CN107233317A - A kind of pharmaceutical composition containing arginine Ibuprofen and preparation method thereof - Google Patents
A kind of pharmaceutical composition containing arginine Ibuprofen and preparation method thereof Download PDFInfo
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- CN107233317A CN107233317A CN201710377002.6A CN201710377002A CN107233317A CN 107233317 A CN107233317 A CN 107233317A CN 201710377002 A CN201710377002 A CN 201710377002A CN 107233317 A CN107233317 A CN 107233317A
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- pharmaceutical composition
- arginine ibuprofen
- composition containing
- ibuprofen
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- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 title claims abstract description 84
- 229960001680 ibuprofen Drugs 0.000 title claims abstract description 80
- 239000004475 Arginine Substances 0.000 title claims abstract description 77
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 title claims abstract description 77
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 44
- 238000002360 preparation method Methods 0.000 title claims abstract description 23
- 235000021355 Stearic acid Nutrition 0.000 claims abstract description 25
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims abstract description 25
- 229930006000 Sucrose Natural products 0.000 claims abstract description 25
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims abstract description 25
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims abstract description 25
- 239000008117 stearic acid Substances 0.000 claims abstract description 25
- 239000005720 sucrose Substances 0.000 claims abstract description 25
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 23
- 239000008213 purified water Substances 0.000 claims abstract description 17
- 239000003814 drug Substances 0.000 claims abstract description 10
- 229940079593 drug Drugs 0.000 claims abstract description 9
- 239000000080 wetting agent Substances 0.000 claims abstract description 9
- 239000002245 particle Substances 0.000 claims description 23
- 239000011122 softwood Substances 0.000 claims description 16
- 238000001035 drying Methods 0.000 claims description 12
- 235000020985 whole grains Nutrition 0.000 claims description 11
- 238000002844 melting Methods 0.000 claims description 10
- 230000008018 melting Effects 0.000 claims description 10
- QGZKDVFQNNGYKY-UHFFFAOYSA-N Ammonia Chemical compound N QGZKDVFQNNGYKY-UHFFFAOYSA-N 0.000 claims description 6
- 238000007873 sieving Methods 0.000 claims description 6
- 238000000034 method Methods 0.000 claims description 5
- 239000002253 acid Substances 0.000 claims description 4
- 239000013618 particulate matter Substances 0.000 claims description 4
- 229910021529 ammonia Inorganic materials 0.000 claims description 3
- 238000001694 spray drying Methods 0.000 claims description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 abstract description 7
- 238000004519 manufacturing process Methods 0.000 abstract description 7
- 206010001598 Alcohol intolerance Diseases 0.000 abstract description 4
- 239000000463 material Substances 0.000 abstract description 4
- 230000000149 penetrating effect Effects 0.000 abstract description 2
- 230000000052 comparative effect Effects 0.000 description 7
- GCCOJNYCFNSJII-VWMHFEHESA-N [n'-[(4s)-4-amino-4-carboxybutyl]carbamimidoyl]azanium;2-[4-(2-methylpropyl)phenyl]propanoate Chemical compound OC(=O)[C@@H](N)CCCN=C(N)N.CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 GCCOJNYCFNSJII-VWMHFEHESA-N 0.000 description 5
- 239000007788 liquid Substances 0.000 description 5
- 239000000203 mixture Substances 0.000 description 5
- 239000000853 adhesive Substances 0.000 description 3
- 230000001070 adhesive effect Effects 0.000 description 3
- AFCARXCZXQIEQB-UHFFFAOYSA-N N-[3-oxo-3-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)propyl]-2-[[3-(trifluoromethoxy)phenyl]methylamino]pyrimidine-5-carboxamide Chemical compound O=C(CCNC(=O)C=1C=NC(=NC=1)NCC1=CC(=CC=C1)OC(F)(F)F)N1CC2=C(CC1)NN=N2 AFCARXCZXQIEQB-UHFFFAOYSA-N 0.000 description 2
- 208000027418 Wounds and injury Diseases 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 239000011248 coating agent Substances 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 238000011156 evaluation Methods 0.000 description 2
- 239000000945 filler Substances 0.000 description 2
- 239000000796 flavoring agent Substances 0.000 description 2
- 235000013355 food flavoring agent Nutrition 0.000 description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- DCXXMTOCNZCJGO-UHFFFAOYSA-N tristearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCCCCCCCCCC)COC(=O)CCCCCCCCCCCCCCCCC DCXXMTOCNZCJGO-UHFFFAOYSA-N 0.000 description 2
- FTLYMKDSHNWQKD-UHFFFAOYSA-N (2,4,5-trichlorophenyl)boronic acid Chemical compound OB(O)C1=CC(Cl)=C(Cl)C=C1Cl FTLYMKDSHNWQKD-UHFFFAOYSA-N 0.000 description 1
