一类创新药苯胺洛芬注射液制剂安全性评价研究

Experiment for Security Evaluation of Class Ⅰ New Drug of Felbinac Trometamol Injection

目的评价苯胺洛芬注射液的制剂安全性,为新药研发提供试验依据。方法选用新西兰兔,Hartly豚鼠、SD大鼠为研究对象,对苯胺洛芬注射液进行了局部刺激性、溶血性和过敏性的研究。结果苯胺洛芬注射液体外对兔的红细胞无溶血和聚集作用,多次给药对兔耳缘静脉血管及单次给药对兔肌肉液也均无明显刺激作用;对豚鼠和SD大鼠均无致敏作用。结论苯胺洛芬注射液相关安全性检测结果符合新药申报要求。

Objective To study the security of Beanluofen injection, so as to provide foundation for clinical research. Methods New Zealand rabbits, Hartly guinea pigs, SD rat were selected in this study, the reaction of Beanluofen injection on local irritation, hemolytic and allergic were studied. Results Beanluofen injection had no hemolyzation and aggregation effect on rabbit erythrocyte in vitro, and no obvious stimulation effect on ear vein of New Zealand rabbit when treated with multiple dose, and no obvious stimulation effect on muscle of the New Zealand rabbit when treated with single dose. No allergic reaction on Hartly guinea pigs and SD rat were observed. Conclusion The security test results of Felbinac Trometamol injection can fit the application requirements of the new drug.