New application of montmorillonite powder

Abstract

The invention discloses a new application of montmorillonite powder, and belongs to the technical field of biological medicines. The montmorillonite powder has a huge specific surface area, a unique pore structure and rich non-uniform charges, can cover gastrointestinal mucosa and adsorb and isolate harmful bacteria, pathogens and the like after being orally taken, only plays a role on the surface of the mucosa, cannot be absorbed by a human body, and is finally discharged out of the body together with harmful substances along with intestinal peristalsis, so that the treatment effect is good. The montmorillonite powder is used for resisting anxiety and improving sleep quality, and after the montmorillonite powder is orally taken, the montmorillonite powder has the effects of obviously improving anxiety and improving sleep quality and is relatively small in side effect.

Description

Technical Field

[0001] The invention belongs to the technical field of biomedicine, and in particular relates to a new use of montmorillonite powder. Background Art

[0002] Attention deficit hyperactivity disorder (ADHD), commonly known as ADHD, is a common neurodevelopmental disorder in children and adolescents. The global incidence rate among school-age children is about 5%, and the proportion of children aged 7-10 with ADHD and comorbid anxiety disorders has reached 18%. Its core symptoms are attention deficit, hyperactivity and impulsivity, often accompanied by other mental and psychological disorders such as anxiety and conduct disorder. Since some symptoms of ADHD, such as hyperactivity and impulsivity, overlap with the tension and anxiety of anxiety symptoms, it is also challenging to diagnose ADHD comorbid anxiety disorders. If the disease is not effectively controlled, it can persist into adolescence and adulthood, adversely affecting the patient's academic, work and social life, and bringing huge mental and economic burdens to the family and society. At present, the treatment of ADHD includes drug and non-drug treatment. However, psychotropic drug treatment has great side effects. Non-drug treatment, including psychological, behavioral, and dietary therapy, has slow progress and insignificant efficacy. Therefore, exploring new treatment options with strong targeting and fewer side effects is a medical problem that needs to be solved urgently. Summary of the invention

[0003] In order to overcome the deficiencies of the prior art, the present application proposes a new use of montmorillonite powder, which, when taken orally, has the effects of significantly improving anxiety, improving sleep quality, and relieving gastrointestinal symptoms in patients with ADHD.

[0004] In order to achieve the above object, the technical solution adopted by the present invention is:

[0005] The invention provides a new use of montmorillonite powder, that is, the montmorillonite powder is used for anti-anxiety.

[0006] Specifically, the intake of the montmorillonite powder is 4 to 9 g / day.

[0007] Specifically, the montmorillonite powder is used for ADHD patients.

[0008] Specifically, the montmorillonite powder is delivered orally.

[0009] Specifically, the montmorillonite powder is a powder.

[0010] The invention also provides a new use of montmorillonite powder, that is, the montmorillonite powder is used to improve sleep quality.

[0011] Specifically, the intake of the montmorillonite powder is 4 to 9 g / day.

[0012] Specifically, the montmorillonite powder is used for ADHD patients.

[0013] Specifically, the montmorillonite powder is delivered orally.

[0014] Specifically, the montmorillonite powder is a powder.

[0015] Compared with the prior art, the present invention has the following beneficial effects:

[0016] The invention provides a new use of montmorillonite powder. Montmorillonite powder (also called smectite or montmorillonite powder) is a very safe and effective strong adsorbent, which has a huge specific surface area, a unique pore structure and rich non-uniform charges. After oral administration, it can cover the gastrointestinal mucosa, adsorb and isolate harmful bacteria, pathogens, etc., and only acts on the mucosal surface, will not be absorbed by the human body, and is eventually discharged from the body with harmful substances along with intestinal peristalsis. Montmorillonite powder is used for anti-anxiety or improving sleep quality. After oral administration, it can significantly improve anxiety, improve sleep quality, and relieve gastrointestinal symptoms of ADHD patients, and the side effects are relatively small. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 A is the total movement distance of ADHD model rats in the open field; Figure 1 B is the proportion of time that ADHD model rats spend active in the central area in the open field; Figure 1 C is the number of times the ADHD model rats entered the central area in the open field;

[0018] Figure 2 A is the number of times the ADHD model rats entered the open arm in the elevated plus maze; Figure 2 B is the proportion of time spent in the open arms of ADHD model rats in the elevated plus maze;

[0019] Figure 3 Anxiety scores were obtained for the first group of ADHD children before treatment, at the end of treatment, and at follow-up;

[0020] Figure 4 Sleep scores were given to the first group of ADHD children before treatment, at the end of treatment, and at follow-up;

