摘要
目的通过临床前动物试验评价重组结核分枝杆菌11kDa变态反应原的安全性。方法通过小鼠的急性毒性试验、豚鼠的一般安全性试验、致敏效应试验、全身过敏试验以及家兔的热原试验等评价重组结核分枝杆菌11kDa变态反应原在动物体内的安全性和耐受性。结果重组结核分枝杆菌11kDa变态反应原未引起小鼠的急性毒性、豚鼠的迟发型超敏反应、全身过敏反应和家兔的热原反应;在豚鼠的安全性实验中未见重组结核分枝杆菌11kDa变态反应原对动物注射部位、体重及各脏器有不良影响。结论重组结核分枝杆菌11kDa变态反应原具有良好的安全性。
Objective To investigate the safety of recombinant mycohacterium tuberculosis 1 lkDa allergen in preclinical animal studies. Methods The safety and tolerability of recombinant mycobacterium tuberculosis 1 lkDa allergen was evaluated through the acute toxicity test in mice as well as the general security,sensitization test and systemic anaphylaxis tests in guinea pigs,and the pyrogen test in rabbits. Results The recombinant Mycobacterium tuberculosis 1 lkDa allergen did not cause any toxicity reaction in mice,delayed type hypersensitivity and systemic allergic reaction in guinea pigs.It also had no adverse effects on the injection site, weight and other organs in guinea pigs of general security test.Meanwhile,it did not cause pyrogen reaction in rabbits. Conclusion Recombinant mycobacterium tuberculosis 1 lkDa allergen has a good safety profile in preclinical evaluation.
出处
《中国医药科学》
2012年第11期27-29,共3页
China Medicine And Pharmacy
基金
"艾滋病和病毒性肝炎等重大传染病防治"科技重大专项(2009ZX10004-803)
重庆市卫生局课题(2009-2-326)
