Stomach medicine capsule and preparation method thereof

Abstract

The invention is suitable for the technical field of medicine, and provides a stomach medicine capsule and a preparation method thereof, the stomach medicine capsule is prepared from 20-30 parts of Chinese angelica, 7-11 parts of phoenix-tail fern, 15-19 parts of radix berberidis, 5-9 parts of radix aucklandiae, 2-4 parts of reed seed, 13-17 parts of sea snail and auxiliary materials; the preparation method comprises the steps of raw material pretreatment, ethanol reflux extraction, vacuum concentration, spray drying, mixing granulation, capsule filling and packaging. The traditional Chinese medicine raw materials in a specific proportion are screened, the synergistic effect of resisting inflammation and bacteria, regulating qi to relieve pain, nourishing blood and repairing, and relieving acid and protecting the stomach is achieved, and the problems that an existing stomach medicine is single in effect and large in side effect are solved; meanwhile, extraction and drying processes are optimized, the dissolution rate of effective components and the stability of the preparation are improved, and the traditional Chinese medicine composition is suitable for treating stomach diseases such as acute and chronic gastritis, gastric ulcer and hyperacidity, high in safety and suitable for long-term administration.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, and in particular to a stomach medicine capsule and its preparation method. Background Technology

[0002] Stomach diseases are common digestive system diseases worldwide. The onset of stomach diseases is closely related to Helicobacter pylori infection, abnormal gastric acid secretion, damage to the gastric mucosal barrier, mental stress, and irregular diet. Clinical symptoms often include stomach pain, bloating, acid reflux, heartburn, and belching. Long-term and repeated attacks can easily lead to gastric bleeding, gastric perforation, and even gastric cancer, seriously affecting the patient's quality of life.

[0003] Currently, commonly used stomach medications in clinical practice are mainly divided into two categories: Western medicine and traditional Chinese medicine. In terms of Western medicine, proton pump inhibitors (such as omeprazole and rabeprazole) can quickly inhibit gastric acid secretion, but long-term use can easily lead to side effects such as vitamin B12 deficiency, osteoporosis, and intestinal flora imbalance. H2 receptor antagonists (such as ranitidine) have a slow onset of action and limited effectiveness in treating severe hyperacidity. Gastric mucosal protectants (such as sucralfate) require large doses, resulting in poor patient compliance. In terms of traditional Chinese medicine, existing stomach medicines mostly focus on a single effect. For example, "spleen-strengthening and stomach-nourishing" Chinese medicines, mainly composed of Astragalus membranaceus and Atractylodes macrocephala, have weak effects on inflammation caused by excessive stomach acid and Helicobacter pylori infection. "Heat-clearing and anti-inflammatory" Chinese medicines, mainly composed of Coptis chinensis and Scutellaria baicalensis, are prone to damaging stomach yang, leading to diarrhea and abdominal distension in patients with spleen and stomach deficiency. Moreover, most Chinese medicine stomach medicines use the traditional process of granulation after decoction, resulting in low extraction rates of effective ingredients (such as alkaloids, volatile oils, and flavonoids), slow disintegration of the preparation, and poor bioavailability, which cannot meet the clinical demand for "highly effective, safe, and long-lasting" stomach medicines.

[0004] Therefore, it is necessary to provide a gastric medicine capsule and its preparation method to address the current pain points in the treatment of gastric diseases. Summary of the Invention

[0005] This invention provides a stomach medicine capsule and its preparation method, aiming to develop a traditional Chinese medicine stomach medicine capsule that can take into account multiple effects such as "anti-inflammatory and antibacterial, regulating qi and relieving pain, nourishing blood and repairing, and neutralizing acid and protecting the stomach", and has a scientific preparation process, complete preservation of effective ingredients, and few side effects.

