CN113499393A

CN113499393A - Composition with gastric mucosa injury protection effect and preparation method thereof

Info

Publication number: CN113499393A
Application number: CN202110931376.4A
Authority: CN
Inventors: 朱志铭; 赵大鹏; 张赞; 李丽丽; 马辉; 韩烁培
Original assignee: Hebei Yuzhilin Pharmaceutical Co ltd; Hebei Yuzhilin Biotechnology Co ltd
Current assignee: Hebei Yuzhilin Pharmaceutical Co ltd
Priority date: 2021-08-13
Filing date: 2021-08-13
Publication date: 2021-10-15
Anticipated expiration: 2041-08-13
Also published as: CN113499393B

Abstract

The invention provides a composition with a gastric mucosa injury protection effect, which comprises the following components in parts by weight: 50-70 parts of hericium erinaceus extract, 40-60 parts of morchella esculenta extract, 30-50 parts of bletilla striata extract, 20-40 parts of fingered citron extract, 260 parts of sea buckthorn oil and 340 parts of beeswax. The morchella esculenta has the effects of harmonizing stomach, promoting digestion, eliminating phlegm and regulating qi; the common bletilla pseudobulb has the effects of astringing and promoting granulation, dissipating stagnation and removing blood stasis, promoting digestion and removing food retention, promoting granulation and removing necrotic tissue, regulating qi and dissipating stagnation, and is used as a ministerial drug together to increase the bleeding amount of gastric mucosa, promote oxygen supply, enhance resistance, and smoothen the blood circulation of gastric mucosa to smooth qi and blood of organism. The fingered citron is an adjuvant drug, has the effects of promoting the circulation of qi, tonifying liver, warming stomach, strengthening spleen, stopping vomiting and the like, is soft in nature and weak, treats both liver and spleen without damaging vital qi, is flexible and suitable in the formula and plays a good auxiliary role.

Description

Composition with gastric mucosa injury protection effect and preparation method thereof

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a composition with a gastric mucosa injury protection effect and a preparation method thereof.

Background

With the acceleration of the pace of life in modern society, the social, psychological and working pressure borne by people is increased, so that the incidence rate of gastric mucosa diseases is correspondingly increased. And the fast-paced life style, the intense work and study, and the frequent reasons of stomach mucosa injury caused by over-drinking wine and the like. The incidence of a disease is high in both developed and developing countries as a worldwide disease. It is reported that more than 10% of people in our national population suffer from gastric ulcer, about 25% suffer from various gastritis, and the total number of patients suffering from gastric diseases in the country is nearly 3 hundred million.

The gastric mucosa defense mechanism is a complex system with multiple angles, layers and properties, and is mainly divided into four stages. The first defense is the mucus-bicarbonate-phospholipid barrier, the second is the gastric mucosal barrier composed of mucosal epithelial cells, the third relies on mucosal microcirculation, and the mucosal immune system constitutes the fourth defense. In addition, there are other defenses such as gastric mucosal self-repair, gastric mucosal blood flow, etc. The analysis of the pathogenesis of gastric mucosa injury from the perspective of traditional Chinese medicine is as follows: the insufficiency of middle-jiao leads to the disorder of transportation and reception and the lack of the source of the transformation, so that the qi movement is not smooth, the obstruction of the vessels and collaterals and the obstruction of the blood and qi movement can be caused after long-term accumulation, the stomach is not nourished, and the further development can lead to the transformation of the intestines and the cancer.

At present, the drugs for treating the loss of the gastric mucosa on the market comprise antacids (sodium bicarbonate and the like), gastric mucosa protective agents (prostaglandin and derivatives thereof, aluminum agents, bismuth agents, teprenone, issorafenib, rebamipide and the like), anti-helicobacter pylori drugs and the like. However, the medicines have side effects, and the problems of tolerance, reduced curative effect and repeated attack and temporary solution but not permanent solution of the disease easily occur to human bodies after long-term administration, and the traditional Chinese medicines mainly care, re-care, temporary solution and permanent solution. Therefore, the search for a high-efficiency traditional Chinese medicine composition with the function of protecting gastric mucosal injury becomes an important and urgent task.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition with a protection effect on gastric mucosa injury and a preparation method and application thereof.

