Comprehensive Pharmacological Evaluation of Salvia Miltiorrhiza Depside Salts for Injection
HAN Sheng1, ZHAO Xi-zi1, SHI Lu-wen1*, LIN Li-kai2, LI Da-kui3, CHEN Kai-xian4, XUAN Li-jiang4, MA Chuan-jiang5, MA Hai-ying6, FANG Wei-yi7, WANG Li-xia8, WEN Ai-dong9, FU Xiu-juan10, ZUO Yan11, LIU Xiao-ling12, LIU Xiang-hong13, LIU Guo-qiang14, ZHU Zhu3, CHEN Wan-sheng15, CHEN Wei-hong16, WU Fang-jian17, WU Yu-bo18, WU Hui19, ZHANG Wei20, ZHANG Bi-kui21, LIN Hui22, ZHOU Guo-hua 23, OUYANG Rong24, HU Yuan-hui8, JIANG Ming-yan25, ZHAO Chun-jing26, JIA Le-chuan27, JIN Yue-ping28, TANG Hong-mei29, CAO Jun-ling30, LIANG Chun15, SHANG Hong-cai31, DONG Zhan-jun32, DONG Yu-gang33, ZHAI Suo-di34
1. Peking University International Research Center for Medical Administration, Beijing 100191, China; 2. Wuhan University Central South Hospital, Wuhan University Hospital Management Institute, Wuhan 430071, China; 3. Peking Union Medical College Hospital, Beijing 100730, China; 4. Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China; 5. Shandong Traditional Chinese Medicine University Hospital, Jinan 250014, China; 6. The Fourth Affiliated Hospital of China Medical University, Shenyang 110000, China; 7. East China Hospital Affiliated to Fudan University, Shanghai 200030, China; 8. Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China; 9. PLA Air Force Military Surgeon The First Affiliated Hospital of University, Xi'an 710032, China; 10. The Second Hospital of Jilin University, Changchun 130041, China; 11. Shaanxi Provincial People's Hospital, Xi'an 710068, China; 12. Inner Mongolia Autonomous Region People's Hospital, Hohhot 010017, China; 13. Qilu Hospital of Shandong University, Jinan 250012, China; 14. The Third Hospital of Hebei Medical University, Shijiazhuang 050051, China; 15. Shanghai Changzheng Hospital, Shanghai 200003, China; 16. Shanxi Bethune Hospital (Shanxi Academy of Medical Sciences), Taiyuan 030032, China; 17. Yangtze River Shipping General Hospital, Wuhan 430015, China; 18. The Fourth Affiliated Hospital of Harbin Medical University, Harbin 150001, China; 19. The First Affiliated Hospital of Kunming Medical University, Kunming 650032, China; 20. Henan Provincial People's Hospital, Zhengzhou 450003, China; 21. The Second Xiangya Hospital of Central South University, Changsha 410011, China; 22. Hainan Province Pharmaceutical Association, Haikou 570102, China; 23. Jinling Hospital Affiliated to Nanjing University School of Medicine, Nanjing 210000, China; 24. The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Changsha 410007, China; 25. The First Affiliated Hospital of China Medical University, Shenyang 110001, China; 26. Chongqing Medical University, The Second Affiliated Hospital of University, Chongqing 400010, China; 27. The General Hospital of Ningxia Medical University, Yinchuan 750004, China; 28. The First Hospital of Shanxi Medical University, Taiyuan 030001, China; 29. The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, China; 30. Beijing Zhong Eastern Hospital of Medical University, Beijing 100078, China; 31. Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100007, China; 32. Hebei Provincial People's Hospital, Shijiazhuang 050051, China; 33. The First Affiliated Hospital of Sun Yat-sen University, Guangzhou 510080, China; 34. Peking University Third Hospital, Beijing 100191, China
Abstract:OBJECTIVE To explore the comprehensive evaluation method of traditional Chinese medicine injection, and to provide reference for the development and improvement of related work in the future. Taking Salvia Miltiorrhiza depside salts for injection as an example. METHODS Through literature and relevant literature materials, comprehensive pharmacological evaluation of Salvia Miltiorrhiza depside salts for injection was carried out in terms of pharmaceutical properties and quality. RESULTS In terms of active ingredients and drug mechanism of action, Salvia Miltiorrhiza depside salts has undergone a lot of basic research. The literature on quality is also abundant. CONCLUSION The research and exploration of Salvia Miltiorrhiza depside salts for injection has a wide range of pharmaceutical properties, and related basic research needs to be further explored.
