Composition, preparation and preparation method for repairing gastroesophageal mucosa

Abstract

The present invention belongs to the field of medical technology, and specifically relates to a composition, a preparation and a preparation method for repairing gastroesophageal mucosa. The composition containing active ingredients for repairing gastroesophageal mucosa includes active ingredients of traditional Chinese medicine for repairing gastroesophageal mucosa, at least one bioadhesive material, and at least one material that floats and is retained in the stomach; the composition can be used to relieve stomach pain, heartburn, and acid reflux caused by excessive gastric acid, improve gastroesophageal reflux disease, and can also be used to protect and repair digestive tract mucosa such as chronic gastritis, gastric ulcer, and duodenal ulcer.

Description

Technical Field

[0001] The present invention belongs to the field of medical technology, and in particular relates to a composition and a preparation for repairing gastroesophageal mucosa and a preparation method thereof. Background Art

[0002] Gastroesophageal reflux disease (GERD) is a common disease of the digestive tract. Due to the dysfunction of the lower esophageal sphincter or other abnormalities in the function-related tissue structure, the lower esophageal sphincter pressure is low, which leads to reflux. Patients often feel heartburn, acid reflux, and swallowing pain and difficulty. In severe cases, the reflux will irritate the pharyngeal mucosa and cause pharyngitis, leading to hoarseness, aspiration pneumonia and other diseases in patients.

[0003] GERD is a multifactorial disease caused by multiple factors, including gastrointestinal motility disorders, the presence of acidic or other harmful substances such as bile acid and pancreatic enzymes. In fact, under normal circumstances, the esophagus itself has the ability to defend against the invasion of gastric acid and duodenal contents, and has anti-reflux barriers, esophageal clearance function, and esophageal mucosal tissue resistance. Gastroesophageal reflux disease is ultimately caused by the decline in the ability of anti-reflux barriers and defense mechanisms, coupled with damage to the esophageal mucosa caused by reflux.

[0004] Chronic gastritis, atrophic gastritis, gastric cancer, etc. are common diseases of the digestive system in clinical practice, and their onset is closely related to different degrees of damage to the gastric mucosal tissue of the human body. Chronic gastritis-atrophic gastritis-intestinal metaplasia-atypical hyperplasia-gastric cancer is the digestive system tumor development model recognized by the WHO. According to epidemiological surveys, the incidence of chronic gastritis in my country is as high as over 60%, of which atrophic gastritis accounts for about 20%, and chronic gastritis accompanied by atrophic gastritis eventually develops into gastric cancer, accounting for about 3% to 4%, which is a considerable number. Therefore, actively protecting the gastric mucosa and repairing damage has important clinical significance for the treatment of digestive system diseases and preventing further deterioration.

[0005] Peptic ulcer mainly refers to chronic ulcers that occur in the stomach and duodenum, also known as gastric and duodenal ulcers. The formation of ulcers is related to the digestive action of gastric acid-pepsin, so it is named. Peptic ulcer is a common clinical disease with a high incidence rate, accounting for about 10% of the population. Duodenal ulcers are more common in young and middle-aged people, and more common in men than in women.

[0006] Although the etiology is not yet fully understood, the basic pathogenesis is the enhancement of mucosal invasive factors and / or the weakening of mucosal defense-repair factors.

[0007] At present, it is believed that abnormal gastric acid secretion, dietary and environmental factors, Helicobacter pylori (Hp) infection, damage to the digestive tract mucosa and other factors are related. When the invasive factors and protective factors lose balance, the related diseases and symptoms will occur. There are many drugs on the market for the treatment of the above indications, most of which are chemical drugs, mainly antacids, proton pump inhibitors and H2 receptor blockers. However, chemical drugs have obvious side effects and are not suitable for long-term use in the chronic stage. There are problems such as repeated attacks. Traditional Chinese medicine, as one of the important methods for the prevention and treatment of digestive system diseases, has a good clinical practice foundation. Due to its multi-target and bidirectional regulatory effects, it has good efficacy, low toxicity and side effects, and low recurrence rate. It is suitable for long-term administration of chronic diseases, and is therefore recognized by the majority of patients. In recent years, more and more studies have found that traditional Chinese medicine can play a protective role in gastric mucosa, providing an effective solution for exploring the clinical prevention and treatment of upper gastrointestinal diseases.