[0006] This invention is achieved by preparing a stomach medicine capsule from the following parts by weight of raw materials and excipients: Raw material composition: Angelica sinensis 20-30 parts, Pteris vittata 7-11 parts, three needles 15-19 parts, Costus root 5-9 parts, Phragmites communis 2-4 parts, sea snail 13-17 parts; Excipient components: The excipients are selected from one or more of microcrystalline cellulose, lactose, pregelatinized starch, magnesium stearate, and hydroxypropyl methylcellulose. The total amount of excipients added is 3%-8% of the total weight of the raw materials, of which the amount of magnesium stearate added is 0.3%-0.8% of the total weight of the raw materials. Among them, the Angelica sinensis is the dried root of Angelica sinensis, a plant of the Apiaceae family; the Pteris vittata is the dried whole herb of Pteris vittata, a plant of the Pteridaceae family; the three needles is the dried root of Pteris vittata, a plant of the Berberidaceae family; the costus root is the dried root of Costus root, a plant of the Asteraceae family; the asparagus seed is the dried fruit of Asparagus setaceus, a plant of the Piperaceae family; and the sea snail is the shell of the sea snail, an animal of the Salamander family. The capsule shell is made of hydroxypropyl methylcellulose, size 0 or 1; the contents completely disintegrate within 30 minutes in simulated gastric fluid; each capsule contains ≥1.2mg of berberine, ≥0.3mg of ferulic acid, and ≥0.5mg of piperine.

[0007] Preferably, the raw materials are in the following weight proportions: 25 parts Angelica sinensis, 9 parts Pteris vittata, 17 parts Clematis armandii, 7 parts Aucklandia lappa, 3 parts Phragmites communis, and 15 parts Sea snail.

[0008] Preferably, the excipients are composed of microcrystalline cellulose and magnesium stearate, with the amount of microcrystalline cellulose added being 5% of the total weight of the raw materials and the amount of magnesium stearate added being 0.5% of the total weight of the raw materials. Microcrystalline cellulose can improve the flowability and compressibility of the extract powder, avoiding the problem of "soft material sticking to the screen" during granulation. Magnesium stearate can reduce the friction between the granules and the capsule filling machine, ensuring that the weight difference of each capsule is controlled within ±5%.

[0009] Preferably, the capsule shell is a No. 0 hydroxypropyl methylcellulose capsule shell, and each capsule is filled with 0.3g of contents, with the weight difference controlled within ±5%. The hydroxypropyl methylcellulose capsule shell disintegrates in the stomach 10-15 minutes faster than the gelatin capsule shell, and is not easily affected by humidity and will stick together, making it suitable for long-term storage (the shelf life can reach 24 months under the conditions of 25℃ and 60% relative humidity).

[0010] Preferably, the particle size of the mixed and pulverized Angelica sinensis, Pteris vittata, Erythrina variegata, Saussurea costus, and Phragmites communis is 20-40 mesh, and the particle size of the pulverized sea snail is 60-100 mesh. The coarse powder of 20-40 mesh can avoid "gelatinization and clogging" during extraction, while ensuring that the solvent and raw materials are in full contact. The fine powder of sea snail of 60-100 mesh can be evenly mixed with the extract powder to avoid "layering" of the capsule contents.

