CN116173074A - Composition and preparation for repairing gastroesophageal mucosa and preparation method thereof - Google Patents

Composition and preparation for repairing gastroesophageal mucosa and preparation method thereof Download PDF

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CN116173074A
CN116173074A CN202211713412.0A CN202211713412A CN116173074A CN 116173074 A CN116173074 A CN 116173074A CN 202211713412 A CN202211713412 A CN 202211713412A CN 116173074 A CN116173074 A CN 116173074A
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gastroesophageal
mucosa
composition
repairing
extract
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赵刚
沈伟
王云
李楠
吴军
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Shanghai Senbo Biotechnology Co ltd
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Shanghai Senbo Biotechnology Co ltd
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Abstract

The invention belongs to the technical field of medicines, and particularly relates to a composition and a preparation for repairing gastroesophageal mucosa and a preparation method thereof. Wherein the composition containing the active ingredients for repairing the gastroesophageal mucosa comprises traditional Chinese medicine active ingredients for repairing the gastroesophageal mucosa, at least one bioadhesive material and at least one material floating and staying in the stomach; the composition can be used for relieving gastralgia, pyrosis, acid regurgitation, and gastroesophageal reflux disease caused by gastric hyperacidity, and protecting and repairing digestive tract mucosa such as chronic gastritis, gastric ulcer, and duodenal ulcer.

Description

Composition and preparation for repairing gastroesophageal mucosa and preparation method thereof
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a composition and a preparation for repairing gastroesophageal mucosa and a preparation method thereof.
Background
Gastroesophageal reflux disease (GERD) is a common disorder of the digestive tract. Lower esophageal sphincter pressure is low, resulting in reflux, due to dysfunction of the patient's lower esophageal sphincter or other dysfunction-related tissue structure. Patients often feel heartburn, acid regurgitation, dysphagia and difficulty, and in severe cases, reflux can irritate pharyngolaryngitis caused by pharyngeal mucosa, so that the patients suffer from hoarseness, humanized pneumonia and other diseases.
GERD is a multifactorial pathogenic disease, which is caused by digestive tract dyskinesia due to various factors, and acid or other harmful substances such as cholic acid, pancreatin, etc. exist. In fact, under normal conditions, the esophagus itself has the ability to defend against gastric acid and duodenal contents, has anti-reflux barrier, esophageal clearance function, and esophageal mucosal tissue resistance, etc. Gastroesophageal reflux disease is caused by the reduction of the anti-reflux barrier and defense mechanism, and the damage of reflux substances to esophageal mucosa, which is finally initiated.
Chronic gastritis, atrophic gastritis, gastric cancer and the like are common diseases of the digestive system in clinic, and the onset of the chronic gastritis, atrophic gastritis, gastric cancer and the like is closely related to the damage of gastric mucosal tissues of human bodies to different degrees. Chronic gastritis, atrophic gastritis, intestinal metaplasia, atypical hyperplasia, gastric cancer are recognized digestive system tumor development patterns by WHO. Epidemiological investigation shows that the incidence rate of chronic gastritis in China is up to more than 60%, wherein the incidence rate of chronic gastritis is about 20%, the incidence rate of chronic gastritis accompanied with chronic gastritis finally developing into gastric cancer is about 3% -4%, and the chronic gastritis has considerable quantity. Therefore, active protection of gastric mucosal repair lesions is of great clinical importance for the treatment of digestive system diseases and prevention of further exacerbations.
Peptic ulcer (peptic ulcer) mainly refers to chronic ulcers occurring in the stomach and duodenum, also known as gastric and duodenal ulcers. The formation of ulcers is known to be associated with gastric acid-pepsin digestion. Peptic ulcers are common clinical diseases with high incidence, accounting for about 10% of the population. Duodenal ulcers are common in young and young ages, with men being more numerous than women.
Although the etiology is not completely understood at present, the basic pathogenesis is that the invasion factor of the mucous membrane is enhanced and/or the defense-repair factor of the mucous membrane is weakened.
