CN112438994A - A small intestine mucosa extract for preventing and treating bipolar disorder - Google Patents
A small intestine mucosa extract for preventing and treating bipolar disorder Download PDFInfo
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- CN112438994A CN112438994A CN202010887152.3A CN202010887152A CN112438994A CN 112438994 A CN112438994 A CN 112438994A CN 202010887152 A CN202010887152 A CN 202010887152A CN 112438994 A CN112438994 A CN 112438994A
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/37—Digestive system
- A61K35/38—Stomach; Intestine; Goblet cells; Oral mucosa; Saliva
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/20—Hypnotics; Sedatives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/24—Antidepressants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biomedical Technology (AREA)
- Chemical & Material Sciences (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Psychiatry (AREA)
- Cell Biology (AREA)
- Nutrition Science (AREA)
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- Developmental Biology & Embryology (AREA)
- Immunology (AREA)
- Physiology (AREA)
- Zoology (AREA)
- Epidemiology (AREA)
- Biotechnology (AREA)
- Hospice & Palliative Care (AREA)
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- Polymers & Plastics (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The invention belongs to the field of food and medicine, and particularly relates to a small intestine mucosa extract with a prevention and treatment effect on bipolar disorder. The invention also provides a health-care product or a medicine containing the small intestine mucosa extract. Pharmacological tests show that compared with the existing treatment methods, the small intestine mucosa extract provided by the invention has remarkable two-way regulation effect on depressive episodes and manic episodes of bipolar disorder, and has the advantages of no toxic or side effect and repeated episode prevention. The method for extracting the small intestine mucosa provided by the invention is simple and feasible, and is suitable for further industrialized mass production.
Description
Technical Field
The invention belongs to the field of food and medicine, and particularly relates to a composition with a prevention and treatment effect on bipolar affective disorder.
Background
The bipolar affective disorder is one of the common clinical mental disorder diseases, has the characteristics of complex disease condition, long disease course, difficult treatment, easy repeated attack and high disability rate, is usually accompanied by symptoms of alternating depressive attack and manic attack, further has great adverse effect on physical and mental health of patients, has the trend of increasing the depression attack rate of the bipolar affective disorder year by year along with the continuous increase of living and working pressure of people in recent years, and needs to provide drug treatment with less adverse reaction, high safety and good curative effect for the patients in order to timely improve the depression symptoms of the patients and stabilize the emotional and psychological states of the patients, thereby effectively improving the physical and mental states of the patients and improving the living and life quality of the patients.
In the medical field, psychological care intervention is often employed in conjunction with drug care to help patients reduce or even eliminate their symptoms of both mania and depression. From the pharmacological point of view, patients who are in need of mental disorders have great dialectics in terms of medication. For manic patients, usually tranquilizers and for depressed patients, antidepressants are used for treatment, and the mutual resistance of the two medicines is not negligible. In addition, when the condition is diagnosed, there is a misdiagnosis phenomenon that the bidirectional affective disorder is diagnosed as monophasic depression. Therefore, it is not easy to treat bipolar disorder patients from the diagnosis of the disease. Therefore, the search for an effective drug which has significant efficacy on bipolar disorder and can reduce the recurrence rate thereof becomes the first task of pharmaceutical workers.
The small intestine is the most important part of the digestive absorption process of food. Jame (1997) states that mucosal digestion is the final stage of digestion of various nutrients, and that intestinal mucosa is the final site of digestion of all nutrients, and is at a critical position. Besides the function of digestion and absorption, the small intestine is also an important endocrine organ, and various active substances including heparin sodium, various enzymes and antibacterial substances are separated from the small intestine and mucosa thereof. The intestinal mucosa extract has multiple biological activities, and is a hot spot of future pharmaceutical workers.
Disclosure of Invention
One of the objects of the present invention is to provide a novel use of an extract from the mucosa of the small intestine, i.e., an extract from the mucosa of the small intestine having a preventive and/or therapeutic effect on bipolar disorder; has obvious improvement effect on depression, mania, learning and memory ability and insomnia of bipolar affective disorder patients.
The small intestine mucosa extract is prepared by extracting and precipitating small intestine mucosa.
The extraction method can be one or more of water extraction method and ultrasonic extraction method; preferably, the extraction method is an ultrasonic extraction method.
The precipitation method can be one or more of ethanol precipitation method, fractional precipitation method and quaternary ammonium salt complexation method; preferably, the precipitation method is an ethanol precipitation method.