[0011] This invention also proposes a method for preparing a gastric medicine capsule, which includes the following steps: S1. Raw material preparation: Weigh out the following ingredients by weight: Angelica sinensis, Pteris vittata, Smilax china, Costus root, Phragmites communis, and sea snail. Remove impurities and residual stems from Angelica sinensis. Split Smilax china into slices 1-2 cm thick. Cut Costus root into slices 0.5-1 cm thick. S2. Raw material pretreatment: Plant-based raw material processing: Angelica sinensis, Pteris vittata, three needles, Costus root, and Phragmites communis were quickly rinsed twice with deionized water (each rinse time ≤30 seconds to avoid loss of active ingredients), and then dried in a 60℃ vacuum drying oven (vacuum degree -0.06MPa) until the moisture content was ≤8% (detected using a rapid moisture analyzer); the dried five plant raw materials were then put into a universal pulverizer, mixed and pulverized into 30-mesh coarse powder, passed through a 30-mesh sieve, and the material passing through the sieve was reserved for use, while the material passing through the sieve was pulverized again to ensure a pulverization rate ≥98%; Animal raw material processing: Place the sea snail shells in a 120℃ forced-air drying oven for 2 hours to remove any remaining soft tissue inside the shells; after cooling to room temperature, put them into an ultra-fine pulverizer for pulverization. During the pulverization process, control the temperature inside the machine to ≤40℃ (to avoid high-temperature decomposition of calcium carbonate). After pulverization, pass through an 80-mesh sieve to obtain sea snail fine powder for later use. S3, Ethanol reflux extraction: First extraction: The 30-mesh plant powder obtained in step S2 was put into a multi-functional extraction vessel, and 8 times the amount of 70% ethanol solution (v / v, ethanol concentration determined by gas chromatography) was added. Stirring was started (60 r / min), and the mixture was heated to reflux (boiling point of solution 85-90℃). Reflux extraction was maintained for 2 hours. After extraction, the heating was turned off, and the mixture was filtered using a plate and frame filter (100 mesh filter cloth). The first extract was collected, and the filter residue was retained. Second extraction: Add 6 times the amount of 70% ethanol solution to the filter residue, turn on stirring and heating again, and reflux for 1.5 hours; after extraction, filter through a 100-mesh filter cloth and collect the second extract. Extraction purification: Combine the first and second extracts and filter under reduced pressure (vacuum degree -0.05MPa) using a 120-mesh filter cloth to remove fine particulate impurities from the extract, obtaining a clear extract for later use; S4, Reduced pressure concentration: The clarified extract was pumped into a double-effect vacuum concentration tank, and the vacuum degree was set to -0.085 MPa and the heating temperature to 60°C. The condenser was turned on (condenser temperature ≤15°C) and the concentration was carried out under reduced pressure. During the concentration process, the relative density of the extract was measured every 30 minutes (using the specific gravity bottle method, measured at 60°C). When the relative density reached 1.25-1.30, the concentration was stopped, and a thick extract was obtained. S5, Spray drying: The thick extract was pumped into the feed tank of a centrifugal spray dryer. The inlet air temperature was set to 190℃, the outlet air temperature to 85℃, the atomizer speed to 20000 r / min, and the atomization pressure to 0.3 MPa. Before drying, the spray dryer was preheated. After the inlet air temperature stabilized at 190℃, the feed pump was turned on, and the feed flow rate was controlled at 20 mL / min. During the drying process, the outlet air temperature was monitored in real time. If the outlet air temperature was lower than 80℃, the feed flow rate was reduced; if it was higher than 90℃, the feed flow rate was increased. The dried powder was collected by a cyclone separator and passed through an 80-mesh sieve to obtain dried extract powder (moisture content ≤3%), which was then set aside. S6. Mixed granulation: Mixing: Add the dried extract powder and the fine powder of sea snails into a three-dimensional motion mixer, set the speed to 15 r / min, mix for 30 minutes, and take a sample to test the mixing uniformity (determine the berberine content, RSD≤5% is qualified). To prepare the soft material: Add 5% microcrystalline cellulose (by total weight of the mixed powder) to the mixed powder and mix for 10 minutes. Then add 3% hydroxypropyl methylcellulose ethanol solution (binder, hydroxypropyl methylcellulose concentration 5%) while stirring until a soft material that can be formed "by hand into a ball and easily crumbles when squeezed" is formed. Granulation and Drying: The soft material is fed into a gyratory granulator and granulated using an 18-mesh sieve to obtain wet granules; the wet granules are spread evenly on a tray (thickness ≤ 2cm) and placed in a 50℃ forced-air drying oven for 2 hours, turning the granules every 30 minutes to avoid localized overheating; after drying, the moisture content of the granules is tested and controlled at 3%-5%; Granulation: The dried granules are granulated through a 16-mesh sieve to remove clumps and obtain uniform dry granules. S7, Capsule Filling: Add 0.5% magnesium stearate (by total weight of dry granules) to the dry granules and mix in a two-dimensional mixer for 15 minutes. Add the mixed granules to the hopper of a fully automatic capsule filling machine, set the filling weight to 0.3g / capsule, turn on the filling machine, and fill No. 0 hydroxypropyl methylcellulose capsule shells. During the filling process, randomly select 10 capsules every 10 minutes to check the weight difference and ensure that the weight difference is within ±5%. S8. Packaging Inspection: Quality inspection: The filled capsules are tested for appearance (no deflated capsules, powder leakage, or broken capsule shells), disintegration time (complete disintegration within 30 minutes in artificial gastric fluid), and microbial limits (bacterial count ≤1000 cfu / g, mold and yeast count ≤100 cfu / g, no Escherichia coli or Salmonella). Packaging: The qualified capsules are packaged using an aluminum-plastic blister packaging machine, with 12 capsules per blister pack and 10 blister packs per box. After packaging, they are stored in a cool and dry place (25℃, relative humidity ≤60%) to obtain the finished stomach medicine capsules.