In order to achieve the above object, the present invention provides the following technical solutions:

a composition with a gastric mucosa injury protection effect comprises the following components in parts by weight:

components	Parts by weight
		Hericium erinaceum extract	50-70 parts of
Morchella extract	40-60 parts
		Bletilla striata extract	30-50 parts of
Extract of finger citron	20-40 parts of
		Sea buckthorn oil	260 portion to 340 portions
Beeswax (Cera flava)	10-30 parts of

Further, the composition with the gastric mucosa injury protection effect comprises the following components in parts by weight:

components	Parts by weight
		Hericium erinaceum extract	55 to 65 portions of
Morchella extract	45 to 55 portions of
		Bletilla striata extract	35-45 parts of
Extract of finger citron	25-35 parts of
		Sea buckthorn oil	280-320 parts
Beeswax (Cera flava)	15-25 parts of

components	Parts by weight
		Hericium erinaceum extract	58 to 62 portions of
Morchella extract	47-53 parts
		Bletilla striata extract	37-43 parts of
Extract of finger citron	28-32 parts
		Sea buckthorn oil	290 part by weight of 310 parts
Beeswax (Cera flava)	17-23 parts

Preferably, in one embodiment of the present invention, a composition having a gastric mucosal lesion protecting effect comprises the following components in parts by weight:

components	Parts by weight
		Hericium erinaceum extract	60 portions of
Morchella extract	50 portions of
		Bletilla striata extract	40 portions of
Extract of finger citron	30 portions of
		Sea buckthorn oil	300 portion to 310 portion
Beeswax (Cera flava)	20-25 parts of

Preferably, in another embodiment of the present invention, a composition having a gastric mucosal lesion protecting effect comprises the following components in parts by weight:

components	Parts by weight
		Hericium erinaceum extract	60 portions of
Morchella extract	50 portions of
		Bletilla striata extract	40 portions of
Extract of finger citron	30 portions of
		Sea buckthorn oil	305 parts of
Beeswax (Cera flava)	22 portions of

The Hericium erinaceus extract, morel extract, rhizoma bletillae extract and fructus Citri Sarcodactylis extract in the composition can be provided by Jiangxi Jiahe Biotech GmbH, and can also be prepared by other extraction methods.

The composition can be prepared into tablets, granules, hard capsules, soft capsules, tablets, powder, pills and oral liquid, and preferably soft capsules.

Another aspect of the present invention is to provide a method for preparing the above composition having a gastric mucosal lesion protecting effect.

A method for preparing a composition with a gastric mucosa injury protection effect comprises the following steps:

1) respectively taking 50-70 parts of hericium erinaceus extract, 40-60 parts of morchella esculenta extract, 30-50 parts of rhizoma bletillae extract and 20-40 parts of fingered citron extract according to weight, and uniformly mixing for later use.

2) Heating to prepare capsule wall materials, wherein the raw materials comprise gelatin, glycerol and water.

3) Uniformly mixing the traditional Chinese medicine powder obtained in the step 1), 340 parts of seabuckthorn oil 260-30 parts of beeswax.

4) Pressing the soft capsules: the weight of the core material in each soft capsule is 0.1-0.5g, and the traditional Chinese medicine soft capsule is prepared.

Further, in the step 4), the weight of the core material in each soft capsule is preferably 0.2 g.

In the traditional Chinese medicine composition with the auxiliary protection function on the gastric mucosa injury, the pharmacological actions of the components are as follows:

hericium erinaceus is a fruit body of Hericium erinaceus (Bull. ex Fr.) Pers, a family of the Bacteromycetes, and is a rare edible and medicinal fungus. Has neutral nature and sweet taste, and has effects of invigorating spleen and stomach, softening hard masses, and eliminating abdominal mass, contains various components such as organic acid and its ester, saponins, saccharide, etc., and can be used for treating gastric ulcer, duodenal ulcer, neurasthenia, hepatitis B, chronic gastritis, and digestive tract tumor. Modern pharmacological research shows that the hericium erinaceus polysaccharide can increase the blood flow of gastric mucosa, so that stress gastric mucosa injury is treated. And the catalyst has a catalytic enhancement effect on various factors in gastric mucosa tissues, so that the defense capability is enhanced, and the aims of protecting the gastric mucosa and resisting ulcer are fulfilled. The hericium erinaceus can reduce the area and the volume of gastric ulcer of a chronic gastric mucosa injury model caused by glacial acetic acid, and the hericium erinaceus extract has an auxiliary protection effect on gastric mucosa injury. The Hericium erinaceus fruiting body polysaccharide can reduce gastric mucosa injury index caused by ethanol, gastric ulcer index caused by indomethacin, and gastric ulcer index caused by acetic acid, and simultaneously increase gastric juice pH value and reduce pepsin activity. The results show that the hericium erinaceus sporocarp polysaccharide and the hericium erinaceus mycelium polysaccharide have obvious inhibition effects on acute ulcer of a rat caused by pylorus ligation and chronic ulcer of the rat caused by acetic acid, have protection effects on gastric mucosa injury caused by ethanol and indomethacin, and simultaneously can reduce the activities of gastric acid and pepsin and have protection effects on chronic gastric mucosa injury.

Morchella is a rare edible fungus, which is named because the surface of the cap is uneven and is like morchella. The book of Xinhua materia medica compendium records that the morchella esculenta has the functions of harmonizing stomach, promoting digestion, eliminating phlegm and regulating qi. Modern medical research shows that the morchella aqueous extract has obvious effects on pylorus ligation gastric ulcer models, acetic acid burning gastric ulcer models, ethanol induced gastric ulcer models and water immersion stress gastric ulcer models, and the reduction of ulcer indexes (areas) and the reduction of gastric juice amount show that the morchella aqueous extract has good treatment and prevention effects on gastric ulcer caused by gastric acid, chemistry and stress conditions. In addition, the research proves that the morchella aqueous extract can not only strengthen the gastrointestinal peristalsis of normal mice and has the effect similar to gastrointestinal motivators, but also inhibit the hyperfunction of the mice on the gastrointestinal function caused by neostigmine load.

Bletilla striata is a dried tuber of the plant Bletilla striata (Thunb.) reichb.f. of the family orchidaceae. Enters lung, liver and stomach meridians, and has effects of promoting blood circulation, stopping bleeding, promoting granulation, and protecting skin. The chemical components of the rhizoma bletillae mainly comprise glycosides, bibenzyls, phenanthrenes, quinones, biphenyls, dihydrophenanthrenes, anthocyanidins, steroids, triterpenes, phenolic acids and the like. Modern pharmacological experiment research proves that the bletilla striata can relieve the aspirin-induced gastric ulcer model of rats, acetic acid gastric ulcer, pylorus ligation ulcer and experimental gastric ulcer of the gastric mucosa of the rats. The bletilla polysaccharide has obvious therapeutic action on acetic acid gastric ulcer of rats, and the therapeutic mechanism of the bletilla polysaccharide can enhance the oxidation resistance of gastric mucosa, inhibit the generation of free radicals, promote the epithelial cell proliferation of gastric mucosa at local ulcer and strengthen the repair of damaged tissues. Clinical tests show that the bletilla striata can remarkably adjust the erythrocyte sedimentation rate and the C-reactive protein level of patients and has an immunoregulation effect on patients with ulcerative colitis; the bletilla striata and angelica sinensis powder has the effects of stopping bleeding, nourishing blood, resisting bacteria, diminishing inflammation and easing pain, and has a remarkable effect of treating upper gastrointestinal hemorrhage. The results show that the bletilla has the functions of astringing, stopping bleeding, promoting granulation, dissipating stagnation and removing necrosis, the mucous membrane barrier of the gastric ulcer patient is damaged due to the ulcer, and the bletilla has high viscosity, so that a membrane with a certain thickness is easily formed in the stomach and is attached to the ulcer surface, further invasion of gastric acid, pepsin and other physical and chemical factors to the ulcer is prevented, healing and repairing of the ulcer are facilitated, and the healing, stopping bleeding and promoting granulation effects of the bletilla are exerted.