Specifically, the preparation method of the small intestine mucosa extract comprises the following steps:
(1) extraction: taking small intestine mucosa, homogenizing and crushing, adding water, performing ultrasonic extraction, and filtering the extract to obtain water extract;
(2) alcohol precipitation: adding monohydric alcohol into the water extract obtained in the step (1), and filtering to obtain a precipitate;
(3) and (3) freeze drying: and (3) freeze-drying the precipitate obtained in the step (2) to obtain the small intestine mucosa extract containing mucopolysaccharide and water-soluble protein.
Wherein the small intestine mucosa in step (1) is selected from small intestine mucosa of mammal; preferably, the small intestine mucosa is porcine small intestine mucosa.
Preferably, the volume mass ratio of water to small intestine mucosa used in the ultrasonic water extraction in the step (1) is 1:1-100:1 (ml/g);
further preferably, the volume-to-mass ratio of water to the small intestinal mucosa used is 80:1 (ml/g).
Preferably, after the monohydric alcohol is added in the step (2), the alcohol concentration of the solution is 25% -95%;
further preferably, the monohydric alcohol added is ethanol, and the ethanol concentration of the solution is 65%.
Therapeutic effect of intestinal mucosa extract on bipolar disorder.
Experimental example 1 research results show that the small intestine mucosa extract provided by the invention can obviously improve the depression state of patients with bipolar affective disorder and can obviously improve the learning and memory abilities of the patients with bipolar affective disorder.
Experimental example 2 the results of the study show that the small intestine mucosa extract provided by the invention can obviously improve the mania state of patients with bipolar affective disorder and can obviously improve the insomnia state of patients with bipolar affective disorder.
The results of clinical trials show that: the small intestine mucosa extract provided by the invention has remarkable curative effect and small toxic and side effect when being used for treating patients with bipolar disorder, and has the advantage of preventing relapse compared with other treatment medicines.
The invention also provides a health product and food containing the small intestine mucosa extract.
Preferably, the health product can be capsule, powder, granule, syrup, honey paste, distillate, fresh juice, tablet, tea, oral liquid, and medicated liquor; the food may be a flour product.
More preferably, the health product can be granule, tablet, capsule, powder and syrup; the flour product can be staple food such as noodle, steamed bread, battercake, etc., and various cake products prepared from flour.
The health product can be prepared by common health product preparation process; all the foods are prepared by adding the composition provided by the invention into common foods according to a preparation process of the common foods.
After the health-care product or the food is eaten by the patient with bipolar affective disorder, the manic and depressive states can be obviously improved, and the insomnia state and the memory of the patient can be obviously improved.
The invention also provides a medicine containing the composition, preferably, the medicine can be tablets, granules, capsules and syrup, and can be prepared according to a common preparation process.
Preferably, the above-mentioned medicament is administered to a human in a dosage of 0.02mg/kg to 200mg/kg, more preferably in a dosage of 0.5mg/kg to 50mg/kg, in the treatment of bipolar disorders.
The health care product or the medicine can only comprise active ingredients, and can also comprise any nutritionally and pharmaceutically acceptable auxiliary materials with guaranteed safety, such as an excipient, an antioxidant, a pH regulator, a preservative, an isotonic agent and the like. The health product can be added with other nutritional ingredients during final preparation, and the nutritional ingredients include starch, glucose, lactose, mannose, sucrose, syrup, Mel, various amino acids, calcium, ferrum, zinc, vitamins, etc.
The health products or medicines of the present invention can be prepared in various types, including not only tablets, granules, capsules and syrups, but also any other forms that change the appearance of the products are within the technical solution that can be imagined by those skilled in the art, and therefore it is within the scope of the present invention to change the shape of the final products.
Compared with the prior art, the small intestine mucosa extract provided by the invention has the following main advantages in prevention and treatment of bidirectional affective disorder:
(1) has remarkable curative effect and no toxic or side effect, and can be added into food to prepare health products for long-term administration.
(2) Compared with other treatment methods, the health care product or the medicine containing the small intestine mucosa extract has the advantage of effectively preventing the recurrence of the bipolar disorder.
DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION
The present invention is further illustrated below by specific examples in order to provide those skilled in the art with a full understanding of the present invention, but it should be understood by those skilled in the art that the examples of the present invention are not to be construed as limiting the present invention in any way.
