Product with efficacy of preventing and treating digestive tract mucosal injury and preparation method thereof

Abstract

The invention belongs to the technical field of digestive tract mucosa protective agents, and relates to a product with the efficacy of preventing and treating digestive tract mucosa injury and a preparation method thereof. The functional component of the product is hydrophilic adhesive material powder, the particle size of the powder is 50-200 meshes, or the functional component is colloid formed after the hydrophilic adhesive material absorbs water and swells, and the viscosity of the colloid is 5-200 cp; the hydrophilic adhesive material is more than one of caesalpinia spinosa gum, Arabic gum, guar gum, konjac gum, carrageenan, tragacanth gum and xanthan gum with specific viscosity. The preparation method comprises the following steps: uniformly mixing the raw materials, grinding, screening until the particle size is 50-200 meshes, and packaging, or adding the raw materials into water until the raw materials absorb water and swell to form colloid with the viscosity of 5-200cp, and packaging. The product takes effect quickly, has no side effect, is simple in preparation method and is suitable for large-scale preparation.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of mucosal protective agents of digestive tract, and relates to a product with the efficacy of preventing and treating mucosal injury of digestive tract and a preparation method thereof. BACKGROUND

[0002] Ulcers caused by mucosal injury of digestive tract seriously affect people's quality of life. The environment of digestive tract is complex, such as containing digestive juice, enzymes and a large number of bacteria, the stomach cavity is a strong acidic environment, and contains food residues, feces in the intestinal tract, which can all stimulate the ulcer caused by mucosal injury and affect healing. In addition to the above-mentioned ulcers caused by the body's own functional defects, unhealthy lifestyle can also lead to the formation of ulcers, such as spicy and irritating food and drinking, which can cause stress injury of mucosa and thus cause ulcers.

[0003] At present, the commonly used methods for preventing and treating mucosal injury of digestive tract in the market are drugs and health care products.

[0004] Drugs are usually mucosal protective agents such as proton pump inhibitors, H2 receptor antagonists and bismuth agents, which all achieve efficacy by exerting pharmacological effects. However, long-term use of drugs can be harmful to the liver and kidneys, for example, long-term use of bismuth agents in large doses can cause neurotoxicity, including headache, fatigue, memory impairment, tremor, etc. The side effects of short-term use include headache, abdominal pain, diarrhea, constipation, bloating, nausea or vomiting, etc. The side effects of long-term use of proton pump inhibitors include causing kidney disease, liver function damage, adverse reactions of blood system, adverse reactions of circulatory system, myopathy, increasing the risk of infection, etc.

[0005] The components of health care products for protecting stomach mainly include glutamine, hericium erinaceus and its extract, propolis, curcumin, etc. These substances are all substances of the same origin of medicine and food, and the human body achieves the purpose of "protecting stomach" by absorbing these substances. For example, glutamine participates in the biosynthesis of digestive tract mucosal mucin, thereby promoting the repair of mucosal epithelial tissue and helping to eliminate digestive tract ulcer lesions. Hericium erinaceus contains various amino acids, polysaccharides and vitamins, etc. Hericium erinaceus polysaccharide can increase gastric mucosal blood flow, promote the secretion of anti-inflammatory factors in mucosal tissue, and inhibit the secretion of pro-inflammatory cytokines, thereby enhancing the gastric mucosal barrier. Propolis and curcumin can restore the vitality of damaged cells by their antibacterial and anti-inflammatory effects and promote tissue regeneration, thereby helping to heal the ulcer site and rebuild the mucosa. However, these health care products have slow effect and are limited in dosage and time.

[0006] Therefore, in view of the disadvantages of the prior art, such as large side effects, slow effect and limited efficacy, it is necessary to study a new product with the efficacy of preventing and treating mucosal injury of digestive tract and a preparation method thereof. SUMMARY

[0007] The present application aims to solve the above-mentioned problems existing in the prior art, and provides a product with the efficacy of preventing and treating damage to the mucous membrane of the digestive tract and a preparation method thereof.

