CN116211807A - Ibuprofen pharmaceutical composition, preparation method and application - Google Patents

Ibuprofen pharmaceutical composition, preparation method and application Download PDF

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CN116211807A
CN116211807A CN202310050722.7A CN202310050722A CN116211807A CN 116211807 A CN116211807 A CN 116211807A CN 202310050722 A CN202310050722 A CN 202310050722A CN 116211807 A CN116211807 A CN 116211807A
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ibuprofen
pharmaceutical composition
ibuprofen pharmaceutical
composition according
regulator
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应述欢
郭桢
王爱慧
王婷婷
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Shanghai Bocimed Pharmaceutical Co Ltd
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Shanghai Bocimed Pharmaceutical Co Ltd
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    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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Abstract

The invention discloses an ibuprofen pharmaceutical composition, a preparation method and application. The ibuprofen pharmaceutical composition provided by the invention comprises the following components: ibuprofen, a slow-release framework material, a suspending agent, a flavoring agent and a pH regulator; the slow-release framework material is glyceryl behenate and ethyl cellulose. The ibuprofen pharmaceutical composition prepared by the invention can enable part of the medicines to be released rapidly, part of the medicines are released continuously, the ibuprofen pharmaceutical composition is convenient to carry and transport, good in stability and convenient to take, the slow release effect of the ibuprofen pharmaceutical composition reaches 12 hours, the medicine taking times of patients are reduced, the peak-valley phenomenon of blood concentration of common dosage forms for administration is reduced, the blood concentration is kept in a stable and durable effective range, and the safety of the medicines is improved.

Description

Ibuprofen pharmaceutical composition, preparation method and application
The application is a divisional application of an invention patent application with the application date of 2020, 11 months and 24 days, the application number of 202011331064.1 and the name of ibuprofen pharmaceutical composition, preparation method and application.
This application claims priority from the following prior applications: patent application number 201911165219.6 filed in 11.25.2019 to China national intellectual property agency is a prior application named as ibuprofen pharmaceutical composition, preparation method and application. The entirety of the prior application is incorporated by reference into this application.
Technical Field
The invention belongs to the field of medicines, and particularly relates to an ibuprofen pharmaceutical composition, a preparation method and application.
Background
Ibuprofen has the effects of resisting inflammation, relieving pain and relieving fever, is suitable for treating rheumatic arthritis, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, neuritis and the like, and is a support product for relieving fever and relieving pain. But the bioavailability of ibuprofen is lower due to its lower solubility in water.
In the patent document of CN101068532, an improved ibuprofen oral solid preparation is proposed, at least 20% of ibuprofen is released within 2 hours, and then ibuprofen is released within at least 8 hours at a relatively constant rate, but the preparation process mostly adopts powder direct compression and pressing into a single tablet, the ibuprofen has poor fluidity, the difficulty of single tablet controlling rapid release and slow sustained release is great, the release effect is not ideal, and the difficulty of industrial production is great. In the patent document of CN201910438690.1, an ibuprofen quick-release and slow-release double-layer tablet and a preparation method thereof are provided, the dosage form consists of an ibuprofen quick-release layer and an ibuprofen slow-release layer, and ibuprofen is dispersed in the quick-release layer and the slow-release layer according to a certain proportion, so that the quick release and the subsequent slow release for 12 hours can be provided, and the effects of quick acting and continuous maintenance of effective blood concentration can be achieved. However, the two layers of tablets have different auxiliary materials, and the two layers of tablets need to be granulated by a wet method for two times and then are tabletted, so that the process is complex and complicated. Therefore, finding a technology with simple process and simple operation to prepare a proper dosage form of ibuprofen, thereby improving bioavailability and achieving a slow release effect is a technical problem which needs to be solved at present.
Disclosure of Invention
The invention aims to overcome the defects of poor slow release effect, poor dissolution effect and the like of ibuprofen suspension in the prior art and provides an ibuprofen pharmaceutical composition, a preparation method and application. The ibuprofen pharmaceutical composition can enable the medicine to be released partially rapidly and partially continuously, is convenient to carry and transport, has good stability, is convenient to take, has a slow release effect for 12 hours, reduces the times of taking medicine by patients, reduces the peak-valley phenomenon of blood concentration of common dosage forms, keeps the blood concentration in a relatively stable and durable effective range, and improves the safety of the medicine.