Example 1 preparation of extract of mucous membrane of small intestine
(1) Water extraction: taking porcine small intestine mucosa, homogenizing, adding water according to the volume mass ratio of 50:1(ml/g), extracting in a water bath at 100 ℃, and filtering the extracting solution to obtain water extracting solution;
(2) alcohol precipitation: adding ethanol into the water extract obtained in the step (1) to ensure that the concentration of the ethanol in the solution is 45%, and filtering to obtain a precipitate;
(3) and (3) freeze drying: and (4) freeze-drying the precipitate obtained in the step (3) to obtain the small intestine mucosa extract containing mucopolysaccharide and water-soluble protein.
Example 2 preparation of extract of mucous membrane of small intestine
(1) Extraction: taking porcine small intestine mucosa, homogenizing and crushing, adding water according to the volume mass ratio of 10:1(ml/g), carrying out ultrasonic extraction, and filtering the extracting solution to obtain a water extracting solution;
(2) alcohol precipitation: adding ethanol into the water extract obtained in the step (1) to ensure that the concentration of the ethanol in the solution is 95%, and filtering to obtain a precipitate;
(3) and (3) freeze drying: and (4) freeze-drying the precipitate obtained in the step (3) to obtain the small intestine mucosa extract containing mucopolysaccharide and water-soluble protein.
Example 3 preparation of extract of mucous membrane of small intestine
(1) Extraction: taking porcine small intestine mucosa, homogenizing and crushing, adding water according to the volume mass ratio of 100:1(ml/g), carrying out ultrasonic extraction, and filtering the extracting solution to obtain a water extracting solution;
(2) alcohol precipitation: adding ethanol into the water extract obtained in the step (1) to enable the concentration of the ethanol in the solution to be 25%, and filtering to obtain a precipitate;
(3) and (3) freeze drying: and (4) freeze-drying the precipitate obtained in the step (3) to obtain the small intestine mucosa extract containing mucopolysaccharide and water-soluble protein.
Example 4 preparation of extract of mucous membrane of small intestine
(1) Extraction: taking porcine small intestine mucosa, homogenizing and crushing, adding water according to the volume mass ratio of 80:1(ml/g), carrying out ultrasonic extraction, and filtering the extracting solution to obtain a water extracting solution;
(2) alcohol precipitation: adding ethanol into the water extract obtained in the step (1) to enable the concentration of the ethanol in the solution to be 65%, and filtering to obtain a precipitate;
(3) and (3) freeze drying: and (4) freeze-drying the precipitate obtained in the step (3) to obtain the small intestine mucosa extract containing mucopolysaccharide and water-soluble protein.
Example 5 preparation of extract of mucous membrane of small intestine
(1) Extraction: taking porcine small intestine mucosa, homogenizing and crushing, adding water according to the volume mass ratio of 60:1(ml/g), carrying out ultrasonic extraction, and filtering the extracting solution to obtain a water extracting solution;
(2) alcohol precipitation: adding ethanol into the water extract obtained in the step (1) to ensure that the concentration of the ethanol in the solution is 45%, and filtering to obtain a precipitate;
(3) and (3) freeze drying: and (4) freeze-drying the precipitate obtained in the step (3) to obtain the small intestine mucosa extract containing mucopolysaccharide and water-soluble protein.
EXAMPLE 6 preparation of a pharmaceutical product containing an extract from the mucous membranes of the small intestine
Sieving the small intestine mucosa extract and starch obtained in example 4, and mixing; adding starch slurry to obtain soft material, sieving, granulating, oven drying, and grading; adding magnesium stearate, mixing, and tabletting to obtain tablet.
Example 7 preparation of health product containing extract of mucous membrane of small intestine
Mixing the small intestine mucosa extract obtained in example 4 with dextrin, lactose and sodium cyclamate, sieving, granulating with ethanol, and drying to obtain granule.
Example 8 preparation of food containing extract of mucous membrane of small intestine
The extract of the mucous membrane of the small intestine obtained in example 4 was added with flour, and then prepared into noodles according to a conventional food process.
Experimental example 1 Effect of the composition on improving depressive behavior of rats in depression model
1. Test method
80 healthy male SD rats were randomly divided into a normal control group, a model group and an experimental group (example 3 group, example 4 group), and 20 rats were each group. The model group and the experimental group of rats establish a depression rat model by combining isolated culture with chronic mild unpredictable stimulation according to a reference method, and the rats are normally bred in a blank control group. During modeling, the test group was gavaged with 20mg/kg of the intestinal mucosal extract obtained in examples 3 and 4, and the control group and the model group were gavaged with 0.9% NaCl in equal amounts for 4 weeks. The model group rats were associated with typical depressive symptoms of water intake, decreased exploratory behavior, weight loss, decreased interest, dull hair color, etc.