[0008] To achieve the above-mentioned purpose, the technical scheme adopted by the present application is as follows:

[0009] The product with the efficacy of preventing and treating damage to the mucous membrane of the digestive tract has a functional component, which is a hydrophilic adhesive material powder;

[0010] The hydrophilic adhesive material is one or more of tara gum, gum arabic, guar gum, konjac gum, carrageenan, tragacanth gum and xanthan gum;

[0011] The viscosity of the tara gum is 4000-8000 cp, the viscosity of the gum arabic is 80-140 cp, the viscosity of the guar gum is 4000-8000 cp, the viscosity of the konjac gum is 5-100 cp, the viscosity of the carrageenan is 5-100 cp, the viscosity of the tragacanth gum is 400-2000 cp, and the viscosity of the xanthan gum is 600-5000 cp;

[0012] The particle size of the powder is 50-200 mesh;

[0013] The principle of the present application is as follows:

[0014] The hydrophilic adhesive material with a specific viscosity selected in the present application is all polysaccharide structure, and contains a large number of hydroxyl functional groups in the molecule. By controlling the particle size of the powder product or the viscosity of the colloid product, the hydrophilic adhesive material can quickly and fully stretch the molecular chain after entering the digestive tract, and the hydroxyl functional groups form hydrogen bonds with the hydroxyl, carboxyl and amino groups on the surface of the mucous membrane of the digestive tract (mainly composed of protein), thereby firmly adhering to the surface of the mucous membrane of the digestive tract before metabolism. Since these hydrophilic adhesive materials are added as functional components, a physical barrier film can be formed on the surface of the mucous membrane of the digestive tract when a certain amount is taken, thereby preventing digestive juice, food residue or bacteria from damaging the damaged site of the mucous membrane; and since these hydrophilic adhesive materials have the effects of resisting acid, alkali and digestive enzymes, they can firmly adhere to the surface of the mucous membrane of the digestive tract for a long time and play a role for a long time.

[0015] Although the prior art adds hydrophilic adhesive materials to the products for the digestive tract, the hydrophilic adhesive materials cannot form a physical barrier film on the surface of the mucous membrane of the digestive tract. On the one hand, the hydrophilic adhesive materials are only added as auxiliary components, and the amount of the hydrophilic adhesive materials entering the digestive tract is small after taking; on the other hand, the particle size, viscosity, etc. of the hydrophilic adhesive materials are not controlled in the prior art, which leads to the fact that the hydrophilic adhesive materials cannot be quickly dissolved after entering the digestive tract, and thus cannot adhere to the surface of the mucous membrane of the digestive tract before metabolism.

[0016] For example, JPH11180868A discloses a peptic ulcer therapeutic agent containing vitamin E, squalene and gum arabic, which utilizes the function of squalene in treating gastric ulcer and duodenal ulcer, and gum arabic is only used as an ingredient to increase the viscosity of the agent, ensure the stable dispersion and suspension of the drug components, so as to facilitate the patient to take and the uniform release of the drug in the body.

[0017] For example, CN107714752A discloses a composition for preventing and treating gastric cancer and colon cancer, which comprises cruciferous vegetable freeze-dried powder, pumpkin freeze-dried powder and konjac gum. The konjac gum mainly has the following functions: reducing blood pressure and resisting cancer (konjac gum can absorb cholesterol in the intestines and stomach and promote its excretion, interfere with the metabolic function of cancer cells, and play a detoxification and anticancer role), cleaning the stomach (konjac gum can promote gastrointestinal peristalsis and reduce the residence time of harmful substances in the stomach, intestines and gallbladder, thereby protecting the gastrointestinal tract), and detoxification and defecation (konjac gum rich in plant cellulose helps to activate the intestinal function and accelerate the excretion of harmful toxins in the body).

[0018] For example, CN1634148A discloses a health food for quickly protecting gastric mucosa, which is made of the following raw materials in the weight percentage: nacre powder 5-95%, carrageenan 5-95%. The nacre powder has an acid-forming effect and can be used to treat symptoms such as gastric and duodenal ulcers, and the carrageenan is used as a pharmaceutical excipient and food additive, which has the functions of excipient, thickening agent, emulsifying agent, blending agent and stabilizer.