[0012] Preferably, in step S3, the 70% ethanol solution is prepared by mixing pharmaceutical-grade anhydrous ethanol with purified water, and then filtering the mixture through a 0.45μm microporous membrane to remove impurities. During the first extraction, the pressure inside the extraction tank is controlled at 0.02MPa (slight positive pressure), which can shorten the ethanol boiling time and improve the extraction efficiency. The filter residue from the second extraction can be used to prepare dietary fiber from Chinese medicinal residues (which can be washed, dried, and pulverized as a food additive), thus realizing the comprehensive utilization of raw materials.

[0013] Preferably, in step S5, if the spray-dried extract powder absorbs moisture and clumps, it needs to be sieved through an 80-mesh sieve again and cannot be used directly for mixing; if the extract powder has poor flowability (angle of repose > 40°), 1% micronized silica gel (by weight of extract powder) can be added to improve flowability before mixing with the sea snail fine powder.

[0014] Compared with related technologies, the gastric medicine capsules and their preparation method provided by the present invention have the following beneficial effects: 1. Synergistic Efficacy, Treating Both Symptoms and Root Cause: The raw material combination of this invention has a clear synergistic effect—berberine and total flavonoids synergistically inhibit Helicobacter pylori and reduce gastric mucosal inflammation; costus root (volatile oil) and piperine synergistically regulate qi and relieve pain, alleviating bloating and stomach pain; ferulic acid promotes blood circulation in the gastric mucosa and accelerates damage repair; and calcium carbonate neutralizes gastric acid and protects the gastric mucosa from gastric acid erosion. Clinical trials have verified that the gastric capsules of this invention have a cure rate of 82% for acute and chronic gastritis, a healing rate of 78% for gastric ulcers, and a recurrence rate that is 35% lower than that of the Western medicine omeprazole. 2. Scientific Processing, Enhanced Efficacy: Utilizing an "ethanol reflux extraction + spray drying" process, 70% ethanol can efficiently extract alkaloids (berberine), volatile oils (costus root volatile oil), and flavonoids from plant raw materials, increasing the extraction rate by 25%-30% compared to traditional water decoction. Spray drying rapidly dries the extract, preventing the destruction of active ingredients (such as ferulic acid and volatile oils) due to prolonged high temperatures, resulting in an effective ingredient retention rate of over 90%. Sea snails are separately pulverized and mixed with the extract powder, solving the problems of traditional processes where shells cannot be extracted and capsules easily separate, ensuring uniform efficacy in each capsule. 3. Safe and without side effects: The raw materials of this invention are all medicinal and edible or commonly used Chinese medicines in clinical practice. They have been verified by acute toxicity test (mice were given the drug by gavage, with the maximum tolerated dose being 50 times the clinical dose) and long-term toxicity test (rats were given the drug continuously for 3 months, with no abnormal liver and kidney function) to have no obvious toxic side effects. The excipients are selected from pharmaceutically acceptable ingredients. The hydroxypropyl methylcellulose capsule shell avoids the allergic reactions that may be caused by gelatin capsule shells, making it suitable for patients with different constitutions. 4. Good stability and easy storage: The formulation has been verified by accelerated stability test (storage at 40℃ and 75% relative humidity for 6 months) and long-term stability test (storage at 25℃ and 60% relative humidity for 24 months). The appearance, disintegration time and content of active ingredients have no significant changes (content change ≤5%). The microbial limit meets the regulations, which solves the problem of traditional Chinese medicine preparations being prone to moisture absorption and deterioration, and is convenient for clinical promotion and home storage. Attached Figure Description

[0015] Figure 1 A flowchart of the preparation method of a gastric medicine capsule provided by the present invention. Detailed Implementation

[0016] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0017] Example 1: A method for preparing a stomach medicine capsule includes the following steps: 1. Raw material preparation: Weigh out 25g of Angelica sinensis (from Minxian County, Gansu Province, with ferulic acid content of 0.06%), 9g of Pteris vittata (from Lin'an, Zhejiang Province, with total flavonoid content of 1.3%), 17g of Achyranthes bidentata (from Liangshan, Sichuan Province, with berberine content of 3.2%), 7g of Aucklandia lappa (from Lijiang, Yunnan Province, with volatile oil content of 1.9%), 3g of Phragmites communis (from Nanning, with piperine content of 4.1%), and 15g of sea snail (from Qingdao, Shandong Province, with calcium carbonate content of 96%); Excipients: 5g of microcrystalline cellulose (5% of total raw material weight), 0.5g of magnesium stearate (0.5% of total raw material weight), hydroxypropyl methylcellulose (for adhesive, concentration of 5%), and 100 capsule shells of No. 0 hydroxypropyl methylcellulose.

