CN110037994A - A kind of brufen quick-release and slow-release double-layer tablets and preparation method thereof - Google Patents
A kind of brufen quick-release and slow-release double-layer tablets and preparation method thereof Download PDFInfo
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- CN110037994A CN110037994A CN201910438690.1A CN201910438690A CN110037994A CN 110037994 A CN110037994 A CN 110037994A CN 201910438690 A CN201910438690 A CN 201910438690A CN 110037994 A CN110037994 A CN 110037994A
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- 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
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- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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Abstract
The present invention provides a kind of brufen quick-release and slow-release double-layer tablets and preparation method thereof, the dosage form is made of brufen release layer and ibuprofen slow-release layer, brufen is dispersed in release layer and slow release layer by a certain percentage, it can provide quick release, and subsequent 12 hours slow releases effect, to achieve the effect that quick acting and persistently maintain effective blood drug concentration.The preparation method of brufen double-layer tablets of the present invention uses wet granulation, after one layer of particle is pre-stamped, is further filled with second layer particle and suppresses to obtain the final product, and preparation process is stablized, and prescription reproducibility is good.
Description
Technical field
The invention belongs to the tune in pharmaceutical technology field to release pharmaceutical preparation, specifically, after being related to a kind of first quick acting
The brufen double-layer tablets and preparation method thereof of slow sustained effectiveness.
Background technique
Brufen chemical name is 2- methyl -4- (2- methyl-propyl) phenylacetic acid, and white crystalline powder is not soluble in water,
It is soluble in ethyl alcohol, chloroform, ether, acetone equal solvent.There is foreign odor, it is tasteless.Fusing point is 75-78 DEG C, and solubility has pH dependence,
It is readily soluble etc. in sodium hydroxide or sodium carbonate test solution.
Brufen is non-steroidal anti-inflammatory drugs, by inhibiting prostaglandin synthesis to generate antipyretic, analgesia and anti-inflammatory effect,
It has clinically used for many years, safety and validity are adequately proved.
Ibuprofen oral absorbs fastly, and half-life period is shorter, and most of dosage form is fast dissolving dosage form on the market, and small part is sustained release agent
Type.Fast dissolving dosage form works rapidly, but the reduction of main ingredient concentration is also fast, takes within general 4~6 hours primary；Sustained-release dosage type can then maintain
Long period effective blood drug concentration is taken once for general 12 hours, but drug often works relatively slowly.And double-layer tablets then may be implemented
Release layer is just starting quick release, makes drug rapid-onset, and slow release layer continues slow release drug again later, when keeping drug long
Between maintain within the scope of effective blood drug concentration.In the patent of Publication No. CN101068532, it was also proposed that a kind of improved
Ibuprofen oral solid preparation, at least 20% brufen releases in 2 hours, then with relative constant rate extremely
Brufen is discharged in 8 hours few, but preparation process mostly uses powder vertical compression and is pressed into monolithic, brufen mobility is poor, right
Composition and technical process are more demanding, and monolithic controls quick release and the requirement of slow sustained release is also higher.
Currently, mainly have 300mg by the sustained release preparations of ibuprofen specification of principal indication of analgesic activity on the market,
400mg and 600mg.Wherein, in the Advil 12hour of Canada's listing, and pair being made of immediate release section and slow-released part
Synusia agent, dosage unit 600mg, tablet total weight about 990mg, tablet quality is big, for Asian, swallows more tired
It is difficult.The ibuprofen sustained release capsules of country's listing are more, and wherein the Fenbid of Sino-U.S. SmithKline company production is also 12h sustained release, dosage
There are 300mg and 400mg, for alleviating chronic ache.Spansule is by sustained release pellet or particles filled obtained by the hard capsule, pellet
Preparation process is relative complex, and reproducibility is bad, more demanding to the apparatus and process of preparation.