[0008] In recent years, a large number of studies on the relationship between traditional Chinese medicine and gastric mucosa have emerged. However, the preparation and processing of traditional Chinese medicine cannot meet clinical needs, such as traditional tablets, granules, capsules, ordinary oral liquids, etc. The above products have not been optimized in terms of administration routes, and there is no relevant research on long-term retention in the stomach for chronic gastritis, gastric ulcers, duodenal ulcers and other digestive tract mucosa protection and repair. Summary of the invention

[0009] The present invention provides a composition and a preparation thereof containing a gastroesophageal mucosa repairing active ingredient of a traditional Chinese medicine for gastroesophageal mucosa repair, which can be retained in the stomach and other digestive tracts for a long time to promote the protection and repair of the mucosa.

[0010] In order to achieve the above object, the present invention adopts the following technical solutions:

[0011] A composition for repairing gastroesophageal mucosa, comprising the following components in parts by mass:

[0012] Gastroesophageal mucosal repair active ingredients 0.1-20

[0013] Bioadhesive material 0.1-10

[0014] Suspended retention component 2-20;

[0015] The bioadhesive material is selected from acrylic acid polymers, cellulose derivatives, polyvinyl methyl ether-maleic anhydride copolymers, natural gums and polysaccharides;

[0016] The suspended retention component comprises part a and part b, wherein part a is selected from gums and polysaccharides of natural origin, vinyl pyrrolidone, copolymers of vinyl pyrrolidone and vinyl acetate, celluloses and their derivatives, acrylic acid polymers and their salts;

[0017] Part b is selected from ingredients that form effervescence with H+, or sodium carboxymethyl cellulose, cross-linked sodium carboxymethyl starch, cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose, and low-substituted hydroxypropyl cellulose.

[0018] For example, polymers such as acrylic acid polymers, vinyl pyrrolidone, and cellulose derivatives can be used as suspended retention components in the present invention due to their structural characteristics; they can also be used as bioadhesive materials.

[0019] Particularly, when the suspended component is insoluble in water / Class II / Class III solvents described by ICH, the particle size is ≤100 um.

[0020] Particularly, the gastroesophageal mucosal repair active ingredient is selected from: American cockroach extract, jasmine extract, licorice extract, atractylodes extract, dendrobium extract, seabuckthorn extract, atractylodes extract, tangerine peel extract, bletilla striata extract, and yanhusuo extract.

[0021] In particular, pharmaceutically acceptable salts and excipients are also included.

[0022] In the present invention,

[0023] The preparation method of the aforementioned gastroesophageal mucosal repair composition comprises the following steps:

[0024] (1) placing a bioadhesive material in a solvent, stirring the mixture evenly, and adjusting the pH value to obtain a mixture 1;

[0025] (2) adding part of the gastric floating retained components, the pharmaceutically acceptable salt and the auxiliary materials into water, stirring evenly to prepare a uniform mixture 2;

[0026] (3) Add mixture 2 to mixture 1, stir thoroughly, add the active ingredients of Chinese herbal medicine for gastroesophageal mucosal repair and the remaining ingredients, make up the water, stir evenly, and fill.

[0027] Particularly, in the step (1), the solvent is deionized water or a Class II / Class III solvent in ICH.

[0028] Particularly, the pH of the finished product is 5.0-9.5 (more preferably 7.0-9.5); the density is 0.9-1.2 g / ml; and the viscosity is ≤4000 mPa·s.

[0029] The present invention also protects the use of the aforementioned gastroesophageal mucosal repair composition in the preparation of medicines for relieving stomach pain, heartburn, acid reflux caused by excessive gastric acid, improving gastroesophageal reflux disease, and repairing and protecting digestive tract mucosa such as chronic gastritis, gastric ulcer, duodenal ulcer, etc.

