CN101658505A - Sustained-release preparation of uloric and preparation method thereof - Google Patents
Sustained-release preparation of uloric and preparation method thereof Download PDFInfo
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- CN101658505A CN101658505A CN200910093378A CN200910093378A CN101658505A CN 101658505 A CN101658505 A CN 101658505A CN 200910093378 A CN200910093378 A CN 200910093378A CN 200910093378 A CN200910093378 A CN 200910093378A CN 101658505 A CN101658505 A CN 101658505A
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Abstract
The invention relates to a sustained-release preparation consisting of uloric, pharmaceutic sustained-release material and other pharmaceutic excipients. The sustained-release preparation comprises two parts of quick release and sustained release, can be a bilayer tablet compressed by a bilayer tablet machine, a tablet with a sustained-release drug being taken as the tablet core and a quick release drug being taken as an external coating, or a sustained-releases capsule consisting of two parts of the quick release and sustained release drugs. The sustained-release preparation can not only cause drugs to take effect quickly, but also maintain the effective concentration of drugs for long time and has more ideal treatment effect.
Description
Technical field
The present invention relates to a kind of slow releasing preparation that is used for the treatment of the gout medicine, relate in particular to and comprise the slow releasing preparation of forming by Febuxostat, medicinal slow-release material and other pharmaceutic adjuvant.
Background technology
Gout be owing to produce uric acid in the body and too much reach kidney and remove ability drop, the uric acid body accumulation causes urate crystal in the joint and each internal organs deposition.Therefore, the means that the treatment of gout is taked usually are: promote urate excretion and suppress uricopoiesis, and adopt adequate measure to improve related symptoms.The generation of the interior uric acid of body is relevant with purine metabolism, and in the final step of purine metabolism, hypoxanthine generates xanthine under the effect of xanthine oxidoreductase enzyme (XOR), further generate uric acid again, and the activity that suppresses XOR can effectively reduce the generation of uric acid.
Over 40 years, allopurinol is a unique clinically medicine that is used to suppress uricopoiesis, and is widely used in clinically as the gold medicine of gout, has obtained original achievement in the treatment of gout.But because allopurinol only has inhibitory action to the XOR of reduced form, in the interaction of allopurinol (and active metabolite oxypurinol) and XOR, XOR can recover active owing to the spontaneous reduction in the molybdenum active center in the enzyme; In addition because allopurinol is a purine analogue, inevitably cause the influence that relates to purine and other enzymatic activitys of pyridine metabolism, therefore in the allopurinol treatment, need repeat heavy dose of administration and keep higher levels of drugs, also bring thus because the serious even fatal untoward reaction due to the drug accumulation.
Febuxostat (Febuxostat) is novel non-purine class XOR enzyme inhibitor, and it has selectivity highly to XOR, and the XOR of oxidized form and reduced form is all had significant inhibitory effect.In vitro study shows: Febuxostat compares with allopurinol, not only has very high selectivity but also has stronger activity.
The commercially available product of this medicine only is the traditional coated tablet by the research and development of Japanese Supreme Being people company up to now, because the half-life of Febuxostat is 5～8 hours, therefore in one day 24 hours treatment, produce the low situation of later stage blood drug level unavoidably, therefore exploitation can make drug effect rapid, and the slow releasing preparation that can keep concentration medicine again for a long time is necessary.
Summary of the invention
In order to develop the slow releasing preparation of this kind, the inventor has carried out a large amount of tests, if find to comprise rapid release and slow release two parts in the preparation, can make drug effect rapid, can keep concentration medicine for a long time again, has promptly reached purpose of the present invention.
Slow releasing preparation of the present invention can be the double-layer tablet that is pressed into through bi-layer tablet press, or makees the tablet that label, immediate release drug are made outer coating by slow releasing pharmaceutical, or the slow releasing capsule of being made up of rapid release and slow release two parts medicine.
The dosage of Febuxostat in unit formulation is 30mg to 160mg in the slow releasing preparation of the present invention, is preferably 40mg to 120mg.
The dosage of Febuxostat in release layer is 10-80mg in the slow releasing preparation of the present invention, and the dosage in slow release layer is 20-100mg.
The dosage of Febuxostat in release layer is preferably 20-60mg in the slow releasing preparation of the present invention, and the dosage in slow release layer is preferably 30-60mg.
Slow releasing preparation of the present invention, when with changeing the basket method when measuring in the 900ml pure water of 100rpm at 37 ℃, the dissolution rate in vitro of said preparation is:
Through discharging the Febuxostat of 25-55% (weight) in 1 hour;
Through discharging the Febuxostat of 40-70% (weight) in 2 hours;
Through discharging the Febuxostat of 65-85% (weight) in 6 hours;
Through the Febuxostat of release in 12 hours greater than 85% (weight).