At present, gastric acid abnormal secretion, diet and environmental factors, helicobacter pylori (Hp) infection, damage of digestive tract mucous membrane and other factors are considered to be related, when the invasion factor and the protective factor are out of balance, related diseases and symptoms are generated, a plurality of medicines for treating the above indications are marketed, chemical medicines are mainly used, antacids, proton pump inhibitors and H2 receptor blockers are mainly used, but chemical medicine side effects are obvious, the problems of long-term taking in a chronic period, repeated attacks and the like are not suitable, the traditional Chinese medicine is one of the important methods for preventing and treating digestive system diseases, and has good clinical practice foundation. In recent years, more and more researches find that the traditional Chinese medicine can play a role in protecting gastric mucosa, and an effective scheme is provided for exploring clinical prevention and treatment of upper gastrointestinal diseases.
In recent years, a great deal of research on the relationship between traditional Chinese medicines and gastric mucosa has been developed. However, the processing of traditional Chinese medicine preparations cannot meet the clinical demands, such as traditional tablets, granules, capsules, common oral liquid and the like, and the products are not optimized in the administration route, and are not used for related researches on protection and repair of digestive tract mucous membranes which are retained in the stomach for a long time and are used for chronic gastritis, gastric ulcer, duodenal ulcer and the like.
Disclosure of Invention
The invention provides a composition containing a traditional Chinese medicine for repairing gastroesophageal mucosa and a preparation thereof, which can be retained in digestive tracts such as stomach for a long time and promote the protection and repair of mucosa.
In order to achieve the above purpose, the present invention adopts the following technical scheme:
a composition for repairing gastroesophageal mucosa, which comprises the following components in parts by mass:
active ingredients for repairing gastroesophageal mucosa of 0.1-20
Bioadhesive material 0.1-10
Suspending the retentate fraction 2-20;
the bioadhesive material is selected from acrylic acid polymers, cellulose derivatives, povidone, polyvinyl methyl ether-maleic anhydride copolymers, gums of natural origin and polysaccharides;
the suspension retention component comprises a part a and a part b, wherein the part a is selected from gums and polysaccharides of natural origin, vinylpyrrolidone, copolymers of vinylpyrrolidone and vinyl acetate, celluloses and derivatives thereof, acrylic acid polymers and salts thereof;
part b is selected from the group consisting of an ingredient that forms an effervescence with h+, or, sodium carboxymethyl cellulose, croscarmellose sodium, crospovidone, croscarmellose sodium, low substituted hydroxypropyl cellulose.
High molecular substances such as acrylic acid polymers, vinyl pyrrolidone, cellulose derivatives and the like can be used as suspended retention components in the invention due to the structural characteristics thereof; and can also be used as a bioadhesive material.
In particular, the suspended retentate fraction has a particle size of 100um or less when insoluble in the class II/III solvents described by water/ICH.
In particular, the gastroesophageal mucosa repair active ingredient is selected from: the extract of Fusarium americanum, herba cistanches, radix Glycyrrhizae, rhizoma Atractylodis Macrocephalae, herba Dendrobii, fructus Hippophae, rhizoma Atractylodis, pericarpium Citri Reticulatae, rhizoma Bletillae, and rhizoma corydalis.
In particular, pharmaceutically acceptable salts and excipients are also included.
In the present invention,
the preparation method of the composition for repairing the gastroesophageal mucosa comprises the following steps:
(1) Placing the bioadhesive material into a solvent, uniformly stirring, and adjusting the pH value to obtain a mixture 1;
(2) Adding part of the floating detention components in the stomach, pharmaceutically acceptable salts and auxiliary materials into water, and uniformly stirring to obtain a uniform mixture 2;
(3) Adding the mixture 2 into the mixture 1, fully stirring, adding the traditional Chinese medicine gastroesophageal mucosa repair active ingredients and the residual ingredients, supplementing water, uniformly stirring, and filling to obtain the traditional Chinese medicine gastroesophageal mucosa repair active ingredients:
in particular, in the step (1), the solvent is deionized water or a class II/III solvent in ICH.
In particular, the pH of the finished product is from 5.0 to 9.5 (more preferably from 7.0 to 9.5); the density is 0.9-1.2g/ml; the viscosity is less than or equal to 4000 mpa.s.
