CN112220885B - Traditional Chinese medicine composition for protecting gastric mucosa and preparation method and application thereof - Google Patents

Traditional Chinese medicine composition for protecting gastric mucosa and preparation method and application thereof Download PDF

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CN112220885B
CN112220885B CN202011292450.4A CN202011292450A CN112220885B CN 112220885 B CN112220885 B CN 112220885B CN 202011292450 A CN202011292450 A CN 202011292450A CN 112220885 B CN112220885 B CN 112220885B
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陈小波
宋仲华
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Ssmei High Tech Wuhan Co ltd
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Abstract

The invention discloses a traditional Chinese medicine composition for protecting gastric mucosa, and a preparation method and application thereof, wherein the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 30-50 parts of kudzu root, 10-20 parts of rhizoma polygonati, 100-200 parts of sesame oil, 100-200 parts of sea buckthorn seed oil, 4-10 parts of hericium erinaceus, 3-5 parts of chitosan oligosaccharide and 5-10 parts of beeswax, wherein the mass ratio of the sesame oil to the sea buckthorn seed oil is 1:0.5 to 3. The invention takes the kudzu root and the sealwort as main components, adds the sesame oil and the sea-buckthorn seed oil with a certain proportion to extract the total flavone, and adds the hericium erinaceus, the chitosan oligosaccharide and the beeswax as auxiliary materials to perform synergistic cooperation to prepare the oil mixture, thereby obviously improving the absorption and utilization rate and effectively protecting the gastric mucosa. The traditional Chinese medicine composition is prepared into a soft capsule preparation, and the kudzu root is taken as one of the components of the soft capsule rubber, so that the protection effect on gastric mucosa can be further improved.

Description

Traditional Chinese medicine composition for protecting gastric mucosa and preparation method and application thereof
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for protecting gastric mucosa and a preparation method and application thereof.
Background
The gastric mucosa is a layer of mucosal tissue existing on the inner wall of the stomach, and has a special protection effect on the gastric wall, but the gastric mucosa is very fragile, and the damage and self-repair of the gastric mucosa are always in dynamic balance to maintain the normal operation of the stomach, but the stimulation given from the outside is too strong, so that the aggressive factors and the protective/defensive factors of the gastric mucosa are out of balance, and the gastric mucosa is damaged. Once damaged, the gastric mucosa is difficult to recover, which in turn leads to a series of symptoms of gastric upset, such as epigastric discomfort or pain, nausea, vomiting, diarrhea, loss of appetite, etc. With the acceleration of life rhythm, the stomach diseases caused by the damage of the gastric mucosa are more and more at present, so that a medicine capable of protecting the gastric mucosa with high efficiency and no side effect is urgently needed.
The common dosage form of the medicine is a soft capsule dosage form, the active ingredients in the common soft capsule are orally taken to enter the stomach, all substances absorbed by the small intestine must enter the portal vein to the liver through stomach digestion, after being treated by the liver, the substances are released to the whole body, a lot of nutrition is transported after being utilized by the liver, the active ingredients are modified and transformed by the liver, and the treatment effect is deteriorated due to the reduction of the concentration. The effective components of the oil-mixed soft capsule can be quickly absorbed from mucosa above the stomach in a molecular form, enter blood circulation and participate in cellular metabolism, so that the effective components in the medicine can quickly enter the circulation, the functions and the effects of the medicine can be better exerted, and the absorption and utilization efficiency of the medicine is improved.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for protecting gastric mucosa and a preparation method and application thereof, wherein kudzu root and rhizoma polygonati are used as main components, sesame oil and sea buckthorn seed oil in a certain proportion are added, so that the total flavone in the medicine is effectively extracted, the absorption and utilization efficiency of the medicine is improved, and hericium erinaceus, chitosan oligosaccharide and beeswax which are auxiliary materials are added to cooperate with the extract, so that the gastric mucosa can be effectively protected; making into soft capsule, and adding radix Puerariae into the capsule shell to further improve the protection effect on gastric mucosa.
In order to achieve the purpose, the invention adopts the technical scheme that:
a traditional Chinese medicine composition for protecting gastric mucosa comprises the following raw materials in parts by weight: 30-50 parts of kudzu root, 10-20 parts of rhizoma polygonati, 100-200 parts of sesame oil, 100-200 parts of sea buckthorn seed oil, 4-10 parts of hericium erinaceus, 3-5 parts of chitosan oligosaccharide and 5-10 parts of beeswax, wherein the mass ratio of the sesame oil to the sea buckthorn seed oil is 1:0.5 to 3.
