identified.PCA showed that the main chemical components affecting the inter-batch quality uniformity of BHC were psoralenoside and isopsoralenoside.Conclusion:The established UPLC fingerprint method was highly specific and could be used for the quality evaluation of BHC.

关 键 词：补肺活血胶囊 指纹图谱 超高效液相色谱串联四极杆飞行时间质谱法 

分 类 号：R286[医药卫生—中药学]