2. Detecting the index
(1) Field experiment:
after the administration, performing field experiment according to the reference method, observing and recording the horizontal movement grid number and vertical erection times of each group of rats within 4min, calculating the sum of horizontal and vertical scores to be the autonomous activity times, and recording the immobility time.
(2) Method for testing and detecting learning and memory functions of rat by Morris water maze
After the administration, each group of rats was subjected to a localized voyage experiment and a space exploration experiment using Morris water maze test system according to the reference (ApoE4 age-dependent increase in susceptibility to stress-induced depressive-like behavior and decline in learning and memory).
3. Test results
(1) Effect of intestinal mucosa extract on Depression behavior of Depression rats
The number of the autonomous activities of the rats in the model group is reduced compared with that of the rats in the normal control group (P is less than 0.01), while the number of the autonomous activities of the rats in the experimental group is increased compared with that of the rats in the model group (P is less than 0.01); the immobility time of the model group rats is longer than that of the normal control group (P is less than 0.01), while the immobility time of the experimental group is shorter than that of the model group (P is less than 0.01), which indicates that the intestinal mucosa extract can obviously improve the depression state of the depression model rats. Specific results are shown in table 1.
Table 1 effect of intestinal mucosa extract on depressive behaviour in depressed rats (n ═ 20)
Compared with the normal control group, the composition has the advantages that,##P<0.01; in comparison to the set of models,&&P<0.01。
(2) influence of small intestine mucosa extract on learning and memory ability of depression rat
Model group rat Morris water maze positioning navigation experiment 1, 2, 3, 4d latency period is prolonged compared with normal control group (P < 0.05); the experimental group is shortened (P is less than 0.05) compared with the model group; the number of times of crossing the test in the Morris water maze space exploration test in the model group is reduced (P is less than 0.01) compared with that in the control group, while the number of times of crossing the test in the test group is increased (P is less than 0.05) compared with that in the model group, which shows that the extract of the small intestinal mucosa can obviously improve the learning and memory ability of the rat in the depression model. The specific results are shown in Table 2.
TABLE 2 influence of intestinal mucosa extract on learning and memory ability of depression rats (n ═ 20)
Compared with the normal control group, the composition has the advantages that,#P<0.05，##P<0.01; in comparison to the set of models,&P<0.05。
experimental example 2 Effect of the composition on improving depressive behavior in manic model rat
1. Molding method
80 healthy SD rats were divided into a normal control group, a model group, and an experimental group (example 3 group, example 4 group) by a random number table method, and 20 rats were each group. The model group and the experimental group adopt the improved multi-platform sleep deprivation method (MMPM) to establish a mania model (refer to the method of reference literature on the influence of the change of the neuron-type nitric oxide synthase expression after sleep deprivation and the refreshment). Rats can eat and drink water on the platform by themselves, and the water in the rat box is changed every day. Rats were acclimated on the platform for 1h each day 1 week prior to the experiment. After the experiment started, rats were all on the platform except the water tank for water change, for a total of 7 days. The normal control group adopts a mouse box with the same size as the model group, but a platform is not placed at the bottom of the mouse box, a fine wire mesh is placed on the bottom of the mouse box, the rat is placed on the mesh, water is placed under the mesh, and the water is up to 1cm below the mesh, so that the rat can obtain normal sleep, and other conditions are the same.
2. Intervention method
The blank control group and the model group are not subjected to intervention treatment, and the experimental group is respectively administered with the intestinal mucosa extracts obtained in the example 3 and the example 4 by intragastric gavage at the dose of 20mg/kg for intervention treatment, wherein the intervention time is 4 weeks.
3. Detecting the index
(1) Rat autonomic behavior determination:
using the Open-Field method (OIT), one rat at a time was placed in the Open-box center square for 3 min. The horizontal score is the number of squares passed by the rat horizontally, 3 or 4 claws of the rat are specified to enter the same grid and is marked as l score; the vertical score was given by 2 hind paws supporting the body and 2 forepaws leaving the floor, with 1 score for each 1 leave.
