摘要
目的研究30 d重复皮肤涂抹利多卡因凝胶对豚鼠产生的毒性反应。方法利多卡因凝胶高、中、低剂量(40、20、10 g/kg)连续皮肤涂抹给药30 d,整个试验期间观察动物的临床症状,测定体质量和摄食量,分别于给药30 d及停药后14 d取部分豚鼠进行血液学、血清生化学、脏器系数和病理组织学检查。结果豚鼠未出现因给药而引起的异常症状,各给药组豚鼠体质量增长和摄食正常;利多卡因凝胶在10、20 g/kg剂量下,豚鼠血液学、血清生化学、脏器系数和病理组织学等均未见毒理学意义的异常改变;40 g/kg利多卡因凝胶导致豚鼠血清K^+水平,肾上腺质量及系数明显增高(P<0.05),但脏器未出现毒性病理改变;停药14 d后,上述异常指标恢复正常,也未见其他延迟毒性。结论在本试验条件下,皮肤涂抹利多卡因凝胶对豚鼠无明显毒性,无毒反应剂量为20 g/kg。
Objective To observe the toxic reaction of lidocaine gel on guinea pig by long-term drug toxicity. Methods Daily dermal administration of lidocaine gel at 40, 20, and 10 g/kg for 30 d was used for high, medium, and low dose groups, respectively. Clinical observation, examination of body weight, and feed consumption were performed during whole experimental stage, and then, the hematology, blood-biochemics, organ coefficient, and pathohistology were examined in the end administration period and recovery period, respectively. Results No abnormity was found in all guinea pigs in terms of appearance, behavior, body weight and food consumption. Lidocaine gel has no toxicological abnormal changes of hematology, blood-biochemics, and pathohistology during end administration and convalescent periods at dose of 20 and 10 g/kg. Lidocaine gel of 40 g/kg significantly enhanced the levels of K~＋, and adrenal gland weight and coefficient in end administration period（P 0.05）, but toxicological abnormal change of pathohistology was not found, then above changed index regained normal and no other flaccid toxicity also was found in recovery period. Conclusion In the situation of this experiment, repeated dermal administration of lidocaine gel dose not lead to significant toxicity, and 20 g/kg of lidocaine gel is the non-toxic reaction dosage.
作者
吴虓飞
高晓欣
胡宇驰
曹春然
高阳
吕晶
WU Xiao-fei GAO Xiao-xin HU Yu-chi CAO Chun-ran GAO Yang LV Jing(Drug Safety Evaluation Center, Beijing Institute for Drug Control, Beijing 100035, China)
出处
《药物评价研究》
CAS
2016年第5期786-791,共6页
Drug Evaluation Research
关键词
利多卡因凝胶
长期毒性
皮肤给药
豚鼠
血清生化
脏器系数
病理组织学
lidocaine gel
long-term toxicity
dermal administration
guinea pig
blood-biochemics
organ coefficient
pathohistology