The invention provides an ibuprofen pharmaceutical composition, which comprises the following components: ibuprofen, a slow-release framework material, a suspending agent, a flavoring agent and a pH regulator; the slow-release framework material is glyceryl behenate and ethyl cellulose.
According to the embodiment of the invention, the ibuprofen can be a conventional commercial ibuprofen bulk drug or an ibuprofen bulk drug prepared by referring to corresponding literature.
According to an embodiment of the present invention, the particle size of the ibuprofen is preferably 10 to 60 mesh, more preferably 16 to 50 mesh, for example 16 to 45 mesh, 16 to 30 mesh or 20 to 50 mesh.
According to an embodiment of the present invention, the suspending agent may be a conventional suspending agent in the art, preferably one or more selected from hydroxypropyl cellulose (HPC), xanthan gum and hydroxypropyl methylcellulose (HPMC), and more preferably xanthan gum.
According to embodiments of the present invention, the flavoring agent may be a conventional flavoring agent in the art, preferably one or more of flavor, sucrose, sucralose, and aspartame, further preferably flavor and/or sucrose.
According to an embodiment of the present invention, the pH adjuster is an organic acid, preferably malic acid and/or citric acid, capable of adjusting the pH of the suspension of the ibuprofen pharmaceutical composition in water to 3.0-4.0.
According to an embodiment of the present invention, the ibuprofen pharmaceutical composition preferably comprises the following components: the components adopt mass fraction of 9.0-12.0% ibuprofen, 20.0-25.0% glyceryl behenate, 1.0-2.0% ethylcellulose, 2.0-3.0% suspending agent, 60-68% flavoring agent and 0.5-1.0% pH regulator, wherein the mass fraction refers to the mass of single component accounting for the total mass of the ibuprofen pharmaceutical composition.
According to an embodiment of the present invention, the ibuprofen pharmaceutical composition preferably comprises the following components: the components adopt mass fraction of 9.5% -11.5% of ibuprofen, 21.0% -23.0% of glyceryl behenate, 1.3% -1.8% of ethylcellulose, 2.3% -2.8% of suspending agent, 62% -66% of flavoring agent and 0.6% -0.9% of pH regulator, wherein the mass fraction refers to the mass of single component accounting for the total mass of the ibuprofen pharmaceutical composition.
According to an embodiment of the present invention, the ibuprofen pharmaceutical composition, even further preferably, consists of the following components: the components are calculated by mass fraction, namely, the mass fraction of the single component accounts for the total mass of the ibuprofen pharmaceutical composition, wherein the mass fraction comprises 10.72% of ibuprofen, 21.44% of glyceryl behenate, 1.69% of ethylcellulose, 2.14% of suspending agent, 63.29% of flavoring agent and 0.72% of pH regulator.
According to an embodiment of the present invention, the ibuprofen pharmaceutical composition, even further preferably, consists of the following components: the components adopt mass fraction, namely, 10.67% of ibuprofen, 21.34% of glyceryl behenate, 1.68% of ethylcellulose, 2.56% of suspending agent, 63.03% of flavoring agent and 0.72% of pH regulator, wherein the mass fraction refers to the percentage of the mass of the single component in the total mass of the ibuprofen pharmaceutical composition.
The invention also provides a preparation method of the ibuprofen pharmaceutical composition, which comprises the following steps:
step 1: mixing ibuprofen with a slow-release framework material to obtain a mixture;
step 2: carrying out hot melt extrusion on the mixture obtained in the step 1 to obtain a hot melt extrudate;
step 3: crushing the hot melt extrudate obtained in the step 2 to obtain a crushed material;
step 4: mixing the crushed material obtained in the step 3 with a suspending agent, a flavoring agent and a pH regulator to obtain the ibuprofen pharmaceutical composition.
According to an embodiment of the present invention, in step 2, the temperature of the hot melt extrusion is preferably 55 to 70 ℃, and more preferably 60 to 70 ℃. The hot-melt extrusion is preferably carried out in a hot-melt extruder.