(2) Sleep latency determination
Continuously depriving the rat of sleep for 7d, and recording the time (namely the sleep latency) from the beginning of the lower platform of the rat to the 1 st sleep of the rat after the molding is finished, wherein the successful molding of the mania is carried out if the time is more than 30 min. The rat falls asleep is defined behaviorally as the rat closes eyes and remains still in bed for 30s or more.
(3) Statistical method
The analysis was performed using SPSS20.0 statistical software. The data are expressed as means ± standard deviation, single-factor analysis of variance (ANOVA) is used for multiple comparisons, and q-test is used for pairwise comparison. P <0.05 is statistically significant for the differences.
4. Results
(1) Comparison of general behavior of rats in each group
Model group: after 1d of sleep deprivation, the sleep shows excitement, and the sleep shows disorderly movement among different platforms, is sensitive to external slight acousto-optic stimulation, and shows a frightened state to the acousto-optic stimulation; after 3 days of sleep deprivation, the patient is dull, slight twitching of the muscles of the head and the face is accompanied by movement of the beard, the patient crouches on a platform, falls into the water repeatedly due to dozing, climbs the platform after waking up, the activity and the food intake are reduced, and after stimulation, the patient has aggressive behaviors such as indiscriminate biting and the like. Sleep deprived 5-7d rats were mentally impatient, had little feeding activity, had generalized hair sticking, were extremely irritable, had increased aggressive biting behavior, and resulted in death of 4 rats during biting.
Blank control group: no manic manifestations of the model group.
Experimental groups: compared with a model group, the manic performance is obviously reduced, and no animal is killed due to the bite behavior.
The results show that the small intestinal mucosa extract can obviously improve the irritability and the aggressive manic state of the manic rats.
(2) Comparison of autonomic behavior results for groups of rats
Compared with the normal control group, the horizontal activity score and the vertical activity score of the rats in the model group are remarkably reduced (P <0.05), and the model building is suggested to cause the reduction of the horizontal activity and the vertical activity of the rats. Compared with the model group, the score of the horizontal activity and the score of the vertical activity of the small intestine mucosa extract group are both obviously improved (P <0.05) compared with the model group, which indicates that the small intestine mucosa extract obviously improves the mania state of the maniac rats. The specific results are shown in Table 3.
TABLE 3 Effect of extracts of the Small intestinal mucosa on manic behavior in manic rats
Compared with the normal control group, the composition has the advantages that,#P<0.05; in comparison to the set of models,&P<0.05。
(3) comparison of sleep latency after experiment in rats of each group
Compared with a normal control group, the sleep latency of the rats in the model group is remarkably prolonged, the difference has statistical significance (P is less than 0.05), and the model building is prompted to cause the sleep latency of the rats to be prolonged; compared with the model group, the sleep latency of the small intestine mucosa extract group is obviously shortened, and the difference has statistical significance (P <0.05), which indicates that the small intestine mucosa extract can obviously improve the insomnia state of the manic rats. The specific results are shown in Table 4.
TABLE 4 Effect of extracts of the Small intestinal mucosa on sleep latency in manic rats
Compared with the normal control group, the composition has the advantages that,#P<0.05; in comparison to the set of models,&P<0.05。
clinical examples
1.1 general data
40 cases of bipolar affective disorder manic-onset patients were selected for study from 1 to 12 visits in 2016, and were divided into two groups on average according to the time of admission, and the two groups were set as a control group and an observation group. The 40 patients who were enrolled met the clinical symptoms and diagnostic criteria for manic episodes of bipolar disorder in CCMD-3, excluding patients with other systemic severe disease, patients in pregnancy or lactation, and patients allergic to therapeutic agents. The general patient data are shown in Table 5.
TABLE 5 general patient data
| Grouping | Number of examples | Male sex | Female with a view to preventing the formation of wrinkles | Mean age |
| Control group | 20 | 11 | 9 | 40.12±6.09 |
| Observation group | 20 | 12 | 8 | 39.88±4.45 |
Note: general data comparison of patients, P > 0.05.
1.2 methods
Control group: the quetiapine fumarate tablets are taken orally in a combined mode, the first dose is 100 mg/day, the treatment course is gradually increased to 400-600 mg/day, and the maximum dose is not more than 800 mg/day; the first dose of the oral valproic acid sodium tablet is 200-400 mg/day, and the dose is gradually increased to 600-1200 mg/day along with the course of treatment.