[0019] For example, CN104547465A discloses a pharmaceutical preparation for treating pharyngeal ulcers, which is made of garlic extract 0.05-0.15g, aloe extract 0.5-1.25g, tetracaine hydrochloride 0.5-1.0g, tragacanth gum 0.5-1.0g, glycerol 50-70ml and purified water 30-50ml. The garlic extract (reducing the content of nitrite in the stomach, inhibiting nitrate reducing bacteria, treating chronic gastric disease, helicobacter pylori (HP) related peptic ulcer and inhibiting gastric acid secretion) and aloe extract (sedative analgesic, promoting wound healing, anti-inflammatory, promoting cell regeneration) play a therapeutic effect on ulcers. Tetracaine hydrochloride plays a local anesthetic effect. Tragacanth gum, a natural substance extracted from the dried branches of the legume plant tragacanth gum tree after being cut, is used as a pharmaceutical excipient. The product obtained by drying is widely used in pharmaceutical preparations such as cream, gel and emulsion.

[0020] As a preferred technical solution:

[0021] The product having the effect of preventing and treating the damage of the digestive tract mucosa as described above, the viscosity of the gum acacia is 4800-7800 cp, the viscosity of the gum arabic is 80-140 cp, the viscosity of the guar gum is 4500-7500 cp, the viscosity of the konjac gum is 7-100 cp, the viscosity of the carrageenan is 5-100 cp, the viscosity of the tragacanth gum is 400-2000 cp, and the viscosity of the xanthan gum is 600-5000 cp.

[0022] The product having the effect of preventing and treating the damage of the digestive tract mucosa as described above, the hydrophilic adhesive material is the gum acacia, the guar gum or the xanthan gum.

[0023] The product having the effect of preventing and treating the damage of the digestive tract mucosa as described above, the functional component is encapsulated in the inside of the water-soluble capsule shell.

[0024] The present application also provides a method for preparing the product having the effect of preventing and treating the damage of the digestive tract mucosa as described above, one or more of the gum acacia, the gum arabic, the guar gum, the konjac gum, the carrageenan, the tragacanth gum and the xanthan gum are mixed uniformly, and then are ground and sieved to a particle size of 50-200 mesh, wherein the viscosity of the gum acacia is 4000-8000 cp, the viscosity of the gum arabic is 80-140 cp, the viscosity of the guar gum is 4000-8000 cp, the viscosity of the konjac gum is 5-100 cp, the viscosity of the carrageenan is 5-100 cp, the viscosity of the tragacanth gum is 400-2000 cp, and the viscosity of the xanthan gum is 600-5000 cp.

[0025] As a preferred technical solution:

[0026] The method as described above, the viscosity of the gum acacia is 4800-7800 cp, the viscosity of the gum arabic is 80-140 cp, the viscosity of the guar gum is 4500-7500 cp, the viscosity of the konjac gum is 7-100 cp, the viscosity of the carrageenan is 5-100 cp, the viscosity of the tragacanth gum is 400-2000 cp, and the viscosity of the xanthan gum is 600-5000 cp.

[0027] The present application also provides a product having the effect of preventing and treating the damage of the digestive tract mucosa, the functional component is a colloid formed after the water-soluble hydrophilic adhesive material is absorbed water and swells;

[0028] The hydrophilic adhesive material is one or more of the gum acacia, the gum arabic, the guar gum, the konjac gum, the carrageenan, the tragacanth gum and the xanthan gum;

[0029] The viscosity of tara gum is 4000-8000 cp, the viscosity of arabic gum is 80-140 cp, the viscosity of guar gum is 4000-8000 cp, the viscosity of konjac gum is 5-100 cp, the viscosity of carrageenan is 5-100 cp, the viscosity of tragacanth gum is 400-2000 cp, and the viscosity of xanthan gum is 600-5000 cp.

[0030] The viscosity of the colloid is 5-200 cp, and the principle of the colloid is the same as that of the powder.

[0031] As a preferred technical solution:

[0032] The product with the effect of preventing and treating damage to the digestive tract mucosa as described above, the viscosity of tara gum is 4800-7800 cp, the viscosity of arabic gum is 80-140 cp, the viscosity of guar gum is 4500-7500 cp, the viscosity of konjac gum is 7-100 cp, the viscosity of carrageenan is 5-100 cp, the viscosity of tragacanth gum is 400-2000 cp, and the viscosity of xanthan gum is 600-5000 cp.