Summary of the invention
Goal of the invention: the purpose of the present invention is to provide a kind of brufen quick-release and slow-release double-layer tablets and preparation method thereof, should
Double-layer tablets include release layer and slow release layer, and brufen is dispersed in by a certain percentage in release layer and slow release layer, and wherein release layer can
So that drug quick release, relieves pain rapidly, slow release layer can make drug maintain 12 hours sustained releases, relieve pain when long, reduce
Take number.
Technical solution: the invention discloses a kind of brufen quick-release and slow-release double-layer tablets and preparation method thereof, the double-layer tablets point
For release layer and slow release layer, wherein release layer is made of brufen, diluent, disintegrating agent, lubricant and adhesive, wherein respectively at
The weight ratio divided are as follows: brufen 50~70%, diluent 20~50%, disintegrating agent 0~10%, lubricant 0~2%, adhesive
In right amount.Slow-released part is made of brufen, sustained-release matrix material, release regulator, diluent and lubricant, the weight of each ingredient
Measure ratio are as follows: brufen 50~70%, sustained-release matrix material 3~25%, diluent 5~20%, release regulator 15~30%, profit
Lubrication prescription 0~2%, or appropriate wetting agent can also be contained.Release layer and the brufen weight ratio of slow release layer are 1:3 to 1:1, preferably
1:2.The burst size of brufen is the 20~40% of accumulated dose, the sustainable release of remainder to 12h in this double-layer tablets 1h.
Brufen quick-release and slow-release double-layer tablets of the present invention, brufen accumulated dose are 200~400mg, preferably 300mg, total tablet
Weight is smaller, is easy to swallow.
Auxiliary material used by brufen quick-release and slow-release double-layer tablets of the present invention is as follows:
Sustained-release matrix material selection carbomer, hydroxypropyl cellulose, hypromellose, ethyl cellulose, polypropylene
The mixing of one or more of acid resin, sodium alginate, polyethylene pyrrole network alkanone, preferably hypromellose.
Release regulator selects hypromellose or polyethylene glycol, preferably hypromellose.
Diluent include microcrystalline cellulose, sucrose, lactose, calcium monohydrogen phosphate, mannitol, dextrin, starch, in pregelatinized starch
One or more of mixing, slow release layer is preferably the mixture of microcrystalline cellulose and pregelatinized starch, and release layer is preferably micro-
The mixture of crystalline cellulose, starch and pregelatinized starch.
Wetting agent includes water or the mixed solution of alcohol, water and alcohol etc..
Adhesive be selected from one of hypromellose, polyethylene pyrrole network alkanone, hydroxypropyl cellulose or starch or
It is several, preferably hypromellose.
Disintegrating agent is croscarmellose sodium, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, dried starch or friendship
Join the mixture of one or more of povidone, preferably croscarmellose sodium.
Lubricant is stearic acid, talcum powder, colloidal state SiO2, one or more of magnesium stearate or calcium mixture, it is excellent
It is selected as stearic acid.
Preparation method of the invention is that slow-released part and immediate release section all use wet granulation, and slow release layer particle is pre-stamped
Afterwards, it is further filled with release layer granulation.Specific step is as follows:
Slow release layer
1, the brufen for crossing 80~100 meshes and framework material, diluent and release regulator are sufficiently mixed；
2, dry under the conditions of 50~60 DEG C by appropriate wetting agent and above-mentioned material mixing granulation；
3, it is sieved after particle drying whole grain, lubricant is added, be uniformly mixed, be denoted as slow release layer particle.
Release layer
1, the brufen for crossing 80~100 meshes and diluent are sufficiently mixed, may choose whether that disintegrating agent is added；
2, dry under the conditions of 50~60 DEG C by suitable amount of adhesive and above-mentioned material mixing granulation；
3, it is sieved after particle drying whole grain, disintegrating agent, lubricant is added, be uniformly mixed, be denoted as release layer particle.
Two parts particle is pressed into double-layer tablets.
