| Objectives :To examinate stability of melatonin and its improving sleep function and its safety as a healthy food. Methods: 1.Determination of me- latonin of variant batch samples in the first, the second, the third and the fourth month by high per-formance liquid chromatography; 2. the experiment of prolonging pentobarbitol sodium- sleep-time, the experiment of shortening barbital sodium sleep-incubation-period and the hypnosis experiment under the pentobarbitol sodium threshold dose were carried on separately to the samples by 2 times, 10 times, 30 time of doses to the date-recommendation dose; 3.The general toxicity in safety was judged through the acute toxicity test in mouse and the 30 days feeding test in rats. Results:1. the values of melatonin in three batch samples were consistence, And the results of stability have not the significance differences during three months.2. Based on the pentobarbitol sodium hypnosis, the sample can prolong the sleep time of mouses, which explained there is the synergism between the pentobarbitol sodium and the samples; Based on the Barbitone sodium hypnosis, the sample can shorten barbital sodium sleep-incubation-period of mouses, which explained there is the synergism between the Barbitone sodium and the samples ; Based on the pentobarbitol sodium hypnosis, the sample can promote the mouse to go to sleep . All above results have the dose-effect relation.3.(1)The results of acute toxicity experiments in mouses: there were not any poisoned symptom and death of mouse during 14 day-long observation periods.the samples accord to the actual non-toxic level according to the acute toxic dose graduation standard. (2) The results of the 30 days feeding experiments :It indicated that the samples had harmless influences on the mouses' activity, eating food, the growth of body weights, the number of red blood cell , the hemoglobin content, the number of white blood cell and the classification,the function of liver and kidney , the metabolism of protein, fat and sugar , the ratio of internal organs and body weights. There were not the specical changes in pathology at every internal organs under eye and microscope .Conclusion: 1.the stability of melatonin in three batch samples is very good.2. melatonin can prolong sleep time ,shorten sleep incubation period and promote the mouse to go to sleep. It had been proved that melatonin can improve sleep function. 3.The highest dose of sample reach to one- hundred times of human daily dose in toxicological test ,so it is safe for human to be used as a healthy food . |