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Genotoxicity and subacute toxicity studies of a new astaxanthin-containing Phaffia rhodozyma extract

机译:一种新的含虾青素的红发夫酵母酶提取物的遗传毒性和亚急性毒性研究

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Experimental and clinical studies demonstrate that astaxanthin (AXN), a xanthophyll carotenoid, has protective effects against oxidative damage. Because most of these studies assessed AXN derived from Haematococcus pluvialis that were cultivated at industrial scales, few studies have examined the toxicity of AXN derived from Phaffia rhodozyma. To evaluate the safety of astaxanthin-containing P. rhodozymaextract (AXN-PRE), genotoxicity was assessed in bacterial reverse mutation test and mouse bone marrow micronucleus test, and general toxicity was assessed in 4-week repeated oral toxicity study in rats. AXN-PRE did not induce reverse mutations in the Salmonella typhimurium strains TA98 or TA100 at concentrations of 5, 000 μg/plate with or without S9 mix, and no chromosome damage was observed at a dose of 2, 000 mg/kg in mouse micronucleus test. In the subacute toxicity study, male and female Sprague-Dawley rats were given AXN-PRE at doses of 0, 500, and 1, 000 mg/kg by gavage for 4 weeks. Body weights, urinalysis, hematology, serum biochemistry, organ weights, or histopathological lesions indicated no distinct toxicity. In conclusion, AXN-PRE had no effect in bacterial reverse mutation test and mouse bone marrow micronucleus test. The no-observed-adverse-effect level for AXN-PRE in 4-week repeated oral toxicity study in rats was determined to be greater than 1, 000 mg/kg (corresponding to dose of 50 mg/kg AXN) regardless of gender.
机译:实验和临床研究表明,叶黄素类胡萝卜素虾青素(AXN)具有抗氧化损伤的保护作用。由于这些研究中的大多数都评估了以工业规模种植的血红球菌来源的AXN,因此很少有研究检查了来自红发夫夫菌的AXN的毒性。为了评估含虾青素的红假单胞菌提取物(AXN-PRE)的安全性,通过细菌反向突变试验和小鼠骨髓微核试验评估了遗传毒性,并在4周的大鼠重复口服毒性研究中评估了一般毒性。 AXN-PRE不会在鼠伤寒沙门氏菌TA98或TA100菌株中诱导浓度为5,000μg/板的S98混合物或不存在S9混合物的反向突变,并且在小鼠微核中剂量为2,000 mg / kg时未观察到染色体损伤测试。在亚急性毒性研究中,雄性和雌性Sprague-Dawley大鼠以管饲法分别以0、500和1,000 mg / kg的剂量给予AXN-PRE,持续4周。体重,尿液分析,血液学,血清生化,器官重量或组织病理学损害均无明显毒性。总之,AXN-PRE在细菌反向突变试验和小鼠骨髓微核试验中没有作用。在大鼠的4周重复口服毒性研究中,AXN-PRE的未观察到的不良反应水平被确定为大于1,000 mg / kg(相当于50 mg / kg AXN的剂量),而不论性别。

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