Pantoprazole pharmaceutical composition, preparation method therefor, and use thereof

Abstract

A pantoprazole pharmaceutical composition, a preparation method therefor, and a use thereof. Provided is a pantoprazole pharmaceutical composition, comprising a pharmaceutically active component and an antacid, wherein: the pharmaceutically active component is selected from one or more of pantoprazole, pantoprazole sodium, other pharmaceutically acceptable salt forms of pantoprazole, and solvates and hydrates thereof; and the antacid is selected from one or more of sodium bicarbonate, sodium carbonate, calcium carbonate, sodium hydroxide, and magnesium hydroxide. The pantoprazole pharmaceutical composition can inhibit the active component from being destroyed by gastric acid, has good prescription compatibility, stable chemical properties, rapid effect, good efficacy, few side effects and good patient compliance, and has simple preparation process steps and good market prospects.

Description

Pantoprazole pharmaceutical composition, preparation method and application thereof

[0001] This application claims priority to a prior application filed with the State Intellectual Property Office of China on September 1, 2023, with application number 202311123175.7, entitled “Pantoprazole Sodium Pharmaceutical Composition, Preparation Method and Use Thereof.” The entire text of the prior application is incorporated herein by reference. Technical Field

[0002] The present invention belongs to the field of pharmaceutical compositions, and relates to a pantoprazole pharmaceutical composition, a preparation method and an application thereof. Background Art

[0003] Peptic ulcers are a common, chronic, and recurring disease. While their mortality rate is low, they cause significant pain to patients and increase the economic burden on the nation and its people. Peptic ulcers are well-defined mucosal diseases that penetrate the muscularis mucosa and develop in areas of the gastrointestinal tract that come into contact with gastric fluid. These ulcers can occur in the lesser curvature of the stomach (gastric ulcers), the pyloric canal (pyloric canal ulcers), the beginning of the duodenum (so-called duodenal bulb ulcers), postduodenal bulb ulcers, lower esophageal ulcers (gastric fluid can reflux into the lower esophagus), and Meckel's diverticulum in the distal ileum (a congenital condition that can cause ulcers).

[0004] Peptic ulcer drug research and treatment have had a significant impact on the quality of life and work potential of millions of people affected, and have helped significantly reduce the prevalence of the disease, the frequency and severity of complications, hospitalization rates, and mortality. Currently, domestic peptic ulcer drugs can be divided into proton pump inhibitors, antacids, H2 receptor antagonists, and other drugs based on their different drug types.

[0005] Pantoprazole (also known as 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)methyl]sulfinyl-1H-benzimidazole, with the structure shown in Formula I) is an anti-ulcer drug and an irreversible proton pump inhibitor. It is activated in the acidic environment of gastric parietal cells to form a cyclic sulfonamide, which then covalently binds specifically to the sulfhydryl group on the proton pump (HtK+ ATPase), the final step in gastric acid secretion, thereby eliminating its acid secretion function. It is used for duodenal ulcers, gastric ulcers, reflux esophagitis, and Zollinger-Ellison syndrome, particularly for ulcers accompanied by bleeding, vomiting, or anorexia, as well as for refractory ulcers and acute pancreatitis. It is also used to prevent stress ulcers caused by major surgery or severe trauma.

[0006] Pantoprazole is a third-generation proton pump inhibitor that selectively acts on gastric mucosal parietal cells, inhibiting the activity of H,K-ATPase. This prevents H transport from the parietal cells to the stomach, thereby inhibiting gastric acid secretion. Pantoprazole is more stable than similar drugs in weakly acidic environments. Upon activation, it binds only to two sites within the proton pump activation site (whereas omeprazole and lansoprazole bind more frequently to these two sites), demonstrating a high degree of selectivity for proton pump binding at the molecular level. Compared with omeprazole and lansoprazole, pantoprazole exhibits less inhibitory activity against cytochrome P450-dependent enzymes. Furthermore, pantoprazole reduces gastric juice secretion and inhibits the secretion and activity of pepsin. Pantoprazole has similar efficacy to omeprazole, but exhibits superior analgesic effects. Pantoprazole intravenous infusion is highly effective in treating peptic ulcers, acute gastric mucosal lesions, and complex ulcers (relieving pain and stopping bleeding), with an overall effective rate of 98.04%. Pantoprazole can also cure peptic ulcers that are resistant to conventional or high-dose H2 receptor antagonists.