DONG P X, HU H, GUAN X D, et al. Cost-consequence analysis of salvianolate injection for the treatment of coronary heart disease[J]. Chin Med, 2018, 13(10):28 .
[4]
ZHANG J H, SUN X. Evidence-based Chinese Medicine(循证中医药学)[M]. Shanghai: Shanghai Science and Technology Press, 2018: 184-186.
[5]
SHI L W, ZHU W T, WU J, et al. Technical Manual of Pharmacoeconomic Evaluation of Chinese Patent Medicine(中成药药物经济学评价手册)[M]. Beijing:Peking Union Medical College Press, 2019:1-2.
[6]
PROJECT TEAM OF GUIDELINES FOR COMPREHENSIVE EVALUATION OF CHINESE DRUGS. Reference Outline of Chinese Guidelines for Comprehensive Evaluation of Drugs (Second Edition)[J]. Pharm Eval(药品评价), 2015,12(8):6-14.
[7]
Group of Guideline for Comprehensive Evaluation of Medicine in China. Guideline for comprehensive evaluation of medicine in China[J]. Drug Eval, 2011, 8(18): 6-22.
[8]
WU W Y, WANG Y P. Pharmacological actions and therapeutic applications of salvia miltiorrhizadepside salt and its active components[J]. Acta Pharm Sin(药学学报), 2012, 47(9):1119-1130.
[9]
LIU Y L, ZHOU X Y, XUAN L J. Magnesium lithospermate B ameliorates microcirculation perfusion in rats by promoting vascular NO production via activating the PI3K/AKT pathway[J]. Acta Pharm Sin(药学学报), 2019,54(3):1-9.
[10]
CHANG C Z, WU S C, KWAN A L, et al. Magnesium lithospermate B alleviates the production of endothelin-1 through an NO-dependent mechanism and reduces experimental vasospasm in rats[J]. Acta Neurochir, 2011, 153(11):2211-2217.
[11]
ZHANG Y. Effect of salvia miltiorrhiza polyphenolate on serum inflammatory factors in acute coronary syndrome and clinical observation[J]. Foreign Med(Antibiotics), 2014, 35(5):230-232.
[12]
ZHANG H, ZHANG Y, YANG R, et al. Related research on the effect of salvia miltiorrhiza polyphenolate on inflammatory factors in patients with acute coronary syndrome[J]. Chin J Integr Tradit Chin Western Med(中国中西医结合杂志), 2013, 33(5):598-601.
[13]
XIONG T, WU X J, WANG Y P. Salvia miltiorrhiza polyphenolate inhibits oxidative modification of low density lipoprotein[J]. Pharm Clin Chin Mater Med, 2004, (4):7-10.
[14]
LI B, LI X, MA X L, et al. Study on the protective effect and mechanism of salvia miltiorrhiza polyphenolate on isolated rat heart ischemia-reperfusion injury[J]. China Emerg Tradit Chin Med(中国中医急症), 2018, 27(5):854-857.
[15]
SHEN J L, ZHU K J, LI Z N, et al. Protective effects of salvia miltiorrhiza polyphenolate pretreatment on myocardial ischemia-reperfusion injury in rats[J]. J Clin Cardiovascular Dis, 2012, 28(9): 707-710.
[16]
XU J P, SUN L S, WU H Y, et al. Protective effects of salvianolic acid B on myocardial ischemia/reperfusion injury in rats[J]. Chin Pharm J(中国药学杂志), 2003,38(8):595-597.
