Wei Li1, Navaneethakrishnan Polachi2, Xiangyang Wang3, Yang Chu3, Yuan Wang2, Meng Tian2, Dekun Li4, Dazheng Zhou4, Shuiping Zhou3, Aichun Ju4, Yubo Li5, Yanjun Zhang5, Min Chen6, Luqi Huang7, Changxiao Liu8. 1. National Resource Center for Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing - 100700, China; Center for Post-doctoral Research, China Academy of Chinese Medical Sciences, Beijing - 100700, China; State Key Laboratory of Core Technology in Innovative Chinese Medicine, Tasly Pharmaceutical Group Co., Ltd., Tianjin - 300410, China; Tasly Academy, Tasly Holding Group Co., Ltd., Tianjin - 300410, China. Electronic address: weili_201617@163.com. 2. School of Chinese Materia Medica, Tianjin University of Traditional Chinese Medicine, Tianjin - 300193, China; State Key Laboratory of Core Technology in Innovative Chinese Medicine, Tasly Pharmaceutical Group Co., Ltd., Tianjin - 300410, China; Tasly Academy, Tasly Holding Group Co., Ltd., Tianjin - 300410, China. 3. State Key Laboratory of Core Technology in Innovative Chinese Medicine, Tasly Pharmaceutical Group Co., Ltd., Tianjin - 300410, China; Tasly Academy, Tasly Holding Group Co., Ltd., Tianjin - 300410, China. 4. State Key Laboratory of Core Technology in Innovative Chinese Medicine, Tasly Pharmaceutical Group Co., Ltd., Tianjin - 300410, China; Tianjin Tasly Pride Pharmaceutical Co., Ltd., Tianjin - 300410, China. 5. School of Chinese Materia Medica, Tianjin University of Traditional Chinese Medicine, Tianjin - 300193, China. 6. National Resource Center for Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing - 100700, China; Center for Post-doctoral Research, China Academy of Chinese Medical Sciences, Beijing - 100700, China. 7. National Resource Center for Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing - 100700, China; Center for Post-doctoral Research, China Academy of Chinese Medical Sciences, Beijing - 100700, China. Electronic address: huangluqi01@126.com. 8. The State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin Institute of Pharmaceutical Research, Tianjin - 300193, China. Electronic address: liuchangxiao@163.com.
Abstract
BACKGROUND: The quality of Chinese medicine (CM) has being an active and challenging research area for CM. Prof. Chang-Xiao Liu et al first proposed the concept of quality marker (Q-Marker) for the quality evaluation and control on CM. This article describe the exploratory studies of Q-Marker in salvianolic acids for injection (SAI) based on this new concept. PURPOSE: This study was designed to screen Q-Marker of SAI and establish its quality control method based on the concept of CM Q-Marker. METHODS: Based on the concept of CM Q-Marker, the SAI was investigated for the identification of chemical components and their sources. The pharmacological effects on cerebral ischemia and reperfusion induced injury in rats were also investigated. Furthermore, the target cell extracts and pharmacokinetic studies were conducted to screen Q-Markers. Finally, the fingerprints and determination based on Q-Markers were established to assess the quality of SAI more effectively. RESULTS: Overall, 20 constituents in SAI were identified. It was found that salvianolic acid B (SA-B), rosmarinic acid (RA), lithospermic acid (LA), salvianolic acid D (SA-D) and salvianolic acid Y (SA-Y) are major chemical components of SAI. Based on chemical components identifications, analysis of their sources, target cell extracts and pharmacokinetic studies, four phenolic acids, namely SA-B, RA, LA and SA-D, were screened and determined as effective Q-Markers of SAI. CONCLUSION: This study demonstrated that the described method is a powerful approach for detecting Q-Markers, which can be used as control index for the quality assessment of CM.
BACKGROUND: The quality of Chinese medicine (CM) has being an active and challenging research area for CM. Prof. Chang-Xiao Liu et al first proposed the concept of quality marker (Q-Marker) for the quality evaluation and control on CM. This article describe the exploratory studies of Q-Marker in salvianolic acids for injection (SAI) based on this new concept. PURPOSE: This study was designed to screen Q-Marker of SAI and establish its quality control method based on the concept of CM Q-Marker. METHODS: Based on the concept of CM Q-Marker, the SAI was investigated for the identification of chemical components and their sources. The pharmacological effects on cerebral ischemia and reperfusion induced injury in rats were also investigated. Furthermore, the target cell extracts and pharmacokinetic studies were conducted to screen Q-Markers. Finally, the fingerprints and determination based on Q-Markers were established to assess the quality of SAI more effectively. RESULTS: Overall, 20 constituents in SAI were identified. It was found that salvianolic acid B (SA-B), rosmarinic acid (RA), lithospermic acid (LA), salvianolic acid D (SA-D) and salvianolic acid Y (SA-Y) are major chemical components of SAI. Based on chemical components identifications, analysis of their sources, target cell extracts and pharmacokinetic studies, four phenolic acids, namely SA-B, RA, LA and SA-D, were screened and determined as effective Q-Markers of SAI. CONCLUSION: This study demonstrated that the described method is a powerful approach for detecting Q-Markers, which can be used as control index for the quality assessment of CM.