前列冲剂大鼠灌胃给药长期毒性试验  

Long-term toxicity studies of qianlie chongji implantation

作　　者：张春和[1] 林咏梅[2] 陆瑛[2] 陈天波[1] 秦国政[1] 李焱风[1] 

机构地区：[1]云南中医学院第一附属医院,云南昆明650021 [2]云南省天然药物药理重点实验室,云南昆明650031

出　　处：《云南中医中药杂志》2007年第3期38-39,共2页Yunnan Journal of Traditional Chinese Medicine and Materia Medica

基　　金：国家高技术研究发展计划(863计划)创新药物与中药现代化重大专项博士基金项目(编号:2003AA2Z3505)

摘　　要：目的:观察前列冲剂重复给药对试验动物所产生的不良反应。方法:用雄性SPF级SD大鼠80只连续灌胃给予前列冲剂6周,停药恢复2周的长期毒性试验,动物随机分为溶媒对照组和前列冲剂3.0、6.0、9.0g/kg体重3个剂量组,相当于临床成人拟用药量的20、40、60倍。于末次给药后24h处死约1/2动物进行血液学指标检查,血清生化指标检查,病理组织学检查。余下动物停药观察2周,检查指标同给药末期。结果:溶媒对照组和3个剂量给药组动物,体重增长,摄食量正常,未见明显毒性反应;血液学仅见停药期MPV组间比较有显著性差异(P<0.05),血清生化学所测指标停药期ALP、TP、ALB组间比较有显著性差异(P<0.05/0.01),但均在本研究历史背景资料范围;脏器、器官组织病理学检查未观察到与受试药物相关的病理组织学改变。结论:前列冲剂在本试验剂量范围条件下对SD大鼠未引起明显毒性反应,即3.0g/kg体重,相当于临床成人拟用药量的20倍以下为安全剂量参考范围。Objective Qianlie chongji was subjected to evaluate the long-term toxicity in rats.Methods 80 SPF grade male SD rats were implanted with qianlie chongji once daily consecutively for six weeks and then stop dosing animals for another two weeks to clean up.Animals were randomly divided into 4 groups,control and 3 doses of qianlie chongji at 3.0,6.0 and 9.0 g/kg,which is 20,40,and 60 times of the clinical dose specification respectively.In 24 hour of last implantation,half of animals in each group were sacrificed for blood testing,serum biochemistry analysis,and histological examination? The other half were sacrificed in 2 weeks for the same tests specified above.Results? Increased weight and food consumption in control group is similar to those in three dosed groups,therefore no significant toxicity indicated.Compared the results of the same group before and after clean up duration,only MPV of blood testing results(P<0.05)and ALP,TP as well as ALB of serum biochemical testing results are significantly different(P<0.05/0.01),however,which,however,are all in the normal range according to the historically statistical data.In addition,no significantly histological change related to visceral is observed.Comment No significant toxicity of?qianlie chongji is observed in SD rats dosed at 3.0 g/kg,20 times less than which is clinical adult safe dose.

关 键 词：前列冲剂 长期毒性 动物试验 

分 类 号：R285.5[医药卫生—中药学]