[17]
YAN P, LUO X P, SHI H M, et al. Clinical study on the effect of salvia miltiorrhiza polyphenolate on platelet function[J]. Mod J Int Tradit Chin Western Med(现代中西医结合杂志), 2005, 14(16):2092-2094.
[18]
WANG W, WANG Y P, SUN W K, et al. Effects of magnesium lithospermate B on aggregation and 5-HT release in rabbit washed platelets[J]. Acta Pharmacol Sin, 2000, 21(9):859-863.
[19]
CHEN Y H, DU G H, ZHANG J T. Salvianolic acid B protects brain against injuries caused by ischemia-reperfusion in rats[J]. Acta Pharmacol Sin, 2000, 21(9):463-466.
[20]
TZEN J T, JINN T R, CHEN Y C, et al. Magnesium lithospermate B possesses inhibitory activity on Na+, K+-ATPase and neuroprotective effects against ischemic stroke[J]. Acta Pharmacol Sin, 2007,28(5):609-615.
[21]
YAO G, XU L, WU X, et al. Preventive effects of salvianolic acid B on transforming growth factor-beta1-induced epithelial-to-mesenchymal transition of human kidney cells[J]. Biol Pharm Bull, 2009, 32(3):882-886.
[22]
PAN R H, XIE F Y, CHEN H M, et al. Salvianolic acid B reverses the epithelial-to-mesenchymal transition of HK-2 cells that is induced by transforming growth factor-beta[J]. Arch Pharm Res, 2011, 34(3):477-483.
[23]
WANG Q L, TAO Y Y, YUAN J L, et al. Salvianolic acid B prevents epithelial-to-mesenchymal transition through the TGF-beta1 signal transduction pathway in vivo and in vitro[J]. BMC Cell Biol, 2010,11(11):31.
[24]
LIN Y L, WU C H, LUO M H, et al. In vitro protective effects of salvianolic acid B on primary hepatocytes and hepatic stellate cells[J]. J Ethnopharmacol, 2006, 105(1-2):215-222.
[25]
PAIK Y H, YOON Y J, LEE H C, et al. Antifibrotic effects of magnesium lithospermate B on hepatic stellate cells and thioacetamide-induced cirrhotic rats[J]. Exp Mol Med, 2011,43(6):341-349.
[26]
TSAI M K, LIN Y L, HUANG Y T. Effects of salvianolic acids on oxidative stress and hepatic fibrosis in rats[J]. Toxicol Appl Pharmacol, 2010, 242(2): 55-164.
[27]
JIANG F, MAO Y, LIU H, et al. Magnesium lithospermate B protects neurons against amyloid beta (1-42)-induced neurotoxicity through the NF-kappaB pathway[J]. Neurochem Res, 2015, 40(9):1954-1965.
[28]
MU D G, JIN F G, CHU D L, et al. Experimental study of salvia miltiorrhiza polyphenolate on the prevention and treatment of acute lung injury[J]. J Pract Med(实用医学杂志), 2010, 26(15):2717-2719.
[29]
YANG D H, YE Z Y, HE X J, et al. Salvia miltiorrhiza polyphenolate improves intestinal mucosal barrier function in rats with experimental liver cirrhosis[J]. Chin J Clin Pharmacol Therapeut(中国临床药理学杂志), 2010, 15(7):758-763.
[30]
JIANG X Y, RONG L, XIA T T, et al. Salvia miltiorrhiza polyphenolic acid modulates NOD-like receptor family including pyrin domain protein 3 inflammasome activity in the treatment of murine colitis[J]. Chin J Digest(中华消化杂志), 2017, 37 (9):619-623.
[31]
LIU G T, CHEN Q, JIN L M, et al. Salvia miltiorrhiza polyphenolate combined with povidone iodine to prevent postoperative intestinal adhesions in rats[J]. Zhejiang J Integr Tradit Chin Western Med(浙江中西医结合杂志), 2015, 25(6):538-541.
[32]
ZHANG B, XIE Q P, CHEN S. Experimental study of salvia miltiorrhiza polyphenolate in preventing vascular crisis of DIEP flap in miniature pigs[J]. Zhejiang Med(浙江医学), 2014, 36(6):494-496.
