Ibuprofen pharmaceutical composition, preparation method and application

Abstract

The present invention discloses an ibuprofen pharmaceutical composition, a preparation method, and an application. The ibuprofen pharmaceutical composition provided by the present invention comprises the following components: ibuprofen, a sustained-release matrix material, a suspending agent, a flavoring agent, and a pH regulator; the sustained-release matrix material is glyceryl behenate and ethyl cellulose. The ibuprofen pharmaceutical composition prepared by the present invention can rapidly release part of the drug and continuously release part of the drug. It is convenient to carry and transport, has good stability, is easy to take, and has a sustained-release effect of up to 12 hours, which reduces the number of times patients take the drug and the peaks and valleys in blood drug concentration seen with conventional dosage forms, thereby maintaining blood drug concentration within a relatively stable and long-lasting effective range and improving drug safety.

Description

[0001] This application is a divisional application of the invention patent application with the application date of November 24, 2020, application number 202011331064.1, and invention name "Ibuprofen pharmaceutical composition, preparation method and application".

[0002] This application claims priority to the following prior application: Patent application number 201911165219.6, filed with the State Intellectual Property Office of China on November 25, 2019, entitled “Ibuprofen Pharmaceutical Composition, Preparation Method, and Use.” The entire text of the prior application is incorporated herein by reference. Technical Field

[0003] The present invention belongs to the field of medicine, and in particular relates to an ibuprofen pharmaceutical composition, a preparation method and an application thereof. Background Art

[0004] Ibuprofen has anti-inflammatory, analgesic, and antipyretic properties and is suitable for treating rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and neuritis, making it a mainstay of antipyretic and analgesic treatments. However, due to its low solubility in water, ibuprofen has low bioavailability.

[0005] In the patent document CN101068532, an improved oral solid preparation of ibuprofen is proposed, in which at least 20% of the ibuprofen is released within 2 hours, and then the ibuprofen is released at a relatively constant rate for at least 8 hours. However, its preparation process mostly adopts direct compression of powder and pressing into a single tablet. The fluidity of ibuprofen is poor, and it is difficult to control the rapid release and slow sustained release of the single tablet. The release effect is not ideal, and industrial production is difficult. In the patent document CN201910438690.1, a double-layer ibuprofen rapid-release and sustained-release tablet and a preparation method thereof are provided. The dosage form consists of an ibuprofen rapid-release layer and an ibuprofen sustained-release layer. Ibuprofen is dispersed in the rapid-release layer and the sustained-release layer in a certain proportion, which can provide rapid release and subsequent slow release for 12 hours, thereby achieving the effect of rapid onset and continuous maintenance of effective blood drug concentration. However, the excipients used in the two-layer tablets are different, and two wet granulations are required before tableting, and the process is relatively complicated and cumbersome. Therefore, finding a technology with simple process and easy operation to prepare an appropriate dosage form of ibuprofen, thereby improving bioavailability and achieving a sustained-release effect is a technical problem that urgently needs to be solved. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to provide an ibuprofen pharmaceutical composition, preparation method, and application thereof in order to overcome the defects of the prior art ibuprofen suspension, such as poor sustained-release effect and unsatisfactory dissolution effect. The ibuprofen pharmaceutical composition of the present invention can release the drug partially rapidly and partially continuously, is convenient to carry and transport, has good stability, is easy to take, and has a sustained-release effect of up to 12 hours. This reduces the number of medications a patient takes and the peaks and valleys in blood drug concentration seen with conventional dosage forms, thereby maintaining blood drug concentration within a relatively stable and long-lasting effective range and improving drug safety.

[0007] The invention provides an ibuprofen pharmaceutical composition, which comprises the following components: ibuprofen, a sustained-release matrix material, a suspending agent, a flavoring agent and a pH regulator; the sustained-release matrix material is glyceryl behenate and ethyl cellulose.

[0008] According to an embodiment of the present invention, the ibuprofen can be a conventional commercially available ibuprofen bulk drug, or an ibuprofen bulk drug prepared with reference to relevant literature.

[0009] According to an embodiment of the present invention, the particle size of the ibuprofen is preferably 10 mesh to 60 mesh, more preferably 16 mesh to 50 mesh, for example 16 mesh to 45 mesh, 16 mesh to 30 mesh or 20 mesh to 50 mesh.