Preferred dissolution rate in vitro is:
Through discharging the Febuxostat of 35-50% (weight) in 1 hour;
Through discharging the Febuxostat of 45-60% (weight) in 2 hours;
Through discharging the Febuxostat of 70-80% (weight) in 6 hours;
Through the Febuxostat of release in 12 hours greater than 90% (weight).
In the slow releasing preparation of the present invention except that principal agent release layer also contain the lubricant of the wetting agent of disintegrating agent, 1-15% of filler, the 1-15% of 20-90% or binding agent, 0.1-5%; Slow release layer also contains the lubricant of the wetting agent of filler, 1-15% of slow-release material, the 5-45% of 30-80% or binding agent, 0.1-5%.
In the slow releasing preparation of the present invention except that principal agent weight content be preferably as follows: release layer contains the lubricant of the wetting agent of disintegrating agent, 2-10% of filler, the 2-10% of 40-70% or binding agent, 0.5-2%; Slow release layer contains the lubricant of the wetting agent of filler, 2-8% of slow-release material, the 10-25% of 40-70% or binding agent, 0.5-2%.
The adoptable excipient of the present invention is an acceptable accessories: the mixture of one or more in slow-release material such as hydroxypropyl emthylcellulose, hydroxypropyl cellulose, methylcellulose, ethyl cellulose, carboxymethyl cellulose, card ripple Mei, xanthan gum, polyacrylic resin class, alginates, stearic acid, stearyl alcohol, Brazil wax, the tristerin; The mixture of one or more in filler such as starch and derivant thereof, inorganic salt (calcium sulfate, calcium hydrogen phosphate etc.), the polyhydric alcohol (as mannitol, sorbitol, xylitol and sucrose etc.); The mixture of one or more in disintegrating agent such as cellulose and derivant thereof, carboxymethyl starch sodium, the crospolyvinylpyrrolidone; Wetting agent or binding agent (solution of Ru Shui, water and alcoholic acid mixture, cellulose derivative, the solution of PVP etc.); The mixture of one or more in lubricant such as stearic acid and salt thereof, Polyethylene Glycol, the micropowder silica gel.
The present invention also provides the preparation method of above-mentioned slow releasing tablet, and this method comprises:
The component of release layer by powder mixes, dry granulation or wet granulation, prepares described release layer granule after mixing; The component of slow release layer by granulating after powder mixes, dry granulation, wet granulation or the fusion, prepares described slow release layer granule after mixing; Release layer and slow release layer are pressed into double-layer tablet through bi-layer tablet press.
The present invention also provides the another kind of preparation method of above-mentioned slow releasing tablet, and this method comprises:
The component of slow release layer by pelletizing press sheet after direct powder compression, dry granulation, wet granulation or the fusion, prepares described slow release layer after mixing; The component of release layer is wrapped on the slow release layer by coating.
The present invention also provides a kind of preparation method of above-mentioned slow releasing capsule, and this method comprises:
Release layer and slow release layer are made micropill respectively, incapsulate behind the mixing.
Description of drawings
Fig. 1 is the cumulative in vitro stripping curve of comparing embodiment and embodiment 1,2,3.
Fig. 2 is the cumulative in vitro stripping curve of embodiment 4,5,6.
Fig. 3 is the cumulative in vitro stripping curve of embodiment 7,8,9.
The specific embodiment
Following examples are used for the present invention is illustrated, and are not intended to limit scope of the present invention.
Comparing embodiment: the preparation of Febuxostat sheet
Prescription:
Preparation technology: principal agent and adjuvant are crossed 100 mesh sieves respectively.With principal agent and the adjuvant mix homogeneously except that magnesium stearate, with purified water system soft material, 16 mesh sieves are granulated, 55 ℃ of dryings, and 16 mesh sieve granulate add magnesium stearate, tabletting.
Embodiment 1: the preparation of Febuxostat double-layer sustained release tablets
Prescription 1:
| Release layer (every) | Slow release layer (every) |
| Febuxostat 15mg lactose 95mg microcrystalline Cellulose 69mg L-HPC 20mg magnesium stearate 1mg | Febuxostat 25mg HPMC (K4M) 125mg microcrystalline Cellulose 49mg magnesium stearate 1mg |
Preparation technology: principal agent and adjuvant are crossed 100 mesh sieves respectively.With principal agent in the release layer and the adjuvant mix homogeneously except that magnesium stearate, with purified water system soft material, 16 mesh sieves are granulated, 55 ℃ of dryings, and 16 mesh sieve granulate add magnesium stearate as the release layer granule; With principal agent in the slow release layer and the adjuvant mix homogeneously except that magnesium stearate, with 70% ethanol system soft material, 16 mesh sieves are granulated, 50 ℃ of dryings, and 16 mesh sieve granulate add magnesium stearate as the slow release layer granule; The double-layer sustained release tablets of this Febuxostat of preparation on bi-layer tablet press.
