鸦胆子油亚纳米乳注射液安全性试验

Safety Evaluation of Brucea Javanica Oil Subnanoemulsion Injection

目的:考察鸦胆子油亚纳米乳注射液的安全性。方法:采用溶血性试验、过敏试验、热原试验、局部血管刺激性试验。结果:鸦胆子油亚纳米乳注射液对家兔红细胞无溶血反应,重复注射不会引起豚鼠速发型过敏反应,热原限度符合规定,局部血管有轻度刺激反应。结论:鸦胆子油亚纳米乳注射液的安全性试验结果提示其较为安全可靠,但存在轻度局部血管刺激性。

Objective： To estimate the safety of Brucea Javanica Oil Subnanoemulsion Injection.Methods： Hemolytic test,hypersensitive test,pyrogen test,vascular irritation test.Results： The test results show there is no hemolyzation or agglutination on rabbit red blood cells in vitro,there is no immediate hypersensitivity on guinea pig in vivo,and its pyrogen accords with the standard limitation,while this prep aration may produce slight local vascular stimulation.Conclusion： Brucea Javanica Oil Subnanoemulsion Injection is safe and reliable,while it may produce slight local irritation.