[0010] According to an embodiment of the present invention, the suspending agent can be a conventional suspending agent in the art, preferably selected from one or more of hydroxypropyl cellulose (HPC), xanthan gum and hydroxypropyl methylcellulose (HPMC), more preferably xanthan gum.

[0011] According to an embodiment of the present invention, the flavoring agent may be a conventional flavoring agent in the art, preferably one or more of essence, sucrose, sucralose and aspartame, more preferably essence and / or sucrose.

[0012] According to an embodiment of the present invention, the pH regulator is an organic acid capable of adjusting the pH of the ibuprofen pharmaceutical composition suspended in water to 3.0-4.0, preferably malic acid and / or citric acid.

[0013] According to an embodiment of the present invention, the ibuprofen pharmaceutical composition preferably comprises the following components: each component is calculated by mass fraction, 9.0% to 12.0% ibuprofen, 20.0% to 25.0% glyceryl behenate, 1.0% to 2.0% ethyl cellulose, 2.0% to 3.0% suspending agent, 60% to 68% flavoring agent and 0.5% to 1.0% pH regulator, where the mass fraction refers to the percentage of the mass of a single component to the total mass of the ibuprofen pharmaceutical composition.

[0014] According to an embodiment of the present invention, the ibuprofen pharmaceutical composition preferably comprises the following components: each component is calculated by mass fraction, 9.5% to 11.5% ibuprofen, 21.0% to 23.0% glyceryl behenate, 1.3% to 1.8% ethyl cellulose, 2.3% to 2.8% suspending agent, 62% to 66% flavoring agent and 0.6% to 0.9% pH regulator, where the mass fraction refers to the percentage of the mass of a single component to the total mass of the ibuprofen pharmaceutical composition.

[0015] According to an embodiment of the present invention, the ibuprofen pharmaceutical composition is further preferably composed of the following components: each component is calculated by mass fraction, 10.72% ibuprofen, 21.44% glyceryl behenate, 1.69% ethyl cellulose, 2.14% suspending agent, 63.29% flavoring agent, and 0.72% pH regulator, where the mass fraction refers to the percentage of the mass of a single component to the total mass of the ibuprofen pharmaceutical composition.

[0016] According to an embodiment of the present invention, the ibuprofen pharmaceutical composition is further preferably composed of the following components: each component is calculated by mass fraction, 10.67% ibuprofen, 21.34% glyceryl behenate, 1.68% ethyl cellulose, 2.56% suspending agent, 63.03% flavoring agent, and 0.72% pH regulator, where the mass fraction refers to the percentage of the mass of a single component to the total mass of the ibuprofen pharmaceutical composition.

[0017] The present invention also provides a method for preparing the ibuprofen pharmaceutical composition, which comprises the following steps:

[0018] Step 1: mixing ibuprofen with a sustained-release matrix material to obtain a mixture;

[0019] Step 2: hot-melt extruding the mixture obtained in step 1 to obtain a hot-melt extrudate;

[0020] Step 3: crushing the hot melt extrudate obtained in step 2 to obtain a crushed product;

[0021] Step 4: Mix the ground product obtained in step 3 with a suspending agent, a flavoring agent, and a pH regulator to obtain an ibuprofen pharmaceutical composition.

[0022] According to an embodiment of the present invention, in step 2, the temperature of the hot melt extrusion is preferably 55° C. to 70° C., more preferably 60° C. to 70° C. The hot melt extrusion is preferably performed in a hot melt extruder.

[0023] According to an embodiment of the present invention, in step 3, the particle size of the pulverized material is preferably 16 mesh to 45 mesh, and more preferably 16 mesh to 30 mesh.

[0024] According to an embodiment of the present invention, in step 4, the crushed material with a certain particle size range obtained in step 3 can be first mixed evenly with a suspending agent, a flavoring agent and a pH regulator, wet granulated, sieved, and dried, and then mixed evenly with a crushed material with a particle size of 16 to 30 mesh to obtain an ibuprofen pharmaceutical composition.

[0025] Preferably, the particle size range of the pulverized material within the certain particle size range may be 30 mesh to 60 mesh or less than 30 mesh.

[0026] Preferably, the sieving is through an 18-mesh sieve.

[0027] Preferably, the drying temperature is 30°C to 40°C, for example 35°C.

[0028] Preferably, the drying time is 1-4 hours, for example 2 hours.

