Qualitative and quantitative analyses of Compound Danshen extract based on1H NMR method and its application for quality control.
In this study, a new approach using1H NMR spectroscopy combined with chemometrics method was developed for qualitative and quantitative analyses of extracts of Compound Danshen Dripping Pills (CDDP). For the qualitative analysis, some metabolites presented in Compound Danshen extract (CDE, extraction intermediate of CDDP) were detected, including phenolic acids, saponins, saccharides, organic acids and amino acids, by the proposed1H NMR method, and metabolites profiles were further analyzed by selected chemometrics algorithms to define the threshold values for product quality evaluation. Moreover, three main phenolic acids (danshensu, salvianolic acid B, and procatechuic aldehyde) in CDE were determined simultaneously, and method validation in terms of linearity, precision, repeatability, accuracy, and stability of the dissolved target compounds in solution was performed. The average recoveries varied between 84.20% and 110.75% while the RSDs were below 6.34% for the three phenolic acids. This1H NMR method offers an integral view of the extract composition, allows the qualitative and quantitative analysis of CDDP, and has the potential to be a supplementary tool to UPLC/HPLC for quality assessment of Chinese herbal medicines.
Tianjin State Key Laboratory of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China; Tasly Academy, Tasly Holding Group Co., Ltd, Tianjin 300410, China.
Kai-Jing
KJ
Yan
Tasly Academy, Tasly Holding Group Co., Ltd, Tianjin 300410, China.
Yang
Y
Chu
TCM and Ethnomedicine Innovation & Development Laboratory, Sino-Luxemburg TCM Research Center, School of Pharmacy, Hunan University of Chinese Medicine, Changsha, 410208, China.
Jian-Hua
JH
Huang
Tianjin State Key Laboratory of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China.
Miao-Miao
MM
Jiang
Tasly Academy, Tasly Holding Group Co., Ltd, Tianjin 300410, China. Electronic address: Liwei_wzhy@163.com.
Wei
W
Li
Tianjin State Key Laboratory of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China.
Yue-Fei
YF
Wang
TCM and Ethnomedicine Innovation & Development Laboratory, Sino-Luxemburg TCM Research Center, School of Pharmacy, Hunan University of Chinese Medicine, Changsha, 410208, China.
Hui-Yong
HY
Huang
TCM and Ethnomedicine Innovation & Development Laboratory, Sino-Luxemburg TCM Research Center, School of Pharmacy, Hunan University of Chinese Medicine, Changsha, 410208, China.
Yu-Hui
YH
Qin
Tasly Academy, Tasly Holding Group Co., Ltd, Tianjin 300410, China.
Xiao-Hui
XH
Ma
Tasly Academy, Tasly Holding Group Co., Ltd, Tianjin 300410, China.
Shui-Ping
SP
Zhou
Tasly Academy, Tasly Holding Group Co., Ltd, Tianjin 300410, China; Tasly Pharmaceuticals Inc., Rockville, MD 20850, USA.
Henry
H
Sun
TCM and Ethnomedicine Innovation & Development Laboratory, Sino-Luxemburg TCM Research Center, School of Pharmacy, Hunan University of Chinese Medicine, Changsha, 410208, China. Electronic address: wangwei402@hotmail.com.
Wei
W
Wang
D001572:Benzofurans / Q000032:analysis; D002392:Catechin / Q000031:analogs & derivatives / Q000032:analysis; D004355:Drug Stability; D004365:Drugs, Chinese Herbal / Q000737:chemistry*; D007773:Lactates / Q000032:analysis; D066244:Proton Magnetic Resonance Spectroscopy / Q000379:methods*; D011786:Quality Control; D015203:Reproducibility of Results; D027561:Salvia miltiorrhiza; D053630:Depsides
D001572:Benzofurans; D002392:Catechin; D004365:Drugs, Chinese Herbal; D007773:Lactates; C028972:dan-shen root extract; C035055:3,4-dihydroxyphenyllactic acid; C076944:salvianolic acid B; D053630:Depsides
(1)H NMR spectroscopy; Chemometrics method; Chinese herbal medicine; Compound danshen dripping pill; Quality control