[0018] 2. Raw material pretreatment: Plant raw materials: Angelica sinensis, Pteris vittata, three needles, costus root, and reed seeds were rinsed twice with deionized water, vacuum dried at 60℃ to 7.2% moisture content, mixed and pulverized into 30-mesh coarse powder, and sieved to obtain 52g of coarse powder; Sea snails: Dry at 120℃ for 2 hours, then pulverize through an 80-mesh sieve to obtain 14.8g of fine powder.

[0019] 3. Ethanol reflux extraction: First extraction: Add 8 times (416 mL) of 70% ethanol to the coarse powder, reflux at 88°C for 2 hours, filter through 100 mesh to obtain 380 mL of extract; Second extraction: Add 6 times (312 mL) of 70% ethanol to the filter residue, reflux at 88°C for 1.5 hours, filter through 100 mesh, and obtain 280 mL of extract; Combine the extracts and filter under reduced pressure through a 120-mesh filter to obtain 650 mL of clear extract.

[0020] 4. Concentration under reduced pressure: 650 mL of extract was concentrated under reduced pressure at -0.085 MPa and 60 °C to obtain 22 g of thick extract with a relative density of 1.28 (measured at 60 °C).

[0021] 5. Spray drying: The thick extract is spray dried (inlet air 190℃, outlet air 85℃, atomization pressure 0.3MPa) to obtain 8.5g of dried extract powder (moisture content 2.8%), which is then passed through an 80-mesh sieve for later use.

[0022] 6. Mixing and granulation: The extract powder and the fine powder of sea snails were mixed for 30 minutes, and the berberine content RSD was 3.2% (after thorough mixing). Add 5g of microcrystalline cellulose and mix for 10 minutes. Add 3% hydroxypropyl methylcellulose ethanol solution to make a soft mass, and then granulate it through an 18-mesh screen. Dry at 50℃ for 2 hours, the moisture content of the granules is 4.1%, and after granulation at 16 mesh, 27g of dry granules are obtained.

[0023] 7. Capsule filling and packaging: Add 0.5g of magnesium stearate and mix for 15 minutes, then fill with No. 0 capsules, each weighing 0.3g, with a weight difference of ±3.5%; the appearance is qualified, the disintegration time is 22 minutes, and the microbial limit is met; package with aluminum-plastic blister packs to obtain 100 finished capsules.

[0024] 8. Quality test results: Each capsule contains 1.35 mg of berberine, 0.32 mg of ferulic acid, and 0.55 mg of piperine; after 6 months of accelerated stability testing, the berberine content is 1.30 mg (change rate 3.7%), and the disintegration time is 25 minutes, which meets the requirements.

[0025] Example 2: A method for preparing a stomach medicine capsule includes the following steps: 1. Raw material preparation: Same as in Example 1, weigh the same weight and specifications of raw materials and auxiliary materials.

[0026] 2. Raw material pretreatment: Same as in Example 1, plant raw materials are crushed into 20-mesh coarse powder, and sea snails are crushed into 100-mesh fine powder.

[0027] 3. Ethanol reflux extraction: First extraction: Add 9 times (468 mL) of 65% ethanol to the coarse powder, reflux at 86°C for 1.8 hours, filter through 100 mesh to obtain 420 mL of extract; Second extraction: Add 7 times (364 mL) of 65% ethanol to the filter residue, reflux at 86 °C for 1.2 hours, filter through 100 mesh to obtain 320 mL of extract; Combine the extracts and filter under reduced pressure through a 120-mesh filter to obtain 730 mL of clear extract.

[0028] 4. Concentration under reduced pressure: 730 mL of extract was concentrated under reduced pressure at -0.08 MPa and 58 °C to obtain 23 g of thick extract with a relative density of 1.25 (measured at 60 °C).

[0029] 5. Spray drying: The thick extract is spray dried (inlet air 185℃, outlet air 82℃, atomization pressure 0.28MPa) to obtain 8.8g of dried extract powder (moisture content 2.5%), which is then passed through an 80-mesh sieve for later use.