Pueraria lobata (Willd.) Ohwi), pueraria thomsonii and Pueraria thomsonii of LeguminosaePueraria lobata （Willd.） OhwiThe dried root of (4); sweet, pungent and cool in nature and taste; mainly used for relieving muscles and allaying fever, promoting the production of body fluid, promoting eruption, invigorating yang and relieving diarrhea. Can be used for treating fever, headache, stiffness and pain of neck and back, thirst, diabetes, measles without adequate eruption, dysentery, and diarrhea; high blood pressure and neck pain.
Rhizoma Polygonati, named as Laticauda gleditsiae, is Polygonatum kingianum of LiliaceaePolygonatum kingianum Coll.et Hemsl.Or rhizoma PolygonatiPolygonatum sibiricum Red.The dried roots and stems of the Chinese medicinal herbs are called "rheum officinale essence", "polygonatum kingianum" and "polygonatum zingiberense" according to different shapes; sweet and mild in nature and taste; spleen, lung and kidney meridians; has effects in invigorating qi, nourishing yin, invigorating spleen, moistening lung, and invigorating kidney; can be used for treating weakness of spleen and stomach, asthenia, xerostomia, anorexia, lung deficiency, cough, essence and blood deficiency, and internal heat diabetes; has antibacterial and blood pressure lowering effects.
Sesame oil, called sesame oil and sesame oil, contains about 40% of unsaturated fatty acids such as linoleic acid and palmitic acid, is easily decomposed, absorbed and utilized by human bodies, and also contains protein, sesamin, sesamol, vitamin E, lecithin, sucrose, calcium, phosphorus, iron and the like, so that the sesame oil is edible oil with rich nutrition.
The sea-buckthorn has a long medicinal history, the sea-buckthorn oil is divided into sea-buckthorn seed oil and sea-buckthorn fruit oil according to different sources, wherein the sea-buckthorn seed oil contains rich unsaturated fatty acid, tocopherol, beta-carotenoid and sterol substances and has a protective effect on cardiovascular and cerebrovascular diseases and gastrointestinal tracts, the beta-sitosterol-beta-D-glucoside in the sea-buckthorn seed oil is an effective component for resisting gastric ulcer, can effectively protect gastric mucosa and inhibit gastric acid secretion, so that the damage degree of the gastric mucosa is reduced, and meanwhile, the sea-buckthorn seed oil has the effects of resisting inflammation, promoting tissue regeneration, promoting ulcer healing, resisting oxidation, enhancing immunity and the like.
Hericium erinaceus, also known as Hericium erinaceus, hericium erinaceus and Cauliflower fungi, is a large fungus, has high nutritive value, contains 16 amino acids, 7 of which are essential amino acids for human body, and has certain medicinal effects in bacteriostasis, gastrointestinal protection, antioxidation, antitumor, preventing neurodegenerative diseases, protecting cardiovascular system, anti-fatigue, anti-depression and the like.
Chitosan oligosaccharide is a natural cationic compound in nature, and is widely applied to various fields of food, medicine, agriculture, environment and the like due to the characteristics of good water solubility, high biological activity, easy absorption and the like. As a sixth vital factor necessary for human body, the chitosan oligosaccharide has the functions of three regulation (regulating immunity, pH value and hormone), three reduction (reducing blood fat, blood sugar and blood pressure), three rows (discharging cholesterol, heavy metal ions and toxin), three inhibition (inhibiting cancer cells, inhibiting cancer cell metastasis and inhibiting cancer toxin), and is also an activating factor of intestinal probiotics (such as bifidobacterium).
Beeswax which is an insect belonging to the family Apidae, apis ceranaApis cerana FahriciusOr Italian beesApis mellifera Linna.eusThe secreted wax is prepared by heating nidus Vespae in water, filtering, condensing to obtain wax or refining. Mainly treats dysentery with pus and blood, burn and scald and various sores, and has the functions of removing active ammonia, inhibiting bacteria and preventing corrosion.
Further, the mass ratio of the sesame oil to the sea buckthorn seed oil is 1:1.
further, 50 parts of kudzuvine root, 20 parts of rhizoma polygonati, 200 parts of sesame oil, 200 parts of sea buckthorn seed oil, 8 parts of hericium erinaceus, 4 parts of chitosan oligosaccharide and 6 parts of beeswax.
