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    巴戟天寡糖幼龄大鼠重复给药毒性研究

    Toxicity of Morinda Officinalis Oligosaccharides in Juvenile Rats After Repeated Administration

      摘要
    • 摘要:
      目的 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，每日1次，给药体积15 mL·kg−1，给药期6周，恢复期4周。实验期间进行临床症状、体质量及摄食量、血液学及血清生化、尿液指标测定及功能观测组合试验(functional observation battery，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、体质量及摄食量、血液学及血清生化、尿液指标、FOB、胫骨长度、骨密度、脏器质量未见明显差异，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，按公斤体质量折算约为人拟用剂量(10 mg·kg−1)的50倍。与成年动物相比，无增加的特殊安全风险。

       

      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 One hundred and twenty juvenile SD rats, half male and half female, were randomly divided into excipient control group(blank aexcipient), 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. Dissected and measured the length and bone density of the tibia, weighed the major organs, and performed histopathological examination on the tissue.
      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. A total of 500 mg·kg−1 is the dosage without obvious adverse effect and approximately 50 times of the planned clinical dose. No additional safety risks are exsisted compared to adult animals.

       

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