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目的对奥扎格雷钠注射液进行安全性评价试验和急性毒性试验,为临床应用提供依据。方法进行豚鼠全身主动过敏性试验,被动皮肤过敏性试验,体外溶血试验,血管刺激性试验及急性毒性试验,评价奥扎格雷钠注射液的安全性。结果奥扎格雷钠注射液豚鼠全身主动过敏性试验及被动皮肤过敏性试验均未见过敏反应;体外溶血试验在3h内未见溶血和凝聚现象;血管刺激性试验病理组织学检查未见血管刺激性反应。急性毒性试验小鼠在14d内无一死亡,尸检主要器官均无异常。与空白组比较,体重增长无显著性差异。结论奥扎格雷钠注射液安全、可靠;小鼠静脉注射最大给药量为500 mg/kg,为临床最大人用剂量(2.7 mg/kg)的185倍。
Objective To evaluate safety evaluation and acute toxicity test of ozagrel sodium for clinical application. Methods Guinea pig systemic active anaphylactic test, passive skin allergy test, in vitro hemolysis test, vascular irritation test and acute toxicity test were used to evaluate the safety of ozagrel sodium injection. Results Ogre sodium injection guinea pig systemic active allergic test and passive skin allergy test showed no allergic reactions; hemolysis in vitro hemolysis and coagulation within 3h; vascular irritation test histopathological examination without vascular irritation Sexual response. There was no death in acute toxicity test mice within 14 days, no abnormality was found in the main organs of autopsy. Compared with the blank group, no significant differences in body weight gain. Conclusion Ozagrel sodium injection is safe and reliable. The maximum intravenous injection dose of 500 mg / kg is 185 times of the maximum human dose (2.7 mg / kg).