The invention also protects the application of the composition for repairing the gastroesophageal mucosa in preparing medicines, medical or dietary health care products for relieving gastralgia, heartburn and acid regurgitation caused by gastric hyperacidity, improving gastroesophageal reflux disease, repairing and protecting digestive tract mucosa such as chronic gastritis, gastric ulcer, duodenal ulcer and the like.
Compared with the prior art, the composition prepared by the invention is a liquid suspension, and is convenient for patients to swallow, especially children and old people. The composition prepared by the invention has rapid onset of action, and can relieve symptoms caused by gastric pain, heartburn, acid regurgitation and gastroesophageal reflux disease caused by gastric hyperacidity within 10min after taking. The composition prepared by the invention has longer action time, can stay in the stomach for 4-6 hours, and prolongs the contact and action time of the active ingredients for repairing the gastric mucosa and the gastric mucosa as well as the duodenal mucosa. The invention mainly takes local action and has high safety.
Drawings
FIG. 1 is a sectional view of a rat stomach tissue sample.
FIG. 2 shows the spleen and stomach of a rat at 2 x 2cm 2 Is a sectional view of a tissue sample.
Detailed Description
For a better understanding of the present invention, reference will now be made to the following description of specific examples, which are included in the terminology used to describe specific embodiments of the invention and are not intended to limit the scope of the invention.
In the invention, the following components are added:
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 vinylpyrrolidone and vinyl acetate; HPMC is hydroxypropyl methylcellulose.
In the present invention, the viscosity was measured at 25℃with a Brosh viscometer at 20 RPM.
Example 1
A method of preparing a composition for gastroesophageal mucosa repair comprising the steps of:
(1) Weighing the following raw materials in parts by mass
Figure BDA0004027259170000041
Figure BDA0004027259170000051
(2) Placing HPMC K100LV, PVP K90 and carbomer in proper amount of water, stirring, dispersing thoroughly, adding PH regulator, stirring uniformly, regulating PH value, and stirring uniformly to obtain mixture 1;
(3) Adding proper amount of water into sodium alginate, pseudoacid pulp colloid, sodium bicarbonate, methylparaben and propylparaben, and stirring to obtain uniform mixture 2;
(4) Adding the mixture 2 into the mixture 1, fully stirring, adding the traditional Chinese medicine gastroesophageal mucosa repair active ingredients, calcium carbonate, sweetener and essence, supplementing water, uniformly stirring, and filling to obtain the traditional Chinese medicine gastroesophageal mucosa repair active ingredients:
the finished product was measured to have a viscosity of 500 mpa.s or less, a ph=8.5 and a density of 0.99g/ml.
Example two
A method of preparing a composition for gastroesophageal mucosa repair comprising the steps of:
(1) Weighing the following raw materials in parts by mass
Figure BDA0004027259170000052
(2) Placing PVP K90 and carbomer in water, stirring, dispersing thoroughly, adding pH regulator, stirring uniformly, regulating pH value, and stirring uniformly to obtain mixture 1;
(3) Adding a proper amount of water into sodium alginate, sodium bicarbonate and methylparaben and propylparaben, and uniformly stirring to obtain a uniform mixture 2;
(4) Adding the mixture 2 into the mixture 1, fully stirring, adding the traditional Chinese medicine gastroesophageal mucosa repair active ingredient, calcium carbonate, sweetener, edible essence, water supplementing, uniformly stirring, and filling to obtain the traditional Chinese medicine:
the finished product is measured, the viscosity is less than or equal to 1150 mpa.S, the pH=7.5, and the density is 1.06g/ml.
Example III
A method of preparing a composition for gastroesophageal mucosa repair comprising the steps of:
(1) Weighing the following raw materials in parts by mass
Figure BDA0004027259170000061
(2) Taking HPMC K100LV and NP700 sodium polyacrylate, placing polycarbophil in water, stirring, fully dispersing, adding a PH regulator, stirring uniformly, regulating the PH value, and stirring uniformly to obtain a mixture 1;
(3) Adding a proper amount of water into sodium alginate, sodium bicarbonate and benzoic acid, and uniformly stirring to obtain a uniform mixture 2;
(4) Adding the mixture 2 into the mixture 1, fully stirring, adding the traditional Chinese medicine gastroesophageal mucosa repair active ingredients, calcium carbonate and a sweetener, supplementing water, uniformly stirring, and filling to obtain the traditional Chinese medicine gastroesophageal mucosa repair active ingredients:
the finished product was measured to have a viscosity of less than or equal to 230 mpa.s, a ph=7.3 and a density of 0.96g/ml.