The utility model has the advantages that compared with prior art, the present invention its remarkable advantage is: 1, it both can realize brufen quick release,
Sustainable release is up to 12 hours again, is achieved the effect that quick acting and is persistently maintained effective blood drug concentration；2, preparation process is steady
Fixed, prescription reproducibility is good.Drug release rate test, release characteristics 1 are carried out in pH6.0 and pH7.2 phosphate buffer
Cumulative release amount is greater than in cumulative release amount 50~65%, 12 hours in cumulative release amount 20~40%, 4 hours in hour
85%.
Detailed description of the invention
Fig. 1 is the release profiles of embodiment 1；
Fig. 2 is the release profiles of embodiment 2；
Fig. 3 is release profiles of the embodiment 3 in pH6.0 phosphate buffer；
Fig. 4 is release profiles of the embodiment 3 in pH7.2 phosphate buffer；
Fig. 5 is release profiles of the embodiment 4 in pH6.0 phosphate buffer；
Fig. 6 is release profiles of the embodiment 5 in pH6.0 phosphate buffer；
Fig. 7 is 1 brufen quick-release and slow-release double-layer tablets of embodiment and commercial preparation brufen quick-release and slow-release double-layer tablets (Advil
Blood concentration-time graph 12hour).
Specific embodiment
Embodiment 1
The preparation (300 amounts, mg/ piece) of brufen quick-release and slow-release double-layer tablets:
Preparation step are as follows:
Slow release layer
1) brufen and hypromellose, microcrystalline cellulose and pregelatinized starch of crossing 80~100 meshes is abundant
Mixing；
2) appropriate 30% ethanol solution is mixed into softwood processed with above-mentioned material, sieving is pelletized, dry 2 under the conditions of 50~60 DEG C
~4h；
3) it is sieved after particle drying whole grain, stearic acid is added, be uniformly mixed, as slow release layer particle
Release layer
1) the crosslinking carboxylic first of the brufen and microcrystalline cellulose, starch, pregelatinized starch and Nei Jia of 80~100 meshes will be crossed
Base sodium cellulosate is sufficiently mixed；
2) the hypromellose E5 solution of 3% concentration being mixed into softwood processed with above-mentioned material, sieving is pelletized, and 50~60
Dry 2~4h under the conditions of DEG C；
3) it is sieved after particle drying whole grain, additional croscarmellose sodium, stearic acid is added, be uniformly mixed, as
Release layer particle.
Two parts particle is pressed into double-layer tablets.
Dissolution test, according to " Chinese Pharmacopoeia " four 0931 dissolution rates of general rule of version in 2015 and drug release determination method first
The regulation of method is tested.It is that release is situated between with 900mL degassed pH6.0 phosphate buffer and pH7.2 phosphate buffer
Matter, medium temperature are 37.0 DEG C ± 0.5 DEG C, revolving speed 100r/min.
Release profiles of the brufen quick-release and slow-release double-layer tablets in pH6.0 phosphate buffer are as shown in Figure 1.
Embodiment 2
The preparation (mg/ piece) of brufen quick-release and slow-release double-layer tablets:
Preparation step are as follows:
Slow release layer
1) brufen for crossing 80~100 meshes is sufficiently mixed with hypromellose；
2) appropriate 30% ethanol solution is mixed into softwood processed with above-mentioned material, sieving is pelletized, dry 2 under the conditions of 50~60 DEG C
~4h；
3) it is sieved after particle drying whole grain, stearic acid is added, be uniformly mixed, as slow release layer particle
Release layer
1) the crosslinking carboxylic first of the brufen and microcrystalline cellulose, starch, pregelatinized starch and Nei Jia of 80~100 meshes will be crossed
Base sodium cellulosate is sufficiently mixed；
2) the hypromellose E5 solution of 3% concentration being mixed into softwood processed with above-mentioned material, sieving is pelletized, and 50~60
Dry 2~4h under the conditions of DEG C；
3) it is sieved after particle drying whole grain, additional croscarmellose sodium, stearic acid is added, be uniformly mixed, as
Release layer particle.