The root, stem, leaf, flower and fruit of Citrus plant of Rutaceae can be used as medicine, and is pungent, bitter, sweet, warm and nontoxic; it has the functions of regulating qi, eliminating phlegm, stopping vomiting, relieving flatulence, soothing liver, strengthening spleen, regulating stomach and other medicinal functions. The specific substances of the volatile oil and the flavonoid substances in the fingered citron can promote the increase of gastric mucus and keep the balance of gastric acid, thereby inhibiting the formation of gastric ulcer.

The oleum Hippophae contains unsaturated fatty acid, vitamins, and trace elements, and has high nutritive value. Modern researches show that the seabuckthorn seed oil has a protective effect on liver injury caused by carbon tetrachloride, and can protect gastric mucosa by stimulating the proximal small intestine to release multiple gastrointestinal hormones.

The traditional Chinese medicine composition can be added with one or more of dextrin, maltodextrin, beta-cyclodextrin, soluble starch, erythritol, mogroside, isomalt and the like as auxiliary materials, and prepared into products in the forms of tablets, granules, hard capsules, soft capsules, tablets, powder, pills, oral liquid and the like according to the production method of modern traditional Chinese medicine products or foods.

Compared with the prior art, the hericium erinaceus extract, the morchella esculenta extract, the bletilla striata extract and the fingered citron extract are creatively prepared into the traditional Chinese medicine composition according to the traditional Chinese medicine theory aiming at the deficiency of qi in spleen and stomach and the unsmooth qi and blood of pathogenesis, and the hericium erinaceus extract in the formula can tonify the spleen and stomach, particularly is good at spleen and stomach channels and is a monarch drug. The morchella esculenta has the effects of harmonizing stomach, promoting digestion, eliminating phlegm and regulating qi; the common bletilla pseudobulb has the effects of astringing and promoting granulation, dissipating stagnation and removing blood stasis, promoting digestion and removing food retention, promoting granulation and removing necrotic tissue, regulating qi and dissipating stagnation, and is used as a ministerial drug together to increase the bleeding amount of gastric mucosa, promote oxygen supply, enhance resistance, and smoothen the blood circulation of gastric mucosa to smooth qi and blood of organism. The fingered citron is an adjuvant drug, has the effects of promoting the circulation of qi, tonifying liver, warming stomach, strengthening spleen, stopping vomiting and the like, is soft in nature and weak, treats both liver and spleen without damaging the body resistance, is flexible and suitable in the formula and plays a good auxiliary role.

The traditional Chinese medicine composition has obviously better treatment effect on gastric mucosa injury than that of a single hericium erinaceus extract or other component composition, and has unexpected technical effect.

The invention provides the pharmaceutical composition with the function of protecting gastric mucosa from injury, which has obvious effect and no toxic or side effect: (1) the test result of a maximum tolerance method shows that the MTD of the pharmaceutical composition provided by the invention to mice of two sexes is more than 20.0 g/kg.bw; the sample was of the nontoxic grade according to the acute toxicity grading criteria. (2) And (3) genetic toxicity test: the Ames test result is negative; the result of the mouse marrow pleochromocyte micronucleus test is negative; the result of the mouse sperm aberration test is negative; the results of the experiment of feeding the sample 30d to the rat show that the sample 30d has no toxic effect on various observation indexes of the rat.

Detailed Description

The invention discloses a composition with a gastric mucosa injury protection effect and a preparation method thereof, and the composition can be realized by combining the relevant principles of traditional Chinese medicines and properly improving process parameters by taking the contents of the composition as reference by the technical personnel in the field. It is expressly intended that all such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the scope of the invention. While the invention has been described in terms of preferred embodiments, it will be apparent to those skilled in the art that variations may be applied, or changes and combinations may be made, in the methods and applications described herein to achieve and use the inventive techniques without departing from the spirit, scope, and content of the invention.

For a better understanding of the invention, and not as a limitation on the scope thereof, all numbers expressing quantities, percentages, and other numerical values used in this application are to be understood as being modified in all instances by the term "about". At the very least, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

The present invention is further illustrated by the following examples, which are not intended to limit the invention in any way.

The hericium erinaceus extract, the morchella esculenta extract, the bletilla striata extract and the fingered citron extract used in the application are all provided by Jiangxi Jiahe biological science and technology company Limited. Can also be prepared by the method of the preparation example of the invention.