[0007] Pantoprazole sodium is the sodium salt of pantoprazole and has the same effects as pantoprazole. Because proton pump inhibitors are acid-labile and easily degrade in the acidic environment of the stomach, reducing their efficacy, these drugs are typically formulated as enteric-coated preparations. These preparations require a special enteric coating to protect the contents from gastric acid damage, resulting in a complex, multi-step process.

[0008] Therefore, there is an urgent need to develop a novel pantoprazole pharmaceutical composition with good acid stability, good prescription compatibility, and / or stable chemical properties, or further with few side effects, good efficacy, and good patient compliance.

[0009] Summary of the Invention

[0010] The present invention provides a pantoprazole pharmaceutical composition, which comprises a pharmaceutically active ingredient and an antacid, wherein the pharmaceutically active ingredient is selected from one or more of pantoprazole, pantoprazole sodium, and other pharmaceutically acceptable salt forms, solvates, and hydrates thereof; and the antacid is selected from one or more of sodium bicarbonate, sodium carbonate, calcium carbonate, sodium hydroxide, and magnesium hydroxide.

[0011] According to an embodiment of the present invention, the active pharmaceutical ingredient is pantoprazole sodium.

[0012] According to an embodiment of the present invention, the content of the pharmaceutically active ingredient may be 1.00% to 10.00%, for example, 9.00%, 8.00%, 7.00%, 6.00%, 5.00%, 4.41%, 4.00%, 3.85%, 3.62%, 3.60%, 3.55%, 3.25%, 3.00%, 2.35%, 2.00% or 1.50%, wherein the content refers to the percentage of the mass of the pharmaceutically active ingredient to the total mass of the pantoprazole pharmaceutical composition.

[0013] According to one embodiment of the present invention, the antacid may be sodium bicarbonate.

[0014] According to an embodiment of the present invention, the content of the antacid is not less than 50.00%, for example, it can be 50.00% to 95.00%, for example, 94.02%, 94.00%, 93.62%, 92.28%, 90.00%, 88.89%, 83.33%, 80.00%, 76.93%, 72.73%, 70.00%, 65.00%, 60.00% or 55.00%, wherein the content refers to the percentage of the mass of the antacid to the total mass of the pantoprazole pharmaceutical composition.

[0015] According to an embodiment of the present invention, the pantoprazole pharmaceutical composition may further comprise one or more of a diluent, a disintegrant, a binder, a lubricant and a glidant.

[0016] According to an embodiment of the present invention, the diluent refers to an inert substance added for dilution in order to increase the weight of the pharmaceutical composition, and is selected from microcrystalline cellulose and / or lactose.

[0017] According to an embodiment of the present invention, the content of the diluent can be 0-30.00%, for example, 1.00%, 5.00%, 10.00%, 15.00%, 20.00% or 25.00%, where the percentage refers to the weight of the diluent relative to the total weight of the pantoprazole pharmaceutical composition.

[0018] According to an embodiment of the present invention, the disintegrant refers to a substance that can cause tablets or granules to disintegrate during dissolution, and is selected from one or more of sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, cross-linked sodium carboxymethyl cellulose, cross-linked polyvinylpyrrolidone, pregelatinized starch and polyclinic potassium, for example, cross-linked polyvinylpyrrolidone.