[0029] The present invention also provides an ibuprofen pharmaceutical composition prepared by the preparation method of the ibuprofen pharmaceutical composition.

[0030] The present invention also provides use of the ibuprofen pharmaceutical composition in preparing a medicament for treating and / or alleviating mild to moderate pain diseases.

[0031] Without violating the common sense in the art, the above-mentioned preferred conditions can be arbitrarily combined to obtain preferred embodiments of the present invention.

[0032] The reagents and raw materials used in the present invention are all commercially available.

[0033] The beneficial effects of the present invention include: the ibuprofen pharmaceutical composition prepared by the present invention has the characteristics of a solid preparation, such as easy portability, convenient transportation, and good stability, and also has the advantages of a liquid preparation, such as being convenient to take and suitable for patients with swallowing difficulties, such as children and the elderly. Moreover, its sustained-release effect greatly reduces the number of times a patient takes the drug. After taking the ibuprofen pharmaceutical composition, the drug can quickly reach a therapeutic concentration in the body and then slowly release the drug to maintain the blood drug concentration within a relatively stable and long-lasting effective range, thereby reducing the peaks and valleys in blood drug concentration exhibited by conventional dosage forms and improving the safety of the drug. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 This is the dissolution curve of the ibuprofen pharmaceutical composition of Example 1.

[0035] Figure 2 This is the dissolution curve of the ibuprofen pharmaceutical composition of Example 2.

[0036] Figure 3 This is the dissolution curve of the ibuprofen pharmaceutical composition of Example 3.

[0037] Figure 4 This is the dissolution curve of the ibuprofen pharmaceutical composition of Example 4.

[0038] Figure 5 This is the dissolution curve of the ibuprofen pharmaceutical composition of Example 5.

[0039] Figure 6 This is the dissolution curve of the ibuprofen pharmaceutical composition of Example 6.

[0040] Figure 7 This is the dissolution curve of the ibuprofen pharmaceutical composition of Example 7.

[0041] Figure 8 This is the dissolution curve of the ibuprofen pharmaceutical composition of Example 8.

[0042] Figure 9 This is the dissolution curve of the ibuprofen pharmaceutical composition of Example 9. DETAILED DESCRIPTION

[0043] 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.

[0044] Unless otherwise specified, the raw materials and reagents used in the following examples are commercially available or can be prepared by known methods.

[0045] Example 1

[0046] Prescription of ibuprofen pharmaceutical composition

[0047] name Mass (mg / bottle) Mass percentage (%) Ibuprofen 100 10.67 Glyceryl Behenate 200 21.34 Ethyl cellulose 15.78 1.68 Xanthan gum 24 2.56 essence 40.53 4.33 Sucrose (fine powder) 550 58.70 citric acid 6.69 0.72 total 937 100.00

[0048] Preparation process:

[0049] After setting the temperature and other parameters of the hot melt extruder (60° C. to 70° C.) according to the properties of the materials, the mixed mixture of ibuprofen, glyceryl behenate and ethyl cellulose was slowly added into the hot melt extruder to obtain a hot melt extrudate.

[0050] The obtained hot melt extrudate was crushed into particles, and a suitable particle size range (16 mesh to 45 mesh) was selected. Other excipients (suspending agent, flavoring agent and pH adjuster) in the above prescription were added and mixed. After mixing evenly, samples were taken per unit prescription amount. The dissolution data of the prepared ibuprofen pharmaceutical composition are shown in Table 1, and the dissolution curve is shown in Table 1. Figure 1 .

[0051] Table 1 Dissolution data of ibuprofen pharmaceutical composition

[0052] Time (min) Cumulative dissolution (%) RSD (%) 5 24.90 4.9 15 32.20 4.1 30 41.00 4.2 60 51.40 4.4 120 62.20 5.4 240 67.40 5.9 360 82.70 12.2 480 86.00 10.6 600 83.40 9.5 720 84.10 10.5

[0053] Example 2

[0054] Prescription of ibuprofen pharmaceutical composition

[0055] name mg / bottle Mass percentage (%) Ibuprofen 100 10.67 Glyceryl Behenate 200 21.34 Ethyl cellulose 15.78 1.68 Xanthan gum 24 2.56 essence 40.53 4.33 Sucrose (granules) 550 58.70 citric acid 6.69 0.72 total 937 100.00

[0056] Preparation process:

[0057] After setting the temperature and other parameters of the hot melt extruder (60° C. to 70° C.) according to the properties of the materials, the mixed mixture of ibuprofen, glyceryl behenate, and ethyl cellulose was slowly added to the hot melt extruder to obtain a hot melt extrudate.