According to an embodiment of the present invention, in step 3, the particle size of the pulverized product is preferably 16 to 45 mesh, more preferably 16 to 30 mesh.
According to the embodiment of the invention, in the step 4, the crushed material with a certain particle size range obtained in the step 3, a suspending agent, a flavoring agent and a pH regulator are uniformly mixed, wet granulation, sieving and drying are performed, and the mixture is uniformly mixed with the crushed material with 16-30 meshes to obtain the ibuprofen pharmaceutical composition.
Preferably, the particle size of the crushed material of the certain particle size range may be 30 mesh to 60 mesh or less than 30 mesh.
Preferably, the sieving is an 18 mesh sieve.
Preferably, the temperature of the drying is from 30 ℃ to 40 ℃, for example 35 ℃.
Preferably, the drying time is 1-4 hours, for example 2 hours.
The invention also provides the ibuprofen pharmaceutical composition prepared by the preparation method of the ibuprofen pharmaceutical composition.
The invention also provides application of the ibuprofen pharmaceutical composition in preparing medicines for treating and/or relieving mild to moderate pain diseases.
The above preferred conditions can be arbitrarily combined on the basis of not deviating from the common knowledge in the art, and thus, each preferred embodiment of the present invention can be obtained.
The reagents and materials used in the present invention are commercially available.
The beneficial effects of the invention include: the ibuprofen pharmaceutical composition prepared by the invention not only has the characteristics of solid preparation, such as convenient carrying, convenient transportation, good stability and the like, but also has the advantages of liquid preparation, is convenient to take, is suitable for patients with dysphagia, such as children and old people, and has a slow release effect greatly reducing the taking times of patients. After the medicine is taken, the medicine can quickly reach the treatment concentration in the body, and then the medicine is slowly released to keep the blood concentration in a relatively stable and durable effective range, so that the peak-valley phenomenon of the blood concentration presented by the administration of the common dosage form is reduced, and the safety of the medicine is improved.
Drawings
Fig. 1 is a dissolution profile of the ibuprofen pharmaceutical composition of example 1.
Fig. 2 is a dissolution profile of the ibuprofen pharmaceutical composition of example 2.
Fig. 3 is a dissolution profile of the ibuprofen pharmaceutical composition of example 3.
Fig. 4 is a dissolution profile of the ibuprofen pharmaceutical composition of example 4.
Fig. 5 is a dissolution profile of the ibuprofen pharmaceutical composition of example 5.
Fig. 6 is a dissolution profile of the ibuprofen pharmaceutical composition of example 6.
Fig. 7 is a dissolution profile of the ibuprofen pharmaceutical composition of example 7.
Fig. 8 is a dissolution profile of the ibuprofen pharmaceutical composition of example 8.
Fig. 9 is a dissolution profile of the ibuprofen pharmaceutical composition of example 9.
Detailed Description
The technical scheme of the invention will be further described in detail below with reference to specific embodiments. It is to be understood that the following examples are illustrative only and are not to be construed as limiting the scope of the invention. All techniques implemented based on the above description of the invention are intended to be included within the scope of the invention.
Unless otherwise indicated, the starting materials and reagents used in the following examples were either commercially available or may be prepared by known methods.
Example 1
Prescription of ibuprofen pharmaceutical composition
Name of the name Quality (mg/bottle) Mass percent (%)
Ibuprofen 100 10.67
Glyceryl behenate 200 21.34
Ethylcellulose 15.78 1.68
(Xanthan)Glue 24 2.56
Essence 40.53 4.33
Sucrose (Fine powder) 550 58.70
Citric acid 6.69 0.72
Totals to 937 100.00
The preparation process comprises the following steps:
according to the properties of each material, setting parameters such as the temperature of a hot-melt extruder (60-70 ℃), and slowly adding the mixed mixture of ibuprofen, glyceryl behenate and ethyl cellulose into the hot-melt extruder to obtain a hot-melt extrudate.