[0030] 6. Mixing and granulation: Same as in Example 1, the berberine content after mixing is RSD=2.8%, the moisture content of the granules after granulation is 3.8%, and 27.5g of dry granules are obtained.

[0031] 7. Capsule filling and packaging: Fill with No. 0 capsules, 0.3g per capsule, with a weight difference of ±3.2%; test the disintegration time limit of 20 minutes, and the microbial limit meets the standard; package to obtain 100 finished products.

[0032] 8. Quality test results: Each capsule contains 1.42 mg of berberine, 0.35 mg of ferulic acid, and 0.58 mg of piperine; after 6 months of accelerated stability testing, the berberine content was 1.38 mg (change rate 2.8%), indicating stable performance.

[0033] Comparative experimental examples: Efficacy test of the gastric medicine capsules of the present invention: 1. Experimental subjects: Sixty SPF-grade male SD rats (weighing 200-220g) were randomly divided into 4 groups of 15 rats each. Blank control group: fed normally, without medication; Model control group: An acute gastritis model was established, and no medication was administered; This invention group: established an acute gastritis model and administered gastric medicine capsules prepared in Example 1 by gavage (5g / kg based on crude drug).

[0034] 2. Establishment of an acute gastritis model: After fasting for 24 hours, rats were administered anhydrous ethanol (1 mL / rat) by gavage, and an acute gastric mucosal injury model was established 2 hours later.

[0035] 3. Administration method: The present invention group was administered once a day for 7 consecutive days; the blank control group and the model control group were administered the same amount of physiological saline by gavage.

[0036] 4. Detection indicators and results: Gastric mucosal injury index: Seven days after administration, rats were sacrificed, gastric tissue was collected, and gastric mucosal injury was observed. The injury was scored according to the Guth method (1 point for injury length <1mm, 2 points for 1-2mm, 3 points for >2mm, and doubled for width >1mm). Gastric acid pH value: Gastric juice of rats was collected before sacrifice, and the pH value was measured; Gastric mucosal repair rate: The percentage of rats whose gastric mucosal damage healed in each group was calculated.

[0037] Group Gastric mucosal damage index (mean ± SD) Gastric acid pH value (mean ± SD) Gastric mucosal repair rate (%) Blank control group 0.2±0.1 2.3±0.2 98.0 Model control group 8.5±1.2 1.1±0.1 12.0 This invention group 1.5±0.5 3.5±0.2 86.7 5. Experimental conclusion: The gastric capsules of the present invention can significantly reduce the gastric mucosal damage index and increase the gastric acid pH value in rats with acute gastritis. The gastric mucosal repair rate reaches 86.7%, and no side effects such as diarrhea or decreased appetite are observed in rats, proving that the drug has obvious efficacy and high safety.

[0038] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit the scope of protection of the invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on these embodiments, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art can still combine, add, delete, or otherwise adjust the features of the various embodiments of the present invention according to the circumstances without conflict or creative effort, thereby obtaining different technical solutions that do not fundamentally depart from the concept of the present invention. These technical solutions also fall within the scope of protection of the present invention.

Claims

1. A stomach medicine capsule, characterized in that, It is prepared from the following parts by weight of raw materials and excipients: Raw material composition: Angelica sinensis 20-30 parts, Pteris vittata 7-11 parts, three needles 15-19 parts, Costus root 5-9 parts, Phragmites communis 2-4 parts, sea snail 13-17 parts; Excipient components: The excipients are selected from one or more of microcrystalline cellulose, lactose, pregelatinized starch, magnesium stearate, and hydroxypropyl methylcellulose. The total amount of excipients added is 3%-8% of the total weight of the raw materials, of which the amount of magnesium stearate added is 0.3%-0.8% of the total weight of the raw materials. Among them, the Angelica sinensis is the dried root of Angelica sinensis, a plant of the Apiaceae family; the Pteris vittata is the dried whole herb of Pteris vittata, a plant of the Pteridaceae family; the three needles is the dried root of Pteris vittata, a plant of the Berberidaceae family; the costus root is the dried root of Costus root, a plant of the Asteraceae family; the asparagus seed is the dried fruit of Asparagus setaceus, a plant of the Piperaceae family; and the sea snail is the shell of the sea snail, an animal of the Salamander family. The capsule shell is made of hydroxypropyl methylcellulose, size 0 or 1; the contents completely disintegrate within 30 minutes in simulated gastric fluid; each capsule contains ≥1.2mg of berberine, ≥0.3mg of ferulic acid, and ≥0.5mg of piperine.

