title: Quantitative analysis of highly similar salvianolic acids with 1H qNMR for quality control of traditional Chinese medicinal preparation Salvianolate Lyophilized Injection.
abstract: Salvianolate Lyophilized Injection (SLI), a traditional Chinese medicinal (TCM) preparation which is used to treat stroke, is composed of multiple salvianolic acids from the aqueous extracts of Salvia miltiorrhiza, and includes mainly protocatechualdehyde, rosmarinic acid, salvianolic acid B, salvianolic acid D, salvianolic acid E, diastereomer of salvianolic acid E, salvianolic acid Y, lithospermic acid and diastereomer of lithospermic acid. It is difficult to quantitatively control the quality of SLI using traditional high performance liquid chromatography due to the highly similar structure of these constituents including three pairs of diastereomers and the lack of commercial resources for most of these constituents as standards. Thus, a highly reproducible, fast, accurate and simple (1)H quantitative nuclear magnetic resonance (qNMR) method without the need for calibration curves and complex computation was established by optimizing the solvent system and acquisition parameters to simultaneously determine the nine salvianolic acids and mannitol in SLI. This method was validated and successfully used to determine 10 batches of SLI and the qNMR data were further analyzed with a vector including angle cosine and the partial least squares method for the quality control of SLI. The results indicated that qNMR can be used as a routine method for the quality control of SLI and may have potential in the quantification of diastereomers in other TCM preparations.
authors.affiliation: Jiangsu Key Lab of TCM Evaluation and Translational Research, China Pharmaceutical University, Nanjing 210009, PR China.
authors.forename: Xialin
authors.initials: X
authors.lastname: Chen
authors.affiliation: Jiangsu Key Lab of TCM Evaluation and Translational Research, China Pharmaceutical University, Nanjing 210009, PR China.
authors.forename: Yujie
authors.initials: Y
authors.lastname: Guo
authors.affiliation: State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao 999078, PR China.
authors.forename: Yuanjia
authors.initials: Y
authors.lastname: Hu
authors.affiliation: Jiangsu Key Lab of TCM Evaluation and Translational Research, China Pharmaceutical University, Nanjing 210009, PR China. Electronic address: boyangyu59@163.com.
authors.forename: Boyang
authors.initials: B
authors.lastname: Yu
authors.affiliation: Jiangsu Key Lab of TCM Evaluation and Translational Research, China Pharmaceutical University, Nanjing 210009, PR China. Electronic address: qijin2006@163.com.
authors.forename: Jin
authors.initials: J
authors.lastname: Qi
mesh_terms: D000475:Alkenes / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D005612:Freeze Drying; D008516:Medicine, Chinese Traditional; D059808:Polyphenols / Q000032:analysis*; D066244:Proton Magnetic Resonance Spectroscopy / Q000379:methods*; D011786:Quality Control
chemical_list: D000475:Alkenes; D059808:Polyphenols; C568740:salvianolic acid
keywords: Diastereomer; Quality control; Salvianolate Lyophilized Injection; Salvianolic acids; Traditional Chinese medicine; qNMR