Study On The Safety And Improving Sleep Function Of The Double Five Poria Cream

Objective:With the rapid development of society,the problem of insomnia is becoming more and more serious.In order to improve this situation,this study selected Acanthopanax senticosus,Schisandra chinensis,Poria cocos as raw materials,and developed the Double Five Poria Cream by modern preparation technology,hoping that they could cooperate mutually to play a role in improving sleep.It has been known that Acanthopanax senticosus,Schisandra chinensis,Poria cocos are safe raw materials for health food,and their sleep improvement function is exact.However,the safety and sleep improvement function of the Double Five Poria Cream made from them are not yet clear.Therefore,in this study,the safety of the Double Five Poria Cream was evaluated,and on the basis,a further study of the sleep improvement function was conducted,to provide the experimental basis for the development of the Double Five Poria Cream as the health care food,which could be safe and improve sleep as well.Methods:According to the process and methods of food security toxicological estimation in the National Food Safety Standards(2014),the acute oral toxicity test using the maximum tolerated dose method,the twenty-eight days feeding test in rats,the micronucleus test of bone marrow cell,the sperm shape abnormality test in mice,and the Ames test have been conducted to study the safety of the Double Five Poria Cream.Meanwhile,according to the methods of sleep improvement function evaluation in the Criterion of Testing and Evaluating Health Foods(2003),the sleep extending test with sodium pentobarbital,the sleep-producing test with subthreshold dose of sodium pentobarbital,the incubation period test with barbital sodium and the direct sleep test have been conducted to study the improvement of sleeping function.Results:In the acute oral toxicity test with the Double Five Poria Cream,the maximum tolerated dose(MTD)of mice was greater than 17.2 g/kg BW,which was ranked as non-toxic grade;The twenty-eight days feeding test in rats showed that the no observed adverse effect level(NOAEL)was greater than 10g/kg BW;The results of the micronucleus test of bone marrow cell,the sperm shape abnormality test in mice and the Ames test were negative showing that the Double Five Poria Cream had no mutagenic effect.Under this experimental condition,acute toxicity,short-term repeated dose toxicity and genetic toxicity were not observed.In the functional tests with the Double Five Poria Cream,compared with the negative control,sleep time of sodium pentobarbital-induced mice was significantly prolonged in the high dose group(P<0.01),the sleep time of mice in medium dose group was also prolonged(P<0.05);In the sleep-producing test with subthreshold dose of sodium pentobarbital,sleep incidence of mice increased in the high dose group,compared with the negative control(P<0.05);Barbital sodium-induced sleep latency of mice with high dose of the Double Five Poria Cream was shortened compared with the negative control(P<0.05);For each dose group,there was no significant difference in sleep time and the number of animals directly to sleep between the dose groups and negative control group.That is,the results of three tests,including the sleep extending test with sodium pentobarbital,the sleep-producing test with subthreshold dose of sodium pentobarbital,and the incubation period test with barbital sodium,were all positive and there was no obvious direct effect on sleep.Conclusion:The acute toxicity,short-term repeated dose toxicity and genetic toxicity of the Double Five Poria Cream were not observed.And the Double Five Poria Cream had the function of improving sleep as well.