- 108010011485 Aspartame Proteins 0.000 description 1
- 208000008035 Back Pain Diseases 0.000 description 1
- BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical compound OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 description 1
- 206010013935 Dysmenorrhoea Diseases 0.000 description 1
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 1
- 206010019233 Headaches Diseases 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 206010054949 Metaplasia Diseases 0.000 description 1
- 235000005135 Micromeria juliana Nutrition 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- 244000018633 Prunus armeniaca Species 0.000 description 1
- 235000009827 Prunus armeniaca Nutrition 0.000 description 1
- 240000000111 Saccharum officinarum Species 0.000 description 1
- 235000007201 Saccharum officinarum Nutrition 0.000 description 1
- 240000002114 Satureja hortensis Species 0.000 description 1
- 235000007315 Satureja hortensis Nutrition 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 230000036592 analgesia Effects 0.000 description 1
- 230000000202 analgesic effect Effects 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 230000001754 anti-pyretic effect Effects 0.000 description 1
- 239000002221 antipyretic Substances 0.000 description 1
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 description 1
- 239000000605 aspartame Substances 0.000 description 1
- 235000010357 aspartame Nutrition 0.000 description 1
- 229960003438 aspartame Drugs 0.000 description 1
- 208000019804 backache Diseases 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 235000013339 cereals Nutrition 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 239000003086 colorant Substances 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- -1 flavouring Substances 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 231100000869 headache Toxicity 0.000 description 1
- 230000008676 import Effects 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 230000008595 infiltration Effects 0.000 description 1
- 238000001764 infiltration Methods 0.000 description 1
- 206010022000 influenza Diseases 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 229960003511 macrogol Drugs 0.000 description 1
- 230000015689 metaplastic ossification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000000041 non-steroidal anti-inflammatory agent Substances 0.000 description 1
- 229940021182 non-steroidal anti-inflammatory drug Drugs 0.000 description 1
- 230000036407 pain Effects 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 229940093429 polyethylene glycol 6000 Drugs 0.000 description 1
- 230000000750 progressive effect Effects 0.000 description 1
- 150000003180 prostaglandins Chemical class 0.000 description 1
- 229940085605 saccharin sodium Drugs 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 229940083542 sodium Drugs 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 208000004371 toothache Diseases 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a kind of pharmaceutical composition containing arginine Ibuprofen and preparation method thereof, the pharmaceutical composition for containing arginine Ibuprofen includes following parts by weight of component：1 part of arginine Ibuprofen, 0.5 50 parts of sucrose, 0.5 50 parts of stearic acid, 0.05 5 parts of purified water.According to the pharmaceutical composition containing arginine Ibuprofen of the present invention, its component is simple, in addition to arginine Ibuprofen, only include two kinds of auxiliary materials of sucrose and stearic acid, but the problem of arginine Ibuprofen has penetrating odor can be efficiently solved, it is in good taste, and production cost is low.In addition, the pharmaceutical composition containing arginine Ibuprofen that the present invention is provided, adopts water as wetting agent, the problem of being remained in the absence of ethanol, it is ensured that the drug safety of alcohol intolerance patient.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, more particularly to a kind of pharmaceutical composition and its preparation containing arginine Ibuprofen
Method.
Background technology
Arginine Ibuprofen (Ibuprofen Arginine) is NSAIDs, can suppress prostaglandin synthesis, tool
There are analgesia, anti-inflammatory and antipyretic.Entitled 2- (4- isobutyl phenenyls) propionic acid-L-arginine salt of arginine Ibuprofen chemistry,
Molecular formula is C19H32N4O4, and molecular weight is 380.48.Arginine Ibuprofen particle is developed by Italian Zambon S.P.A,
It is mainly used in being applied to toothache, dysmenorrhoea, the pain caused by wound such as motional injury, joint and desmalgia, backache, headache,
And generated heat caused by influenza.Because its active ingredient is ibuprofen arginine salt, the solubility of brufen is substantially increased, than
The infiltration rate of brufen faster, reaches analgesic effect, and sustainable 6 hours in 15-30 minutes after medication.