Further, the traditional Chinese medicine composition is in a soft capsule dosage form, and a rubber sheet of the soft capsule is prepared from the following raw materials in parts by weight: 80 to 120 portions of gelatin, 30 to 55 portions of glycerol, 80 to 120 portions of pure water, 8 to 12 portions of kudzu root, 5 to 10 portions of titanium dioxide and 3 to 5 portions of cocoa shell pigment.
The invention also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
step 1, crushing and mixing radix puerariae and rhizoma polygonati, adding water to dissolve the mixture, and adding sesame oil and sea buckthorn seed oil;
step 2, heating to 120-130 ℃ while stirring; stopping heating, continuously stirring until the temperature is reduced to 100 ℃, standing and extracting overnight;
step 3, distilling under reduced pressure to remove water, sequentially adding hericium erinaceus, chitosan oligosaccharide and beeswax, and continuously stirring for 1-2 hours;
and 4, introducing nitrogen into the mixture obtained in the step 3 to exhaust air, and homogenizing and emulsifying by using a colloid mill to obtain the traditional Chinese medicine composition.
The invention also provides a preparation method of the soft capsule of the traditional Chinese medicine composition, which comprises the following steps:
(1) Preparing a rubber sheet: mixing radix Puerariae and pure water, heating to 70-80 deg.C, stirring thoroughly, decocting for 1-2 hr, cooling to room temperature, and filtering to obtain radix Puerariae water solution; mixing radix Puerariae aqueous solution with glycerol, titanium dioxide and cacao shell pigment, heating to 50-60 deg.C, adding gelatin, and heating to 65-75 deg.C until gelatin is completely dissolved; then vacuumizing to-0.06-0.08 Mpa, and keeping for 10-30min until the viscosity of the glue solution mixture is 1.5 × 10 4 -3.0×10 4 mPa.s; filtering, and standing at 50-60 deg.C for 2 hr to obtain the rubber sheet;
(2) Preparation of the contents: the traditional Chinese medicine composition obtained by the preparation method of the traditional Chinese medicine composition is the content;
(3) Preparing the Chinese medicinal composition soft capsule: placing the rubber and the content in a soft capsule forming machine, pressing into soft capsule preparation with thickness of 0.6-0.85mm, shaping, and air drying until the water content of the rubber is 6.0% -11.0%, to obtain the Chinese medicinal composition soft capsule.
Further, in the preparation process of the Chinese medicinal composition soft capsule, the rotating speed of a soft capsule forming machine is 2.0-4.0 r/min, and the temperature is controlled to be 37-45 ℃.
The invention also provides application of the traditional Chinese medicine composition in preparation of gastric mucosa protective agents.
Compared with the prior art, the invention has the beneficial effects that:
(1) The invention takes the kudzu root and the sealwort as main components, adds a certain amount of sesame oil and seabuckthorn seed oil to extract the total flavonoids of the effective components in the kudzu root and the sealwort, and adds the auxiliary materials of hericium erinaceus, chitosan oligosaccharide, beeswax to be matched with the extract to prepare the oil mixture, thereby obviously improving the absorption and utilization efficiency of the effective components by human body, further effectively protecting gastric mucosa and avoiding the damage of external stimulation or gastric acid to the gastric mucosa;
(2) The invention finds that the ratio of the sesame oil to the sea buckthorn seed oil in the traditional Chinese medicine composition has influence on the extraction amount of the total flavonoids, and the extraction amount of the total flavonoids can be obviously improved by adjusting the ratio of the sesame oil to the sea buckthorn seed oil, so that the protection effect of the prepared traditional Chinese medicine composition on gastric mucosa is effectively improved;
(3) The invention prepares the traditional Chinese medicine composition into the soft capsule preparation to obtain the oil-mixed soft capsule, which not only can improve the absorption utilization rate of organisms, but also takes the kudzuvine root as one of the components of the soft capsule rubber to further improve the protection effect on gastric mucosa;
(4) The preparation method is simple and quick, is suitable for large-scale production, and all the operation steps are finished in 10 ten thousand sterile production workshops, thereby meeting GMP regulations.