Two parts particle is pressed into double-layer tablets.
For dissolution test with embodiment 1, release of the brufen quick-release and slow-release double-layer tablets in pH6.0 phosphate buffer is bent
Line is as shown in Figure 2.
Embodiment 3
The preparation (mg/ piece) of brufen quick-release and slow-release double-layer tablets:
Preparation step are as follows:
Slow release layer
1) brufen and hypromellose, microcrystalline cellulose and pregelatinized starch of crossing 80~100 meshes is abundant
Mixing；
2) appropriate 30% ethanol solution is mixed into softwood processed with above-mentioned material, sieving is pelletized, dry 2 under the conditions of 50~60 DEG C
~4h；
3) be sieved whole grain, addition stearic acid and colloidal state SiO after particle drying2, it is uniformly mixed, as slow release layer particle
Release layer
1) the crosslinking carboxylic first of the brufen and microcrystalline cellulose, starch, pregelatinized starch and Nei Jia of 80~100 meshes will be crossed
Base sodium cellulosate is sufficiently mixed；
2) the hypromellose E5 solution of 3% concentration being mixed into softwood processed with above-mentioned material, sieving is pelletized, and 50~60
Dry 2~4h under the conditions of DEG C；
3) it is sieved after particle drying whole grain, additional croscarmellose sodium, colloidal state SiO is added2, it is uniformly mixed, makees
For release layer particle
Two parts particle is pressed into double-layer tablets.
For dissolution test with embodiment 1, release of the brufen quick-release and slow-release double-layer tablets in pH6.0 phosphate buffer is bent
Line is as shown in figure 3, the release profiles in pH7.2 phosphate buffer are as shown in Figure 4.
Embodiment 4
The preparation (mg/ piece) of brufen quick-release and slow-release double-layer tablets:
Preparation step are as follows:
Slow release layer
1) brufen and hypromellose, microcrystalline cellulose and pregelatinized starch of crossing 80~100 meshes is abundant
Mixing；
2) appropriate 30% ethanol solution is mixed into softwood processed with above-mentioned material, sieving is pelletized, dry 2 under the conditions of 50~60 DEG C
~4h；
3) it is sieved after particle drying whole grain, stearic acid is added, be uniformly mixed, as slow release layer particle
Release layer
1) the crosslinking carboxylic first of the brufen and microcrystalline cellulose, starch, pregelatinized starch and Nei Jia of 80~100 meshes will be crossed
Base sodium cellulosate is sufficiently mixed；
2) the hypromellose E5 solution of 3% concentration being mixed into softwood processed with above-mentioned material, sieving is pelletized, and 50~60
Dry 2~4h under the conditions of DEG C；
3) it is sieved after particle drying whole grain, additional croscarmellose sodium, stearic acid is added, be uniformly mixed, as
Release layer particle
Two parts particle is pressed into double-layer tablets.
For dissolution test with embodiment 1, release of the brufen quick-release and slow-release double-layer tablets in pH6.0 phosphate buffer is bent
Line is as shown in Figure 5.
Embodiment 5
The preparation (mg/ piece) of Ibumetin Retavd:
Preparation step are as follows:
Slow-released part
1) brufen and hypromellose, microcrystalline cellulose and pregelatinized starch of crossing 80~100 meshes is abundant
Mixing；
2) appropriate 30% ethanol solution is mixed into softwood processed with above-mentioned material, sieving is pelletized, dry 2 under the conditions of 50~60 DEG C
~4h；
3) it is sieved after particle drying whole grain, stearic acid is added, be uniformly mixed, as slow-released part particle
Immediate release section
1) the crosslinking carboxylic first of the brufen and microcrystalline cellulose, starch, pregelatinized starch and Nei Jia of 80~100 meshes will be crossed
Base sodium cellulosate is sufficiently mixed；
2) the hypromellose E5 solution of 3% concentration being mixed into softwood processed with above-mentioned material, sieving is pelletized, and 50~60
Dry 2~4h under the conditions of DEG C；
3) it is sieved after particle drying whole grain, additional croscarmellose sodium, stearic acid is added, be uniformly mixed, as
Immediate release section particle
Two parts particle is uniformly mixed by 9:5 (weight ratio), compressed single piece.