[0021] Figure 5 The severity of the disease in the first group of ADHD children was scored before treatment, at the end of treatment and at follow-up;

[0022] Figure 6 Anxiety scores were obtained for the second group of ADHD children before treatment, at the end of treatment, and at follow-up;

[0023] Figure 7 Sleep scores were given to the second group of ADHD children before treatment, at the end of treatment, and at follow-up;

[0024] Figure 8 The severity of the disease was scored for the second group of ADHD children before treatment, at the end of treatment, and at follow-up;

[0025] Fig. 9 Anxiety scores were obtained for the third group of ADHD children before treatment, at the end of treatment, and at follow-up;

[0026] Fig.10 Sleep scores were given to the third group of ADHD children before treatment, at the end of treatment, and at follow-up;

[0027] Fig.11 The disease severity of the third group of ADHD children was scored before treatment, at the end of treatment and at follow-up. DETAILED DESCRIPTION

[0028] The present invention is not limited to the following specific embodiments. A person skilled in the art can implement the present invention in various other specific embodiments according to the contents disclosed in the present invention, or any simple changes or modifications made to the design structure and ideas of the present invention fall within the protection scope of the present invention. It should be noted that the embodiments and features in the embodiments of the present invention can be combined with each other without conflict.

[0029] The montmorillonite powder used in the embodiments of the present invention is Xieliting Montmorillonite Powder produced by Harbin Pharmaceutical Group Traditional Chinese Medicine Factory No. 2, with approval number: National Medicine Standard H20093375.

[0030] Example 1 Montmorillonite powder can improve the anti-anxiety ability of mice

[0031] 1. Select two groups of ADHD model rats, namely the drug treatment group and the control group, with a sample size of 9 in each group.

[0032] The ADHD model rats in the drug administration group were fed with a feed containing 5% montmorillonite powder at a rate of 15 g / 100 g / day according to their daily body weight for two weeks.

[0033] The ADHD model rats in the control group were fed with ordinary feed at 15g / 100g / day for two weeks according to their daily body weight. The only difference between the feed consumed by the control group and the feed consumed by the drug-treated group was that the feed consumed by the control group did not contain montmorillonite powder.

[0034] 2. The efficacy of the two groups of ADHD model rats was verified as follows:

[0035] (1) Open field test

[0036] The rats were placed in the center of the bottom of an open field reaction box (100 cm × 100 cm × 50 cm) with a bottom area of ​​1 square meter. A camera was placed above the reaction box for recording and timing. The total movement distance of the rats in the open field within 30 minutes, the time spent in the middle area, and the number of times they entered the center area were recorded. The Smart 3.0 animal behavior analysis system was used to record animal activities throughout the process. After the experiment, the animals were removed and the experimental area was sprayed with 75% ethanol to remove the remaining excrement and odor of the animals.

[0037] (2) Elevated plus maze test

[0038] The rat was placed in the center of the maze with its head facing one of the open arms, and its activities in the maze were observed within 5 minutes. The number of times the rat entered the open arm and the proportion of time in the open arm were counted, and the open arm residence time = open arm entry number / (open arm entry number + closed arm entry number) × 100%.

[0039] (3) Statistical analysis

[0040] GraphPad Prism 8 was used for statistical analysis and graphing. All statistical data were expressed as mean ± standard deviation. Unpaired t-test was used for comparison between the two groups. P < 0.05 was considered statistically significant.

[0041] 3. The efficacy of the two groups of ADHD model rats was verified, and the results were as follows:

[0042] Depend on Figure 1 It can be seen that after ADHD model mice consumed feed containing montmorillonite, the total activity distance in the open field did not change, the proportion of time in the central area increased significantly, and the number of times they entered the central area increased, indicating that their anti-anxiety ability improved.

[0043] Depend on Figure 2 It can be seen that after ADHD model mice consumed feed containing montmorillonite, the number of times they entered the open arm in the elevated plus maze and the proportion of time in the open arm increased significantly, further indicating that their anti-anxiety ability was improved.

[0044] Example 2 Montmorillonite powder can enhance people's anti-anxiety ability and improve people's sleep quality

[0045] 1. Recruitment of subjects

[0046] 1.1 Inclusion criteria:

[0047] (1) Aged 6 to 18, with half male and half female;

[0048] (2) DSM-V diagnostic criteria combined with clinical manifestations to confirm ADHD;

[0049] (3) Agree to participate in this study and sign a written informed consent.