Example IV
A method of preparing a composition for gastroesophageal mucosa repair comprising the steps of:
(1) Weighing the following raw materials in parts by mass
Figure BDA0004027259170000062
Figure BDA0004027259170000071
(2) Adding carbomer into water, stirring, dispersing, adding PH regulator, stirring, regulating PH value, and stirring to obtain mixture 1;
(3) Adding a proper amount of water into sodium alginate, pseudoacid pulp colloid, sodium bicarbonate and methylparaben, and uniformly stirring to obtain a uniform mixture 2;
(4) Adding the mixture 2 into the mixture 1, fully stirring, adding the traditional Chinese medicine gastroesophageal mucosa repair active ingredients, calcium carbonate and a sweetener, edible essence, supplementing water, uniformly stirring, and filling to obtain the traditional Chinese medicine gastroesophageal mucosa repair active ingredients:
the finished product is measured, the viscosity is less than or equal to 1280 mpa.S, the pH=7.6, and the density is 1.10g/ml.
Example five
A method of preparing a composition for gastroesophageal mucosa repair comprising the steps of:
(1) Weighing the following raw materials in parts by mass
Figure BDA0004027259170000072
(2) Adding carbomer and PVP K90 into water, stirring, dispersing, adding pH regulator, stirring, regulating pH value, and stirring to obtain mixture 1;
(3) Adding a proper amount of water into sodium alginate and sodium bicarbonate, and uniformly stirring to obtain a uniform mixture 2;
(4) Adding the mixture 2 into the mixture 1, fully stirring, adding the traditional Chinese medicine gastroesophageal mucosa repair active ingredients, calcium carbonate, sucralose, edible essence, supplementing water, uniformly stirring, and filling to obtain the traditional Chinese medicine:
the finished product was measured to have a viscosity of 1650 mpa.S, pH=9.3 and a density of 1.18g/ml.
Example six
A method of preparing a composition for gastroesophageal mucosa repair comprising the steps of:
(1) Weighing the following raw materials in parts by mass
Figure BDA0004027259170000081
(2) Adding carbomer into water, stirring, dispersing, adding PH regulator, stirring, regulating PH value, and stirring to obtain mixture 1;
(3) Adding a proper amount of water into sodium alginate, potassium bicarbonate and methylparaben, and stirring uniformly to obtain a uniform mixture 2;
(4) Adding the mixture 2 into the mixture 1, fully stirring, adding traditional Chinese medicine gastroesophageal mucosa repair active ingredients and calcium carbonate, polycarbophil, saccharin calcium, edible essence, supplementing water, uniformly stirring, and filling to obtain the traditional Chinese medicine:
the finished product was measured to have a viscosity of 3850 mpa.s, ph=8.7 and a density of 1.06g/ml.
Example seven
A method of preparing a composition for gastroesophageal mucosa repair comprising the steps of:
(1) Weighing the following raw materials in parts by mass
Figure BDA0004027259170000091
/>
(2) Adding carbomer into water, stirring, dispersing, adding PH regulator, stirring, regulating PH value, and stirring to obtain mixture 1;
(3) Adding a proper amount of water into sodium alginate, sodium bicarbonate and methylparaben and propylparaben, and uniformly stirring to obtain a uniform mixture 2;
(4) Adding the mixture 2 into the mixture 1, fully stirring, adding traditional Chinese medicine gastroesophageal mucosa repair active ingredients and calcium carbonate, polycarbophil, saccharin sodium, edible essence, supplementing water, uniformly stirring, and filling to obtain the traditional Chinese medicine:
the finished product was measured to have a viscosity of 2950 mpa.s, ph=9.0 and a density of 1.01g/ml.
