| 引用本文: | 赵曼曼,杨海润,杨硕,魏胜焦,杨莹,屈哲,晁利平,王三龙,耿兴超,吴笑如,周晓冰.巴戟天寡糖幼龄大鼠重复给药毒性研究[J].中国现代应用药学,2024,41(22):45-51. |
| zhaomanman,yanghairun,yangshuo,weishengjiao,yangying,quzhe,chaoliping,wangsanlong,gengxingchao,wuxiaoru,zhouxiaobing.Toxicity of Morinda officinalis oligosaccharides in young rats after repeated administration[J].Chin J Mod Appl Pharm(中国现代应用药学),2024,41(22):45-51. |
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| 巴戟天寡糖幼龄大鼠重复给药毒性研究 |
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赵曼曼1, 杨海润2, 杨硕2, 魏胜焦3, 杨莹1, 屈哲1, 晁利平1, 王三龙1, 耿兴超1, 吴笑如2, 周晓冰1
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1.中国食品药品检定研究院 国家药物安全评价监测中心;2.北京同仁堂股份有限公司科学研究所;3.贵州省食品药品检验所
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| 摘要: |
| 目的 该实验研究巴戟天寡糖连续给药6周对幼龄SD大鼠生长发育的影响,为巴戟天寡糖应用于青少年的安全性提供参考。方法 将120只26日龄SD大鼠(雌雄各半)随机分为辅料对照组(空白辅料)及巴戟天寡糖低剂量组(50 mg.kg-1)、中剂量组(160 mg.kg-1)和高剂量组(500 mg.kg-1),重复灌胃给予辅料或巴戟天寡糖混悬液,每天1次,给药体积15 mL.kg-1,给药期6周,恢复期4周。试验期间进行临床症状、体重及摄食量、血液学及血清生化、眼科学、尿液指标测定及功能观测组合试验(FOB),解剖测定胫骨长度、骨密度,取主要脏器称重并进行组织病理学检查。结果 与辅料对照组比,巴戟天寡糖处理组大鼠临床症状、体重及摄食量、血液学及血清生化、眼科学、尿液指标、FOB、胫骨长度、骨密度、脏器重量未见明显差异,未见巴戟天寡糖相关组织病理学改变。结论 在本实验条件下,幼龄 SD 大鼠灌胃给予巴戟天寡糖6周,未见不良反应剂量为500 mg.kg-1,按公斤体重折算约为人拟用剂量(10 mg.kg-1)的50倍,提示本品应用于青少年人群安全范围较宽。与成年动物相比,无增加的特殊安全风险。 |
| 关键词: 巴戟天寡糖 幼龄大鼠 生长发育 安全性 |
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| Toxicity of Morinda officinalis oligosaccharides in young rats after repeated administration |
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zhaomanman1, yanghairun2, yangshuo2, weishengjiao3, yangying1, quzhe1, chaoliping1, wangsanlong1, gengxingchao1, wuxiaoru2, zhouxiaobing1
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1.National Institutes for Food and Drug Control, National Center for Safety Evaluation of Drugs;2.Research Institute of Beijing Tongrentang Co., LTD;3.Guizhou Institute for Food and Drug Control
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| Abstract: |
| ABSTRACT: OBJECTIVE To study the effects of continuous administration of Morinda officinalis oligosaccharides (MOO) for 6 weeks on the growth and development in juvenile SD rats, and to provide a reference for the safety of MOO application in adolescents. METHODS 120 juvenile SD rats,half male and half female, were randomly divided into blank control group, and MOO low(50 mg·kg-1), medium(160 mg·kg-1), and high dose groups(500 mg·kg-1). Excipient or MOO suspension was given by repeated intragastric administration, intragastric volume was 15 mL·kg-1, once daily for 6 weeks with a 4-week recovery phase. Clinical symptoms, body weight and food intake, hematology and serum biochemistry, ophthalmology, urine indexes and Functional Observation Battery(FOB) were performed during the trial. RESULTS Compared with the excipient control group, there were no significant differences in clinical symptoms, body weight and food intake, hematology and serum biochemistry, ophthalmology, urine indexes, FOB, tibial length, bone density and organ weights, and no histopathological changes were observed in the MOO treatment groups. CONCLUSION Under the conditions of this experiment, juvenile SD rats were orally administered by MOO for 6 weeks. 500 mg·kg-1 is the dosage |
| Key words: Morinda officinalis oligosaccharides juvenile rats growth and development safety |
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