[0019] According to an embodiment of the present invention, the content of the disintegrant may be 0 to 30.00%, for example 25.00%, 20.00%, 15.00%, 11.22%, 10.00%, 7.65%, 6.15%, 5.05%, 4.00%, 3.00%, 2.91%, 2.00%, 1.51%, 1.50% or 1.00%, preferably 1.00% to 5.00%, further preferably 1.00% to 3.50%, more preferably 1.50% to 2.91%, wherein the percentage refers to the weight of the disintegrant to the total weight of the pantoprazole pharmaceutical composition.

[0020] According to an embodiment of the present invention, the binder can be a conventional additive in the art that can increase the viscosity of the dispersion medium to reduce the sedimentation rate of the microparticles or increase the hydrophilicity of the microparticles, and can be selected from one or more of hydroxypropyl methylcellulose, hydroxypropyl cellulose, povidone (e.g., povidone K30), copovidone, hydroxyethyl cellulose, sodium carboxymethyl cellulose, carbomer, polyethylene oxide, and ethyl cellulose.

[0021] According to an embodiment of the present invention, the content of the binder can be 1.0% to 30.00%, for example, 25.00%, 20.00%, 16.36%, 15.00%, 13.85%, 10.00% or 5.00%, where the percentage refers to the weight of the binder relative to the total weight of the pantoprazole pharmaceutical composition.

[0022] According to an embodiment of the present invention, the lubricant can be a conventional substance with lubricating effect in the art, selected from one or more of metal stearates, stearic acid, stearic acid esters and polyethylene glycol. For example, the metal stearate is selected from one or more of magnesium stearate, calcium stearate and sodium stearyl fumarate. For example, the stearic acid ester is glyceryl stearate. In one embodiment, the lubricant is sodium stearyl fumarate.

[0023] According to an embodiment of the present invention, the content of the lubricant is 0% to 5.00%, for example 4.00%, 3.00%, 2.00%, 1.50%, 1.40%, 1.30%, 1.28%, 1.26%, 1.25%, 1.20%, 1.04%, 1.11%, 0.92%, 0.91%, 0.85%, 0.80% or 0.50%, preferably 0.50% to 2.00%, further preferably 0.70% to 1.40%, more preferably 0.85% to 1.28%, wherein the percentage refers to the weight of the lubricant relative to the total weight of the pantoprazole pharmaceutical composition.

[0024] According to an embodiment of the present invention, the glidant can be a conventional auxiliary material in the art that can reduce the friction between particles and improve the fluidity of powders or granules, and is selected from one or more of talc, micropowder silica and colloidal silicon dioxide.

[0025] According to an embodiment of the present invention, the content of the glidant is preferably 0% to 5.0%, and the percentage refers to the percentage of the weight of the glidant to the total weight of the pantoprazole pharmaceutical composition.

[0026] In one embodiment, the pantoprazole pharmaceutical composition comprises or consists essentially of a pharmaceutically active ingredient, an antacid, a disintegrant, and a lubricant;

[0027] Preferably, the active ingredient of the drug is pantoprazole sodium, with a content of 1.00% to 10.00%; the antacid is sodium bicarbonate, with a content of 60.00 to 95.00%; the disintegrant is cross-linked polyvinylpyrrolidone, with a content of 1.00% to 5.00%; and the lubricant is sodium stearyl fumarate, with a content of 0.50% to 2.00%.

[0028] The pantoprazole pharmaceutical composition of the present invention can be any of the following prescriptions:

[0029] Prescription 1: 4.41% pantoprazole sodium, 83.33% sodium bicarbonate, 11.22% sodium carboxymethyl starch, and 1.04% sodium stearyl fumarate; the percentages mentioned refer to the mass of each component as a percentage of the total mass of the pantoprazole pharmaceutical composition;

[0030] Prescription 2: 2.35% pantoprazole sodium, 88.89% sodium bicarbonate, 7.65% sodium carboxymethyl starch, and 1.11% sodium stearyl fumarate; the percentages mentioned refer to the mass of each component as a percentage of the total mass of the pantoprazole pharmaceutical composition;