Arginine Ibuprofen granular raw grinds product description and discloses its composition for arginine Ibuprofen, bicarbonate
The savory essence of sodium, saccharin sodium, aspartame, apricot, sucrose, but it is in use, when solution is made in warm water, with stronger
Acid, the problem of there is patient medication biddability.
Disclose a kind of containing ibuprofen arginine composition in Publication No. CN1237964C Chinese invention patent
Preparation method of granules, its composition composition is ibuprofen arginine, diluent, adhesive, and solved by coating mode
The irritating problem of grain, but due to using art for coating, production cost is added, and it is higher to equipment requirement, it is unfavorable for industry
Metaplasia is produced.
A kind of arginine Ibuprofen particle and its system are disclosed in Publication No. CN102961371B Chinese invention patent
Preparation Method, its particle group turns into ibuprofen arginine, filler, taste masked agent, adhesive, flavouring, flavoring agent and coloring
Agent, by the synergy of filler and flavouring, and is aided with the mouthfeel that taste masked agent and flavoring agent adjust particle jointly, solution
The irritating problem of particle of having determined, and it is good in taste, but the particle component is more complicated, and production cost is still higher.In addition, the particle
In preparation process, using ethanol solution as adhesive, for the patient of alcohol intolerance, there is certain potential safety hazard.
The content of the invention
The technical problems to be solved by the invention are to provide that a kind of production cost is low, safe and patient medication biddability
Good arginine Ibuprofen particle and preparation method thereof, its overcome in the prior art arginine Ibuprofen particle there is excitant gas
Taste, production cost are high, there is the defects such as drug safety hidden danger.
The technical problems to be solved by the invention are achieved through the following technical solutions：
A kind of pharmaceutical composition containing arginine Ibuprofen, including following parts by weight of component：1 part of arginine Ibuprofen, sugarcane
Sugared 0.5-50 parts, 0.5-50 parts of stearic acid, 0.05-5 parts of purified water.
Preferably, in above-mentioned technical proposal, including following parts by weight of component：1 part of arginine Ibuprofen, 1-20 parts of sucrose,
1-20 parts of stearic acid, 0.1-2 parts of purified water.
Preferably, in above-mentioned technical proposal, including following parts by weight of component：1 part of arginine Ibuprofen, 5 parts of sucrose, tristearin
Sour 2 parts, 0.5 part of purified water.
A kind of preparation method of the pharmaceutical composition containing arginine Ibuprofen, comprises the following steps：
1) stearic acid is heated to after melting, adds arginine Ibuprofen, be stirred until homogeneous；
2) it is spray-dried, obtains particulate matter sieving；
3) sucrose after sieving is added into particulate matter, after being well mixed, sieving；
4) add pure water and make wetting agent, cross sieve series softwood；
5) softwood is dried, whole grain, obtain the pharmaceutical composition containing arginine Ibuprofen.
Preferably, in above-mentioned technical proposal, step 1) stearic acid melting temperature be 60-100 DEG C, preferably 70-80 DEG C.
Preferably, in above-mentioned technical proposal, step 2) spray drying process in：Sample temperature is controlled at 70-95 DEG C, excellent
Select 85 DEG C；Air temperature control is at 20-40 DEG C, preferably 30 DEG C；Particle crosses 60-100 mesh sieves, preferably 80 mesh sieves.
Preferably, in above-mentioned technical proposal, step 3) in, sucrose crosses 60-100 mesh sieves, preferably 80 mesh sieves.
Preferably, in above-mentioned technical proposal, step 4) in softwood cross 60 mesh sieves.
Preferably, in above-mentioned technical proposal, step 5) in：Drying temperature is controlled at 40-60 DEG C, preferably 50 DEG C；Time is controlled
System is in 1-2h, preferably 1.5h.
Preferably, in above-mentioned technical proposal, step 5) whole grain process in：Whole grain crosses 40 mesh sieves.
Above-mentioned technical proposal of the present invention, has the advantages that：
(1) pharmaceutical composition containing arginine Ibuprofen that the present invention is provided, component is simple, in addition to arginine Ibuprofen,
Two kinds of auxiliary materials of sucrose and stearic acid are only included, but can efficiently solve the problem of arginine Ibuprofen has penetrating odor,
It is in good taste, and production cost is low.
