摘要
目的研究连续静脉给予鸦胆子油乳注射液对SD大鼠产生的毒性反应。方法鸦胆子油乳注射液(含总酸量以[油酸]计)1000、330、100 mg.kg-1.d-(1高、中、低剂量)连续静脉给药26周,分别于给药13周、给药26周及停药后6周时取部分大鼠进行血液学指标、血液生化学指标、病理组织学检查。结果高剂量组所有大鼠出现稀便、皮毛无光泽、精神萎靡等反应,其中3只大鼠死亡,死亡前表现为俯卧不动、呼吸急促、嘴角出现红色血样物,死亡率7.5%。高、中剂量可导致大鼠体重增长明显减慢。高剂量在给药26周时可导致大鼠血清ALT、AST、BUN、CR明显升高(P<0.05),停药6周后恢复正常。高剂量组死亡动物肺脏肺泡壁毛细血管扩张充血,肺泡腔内可见大量均质淡红染水肿液,弥散性分布。结论长期大剂量给予鸦胆子油乳注射液,可导致SD大鼠出现肝脏和肾脏功能损伤及急性肺水肿。大鼠无毒反应剂量为100 mg.kg-1.d-1。
Objective To observe the long-term toxicity of the Brucea Jananica Oil Injection by repeated intravenous injection. Methods Daffy doses ofBrucea Jananica Off Injection（content of acid by means of olegic acid） at 1000 mg ·kg^-1·d^-1 330mg·kg^-1·d^-1 and 100mg·kg^-1·d^-1 for 26 week were used for high, mid and low dose group, respectively. Examinations including haematological indexes, biochemical indexes and histopathology were performed on the 13th week, on the 26th week during the administration, and on the 6th week after the withdrawal, respectively. Results The rats in high dose group appeared diarrhea, depressed and the fur lacked luster during the administration. Three animals died and appeared face lying, breathlessness, blood excretion at the angulus oris in extremis. The mortality was 7.5% in high dose group. The high and mid doses inhibited the animals＇ body weight growth. The levels of ALT, AST, BUN and CR in blood serum in high dose group were significantly higher than those in control group on the 26th weeks after administration（P 〈0.05 ）. Those changed indexes of hematology and blood biochemistery regained normal on the 6th weeks after withdrawal. The lung of dead rats in high dose group appeared pathological changes, micrangium in alveolar wall displayed distension and congestion, and there was considerable erythroic fluid in alveolar space. Conclusion Repeated administration of the Brucea Jananica Oil Injection at high dose could lead to damage to liver and kidney function and acute pulmonary edema. The no observed adversed effect level （NOAEL） of the Brucea Jananica Oil Injection on rats was 100mg·kg^-1·d^-1.
出处
《中国药物警戒》
2013年第6期330-333,共4页
Chinese Journal of Pharmacovigilance
关键词
鸦胆子油乳
大鼠
长期毒性
Brucea Jananica Oil
rat
long-term toxicity
