title: Comprehensive Quantitative Analysis of SQ Injection Using Multiple Chromatographic Technologies.
abstract: Quality control of Chinese medicine injections remains a challenge due to our poor knowledge of their complex chemical profile. This study aims to investigate the chemical composition of one of the best-selling injections, Shenqi Fuzheng (SQ) injection (SQI), via a full component quantitative analysis. A total of 15 representative small molecular components of SQI were simultaneously determined using ultra-high performance liquid chromatography (UHPLC) coupled with quadrupole tandem time-of-flight mass spectrometry (Q-TOF-MS); saccharide composition of SQI was also quantitatively determined by high performance liquid chromatography (HPLC) with evaporative light scattering detector (ELSD) on an amino column before and after acid hydrolysis. The existence of polysaccharides was also examined on a gel permeation chromatography column. The method was well validated in terms of linearity, sensitivity, precision, accuracy and stability, and was successfully applied to analyze 13 SQI samples. The results demonstrate that up to 94.69% (w/w) of this injection product are quantitatively determined, in which small molecules and monosaccharide/sucrose account for 0.18%-0.21%, and 53.49%-58.2%, respectively. The quantitative information contributes to accumulating scientific evidence to better understand the therapy efficacy and safety of complex Chinese medicine injections.
authors.affiliation: School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, China. dumdum1986@msn.com.
authors.forename: Siu-Leung
authors.initials: SL
authors.lastname: Chau
authors.affiliation: State Key Laboratory of Food Science and Technology, Sino-Germany Joint Research Institute, Nanchang University, Nanchang 330047, China. hzbchem@ncu.edu.cn.
authors.forename: Zhi-Bing
authors.initials: ZB
authors.lastname: Huang
authors.affiliation: Limin Pharmaceutical Factory, Livzon Group, Shaoguang 512028, China. Songyangang@livzon.cn.
authors.forename: Yan-Gang
authors.initials: YG
authors.lastname: Song
authors.affiliation: School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, China. rickyyue@126.com.
authors.forename: Rui-Qi
authors.initials: RQ
authors.lastname: Yue
authors.affiliation: School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, China. alanhhm@hkbu.edu.hk.
authors.forename: Alan
authors.initials: A
authors.lastname: Ho
authors.affiliation: Institute of Clinical Pharmacology, Guangzhou University of Traditional Chinese Medicine, Guangzhou 510405, China. linchaozhan@gzucm.edu.cn.
authors.forename: Chao-Zhan
authors.initials: CZ
authors.lastname: Lin
authors.affiliation: Limin Pharmaceutical Factory, Livzon Group, Shaoguang 512028, China. huangwenhua01@livzon.cn.
authors.forename: Wen-Hua
authors.initials: WH
authors.lastname: Huang
authors.affiliation: School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, China. simonhan@hkbu.edu.hk.
authors.forename: Quan-Bin
authors.initials: QB
authors.lastname: Han
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000032:analysis* / Q000737:chemistry / Q000592:standards; D000067493:Dynamic Light Scattering; D006801:Humans; D007267:Injections; D008516:Medicine, Chinese Traditional / Q000592:standards; D015394:Molecular Structure; D011134:Polysaccharides / Q000302:isolation & purification*; D054852:Small Molecule Libraries / Q000302:isolation & purification*; D053719:Tandem Mass Spectrometry / Q000379:methods
chemical_list: D004365:Drugs, Chinese Herbal; D011134:Polysaccharides; D054852:Small Molecule Libraries; C521737:shenqi fuzheng
keywords: Chinese medicine formula; Shenqi Fuzheng injection; chemical profile; quantitative analysis