[0030] Compared with the prior art, the composition prepared by the present invention is a liquid suspension, which is convenient for patients to swallow, especially children and the elderly. The composition prepared by the present invention takes effect quickly, and can relieve stomach pain, heartburn (heartburn), acid reflux caused by excessive gastric acid within 10 minutes after taking it, and the symptoms caused by gastroesophageal reflux disease. The composition prepared by the present invention has a longer action time, can stay in the stomach for 4-6 hours, and prolong the contact and action time of the active ingredients for repairing gastroesophageal mucosa with the gastric mucosa and duodenal mucosa. The present invention is mainly local in action and has high safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 This is a cross-section of a rat stomach tissue sample.

[0032] Figure 2 For rat spleen and stomach 2*2cm 2 Cross-section of tissue samples. DETAILED DESCRIPTION

[0033] In order to better understand the present invention, the present invention is further described below in conjunction with specific examples, wherein the terms used in the examples are for describing specific embodiments and do not constitute limitations on the scope of protection of the present invention.

[0034] In the present invention:

[0035] PVM / MA is a cross-linked polymer of polyvinyl methyl ether / methyl acrylate and decadiene (decadiene cross-linked polymer); PVP is vinyl pyrrolidone; PVP / VA is a copolymer of vinyl pyrrolidone and vinyl acetate; HPMC is hydroxypropyl methylcellulose.

[0036] In the present invention, the viscosity is measured at 25° C. and 20 RPM using a Bush viscometer.

[0037] Embodiment 1

[0038] A method for preparing a composition for repairing gastroesophageal mucosa, comprising the following steps:

[0039] (1) Weigh the raw materials according to the following mass parts

[0040]

[0041]

[0042] (2) HPMC K100LV, PVP K90 and carbomer are placed in an appropriate amount of water, stirred, fully dispersed, a pH regulator is added, stirred evenly, the pH value is adjusted, and stirred evenly to obtain a mixture 1;

[0043] (3) adding appropriate amount of water to sodium alginate, Pseudophyllaria japonica colloid, sodium bicarbonate, methylparaben, and propylparaben, and stirring evenly to obtain a uniform mixture 2;

[0044] (4) Add mixture 2 to mixture 1, stir thoroughly, add active ingredients of traditional Chinese medicine for repairing gastroesophageal mucosa, calcium carbonate, sweetener and flavor, replenish water, stir evenly, and fill.

[0045] The finished product was measured and found to have a viscosity of ≤500 mpa·s, a pH of 8.5, and a density of 0.99 g / ml.

[0046] Embodiment 2

[0047] A method for preparing a composition for repairing gastroesophageal mucosa, comprising the following steps:

[0048] (1) Weigh the raw materials according to the following mass parts

[0049]

[0050] (2) PVP K90 and carbomer are placed in water, stirred, fully dispersed, a pH regulator is added, stirred evenly, the pH value is adjusted, and stirred evenly to obtain a mixture 1;

[0051] (3) adding an appropriate amount of water to sodium alginate, sodium bicarbonate, methylparaben and propylparaben, and stirring evenly to obtain a uniform mixture 2;

[0052] (4) Add mixture 2 to mixture 1, stir thoroughly, add Chinese herbal medicine gastroesophageal mucosal repair active ingredients and calcium carbonate, sweetener, edible flavor, replenish water, stir evenly, and fill:

[0053] The finished product was measured and found to have a viscosity of ≤1150 mpa·s, a pH of 7.5, and a density of 1.06 g / ml.

[0054] Embodiment 3

[0055] A method for preparing a composition for repairing gastroesophageal mucosa, comprising the following steps:

[0056] (1) Weigh the raw materials according to the following mass parts

[0057]

[0058] (2) HPMC K100LV, NP700 sodium polyacrylate and polycarbophil are placed in water, stirred and fully dispersed, a pH regulator is added, stirred evenly, the pH value is adjusted, and stirred evenly to obtain a mixture 1;

[0059] (3) Add appropriate amount of water to sodium alginate, sodium bicarbonate and benzoic acid, stir evenly to obtain a uniform mixture 2;

[0060] (4) Add mixture 2 to mixture 1, stir thoroughly, add active ingredients of traditional Chinese medicine for repairing gastroesophageal mucosa, calcium carbonate and sweetener, replenish water, stir evenly, and fill.