The obtained hot melt extrudate is crushed into particles, and other auxiliary materials (suspending agent, flavoring agent and pH regulator) in the prescription are added and mixed with the particles with proper particle size range (16-45 meshes). After mixing uniformly, sampling the unit prescription amount. The dissolution data of the obtained ibuprofen pharmaceutical composition are shown in table 1, and the dissolution curve is shown in fig. 1.
Table 1 dissolution data table for ibuprofen pharmaceutical compositions
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
Example 2
Prescription of ibuprofen pharmaceutical composition
Name of the name mg/bottle Mass percent (%)
Ibuprofen 100 10.67
Glyceryl behenate 200 21.34
Ethylcellulose 15.78 1.68
Xanthan gum 24 2.56
Essence 40.53 4.33
Sucrose (granule) 550 58.70
Citric acid 6.69 0.72
Totals to 937 100.00
The preparation process comprises the following steps:
according to the properties of each material, setting parameters such as the temperature of a hot-melt extruder (60-70 ℃), and slowly adding the mixed mixture of ibuprofen, glyceryl behenate and ethyl cellulose into the hot-melt extruder to obtain a hot-melt extrudate.
The hot melt extrudate is crushed into particles, and other auxiliary materials (suspending agent, flavoring agent and pH regulator) are added and mixed with the particles with a proper particle size range (16-30 meshes). After mixing uniformly, sampling the unit prescription amount. The dissolution data of the prepared ibuprofen pharmaceutical composition are shown in table 2, and the dissolution curve is shown in fig. 2.
Table 2 dissolution data of ibuprofen pharmaceutical compositions
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
Example 3
Prescription of ibuprofen pharmaceutical composition
Name of the name mg/bottle Mass percent (%)
Ibuprofen 100 10.67
Glyceryl behenate 200 21.34
Ethylcellulose 15.78 1.68
Xanthan gum 24 2.56
Essence 40.53 4.33
Sucrose 550 58.70
Citric acid 6.69 0.72
Totals to 937 100.00
The preparation process comprises the following steps:
according to the properties of each material, setting parameters such as the temperature (60-70 ℃) of a hot-melt extruder, and slowly adding the mixed mixture of ibuprofen, glyceryl behenate and ethyl cellulose into the hot-melt extruder to obtain a hot-melt extrudate.
The hot melt extrudate is crushed into particles, and other auxiliary materials (suspending agent, flavoring agent and pH regulator) are added and mixed with the particles with a proper particle size range (20-50 meshes). After mixing uniformly, sampling the unit prescription amount. The dissolution data of the obtained ibuprofen pharmaceutical composition are shown in Table 3, and the dissolution curve is shown in FIG. 3.
Table 3 dissolution data table for ibuprofen pharmaceutical compositions
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
Example 4
Prescription of ibuprofen pharmaceutical composition
Name of the name mg/bottle Mass percent (%)
Ibuprofen 100 10.67
Glyceryl behenate 200 21.34
Ethylcellulose 15.78 1.68
Xanthan gum 24 2.56
Essence 40.53 4.33
Sucrose 550 58.70
Citric acid 6.69 0.72
Totals to 937 100.00
The preparation process comprises the following steps:
according to the properties of each material, setting parameters such as the temperature (60-70 ℃) of a hot-melt extruder, and slowly adding the mixed mixture of ibuprofen, glyceryl behenate and ethyl cellulose into the hot-melt extruder to obtain a hot-melt extrudate.
Pulverizing the hot melt extrudate into particles, taking a proper particle size range (30-60 meshes), adding other auxiliary materials (suspending agent, flavoring agent and pH regulator), uniformly mixing, granulating by a wet method, and sieving by a 18-mesh sieve. And (3) drying in a baking oven at 35 ℃ for 2 hours, adding ibuprofen particles with 16-30 meshes, uniformly mixing, and sampling according to unit prescription amount. The dissolution data of the obtained ibuprofen pharmaceutical composition are shown in Table 4, and the dissolution curve is shown in FIG. 4.