(2) pharmaceutical composition containing arginine Ibuprofen that the present invention is provided, adopts water as wetting agent, residual in the absence of ethanol
The problem of staying, it is ensured that the drug safety of alcohol intolerance patient.
Embodiment
The specific embodiment of the present invention is described in detail below, in order to further understand the present invention.
All experimental methods used are conventional method unless otherwise specified in following examples.In following examples
Material, reagent used etc., unless otherwise specified, can be obtained by commercial sources.
Embodiment 1
A kind of pharmaceutical composition containing arginine Ibuprofen, including following parts by weight of component：
The preparation method of the above-mentioned pharmaceutical composition containing arginine Ibuprofen, comprises the following steps：
1) stearic acid is taken to be heated to melting, temperature control is at 60 DEG C；
2) arginine Ibuprofen is added into above-mentioned stearic acid melt liquid, is stirred evenly；
3) it is spray-dried, sample temperature is controlled at 70 DEG C, and air temperature control is at 20 DEG C, and gained particle crosses 60 mesh sieves；
4) sucrose is taken, 60 mesh sieves is crossed, is mixed with above-mentioned particle, and crosses 40 mesh sieves and is mixed；
5) take purified water as wetting agent, cross 60 mesh sieve series softwoods；
6) above-mentioned softwood is taken to be dried, drying temperature is 60 DEG C, and drying time is 1h；
7) 40 mesh sieve whole grains are crossed, the pharmaceutical composition containing arginine Ibuprofen is obtained.
Embodiment 2
A kind of pharmaceutical composition containing arginine Ibuprofen, including following parts by weight of component：
| Arginine Ibuprofen | 1 part |
| Sucrose | 0.5 part |
| Stearic acid | 0.5 part |
| Purified water | 0.05 part |
The preparation method of the above-mentioned pharmaceutical composition containing arginine Ibuprofen, comprises the following steps：
1) stearic acid is taken to be heated to melting, temperature control is at 100 DEG C；
2) arginine Ibuprofen is added into above-mentioned stearic acid melt liquid, is stirred evenly；
3) it is spray-dried, sample temperature is controlled at 95 DEG C, and air temperature control is at 40 DEG C, and gained particle crosses 100 mesh sieves；
4) sucrose is taken, 100 mesh sieves is crossed, is mixed with above-mentioned particle, and crosses 40 mesh sieves and is mixed；
5) take purified water as wetting agent, cross 60 mesh sieve series softwoods；
6) above-mentioned softwood is taken to be dried, drying temperature is 40 DEG C, and drying time is 2h；
7) 40 mesh sieve whole grains are crossed, the pharmaceutical composition containing arginine Ibuprofen is obtained.
Embodiment 3
A kind of pharmaceutical composition containing arginine Ibuprofen, including following parts by weight of component：
| Arginine Ibuprofen | 1 part |
| Sucrose | 20 parts |
| Stearic acid | 20 parts |
| Purified water | 2 parts |
The preparation method be the same as Example 1 of the above-mentioned pharmaceutical composition containing arginine Ibuprofen.
Embodiment 4
A kind of pharmaceutical composition containing arginine Ibuprofen, including following parts by weight of component：
| Arginine Ibuprofen | 1 part |
| Sucrose | 1 part |
| Stearic acid | 1 part |
| Purified water | 0.1 part |
The preparation method be the same as Example 2 of the above-mentioned pharmaceutical composition containing arginine Ibuprofen.
Embodiment 5
A kind of pharmaceutical composition containing arginine Ibuprofen, including following parts by weight of component：
| Arginine Ibuprofen | 1 part |
| Sucrose | 5 parts |
| Stearic acid | 2 parts |
| Purified water | 0.5 part |
The preparation method of the above-mentioned pharmaceutical composition containing arginine Ibuprofen, comprises the following steps：
1) stearic acid is taken to be heated to melting, temperature control is at 75 DEG C；
2) arginine Ibuprofen is added into above-mentioned stearic acid melt liquid, is stirred evenly；
3) it is spray-dried, sample temperature is controlled at 85 DEG C, and air temperature control is at 30 DEG C, and gained particle crosses 80 mesh sieves；
4) sucrose is taken, 80 mesh sieves is crossed, is mixed with above-mentioned particle, and crosses 40 mesh sieves and is mixed；
5) take purified water as wetting agent, cross 60 mesh sieve series softwoods；
6) above-mentioned softwood is taken to be dried, drying temperature is 50 DEG C, and drying time is 1.5h；
7) 40 mesh sieve whole grains are crossed, the pharmaceutical composition containing arginine Ibuprofen is obtained.