[0031] Prescription 3: 3.85% pantoprazole sodium, 72.73% sodium bicarbonate, 16.36% povidone K30, 6.15% sodium carboxymethyl starch, and 0.91% sodium stearyl fumarate; the percentages mentioned refer to the percentage of the mass of each component to the total mass of the pantoprazole pharmaceutical composition;

[0032] Prescription 4: 3.25% pantoprazole sodium, 76.93% sodium bicarbonate, 13.85% povidone K30, 5.05% sodium carboxymethyl starch, and 0.92% sodium stearyl fumarate; the percentages mentioned refer to the percentage of the mass of each component to the total mass of the pantoprazole pharmaceutical composition;

[0033] Prescription 5: 3.55% pantoprazole sodium, 92.28% sodium bicarbonate, 2.91% crospovidone, 1.26% sodium stearyl fumarate; the percentages mentioned refer to the mass of each component as a percentage of the total mass of the pantoprazole pharmaceutical composition;

[0034] Prescription 6: 3.60% pantoprazole sodium, 93.62% sodium bicarbonate, 1.50% crospovidone, 1.28% sodium stearyl fumarate; the percentages mentioned refer to the percentage of the mass of each component to the total mass of the pantoprazole pharmaceutical composition;

[0035] Prescription 7: 3.62% pantoprazole sodium, 94.02% sodium bicarbonate, 1.51% cross-linked polyvinylpyrrolidone, 0.85% sodium stearyl fumarate; the percentages mentioned refer to the percentage of the mass of each component to the total mass of the pantoprazole pharmaceutical composition.

[0036] According to an embodiment of the present invention, the pantoprazole pharmaceutical composition may contain a dosage of pantoprazole active ingredient (calculated as pantoprazole) of 20 mg to 40 mg, for example, 20 mg, 25 mg, 30 mg, 35 mg or 40 mg.

[0037] The present invention also provides a method for preparing the pantoprazole pharmaceutical composition, which includes but is not limited to a powder direct compression method, a wet granulation method, a dry granulation method and a fluidized granulation method.

[0038] The present invention also provides the use of the pantoprazole pharmaceutical composition in preparing pharmaceutical preparations.

[0039] The present invention also provides a pharmaceutical preparation, comprising the pantoprazole pharmaceutical composition or prepared from the pantoprazole pharmaceutical composition.

[0040] According to an embodiment of the invention, the pharmaceutical preparation may be an oral pharmaceutical preparation; the dosage form of the oral pharmaceutical preparation includes but is not limited to tablets, capsules, micropills, microtablets or dry suspensions.

[0041] According to an embodiment of the invention, the pharmaceutical preparation may further comprise a coating agent. The coating agent may be a film coating powder. The content of the coating agent is preferably 0% to 10.0%, for example 3.0%, where the percentage refers to the weight of the coating agent relative to the total weight of the pantoprazole pharmaceutical composition.

[0042] According to an embodiment of the invention, the pharmaceutical preparation may contain the pantoprazole active ingredient (calculated as pantoprazole) in a dosage of 20 mg to 40 mg, for example, 20 mg, 25 mg, 30 mg, 35 mg or 40 mg.

[0043] According to an embodiment of the invention, the pharmaceutical preparation is for use in treating and / or preventing peptic ulcer disease.

[0044] The present invention also provides use of the pantoprazole pharmaceutical composition in preparing a medicament for treating and / or preventing peptic ulcer.

[0045] The present invention also provides a method for treating and / or preventing peptic ulcer, which comprises administering a therapeutically effective amount of the pantoprazole pharmaceutical composition or pharmaceutical preparation to a patient in need.

[0046] Definitions and Explanations of Terms

[0047] The above-mentioned "plurality" refers to more than two, for example, two, three or four.