Example eight
A method of preparing a composition for gastroesophageal mucosa repair comprising the steps of:
(1) Weighing the following raw materials in parts by mass
Figure BDA0004027259170000092
Figure BDA0004027259170000101
(2) Adding carbomer into water, stirring, dispersing, adding PH regulator, stirring, regulating PH value, and stirring to obtain mixture 1;
(3) Adding a proper amount of water into sodium alginate, sodium bicarbonate, methylparaben, propylparaben and crystallization inhibitor, and stirring uniformly to obtain a uniform mixture 2;
(4) Adding the mixture 2 into the mixture 1, fully stirring, adding traditional Chinese medicine gastroesophageal mucosa repair active ingredients and calcium carbonate, polycarbophil, saccharin sodium, edible essence, supplementing water, uniformly stirring, and filling to obtain the traditional Chinese medicine:
the obtained composition is in the form of emulsion with viscosity of no more than 3350mpa.s, pH of 9.2, and density of 1.01g/ml
Example 9
(1) Weighing the following raw materials in parts by mass
Figure BDA0004027259170000102
Figure BDA0004027259170000111
(2) Placing PVM/MA (S97), xanthan gum and chitosan into water, stirring, dispersing thoroughly to obtain uniform solution or suspension 1, and adding sodium hydroxide to adjust pH;
(3) Taking partial copolymer of vinyl pyrrolidone (PVP K30), vinyl pyrrolidone and vinyl acetate
Figure BDA0004027259170000112
SR), HPMC E15, guar gum, zein, potassium bicarbonate, zinc carbonate, sodium carboxymethyl cellulose, sodium cross-linked carboxymethyl starch, and cross-linked povidoneAdding cross-linked sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, benzoic acid and sweetener into water, and stirring uniformly to obtain a uniform mixture 2; />
(4) Adding the mixture 2 into the mixture 1, stirring thoroughly, adding Chinese medicinal components and the rest components composed of Atractylodis rhizoma, herba Dendrobii, fructus Hippophae, rhizoma Atractylodis, pericarpium Citri Tangerinae, and rhizoma Bletillae, stirring uniformly, and packaging:
the resulting composition formulation was a suspension with a viscosity of no more than 950mpa.s, a pH of 7.2 and a density of 9.82g/ml.
The compositions of examples one to nine above were tested.
1. In vitro artificial gastric juice floating time test
The testing method comprises the following steps: 500ml of HCl buffer solution with ph=1.2 was filled in a volumetric flask, the filling distance was about 1cm below the bottleneck constriction, 10ml of test sample was injected into the volumetric flask in 10s by syringe, the timing was started until the gel was all floating to the liquid level, and the timing was stopped. The results are shown in Table 1, and each group was repeated 10 times.
TABLE 1 Floating time period
Figure BDA0004027259170000113
Figure BDA0004027259170000114
Figure BDA0004027259170000121
2. Release Rate test
The testing method comprises the following steps: adding 500ml of pH=1.2 hydrochloric acid buffer solution into a flask with a neck at the side part of a flat bottom, adding a magnetic stirring device at the bottom of the flask, placing the flask in a constant-temperature water bath with a side opening for sampling and fluid supplementing, adding 10ml of sample when the temperature of the buffer solution reaches 37+/-0.5 ℃, and starting magnetic stirring at the rotating speed of 50rpm/min; samples were taken at 60 minutes, 120 minutes, 180 minutes, 240 minutes, and 360 minutes, respectively, and the amount of the gastroesophageal mucosa repair active ingredient at each sampling point was measured, and the release rate was calculated. The results are shown in Table 2, and each set was repeated 10 times.
