马来酸环嘧耐平注射液特殊安全性实验研究

目的观察马来酸环嘧耐平注射液的血管刺激性、溶血性和过敏性,为其临床静脉给药的安全性提供参考。方法刺激性采用家兔同体左右侧自身对比法;溶血性采用常规体外试管法;过敏性采用豚鼠全身主动过敏实验(ASA)和大鼠被动皮肤过敏实验(PCA)。结果马来酸环嘧耐平注射液对家兔耳静脉给药部位无明显刺激性;对家兔红细胞无溶血和凝集反应;豚鼠全身主动过敏实验和大鼠被动皮肤过敏实验均呈阴性。结论实验所用的马来酸环嘧耐平注射液静脉滴注给药符合临床用药安全性要求。

Safety Study on Cycpyrimidiniping Maleate Injection

Objective To investigate the vascular irritation,haemolyticus and allergia of Cycpyrimidiniping Maleate injection for the sake of safe clinical administration. Methods Irritation was observed by comparing left and right side of body;haemolyticus was determined by conventional haemolytic in vitro test tube method and active systematic allergic guinea pig test(ASA) and the rat passive cutaneous anaphylaxis test(PCA) were used as sensitization testing. Results Test of Cycpyrimidiniping Maleate injection showed that intravenous drip showed no obvious irritation.No hemolysis of rabbit red blood cells and the agglutination were observed and negative results in both active systematic allergic test on guinea pig and passive cutaneous anaphylaxis test on rat. Conclusion The Cycpyrimidiniping Maleate injection meets the security requirement for clinical administration.