[0061] The finished product was measured and found to have a viscosity of ≤230 mpa·s, a pH of 7.3, and a density of 0.96 g / ml.

[0062] Embodiment 4

[0063] A method for preparing a composition for repairing gastroesophageal mucosa, comprising the following steps:

[0064] (1) Weigh the raw materials according to the following mass parts

[0065]

[0066]

[0067] (2) placing carbomer in water, stirring, fully dispersing, adding a pH adjuster, stirring evenly, adjusting the pH value, and stirring evenly to obtain a mixture 1;

[0068] (3) Add appropriate amount of water to sodium alginate, Pseudophyllaria japonica colloid, sodium bicarbonate, methylparaben, and propylparaben, and stir evenly to obtain a uniform mixture 2;

[0069] (4) Add mixture 2 to mixture 1, stir thoroughly, add active ingredients of traditional Chinese medicine for repairing gastroesophageal mucosa, calcium carbonate and sweetener, edible flavor, replenish water, stir evenly, and fill.

[0070] The finished product was measured and found to have a viscosity of ≤1280 mpa·s, a pH of 7.6, and a density of 1.10 g / ml.

[0071] Embodiment 5

[0072] A method for preparing a composition for repairing gastroesophageal mucosa, comprising the following steps:

[0073] (1) Weigh the raw materials according to the following mass parts

[0074]

[0075] (2) Carbomer and PVP K90 are placed in water, stirred, and fully dispersed, a pH regulator is added, stirred evenly, the pH value is adjusted, and stirred evenly to obtain a mixture 1;

[0076] (3) Add appropriate amount of water to sodium alginate and sodium bicarbonate, stir evenly to obtain a uniform mixture 2;

[0077] (4) Add mixture 2 to mixture 1, stir thoroughly, add active ingredients for gastroesophageal mucosal repair of traditional Chinese medicine, calcium carbonate and sucralose, edible flavors, add water, stir evenly, and fill.

[0078] The finished product was measured and found to have a viscosity of ≤1650 mpa·s, a pH of 9.3, and a density of 1.18 g / ml.

[0079] Embodiment 6

[0080] A method for preparing a composition for repairing gastroesophageal mucosa, comprising the following steps:

[0081] (1) Weigh the raw materials according to the following mass parts

[0082]

[0083] (2) placing carbomer in water, stirring, fully dispersing, adding a pH adjuster, stirring evenly, adjusting the pH value, and stirring evenly to obtain a mixture 1;

[0084] (3) adding an appropriate amount of water to sodium alginate, potassium bicarbonate, methylparaben and propylparaben, and stirring evenly to obtain a uniform mixture 2;

[0085] (4) Add mixture 2 to mixture 1, stir thoroughly, add active ingredients of traditional Chinese medicine for repairing gastroesophageal mucosa, calcium carbonate, calcium polycarbophil, calcium saccharin, edible flavors, add water, stir evenly, and fill.

[0086] The finished product was measured and found to have a viscosity of ≤3850 mpa·s, a pH of 8.7, and a density of 1.06 g / ml.

[0087] Embodiment 7

[0088] A method for preparing a composition for repairing gastroesophageal mucosa, comprising the following steps:

[0089] (1) Weigh the raw materials according to the following mass parts

[0090]

[0091] (2) placing carbomer in water, stirring, fully dispersing, adding a pH adjuster, stirring evenly, adjusting the pH value, and stirring evenly to obtain a mixture 1;

[0092] (3) adding an appropriate amount of water to sodium alginate, sodium bicarbonate, methylparaben and propylparaben, and stirring evenly to obtain a uniform mixture 2;

[0093] (4) Add mixture 2 to mixture 1, stir thoroughly, add active ingredients of traditional Chinese medicine for gastroesophageal mucosal repair, calcium carbonate, calcium polycarbophil, sodium saccharin, edible flavor, add water, stir evenly, and fill.

[0094] The finished product was measured and found to have a viscosity of ≤2950 mpa·s, a pH of 9.0, and a density of 1.01 g / ml.