[0033] The product with the effect of preventing and treating damage to the digestive tract mucosa as described above, the hydrophilic adhesive material is tara gum, guar gum or xanthan gum.

[0034] The product with the effect of preventing and treating damage to the digestive tract mucosa as described above, characterized in that the functional components are encapsulated inside a glass bottle or a plastic bottle or bag.

[0035] The present application also provides a method for preparing the product with the effect of preventing and treating damage to the digestive tract mucosa as described above, one or more of tara gum, arabic gum, guar gum, konjac gum, carrageenan, tragacanth gum and xanthan gum are added to water, and after being absorbed and swelled to form a colloid with a viscosity of 5-200 cp, encapsulation is performed, wherein the viscosity of tara gum is 4000-8000 cp, the viscosity of arabic gum is 80-140 cp, the viscosity of guar gum is 4000-8000 cp, the viscosity of konjac gum is 5-100 cp, the viscosity of carrageenan is 5-100 cp, the viscosity of tragacanth gum is 400-2000 cp, and the viscosity of xanthan gum is 600-5000 cp.

[0036] As a preferred technical solution:

[0037] The method as described above, the viscosity of tara gum is 4800-7800 cp, the viscosity of arabic gum is 80-140 cp, the viscosity of guar gum is 4500-7500 cp, the viscosity of konjac gum is 7-100 cp, the viscosity of carrageenan is 5-100 cp, the viscosity of tragacanth gum is 400-2000 cp, and the viscosity of xanthan gum is 600-5000 cp.

[0038] Advantages:

[0039] (1) The product of the present application has the effect of preventing and treating damage to the mucous membrane of the digestive tract. The hydrophilic adhesive material is firmly adhered to the surface of the mucous membrane of the digestive tract before metabolism, and forms a physical barrier film on the surface of the mucous membrane of the digestive tract, preventing digestive juice, food residue or bacteria from damaging the damaged site of the mucous membrane, and having good effect and fast effect. Moreover, these hydrophilic adhesive materials have the effects of resisting acid, alkali and digestive enzymes, and can be firmly adhered to the surface of the mucous membrane of the digestive tract for a long time, and can play a role for a long time.

[0040] (2) The product of the present application has the effect of preventing and treating damage to the mucous membrane of the digestive tract. The hydrophilic adhesive material has no toxic side effects on the human body, and is suitable for long-term use.

[0041] (3) The preparation method of the present application has simple steps, and the raw materials are easy to obtain, and is suitable for large-scale industrial application. BRIEF DESCRIPTION OF DRAWINGS

[0042] Figure 1 is a test photo of the present application in vitro adhesion;

[0043] Figure 2 is a rat gastric ulcer picture of the present application in the prevention of rat gastric mucosal damage test;

[0044] Figure 3 is a rat gastric tissue pathology picture of the present application in the prevention of rat gastric mucosal damage test;

[0045] Figure 4 is a rat gastric ulcer picture of the present application in the treatment of rat gastric mucosal damage test;

[0046] Figure 5 is a rat gastric tissue pathology picture of the present application in the treatment of rat gastric mucosal damage test. DETAILED DESCRIPTION

[0047] The present application will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present application and not to limit the scope of the present application. In addition, it should be understood that those skilled in the art can make various modifications or changes to the present application after reading the content taught by the present application, and these equivalent forms also fall within the scope defined by the claims attached hereto.

[0048] The following are the test methods of the relevant performance indicators in each example and comparative example:

[0049] I. Viscosity test: detected by Brookfield DV2T2V viscometer, temperature is 25℃, and rotation speed is 100rpm.

[0050] II. In vitro adhesion test, the steps are as follows:

[0051] (1) Artificial gastric juice preparation;

[0052] Take 16.4 mL of dilute hydrochloric acid (concentration of 10 wt%), add 800 mL of deionized water and 10 g of pepsin, shake well to dissolve, then dilute with deionized water to 1000 mL.