Observation group: the extract of the mucosa of the small intestine of example 3 was administered at 2mg/kg once a day.
The treatment course is 8 weeks for two groups of patients.
1.3 Observation index
The mental symptoms of 2 groups of patients are evaluated before and after treatment by using a BRMS scoring scale, and the curative effect is judged to be obvious: the BRMS score is reduced by 75 percent before and after treatment, and clinical symptoms disappear or are obviously improved; the method has the following advantages: the BRMS score is reduced by 50-75 percent before and after treatment, and the clinical symptoms are improved; and (4) invalidation: the BRMS score is reduced by less than 50 percent before and after treatment, and the clinical symptoms are not improved basically. Total efficiency was 1-inefficiency. Adverse reactions (dizziness, somnolence, nausea, vomiting, allergic reactions) were counted for two groups of patients.
1.4 relapse Rate statistics after drug withdrawal
1.5 statistical methods
The data were all statistically analyzed by SPSS20.0, and the counting data are expressed in (%) and the difference P <0.05 is statistically significant.
2 results
2.1 comparison of the efficacy of the two groups of patients
The results show that the overall effective rate of the patients in the observation group is obviously higher than that of the patients in the control group, the difference between the groups is obvious, and the statistical significance is achieved. The specific results are shown in Table 6.
TABLE 6 patient efficacy and comparison (n,%)
| Grouping | Number of examples | Show effect | Is effective | Invalidation | Total effective rate |
| Control group | 20 | 7(35％) | 7(35％) | 6(30％) | 14(70％) |
| Observation group | 20 | 11(55％) | 7(35％) | 2(10％) | 18(90％)﹩ |
Note: compared with the control group, the compound of the formula,﹩P<0.05。
2.2 adverse reaction comparison of patients
The incidence rate of adverse reactions of patients in the control group is 15% (1 case for dizziness, 1 case for sleepiness, and 3 cases for 1 case for nausea and vomiting); the patients in the observation group have no adverse reactions such as dizziness, somnolence, nausea and vomiting, and only have 1 case of anaphylactic reaction, and the incidence rate is 5% (comparison among groups, P is less than 0.05). This allergic reaction may be caused by impurities present in the extract of the mucosa of the small intestine, and the occurrence of allergic reaction can be avoided by increasing its purity.
2.3 drug withdrawal relapse Rate comparison
After the 8-week treatment course is finished, the medicine taking state is continuously kept for half a year so as to stabilize the state of the illness. Follow-up visit is carried out after the medicine is stopped for 1 year, 8 people in the control group relapse, and the relapse rate is 57.14%; the observation group had no recurrence.
The above results show that: the composition has remarkable curative effect and small side effect when used for treating the bipolar disorder, and has the advantage of preventing relapse compared with other treatment medicaments.
Claims (10)
1. Use of an extract of the mucosa of the small intestine for the preparation of a product for the prevention and/or treatment of bipolar disorder.
2. Use of an extract of the mucosa of the small intestine for the manufacture of a product for improving the depressive state in bipolar disorder.
3. Use of an extract of the mucosa of the small intestine in the manufacture of a product for the amelioration of manic states in bipolar disorders.
4. Use of an extract of the mucosa of the small intestine for the preparation of a product for improving the learning and memory capacity in bipolar disorder.
5. Use of an extract of the mucosa of the small intestine for the preparation of a product for improving the state of insomnia in bipolar disorder.
6. The use according to any one of claims 1 to 5, wherein the extract of the mucosa of the small intestine is prepared by extracting and precipitating the mucosa of the small intestine; preferably, the extraction method is one or more of water extraction method and ultrasonic extraction method; preferably, the precipitation method is one or more of ethanol precipitation, fractional precipitation and quaternary ammonium salt complexation.
7. A health product or food comprising the extract of the mucosa of the small intestine according to any one of claims 1 to 5.
8. The health product or food of claim 7, wherein the health product is one or more of a capsule, a powder, a granule, a syrup, a honey paste, a lotion, a fresh juice, a tablet, a tea drink, an oral liquid, and a medicated wine; the food is a flour product; preferably, the health care product is one or more of granules, tablets, capsules, powder and syrup.
9. A pharmaceutical product comprising the extract of the mucosa of the small intestine according to any one of claims 1 to 5.
10. The pharmaceutical product of claim 9, wherein the pharmaceutical product is administered at a dose of 0.02mg/kg to 200mg/kg for the treatment of bipolar disorder.
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