Zhongguo youzhi (Nov 2022)

沙棘亚麻籽油软胶囊降血脂功能及其安全性评价Lipidlowering function and safety evaluation of sea buckthorn flaxseed oil soft capsule

  • 侯兴琳1,张同军2,兰莹1 HOU Xinglin1 , ZHANG Tongjun2, LAN Ying1

DOI
https://doi.org/10.19902/j.cnki.zgyz.1003-7969.210451
Journal volume & issue
Vol. 47, no. 11
pp. 30 – 37，79

Abstract

Read online

为了开发降血脂食品，以沙棘籽油、亚麻籽油为主要原料，并以天然维生素E、明胶、纯净水、甘油等为辅料制成沙棘亚麻籽油软胶囊，以雄性SD大鼠为实验动物，对沙棘亚麻籽油软胶囊的降血脂功能进行评价，再通过小鼠急性经口毒性实验、遗传毒性实验和大鼠30 d喂养实验对其毒理性进行评价，并选择110例符合纳入标准的高脂血症患者，连续服用沙棘亚麻籽油软胶囊45 d后测定相应指标，评价其对人体的降血脂功能和安全性。结果表明：高剂量组(0.667 g/kg)大鼠血清中TC、TG和LDL-C含量分别平均下降了15.6%、22.3%、29.0%，与模型对照组相比均差异极显著(p<0.01)；毒理学实验结果显示沙棘亚麻籽油软胶囊安全无毒性；受试者试食后血脂下降总有效率为78.4%，与对照组相比差异极显著(p<0.01)，并且试食期间受试者所有体征均正常。因此，沙棘亚麻籽油软胶囊具有显著降血脂功能，并且对人体健康无不良影响。 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.

Keywords