BCG-CpG-DNA重复给药对家兔的安全性评价  

Safety Evaluation of Repeated Administration with BCG-CpG-DNA in Rabbits

作　　者：蔡皇界[1] 赵爱华[2] 王雯 李凤祥[2] 王国治[2] 吴小南[1] 

机构地区：[1]福建医科大学公共卫生学院营养与保健医学系,福州350004 [2]中国食品药品检定研究院 [3]安徽龙科马生物制药有限公司

出　　处：《中国药事》2011年第5期430-433,共4页Chinese Pharmaceutical Affairs

基　　金：十一五863课题(编号2006AA02A240)

摘　　要：目的观察BCG-CpG-DNA对家兔的毒性作用,进行安全性评价。方法用BCG-CpG-DNA 100、250、500μg在28d内分7次对家兔进行肌肉免疫,大腿股四头肌局部刺激,对照组注射等量生理盐水。观察每次注射后注射局部变化情况,末次免疫后2d检测血液学、血液生化学指标及主要脏器系数,观察注射局部肌肉刺激情况,并取注射部位肌肉和主要免疫器官做病理学检查。结果 BCG-CpG-DNA重复给药后肉眼观察对注射部位皮肤和肌肉无明显刺激作用;血液学结果显示可提高免疫细胞的数量,对血液学其他指标、血液生化学指标和脏器系数无明显的影响;病理学检查结果提示BCG-CpG-DNA引起注射部位肌肉的轻微炎症反应,对主要免疫器官无影响。结论 BCG-CpG-DNA对家兔具有较好的安全性。Objective To observe the toxicities of BCG-CpG-DNA in rabbits and evaluate its safety.Methods 12 rabbits were divided into one control and three test groups.The rabbits were i.m.injected for 7 times in the quadriceps femoris,while those in three test groups each time with 100,250 and 500μg of BCG-CpG-DNA.The changes of local injection skin were observed after each injection.The hematological,blood biochemical and main organ coefficients were determined 2 days after the last injection.Then observe the changes on local muscle after dissect and check for the local muscle and main immune organ on pathology.Results After repeat administration with BCG-CpG-DNA,there is no visual change in local muscle and skin;the immune cell counts in the blood increased and no abnormalities in the other hematological indexes,blood biochemical and main organ coefficients.The result of pathology is that BCG-CpG-DNA caused inflammation in the local muscle and did not affect those main immune organ.Conclusion BCG-CpG-DNA has good safety in rabbits.

关 键 词：BCG-CPG-DNA 毒性 安全性评价 

分 类 号：R967[医药卫生—药理学]