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马来酸环嘧耐平注射液特殊安全性实验研究

Safety Study on Cycpyrimidiniping Maleate Injection
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摘要 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。 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.
机构地区 辽宁大学药学院
出处 《时珍国医国药》 CAS CSCD 北大核心 2012年第1期14-16,共3页 Lishizhen Medicine and Materia Medica Research
基金 国家"十二五"规划"重大新药创制"重大科技专项资助项目(No.2011ZX09102-007-02) 辽宁大学"211工程"三期建设重点资助项目
关键词 马来酸环嘧耐平 血管刺激性 溶血性 过敏性 Cycpyrimidiniping Maleate Vascular irritation test Hemolysis test Allergy test
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参考文献3

  • 1徐利锋.芳杂环并嘧啶衍生物和类似物及其制备方法和用途[P]中国专利:101671336A,2010-03-17.
  • 2徐叔云,等.药理试验方法学第3版[M].北京:人民卫生出版社,2002:1042.
  • 3化学药物刺激性、过敏性和溶血性研究技术指导原则[S].2005:10-13.

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