[0053] (2) Test model;

[0054] (2.1) Open the pig stomach, with the mucosa layer upwards, lay it on the inclined plate, destroy the surface of the gastric mucosa, and the damaged area is about 1 cm 2 , control the angle of the inclined plate to about 40°;

[0055] (2.2) Weigh 0.3 g of the sample to be tested and evenly sprinkle it on the damaged gastric mucosa;

[0056] (2.3) Stain and moisten the powder with red ink, and turn on the peristaltic pump;

[0057] (2.4) Align the artificial gastric juice with the sample to be tested and place it about 1 cm above the sample to be tested; adjust the speed so that the flushing liquid flow rate on each sample to be tested is 1.75 mL / min, and start flushing;

[0058] (2.5) Record, take a photo and record any special circumstances every hour.

[0059] III. Rat gastric mucosa damage prevention test, the steps are as follows:

[0060] (1) Test grouping;

[0061] Randomly divide the rats into groups, 10 rats in each group, respectively, normal group, model group, test group (each test group corresponds to an embodiment, that is, one embodiment corresponds to 10 rats);

[0062] (2) Modeling;

[0063] Normal group: model by gavage with drinking water (10 mL / kg), as a blank control;

[0064] Model group: model by gavage with anhydrous ethanol (10 mL / kg);

[0065] Test group: give the drug 2h in advance, model by gavage with anhydrous ethanol (10 mL / kg), and observe the effect of the drug; the administration route and dose are as follows:

[0066] Capsule preparation: use straight forceps to hold the capsule and put it into the throat of the test group rat, and use a gavage needle to gavage with water to take the capsule; each rat is given 1 capsule orally, and 4 capsules are given continuously, and the net content of functional ingredients in 1 capsule is 10 mg;

[0067] Colloidal preparations: 5 mL of the colloidal preparation was administered to rats via gavage, for a total of 20 mL, and was completed within 30 minutes.

[0068] (3) Material sourcing and testing;

[0069] First, 2 hours after modeling, the rats in each group were anesthetized, the rats were sacrificed, and their stomachs were removed and dissected. The stomachs were washed with physiological saline, dried with filter paper, and the mucus, blood clots and other substances on the surface of the gastric mucosa were removed. After washing away the residual contents, the stomachs were unfolded and fixed, and then laid out on a white board.

[0070] Then, take photos and use ImageJ software to circle the total area of ​​the gastric ulcer in each group of rats;

[0071] Next, the ulcer inhibition rate was calculated as follows: Ulcer inhibition rate = (ulcer area in the model group - ulcer area in the experimental group) / ulcer area in the model group × 100%;

[0072] Finally, the stomach was fixed with 4wt% paraformaldehyde and then subjected to pathological examination. HE staining (hematoxylin-eosin staining) was used to observe the pathological changes of the stomach tissue of rats in each group. The bleeding and necrosis were scored according to the degree of bleeding, divided into no (0 points), mild (1 point), moderate (2 points), and severe (3 points). The total score of bleeding and necrosis was used as the pathological score.

[0073] IV. Experiment on the treatment of gastric mucosal injury in rats, the steps are as follows:

[0074] (1) Experimental grouping;

[0075] Rats were randomly divided into three groups of 10 each: normal group, model group, and experimental group (each experimental group corresponds to one implementation example, i.e., one implementation example corresponds to 10 rats).

[0076] (2) Model making;

[0077] Normal group: Model was established by gavage administration of drinking water (10 mL / kg), serving as a blank control;

[0078] Model group: Model was established by gavage administration of anhydrous ethanol (10 mL / kg);

[0079] Experimental group: Model was established by gavage administration of anhydrous ethanol (10 mL / kg), followed by drug administration, and the effects of drug administration were observed; the route of administration, dosage, and frequency are as follows:

[0080] Capsule preparation: For oral administration, the capsule was placed in the throat of the rats in the experimental group by holding it with forceps and then administered with water using a gavage needle; each rat was given 1 capsule orally, and 4 capsules were given continuously (4 capsules / time / rat). The administration was repeated once at 1 hour and 25 hours after modeling.