[0058] The hot melt extrudate was crushed into particles, and the appropriate particle size range (16 mesh to 30 mesh) was selected. Other excipients (suspending agent, flavoring agent and pH regulator) were added and mixed. After mixing evenly, samples were taken per unit prescription amount. The dissolution data of the prepared ibuprofen pharmaceutical composition are shown in Table 2, and the dissolution curve is shown in Figure 2 .

[0059] Table 2 Dissolution data of ibuprofen pharmaceutical composition

[0060] Time (min) Cumulative dissolution (%) RSD (%) 5 17.40 10.4 15 26.30 10.6 30 34.00 10.4 60 43.50 10.3 120 53.90 10.7 240 64.20 11.0 360 69.60 11.2 480 72.70 11.5 600 74.70 11.7 720 76.10 11.7

[0061] Example 3

[0062] Prescription of ibuprofen pharmaceutical composition

[0063] name mg / bottle Mass percentage (%) Ibuprofen 100 10.67 Glyceryl Behenate 200 21.34 Ethyl cellulose 15.78 1.68 Xanthan gum 24 2.56 essence 40.53 4.33 sucrose 550 58.70 citric acid 6.69 0.72 total 937 100.00

[0064] Preparation process:

[0065] After setting the temperature of the hot melt extruder (60° C. to 70° C.) and other parameters according to the properties of the materials, the mixed mixture of ibuprofen, glyceryl behenate and ethyl cellulose was slowly added into the hot melt extruder to obtain a hot melt extrudate.

[0066] The hot melt extrudate was crushed into particles, and a suitable particle size range (20 mesh to 50 mesh) was selected. Other excipients (suspending agent, flavoring agent and pH regulator) were added and mixed. After uniform mixing, samples were taken per unit prescription amount. The dissolution data of the prepared ibuprofen pharmaceutical composition are shown in Table 3, and the dissolution curve is shown in Figure 3 .

[0067] Table 3 Dissolution data of ibuprofen pharmaceutical composition

[0068] Time (min) Cumulative dissolution (%) RSD (%) 5 25.6 3.6 15 37.10 2.9 30 46.80 2.4 60 58.00 2.4 120 69.50 2.8 240 79.90 3.1 360 84.70 3.4 480 87.40 3.7 600 89.00 3.6 720 90.00 3.8

[0069] Example 4

[0070] Prescription of ibuprofen pharmaceutical composition

[0071] name mg / bottle Mass percentage (%) Ibuprofen 100 10.67 Glyceryl Behenate 200 21.34 Ethyl cellulose 15.78 1.68 Xanthan gum 24 2.56 essence 40.53 4.33 sucrose 550 58.70 citric acid 6.69 0.72 total 937 100.00

[0072] Preparation process:

[0073] After setting the temperature of the hot melt extruder (60° C. to 70° C.) and other parameters according to the properties of the materials, the mixed mixture of ibuprofen, glyceryl behenate and ethyl cellulose was slowly added into the hot melt extruder to obtain a hot melt extrudate.

[0074] The hot melt extrudate was crushed into granules, and the appropriate particle size range (30 mesh to 60 mesh) was selected. Other excipients (suspending agent, flavoring agent and pH regulator) were added and mixed evenly. Then, wet granulation was performed and passed through an 18-mesh sieve. After drying in an oven at 35°C for 2 hours, 16-30 mesh ibuprofen granules were added and mixed evenly. Samples were taken per unit prescription. The dissolution data of the prepared ibuprofen pharmaceutical composition are shown in Table 4, and the dissolution curve is shown in Table 4. Figure 4 .

