柴连感冒颗粒对大鼠的长期毒性研究
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摘要
目的考察柴连感冒颗粒对大鼠的长期毒性,为其临床安全用药提供实验依据。方法将120只SD大鼠随机分为柴连感冒颗粒大、中、小剂量组(均灌胃给予柴连感冒颗粒,剂量以生药计分别为45.0,24.0,12.0 g·kg-1)及溶媒对照组(灌胃给予纯化水),每组30只,雌雄各半,20 mL·kg-1·d-1,qd,连续31 d。观察给药期间和停药14 d后大鼠的一般状况及体质量、血液学、血液生化学、脏器系数及病理组织学变化。结果与同期溶媒对照组比较,柴连感冒颗粒大剂量组体质量增长减缓,给药第7天与第14天摄食量减少,胸腺系数降低,肝脏和肾上腺系数增加,胆固醇降低,停药后逐渐恢复正常;柴连感冒颗粒中小剂量组大鼠体质量、摄食量、血液学、血液生化指标、脏器系数和病理学检查未见明显异常。结论在该实验条件下,柴连感冒颗粒对大鼠重复灌胃给药31 d的无毒反应剂量为24.0 g·kg-1,相当于临床拟用剂量的28倍。
Objective To observe the long-term toxicity of Chailian Ganmao granules on rats to provide a scientific experimental basis for clinical treatment.Methods Totally,120 SD rats were randomly divided into high,middle,low dose Chailian Ganmao granules groups and solvent control group.They were intragastrically administered with Chailian Ganmao Granules at 45.0,24.0 and 12.0 g·kg-1(in crude drugs),and 20 mL·kg-1·d-1 pure water,respectively daily for 31 d.The general condition of rats and body weight,the hematology index,blood biochemistry index,viscera coefficient and histopathological changes during administration and 14 d after drug withdrawal were observed.Results In comparison with the solvent control group,the growth of body mass was reduced in the high dose group,food consumption only in the 7 th and 14 th day decreased,the coefficient of thymus gland reduced,the coefficient of liver and adrenal gland increased,cholesterol decreased,and gradually recovered after drug withdrawal.The body weight,food intake,hematology index,blood biochemical parameters,organ coefficient and pathological examination indexes of rats were not changed significantly.Conclusion Under the experimental conditions,the non-toxic reaction dose of Chailian Ganmao granules is considered to be 24.0 g·kg-1(28 times as much as the clinical dosage) for 31 d in rats.
Objective To observe the long-term toxicity of Chailian Ganmao granules on rats to provide a scientific experimental basis for clinical treatment.Methods Totally,120 SD rats were randomly divided into high,middle,low dose Chailian Ganmao granules groups and solvent control group.They were intragastrically administered with Chailian Ganmao Granules at 45.0,24.0 and 12.0 g·kg-1(in crude drugs),and 20 mL·kg-1·d-1 pure water,respectively daily for 31 d.The general condition of rats and body weight,the hematology index,blood biochemistry index,viscera coefficient and histopathological changes during administration and 14 d after drug withdrawal were observed.Results In comparison with the solvent control group,the growth of body mass was reduced in the high dose group,food consumption only in the 7 th and 14 th day decreased,the coefficient of thymus gland reduced,the coefficient of liver and adrenal gland increased,cholesterol decreased,and gradually recovered after drug withdrawal.The body weight,food intake,hematology index,blood biochemical parameters,organ coefficient and pathological examination indexes of rats were not changed significantly.Conclusion Under the experimental conditions,the non-toxic reaction dose of Chailian Ganmao granules is considered to be 24.0 g·kg-1(28 times as much as the clinical dosage) for 31 d in rats.
引文
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[4]苏晓欧,戴益民,弓雪莲,等.毒性试验中SD大鼠常见自发性病变[J].中国药理学与毒理学杂志,2013,27(3):518.
[5]贺学英,王辉,汤菊莉,等.SD大鼠血液生化指标正常区间初步建立[J].医疗装备,2015,6(2):13-15.
[2]国家食品药品监督管理总局.药物重复给药毒性研究技术指导原则[S].国家食品药品监督管理总局,2014:53-64.
[3]谢恩C.加德.药物安全性评价[M].北京:化学工业出版社,2005:202-211.
[4]苏晓欧,戴益民,弓雪莲,等.毒性试验中SD大鼠常见自发性病变[J].中国药理学与毒理学杂志,2013,27(3):518.
[5]贺学英,王辉,汤菊莉,等.SD大鼠血液生化指标正常区间初步建立[J].医疗装备,2015,6(2):13-15.