Safety Evaluation of Jingshen Tablet and Its Anti-acute Alcoholic Liver Injury
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摘要: 目的: 本文对景参片进行安全性评价,并研究其对急性酒精性肝损伤的辅助保护功能。方法: 通过小鼠急性毒性试验、小鼠骨髓嗜多染红细胞微核试验、小鼠精子畸形试验、Ames试验及大鼠30 d喂养试验,进行景参片的安全性毒理学评价。60只小鼠随机分为5组,空白对照组给予无菌水,模型对照组及各剂量组给予50%乙醇建立酒精性肝损伤模型。造模成功后,将景参片经口灌胃,按人体推荐剂量(4.8 g/60 kg·BW)的5、10、30倍(0.40、0.80、2.40 g·kg-1)给药,记录并观察景参片对小鼠肝组织中丙二醛(MDA)、还原型谷胱甘肽(GSH)和甘油三酯(TG)含量的影响。结果: 小鼠急性经口试验最大给药量均大于15 g/(kg·BW),急性毒性分级属无毒级;小鼠各剂量组骨髓嗜多染红细胞微核率、精子畸形发生率与溶剂对照组比较均无显著性差异(P>0.05),Ames试验中各剂量组回变菌落数均未超过溶剂对照组、未处理对照组回变菌落数2倍以上,说明景参片无诱发突变作用;大鼠30 d喂养试验脏器指数、生化及血液指标与溶剂对照组比较均无显著性差异(P>0.05);与模型对照组比较,2.40 g·(kg·BW)-1组能显著降低肝组织中丙二醛及甘油三酯含量(P<0.05);病理结果显示,景参片各剂量组均能减轻肝细胞中的脂肪变性及炎性浸润。结论: 景参片具有抗急性酒精性肝损伤作用,在受试剂量范围内,安全无毒。Abstract: Objective: This article evaluates the safety of Jingshen Tablets and studies its auxiliary protective function on acute alcoholic liver injury. Methods: Through the acute toxicity test in mice, the micronucleus test in mouse bone marrow polychromatic erythrocytes, the sperm deformity test in mice, the Ames test and the 30-day feeding test in rats, the safety and toxicological evaluation of Jingshen tablets were carried out.60 mice were randomly divided into 5 groups. The control group of the blank group was given sterile water, and the model control group and each dose group were given 50% ethanol to establish an alcoholic liver injury model. After successful model building, the Jingshen tablets were administered orally and administered at 5, 10, and 30 times(0.40, 0.80, 2.40 g·kg-1) of the recommended human dose(4.8 g/60 kg·BW), and the scene was recorded and observed. The effect of ginseng tablets on the contents of malondialdehyde(MDA), reduced glutathione(GSH) and triglyceride(TG) in mouse liver tissue.Results: The maximum dose in the acute oral test in mice was all greater than 15 g/(kg·BW), and the acute toxicity was classified as non-toxic, the micronucleus rate of bone marrow polychromatic erythrocytes and the incidence of sperm abnormalities in each dose group of mice were no significant difference(P>0.05), compared with those in the solvent control group. In the Ames test, the number of reverted colonies in each dose group did not exceed the number of reverted colonies in the solvent control group and the untreated control group by more than 2 times, indicating that Jingshen tablets have no mutagenic effect, There was no significant difference in organ index, biochemical and blood indexes between rats fed for 30 days and solvent control group(P>0.05), compared with model control group, 2.40 g·(kg·BW) -1 group could significantly reduce liver tissue the content of malondialdehyde and triglyceride in the medium(P<0.05). The pathological results showed that all dose groups of Jingshen tablets could alleviate steatosis and inflammatory infiltration in liver cells. Conclusion: Jingshen tablets have the effect of anti-acute alcoholic liver injury, and are safe and non-toxic within the scope of the dose.
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Keywords:
- Jingshen tablet /
- safety /
- liver injury /
- functional food
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