[0048] The above-mentioned “mainly composed of…” means that the sum of the masses of these components accounts for not less than 85% of the total mass of the pantoprazole pharmaceutical composition, for example not less than 90%, exemplified by 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% or 100%.

[0049] The above-mentioned "peptic ulcer diseases" include, for example, duodenal ulcer, gastric ulcer, reflux esophagitis and Zollinger-Ellison syndrome as described in the background art, and are particularly used for ulcers accompanied by bleeding, vomiting or inability to eat, as well as refractory ulcers and acute pancreatitis; and stress ulcers caused by major surgery or severe trauma.

[0050] Beneficial effects of the present invention

[0051] The pantoprazole pharmaceutical composition of the present invention achieves at least one of the following effects: it can inhibit the destruction of pantoprazole sodium by gastric acid, has good prescription compatibility, stable chemical properties, rapid onset, good efficacy, few side effects, good patient compliance, and has a simple preparation process and good market prospects. DETAILED DESCRIPTION

[0052] The technical solutions of the present invention will be described in further detail below with reference to specific embodiments. It should be understood that the following embodiments are merely illustrative and explanations of the present invention and should not be construed as limiting the scope of protection of the present invention. All technologies implemented based on the above content of the present invention are encompassed within the scope of protection that the present invention is intended to protect.

[0053] Unless otherwise specified, the raw materials and reagents used in the following examples are commercially available or can be prepared by known methods.

[0054] Examples 1-2

[0055] Preparation process:

[0056] Pantoprazole sodium, sodium bicarbonate, and sodium carboxymethyl starch in the above prescription were added to a hopper mixer, the mixing speed was set to 10 rpm, and the mixture was mixed for 30 minutes. Then, sodium stearyl fumarate was added and mixed for 5 minutes. The mixed powder was pressed into tablets according to the theoretical tablet weight, and then coated with a 10% concentration of a film coating powder aqueous solution (the percentage refers to the percentage of the mass of the film coating powder to the total mass of the film coating powder aqueous solution) to obtain pantoprazole sodium bicarbonate tablets.

[0057] Examples 3-4

[0058] Preparation process:

[0059] The pantoprazole sodium, sodium bicarbonate, and povidone K30 in the above prescription were added to a wet granulation mixer, the stirring speed was set to 150 rpm, the cutting speed was 800 rpm, and the mixture was mixed for 10 minutes. Then, a soft material was prepared with 50% ethanol, and the soft material was passed through an 18-mesh sieve for wet granulation to obtain wet granules. The wet granules were then placed in a blast drying oven, set to a drying temperature of 50° C., dried until the moisture content was less than 2.0%, and then granulated using a 20-mesh sieve (the percentage refers to the percentage of the mass of water to the mass of the wet granules). The granules after granulation were then added to a hopper mixer, sodium carboxymethyl starch and sodium stearyl fumarate were added, the mixing speed was set to 10 rpm, and the mixture was mixed for 10 minutes. The obtained pantoprazole sodium bicarbonate mixed granules were filled into capsules to obtain pantoprazole sodium bicarbonate capsules.

[0060] Detection methods of related substances in Examples 5-8:

[0061] The related substances of pantoprazole sodium were detected using a high performance liquid chromatography (HPLC) using a Zhongpu Technology XR-C18, 4.6 mm × 250 mm, 5 μm column and acetonitrile, 1.74 g / L dipotassium hydrogen phosphate solution (pH adjusted to 7.0 with phosphoric acid)-acetonitrile (90:10) as the mobile phase.

[0062] Examples 5-6

[0063] Pantoprazole sodium, sodium bicarbonate, cross-linked polyvinylpyrrolidone, sodium carboxymethyl starch, and low-substituted hydroxypropyl cellulose were exposed to high temperature (60°C) for 10 days to investigate the compatibility of raw and auxiliary materials. The results are shown in the table below:

[0064] Test results showed that when sodium carboxymethyl starch and low-substituted hydroxypropyl cellulose were heated at 60°C for 10 days, the content of related substances increased significantly, indicating poor compatibility. However, when the mixture of crospovidone and the API was heated at 60°C for 10 days, the content of related substances remained essentially unchanged, indicating good compatibility. Therefore, crospovidone is the preferred disintegrant.

