壳寡糖牛磺酸口服液食用安全性及其对小鼠免疫功能增强作用研究
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1.天津科技大学;2.蔻诗美(天津)生物科技有限公司

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R932?

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Study on the Edible Safety and Immunomodulatory Effects of Chitosan oligosaccharide Taurine Oral Liquid in Mice
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1.Tianjin University of Science and Technology;2.COSMAKER Tianjin Biological Science Co,Ltd

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    摘要:

    目的 本研究旨在评估壳寡糖牛磺酸口服液食用安全性及其对小鼠免疫功能的影响。方法:通过急性毒性实验、28 d喂养毒性实验和遗传毒性实验评价壳寡糖牛磺酸口服液的安全性。通过测定小鼠DTH程度、淋巴细胞增殖能力、溶血空斑数、血清溶血素、单核-巨噬细胞功能及NK细胞活性确定壳寡糖牛磺酸口服液是否具有影响小鼠免疫力的功能。结果 急性毒性实验结果显示服用壳寡糖牛磺酸口服液3倍浓缩液的雌、雄大鼠急性经口毒性试验LD50>30000 mg/ kg·BW(以口服液量计算),根据急性毒性剂量分级标准,该样品属实际无毒级。28d喂养毒性实验结果显示壳寡糖牛磺酸口服液各剂量组受试动物一般情况良好,体重、食物利用率、脏器重量、脏器系数均无异常改变;眼部检查未发现异常变化;尿液指标、血液学指标及生化指标结果显示,各项指标均在正常范围;各脏器病理组织学检查均未见与受试样品有关的病理改变。遗传毒性实验结果显示Ames实验、哺乳动物红细胞微核实验和小鼠精母细胞染色体畸变实验结果均为阴性,未见致畸变作用。功能学研究结果显示壳寡糖牛磺酸口服液以2.5、5.0、10.0 mL/(kg·BW·d)三个剂量经口给予小鼠30天后,对实验动物的体重、脏器/体重比值无明显影响;中、高剂量组与阴性对照组相比,小鼠足趾肿胀度及溶血空斑数均有显著差异(p<0.05 或 p<0.01),说明小鼠细胞免疫与体液免疫试验结果均为阳性;单核-巨噬细胞功能及NK细胞活性结果均为阴性。结论 壳寡糖牛磺酸口服液食用安全且具有增强小鼠免疫力的功能。

    Abstract:

    Qbjective This study aimed to evaluate the safety of Chitosan oligosaccharide-taurine oral liquid for consumption and its effect on the immune function of mice. Methods Safety was evaluated through acute toxicity tests, a 28-day feeding toxicity study, and genotoxicity experiments. The immunomodulatory effects were determined by measuring delayed-type hypersensitivity (DTH), lymphocyte proliferation capacity, hemolytic plaque count, serum hemolysin levels, monocyte-macrophage function, and NK cell activity. Results The acute toxicity test demonstrated that the LD50 of a 3× concentrated Chitosan oligosaccharide-taurine oral liquid was greater than 30,000 mg/kg·BW (Calculated by the amount of oral solution) in both female and male rat. According to acute toxicity classification standards, the sample is considered practically non-toxic. The 28-day feeding study revealed no adverse effects on general condition, body weight, food utilization, organ weight, or organ coefficients in any dose group. No abnormal ocular changes were observed. Urinalysis, hematological, and biochemical indicators all fell within normal ranges. Histopathological examination of organs showed no abnormalities related to the test substance. Genotoxicity tests, including the Ames test, mammalian erythrocyte micronucleus assay, and mouse spermatocyte chromosomal aberration test, all yielded negative results, indicating no mutagenic or teratogenic effects. The functional study results showed that after 30 days of oral administration at doses of 2.5, 5.0, and 10.0 mL/(kg·BW·d), the Chitosan oligosaccharide-taurine oral liquid had no significant effects on mouse body weight or organ/body weight ratios.Compared with the negative control group, there were significant differences (p<0.05 or p<0.01) in the degree of toe swelling and the number of hemolytic plaques in the medium and high dose groups of mice, indicating that both the cellular and humoral immune test results of mice were positive;The results for monocyte-macrophage function and NK cell activity were negative. Conclusion This study demonstrates that the Chitosan oligosaccharide-taurine oral liquid exhibits a good safety profile and can modulate immune function in mice.

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  • 收稿日期:2025-09-10
  • 最后修改日期:2025-09-22
  • 录用日期:2025-09-23
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