Pantoprazole pharmaceutical composition as well as preparation method and application thereof

Abstract

The invention discloses a pantoprazole pharmaceutical composition as well as a preparation method and application thereof. The invention provides a pantoprazole pharmaceutical composition, which comprises an active pharmaceutical ingredient and an antacid, and the active pharmaceutical ingredient is selected from one or more of pantoprazole, pantoprazole sodium, other pharmaceutically acceptable salt forms, solvates and hydrates thereof; 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 active ingredients from being damaged by gastric acid, and is good in prescription compatibility, stable in chemical property, fast in effect taking, good in curative effect, small in side effect, good in patient compliance, simple in preparation process and good in market prospect.

Description

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

[0002] The 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 ulcer is a common chronic and recurrent disease. Its mortality rate is very low, but it will cause great pain to patients and increase the economic burden on the country and the people. Peptic ulcer is a well-defined mucosal disease that can penetrate the muscularis mucosa and occur in areas of the gastrointestinal tract that come into contact with gastric juice. It can be seen in the lesser curvature of the stomach (gastric ulcer), the pyloric canal (pyloric canal ulcer), the beginning of the duodenum, the so-called duodenal bulb ulcer, the post-duodenal bulb ulcer, the lower esophageal ulcer (gastric juice can reflux into the lower esophagus), and Meckel's diverticulum in the distal ileum (a congenital disease that can cause ulcers).

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

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

[0006] Pantoprazole is a third-generation proton pump inhibitor that can selectively act on gastric mucosal parietal cells, inhibit the activity of H, K-ATPase in parietal cells, and prevent H in parietal cells from being transported to the stomach, thereby inhibiting the secretion of gastric acid. Pantoprazole is more stable than similar drugs in a weak acid environment. After being activated, it only binds to two sites on the activation site of the proton pump (while omeprazole and lansoprazole show more binding to the two sites of the activation site), showing a high degree of selectivity for binding to the proton pump at the molecular level. Compared with omeprazole and lansoprazole, pantoprazole has a weaker inhibitory effect on cytochrome P450-dependent enzymes. In addition, pantoprazole can also reduce gastric juice secretion and inhibit the secretion and activity of pepsin. Pantoprazole has similar efficacy to omeprazole, but its analgesic effect is better than omeprazole. Pantoprazole intravenous drip has significant efficacy in the treatment of peptic ulcer, acute gastric mucosal lesions, and complex ulcers (pain relief and hemostasis), with a total effective rate of 98.04%. At the same time, pantoprazole can cure peptic ulcers that are ineffective with conventional or high-dose H2 receptor antagonists.

[0007]

[0008] Pantoprazole sodium is the sodium salt of pantoprazole, and its effect is the same as that of pantoprazole. Since proton pump inhibitors are unstable to acid and are easily degraded in the gastric acid environment, which reduces their efficacy, such drugs are usually made into enteric-coated preparations, which require special enteric materials to coat their contents to prevent gastric acid damage. Therefore, their preparation process is cumbersome and requires multiple processes.

[0009] 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 having small side effects, good efficacy, and good patient compliance. Summary of the invention

[0010] The 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, 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 ingredient of the medicine is pantoprazole sodium.

[0012] According to an embodiment of the present invention, the content of the active pharmaceutical ingredient can 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 active pharmaceutical 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%, and 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%, and the percentage refers to the weight of the diluent as a percentage of 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 can 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 as a percentage of 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 particles or increase the hydrophilicity of the particles, selected from one or more of hydroxypropyl methylcellulose, hydroxypropyl cellulose, povidone (e.g., povidone K30), copovidone, hydroxyethyl cellulose, sodium carboxymethyl cellulose, carbomer, polyoxyethylene 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 as a percentage of 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 stearic acid metal salts, stearic acid, stearic acid esters and polyethylene glycol. For example, the stearic acid metal salt 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%, preferably 0.70% to 1.40%, more preferably 0.85% to 1.28%, wherein the percentage refers to the weight of the lubricant as a percentage of the total weight of the pantoprazole pharmaceutical composition.

[0024] According to an embodiment of the present invention, the glidant may be a conventional auxiliary material in the art that can reduce the friction between particles and improve the fluidity of powder or granules, selected from one or more of talc, micro-powder 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 mainly 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 refer to the percentage of the mass of each component to 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 refer to the percentage of the mass of each component to 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 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 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% 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;

[0034] 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;

[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 in 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 application 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%, and the percentage refers to the weight of the coating agent to the total weight of the pantoprazole pharmaceutical composition.

[0042] According to an embodiment of the invention, the dosage of the pantoprazole active ingredient (calculated as pantoprazole) contained in the pharmaceutical preparation may be 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 used for treating and / or preventing peptic ulcer disease.

[0044] The present invention also provides use of the pantoprazole pharmaceutical composition in preparing a drug 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 thereof.

[0046] Definition and explanation 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 "diseases of peptic ulcer" include, for example, those recorded in the background art: duodenal ulcer, gastric ulcer, reflux esophagitis and Zollinger-Ellison syndrome, especially ulcers with 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 has at least one of the following effects: it can inhibit pantoprazole sodium from being destroyed by gastric acid, has good prescription compatibility, stable chemical properties, rapid onset, good efficacy, small side effects, good patient compliance, simple preparation process, and good market prospects. DETAILED DESCRIPTION

[0052] The technical scheme of the present invention will be further described in detail below in conjunction with specific embodiments. It should be understood that the following embodiments are only exemplary descriptions 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 included in the scope 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] Embodiment 1-2

[0055]

[0056] Preparation process:

[0057] Add pantoprazole sodium, sodium bicarbonate and sodium carboxymethyl starch in the above prescription into a hopper mixer, set the mixing speed to 10 rpm, mix for 30 minutes, then add sodium stearyl fumarate and mix for 5 minutes; press the mixed powder into tablets according to the theoretical tablet weight, and then coat them with a 10% concentration of 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.

