title: Simultaneous Qualitative and Quantitative Analysis of Multiple Chemical Constituents in YiQiFuMai Injection by Ultra-Fast Liquid Chromatography Coupled with Ion Trap Time-of-Flight Mass Spectrometry.
abstract: YiQiFuMai injection (YQFM) is a modern lyophilized powder preparation derived from the traditional Chinese medicine Sheng-mai san (SMS) used for treating cardiovascular diseases, such as chronic heart failure. However, its chemical composition has not been fully elucidated, particularly for the preparation derived from Ophiopogon japonicus. This study aimed to establish a systematic and reliable method to quickly and simultaneously analyze the chemical constituents in YQFM by ultra-fast liquid chromatography coupled with ion trap time-of-flight mass spectrometry (UFLC-IT-TOF/MS). Sixty-five compounds in YQFM were tentatively identified by comparison with reference substances or literature data. Furthermore, twenty-one compounds, including three ophiopogonins, fifteen ginsenosides and three lignans were quantified by UFLC-IT-TOF/MS. Notably, this is the first determination of steroidal saponins from O. japonicus in YQFM. The relative standard deviations (RSDs) of intra- and inter-day precision, reproducibility and stability were <4.9% and all analytes showed good linearity (R² ≥ 0.9952) and acceptable recovery of 91.8%-104.2% (RSD ≤ 5.4%), indicating that the methods were reliable. These methods were successfully applied to quantitative analysis of ten batches of YQFM. The developed approach can provide useful and comprehensive information for quality control, further mechanistic studies in vivo and clinical application of YQFM.
authors.affiliation: Jiangsu Key Laboratory of TCM Evaluation and Translational Research, China Pharmaceutical University, Nanjing 211198, China. liu_hua139@126.com.
authors.forename: Chunhua
authors.initials: C
authors.lastname: Liu
authors.affiliation: Department of Technology Development, TianJin Tasly Pride Pharmaceutical Co., Ltd., Tianjin 300410, China. juach@tasly.com.
authors.forename: Aichun
authors.initials: A
authors.lastname: Ju
authors.affiliation: Department of Technology Development, TianJin Tasly Pride Pharmaceutical Co., Ltd., Tianjin 300410, China. zhoudz@tasly.com.
authors.forename: Dazheng
authors.initials: D
authors.lastname: Zhou
authors.affiliation: Department of Technology Development, TianJin Tasly Pride Pharmaceutical Co., Ltd., Tianjin 300410, China. lidekun@tasly.com.
authors.forename: Dekun
authors.initials: D
authors.lastname: Li
authors.affiliation: Jiangsu Key Laboratory of TCM Evaluation and Translational Research, China Pharmaceutical University, Nanjing 211198, China. junpingkou@163.com.
authors.forename: Junping
authors.initials: J
authors.lastname: Kou
authors.affiliation: Jiangsu Key Laboratory of TCM Evaluation and Translational Research, China Pharmaceutical University, Nanjing 211198, China. boyangyu59@163.com.|State Key Laboratory of Natural Medicines, China Pharmaceutical University, Nanjing 210009, China. boyangyu59@163.com.
authors.forename: Boyang
authors.initials: B
authors.lastname: Yu
authors.affiliation: Jiangsu Key Laboratory of TCM Evaluation and Translational Research, China Pharmaceutical University, Nanjing 211198, China. qijin2006@163.com.
authors.forename: Jin
authors.initials: J
authors.lastname: Qi
mesh_terms: D002845:Chromatography; D002853:Chromatography, Liquid; D004365:Drugs, Chinese Herbal / Q000032:analysis / Q000737:chemistry* / Q000627:therapeutic use; D036145:Ginsenosides / Q000737:chemistry* / Q000302:isolation & purification; D006801:Humans; D017705:Lignans / Q000737:chemistry* / Q000302:isolation & purification; D013058:Mass Spectrometry; D008516:Medicine, Chinese Traditional; D012503:Saponins / Q000737:chemistry* / Q000302:isolation & purification
chemical_list: D004365:Drugs, Chinese Herbal; D036145:Ginsenosides; D017705:Lignans; D012503:Saponins; C584693:yi-qi-fu-mai
keywords: UFLC-IT-TOF/MS; YiQiFuMai injection; identification; ophiopogonins; quantification