[0095] Embodiment 8

[0096] A method for preparing a composition for repairing gastroesophageal mucosa, comprising the following steps:

[0097] (1) Weigh the raw materials according to the following mass parts

[0098]

[0099]

[0100] (2) placing carbomer in water, stirring, fully dispersing, adding a pH adjuster, stirring evenly, adjusting the pH value, and stirring evenly to obtain a mixture 1;

[0101] (3) Take sodium alginate, sodium bicarbonate, methylparaben, propylparaben, and a crystallization inhibitor, add an appropriate amount of water, stir evenly, and prepare a uniform mixture 2;

[0102] (4) Add mixture 2 to mixture 1, stir thoroughly, add active ingredients for repairing gastroesophageal mucosa of traditional Chinese medicine, calcium polycarbophil, sodium saccharin, edible flavor, add water, stir evenly, and fill.

[0103] The obtained composition preparation is an emulsion, the viscosity of which does not exceed 3350 mPa.s, pH = 9.2, density = 1.01 g / ml Example 9

[0104] (1) Weigh the raw materials according to the following mass parts

[0105]

[0106]

[0107] (2) PVM / MA (S97), xanthan gum, and chitosan are placed in water, stirred, and fully dispersed to obtain a uniform solution or suspension 1, and sodium hydroxide is added to adjust the pH value;

[0108] (3) Take some vinyl pyrrolidone (PVP K30), vinyl pyrrolidone and vinyl acetate copolymer ( SR), HPMC E15, guar gum, zein, potassium bicarbonate, zinc carbonate, sodium carboxymethyl cellulose, cross-linked sodium carboxymethyl starch, cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose and benzoic acid, sweetener, add to water, stir evenly, and prepare a uniform mixture 2;

[0109] (4) Add mixture 2 to mixture 1, stir thoroughly, add the Chinese medicinal ingredients consisting of Atractylodes macrocephala, Dendrobium officinale, Hippophae rhamnoides, Atractylodes lancea, Tangerine peel, Bletilla striata and the remaining ingredients, stir evenly, and fill.

[0110] The obtained composition preparation is a suspension, the viscosity of which does not exceed 950 mPa.s, the pH is between 7.2, and the density is between 9.82 g / ml.

[0111] The compositions of Examples 1 to 9 above were tested.

[0112] 1. In vitro artificial gastric juice floating time test

[0113] Test method: Fill a volumetric flask with 500 ml of HCl buffer solution with pH = 1.2, about 1 cm below the neck constriction, inject 10 ml of the test sample into the volumetric flask through a syringe within 10 seconds, start timing, and stop timing when all the gel floats to the liquid surface. The results are shown in Table 1, and each group was tested 10 times.

[0114] Table 1 Floating time limit

[0115]

[0116]

[0117] 2. Release rate test

[0118] Test method: Add 500ml of pH=1.2 hydrochloric acid buffer solution to a flat-bottomed flask with a neck on the side. A magnetic stirring device is added to the bottom of the flask. The side port is used for sampling and rehydration. The flask is placed in a constant temperature water bath. When the buffer temperature reaches 37℃±0.5℃, add 10ml of sample, turn on magnetic stirring, and rotate at 50rpm / min; take samples at 60 minutes, 120 minutes, 180 minutes, 240 minutes, and 360 minutes, and measure the amount of gastroesophageal mucosal repair active ingredients at each sampling point to calculate the release rate. The results are shown in Table 2. Each group was tested 10 times.

[0119] Table 2 Release rate

[0120]

[0121] 3. Gastric mucosal damage repair ability test

[0122] Test method: 6 normal SD rats were taken as the normal control group, and 30 rats with acute gastric mucosal injury model (Note: The preparation of the acute gastric mucosal injury model adopts the selection of 600g / L ethanol gavage to cause gastric mucosal injury model, that is: fasting but not water for 24h before modeling, gavage with 600g / L ethanol, 2mL / rat.) were randomly divided into 5 groups, 6 rats in each group, respectively used for experimental observation of the model control group, the commercial product control group, the first embodiment, the second embodiment, and the eighth embodiment. The normal control group and the model control group were raised normally, and the commercial product control group, the first embodiment, the second embodiment, and the eighth embodiment were given the corresponding test drugs, all of which were gavage-administered 0.2mL / time (kg·d), 3 times / d, for 3 consecutive days.