Detailed Description
The technical solutions of the present invention will be described clearly and completely with reference to the following embodiments of the present invention, and it should be understood that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1 optimization of sesame oil and sea buckthorn seed oil mass ratio
In this embodiment, the mass ratio of the sesame oil to the sea buckthorn seed oil in the components is mainly optimized to obtain the optimal total flavone extraction amount, which is specifically as follows:
pulverizing 50g radix Puerariae and 20g rhizoma Polygonati into 100 mesh powder, adding appropriate amount of water to dissolve, and adding 400g oleum Sesami and oleum Hippophae mixture. Mixing, heating to 120 deg.C under stirring, stopping heating, and stirring, wherein the effective components in radix Puerariae and rhizoma Polygonati can be accelerated to enter solvent to increase the extraction rate of effective components. Stopping stirring when the temperature of the mixture is reduced to 100 ℃, standing overnight for full extraction, and then distilling the extract under reduced pressure to remove water in the mixture to obtain a concentrated solution, wherein the mass ratio of the sesame oil and the sea buckthorn seed oil is shown in the following table:
group of Sesame oil: sea-buckthorn seed oil (quality ratio)
Group 1 1：0.3
Group 2 1：0.5
Group 3 1：1
Group 4 1：2
Group 5 1：3
Group 6 1：4
The concentrated solutions obtained from the above 6 groups were taken, respectively, and a standard curve was prepared using rutin as a standard substance by spectrophotometry, and the content of total flavonoids (mg/100 g, i.e., the content of total flavonoids extracted from 100g of raw materials) in the concentrated solutions of the 6 groups was measured, with the results shown in table 1.
TABLE 1 measurement results of total flavone extraction amount
Group of Total Flavonoids extraction amount (mg/100 g)
Group 1 23.43
Group 2 42.15
Group 3 60.57
Group 4 55.61
Group 5 48.77
Group 6 37.41
According to the determination results in table 1, when the sesame oil and the seabuckthorn seed oil are used for extracting the total flavone content in the kudzuvine root and the siberian solomonseal rhizome, the mass ratio of the sesame oil to the seabuckthorn seed oil has certain influence on the extraction effect. The total flavone (in terms of rutin) can inhibit freezing-constraint stress and gastric mucosa injury caused by acidic ethanol, and can also increase H 2 Cimi as receptor blocking agentThe protective effect of the tiudinate on gastric mucosa. Therefore, the group with the highest extraction efficiency of the total flavonoids is preferred, namely when the mass ratio of the sesame oil to the sea buckthorn seed oil is 1:1, the extraction efficiency of the total flavonoids in the kudzuvine root and the rhizoma polygonati is the highest.
Example 2
The embodiment provides a traditional Chinese medicine composition for protecting gastric mucosa, which comprises the following components: 50g of kudzuvine root, 20g of rhizoma polygonati, 200g of sesame oil, 200g of sea-buckthorn seed oil, 8g of hericium erinaceus, 4g of chitosan oligosaccharide and 6g of beeswax.
Also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
step 1, weighing a certain amount of kudzu root and rhizoma polygonati according to a formula, crushing and mixing the kudzu root and the rhizoma polygonati with 100 meshes, adding a proper amount of water to dissolve the mixture, and adding sesame oil and sea buckthorn seed oil according to the formula;
step 2, continuously stirring and heating, stopping heating and continuously stirring after the temperature is raised to 120-130 ℃ to accelerate the effective components in the radix puerariae and the rhizoma polygonati to enter the sesame oil and the sea buckthorn seed oil, stopping stirring and standing for overnight extraction when the temperature is lowered to 100 ℃, so that the effective components in the radix puerariae and the rhizoma polygonati are extracted into the sesame oil and the sea buckthorn seed oil;
step 3, distilling under reduced pressure after extraction, removing water in the mixture, then pouring into a mixing tank, sequentially adding hericium erinaceus, chitosan oligosaccharide and beeswax according to the formula amount, and continuously stirring for 1-2 hours;
and 4, directly inserting nitrogen into the mixing tank to exhaust air in the mixture, cooling, discharging the material, homogenizing by a colloid mill, and emulsifying to obtain the traditional Chinese medicine composition.
Example 3
The present embodiment is different from embodiment 2 in that: the traditional Chinese medicine composition of the embodiment comprises: 30g of kudzuvine root, 10g of rhizoma polygonati, 100g of sesame oil, 100g of sea-buckthorn seed oil, 4g of hericium erinaceus, 3g of chitosan oligosaccharide and 5g of beeswax.