[0065] Based on the results of the compatibility study, cross-linked polyvinylpyrrolidone was used as a disintegrant to further evaluate the effect of its dosage on product quality.

[0066] Preparation process: Step 1: Add half of the sodium bicarbonate and pantoprazole sodium in the above prescription into a mixing hopper, set the mixing speed to 10 rpm, and mix for 10 minutes; Step 2: Add the other half of the sodium bicarbonate and cross-linked polyvinylpyrrolidone, set the mixing speed to 10 rpm, and mix for 15 minutes; Step 3: After the mixing is completed, add sodium stearyl fumarate, set the mixing speed to 10 rpm, and mix for 10 minutes; Step 4: After the mixing is completed, sieve and disperse with a 50-mesh sieve; Step 5: Add the sieved material into the mixing hopper, set the speed to 10 rpm, and mix for 7 minutes to obtain a total mixed material; Step 6: Fill the obtained total mixed material into capsules to obtain pantoprazole sodium bicarbonate capsules.

[0067] The samples prepared above were subjected to dissolution curve comparison using a paddle method at 75 rpm, 900 ml, and pH 7.4 phosphate buffer. See the table below:

[0068] The results showed that the proportion of cross-linked polyvinylpyrrolidone in each capsule was in the range of 1.51% to 2.91%, and the cumulative dissolution amount in 30 minutes was greater than 85%, with a fast dissolution rate, which was in line with expectations.

[0069] Example 8

[0070] Pantoprazole sodium, sodium bicarbonate, magnesium stearate, calcium stearate, and sodium stearyl fumarate were placed open for 10 days at high temperature of 60°C and high humidity of 92.5% RH to investigate the compatibility of raw materials and excipients. The results are shown in the table below:

[0071] The test results showed that when magnesium stearate and the API mixture were exposed to high humidity at 92.5% RH for 10 days, the content of related substances increased significantly, indicating poor compatibility. However, when calcium stearate and sodium stearyl fumarate were exposed to high humidity at 60°C and 92.5% RH for 10 days, the content of related substances increased less significantly, indicating better compatibility. Therefore, sodium stearyl fumarate is the preferred lubricant.

[0072] According to the results of the compatibility study, the preparation process of Example 5 was adopted, and sodium stearyl fumarate was used as a lubricant to evaluate the effects of different dosages on product dissolution and the fluidity of the total mixed material.

[0073] The angle of repose of the prepared total mixture was tested; the capsules were subjected to dissolution curve comparison using a paddle method at 75 rpm, 900 ml, and pH 7.4 phosphate buffer. The results are shown in the table below:

[0074] Test results showed that the percentage of sodium stearyl fumarate in each capsule ranged from 0.85% to 1.28%, and the cumulative dissolution rate within 30 minutes exceeded 85%, indicating that the product dissolution met expectations. The angle of repose of the overall blend was less than 45°, and the fluidity met filling requirements.

[0075] Example 9

[0076] The formulation of Example 5 was used to investigate the effect of different mixing times in the fifth step of the preparation process on mixing uniformity.

[0077] The test results show that the product has good mixing uniformity and meets product requirements.

[0078] Example 10

[0079] Pantoprazole sodium bicarbonate capsules with different sodium bicarbonate dosages were prepared using the preparation process of Example 5 to simulate the acidic environment in the body when taking the drug. The pantoprazole content was used to evaluate the rationality of the sodium bicarbonate dosage.

[0080] Prepare a medium of 72 ml of pH 1.2 hydrochloric acid solution + 240 ml of purified water, test the pH value, and add it to the dissolution cup; take the above sample and stir it at 50 rpm for 30 minutes, then test the pH value; take a sample and add alkaline solution for protection to test the pantoprazole content.

