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投稿时间：2025-12-17
投稿时间：2025-12-17
中文摘要: 该研究开发一种以多不饱和脂肪酸（polyunsaturated fatty acids，PUFA）为主要活性成分的鱼油软胶囊制剂，并通过动物模型对其安全性及降血脂作用进行系统评价。艾姆氏实验、小鼠骨髓嗜多染红细胞微核实验及小鼠精子畸形实验均未呈阳性。急性经口毒性实验及30 d喂养实验表明，在最大剂量条件下未观察到明显毒性反应，样品耐受性良好。在功效评价方面，与高脂对照组相比，中、高剂量组血清总胆固醇（total cholesterol，TC）水平和甘油三酯（triglyceride，TG）水平显著降低（P＜0.05）。而高密度脂蛋白胆固醇（high-density lipoprotein cholesterol，HDL-C）水平差异不显著（P＞0.05）。上述结果表明，该PUFA软胶囊在动物实验条件下表现出良好的安全性，并具有明确的辅助降血脂作用。
Abstract:A fish oil soft capsule formulation containing polyunsaturated fatty acids （PUFA） as the primary active components was developed，and its safety and lipid-lowering effects were evaluated using animal models.Genotoxicity assays，including the Ames test，mouse bone marrow micronucleus test，and mouse sperm abnormality test，showed negative results. Acute oral toxicity and a 30-day feeding study revealed no obvious toxic effects at the maximum tested dose，indicating good tolerability. In the efficacy evaluation，compared with the high-fat control group, the levels of total cholesterol （TC） and triglyceride （TG） in the medium- and high-dose groups were significantly reduced (P＜0.05). Additionally，no significant difference was observed in highdensity lipoprotein cholesterol （HDL-C） levels （P＞0.05）. These results suggest that the PUFA soft capsule has good safety and exhibits a beneficial lipid-lowering effect.
keywords: polyunsaturated fatty acids fish oil safety evaluation functional food lipid-lowering effect
文章编号：202614013 中图分类号： 文献标志码：
基金项目:海洋生物活性成分和药食同源中药材在功能性食品中的应用及功效验证（HX-2025-06-025）
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