Preparation example 1: hericium erinaceum extract

1) Taking dried hericium erinaceus, crushing, and sieving with a 120-mesh sieve to obtain dried hericium erinaceus powder;

2) adding Hericium erinaceus dry powder into deionized water, boiling for 30-45min, stirring, centrifuging, and separating supernatant a;

3) adding deionized water into the precipitate, boiling for 30-45min, stirring, centrifuging, and separating to obtain supernatant b;

4) mixing the supernatant a and the supernatant b, concentrating, and freeze-drying to obtain Hericium erinaceum extract.

Preparation example 2: morchella extract

1) Taking morchella esculenta, cleaning and drying the morchella esculenta, crushing the morchella esculenta, sieving the morchella esculenta with a 100-mesh sieve to obtain powder, adding 0.1-1% of 5' -phosphodiesterase solution by weight of the powder into the powder, carrying out enzymolysis for 2 hours at 50 ℃ under the condition that the pH value is 5-6, then carrying out enzyme deactivation treatment, and filtering to obtain a first morchella esculenta enzymolysis solution and a first filter residue;

2) adding papain solution 1-5% of the first filter residue, performing enzymolysis at 45 deg.C and pH 4.5-5.5 for 1.5 hr, inactivating enzyme, and filtering to obtain second enzymolysis solution of Morchella esculenta and second filter residue;

3) adding 0.1-0.5% of 5' -phosphodiesterase solution into the second filter residue, performing enzymolysis at 50-55 deg.C and pH 6-7 for 2 hr, inactivating enzyme, filtering to obtain a third enzymolysis solution of Morchella esculenta,

4) mixing the three enzymolysis solutions, and freeze drying to obtain Morchella esculenta extract.

Preparation example 3: and (3) common bletilla pseudobulb extract:

pulverizing rhizoma Bletillae crude product, sieving with 80-100 mesh sieve, weighing sieved rhizoma Bletillae powder, adding 8-10 times of 95% ethanol, reflux extracting for 3-5 times, each time for 0.5-1 hr, mixing extractive solutions, and freeze drying to obtain dry powder rhizoma Bletillae extract.

Preparation example 4: fingered citron extract:

1) soaking: taking dried fingered citron fruits, crushing the dried fingered citron fruits into powder by a traditional Chinese medicine crusher, taking 80% ethanol as an extraction solvent, and mixing the materials according to a material-liquid ratio of 1: 20, soaking for one week.

2) And (3) freeze drying: and (4) carrying out suction filtration on the soaked sample, taking out filtrate, and carrying out freeze drying to obtain the fingered citron extract.

Example 1: composition comprising a metal oxide and a metal oxide

The method comprises the following steps:

components	Number of parts	Remarks for note
			Hericium erinaceum extract	60 portions of	Preparation example 1
Morchella extract	50 portions of	Preparation example 2
			Bletilla striata extract	40 portions of	Preparation example 3
Extract of finger citron	30 portions of	Preparation example 4
			Sea buckthorn oil	305 parts of	-
Beeswax (Cera flava)	22 portions of	-

Secondly, the preparation method comprises the following steps:

1) taking 60 parts of hericium erinaceus extract, 50 parts of morchella esculenta extract, 40 parts of rhizoma bletillae extract and 30 parts of fingered citron extract according to weight parts, and uniformly mixing for later use.

2) Heating to prepare the soft capsule wall material, wherein the raw materials comprise gelatin, glycerol and water.

3) Uniformly mixing the traditional Chinese medicine powder obtained in the step 1), 305 parts of seabuckthorn oil and 22 parts of beeswax.

4) Pressing the soft capsules: the weight of the core material in each soft capsule is 0.2g, and the traditional Chinese medicine soft capsule is prepared.

Example 2: composition comprising a metal oxide and a metal oxide

The method comprises the following steps:

components	Number of parts	Remarks for note
			Hericium erinaceum extract	50 portions of	Jianxi Jiahe biology
Morchella extract	40 portions of	Jianxi Jiahe biology
			Bletilla striata extract	30 portions of	Jianxi Jiahe biology
Extract of finger citron	20 portions of	Jianxi Jiahe biology
			Sea buckthorn oil	260 portions of	-
Beeswax (Cera flava)	10 portions of	-

Secondly, the preparation method comprises the following steps:

1) respectively taking 50 parts of hericium erinaceus extract, 40 parts of morchella esculenta extract, 30 parts of rhizoma bletillae extract and 20 parts of fingered citron extract according to weight, and uniformly mixing for later use.

