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Lipid lowering function and safety evaluation of sea buckthorn flaxseed oil soft capsule |
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KeyWord:sea buckthorn seed oil flaxseed oil lipid-lowering acute toxicity genotoxicity human experiment |
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Abstract: |
In order to develop lipid-lowering food, sea buckthorn seed oil and flaxseed oil were used as the main raw materials, and natural vitamin E, gelatin, purified water and glycerol were used as excipients to make sea buckthorn flaxseed oil soft capsule, and male SD rats were used as experimental animals to evaluate the lipid-lowering function of sea buckthorn flaxseed oil soft capsule. The toxicity of the capsule was assessed by acute oral toxicity test, genotoxicity test in mice and 30 d feeding test in rats. The 110 hyperlipidemia volunteers meeting the inclusion criteria were selected, and the corresponding indexes were measured to evaluate its lipid-lowering function and safety after continuous administration of sea buckthorn flaxseed oil soft capsule for 45 d. The results showed that the mean decreases of TC, TG and LDL-C contents in serum of rats in the high-dose group(0.667 g/kg) were 15.6%, 22.3% and 29.0%, respectively, all of which were highly significant (p<0.01) compared with the model control group. The toxicology test showed that sea buckthorn flaxseed oil soft capsule was safe and non-toxic. The results of human experiment showed that the total effective rate of lowering lipid was 78.4% after the human experiment, which was highly significant (p<0.01) compared with the control group, and all physical signs of the volunteers were normal during the human experiment. Therefore, sea buckthorn flaxseed oil soft capsule has significant lipid-lowering function and has no adverse effect on human health. |
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