| 引用本文: | 方云涛,孙武,何金友,宋青青,周波.消毒散（XDS）对幼龄SD大鼠经口重复给药13周毒性试验[J].中国现代应用药学,2025,42(6):1-9. |
| fangyuntao,snwu,hejinyou,songqingqing,zhoubo.Toxicity Study of the 13 Weeks Repeated-dose of Xiao Du San (XDS) on Juvenile SD Rats[J].Chin J Mod Appl Pharm(中国现代应用药学),2025,42(6):1-9. |
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| 摘要: |
| 摘要：目的 通过对幼龄SD大鼠经口重复给药13周毒性试验，评价药物XDS的安全性与其对幼龄SD大鼠生长发育的影响。方法 160只幼龄SD大鼠（起始给药年龄为21 d）随机分为四组：溶媒对照组（1% CMC-Na），低剂量组（1250 mg·kg-1·day-1），中剂量组（2500 mg·kg-1·day-1），高剂量组（5000 mg·kg-1·day-1）；每组40只，雌雄各半。经口灌胃给药，每 d一次，连续13周，恢复期4周。于第6周，13周及恢复期分批完成解剖，观察指标为体重、摄食量、骨骼测量、性发育指标、行为学指标、血液学、血生化、凝血指标等。结果 1）5000 mg·kg-1和2500 mg·kg-1 XDS可引起受试大鼠肝脏相对重量增加、肝细胞肥大以及受试雄鼠总胆红素水平升高；2）5000 mg·kg-1 XDS可引起肾脏肾小管上皮细胞肥大以及受试雄鼠肾脏相对重量增加；3）各剂量XDS对幼龄SD大鼠生长发育无显著影响。结论 在本试验条件下，幼龄大鼠经口重复给予13周XDS后，其最大无毒性反应剂量（NOAEL）为1250 mg·kg-1。 |
| 关键词: 消毒散 幼龄大鼠 重复给药毒性试验 非临床评价 |
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| Toxicity Study of the 13 Weeks Repeated-dose of Xiao Du San (XDS) on Juvenile SD Rats |
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fangyuntao, snwu, hejinyou, songqingqing, zhoubo
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Jiangsu center for safety evaluation of drugs
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| Abstract: |
| ABSTRACT: OBJECTIVE To evaluate the non-clinical safety of XDS on juvenile SD rats after 13weeks oral administration. METHODS 160 juvenile SD rats were randomly divided into four groups: Vehicle control group (1% CMC-Na), low dose、medium dose、high dose group(1250、2500、5000 mg·kg-1·day-1); the rats were orally administered once a day with vehicle or XDS for 13weeks, followed a 4 weeks recovery period. The animals were dissected in batches at weeks 6, 13, and the end of recovery period, Test items included body weight, food intake, bone measurement, sexual development indicators, behavioral indicators, hematology, blood biochemistry, coagulation indicators, etc. RESULT 1) 5000 mg·kg-1 and 2500 mg·kg-1 XDS cause an increase in relative liver weight, liver cell hypertrophy, and an increase in total bilirubin levels in male rats. 2) 5000 mg·kg-1 can cause hypertrophy of renal tubular epithelial cells and an increase in the relative weight of the kidneys in male rats. 3) There was no significant effect of XDS on the growth and development of juvenile SD rats. CONCLUSION Under the conditions of this experiment, the no observed adverse effect level (NOVEL) of juvenile rats in repeated oral administration toxicity test for 13 weeks was 1250 mg·kg-1. |
| Key words: XDS juvenile animal, repeated dose toxicity, non-clinical safety evaluation |