2) Heating to prepare a capsule wall material, wherein the raw materials comprise gelatin, glycerol and water; .

3) Uniformly mixing the traditional Chinese medicine powder obtained in the step 1), 260 parts of seabuckthorn oil and 10 parts of beeswax.

Example 3: composition comprising a metal oxide and a metal oxide

The method comprises the following steps:

components	Number of parts	Remarks for note
			Hericium erinaceum extract	60 portions of	Preparation example 1
Morchella extract	48 portions of	Preparation example 2
			Bletilla striata extract	42 portions of	Preparation example 3
Extract of finger citron	30 portions of	Preparation example 4
			Sea buckthorn oil	298 parts by weight	-
Beeswax (Cera flava)	22 portions of	-

Secondly, the preparation method comprises the following steps:

1) taking 60 parts of hericium erinaceus extract, 48 parts of morchella esculenta extract, 42 parts of rhizoma bletillae extract and 30 parts of fingered citron extract according to weight, and uniformly mixing for later use.

3) Mixing the traditional Chinese medicine powder obtained in the step 1) with 298 parts of seabuckthorn oil and 22 parts of beeswax uniformly.

4) Pressing the soft capsules: the weight of the core material in each soft capsule is 0.3g, and the traditional Chinese medicine soft capsule is prepared.

Example 4: composition comprising a metal oxide and a metal oxide

The method comprises the following steps:

components	Number of parts	Remarks for note
			Hericium erinaceum extract	60 portions of	Preparation example 1
Morchella extract	53 portions of	Preparation example 2
			Bletilla striata extract	37 portions of	Preparation example 3
Extract of finger citron	28 portions of	Preparation example 4
			Sea buckthorn oil	302 portions of	-
Beeswax (Cera flava)	20 portions of	-

Secondly, the preparation method comprises the following steps:

1) taking 60 parts of hericium erinaceus extract, 53 parts of morchella esculenta extract, 37 parts of rhizoma bletillae extract and 28 parts of fingered citron extract according to weight, and uniformly mixing for later use.

3) Uniformly mixing the traditional Chinese medicine powder obtained in the step 1), 302 parts of seabuckthorn oil and 20 parts of beeswax.

4) Pressing the soft capsules: the weight of the core material in each soft capsule is 0.4g, and the traditional Chinese medicine soft capsule is prepared.

Example 5: composition comprising a metal oxide and a metal oxide

The method comprises the following steps:

components	Number of parts	Remarks for note
			Hericium erinaceum extract	58 portions of	Jianxi Jiahe biology
Morchella extract	53 portions of	Jianxi Jiahe biology
			Bletilla striata extract	43 portions of	Jianxi Jiahe biology
Extract of finger citron	28 portions of	Jianxi Jiahe biology
			Sea buckthorn oil	290 portions of	-
Beeswax (Cera flava)	23 portions of	-

Secondly, the preparation method comprises the following steps:

1) and uniformly mixing 58 parts of hericium erinaceus extract, 53 parts of morchella esculenta extract, 43 parts of rhizoma bletillae extract and 28 parts of fingered citron extract according to weight for later use.

3) Uniformly mixing the traditional Chinese medicine powder obtained in the step 1), 290 parts of seabuckthorn oil and 23 parts of beeswax.

4) Pressing the soft capsules: the weight of the core material in each soft capsule is 0.5g, and the traditional Chinese medicine soft capsule is prepared.

Example 6: composition comprising a metal oxide and a metal oxide

The method comprises the following steps:

components	Number of parts	Remarks for note
			Hericium erinaceum extract	62 portions of	Preparation example 1
Morchella extract	47 parts of	Preparation example 2
			Bletilla striata extract	37 portions of	Preparation example 3
Extract of finger citron	32 portions of	Preparation example 4
			Sea buckthorn oil	310 portions of	-
Beeswax (Cera flava)	17 portions of	-

Secondly, the preparation method comprises the following steps:

1) and uniformly mixing 62 parts of hericium erinaceus extract, 47 parts of morchella esculenta extract, 37 parts of rhizoma bletillae extract and 32 parts of fingered citron extract according to weight for later use.

