| Objective: Chronic constipation is a clinically more prone to disease that can have a serious impact on the quality of life of patients and increase the economic burden of the individual's economy and society.We need to find a better way to treat chronic constipation.Fructooligosaccharides as a natural active substance,with a variety of important functions,can proliferate Bifidobacterium,produce organic acids,improve intestinal flora,prevent constipation,etc,due to these prominent physiological functions,oligofructose can be used Health Care Products.In this study,the toxicology of oligofructose was evaluated and the results of the test were analyzed by the human body test.The effect of the treatment of constipation was evaluated.Methods: The toxicity of the product was determined by acute toxicity test,genotoxicity test and 30-day feeding test.A randomized,double-blind,placebo-controlled study was conducted in October 2013 to January 2015 to select 307 chronic constipation subjects in a physical examination center in a tertiary hospital in Lanzhou for a 7-day treatment period.All subjects A total of seven consecutive days of bowel movements were recorded before and after the meal,and the patient's general condition was recorded.Subjects were asked daily and symptoms related to constipation(defecation,defecation,stool)were recorded,collect stools before and after the test.The subjects in the group received 5g / day,the test group(n = 154)and placebo in the control group(n = 153).A week after the statistics of the indicators(defecation frequency,defecation status,fecal traits,fecal water content),to assess the improvement of constipation symptoms of this product.Results: The maximal tolerance(MTD)of the preparation was greater than 20 g / kg BW by oral acute toxicity test in female and male mice.2.The preparation of the genetic toxicity test: mouse bone marrow micronucleus test results were negative.Mice sperm deformity test results were negative.Ames test results were negative,the test object without direct or indirect mutagenic effect.3.Animals were sacrificed 30 days after intragastric administration in the three doses of 4.17,8.33 and 16.67 g / kg BW,and no adverse effects were observed in food utilization.4.The average number of defecation sessions was 0.35 ± 0.13,0.70 ± 0.27,the defecation score was 1.40 ± 0.46,1.05 ± 0.32,the fecal traits were 1.27 ± 0.46 and 0.76 ± 0.37,respectively.Water was 62.18 ± 7.54,74.00 ± 9.42,and the difference was statistically significant(P <0.05).The average daily defecation frequency of the control group was 0.34 ± 0.10 and 0.38 ± 0.12,the defecation score was 1.45 ± 0.56,1.29 ± 0.38,the stool score was 1.27 ± 0.50,1.20 ± 0.38 and the fecal water content was 61.94 ± 4.34 and 62.36 ± 5.47.(P <0.05),and the other three differences were not statistically significant(P> 0.05).The defecation status and fecal traits improved significantly,and the fecal water content increased significantly.Compared with the control group and the control group,the number of defecation,stool status,feces Traits,fecal water content were better than the control group.Conclusions: 1.The fructooligosaccharide preparation is a non-toxic substance.2.Genotoxicity test no mutagenicity was observed.3.30 days feeding test,the general physiological signs of rats,behavior,urine,fur and so no abnormalities,weight and food utilization indicators normal.4.The fructooligosaccharide preparation can effectively improve chronic constipation symptoms. |
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