Example 4
The present embodiment is different from embodiment 2 in that: the traditional Chinese medicine composition comprises: 50g of kudzuvine root, 20g of rhizoma polygonati, 150g of sesame oil, 150g of sea-buckthorn seed oil, 10g of hericium erinaceus, 5g of chitosan oligosaccharide and 10g of beeswax.
Example 5
The present embodiment is different from embodiment 2 in that: the traditional Chinese medicine composition described in the embodiment 2 is prepared into a soft capsule dosage form, wherein the capsule shell is: 100g of gelatin, 45g of glycerol, 100g of pure water, 10g of kudzu root, 8g of titanium dioxide and 4g of cocoa shell pigment, and the specific preparation method comprises the following steps:
(1) Preparing a rubber sheet: (1) pulverizing 10g radix Puerariae, mixing with 100g pure water, heating to 70-80 deg.C, decocting for 1-2 hr, stirring, filtering to remove residue to obtain radix Puerariae water solution;
(2) putting 45g of glycerol and the radix puerariae aqueous solution obtained in the step (1) into a gelatin melting tank, adding 8g of titanium dioxide and 4g of cocoa shell pigment, heating to 50-60 ℃, then putting 100g of gelatin, continuously heating to 65-75 ℃, and dissolving the gelatin for 40-60min until the gelatin is completely dissolved;
(3) vacuumizing the mixed material obtained in the step (2) until the vacuum degree is-0.07 Mpa, and keeping for 10-30min until the viscosity of the mixed material is 2.0 multiplied by 10 4 mPa & s, filtering the mixture by a 120-mesh filter bag, and standing the mixture for 2 hours at the temperature of between 50 and 60 ℃ to obtain the rubber for later use;
(2) Preparation of the contents: the Chinese medicinal composition obtained according to the method of example 2 is the content.
(3) Preparing the Chinese medicinal composition soft capsule: pressing the prepared content and the rubber into soft capsules in a soft capsule forming machine, keeping the rotating speed at 2.0-4.0 r/min, keeping the spraying temperature at 37-45 ℃, and keeping the thickness of the rubber at 0.60-0.85 mm; shaping the pressed soft capsule for 2.5-5 hours, and drying by ventilation until the water content of the capsule shell is 6.0-11.0 percent, thus obtaining the soft capsule of the traditional Chinese medicine composition.
The preparation process comprises the steps of weighing, preparing rubber, preparing contents, pelleting, shaping and drying at the temperature of 25 +/-2 ℃; the humidity is 45% +/-5%, and the process is finished in a 10 ten thousand sterile workshop which meets GMP regulations.
The gelatin skin contains flavone extracted from radix Puerariae, the flavone in the gelatin skin cooperates with flavone, vitamins, beta-sitosterol-beta-D-glucoside, linoleic acid, oleic acid and other substances in contents, so that the protection of gastric mucosa can be enhanced, the gastrointestinal mucosa can be prevented from being damaged by various irritant foods and gastric acid, and sterol and lipid components can form a reticular protective layer with gastric juice to protect the gastric mucosa and promote gastrointestinal absorption.
Comparative example 1
This comparative example differs from example 2 in that: the traditional Chinese medicine composition does not contain sesame oil and sea buckthorn seed oil, and flavone in the kudzuvine root and the rhizoma polygonati is extracted by water only, namely the composition specifically comprises the following components: 50g of kudzuvine root, 20g of rhizoma polygonati, 400g of pure water, 8g of hericium erinaceus, 4g of chitosan oligosaccharide and 6g of beeswax, and the preparation method comprises the following steps:
step 1, weighing radix puerariae and rhizoma polygonati according to a formula, crushing by 100 meshes, mixing, and adding 300g of pure water for dissolving;
step 2, continuously stirring and heating, stopping heating and continuously stirring after the temperature is raised to 120-130 ℃, and stopping stirring and standing overnight when the temperature is lowered to 100 ℃;
step 3, pouring the aqueous solution obtained in the step 2 into a mixing tank, sequentially adding hericium erinaceus, chitosan oligosaccharide and beeswax according to the formula amount, and continuously stirring for 1-2 hours;
and 4, directly inserting nitrogen into the mixing tank to exhaust air in the mixture, cooling, discharging the material, and homogenizing by using a colloid mill to obtain the traditional Chinese medicine composition.