Dissolution test is the same as embodiment 1, release profiles of the Ibumetin Retavd in pH6.0 phosphate buffer such as Fig. 6
It is shown.
As can be seen from the above-described embodiment, brufen quick-release and slow-release double-layer tablets of the present invention make drug that quick release may be implemented
With slow sustained release, drug is rapid-action in vivo, and the long period keeps effective drug concentration, reduces drug agent to reach
Amount improves drug effect, extends drug treating time and reduces the purpose of adverse drug reaction.Wet granulation Double layer pellet is used simultaneously
Technique, technique is also relatively simple, favorable reproducibility, cost savings, reduces patient medication burden.
The Internal pharmacokinetics of brufen quick-release and slow-release double-layer tablets are studied:
300mg brufen quick-release and slow-release double-layer tablets and commercially available 600mg brufen quick-release and slow-release in selection example 1 are double-deck
Piece Advil 12hour (Pfizer) carries out binary cycle dual crossing test in beagle dog body.Taking beagle dog 4, (number is
1,2,3,4), weight is between 10.0~11.0kg, the fasting 12h before being administered, during which can free water, by commercial preparation (R),
Self-control Ibumetin Retavd (by test preparation T) tested, dosage 600mg (R once take it is a piece of, it is primary by test preparation T
Take 2).In administration before and administration after 10min, 20min, 30min, 45min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h,
12h and appropriate in the blood sampling of foreleg vein clump for 24 hours, is placed in anticoagulant heparin pipe, after 4000rpm is centrifuged 10min, takes upper plasma
It is spare after being stored under the conditions of being stored in -20 DEG C.After plasma treatment, using high performance liquid chromatography, brufen in blood plasma is measured
Concentration, internal blood concentration-time curve are shown in Fig. 7.
The result shows that the brufen quick-release and slow-release double-layer tablets Cmax of the embodiment of the present invention 1 is 66.05 ± 8.48 μ g/mL,
Tmax is 0.94 ± 0.43h, and AUC is 511.38 ± 94.38 μ g/mLh；Advil 12hour double-layer tablets Cmax be 71.15 ±
15.00 μ g/mL, Tmax are 0.75 ± 0.50h, and AUC is 502.78 ± 78.89 μ g/mLh, and brufen quick-release of the invention is slow
Double-layer tablets are released compared with Advil 12hour double-layer tablets, the Relative biological that Cmax ratio is 92.83% ± 27.24%, AUC utilizes
Degree is 101.71 ± 22.37%.
Claims (9)
1. a kind of quick-release and slow-release double-layer tablets containing active pharmaceutical ingredient brufen, including release layer and slow release layer, feature exist
It is made of in release layer brufen, diluent, disintegrating agent, lubricant and adhesive；Slow release layer is by brufen, sustained-release matrix material
Material, release regulator, diluent, lubricant composition.
2. quick-release and slow-release double-layer tablets according to claim 1, it is characterised in that brufen accumulated dose is 200~400mg, speed
The brufen weight ratio for releasing layer and slow release layer is 1:3-1:1.
3. quick-release and slow-release double-layer tablets according to claim 2, it is characterised in that brufen accumulated dose is 300mg.
4. quick-release and slow-release double-layer tablets according to claim 2, it is characterised in that the brufen weight of release layer and slow release layer
Than for 1:2.