Comparative example 1
A kind of pharmaceutical composition containing arginine Ibuprofen, including following parts by weight of component：
| Arginine Ibuprofen | 1 part |
| Sucrose | 0.5 part |
| Polyvinylpyrrolidone | 0.5 part |
| Purified water | 0.05 part |
The preparation method of the above-mentioned pharmaceutical composition containing arginine Ibuprofen, comprises the following steps：
1) polyvinylpyrrolidone is taken to be heated to melting, temperature control is at 100 DEG C；
2) arginine Ibuprofen is added into above-mentioned stearic acid melt liquid, is stirred evenly；
3) it is spray-dried, sample temperature is controlled at 95 DEG C, and air temperature control is at 40 DEG C, and gained particle crosses 100 mesh sieves；
4) sucrose is taken, 100 mesh sieves is crossed, is mixed with above-mentioned particle, and crosses 40 mesh sieves and is mixed；
5) take purified water as wetting agent, cross 60 mesh sieve series softwoods；
6) above-mentioned softwood is taken to be dried, drying temperature is 40 DEG C, and drying time is 2h；
7) 40 mesh sieve whole grains are crossed.
Comparative example 2
A kind of pharmaceutical composition containing arginine Ibuprofen, including following parts by weight of component：
| Arginine Ibuprofen | 1 part |
| Sucrose | 5 parts |
| Macrogol 6000 | 2 parts |
| Purified water | 0.5 part |
The preparation method of the above-mentioned pharmaceutical composition containing arginine Ibuprofen, comprises the following steps：
1) taking polyethylene glycol 6000 is heated to melting, and temperature control is at 80 DEG C；
2) arginine Ibuprofen is added into above-mentioned stearic acid melt liquid, is stirred evenly；
3) it is spray-dried, sample temperature is controlled at 85 DEG C, and air temperature control is at 30 DEG C, and gained particle crosses 80 mesh sieves；
4) sucrose is taken, 180 mesh sieves is crossed, is mixed with above-mentioned particle, and crosses 40 mesh sieves and is mixed；
5) take purified water as wetting agent, cross 60 mesh sieve series softwoods；
6) above-mentioned softwood is taken to be dried, drying temperature is 50 DEG C, and drying time is 1.5h；
7) 40 mesh sieve whole grains are crossed.
The medicine containing arginine Ibuprofen prepared to the present invention according to above-described embodiment 1-5 and comparative example 1-2
Composition is analyzed：
(1) smell is pierced to the sample that above-described embodiment 1-5 and comparative example 1-2 is obtained and mouthfeel is investigated, as a result such as table 1
Shown in (smell and mouthfeel evaluation)：
The smell of table 1 and mouthfeel evaluation
Above-mentioned result of the test shows that the smell and mouthfeel of embodiment 1-5 products are substantially better than comparative example product.
(2) according to import of drugs standard JX20020151 regulation, to above-described embodiment and the sample progressive of comparative example
Shape, content uniformity, melting, free brufen and content are investigated, and are as a result met regulation, are referred to table 2 (sample investigation).
The sample of table 2 is investigated
Above-mentioned result of the test shows that embodiment 1-5 products are substantially better than comparative example in the free brufen control aspect of impurity
Product.
(3) possibility utilized in industry
The present invention in the pharmaceutical composition containing arginine Ibuprofen, by sucrose, two kinds of auxiliary materials of stearic acid should
With, it can be had no irritating odor, the arginine Ibuprofen particle of good mouthfeel, and production cost is significantly lower than in the prior art
Disclosed arginine Ibuprofen particle, this point industrially has significant effect.In addition, disclosed by the invention contain smart ammonia
In the pharmaceutical composition of ibuprofen acid, not using alcohol solvent, the security of alcohol intolerance patient medication is improved, with good
Social benefit.
Although the present invention is disclosed as above with embodiment, so it is not intended to limit the present invention, any people in the art
Member, without departing from the spirit and scope of the present invention, can make a variety of selections and modification, therefore the protection model of the present invention
Enclose and limited by claims and its equivalents.
Claims (10)
1. a kind of pharmaceutical composition containing arginine Ibuprofen, it is characterised in that the drug regimen containing arginine Ibuprofen
Thing includes following parts by weight of component：1 part of arginine Ibuprofen, 0.5-50 parts of sucrose, 0.5-50 parts of stearic acid, purified water 0.05-5
Part.
