三勒浆安全性评价及功能作用研究

Safety Evaluation and Functional Effects of Sanajon

目的:评价保健食品三勒浆安全性及其抗疲劳、免疫调节和耐缺氧的功能。方法:通过急性毒性实验、30 d喂养实验、微生物回复突变埃姆斯(Ames)实验、小鼠微核实验和小鼠精子畸形实验对三勒浆进行安全性毒理学评价。通过负重游泳实验、血清尿素氮含量、肝糖原含量、血乳酸含量测定,研究三勒浆的抗疲劳作用;通过迟发性变态反应(足趾增厚法)、血清溶血素测定(血凝法)、小鼠腹腔巨噬细胞吞噬鸡红细胞实验(半体内法)、自然杀伤细胞活性测定,研究三勒浆的免疫调节作用;通过常压耐缺氧实验、急性脑缺血性缺氧实验及亚硝酸钠中毒存活实验,研究三勒浆的耐缺氧作用。结果:三勒浆对小鼠和大鼠的经口半数致死剂量都大于21.5 mL/kg,急性毒性属实际无毒(级);大鼠30 d喂养实验的无作用剂量大于10.0 mL/kg;3项遗传毒性实验均为阴性结果。三勒浆灌胃30 d,可显著延长各剂量组小鼠的负重游泳时间,降低血清尿素氮与乳酸水平,提高肝糖原含量,具有明显的抗疲劳作用。三勒浆灌胃25 d,各剂量能提高小鼠溶血素抗体积数,中剂量、高剂量能提高小鼠迟发性变态反应能力、小鼠腹腔巨噬细胞吞噬百分率和吞噬指数,表明三勒浆具有免疫调节作用。耐缺氧实验结果表明三勒浆可显著提高小鼠的急性脑缺血性缺氧时间,亚硝酸钠中毒小鼠的存活时间显著长于对照组,表明三勒浆具有耐缺氧作用。结论:三勒浆具有很好的安全性和确切的抗疲劳、免疫调节和耐缺氧作用。

Objective:To evaluate the safety of Sanajon,a health food,and its anti-fatigue,immune regulatory and anti-hypoxia functions.Methods:Acute toxicity test,30 day feeding test,Ames test,micronucleus test of polychromatic erythrocytes in mice bone marrow,and sperm malformation test in mice were used to explore the safety and toxicology of Sanajon.The anti-fatigue effect of Sanajon was studied by weight-loaded swimming test and determination of serum urea nitrogen,liver glycogen and blood lactic acid.The immunomodulatory effect of Sanajon was observed by delayed allergic reaction(toe thickening method),serum hemolysin determination(hemagglutination method),mouse peritoneal macrophage phagocytosis of chicken red blood cells test(ex vivo method),and natural killer(NK)cell activity test.Additionally,normal pressure hypoxia tolerance test,acute cerebral ischemia/hypoxia test and survival of mice poisoned with sodium nitrite test were carried out to detect the hypoxia tolerance of Sanajon.Results:The oral LD50 of Sanajon in mice and rats was both more than 21.5 mL/kg,and the acute toxicity was actually non-toxic(grade).The no-effective dose in the 30 day feeding test was more than 10.0 mL/kg,and the three genetic toxicity tests were negative.Sanajon significantly prolonged the weight-loaded swimming time of mice,reduced the levels of serum urea nitrogen and lactic acid,and increased the content of liver glycogen,showing obvious anti-fatigue effect after 30 days of gavage.After 25 days of Sanajon by intragastric administration,5.0 mL/kg,10.0 mL/kg and 15.0 mL/kg of Sanajon increased the amount of hemolysin antibody in mice,and medium and high doses of Sanajon improved the ability of delayed allergic reaction in mice and the percentage of phagocytosis and phagocytosis index of peritoneal macrophages in mice,indicating that Sanajon had immune regulatory effect.The hypoxia tolerance tests demonstrated that Sanajon remarkably boosted the time of acute cerebral ischemia/hypoxia in mice,and the survival time of mice poisoned with sodium nitrite was significantly longer than that of the control group,indicating that Sanajon had hypoxia tolerance.Conclusion:Sanajon had high safety,and definite anti-fatigue,immune regulatory and anti-hypoxia effects.