[0075] Table 4 Dissolution data of Ibuprofen drug composition

[0076] Time (min) Cumulative dissolution (%) RSD (%) 5 18.4 2.8 15 28.9 1.8 30 37.8 1.7 60 48.3 1.6 120 60.9 1.6 240 74.6 1.9 360 82.2 2.1 480 87.6 2.3 600 90.8 2.6 720 93.1 2.6

[0077] Example 5

[0078] Prescription of ibuprofen pharmaceutical composition

[0079] name mg / bottle Mass percentage (%) Ibuprofen 100 10.67 Glyceryl Behenate 200 21.34 Ethyl cellulose 15.78 1.68 Xanthan gum 24 2.56 essence 40.53 4.33 sucrose 550 58.70 citric acid 6.69 0.72 total 937 100.00

[0080] Preparation process:

[0081] After setting the temperature and other parameters of the hot melt extruder according to the properties of the materials, the mixed mixture of ibuprofen, glyceryl behenate and ethyl cellulose is slowly added into the hot melt extruder to obtain a hot melt extrudate.

[0082] The hot melt extrudate was crushed into granules with a particle size range of 16-30 mesh: 30-60 mesh: <60 mesh = 2:1:1. The <30 mesh granules were added with other excipients (suspending agents, flavoring agents and pH regulators) and mixed evenly, and then wet granulated through an 18-mesh sieve. After drying in a 35°C oven for 2 hours, the 16-30 mesh hot melt extruded ibuprofen granules were added, mixed evenly, and samples were taken per unit prescription. The dissolution data of the prepared ibuprofen pharmaceutical composition are shown in Table 5, and the dissolution curve is shown in Figure 5 .

[0083] Table 5 Dissolution data of ibuprofen pharmaceutical composition

[0084] Time (min) Cumulative dissolution (%) RSD (%) 5 24.9 4.6 15 38.7 3.8 30 48.5 3.8 60 58.9 3.1 120 69.3 2.3 240 79.5 1.9 360 84.6 1.3 480 92.4 0.9 600 94.8 0.6 720 96.0 0.4

[0085] Example 6

[0086] Prescription of ibuprofen pharmaceutical composition

[0087] name mg / bottle Mass percentage (%) Ibuprofen 100 10.67 Glyceryl Behenate 200 21.34 Ethyl cellulose 15.78 1.68 Xanthan gum 24 2.56 essence 40.53 4.33 sucrose 550 58.70 citric acid 6.69 0.72 total 937 100.00

[0088] Preparation process:

[0089] After setting the temperature of the hot melt extruder (60° C. to 70° C.) and other parameters according to the properties of the materials, the mixed mixture of ibuprofen, glyceryl behenate and ethyl cellulose was slowly added to the hot melt extruder, and the hot melt extrudate was collected.

[0090] The hot melt extrudate was crushed into granules with a particle size range of 16-30 mesh: 30-60 mesh: <60 mesh = 5:4:1. After adding other excipients and mixing evenly, the <30 mesh granules were wet granulated and passed through an 18 mesh sieve. After drying in a 35°C oven for 2 hours, the 16-30 mesh hot melt extruded ibuprofen granules were added, mixed evenly, and samples were taken per unit prescription. The dissolution data of the prepared ibuprofen pharmaceutical composition are shown in Table 6, and the dissolution curve is shown in Table 6. Figure 6 .

[0091] Table 6 Dissolution data of ibuprofen pharmaceutical composition

[0092] Time (min) Cumulative dissolution (%) RSD (%) 5 18.2 3.6 15 31.8 2.9 30 42.3 2.4 60 54.4 2.8 120 66.7 3.1 240 78.0 1.9 360 83.5 3.6 480 91.8 0.8 600 94.5 0.4 720 95.4 0.3

[0093] Example 7

[0094] Prescription of ibuprofen pharmaceutical composition

[0095] name mg / bottle Mass percentage (%) Ibuprofen 100 10.67 Glyceryl Behenate 200 21.34 Ethyl cellulose 15.78 1.68 Xanthan gum 24 2.56 essence 40.53 4.33 sucrose 550 58.70 citric acid 6.69 0.72 total 937 100

[0096] Preparation process:

[0097] After setting the temperature of the hot melt extruder (60° C. to 70° C.) and other parameters according to the properties of the materials, the mixed mixture of ibuprofen, glyceryl behenate and ethyl cellulose was slowly added to the hot melt extruder, and the hot melt extrudate was collected.