Table 4 dissolution data table for ibuprofen pharmaceutical compositions
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
Example 5
Prescription of ibuprofen pharmaceutical composition
Name of the name mg/bottle Mass percent (%)
Ibuprofen 100 10.67
Glyceryl behenate 200 21.34
Ethylcellulose 15.78 1.68
Xanthan gum 24 2.56
Essence 40.53 4.33
Sucrose 550 58.70
Citric acid 6.69 0.72
Totals to 937 100.00
The preparation process comprises the following steps:
according to the properties of each material, setting parameters such as the temperature of a hot-melt extruder, and slowly adding the mixed mixture of ibuprofen, glyceryl behenate and ethylcellulose into the hot-melt extruder to obtain a hot-melt extrudate.
The hot melt extrudate is crushed into particles, the particle size range of the particles is 16-30 meshes, 30-60 meshes is less than 60 meshes=2:1:1, the particles less than 30 meshes are added with other auxiliary materials (suspending agent, flavoring agent and pH regulator) and are uniformly mixed, and then the particles are wet granulated and pass through a 18-mesh sieve. Drying in a 35 ℃ oven for 2 hours, adding the ibuprofen particles which are extruded by hot melting and have 16-30 meshes, uniformly mixing, and sampling according to unit prescription amount. The dissolution data of the obtained ibuprofen pharmaceutical composition are shown in Table 5, and the dissolution curve is shown in FIG. 5.
Table 5 dissolution data table for ibuprofen pharmaceutical compositions
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
Example 6
Prescription of ibuprofen pharmaceutical composition
Name of the name mg/bottle Mass percent (%)
Ibuprofen 100 10.67
Glyceryl behenate 200 21.34
Ethylcellulose 15.78 1.68
Xanthan gum 24 2.56
Essence 40.53 4.33
Sucrose 550 58.70
Citric acid 6.69 0.72
Totals to 937 100.00
The preparation process comprises the following steps:
according to the properties of each material, setting parameters such as the temperature (60-70 ℃) of a hot-melt extruder, slowly adding the mixed mixture of ibuprofen, glyceryl behenate and ethyl cellulose into the hot-melt extruder, and collecting the hot-melt extrudate.
The hot melt extrudate is crushed into particles, the particle size range of the particles is 16-30 meshes, 30-60 meshes, the particle size is less than 60 meshes=5:4:1, the particles less than 30 meshes are added with other auxiliary materials and uniformly mixed, and the particles are wet granulated and pass through a 18-mesh sieve. And (3) drying in a 35 ℃ oven for 2 hours, adding the ibuprofen particles which are extruded by hot melting and have 16-30 meshes, uniformly mixing, and sampling according to unit prescription amount. The dissolution data of the obtained ibuprofen pharmaceutical composition are shown in Table 6, and the dissolution curve is shown in FIG. 6.
Table 6 dissolution data table of ibuprofen pharmaceutical compositions
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
Example 7
Prescription of ibuprofen pharmaceutical composition
Name of the name mg/bottle Mass percent (%)
Ibuprofen 100 10.67
Glyceryl behenate 200 21.34
Ethylcellulose 15.78 1.68
Xanthan gum 24 2.56
Essence 40.53 4.33
Sucrose 550 58.70
Citric acid 6.69 0.72
Totals to 937 100
The preparation process comprises the following steps:
according to the properties of each material, setting parameters such as the temperature (60-70 ℃) of a hot-melt extruder, slowly adding the mixed mixture of ibuprofen, glyceryl behenate and ethyl cellulose into the hot-melt extruder, and collecting the hot-melt extrudate.
The hot melt extrudate is crushed into particles, the particle size range of the particles is 16-30 meshes and 30-60 meshes, the particle size range is less than 60 meshes=3:3:4, the particles less than 30 meshes are added with other auxiliary materials and are uniformly mixed, and the particles are wet granulated and pass through a 18-mesh sieve. And (3) drying in a 35 ℃ oven for 2 hours, adding the ibuprofen particles which are extruded by hot melting and have 16-30 meshes, uniformly mixing, and sampling according to unit prescription amount. The dissolution data of the obtained ibuprofen pharmaceutical composition are shown in Table 7, and the dissolution curve is shown in FIG. 7.