[0081] Colloidal preparation: the colloidal was fed to rats with a gavage needle, 5 mL per rat, a total of 20 mL, completed in 30 minutes (20 mL / time / rat), once at 1 h and 25 h after modeling;

[0082] (3) Sampling and testing;

[0083] First, 48 h after modeling, the rats in each group were anesthetized, and the rat stomach was removed and dissected after the rats were sacrificed, washed with physiological saline, and the mucus, blood clots, etc. on the surface of the gastric mucosa were absorbed and cleaned with filter paper, and the residual contents were washed out, unfolded and fixed, and spread on a white background plate;

[0084] Then, take a photo, and use Image J software to circle the total area of the gastric ulcer of each group of rats;

[0085] Next, calculate the ulcer inhibition rate, ulcer inhibition rate = (model group ulcer area-test group ulcer area) / model group ulcer area x 100%;

[0086] Finally, after fixing the stomach with 4wt% paraformaldehyde, pathological examination was performed, HE staining was used to observe the pathological changes of the gastric tissue of each group of rats, and scoring was performed according to the bleeding and exfoliation necrosis, which was divided into no (0 points), light (1 point), medium (2 points), and heavy (3 points), and the total score of bleeding and exfoliation necrosis was used as the pathological score.

[0087] Examples 1-33

[0088] A method for preparing a product with the effect of preventing and treating damage to the digestive tract mucosa, the specific steps are as follows:

[0089] (1) Preparation of raw materials;

[0090] Water-soluble capsule shell: water-soluble gelatin capsule shell;

[0091] Hydrophilic adhesive material: powder, as shown in Tables 1 and 2;

[0092] Table 1 Hydrophilic adhesive material of examples 1-21

[0093]

[0094] Table 2 Hydrophilic adhesive material of examples 22-33

[0095]

[0096] (2) Grinding and sieving;

[0097] Mix the hydrophilic adhesive material evenly, and grind and sieve to a particle size of 50-200 mesh;

[0098] (3) Packaging;

[0099] The product is obtained by encapsulating the ground and sieved hydrophilic adhesive material powder inside a water-soluble capsule shell.

[0100] The prepared product was subjected to in vitro adhesion tests, a rat gastric mucosal injury prevention test, and a rat gastric mucosal injury treatment test. The test results are as follows: Figures 1 to 5 As shown in Table 3.

[0101] Table 3 Test and experimental results of capsule products

[0102]

[0103]

[0104] Depend on Figure 1 It can be seen that the products prepared in Examples 1 to 33 adhered and remained on the isolated porcine gastric mucosa wound for ≥24 hours.

[0105] Depend on Figure 2 and Figure 4 It can be seen that, compared with the model group, the products prepared in Examples 1 to 33 can significantly reduce the gastric ulcer area in rats.

[0106] Depend on Figure 3 and Figure 5 It can be seen that the normal group of rats had intact and smooth gastric mucosa without abnormal pathological morphology such as congestion, edema and ulceration, and the glands were arranged neatly without shedding or defects; the model group showed gastric mucosal layer damage and severe interstitial bleeding, indicating that the model was successful; compared with the model group, the products prepared in Examples 1 to 33 can improve the gastric mucosal tissue damage of rats, with less epithelial layer shedding and interstitial bleeding.

[0107] As shown in Table 3, the rat gastric ulcer area, rat gastric tissue pathological score, and rat gastric ulcer inhibition rate, the products prepared in Examples 1-33 have a significant inhibitory effect on gastric ulcers, indicating that the products prepared in Examples 1-33 have the effect of preventing and treating gastric mucosal damage.

[0108] Comparative Example 1

[0109] The preparation method of the product is basically the same as that in Example 1, except that the viscosity of the thorny cloud fruit glue is 10000cp.

[0110] The prepared product was subjected to in vitro adhesion test and rat gastric mucosal injury treatment test. The hydrophilic adhesive material adhered to the lesion of isolated porcine gastric mucosa for 12 hours, and the inhibition rate of rat gastric ulcer was 31%.

[0111] Comparative Example 1

[0112] Comparative Example 2

[0113] A method for preparing a product, which is substantially the same as that of Example 1, except that the viscosity of the Holarrhena glutinosa gum is 1000 cp.

[0114] The prepared product was subjected to the in vitro adhesion test and the rat gastric mucosa injury treatment test. The hydrophilic adhesive material adhered to the wound surface of the isolated pig gastric mucosa for 8 h, and the rat gastric ulcer inhibition rate was 25%.

[0115] Comparative Example 2

[0116] Comparative Example 3

[0117] A method for preparing a product, which is substantially the same as that of Example 7, except that in step (2), the grinding and sieving were performed to a particle size of greater than 50 mesh.

