Developmental toxicity of Qinxiang Qingjie oral solution for 4-day-old young rats
10.3867/j.issn.1000-3002.2023.12.003
- VernacularTitle:芩香清解口服液对4日龄大鼠的发育毒性
- Author:
Jianmin GUO
1
,
2
;
Wenqiang ZHANG
;
Yinghua DENG
;
Feibiao MENG
;
Songqiang XIE
;
Chun LIANG
;
Wei YANG
Author Information
1. 广州湾区生物医药研究院,广东莱恩医药研究院有限公司,广东省药物非临床评价研究企业重点实验室,国家中药现代化工程技术研究中心中药非临床评价分中心,广东省创新药物评价与研究工程技术研究中心,广东 广州 510990
2. 香港科技大学生命科学部,香港 999077
- Keywords:
Qinxiang Qingjie oral solution;
juvenile rats;
repeated administration;
developmental toxicity
- From:
Chinese Journal of Pharmacology and Toxicology
2023;37(12):904-913
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To investigate the effects of Qinxiang Qingjie oral liquid(QXQJ)on growth and development after repeated administration of 18 d to postnatal day 4(PND4)rats.METHODS The number and sex of PND2 pups were adjusted using the cross-breeding method.These pups were ran-domly divided into the normal control,QXQJ 3.45,10.35 and 28.05 g·kg-1 groups.PND4,juvenile rats were ig given QXQJ every day,while the normal control group was given pure water,once a day,for 18 d,before observation of 3 weeks was resumed.During the experiment,the general condition,body mass,growth and development,physique,bone,hematology and coagulation of the rats in each group were detected.RESULTS 18 d after continuous administration of QXQJ,there was no obvious effect on the food intake,growth and development,nerve reflex,spontaneous behavior,hematology,coagula-tion,blood biochemistry,immunity,growth hormone,histopathology and other examination indexes of juve-nile rats.From PND5,juvenile rats in the QXQJ 10.35 and 28.05 g·kg-1groups developed yellow-brown soft or loose stools and abdominal distention,but the symptoms generally recovered at PND22.The body mass,top-rump length,tail length and limb length of the juvenile rats in the 28.05 g·kg-1 group were signifi-cantly lower at PND7(P<0.05),but recovered one week after drug withdrawal.The bone mineral specific gravity and bone mineral density of the 28.05 g·kg-1 group were significantly lower than those of the normal control group at PND22(P<0.05),but there was no significant difference at PND42.CONCLU-SION QXQJ can cause such indigestion symptoms as yellow brown soft stool or loose stool and abdominal enlargement in unweaned juvenile rats,thus affecting the physical development indicators of rats,but the symptoms can recover after withdrawal of medication or withdrawal from milk.The no observed adverse effect level(NOAEL)of QXQJ administered to 4-day-old rats for 18 d is 3.45 g·kg-1.