TABLE 2 Release Rate
Figure BDA0004027259170000122
/>
Figure BDA0004027259170000123
3. Gastric mucosal lesion repair capability test
The testing method comprises the following steps: taking 6 normal SD rats as normal control groups, and randomly dividing 30 rats with acute gastric mucosal injury models (injection: preparation of acute gastric mucosal injury models, injection: gastric mucosal injury molding by adopting 600g/L ethanol gastric lavage, namely, no water forbidden for 24 hours before molding, injection of 600g/L ethanol gastric lavage, 2 mL/L.) into 5 groups, wherein 6 rats in each group are respectively used for experimental observation of model control groups, commercial product control groups, one group of embodiments, two groups of embodiments and eight groups of embodiments. The normal control group and the model control group are subjected to normal feeding, and the commercial product control group, the first group of the examples, the second group of the examples and the eighth group of the examples are respectively given with corresponding test medicines, and are respectively given with 0.2 mL/time (kg.d) and 3 times/d of gastric administration for 3 days.
1) Gastric tissue samples, normal saline wash after ligation, 10% neutral formaldehyde fixation for 10 minutes, shearing along the greater curvature of the stomach, washing the contents, removing residual liquid, tiling, observing apparent morphology, and photographing for recording.
The results are shown in fig. 1, and the gastric wall mucous membrane is normal, and no ulcer points or ulcer surfaces or mucous membrane injuries are observed by naked eyes. The gastric wall mucosa of the rat in the model control group is seriously damaged, and has a plurality of brown blood stasis spots, and the gastric body has a plurality of ulcer surfaces; the gastric ulcer lesions of rats in the control group of the commercial products are obviously reduced compared with those in the model control group, and the ulcer surface is obviously reduced.
The stomach wall injury of rats in the eight groups of examples, the two groups of examples and the one group of examples is obviously reduced compared with the rats in the commercial control group, and the ulcer points and the ulcer surfaces are obviously disappeared.
2) The same position of spleen and stomach of each group of rats is about 2 x 2cm 2 Size stomach tissue, fixed with 10% neutral formaldehyde for 24h, paraffin embedded sections, conventional HE staining, microscopic observation of stomach tissue pathology.
The results show that the mucous membrane of the gastric wall tissue is normally intact, and no ulcer points or ulcer surfaces or mucous membrane lesions are found.
The gastric wall mucous membrane of the rat in the model control group is mainly erosion and ulcer, mucous membrane epithelium is shed, inflammatory cells are seriously infiltrated, and submucosa is accumulated;
the gastric tissue congestion and edema of the rats in the control group of the commercial products are obviously reduced, and the ulcer surface is obviously reduced;
the stomach tissue of rats in the eight groups of examples, the two groups of examples and the one group of examples is nearly complete compared with the rats in the group of commercially available control groups, the ulcer surface is obviously disappeared, and the cell infiltration and the tissue edema are obviously disappeared.
3) Ulcer inhibition rate
Area of each ulcer was measured with vernier callipers, ulcer diameter>1mm to calculate ulcer area, 10 ulcer points with the area smaller than 1mm and corresponding to ulcer surface and 1mm 2 The ulcer index was evaluated in terms of square millimeters of the sum of the ulcer areas, and the percentage of inhibition of the ulcer was calculated as follows:
percent ulcer inhibition = (sum of ulcer areas of model control-sum of ulcer areas of dosing group)/sum of ulcer areas of model control × 100%.
Table 3 comparison of ulcer inhibition rates
Figure BDA0004027259170000131
/>
Figure BDA0004027259170000132
Figure BDA0004027259170000141
The ulcer inhibition rates of the eight groups of the examples, the two groups of the examples and the one group of the examples are higher than those of the control group of the commercial products.
4. Expansion test
The remaining examples were tested using the same method as in 3. Gastric mucosal lesion repair capability test, and the results are shown in graph 4.
Table 4 comparative ulcer inhibition ratio in expansion test
Figure BDA0004027259170000142
Test group Area of ulcer (mm) 2 ) Ulcer inhibition (%)
Normal control group 0.00±0.00 100
Examples three groups 9.6±3.5 64.87
Example four groups 9.4±3.2 66.81
Example five groups 9.5±2.8 65.28
Example six groups 9.6±3.4 66.31
Example seven groups 9.8±3.6 64.59
Example nine groups 8.9±2.7 67.01
The foregoing detailed description is directed to one of the possible embodiments of the present invention, which is not intended to limit the scope of the invention, but is to be accorded the full scope of all such equivalents and modifications so as not to depart from the scope of the invention.