2. a kind of pharmaceutical composition containing arginine Ibuprofen according to claim 1, it is characterised in that described containing smart ammonia
The pharmaceutical composition of ibuprofen acid includes following parts by weight of component：1 part of arginine Ibuprofen, 1-20 parts of sucrose, stearic acid 1-20
Part, 0.1-2 parts of purified water.
3. a kind of pharmaceutical composition containing arginine Ibuprofen according to claim 2, it is characterised in that described containing smart ammonia
The pharmaceutical composition of ibuprofen acid includes following parts by weight of component：1 part of arginine Ibuprofen, 5 parts of sucrose, 2 parts of stearic acid, purifying
0.5 part of water.
4. according to a kind of preparation method of any described pharmaceutical compositions containing arginine Ibuprofen of claim 1-3, it is special
Levy and be, comprise the following steps：
1) stearic acid is heated to after melting, adds arginine Ibuprofen, be stirred until homogeneous；
2) it is spray-dried, obtains particulate matter sieving；
3) sucrose after sieving is added into particulate matter, after being well mixed, sieving；
4) add pure water and make wetting agent, cross sieve series softwood；
5) softwood is dried, whole grain, obtain the pharmaceutical composition containing arginine Ibuprofen.
5. a kind of preparation method of pharmaceutical composition containing arginine Ibuprofen according to claim 4, it is characterised in that
The step 1) stearic acid melting temperature be 60-100 DEG C, preferably 70-80 DEG C.
6. a kind of preparation method of pharmaceutical composition containing arginine Ibuprofen according to claim 4, it is characterised in that
The step 2) spray drying process in：Sample temperature is controlled at 70-95 DEG C, preferably 85 DEG C；Air temperature control is in 20-40
DEG C, preferably 30 DEG C；Particle crosses 60-100 mesh sieves, preferably 80 mesh sieves.
7. a kind of preparation method of pharmaceutical composition containing arginine Ibuprofen according to claim 4, it is characterised in that
The step 3) in, sucrose crosses 60-100 mesh sieves, preferably 80 mesh sieves.
8. a kind of preparation method of pharmaceutical composition containing arginine Ibuprofen according to claim 4, it is characterised in that
The step 4) in softwood cross 60 mesh sieves.
9. a kind of preparation method of pharmaceutical composition containing arginine Ibuprofen according to claim 4, it is characterised in that
The step 5) in：Drying temperature is controlled at 40-60 DEG C, preferably 50 DEG C；Time control is in 1-2h, preferably 1.5h.
10. a kind of preparation method of pharmaceutical composition containing arginine Ibuprofen according to claim 4, its feature exists
In the step 5) whole grain process in：Whole grain crosses 40 mesh sieves.
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| CN201710377002.6A CN107233317B (en) | 2017-05-25 | 2017-05-25 | Pharmaceutical composition containing ibuprofen arginine and preparation method thereof |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1054508C (en) * | 1987-05-14 | 2000-07-19 | 格拉克索集团有限公司 | Method for preparing pharmaceutical composition |
| CN1528278A (en) * | 2003-10-15 | 2004-09-15 | 杭州容立医药科技有限公司 | Method for preparing composition granules containing ibuprofen amino guanidyl valeric acid |
| WO2008090038A1 (en) * | 2007-01-22 | 2008-07-31 | Masterfarm, S.L. | Pulverulent pharmaceutical composition comprising ibuprofen and a polyalcohol |
-
2017
- 2017-05-25 CN CN201710377002.6A patent/CN107233317B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1054508C (en) * | 1987-05-14 | 2000-07-19 | 格拉克索集团有限公司 | Method for preparing pharmaceutical composition |
| CN1528278A (en) * | 2003-10-15 | 2004-09-15 | 杭州容立医药科技有限公司 | Method for preparing composition granules containing ibuprofen amino guanidyl valeric acid |
| WO2008090038A1 (en) * | 2007-01-22 | 2008-07-31 | Masterfarm, S.L. | Pulverulent pharmaceutical composition comprising ibuprofen and a polyalcohol |
Non-Patent Citations (1)
| Title |
|---|
| 胡崇茂编著: "《药用辅料 薄膜包衣预混剂生产和应用》", 31 May 2014, 中国医药科技出版社 * |
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