[0058] Embodiment 3-4

[0059]

[0060] Preparation process:

[0061] The pantoprazole sodium, sodium bicarbonate and povidone K30 in the above prescription are added to a wet granulation mixer, the stirring speed is set to 150 rpm, the cutting speed is set to 800 rpm, and the mixture is mixed for 10 minutes. Then, a soft material is prepared with 50% ethanol, and the soft material is passed through an 18-mesh sieve for wet granulation to obtain wet granules. The wet granules are then placed in a blast drying oven, the drying temperature is set to 50° C., and after drying to a moisture content of less than 2.0%, the granules are 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 are then added to a hopper mixer, sodium carboxymethyl starch and sodium stearyl fumarate are added, the mixing speed is set to 10 rpm, and the mixture is mixed for 10 minutes. The obtained pantoprazole sodium bicarbonate total mixed granules are filled into capsules to obtain pantoprazole sodium bicarbonate capsules.

[0062] Detection methods of related substances in Examples 5-8:

[0063] A high performance liquid chromatograph was used with a Zhongpu Technology XR-C18, 4.6 mm × 250 mm, 5 μm chromatographic 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 to detect related substances in pantoprazole sodium.

[0064] Embodiment 5-6

[0065] Pantoprazole sodium, sodium bicarbonate, cross-linked polyvinylpyrrolidone, sodium carboxymethyl starch, and low-substituted hydroxypropyl cellulose were left open at high temperature of 60°C for 10 days to investigate the compatibility of raw materials and excipients. The results are shown in the following table:

[0066]

[0067] The test results show that when sodium carboxymethyl starch and low-substituted hydroxypropyl cellulose are mixed with the raw material at a high temperature of 60°C for 10 days, the related substances increase significantly, and the compatibility is poor; when cross-linked polyvinylpyrrolidone is mixed with the raw material at a high temperature of 60°C for 10 days, the related substances basically do not change, and the compatibility is good. Therefore, cross-linked polyvinylpyrrolidone is preferably used as the disintegrant.

[0068] According to the results of compatibility studies, cross-linked polyvinylpyrrolidone was used as a disintegrant to further evaluate the effect of its dosage on product quality.

[0069]

[0070] 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 mixing, add sodium stearyl fumarate, set the mixing speed to 10 rpm, and mix for 10 minutes; Step 4: after mixing, sieve and disperse through a 50-mesh sieve; Step 5: add the sieved material into a 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.

[0071] The samples prepared above were subjected to dissolution curve comparison using the paddle method at 75 rpm, 900 ml, pH 7.4 phosphate buffer, as shown in the following table:

[0072]

[0073] 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 >85%. The dissolution rate was fast, which was in line with expectations.

[0074] Example 8

[0075] 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 following table:

[0076]

[0077] The test results show that when magnesium stearate and the raw material drug mixture are placed under high humidity 92.5% RH for 10 days, the related substances increase significantly, and the compatibility is poor; when calcium stearate and sodium stearyl fumarate are placed under high temperature 60°C and high humidity 92.5% RH for 10 days, the related substances increase less, and the compatibility is good. Therefore, sodium stearyl fumarate is the preferred lubricant.

[0078] 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 amounts on product dissolution and fluidity of the total mixed material.

[0079]

[0080] The angle of repose of the total mixed material prepared above was tested; the dissolution curve of the capsule was compared using the paddle method at 75 rpm, 900 ml, pH 7.4 phosphate buffer. The results are shown in the following table:

[0081]

[0082] The test results show that the proportion of sodium stearyl fumarate in each capsule is in the range of 0.85% to 1.28%, the cumulative dissolution in 30 minutes is greater than 85%, and the product dissolution is in line with expectations. The angle of repose of the total mixed material is less than 45°, and the fluidity meets the filling requirements.

[0083] Example 9

[0084] 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.

[0085]

[0086] The test results show that this product has good mixing uniformity and meets product requirements.

[0087] Example 10

[0088] 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 medicine, and the pantoprazole content was used to evaluate the rationality of the sodium bicarbonate dosage.

[0089] Prepare a medium of 72 ml pH 1.2 hydrochloric acid solution + 240 ml purified water, test the pH value, and add it to the dissolution cup; take the above sample, stir it at 50 rpm for 30 min, stop, and test the pH value; take a sample and add alkaline solution for protection to test the content of pantoprazole.

[0090]

[0091] 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 to prevent degradation of the active ingredient.

[0092] Detection method of pantoprazole content:

[0093] The content of pantoprazole was detected by using a 4.6 mm × 150 mm, 5 μm chromatographic column (XR-C18) from Zhongpu Technology and a 0.001 mol / L sodium hydroxide solution-acetonitrile (1:1) solvent.

[0094] The above research results show that when pantoprazole sodium is used in combination with sodium bicarbonate, sodium bicarbonate can help pantoprazole sodium maintain a stable state in an acidic environment and exert a good pharmacological effect.

[0095] The above is an explanation of the embodiments of the present invention. However, the present invention is not limited to the above embodiments. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope 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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