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纸质出版日期:2013
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谢暕, 王军成, 王爱武. 3种中药注射液安全性评价[J]. 中国实验方剂学杂志, 2013,19(16):263-267.
XIE Jian, WANG Jun-cheng, WANG Ai-wu. Safety Evaluation of Three Traditional Chinese Medicine Injections[J]. Chinese journal of experimental traditional medical formulae, 2013, 19(16): 263-267.
谢暕, 王军成, 王爱武. 3种中药注射液安全性评价[J]. 中国实验方剂学杂志, 2013,19(16):263-267. DOI: 10.11653/syfj2013160263.
XIE Jian, WANG Jun-cheng, WANG Ai-wu. Safety Evaluation of Three Traditional Chinese Medicine Injections[J]. Chinese journal of experimental traditional medical formulae, 2013, 19(16): 263-267. DOI: 10.11653/syfj2013160263.
目的: 评价血栓通注射液、苦碟子注射液和喜炎平注射液的安全性。 方法: 采用主动全身过敏试验、被动皮肤过敏试验、血管刺激性试验和体外溶血试验考察以上3种中药注射液的安全性。 结果: 主动全身过敏试验中阳性对照过敏反应呈极强阳性
3种注射液均未见过敏反应
各组豚鼠的体重变化未见明显差异;被动皮肤过敏试验中
阳性对照组各动物均出现蓝斑
且直径>5 mm
血清IgE含量明显增高(P<0.01)
3种注射液均未出现直径>5 mm的蓝斑
血清IgE含量未见明显改变;血管刺激性试验中
各组动物的左耳和右耳给药局部血管肉眼观察均未见任何刺激反应症状
病理学结果显示给药结束及恢复期
实验动物双耳血管及周围组织均未见明显异常;体外溶血试验中
3种注射液均末见溶血或凝集现象。 结论: 血栓通注射液、苦碟子注射液和喜炎平注射液在该实验条件下安全可靠。
Objective: Evaluate thesafety of Xueshuantong Injection
Kudiezi Injection and Xiyanping Injection. Method: Active systemic anaphylaxis (ASA) test
passive cutaneous anaphylaxis (PCA) test
vascular irritation test and In vitro hemolysis test were used to evaluate the safety of three traditional Chinese medicine injections (TCMI). Result: In the ASA test
positive control group showed strong anaphylaxis effect
three TCMI didn't produce allergic reaction and body weight of all groups showed no significant differences. In the PCA test
all rats of positive control group caused blue spots of which the diameters were all greater than 5 mm and the IgE were significantly increased. However
three TCMI didn't produce blue spots of which the diameters were greater than 5 mm and the IgE levels showed no significant differences compared with negative control group. In the vascular irritation test
local blood vessels by near the administration site of both left and right ears of the animals did not observe irritative reaction symptoms
pathology results showed that after administration and recovery phase
blood vessels and surrounding tissues of auresunitas of the animals didn't appear apparent abnormality. In vitro hemolysis test showed that no haemolysis or agglutination phenomenon were induced by any of the three TCMI. Conclusion: Xueshuantong Injection
Kudiezi Injection and XiyanpingInjection were safety under these experimental conditions.
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