[33]
SONG S H, GUO W Y, FU Z R, et al. Donor liver salvia polyphenolate pretreatment reduces biliary tract injury after liver transplantation in recipient rats[J]. J Second Mil Med Univ(第二军医大学学报), 2010, 31(2):136-139.
[34]
LI X, YU C, LU Y, et al. Pharmacokinetics, tissue distribution, metabolism, and excretion of depside salts from Salvia miltiorrhiza in rats[J]. Drug Metab Dispos, 2007, 35(2):234-239.
[35]
LI X, YU C, SUN W, et al. Simultaneous determination of magnesium lithospermate B, rosmarinic acid, and lithospermic acid in beagle dog serum by liquid chromatography/tandem massspectrometry[J]. Rapid Commun Mass Spectrom, 2004, 18(23):2878-2882.
[36]
JIA J Y, LU Y L, LI X C, et al. Pharmacokinetics of depside salts from Salvia miltiorrhiza in healthy Chinese volunteers: a randomized, open-label, single-dose study[J]. Curr Ther Res, 2010, 71(4):260-271.
[37]
GAO R, ZHANG Y, WANG S C. Pharmacokinetics and pharmacodynamics of salvianolic acid in healthy volunteers[J]. Chin J Clin Pharm Ther(中国临床药理学与治疗学杂志), 2004, 9(11):1209-1212.
[38]
ZHANG Y, GAO R, et al. Pharmacokinetics of salvianolic acid B in patients with coronary heart disease and blood stasis syndrome[J]. Pharm Clin Chin Mater Med(中药药理与临床), 2010, 26(6):22-24.
[39]
LU S W, GUO J Y, ZHU Y L. Analysis of the use of Salvia miltiorrhiza polyphenolate for injection in tertiary first-class hospitals[J]. China Med Herald(中国医药导报), 2014, 11(36):96-99.
[40]
ZHOU X, GUO D H, ZHU M, et al. Observation and study on the clinical application of Salvia Miltiorrhiza Polyphenolate for injection in diabetic patients[J]. Chin J Drug Appl Monitor(中国药物应用与监测), 2014, 11(3):142-145.
[41]
WANG Z Z. Study on the stability of Salvia Miltiorrhiza Polyphenolate for injection and 12 solvents[J]. Chin Pharm(中国药师), 2009, 12(6):774-776.
[42]
GAO Y C, SU L L, ZHAO Z G. A case report of allergic reaction caused by compound Danshen injection[J]. Chin Pharm J(中国药学杂志), 2007,42(18):1439.
[43]
GONG C Y, SHEN G Q, CHEN L. Compatible application of compound Danshen injection with fleroxacin glucose injection[J]. Jiangsu Pharm Clin Res(江苏药学与临床研究), 2004,(S1):27-28.
[44]
WANG Z Y, TONG A, TANG H. Tashinone ⅡA sodium sulfonate and potassium chloride exist compatibility taboo[J]. Acta Nur Care(护理学报), 2009, 16(2):73.
[45]
LIU W, DU X F, ZHANG M L, et al. Study on the stability of phenolic acids in the compatibility of Danhong injection and vitamin B6 injection[J]. J Hebei Med Univ(河北医科大学学报), 2009, 30(6):582-584.
[46]
ZHANG M L, WANG L Y, ZHANG J R, et al. Study on the stability of the compatibility of Danhong injection with several common clinical drugs[J]. Hebei Med(河北医药), 2008(9):1422-1423.
[47]
CAO J Y. There are contraindications in the compatibility of tanshinone ⅡA sodium sulfonate and potassium chloride in the same syringe[J]. Anhui Med(安徽医药), 2010, 14(5):595.
[48]
LIN P. Intervention of botanical drugs for risk factors of cardiovascular and cerebrovascular diseases and changes in compatibility[J]. Pract J Cardio-Cerebral Pneumal Vascul Dis(实用心脑肺血管病杂志), 2009, 17(10):897-898.