[0098] The hot melt extrudate was crushed into granules with a particle size range of 16-30 mesh: 30-60 mesh: <60 mesh = 3:3:4. After adding other excipients and mixing evenly, the <30 mesh granules were wet granulated and passed through an 18 mesh sieve. After drying in a 35°C oven for 2 hours, the 16-30 mesh hot melt extruded ibuprofen granules were added, mixed evenly, and samples were taken per unit prescription. The dissolution data of the prepared ibuprofen pharmaceutical composition are shown in Table 7, and the dissolution curve is shown in Figure 7 .

[0099] Table 7 Dissolution data of ibuprofen pharmaceutical composition

[0100] Time (min) Cumulative dissolution (%) RSD (%) 5 33.2 3.2 15 49.7 1.9 30 60.3 1.9 60 70.0 2.3 120 78.6 2.8 240 86.0 3.8 360 89.4 1.7 480 94.6 0.6 600 96.4 0.6 720 96.9 0.9

[0101] Example 8

[0102] Ibuprofen suspension (commercially available) (Shanghai Johnson & Johnson Pharmaceutical Co., Ltd., batch number: 190603296), its dissolution data are shown in Table 8, and the dissolution curve is shown in Figure 8 .

[0103] Table 8 Dissolution data of ibuprofen suspension

[0104] Time (min) Cumulative dissolution (%) RSD (%) 5 62.30 6.3 15 83.40 1.4 30 93.40 0.9 60 97.80 1.0 120 99.10 1.2

[0105] Example 9

[0106] Ibuprofen sustained-release suspension (commercially available) (Sichuan Zhongfang Pharmaceutical Co., Ltd., batch number: 180404), its dissolution data are shown in Table 9, and the dissolution curve is shown in Figure 9 .

[0107] Table 9 Dissolution data of ibuprofen suspension

[0108]

[0109]

[0110] As can be seen from the above examples, the ibuprofen pharmaceutical composition of the present invention can achieve rapid release and slow sustained release, the drug takes effect quickly in the body, and maintains an effective drug concentration for a long time, thereby achieving the effects of reducing drug dosage, improving drug efficacy, prolonging drug action time, and reducing adverse drug reactions.

[0111] 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. An ibuprofen pharmaceutical composition, characterized in that The ibuprofen pharmaceutical composition is composed of the following components: 9.5% to 11.5% ibuprofen, 21.0% to 23.0% glyceryl behenate, 1.3% to 1.8% ethyl cellulose, 2.3% to 2.8% suspending agent, 62% to 66% flavoring agent, and 0.6% to 0.9% pH adjuster, calculated by mass fraction. The mass fraction refers to the percentage of the mass of a single component to the total mass of the ibuprofen pharmaceutical composition. Glyceryl behenate and ethylcellulose constitute the sustained-release matrix material; The pH regulator is an organic acid that can adjust the pH of the ibuprofen pharmaceutical composition suspended in water to 3.0-4.

0.

2. The ibuprofen pharmaceutical composition according to claim 1, wherein: The particle size of the ibuprofen is 10 meshes to 60 meshes.

3. The ibuprofen pharmaceutical composition according to claim 1, wherein: The suspending agent is one or more of hydroxypropyl cellulose, xanthan gum and hydroxypropyl methylcellulose.

4. The ibuprofen pharmaceutical composition according to claim 1, wherein: The flavoring agent is one or more of essence, sucrose, sucralose and aspartame.

5. The ibuprofen pharmaceutical composition according to claim 1, wherein: The organic acid is malic acid and / or citric acid.

6. The method for preparing the ibuprofen pharmaceutical composition according to any one of claims 1 to 5, wherein: The preparation method comprises the following steps: Step 1: mixing ibuprofen with a sustained-release matrix material to obtain a mixture; Step 2: hot-melt extruding the mixture obtained in step 1 to obtain a hot-melt extrudate; Step 3: crushing the hot melt extrudate obtained in step 2 to obtain a crushed product; Step 4: Mix the ground product obtained in step 3 with a suspending agent, a flavoring agent, and a pH regulator to obtain an ibuprofen pharmaceutical composition.

7. The preparation method according to claim 6, characterized in that In step 2, the temperature of the hot melt extrusion is 55°C to 70°C; and / or, In step 2, the hot melt extrusion is carried out in a hot melt extruder; and / or, In step 3, the particle size of the crushed particles is 16 mesh to 45 mesh.

8. Use of the ibuprofen pharmaceutical composition according to any one of claims 1 to 5 in the preparation of a medicament for treating and / or alleviating mild to moderate pain diseases.

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