Evaluation Of Toxicology And Laxative Function For Formula Products With Psyllium Husk And Seabuckthorn

Objective: Constipation is a common disease,and it has greater potential hazard for human,there is still no specific treatment methods for constipation.A number of research showed that increasing dietary fiber intake has the effect to relieve the symptoms of constipation.In this paper,we performed toxicological evaluation,and human body test,analysis the component of product.Evaluate the laxative efficacy of the products and investigate the significance of this product in improving constipation.Methods: According to the < Standard for safety assessment of health foods >,the acute toxicity test,genetic toxicity test and 30 days feeding test were performed.According to the <Technical specification for inspection and evaluation of health food >,collected 309 volunteers from a hospital in Lanzhou meeting the inclusion criteria,randomly divided into test group and placebo group,test group 156 cases,and 153 patients in the placebo group for human test.Before the experiment,the intake of dietary fiber was investigated,the 6 days defecation status(including frequency of defecation,defecation and stool characteristics)were recorded before the test.During the 7 days test,test group taking the products with Psyllium Husk and Seabuckthorn;The control group received placebo,recorded the defecation(defecation frequency,defecation status,fecal characteristics)of the two groups during the test.Fecal samples were collected at the beginning and after the test to measure the fecal water content.Data were collected and analyzed to evaluate the laxative function of the product.Results: 1.In the acute toxicity test,therewere no mice die,and no other abnormal performance,the maximal tolerance dose of mice was > 24g/kg,The tested substance belonged to non-toxic substance;In the mouse bone marrow micronucleus test,compared with the negative control group,the micronucleus rate of each dose group was not statistically significant(P>0.05);Sperm abnormality test In the Sperm abnormality test,the sperm abnormality rate of mice in each dose group was not statistically significant compared with the negative control group(P>0.05);Ames test,with or without S9,the number of colonies in each dose group was no more than 2 times of the natural reversion colony.There were no deaths in the rats in each dose group after 30 days feeding test.During the experiment,the daily food intake(100g weight),blood test,biochemical index and organ coefficient of each group were not statistically significant compared with the control group(P>0.05).In addition to the high dose group of male rats in the experiment around a slow increase of body weight,other groups of male and female rats weekly weight gain compared with the control group,the difference was not statistically significant(P>0.05);each animal by the gross anatomy showed no obvious pathological change.2.In the human experiment,before and after test,the test group daily average defecation times were 0.30±0.16,0.69±0.16;defecation integra l1.58±0.29,1.15±0.32;Fecal character score 1.34±0.28,1.08±0.58;The fecal water content were 62.66±10.08,74.91±8.70.Before and after the test,the difference was statistically significant(P<0.05).Before and after test,The placebo group daily average defecation times were 0.34±0.10,0.38±0.120;defecation integral 1.45±0.56,1.29±0.38;fecal character score 1.27±0.50,1.20±0.38;The fecal water content were 61.94±4.34,62.36±5.47;There was significant difference in the number of defecation before and after the test in the placebo group(P<0.05),the other three items were not statistically significant(P>0.05).Conclusions:1.Acute toxicity experiments,the experimental animals did not die,the MTD > 24g/kg.The micronucleus test of bone marrow did not affect the micronucleus rate of bone marrow;the sperm abnormality test did not affect the sperm abnormality rate of the experimental animals;the Ames test showed no direct or indirect mutagenicities.The 30 day feeding test showed no obvious toxicity in the tested animals,indicating that the product was safe.2 the formula product can effectively improve constipation symptoms,increase the number of defecation,increase fecal water content,improve defecation and fecal characteristics,suggesting the formulation of the product has a laxative laxative effect.