[0118] The prepared product was subjected to the in vitro adhesion test and the rat gastric mucosa injury treatment test. The hydrophilic adhesive material adhered to the wound surface of the isolated pig gastric mucosa for 4 h, and the rat gastric ulcer inhibition rate was 23%.

[0119] Comparative Example 3

[0120] Comparative Example 4

[0121] A method for preparing a product, substantially the same as Example 7, except that in step (2), the grinding and sieving is to a particle size of less than 200 mesh.

[0122] The product prepared is subjected to in vitro adhesion test and treatment of gastric mucosal injury in rats, the hydrophilic adhesive material adheres to the wound surface of the in vitro pig gastric mucosa for 6 hours, and the gastric ulcer inhibition rate in rats is 40%.

[0123] Comparing the in vitro adhesion test and treatment of gastric mucosal injury in rats of Example 7 with Comparative Example 4, the hydrophilic adhesive material of Comparative Example 4 significantly shortens the adhesion time on the wound surface of the in vitro pig gastric mucosa by 75%, and the gastric ulcer inhibition rate in rats is significantly reduced by 39.7%. This is because the particle size of the hydrophilic adhesive material is too small, and after water absorption on the surface, water cannot further penetrate inside, forming a "gel-coated powder", which is quickly washed away by gastric juice, and cannot form a physical barrier film on the mucosal surface, so the effect of Comparative Example 4 is worse than that of Example 7.

[0124] Examples 34-66

[0125] A method for preparing a product having the effect of preventing and treating damage to the mucosa of the digestive tract, the specific steps are as follows:

[0126] (1) Preparation of raw materials;

[0127] Water: deionized water;

[0128] Hydrophilic adhesive material: powder, as shown in Table 4 and Table 5;

[0129] Table 4 Hydrophilic adhesive material of Examples 34-54

[0130]

[0131] Table 5 Hydrophilic adhesive material of Examples 55-66

[0132]

[0133]

[0134] (2) Swelling;

[0135] The hydrophilic adhesive material is added to water until it swells to form a colloid with a viscosity of 5-200 cp, and the product is obtained;

[0136] (3) Packaging;

[0137] The product obtained in step (2) is packaged inside a glass bottle / bag for use.

[0138] The prepared product was subjected to a preventive rat gastric mucosal injury test and a therapeutic rat gastric mucosal injury test, and the test results are shown in Table 6.

[0139] Table 6 Test results of the colloidal product

[0140]

[0141]

[0142] As can be seen from the ulcer area of the rats, the rat gastric tissue pathological score, and the rat gastric ulcer inhibition rate in Table 6, the products prepared in Examples 34 to 66 have a significant effect of inhibiting gastric ulcer, indicating that the colloidal product prepared in Examples 34 to 66 has a preventive and therapeutic effect on gastric mucosal injury.

[0143] Comparative Example 5

[0144] A product was prepared according to the method of Example 52, except that in step (2), the water-soluble polymer was swelled to form a colloidal product having a viscosity of 300 to 500 cp.

[0145] The prepared product was subjected to a therapeutic rat gastric mucosal injury test, and the rat gastric ulcer inhibition rate was 15%.

[0146] Comparing the therapeutic rat gastric mucosal injury test of Example 52 with that of Comparative Example 5, the rat gastric ulcer inhibition rate of Comparative Example 5 was significantly reduced by 73.9%, because the viscosity of the colloidal product was too high, and after being temporarily adhered to the mucosal surface, the volume and weight of the colloidal product increased due to continuous water absorption, so that the colloidal product was detached as a whole and could not form a physical barrier film on the mucosal surface. Therefore, Comparative Example 5 was less effective than Example 52.

[0147] Comparative Example 6

[0148] A product was prepared according to the method of Example 52, except that in step (2), the water-soluble polymer was swelled to form a colloidal product having a viscosity of 1 to 5 cp.

[0149] The prepared product was subjected to a therapeutic rat gastric mucosal injury test, and the rat gastric ulcer inhibition rate was 13%.

[0150] Comparing the therapeutic rat gastric mucosal injury test of Example 52 with that of Comparative Example 6, the rat ulcer inhibition rate of Comparative Example 6 was significantly reduced by 77.3%, because the viscosity of the colloidal product was too low, and after being swelled by water absorption on the mucosal surface, the colloidal product was quickly dissolved and easily washed away, so that the colloidal product could not form a physical barrier film on the mucosal surface. Therefore, Comparative Example 6 was less effective than Example 52.