[0081] The results of the in vitro acid resistance test showed that when the dosage of sodium bicarbonate was between 900 mg and 1680 mg, the pantoprazole content was greater than 97.0%, which could effectively protect pantoprazole sodium and prevent the degradation of the active ingredient.

[0082] Detection method of pantoprazole content:

[0083] The content of pantoprazole was determined using a 4.6 mm × 150 mm, 5 μm column (XR-C18) from Zhongpu Technology and a 0.001 mol / L sodium hydroxide solution-acetonitrile (1:1) solvent.

[0084] The above research results show that when pantoprazole sodium is used in combination with sodium bicarbonate, sodium bicarbonate helps pantoprazole sodium maintain a stable state in an acidic environment and exert good pharmacological efficacy.

[0085] The above describes the embodiments of the present invention. However, the present invention is not limited to the above embodiments. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included in the scope of protection of the present invention.

Claims

1. A pantoprazole pharmaceutical composition, characterized in that: The pantoprazole pharmaceutical composition comprises: a pharmaceutically active ingredient and an antacid, wherein the pharmaceutically active ingredient is selected from one or more of pantoprazole, pantoprazole sodium, other pharmaceutically acceptable salt forms, solvates and hydrates thereof; and the antacid is selected from one or more of sodium bicarbonate, sodium carbonate, calcium carbonate, sodium hydroxide and magnesium hydroxide.

2. The pantoprazole pharmaceutical composition according to claim 1, wherein: The content of the active pharmaceutical ingredient is 1.00% to 10.00%, and the content refers to the percentage of the mass of the active pharmaceutical ingredient to the total mass of the pantoprazole pharmaceutical composition; and / or, The content of the antacid is not less than 50.00%, for example, 50.00% to 95.00%, and the content refers to the percentage of the mass of the antacid to the total mass of the pantoprazole pharmaceutical composition.

3. The pantoprazole pharmaceutical composition according to claim 1, wherein: The pantoprazole pharmaceutical composition further comprises one or more of a diluent, a disintegrant, a binder, a lubricant and a glidant.

4. The pantoprazole pharmaceutical composition according to claim 3, wherein: The diluent is selected from microcrystalline cellulose and / or lactose; and / or, The disintegrant is selected from one or more of sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, cross-linked sodium carboxymethyl cellulose, cross-linked polyvinylpyrrolidone, pregelatinized starch and polyclinic potassium; and / or, The binder is selected from one or more of hydroxypropyl methylcellulose, hydroxypropyl cellulose, povidone, copovidone, hydroxyethyl cellulose, sodium carboxymethyl cellulose, carbomer, polyethylene oxide and ethyl cellulose; and / or, The lubricant is selected from one or more of metal stearate, stearic acid, stearate and polyethylene glycol; and / or, The glidant is selected from one or more of talc, micro-powder silica gel and colloidal silicon dioxide.

5. The pantoprazole pharmaceutical composition according to claim 3 or 4, characterized in that: The content of the diluent is 0-30.0%, and the percentage refers to the percentage of the weight of the diluent to the total weight of the pantoprazole pharmaceutical composition; and / or, The content of the disintegrant is 0-30.0%, and the percentage refers to the weight of the disintegrant in the total weight of the pantoprazole pharmaceutical composition; and / or, The content of the binder is 1.0% to 30.0%, and the percentage refers to the percentage of the weight of the binder to the total weight of the pantoprazole pharmaceutical composition; and / or, The content of the lubricant is 0% to 5.0%, and the percentage refers to the percentage of the weight of the lubricant to the total weight of the pantoprazole pharmaceutical composition; and / or, The content of the glidant is 0% to 5.0%, and the percentage refers to the percentage of the weight of the glidant to the total weight of the pantoprazole pharmaceutical composition.