Comparative example 2
The comparative example differs from example 2 in that: the present comparative example provides a traditional Chinese medicine composition comprising: 50g of kudzuvine root, 20g of rhizoma polygonati, 200g of sesame oil, 200g of sea-buckthorn seed oil, 3g of hericium erinaceus, 2g of chitosan oligosaccharide and 4g of beeswax.
Comparative example 3
This comparative example differs from example 2 in that: the present comparative example provides a traditional Chinese medicine composition comprising: 50g of kudzuvine root, 20g of rhizoma polygonati, 200g of sesame oil, 200g of sea-buckthorn seed oil, 12g of hericium erinaceus, 6g of chitosan oligosaccharide and 12g of beeswax.
Evaluation protocol
Animal experiments are carried out by respectively detecting the traditional Chinese medicine composition or the traditional Chinese medicine composition soft capsule obtained in the examples 2-5 and the comparative examples 1-3 to verify the protective effect of the soft capsule on a rat model with gastric mucosa injury caused by inflammation pain and a rat model with gastric mucosa injury caused by absolute ethyl alcohol, and the method comprises the following specific steps:
(1) Wistar rats weighing 220-240g and half of male and female are randomly grouped, after fasting and water prohibition for 48 hours, the traditional Chinese medicine composition or the traditional Chinese medicine composition soft capsule prepared in the examples 2-5 and the comparative examples 1-3 are respectively used for intragastric administration, the dosage is 2 mL/mouse, the intragastric administration with equal volume of water is used as a control group, after 30 minutes, the indomethacin is injected into the abdominal cavity for 20 mg/kg, after 4.5 hours, the rats are killed, the stomach is taken out, the rats are filled with 10mL of water, fixed in 1% formaldehyde solution, after 30 minutes, the stomach is cut open, and the number of gastric mucosal ulcers is counted, and the results are shown in Table 2.
(2) Wistar rats weighing 220-240g and half of males and females are randomly grouped, after fasting and water prohibition for 48h, the traditional Chinese medicine composition or the traditional Chinese medicine composition soft capsule prepared in the examples 2-5 and the comparative examples 1-3 are respectively used for intragastric administration, the dosage is 2 mL/mouse, the intragastric administration with equal volume of water is used as a control group, 1.0 mL/mouse of absolute ethyl alcohol is given after 2h, the animals are sacrificed after 1h, the stomach is taken out, the animals are filled with 10mL of water, fixed in 1% formaldehyde solution, the stomach is cut open after 30min, and the number of gastric mucosal ulcers is counted, and the results are shown in Table 3.
TABLE 2 Effect on rats model of gastric mucosal injury due to Inflammatory pain
Group of Animal number (only) Dosage (ml/dose) Ulcer number (X + -S D)
Control group 10 2 (Water) 24.3 ±9.2
Example 2 10 2 9.6 ±3.2＊＊＊
Example 3 10 2 12.7 ±4.3＊＊＊
Example 4 10 2 10.3 ±3.5＊＊＊
Example 5 10 2 8.5±2.1＊＊＊
Comparative example 1 10 2 20.1±8.5
Comparative example 2 10 2 17.8±6.5＊＊
Comparative example 3 10 2 15.4±5.1＊＊
Note: in the above table ＊＊＊ Shows a very significant difference from the control group (P＜0.01）， ＊＊ Shows significant difference from the control group (P＜0.05）.
TABLE 3 Effect on Anhydrous ethanol-induced gastric mucosal injury rat model
Group of Animal number (only) Dosage (ml/dose) Ulcer number (X + -S D)
Control group 10 2 (Water) 67.8 ±35.5
Example 2 10 2 14.3±6.3＊＊＊
Example 3 10 2 23.7±10.2＊＊＊
Example 4 10 2 19.5±9.4＊＊＊
Example 5 10 2 7.7±2.5＊＊＊
Comparative example 1 10 2 58.9 ±27.7
Comparative example 2 10 2 39.3±18.9＊＊
Comparative example 3 10 2 32.1±16.1＊＊
Note: in the above table ＊＊＊ Shows a very significant difference from the control group (P＜0.01）， ＊＊ Shows significant difference from the control group (P＜0.05）
Combining the determination results in tables 2 and 3, comparative example 1 does not adopt sesame oil and sea buckthorn seed oil for extraction, but only water is used for extracting total flavonoids, so that the protective effect on the gastric mucosa of rats is poor, and the ulcer number is not different from that of a control group after the stimulation of indomethacin or absolute ethyl alcohol, and comparative examples 2-3 change the contents of the auxiliary materials of hericium erinaceus, chitosan oligosaccharide and beeswax compared with example 2, so that the synergistic effect among the components is weakened, therefore, compared with example 2, after the stimulation of comparative examples 2-3 by indomethacin or absolute ethyl alcohol, the ulcer number is increased, namely, the protective effect on the gastric mucosa is reduced, but the comparative examples are still significantly different from that of the control group. After the medicines in the embodiments 2 to 5 are given, the components exert synergistic interaction, and the protection effect on the gastric mucosa of the rat model is enhanced, so that compared with an anti-inflammatory pain gastric mucosa injury model or an absolute ethyl alcohol gastric mucosa injury model of a control group, the ulcer number of the rat stomach in the embodiments 2 to 5 is remarkably reduced, and further, after the traditional Chinese medicine composition soft capsule prepared in the embodiment 5 is given, the ulcer number is the least, namely the protection effect is the strongest.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are included in the scope of the present invention.