[0123] 1) Gastric tissue samples were washed with physiological saline after ligation, fixed with 10% neutral formaldehyde for 10 minutes, cut open along the greater curvature of the stomach, washed out the contents, removed residual liquid, laid flat, observed the morphology, and photographed for record.

[0124] The results are as follows Figure 1 As shown in the figure, the normal tissue is that the gastric wall mucosa is intact and ruddy, and no ulcer points or ulcer surfaces or mucosal damage can be seen by naked eye observation. The gastric wall mucosal damage of rats in the model control group was serious, with multiple brown congestion spots and multiple ulcer surfaces in the stomach body; the gastric ulcer damage of rats in the commercial product control group was significantly reduced compared with the model control group, and the ulcer surface was significantly reduced.

[0125] Compared with the rats in the commercially available control group, the stomach wall damage of the rats in the Example 8 group, the Example 2 group, the Example 1 group was significantly alleviated, and the ulcer points and the ulcer surface disappeared significantly.

[0126] 2) Gastric tissues of about 2*2 cm2 in size at the same position of the spleen and stomach of rats in each group were fixed with 10% neutral formaldehyde for 24 hours, embedded in paraffin, sectioned, and stained with conventional HE. Pathological changes of gastric tissues were observed under a microscope.

[0127] The results showed that the normal gastric wall tissue mucosa was intact, with no ulcer points or ulcer surfaces, or mucosal damage.

[0128] The gastric mucosa of rats in the model control group was mainly eroded and ulcerated, with mucosal epithelial exfoliation and severe inflammatory cell infiltration, which accumulated in the submucosal layer;

[0129] The gastric tissue congestion and edema of the rats in the control group of the commercial product were significantly reduced, and the ulcer surface was significantly reduced;

[0130] Compared with the rats in the commercially available control group, the stomach tissues of the rats in the Example 8 group, the Example 2 group, the Example 1 group were nearly intact, the ulcer surface disappeared significantly, and the cell infiltration and tissue edema disappeared significantly.

[0131] 3) Ulcer inhibition rate

[0132] The area of ​​each ulcer was measured with a vernier caliper. The ulcer area was calculated for ulcers with a diameter > 1 mm. For ulcers with an area less than 1 mm, 10 points were equivalent to the ulcer surface and 1 mm. 2 The ulcer index was evaluated by the square millimeters of the total ulcer area, and the ulcer inhibition percentage was calculated using the following formula:

[0133] Ulcer inhibition percentage = (total ulcer area of ​​model control group - total ulcer area of ​​drug administration group) / total ulcer area of ​​model control group * 100%.

[0134] Table 3 Comparison of ulcer inhibition rate

[0135]

[0136]

[0137] The ulcer inhibition rates of Example 8 Group, Example 2 Group, and Example 1 Group were all higher than that of the commercially available product control group.

[0138] 4. Expand the trial

[0139] The same method as 3. Gastric mucosal injury repair ability test was used to test the remaining embodiments, and the results are shown in Figure 4.

[0140] Table 4 Comparison of ulcer inhibition rate in the expanded test

[0141] Experimental Group <![CDATA[Ulcer area (mm 2 )]]> Ulcer inhibition rate (%) Normal control group 0.00±0.00 100 Embodiment 3 9.6±3.5 64.87 Example 4 9.4±3.2 66.81 Example 5 9.5±2.8 65.28 Example 6 9.6±3.4 66.31 Embodiment 7 Group 9.8±3.6 64.59 Embodiment 9 Group 8.9±2.7 67.01

[0142] The above detailed description is a specific description of one feasible embodiment of the present invention. The embodiment is not intended to limit the patent scope of the present invention. Any equivalent implementation or modification that does not deviate from the present invention should be included in the scope of the technical solution of the present invention.

Claims

1. A composition for repairing gastroesophageal mucosa, characterized in that: Calculated by mass, it includes the following components: 1.8 parts of American cockroach extract, 3 parts of HPMC K100LV, 3 parts of PVP K90, 0.2 parts of carbomer, 3 parts of sodium alginate, 1 part of pseudophysalis gum, 1 part of calcium carbonate, 1 part of sodium bicarbonate, 4.2 parts of potassium hydroxide, 0.1 part of saccharin sodium, 0.2 parts of saccharin calcium, 0.1 part of methylparaben, 0.01 part of propylparaben and 1 part of edible flavor.