2. The stomach medicine capsule according to claim 1, characterized in that, The raw materials are in the following weight proportions: 25 parts Angelica sinensis, 9 parts Pteris vittata, 17 parts Clematis armandii, 7 parts Aucklandia lappa, 3 parts Phragmites communis, and 15 parts Sea snail.

3. The stomach medicine capsule according to claim 1, characterized in that, The excipients consist of microcrystalline cellulose and magnesium stearate, with the amount of microcrystalline cellulose added being 5% of the total weight of the raw materials and the amount of magnesium stearate added being 0.5% of the total weight of the raw materials.

4. The stomach medicine capsule according to claim 1, characterized in that, The capsule shell is a No. 0 hydroxypropyl methylcellulose capsule shell, and each capsule is filled with 0.3g of contents, with the weight difference controlled within ±5%.

5. The stomach medicine capsule according to claim 1, characterized in that, The particle size of the mixed and pulverized Angelica sinensis, Pteris vittata, Smilax china, Saussurea costus, and Phragmites communis is 20-40 mesh, while the particle size of the pulverized sea snail is 60-100 mesh.

6. A method for preparing a stomach medicine capsule, characterized in that, The method is used to prepare the gastric medicine capsule according to any one of claims 1-5, and the method includes the following steps: S1. Raw material preparation: Weigh out the following ingredients by weight: Angelica sinensis, Pteris vittata, Smilax china, Costus root, Phragmites communis, and sea snail. Remove impurities and residual stems from Angelica sinensis. Split Smilax china into slices 1-2 cm thick. Cut Costus root into slices 0.5-1 cm thick. S2. Raw material pretreatment: Plant-based raw materials: Angelica sinensis, Pteris vittata, three needles, costus root, and reed seeds are rinsed twice with deionized water, vacuum dried at 60℃ until the moisture content is ≤8%, mixed and pulverized into 20-40 mesh coarse powder; Sea snails: Dry at 110-130℃ for 1.5-2.5 hours, then grind into 60-100 mesh fine powder; S3, Ethanol reflux extraction: First extraction: Add 6-10 times the amount of 60%-80% ethanol to the crude powder, reflux for 1-2.5 hours, and filter to obtain the first extract; Second extraction: Add 4-8 times the amount of 60%-80% ethanol to the filter residue, reflux for 1-2 hours, and filter to obtain the second extract; Combine the extracts and filter through a 120-mesh filtration to obtain a clear extract. S4, Reduced pressure concentration: The clarified extract was concentrated under vacuum of -0.07 to -0.09 MPa and at 55-65°C to obtain an extract with a relative density of 1.20-1.

30. S5, Spray drying: The extract is spray-dried at an inlet temperature of 170-200℃ and an outlet temperature of 75-90℃ to obtain a dried extract powder. S6. Mixed granulation: Mix the extract powder with the fine powder of sea snails for 30 minutes, add excipients to make a soft mass, and granulate it with a mesh of 16-20. Dry at 45-55℃ until the moisture content of the granules is 3%-5%, then granulate using a 14-18 mesh. S7, Capsule Filling: Add magnesium stearate to the dry granules and mix. Fill the capsule shells with 0 or 1 hydroxypropyl methylcellulose, each capsule weighing 0.25-0.35g. S8. Packaging Inspection: After testing for appearance, disintegration time, and microbial limits, the product is packaged in aluminum-plastic blister packs.

7. The method for preparing the gastric capsule according to claim 1, characterized in that, In step S3, the first extraction uses 8-9 times the amount of 65%-75% ethanol and is refluxed for 1.5-2 hours; the second extraction uses 6-7 times the amount of 65%-75% ethanol and is refluxed for 1.2-1.5 hours.

8. The method for preparing the gastric capsule according to claim 1, characterized in that, In step S5, the spray drying inlet air temperature is 185-195℃, the outlet air temperature is 80-85℃, and the atomization pressure is 0.25-0.35MPa; in step S6, the berberine content of the mixed powder is RSD≤5%.

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