Claims (10)

1. A composition for gastroesophageal mucosa repair, characterized by comprising the following components in parts by mass:
active ingredients for repairing gastroesophageal mucosa of 0.1-20
Bioadhesive material 0.1-10
Suspending the retentate fraction 2-20;
the bioadhesive material is selected from acrylic acid polymers, cellulose derivatives, povidone, polyvinyl methyl ether-maleic anhydride copolymers, gums of natural origin and polysaccharides;
the suspension retention component comprises a part a and a part b, wherein the part a is selected from gums and polysaccharides of natural origin, vinylpyrrolidone, copolymers of vinylpyrrolidone and vinyl acetate, celluloses and derivatives thereof, acrylic acid polymers and salts thereof;
part b is selected from H + The effervescent component can be produced by absorbing water such as sodium carboxymethyl cellulose, crosslinked sodium carboxymethyl starch, crosslinked povidone, crosslinked sodium carboxymethyl cellulose, and low substituted hydroxypropyl celluloseA strongly expanding component.
2. The composition for gastroesophageal mucosa repair of claim 1, wherein the portion a of the suspended retention ingredient is selected from the group consisting of: sodium alginate, pseudoacid syrup, polycarbophil, vinylpyrrolidone, copolymers of vinylpyrrolidone and vinyl acetate, celluloses and derivatives thereof, acrylic acid polymers and salts thereof;
part b is selected from: sodium bicarbonate, calcium carbonate, potassium bicarbonate, and zinc carbonate; sodium carboxymethyl cellulose, sodium cross-linked carboxymethyl starch, cross-linked povidone, sodium cross-linked carboxymethyl cellulose, and low-substituted hydroxypropyl cellulose.
3. The composition for gastroesophageal mucosa repair according to claim 1, wherein the suspended retention component has a particle size of 100um or less when insoluble in a class II/III solvent described by water/ICH.
4. The composition for repairing gastroesophageal mucosa according to claim 1, wherein the gastroesophageal mucosa repairing active ingredient is a traditional Chinese medicine active ingredient which is conventional in the art and can repair or assist in repairing digestive tract mucosa.
5. The composition for repairing gastroesophageal mucosa according to claim 4, wherein the active ingredients for repairing gastroesophageal mucosa are at least one of a sickle americana extract, a just-in-should extract, a licorice extract, a bighead atractylodes rhizome extract, a dendrobium extract, a sea buckthorn extract, a rhizoma atractylodis extract, a dried orange peel extract, a bletilla striata extract, and a rhizoma corydalis extract.
6. A formulation comprising the composition for gastroesophageal mucosa repair of any one of claims 1-5, further comprising a pharmaceutically acceptable salt and an adjuvant.
7. A method of preparing a formulation of a composition for gastroesophageal mucosa repair according to claim 6, comprising the steps of:
(1) Placing the bioadhesive material into a solvent, uniformly stirring, and adjusting the pH value to obtain a mixture 1;
(2) Adding part of the floating detention components in the stomach, pharmaceutically acceptable salts and auxiliary materials into water, and uniformly stirring to obtain a uniform mixture 2;
(3) Adding the mixture 2 into the mixture 1, stirring thoroughly, adding the active ingredients and the rest ingredients for repairing the gastroesophageal mucosa of the traditional Chinese medicine, supplementing water, stirring uniformly, and filling to obtain the finished product.
8. The method of preparing a composition for gastroesophageal mucosa repair according to claim 7, wherein the solvent in the step (1) is deionized water or a class II/III solvent belonging to ICH.
9. A method of preparing a composition for gastroesophageal mucosa repair according to claim 8, wherein; the PH of the finished product is 5.0-9.5; the density is 0.9-1.2g/ml; the viscosity is less than or equal to 4000 mpa.s.
10. The use of a composition for gastroesophageal mucosa repair according to any one of claims 1-5 for the preparation of a medicament, medical or dietary care product for alleviating gastric pain, heartburn, acid regurgitation, amelioration of gastroesophageal reflux disease caused by gastric hyperacidity, and repair and protection of digestive tract mucosa such as chronic gastritis, gastric ulcer, duodenal ulcer, and the like.
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