3) Uniformly mixing the traditional Chinese medicine powder obtained in the step 1), 310 parts of seabuckthorn oil and 17 parts of beeswax.

Comparative example 1: composition comprising a metal oxide and a metal oxide

The method comprises the following steps:

components	Number of parts	Remarks for note
			Hericium erinaceum extract	60 portions of	Preparation example 1
Sea buckthorn oil	305 parts of	-
			Beeswax (Cera flava)	22 portions of	-

Secondly, the preparation method comprises the following steps: the same as in example 1.

Comparative example 2: composition comprising a metal oxide and a metal oxide

The method comprises the following steps:

components	Number of parts	Remarks for note
			Hericium erinaceum extract	60 portions of	Preparation example 1
Morchella extract	50 portions of	Preparation example 2
			Sea buckthorn oil	305 parts of	-
Beeswax (Cera flava)	22 portions of	-

Comparative example 3: composition comprising a metal oxide and a metal oxide

The method comprises the following steps:

components	Number of parts	Remarks for note
			Hericium erinaceum extract	60 portions of	Preparation example 1
Bletilla striata extract	40 portions of	Preparation example 3
			Extract of finger citron	30 portions of	Preparation example 4
Sea buckthorn oil	305 parts of	-
			Beeswax (Cera flava)	22 portions of	-

Example 7: evaluation of protective action of composition of the present invention on alcohol-induced gastric mucosal injury

1. Materials and methods

1.1 test substance: the compositions of examples 1-6, the hericium erinaceus extract of comparative example 1, and the compositions of comparative examples 2-3.

1.2 Experimental animals: SPF grade SD rats, male, weighing 180-.

1.3 Experimental methods: alcohol model adopting acute gastric mucosa injury

Dose grouping and test sample administration time: experiments were carried out by feeding 10 animals each of 11 groups of examples 1 to 6, comparative examples 1 to 3, blank control group and model control group with gavage volume of l.0ml/100g for 30 consecutive days, and feeding equal volume of physiological saline to the blank control group and the model control group.

1.3.2 Experimental procedures: after 30 days of gastric lavage of each group, all animals were strictly fasted for 24h (without water deprivation) and were not given test substances, except for the blank control group, all animals of the test groups were given 1.0 ml/animal of absolute ethanol, the animals were sacrificed after 1h, the intact stomach was exposed, the pylorus was ligated, an appropriate amount of 10% formaldehyde solution was perfused, fixed for 20min, then cut open along the greater curvature of the stomach, the stomach contents were washed, the gastric mucosa was developed, and the length and width of the bleeding spot or the bleeding band were measured with a vernier caliper. The scoring criteria were: the score for gastric injury is the number of bleeding points + length of the bleeding zone + width of the bleeding zone x 2 (double score because the severity of the injury represented by the width is much greater than the length).

1.4 data processing: statistics are carried out by a pairwise comparison method of mean numbers between a plurality of experimental groups and a plurality of control groups.

2. As a result: the results are shown in Table 1.

Table 1: results of alcohol-induced gastric mucosal injury with the inventive compositions

Experimental group	Number of animals	Gastric injury scoring
			Blank control group	10	0.00±0.00
Model control group	10	27.73±5.59
			Example 1	10	15.73±5.66**^##
Example 2	10	15.12±5.00**^##
			Example 3	10	16.94±5.69**^#
Example 4	10	17.43±5.27**^#
			Example 5	10	18.45±6.34**^#
Example 6	10	18.47±5.02**^#
			Comparative example 1 group	10	22.92±6.99*
Comparative example 2 group	10	22.36±5.49*
			Comparative example 3 group	10	22.12±5.11*

Note: p < 0.05; p <0.01 compared to model control,

^#P<0.05，^##P<0.01, compared to comparative example 1.