[0050] 1.2 Exclusion criteria: Subjects who meet any of the following criteria will not be included:

[0051] (1) Patients with other mental and neurological diseases (such as autism spectrum disorder, tic disorder, anxiety disorder, major depressive disorder, conduct disorder, epilepsy or other mental and neurological diseases);

[0052] (2) IQ score is less than 75 points;

[0053] (3) oral, injectable, or inhaled antibiotics within 30 days before screening;

[0054] (4) Severe constipation;

[0055] (5) Currently taking ADHD-related control or extended-release medications;

[0056] (6) History of inflammatory bowel disease, intestinal obstruction, diverticular disease or colon polyps, or history of major gastric or intestinal surgery (excluding appendectomy).

[0057] 1.3 Diagnostic criteria: The diagnosis is made by a clinician based on the DSM-V diagnostic criteria and the child's symptoms.

[0058] 1.4 Sample size: There are 3 groups in total, with 10 samples in each age group of 6-10 years old, 10-14 years old, and 14-18 years old. In each age group, males and females each account for half of the sample size.

[0059] 2. Conduct an open-label, self-controlled clinical trial on the samples.

[0060] The first group of ADHD children recruited took the medicine once in the morning and once in the evening, with each person taking 2g each time for 28 days.

[0061] The second group of ADHD children recruited took the medicine once in the morning and once in the evening, with each person taking 3g each time for 28 days.

[0062] The third group of ADHD children recruited took the medicine once in the morning and once in the evening, with each person taking 4.5g each time for 28 days.

[0063] 3. Verify the efficacy of the recruited children with ADHD as follows:

[0064] (1) The SNAP-IV parent scale (26 items) was used to evaluate whether oral montmorillonite powder can improve the core clinical symptoms of ADHD, such as inattention, hyperactivity, and impulsivity.

[0065] (2) The anxiety scale and the children's sleep disorder scale were used to assess the mood and sleep status of children with ADHD. The gastrointestinal symptom scale and the Bristol stool classification chart were used to assess the gastrointestinal improvement of children with ADHD.

[0066] (3) Statistical analysis

[0067] The questionnaire star was used to collect the scale information of the subjects. All clinical data were expressed as mean ± standard deviation and analyzed by repeated measures ANOVA, linear mixed effects model or paired t-test. P < 0.05 was considered statistically significant.

[0068] 4. The results of efficacy verification of recruited children with ADHD are as follows:

[0069] Depend on Figure 3 , Figure 6 and Fig. 9 It can be seen that the anxiety scores of children with ADHD decreased significantly after one month of treatment with montmorillonite powder, and the effect persisted during the follow-up period.

[0070] Depend on Figure 4 , Figure 7 and Fig.10 It can be seen that the sleep scores of children with ADHD decreased significantly one month after receiving montmorillonite powder treatment, especially during the follow-up period, the scores decreased significantly, indicating that montmorillonite powder can significantly improve the sleep quality of children.

[0071] Depend on Figure 5 , Figure 8 and Fig.11 It can be seen that the Clinical Global Impression Scale-Disease Severity (CGI-S) scores of children with ADHD decreased significantly one month after treatment with montmorillonite powder and during the follow-up period, indicating that montmorillonite powder can significantly improve the symptoms of children.

[0072] The above description is only a preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical solutions and concepts of the present invention within the technical scope disclosed by the present invention, which should be covered by the protection scope of the present invention.

Claims

1. Montmorillonite powder is used to relieve anxiety.

2. The montmorillonite powder according to claim 1 is used for anti-anxiety, characterized in that: The intake amount of the montmorillonite powder is 4 to 9 g / day.

3. The montmorillonite powder according to claim 1 is used for anti-anxiety, characterized in that: The montmorillonite powder is used for ADHD patients.

4. The montmorillonite powder according to claim 1 is used for anti-anxiety, characterized in that: The montmorillonite powder is delivered orally.

5. The montmorillonite powder according to claim 1 is used for anti-anxiety, characterized in that: The montmorillonite powder is a powder.

6. Montmorillonite powder is used to improve sleep quality.

7. The montmorillonite powder according to claim 6 is used for improving sleep quality, characterized in that: The intake amount of the montmorillonite powder is 4 to 9 g / day.

8. The montmorillonite powder according to claim 6 is used for improving sleep quality, characterized in that: The montmorillonite powder is used for ADHD patients.

9. The montmorillonite powder according to claim 6 is used for improving sleep quality, characterized in that: The montmorillonite powder is delivered orally.

10. The montmorillonite powder according to claim 6 is used for improving sleep quality, characterized in that: The montmorillonite powder is a powder.

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