2. A composition for repairing gastroesophageal mucosa, characterized in that: Calculated by mass, it includes the following components: 2 parts of American cockroach extract, 3 parts of PVP K90, 1 part of carbomer homopolymer type B, 5 parts of sodium alginate, 1.6 parts of calcium carbonate, 2.67 parts of sodium bicarbonate, 3 parts of sodium hydroxide, 0.5 parts of saccharin sodium, 0.40 parts of methylparaben, 0.04 parts of propylparaben and 0.2 parts of edible flavor.

3. A composition for repairing gastroesophageal mucosa, characterized in that: Calculated by mass, it includes the following components: 1 part of American cockroach extract, 0.5 part of carbomer, 5 parts of sodium alginate, 2.67 parts of sodium bicarbonate, 3.2 parts of calcium polycarbophil, 3 parts of sodium hydroxide, 3 parts of crystallization inhibitor PVPK30, 0.2 parts of saccharin sodium, 0.2 parts of methylparaben, 0.02 parts of propylparaben and 0.2 parts of edible flavor.

4. The method for preparing the composition for repairing gastroesophageal mucosa according to claim 1, characterized in that: The preparation method comprises the following steps: S1-1. Take HPMC K100LV, PVP K90 and carbomer in water, stir, fully disperse, add PH regulator, stir evenly, adjust the PH value, and stir evenly to obtain a mixture 1; S1-2. Take sodium alginate, pseudophysalis colloid, sodium bicarbonate, methylparaben, propylparaben, add an appropriate amount of water and stir to obtain a uniform mixture 2; S1-3. Add mixture 2 to mixture 1, stir thoroughly, add active ingredients of Chinese herbal medicine for gastroesophageal mucosal repair, calcium carbonate, sweetener and flavor, make up the water, stir evenly, and fill: measure the finished product, its viscosity is ≤500mpa·S, pH=8.5, and density is 0.99g / ml.

5. The method for preparing the composition for repairing gastroesophageal mucosa according to claim 2, characterized in that: The preparation method comprises the following steps: S2-1. PVP K90 and carbomer were placed in water, stirred, fully dispersed, a PH regulator was added, stirred evenly, the PH value was adjusted, and stirred evenly to obtain a mixture 1; S2-2 Take sodium alginate, sodium bicarbonate, methylparaben, propylparaben, add an appropriate amount of water, stir well to obtain a uniform mixture 2; S2-3. Add mixture 2 to mixture 1, stir thoroughly, add active ingredients of traditional Chinese medicine for gastroesophageal mucosal repair and calcium carbonate, sweetener, edible flavor, make up the water, stir evenly, and fill: measure the finished product, its viscosity is ≤1150mpa·S, pH=7.5, and density is 1.06g / ml.

6. The method for preparing the composition for repairing gastroesophageal mucosa according to claim 3, characterized in that: The preparation method comprises the following steps: S3-1. Take carbomer and place it in water, stir, fully disperse, add PH regulator, stir evenly, adjust the PH value, and stir evenly to obtain a mixture 1; S3-2. Take sodium alginate, sodium bicarbonate, methylparaben, propylparaben, a crystallization inhibitor, add an appropriate amount of water, stir well, and obtain a uniform mixture 2; S3-3. Add mixture 2 to mixture 1, stir thoroughly, add Chinese medicine gastroesophageal mucosal repair active ingredients, polycarbophil calcium, saccharin sodium, edible flavors, make up the water, stir evenly, and fill: the resulting composition preparation is an emulsion with a viscosity not exceeding 3350mpa.s, PH = 9.2, and a density = 1.01g / ml.

7. Use of the composition for repairing gastroesophageal mucosa according to any one of claims 1 to 3 in the preparation of medicines for relieving stomach pain, heartburn, acid reflux caused by excessive gastric acid, improving gastroesophageal reflux disease, and repairing and protecting digestive tract mucosa such as chronic gastritis, gastric ulcer, duodenal ulcer, etc.

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