And (4) conclusion: the effect of the pharmaceutical composition on protecting gastric mucosa injury is evaluated by an acute gastric mucosa injury model, and the result shows that compared with a model control group, the pharmaceutical composition provided by the invention can obviously reduce the gastric mucosa injury and has very obvious difference (P < 0.01); compared with the singly-used hericium erinaceus extract in the comparative example 1, the pharmaceutical composition provided by the invention can obviously reduce the damage of gastric mucosa, and has obvious difference (P <0.05) or very obvious difference (P < 0.01). The pharmaceutical composition provided by the invention has a protection effect on gastric mucosa injury, and the hericium erinaceus extract, the morchella esculenta extract, the bletilla striata extract, the fingered citron extract and the like have a synergistic effect, so that the gastric mucosa injury is remarkably reduced.

Example 8: human body test eating test

1. Test subjects: selecting a patient with superficial gastritis as a subject, and the diagnosis criteria are: prolonged course of disease, with different degrees of clinical symptoms such as dyspepsia, epigastric pain, heartburn, belching, acid regurgitation, abdominal distension, etc., and mild tenderness of the upper abdomen. The test subjects were randomly divided into the group of example 1 and the control group according to their symptoms, and the disease course, age, sex and other factors were considered in the grouping, and each group was designed by self-control and two groups of control. The number of the complete data at the end of the test is 103, wherein 51 of the drug composition groups of the invention and 52 of the control groups.

2. The test method comprises the following steps: the subjects were to maintain their daily life and eating habits during the test period, the pharmaceutical composition group of the present invention took the samples prepared in example 12 times a day, 3 times a day (0.5 g/capsule), and the control group took Weijiean capsule (bio-engineering limited, Junshan mountain Jinan, 2 times a day, 4 capsules a time), continuously for 1 month.

3. Evaluation index

3.1 symptom score: stomachache, belching, acid regurgitation, abdominal distension, inappetence, anorexia and other clinical symptoms. The score was counted according to the severity of the symptoms (3 points of severe, 2 points of moderate, 1 point of mild).

Grading table for severity of symptoms

4. Results

(1) The symptom score, the disease course, the age, the sex and the blood pressure of the medicine composition group have no significant difference with those of a control group, and the balance among the groups is comparable.

(2) The inquiry and investigation are carried out on the mental, sleep, diet and defecation conditions of the test eaters, and the general conditions before and after two groups of test foods have no significant difference.

(3) The symptom integral conditions of the pharmaceutical composition group and the control group before and after the test are shown in table 2, the integral conditions of the two groups before the test are not significantly different, the integral conditions of the pharmaceutical composition group and the control group after the test are significantly different (P is less than 0.05), the integral conditions of the pharmaceutical composition group and the control group before the test are significantly different (P is less than 0.05), and the integral reduction is significantly better than that of the control group.

Table 2: change of symptom score before and after test eating

Injecting; p<0.05, compared with before tasting;^#P<0.05, compared to the control group.

Claims

1. A composition with a gastric mucosa injury protection effect comprises the following components in parts by weight:

2. The composition according to claim 1, characterized by consisting of, in parts by weight:

。

3. The composition according to claim 1, characterized by consisting of, in parts by weight:

。

4. The composition according to claim 1, characterized by consisting of, in parts by weight:

5. the composition as claimed in claim 1, wherein the composition is in the form of tablet, granule, hard capsule, soft capsule, tablet, powder, pill, or oral liquid.

6. The composition as claimed in claim 1, wherein the composition is in the form of a soft capsule.

7. A method for preparing the composition with the effect of protecting gastric mucosa from injury according to claim 5 or 6, comprising the following steps:

1) respectively taking 50-70 parts of hericium erinaceus extract, 40-60 parts of morchella esculenta extract, 30-50 parts of bletilla extract and 20-40 parts of fingered citron extract according to weight, and uniformly mixing for later use;

2) heating to prepare a capsule wall material, wherein the raw materials comprise gelatin, glycerol and water;

3) uniformly mixing the traditional Chinese medicine powder obtained in the step 1), 340 parts of seabuckthorn oil 260-22 parts and 10-30 parts of beeswax;

8. The process according to claim 7, wherein in the step 4), the weight of the core material in each soft capsule is preferably 0.2 g.