Claims

1. An article having an effect of preventing and treating damage to the mucous membrane of the digestive tract, characterized by, The functional ingredient is a powder of a hydrophilic adhesive material; The hydrophilic adhesive material is one or more of gum ghatti, gum arabic, guar gum, konjac gum, carrageenan, tragacanth gum, and xanthan gum; The gum ghatti has a viscosity of 4000-8000 cp, the gum arabic has a viscosity of 80-140 cp, the guar gum has a viscosity of 4000-8000 cp, the konjac gum has a viscosity of 5-100 cp, the carrageenan has a viscosity of 5-100 cp, the tragacanth gum has a viscosity of 400-2000 cp, and the xanthan gum has a viscosity of 600-5000 cp; The powder has a particle size of 50-200 mesh.

2. The preparation having preventive and therapeutic effects on damage to the mucous membrane of the digestive tract according to claim 1, wherein The hydrophilic adhesive material is gum ghatti, guar gum, or xanthan gum.

3. The preparation having preventive and therapeutic effects on damage to the mucous membrane of the digestive tract according to claim 1, wherein the preparation is a preparation for oral administration. The functional ingredient is encapsulated inside a water-soluble capsule shell.

4. A method of preparing the preparation having the effect of preventing and treating the damage of the mucous membrane of the digestive tract according to any one of claims 1 to 3, characterized by, One or more of gum ghatti, gum arabic, guar gum, konjac gum, carrageenan, tragacanth gum, and xanthan gum are mixed uniformly, ground, and sieved to a particle size of 50-200 mesh, and then encapsulated, wherein the gum ghatti has a viscosity of 4000-8000 cp, the gum arabic has a viscosity of 80-140 cp, the guar gum has a viscosity of 4000-8000 cp, the konjac gum has a viscosity of 5-100 cp, the carrageenan has a viscosity of 5-100 cp, the tragacanth gum has a viscosity of 400-2000 cp, and the xanthan gum has a viscosity of 600-5000 cp.

5. A preparation having an effect of preventing and treating damage to the mucous membrane of the digestive tract, characterized by, The functional ingredient is a colloid formed after a hydrophilic adhesive material absorbs water and swells; The hydrophilic adhesive material is one or more of gum ghatti, gum arabic, guar gum, konjac gum, carrageenan, tragacanth gum, and xanthan gum; The gum ghatti has a viscosity of 4000-8000 cp, the gum arabic has a viscosity of 80-140 cp, the guar gum has a viscosity of 4000-8000 cp, the konjac gum has a viscosity of 5-100 cp, the carrageenan has a viscosity of 5-100 cp, the tragacanth gum has a viscosity of 400-2000 cp, and the xanthan gum has a viscosity of 600-5000 cp; The colloid has a viscosity of 5-200 cp.

6. The preparation having an effect of preventing and treating damage to the mucous membrane of the digestive tract according to claim 5, wherein The hydrophilic adhesive material is gum ghatti, guar gum, or xanthan gum.

7. The preparation having an effect of preventing and treating damage to the mucous membrane of the digestive tract according to claim 5, wherein the preparation is a preparation for oral administration. The functional ingredient is encapsulated inside a glass bottle or a plastic bottle / bag.

8. A method of preparing the preparation having the effect of preventing and treating the damage of the mucous membrane of the digestive tract according to any one of claims 5 to 7, characterized by, One or more of gum ghatti, gum arabic, guar gum, konjac gum, carrageenan, tragacanth gum, and xanthan gum are added to water, and after absorbing water and swelling to form a colloid with a viscosity of 5-200 cp, encapsulation is performed, wherein the gum ghatti has a viscosity of 4000-8000 cp, the gum arabic has a viscosity of 80-140 cp, the guar gum has a viscosity of 4000-8000 cp, the konjac gum has a viscosity of 5-100 cp, the carrageenan has a viscosity of 5-100 cp, the tragacanth gum has a viscosity of 400-2000 cp, and the xanthan gum has a viscosity of 600-5000 cp.

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