Study On Toxicological Assessment And Defecation Functions Of Multiple Products

Objective: Constipation is a common multifactor gastrointestinal disease.Constipation due to its high prevalence,high economic cost and have the adverse effect for quality of life and health,Therefore,it has become a major public health problem.So it is necessary to explore more effective treatment methods to alleviate or reduce the symptoms of patients.The purpose of this paper is to study the function of the composite product(which include Hemp seed,Semen Pruni and peach kernel)on constipation through the safety toxicology test,animal function test and human food test,evaluate the safety and effectiveness of the treatment of constipation.Provide reference for the development of health products with laxative function.Methods: 1.The evaluation of the safety toxicological of the composite products includes: acute oral toxicity test,genetic toxicity test,and 30-day feeding test;2.Laxative function of the product 2.1 Constipation mice model was established by Diphenoxylate.And the percentage of ink propellant in small intestine were computed 2.2 In defecation test,the first defecation time of each animal were record,The amount of feces within 6 hours were record and the weight of the stool were weighed to observe the laxative action of the products.2.3 In the human food trial,110 patients with chronic constipation were selected for the trial(Informed consent has been signed before the experiment),who were met the conditions for the inclusion and exclusion criteria,The experiment was conducted according to the principle of randomization,control and double blindness,and the experiment was controlled by placebo,The trial time was 7 days.After 7 days,the general condition,symptoms,signs,biochemical level and diet of the subjects were analyzed.the improvement of functional constipation in patients with products was evaluated.The main statistical methods used are t-test and chi-square test,and the test level is ?=0.05.Result: 1.Acute oral toxicity test: The acute oral MTD of SD rats were more than 15 g/kg.bw.According to the relevant grading standards of the Ministry of Health,the sample belongs to non-toxic grade.2.Among the three genetic toxicity tests were all negative.It showed that the product had no genetic toxicity.3.The results of the 30-days-feeding study were negative.They showed that there was no significant influence on health status,physiological and biochemical functions,organ tissue morphology and other important indicators of rats.Preliminary estimates showed that the maximum no-effect dose was more than 4.25 g/kg.bw.equivalent to 64 times of the recommended dosage for human body.4.The small intestinal motility test and defecation test shows: model group and three experimental groups mice small intestinal ink propulsion rate significantly decreased,that is,successful modeling;After the experiment,the first defecation time of mice in the experimental group was shortened,the number of defecation granules increased in 6 hours(P < 0.05),and the weight of feces increased in 6 hours(P < 0.05)in the 0.67g/kg.bw dosage group.5.In the human trial,There were significant differences in the number of stools,defecation status and fecal characteristics(1.88 ±0.82,0.66±0.68,0.42±0.57)between the trial group and the pre-trial group(0.63±0.58,1.40±0.95,0.96±0.69)(P < 0.05),There was also a significant difference between the trial group and control group.And there was no statistical difference between the control group and the pre-trial group(P >0.05).Conclusion: 1.The product is safe,non-toxic and it belongs to non-toxic substances.2.There are have no mutagenicity ware found in the genotoxicity test.3.During the 30-day feeding test,the general physiological signs and behavior of rats were normal,and there were no abnormal changes in animal health,biochemical,hematological parameters and organ and tissue morphology.4.The product has the function of defecation in animal defecation test.5.Compound products with hemp seed,Semen Pruni and peach seed as main raw materials can improve the symptoms and signs of constipation.