6. The pantoprazole pharmaceutical composition according to any one of claims 1 to 5, characterized in that: The pantoprazole pharmaceutical composition comprises a pharmaceutically active ingredient, an antacid, a disintegrant and a lubricant or is mainly composed of a pharmaceutically active ingredient, an antacid, a disintegrant and a lubricant; Preferably, the active ingredient of the drug is pantoprazole sodium, the content of which is 1.00% to 10.00%; the antacid is sodium bicarbonate, the content of which is 60.00 to 95.00%; the disintegrant is cross-linked polyvinylpyrrolidone, the content of which is 1.00% to 5.00%; the lubricant is sodium stearate fumarate, the content of which is 0.50% to 2.00%; Preferably, the pantoprazole pharmaceutical composition is selected from any of the following prescriptions: Prescription 1: 4.41% pantoprazole sodium, 83.33% sodium bicarbonate, 11.22% sodium carboxymethyl starch and 1.04% sodium stearyl fumarate; the percentages refer to the percentage of the mass of each component to the total mass of the pantoprazole pharmaceutical composition; Prescription 2: 2.35% pantoprazole sodium, 88.89% sodium bicarbonate, 7.65% sodium carboxymethyl starch and 1.11% sodium stearyl fumarate; the percentages refer to the percentage of the mass of each component to the total mass of the pantoprazole pharmaceutical composition; Prescription 3: 3.85% pantoprazole sodium, 72.73% sodium bicarbonate, 16.36% povidone K30, 6.15% sodium carboxymethyl starch and 0.91% sodium stearyl fumarate; the percentages refer to the percentage of the mass of each component to the total mass of the pantoprazole pharmaceutical composition; Prescription 4: 3.25% pantoprazole sodium, 76.93% sodium bicarbonate, 13.85% povidone K30, 5.05% sodium carboxymethyl starch and 0.92% sodium stearyl fumarate; the percentages refer to the percentage of the mass of each component to the total mass of the pantoprazole pharmaceutical composition; Prescription 5: 3.55% pantoprazole sodium, 92.28% sodium bicarbonate, 2.91% cross-linked polyvinylpyrrolidone, 1.26% sodium stearyl fumarate; the percentages refer to the percentage of the mass of each component to the total mass of the pantoprazole pharmaceutical composition; Prescription 6: 3.60% pantoprazole sodium, 93.62% sodium bicarbonate, 1.50% cross-linked polyvinylpyrrolidone, 1.28% sodium stearyl fumarate; the percentages refer to the percentage of the mass of each component to the total mass of the pantoprazole pharmaceutical composition; Prescription 7: 3.62% pantoprazole sodium, 94.02% sodium bicarbonate, 1.51% cross-linked polyvinylpyrrolidone, 0.85% sodium stearyl fumarate; the percentages mentioned refer to the percentage of the mass of each component in the total mass of the pantoprazole pharmaceutical composition.

7. Use of the pantoprazole pharmaceutical composition according to any one of claims 1 to 6 in the preparation of a pharmaceutical preparation.

8. A pharmaceutical preparation comprising the pantoprazole pharmaceutical composition according to any one of claims 1 to 6.

9. The pharmaceutical preparation according to claim 8, characterized in that: The pharmaceutical preparation is an oral pharmaceutical preparation; The pharmaceutical preparation may further comprise a coating agent; the coating agent may be a film coating powder; the content of the coating agent is preferably 0% to 10.0%, and the percentage refers to the percentage of the weight of the coating agent to the total weight of the pantoprazole pharmaceutical composition; Preferably, The dosage form of the oral pharmaceutical preparation includes but is not limited to tablets, capsules, micropills, microtablets or dry suspensions.

10. Use of the pantoprazole pharmaceutical composition according to any one of claims 1 to 6 or the pharmaceutical preparation according to any one of claims 8 to 9 in the preparation of a medicament for treating and / or preventing peptic ulcer.

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