Claims (5)

1. The soft capsule for protecting gastric mucosa is characterized in that the content of the soft capsule is prepared from the following raw materials: 50g of kudzuvine root, 20g of rhizoma polygonati, 200g of sesame oil, 200g of sea buckthorn seed oil, 8g of hericium erinaceus, 4g of chitosan oligosaccharide and 6g of beeswax; the rubber of the soft capsule is prepared from the following raw materials: 100g of gelatin, 45g of glycerol, 100g of pure water, 10g of kudzu root, 8g of titanium dioxide and 4g of cocoa shell pigment; the contents were prepared as follows:
step 1, crushing and mixing radix puerariae and rhizoma polygonati, adding water for dissolving, and adding sesame oil and sea buckthorn seed oil;
step 2, heating to 120-130 ℃ while stirring, stopping heating, continuously stirring until the temperature is reduced to 100 ℃, standing and extracting overnight;
step 3, distilling under reduced pressure to remove water, sequentially adding hericium erinaceus, chitosan oligosaccharide and beeswax, and continuously stirring for 1-2 hours;
and 4, introducing nitrogen into the mixture obtained in the step 3 to exhaust air, and then homogenizing and emulsifying by using a colloid mill to obtain the content.
2. A process for the preparation of the soft capsules according to claim 1, wherein the contents are prepared as follows:
step 1, crushing and mixing radix puerariae and rhizoma polygonati, adding water for dissolving, and adding sesame oil and sea buckthorn seed oil;
step 2, heating to 120-130 ℃ while stirring, stopping heating, continuously stirring until the temperature is reduced to 100 ℃, standing and extracting overnight;
step 3, distilling under reduced pressure to remove water, sequentially adding hericium erinaceus, chitosan oligosaccharide and beeswax, and continuously stirring for 1-2h;
and 4, introducing nitrogen into the mixture obtained in the step 3 to exhaust air, and homogenizing and emulsifying by using a colloid mill to obtain the content.
3. A process for the preparation of the soft capsules according to claim 1, which comprises:
(1) Preparing a rubber sheet: mixing radix Puerariae and pure water, heating to 70-80 deg.C, stirring, decocting for 1-2 hr, cooling to room temperature, and filtering to obtain radix Puerariae water solution; mixing radix Puerariae aqueous solution, glycerol, titanium dioxide and cacao shell pigment, heating to 50-60 deg.C, adding gelatin, and heating to 65-75 deg.C until gelatin is completely dissolved; then vacuumizing to-0.06-0.08 Mpa, and keeping for 10-30min until the viscosity of the glue solution mixture is 1.5 × 10 4 -3.0×10 4 mPa.s; filtering, and standing at 50-60 deg.C for 2 hr to obtain the rubber sheet;
(2) Preparation of the contents: the method for preparing the content according to claim 1;
(3) Preparing the soft capsule: placing the rubber and the content in a soft capsule forming machine, pressing into soft capsule preparation with thickness of 0.6-0.85mm, shaping, and air drying until the water content of the rubber is 6.0% -11.0%, to obtain the soft capsule.
4. The process according to claim 3, wherein the rotation speed of the softgel forming machine is 2.0 to 4.0 rpm and the temperature is controlled to be 37 to 45 ℃ during the process of preparing the softgel.
5. The use of the soft capsule of claim 1 for the preparation of a medicament for protecting gastric mucosa.
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