To investigate the protective effects and toxicological safety of the American ginseng ultrafine powder compound on alcoholic liver injury in mice.

The 50 ICR mice were randomly divided into 5 groups of 10 mice each, including the negative control group, the model control group, the American ginseng-free compound group, the American ginseng extract compound group and the American ginseng ultrafine powder compound group. The negative control group and model control group were gavaged with the same amount of purified water, and the remaining groups were gavaged with the corresponding test substances daily for 30 days. Except for the negative control group, the rest of groups were gavaged with 50% ethanol once after the last administration to establish an acute alcoholic liver injury model in mice. The body weight of mice, the content of malondialdehyde (MDA), glutathione(GSH) and triglyceride (TG) in liver tissue were determined. Additionally, the pathological analysis of liver tissue stained with Oil Red O was performed to evaluate the protective effect of test substances. After screening the optimal compound, according to the Technical standards for testing & assessment of health food (2003 edition), the tests of acute oral toxicity, genetic toxicity and 28 days oral toxicity were performed to systematically evaluate its toxicological safety.

Compared with the model control group, the content of MDA and TG in the liver tissue of the American ginseng ultrafine powder compound group were significantly decreased (P<0.05), and the content of GSH was significantly increased (P<0.05), and the degree of fatty degeneration of liver cells was significantly reduced (P<0.05).Although the indicators in the American ginseng-free compound group and American ginseng extract compound group showed improvement trends, the differences were not statistically significant (P>0.05). The results of toxicological safety showed that the maximum tolerated dose of the American ginseng ultrafine powder compound for both male and female mice was greater than 12.0 g/kg BW, indicating that it was practically non-toxic. The results of Ames test, bone marrow micronucleus test and sperm malformation test were all negative, indicating that it had no genotoxicity. No toxicological effects on body weight, feed intake, feed utilization rate, blood physiological and biochemical indicators, organ/body weight ratio and main tissues in rats were found in the 28 days oral toxicity test. The no-observed-adverse-effect level of the American ginseng ultrafine powder compound was 4.5 g/kg BW.

The American ginseng ultrafine powder compound has a significant protective effect on alcoholic liver injury in mice, and its effect is better than that of the American ginseng extract compound and the American ginseng-free compound.Moreover, the compound has high food safety within the experimental dose range.