一种杂色蛤核苷胶囊的安全性评价和护肝功能研究

Safety evaluation and protective function study of Ruditape Philippinarum nucleosides capsule

目的研究杂色蛤核苷的食品安全性及对酒精性肝损伤的保护功能。方法通过经口急性毒性试验、遗传毒性试验(细菌回复突变试验、小鼠骨髓嗜多染红细胞微核试验、小鼠睾丸精母细胞染色体畸变试验)及30天喂养试验对一种杂色蛤核苷胶囊进行安全性评价;利用酒精诱导肝细胞损伤,建立急性酒精性肝损伤模型,通过比较剂量组与模型组肝匀浆中的丙二醛(MDA)、谷胱甘肽(GSH)和甘油三酯(TG)水平,并进行组织病理检查来评价杂色蛤核苷的保肝功能。结果急性经口毒性试验中,杂色蛤核苷胶囊的最大耐受剂量大于15000 mg/kg b.wt.;3项遗传毒性试验结果均为阴性,未显示出致突变性;30 d喂养试验中,大鼠活动、体重、食物利用率、脏体比、组织病理学检查均未见明显异常,血液以及血生化指标均在本实验室正常波动范围内。成功建立小鼠急性酒精性肝损伤模型,肝生化测定中,还原型GSH和TG两项结果和病理组织学检查结果均显示剂量组与模型组有统计学差异,根据保健食品检验与评价技术规范(2003版),可判定杂色蛤核苷对酒精性肝损伤有辅助保护作用。结论杂色蛤核苷胶囊具有较好的食用安全性,对酒精性肝损伤具有很好的辅助保护效果。

Objective To study the toxicological safety of Ruditape Philippinarum nucleosides capsule and its protective function for alcoholic liver injury.Methods The safety evaluation was conducted by acute oral toxicity test,genetic toxicity tests(bacterial reversion mutation test,mouse micronucleus test,spermatocyte chromosome aberration test)and 30-d feeding test.The liver injury model was established by acute alcohol induction for hepatocyte injury,the hepatoprotective function was evaluated by comparing MDA,GSH,TG levels and histopathological examination in liver homogenates among dose and model groups.Results The maximum tolerated dose of the Ruditape Philippinarum nucleoside capsule was greater than 15000 mg/kg b.wt.in the acute oral toxicity test,and 3 genetic toxicity test results were all negative,showing no mutagenicity effect,In the 30 d feeding experiment,the activity,body weight,food utilization,spleen to body ratio and histopathological examination of the rats showed no obvious abnormalities,and blood as well as blood biochemical parameters were within the normal fluctuation ranges set in the laboratory.An acute alcoholic liver injury model was successfully established.Compared with control group,the GSH,TG levels in liver biochemical assay and histopathological examination were significant different.According to the Technical Specification for Inspection and Evaluation of Health Food(2003 ed),Ruditape Philippinarum nucleosides capsule showed auxiliary protective effect on alcoholic liver injury.Conclusion The Ruditape Philippinarum nucleoside capsule has a relatively good food safety profile and a good auxiliary protective effect for alcoholic liver injury.