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Postmarketing safety evaluation: depside salt injection made from Danshen (Radix Salviae Miltiorrhizae)
Alternative TitlePostmarketing safety evaluation: depside salt injection made from Danshen (RadixSalviae Miltiorrhizae)
Chang Yanpeng1; Zhang Wen1; Xie Yanming1; Xu Xiangyang3; Sun Rendi3; Wang Zheng3; Yan Ruihua3
2014
Source PublicationJOURNAL OF TRADITIONAL CHINESE MEDICINE
ISSN0255-2922
Volume34Issue:6Pages:749-753
AbstractOBJECTIVE: To systematically examine the post-marketing safety of depside salt injection made from Danshen (Radix Salviae Miltiorrhizae), identify the potential risk factors, and ensure its clinical safety.
Other AbstractOBJECTIVE: To systematically examine the postmarketing safety of depside salt injection made from Danshen (Radix SalviaeMiltiorrhizae), identify the potential risk factors, and ensure its clinical safety. METHODS: We examined a comprehensive series of studies on the production process, quality standards, pharmacology, population pharmacokinetics, and safety evaluation of depside salt injection made from Danshen (RodixSalvioeMiltiorrhizae). Data from I -IV clinical drug trials, hospital information systems (HIS), and spontaneous reporting systems (SRS) were also analyzed. RESULTS: The effective components of salvianolic acid salt content reached almost 100%, and the magnesium lithospermate B content reached more than 80%. The median lethal dose (LD50) calculated by the Bliss method was 1.49 g/kg, with 95% confidence intervals of 1.29-1.72 g/kg. Long-term tests on Beagle dogs indicated that doses of less than 80 mg/kg were safe and doses of 320 mg/kg were toxic. Adverse drug reactions (ADRs) included digestive disorders; drug-induced erythrocyte deformation in lung, liver, spleen, kidney, bone marrow, intestinal mucosa, lymph nodes, and other tissues; megakaryocytes in lung, liver, and spleen resulting from mild hemolysis; and mild hyperplasia in bone marrow hematopoietic tissue. Other studies indicated no irritative effect of the injection on local tissues and blood vessels, and no allergic reactions, erythrocyte coagulation, or hemolysis. SRS data showed that the most common ADRs were headache, head distention, dizziness, facial flushing, skin itching, thrombocytopenia, and the reversibility of elevated Aspartate transaminase. HIS data indicated no damage to renal function from using depside salt injection made from Danshen (Radix Salviae Miltiorrhizae) at a dosage higher than the recommended dose. CONCLUSION: This study analyzes the clinical characteristics of ADRs from depside salt injection made from Danshen (Radix Salviae Miltiorrhizae), and discusses the factors influencing such reactions. It provides scientific reference and recommendations for clinically safe medication of the Danshen injection.
KeywordMAGNESIUM LITHOSPERMATE-B Product surveillance postmarketing Chinese medicine Safety Danshen (Radix Salviae Miltiorrhizae) Depside salt injection
Indexed ByCSCD
Language英语
Funding Project[National Science and Technology Major Projects for "Major New Drugs Innovation and Development": Study on Key Technologies of Postmarketing Evaluation for Chinese Medicine]
CSCD IDCSCD:5305872
Citation statistics
Document Type期刊论文
Identifierhttp://ir.imr.ac.cn/handle/321006/151603
Collection中国科学院金属研究所
Affiliation1.中国科学院
2.中国科学院金属研究所
3.Shanghai Green Valley Pharmaceut Ltd, Shanghai 201203, Peoples R China
Recommended Citation
GB/T 7714
Chang Yanpeng,Zhang Wen,Xie Yanming,et al. Postmarketing safety evaluation: depside salt injection made from Danshen (Radix Salviae Miltiorrhizae)[J]. JOURNAL OF TRADITIONAL CHINESE MEDICINE,2014,34(6):749-753.
APA Chang Yanpeng.,Zhang Wen.,Xie Yanming.,Xu Xiangyang.,Sun Rendi.,...&Yan Ruihua.(2014).Postmarketing safety evaluation: depside salt injection made from Danshen (Radix Salviae Miltiorrhizae).JOURNAL OF TRADITIONAL CHINESE MEDICINE,34(6),749-753.
MLA Chang Yanpeng,et al."Postmarketing safety evaluation: depside salt injection made from Danshen (Radix Salviae Miltiorrhizae)".JOURNAL OF TRADITIONAL CHINESE MEDICINE 34.6(2014):749-753.
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