[49]
YU M M. Salvia Miltiorrhiza Polyphenolate for injection and amoxicillin sodium for injection and flucloxacillin sodium for injection have contraindications[J]. Chin J Mod Nur(中华现代护理杂志), 2011, 17(22):2712-2712.
[50]
CHEN Y, LIU Q Q, XIAO Y T. Study on the stability of compatibility of cefmetazole sodium for injection with two drugs[J]. J China Pharm(中国药房), 2012, 23(18):1679-1681.
[51]
ZHOU X H. There are contraindications between Salvia miltiorrhiza polyphenolate for injection and Ciprofloxacin lactate and sodium chloride injection[J]. Chin J Pract Nurs(中国实用护理杂志), 2013,29(15):14.
[52]
LUO L X, LIU D P, XIA F Q. Salvia Miltiorrhiza Polyphenolate for injection and potassium magnesium aspartate injection have contraindications[J]. Med Nat Defense Southwest China(西南国防医药), 2011, 21(12):1362.
[53]
REN X, XIE N, XU X Y, et al. Study on the stability of compatibility of Salvia miltiorrhiza polyphenolate for injection with 21 common clinical drugs[J]. China Pharm(中国药业), 2012, 21(2):22-25.
[54]
LI S, LIANG L, LIU J, et al. Salvia Miltiorrhiza Polyphenolate for injection and fasudil hydrochloride injection have compatibility contraindications[J]. Chin J Lung Dis(Elec Ed)(中华肺部疾病(电子版)), 2013, 6(5): 415.
[55]
ZHANG H L. There are contraindications between Salvia Miltiorrhiza Polyphenolate for injection and Cinepazide maleate injection[J]. North China Nat Defense Med(华北国防医药), 2011, 22(4):138.
[56]
DENG L, ZHANG J H, LIU X. There is a contraindication between Vinpocetine injection and Salvia Miltiorrhiza Polyphenolate for injection[J]. J Clin Rat Use(临床药理学用药杂志), 2013, 6(26):90.
[57]
REN X, et al. Study on the stability of compatibility of Salvia Miltiorrhiza Polyphenolate for injection with 21 common clinical drugs[J]. China Pharm(中国药业), 2012, 21(2):22-25.
[58]
LU Y L. Omeprazole sodium for injection and Salvia Miltiorrhiza Polyphenolate for injection have contraindications[J]. Chin J Mod Nur(中国现代护理杂志), 2011, 17(9):1074.
[59]
WANG Y X. There is a contraindication between Salvia Miltiorrhiza Polyphenolate for injection and Lansoprazole for injection[J]. Chin J Misdiag(中国误诊学杂志), 2011, 11(15):3728.
[60]
LU Z X, ZHONG Y X, BAN F, et al. Pantoprazole sodium for injection and Salvia Miltiorrhiza Polyphenolate for injection have contraindications[J]. Qilu J Nur(齐鲁护理杂志), 2011, 17(12):20.
[61]
LI Y Z, WEI F L. SSalvia Miltiorrhiza Polyphenolate for injection and ondansetron hydrochloride have contraindications[J]. J Clin Rat Use(临床合理用药), 2012, (3):70.
[62]
HUANG L L. There is a contraindication between Salvia Miltiorrhiza Polyphenolate for injection and papaverine hydrochloride[J]. Contem Nur(当代护士), 2016, (3):117.
[63]
LIN X M. Study on the compatibility and stability of Danshen injection[J]. Chin J Drug Eval(中国药学评价), 2016, 33(1):20-23.
[64]
MO Y Y. The observation experience of the compatibility of compound Danshen injection with three drugs[J]. J Guilin Med College(桂林医学院学报), 1996,(S1):97-98.
[65]
HUANG T Y, SHI S Y, ZHOU L Q. Reevaluation of the stability of Salvia Miltiorrhiza Polyphenolate for injection[J]. Chin J Biochem Pharm(中国生化药物杂志), 2016, 3(36):157-162.