3种中药注射液安全性评价

Safety Evaluation of Three Traditional Chinese Medicine Injections

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。

Injection. Method ： irritation test and In injections （TCMI）. Objective： Evaluate thesafety of Xueshuantong Active systemic anaphylaxis （ASA） test, passive Injection, Kudiezi Injection and Xiyanping cutaneous anaphylaxis （PCA） test, vascular vitro hemolysis test were used to evaluate the safety of three traditional Chinese medicine Result： In the ASA test, positive control group showed strong anaphylaxis effect, three TCMIdidn＇ 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.