Table 7 dissolution data table for ibuprofen pharmaceutical compositions
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
Example 8
Ibuprofen suspension (commercially available) (Shanghai Qiangsheng pharmaceutical Co., ltd., lot number 190603296) with dissolution data as shown in Table 8 and dissolution profile as shown in FIG. 8.
Table 8 dissolution data table for ibuprofen suspension
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
Example 9
Ibuprofen sustained release suspension (commercially available) (Sichuan pharmaceutical Co., ltd., lot number: 180404) with dissolution data shown in Table 9 and dissolution profile shown in FIG. 9.
Table 9 dissolution data table for ibuprofen suspension
Figure BDA0004057802480000121
Figure BDA0004057802480000131
From the above examples, the ibuprofen pharmaceutical composition of the present invention can realize rapid release and slow sustained release, and the drug has rapid onset of drug action in vivo and maintains 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.
The embodiments of the present invention have been described above. However, the present invention is not limited to the above embodiment. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (10)

1. An ibuprofen pharmaceutical composition, which is characterized by comprising the following components: ibuprofen, a slow-release framework material, a suspending agent, a flavoring agent and a pH regulator; the slow-release framework material is glyceryl behenate and ethyl cellulose.
2. The ibuprofen pharmaceutical composition according to claim 1, characterized in that: the particle size of the ibuprofen is 10-60 meshes.
3. The ibuprofen pharmaceutical composition according to claim 1 or 2, characterized in that: the suspending agent is one or more of hydroxypropyl cellulose, xanthan gum and hydroxypropyl methylcellulose.
4. A pharmaceutical ibuprofen composition according to any one of claims 1-3, characterized in that: the flavoring agent is one or more of essence, sucrose, sucralose and aspartame.
5. The ibuprofen pharmaceutical composition according to any one of claims 1-4, characterized in that: the pH regulator is an organic acid capable of regulating the pH of a suspension solution of the ibuprofen pharmaceutical composition in water to 3.0-4.0.
6. The ibuprofen pharmaceutical composition according to claim 5, characterized in that: the organic acid is malic acid and/or citric acid.
7. The ibuprofen pharmaceutical composition according to any one of claims 1-6, characterized in that: the ibuprofen pharmaceutical composition comprises the following components: the components adopt mass fraction of 9.0-12.0% ibuprofen, 20.0-25.0% glyceryl behenate, 1.0-2.0% ethylcellulose, 2.0-3.0% suspending agent, 60-68% flavoring agent and 0.5-1.0% pH regulator, wherein the mass fraction refers to the mass of single component accounting for the total mass of the ibuprofen pharmaceutical composition.
Preferably, the ibuprofen pharmaceutical composition consists of the following components: the components are calculated by mass fraction, namely, the mass fraction of the single component accounts for the total mass of the ibuprofen pharmaceutical composition, wherein the mass fraction comprises 10.72% of ibuprofen, 21.44% of glyceryl behenate, 1.69% of ethylcellulose, 2.14% of suspending agent, 63.29% of flavoring agent and 0.72% of pH regulator.
8. A process for the preparation of an ibuprofen pharmaceutical composition according to any one of claims 1 to 7, characterized in that it comprises the following steps:
step 1: mixing ibuprofen with a slow-release framework material to obtain a mixture;
step 2: carrying out hot melt extrusion on the mixture obtained in the step 1 to obtain a hot melt extrudate;
step 3: crushing the hot melt extrudate obtained in the step 2 to obtain a crushed material;
step 4: mixing the crushed material obtained in the step 3 with a suspending agent, a flavoring agent and a pH regulator to obtain the ibuprofen pharmaceutical composition.
Preferably, in the step 2, the temperature of the hot melt extrusion is 55-70 ℃;
and/or the number of the groups of groups,
in the step 2, the hot-melt extrusion is preferably performed in a hot-melt extruder;
and/or the number of the groups of groups,
in the step 3, the crushed grain size is 16-45 meshes.
9. The method for preparing an ibuprofen pharmaceutical composition according to claim 8, wherein the ibuprofen pharmaceutical composition is prepared.
10. Use of an ibuprofen pharmaceutical composition according to any one of claims 1 to 7 and claim 9 for the preparation of a medicament for the treatment and/or alleviation of mild to moderate pain conditions.
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