中国药理学与毒理学杂志2023，Vol.37Issue(12)：895-903,9.DOI:10.3867/j.issn.1000-3002.2023.12.002
中药复方馥感啉口服液对不同年龄段SD大鼠发育毒性
Developmental toxicity of Fuganlin oral liquid in SD rats of different ages
摘要
Abstract
OBJECTIVE To investigate the potential developmental toxicity and delayed toxicity of Fuganline oral liquid(FGLOL)after long-term administration in juvenile SD rats via a three-stage juve-nile animal study(JAS).METHODS Stage 1:according to the proposed clinical dose for infants within one year of age,FGLOL 3.88,11.64,38.75 g·kg-1 was orally administered to rats of postnatal day 4(PND4)rats for 18 days,and the drug was stopped for 3 weeks.Stage 2:according to the proposed clinical dose for children ages 1 to 6,FGLOL 3.88,11.64,38.75 g·kg-1 was orally administered to PND15 rats for 31 d,and the drug was discontinued for 3 weeks.Stage 3:according to the proposed clinical dose for children aged 7 to 12,FGLOL 29.06,58.13,116.25 g·kg-1 was orally administered to PND40 rats for 66 d,and the drug was stopped for 4 weeks.The effects of FGLOL on health status,food intake,body mass,growth and development,nerve reflex development,learning and memory ability,physical development(body length),bone development(bone mineral density),hematology and coagulation(white blood cells,red blood cells and platelet count),blood biochemistry(glutamate dehydrogenase,urea nitrogen and triglycerides)and histopathology were investigated in young rats.RESULTS In the three-stage JAS test,long-term administration of FGLOL did not cause rat death,and no toxicological effects were observed on body mass,growth and development,nerve reflex development,physical development,bone development,hematology and coagulation,blood biochemistry and histopathology of juvenile rats compared with the vehicle control group.CONCLUSION The no observed adverse effect level(NOAEL)of FGLOL is 38.75 g·kg-1 for the JAS test corresponding to humans between 1 and 6 years old,while the NOAEL of FGLOL is 116.25 g·kg-1 for the JAS test and repeated drug toxicity test corresponding to humans aged 7 to 12.关键词
馥感啉口服液/幼龄动物试验/幼龄大鼠/发育毒性Key words
Fuganlin oral liquid/juvenile animal study/juvenile rats/developmental toxicity分类
中医学引用本文复制引用
郭健敏,张文强,邓应华,蒙飞彪,梁纯,杨威..中药复方馥感啉口服液对不同年龄段SD大鼠发育毒性[J].中国药理学与毒理学杂志,2023,37(12):895-903,9.基金项目
国家科技重大专项(2018ZX09721003-009-025) （2018ZX09721003-009-025）
广东省实验室建设项目(2023B1212070029) （2023B1212070029）
广东省领军人才工程项目(210183503006) （210183503006）
广东省重点领域研发计划(2020B1111030005) National Science and Technology Major Project of China(2018ZX09721003-009-025) （2020B1111030005）
Guangdong Provincial Laboratory Construction Project(2023B1212070029) （2023B1212070029）
Guangdong Provincial Significant Talent Project(210183503006) （210183503006）
and Guangdong Provincial Key Research and Development Plan Funding(2020B1111030005) （2020B1111030005）