5. quick-release and slow-release double-layer tablets according to claim 1, it is characterised in that in release layer diluent ratio be 20~
50%, material selection microcrystalline cellulose, sucrose, lactose, calcium monohydrogen phosphate, mannitol, dextrin, starch, one in pregelatinized starch
Kind is several；Disintegrating agent ratio is 0~10%, material selection croscarmellose sodium, sodium carboxymethyl starch, low substitution hydroxyl
One or more of propyl cellulose, dried starch or crospovidone；Lubricant ratio is 0~2%, and material selection is stearic
Acid, talcum powder, colloidal state SiO2, one or more of magnesium stearate or calcium；Appropriate adhesive, selected from hypromellose,
One or more of polyethylene pyrrole network alkanone, hydroxypropyl cellulose or starch.
6. according to quick-release and slow-release double-layer tablets according to claim 5, it is characterised in that release layer selects microcrystalline cellulose, forms sediment
The mixture of powder and pregelatinized starch；Disintegrating agent is croscarmellose sodium；Lubricant is stearic acid；Adhesive is hydroxypropyl
Methylcellulose.
7. quick-release and slow-release double-layer tablets according to claim 1, it is characterised in that slow release layer middle skeleton material proportion be 3~
25%, material selection carbomer, hydroxypropyl cellulose, hypromellose, ethyl cellulose, polyacrylic resin, seaweed
One or more of sour sodium, polyethylene pyrrole network alkanone；Diluent ratio is 5~20%, material selection microcrystalline cellulose, sugarcane
One or more of sugar, lactose, calcium monohydrogen phosphate, mannitol, dextrin, starch, pregelatinized starch；Release regulator ratio is 15
~30%, material selection hypromellose or polyethylene glycol；Lubricant 0~2%, material selection stearic acid, talcum powder, glue
State SiO2, one or more of magnesium stearate or calcium；Appropriate wetting agent, the mixed solution including water or alcohol, water and alcohol.
8. quick-release and slow-release double-layer tablets according to claim 7, it is characterised in that material selection hydroxypropyl is fine in slow release layer
Dimension element；The mixture of diluent materials selection microcrystalline cellulose and pregelatinized starch；Release regulator selects hydroxypropyl methylcellulose
Element；Lubricant selects stearic acid.
9. a kind of preparation method of brufen quick-release and slow-release double-layer tablets described in claim 1, it is characterised in that release layer and slow
It releases layer wet granulation is respectively adopted and be prepared into required particle, after slow release layer particle is pre-stamped, be further filled with release layer granulation.
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Cited By (5)
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| CN111481527A (en) * | 2020-04-30 | 2020-08-04 | 福建太平洋制药有限公司 | Method for improving yield of ibuprofen sustained-release capsule finished product |
| WO2021057881A1 (en) * | 2019-09-27 | 2021-04-01 | 广东东阳光药业有限公司 | Oseltamivir preparation |
| CN112891322A (en) * | 2021-03-26 | 2021-06-04 | 海南慧谷药业有限公司 | Dexibuprofen preparation and preparation method thereof |
| CN113750078A (en) * | 2021-09-10 | 2021-12-07 | 华中药业股份有限公司 | Ibuprofen quick-release and slow-release nanoparticles and preparation method thereof |
| CN114177155A (en) * | 2020-09-08 | 2022-03-15 | 越洋医药开发(广州)有限公司 | Ibuprofen controlled release tablet and preparation method thereof |
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| CN114177155B (en) * | 2020-09-08 | 2023-10-03 | 越洋医药开发(广州)有限公司 | Ibuprofen controlled release tablet and preparation method thereof |
| CN112891322A (en) * | 2021-03-26 | 2021-06-04 | 海南慧谷药业有限公司 | Dexibuprofen preparation and preparation method thereof |
| CN113750078A (en) * | 2021-09-10 | 2021-12-07 | 华中药业股份有限公司 | Ibuprofen quick-release and slow-release nanoparticles and preparation method thereof |
| CN113750078B (en) * | 2021-09-10 | 2023-10-10 | 华中药业股份有限公司 | Ibuprofen quick-release slow-release nanoparticle and preparation method thereof |
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