Embodiment 2: the preparation of Febuxostat double-layer sustained release tablets
Prescription 2:
| Release layer (every) | Slow release layer (every) |
| Febuxostat 10mg mannitol 39mg microcrystalline Cellulose 50mg PVPP 5mg magnesium stearate 1mg | Febuxostat 30mg HPMC (K100M) 61mg microcrystalline Cellulose 33mg magnesium stearate 1mg |
Preparation technology: principal agent and adjuvant are crossed 100 mesh sieves respectively.With principal agent in the release layer and the adjuvant mix homogeneously except that magnesium stearate, with purified water system soft material, 16 mesh sieves are granulated, 55 ℃ of dryings, and 16 mesh sieve granulate add magnesium stearate as the release layer granule; With principal agent in the slow release layer and the adjuvant mix homogeneously except that magnesium stearate, with 70% ethanol system soft material, 16 mesh sieves are granulated, 50 ℃ of dryings, and 16 mesh sieve granulate add magnesium stearate as the slow release layer granule; The double-layer sustained release tablets of this Febuxostat of preparation on bi-layer tablet press.
Embodiment 3: the preparation of Febuxostat double-layer sustained release tablets
Prescription 3:
| Release layer (every) | Slow release layer (every) |
| Febuxostat 30mg pregelatinized Starch 80mg microcrystalline Cellulose 54mg PVPP 5mg magnesium stearate 1mg | Febuxostat 50mg ethyl cellulose 60mg card ripple Mei 25mg lactose 34mg magnesium stearate 1mg |
Preparation technology: principal agent and adjuvant are crossed 100 mesh sieves respectively.With the principal agent in the release layer and pregelatinized Starch, microcrystalline Cellulose mix homogeneously, with purified water system soft material, 16 mesh sieves are granulated, 55 ℃ of dryings, and 16 mesh sieve granulate add PVPP, magnesium stearate as the release layer granule; With principal agent in the slow release layer and the adjuvant mix homogeneously except that magnesium stearate, with 70% ethanol system soft material, 16 mesh sieves are granulated, 50 ℃ of dryings, and 16 mesh sieve granulate add magnesium stearate as the slow release layer granule; The double-layer sustained release tablets of this Febuxostat of preparation on bi-layer tablet press.
Embodiment 4: the preparation of Febuxostat double-layer sustained release tablets
Prescription 4:
| Release layer (every) | Slow release layer (every) |
| Febuxostat 40mg CaHPO4 90mg microcrystalline Cellulose 49mg CMS-Na 10mg magnesium stearate 1mg | Febuxostat 80mg Brazil wax 35mg stearyl alcohol 70mg microcrystalline Cellulose 54mg magnesium stearate 1mg |
Preparation technology: principal agent and adjuvant are crossed 100 mesh sieves respectively.With principal agent in the release layer and adjuvant mix homogeneously, as the powder of release layer; Brazil wax in the slow release layer and stearyl alcohol are heated to fusion, add the principal agent mix homogeneously, add microcrystalline Cellulose again, 16 mesh sieves are granulated, 40 ℃ of dryings, and 16 mesh sieve granulate add magnesium stearate as the slow release layer granule; The double-layer sustained release tablets of this Febuxostat of preparation on bi-layer tablet press.
Embodiment 5: the preparation of Febuxostat double-layer sustained release tablets
Prescription 5:
| Release layer (every) | Slow release layer (every) |
| Febuxostat 50mg pregelatinized Starch 68mg microcrystalline Cellulose 30mg CCNa 9mg magnesium stearate 1mg | Febuxostat 70mg HPC 65mg xanthan gum 30mg microcrystalline Cellulose 34mg magnesium stearate 1mg |
Preparation technology: principal agent and adjuvant are crossed 100 mesh sieves respectively.With the principal agent in the release layer and pregelatinized Starch, microcrystalline Cellulose mix homogeneously, with purified water system soft material, 16 mesh sieves are granulated, 55 ℃ of dryings, and 16 mesh sieve granulate add CCNa, magnesium stearate as the release layer granule; With principal agent in the slow release layer and the adjuvant mix homogeneously except that magnesium stearate, with 70% ethanol system soft material, 16 mesh sieves are granulated, 50 ℃ of dryings, and 16 mesh sieve granulate add magnesium stearate as the slow release layer granule; The double-layer sustained release tablets of this Febuxostat of preparation on bi-layer tablet press.
Embodiment 6: the preparation of Febuxostat double-layer sustained release tablets
Prescription 6:
| Release layer (every) | Slow release layer (every) |
| Febuxostat 20mg starch 70mg lactose 54mg PVPP 5mg magnesium stearate 1mg | Febuxostat 60mg sodium alginate 50mg card ripple Mei 25mg lactose 24mg magnesium stearate 1mg |
Preparation technology: principal agent and adjuvant are crossed 100 mesh sieves respectively.With principal agent in the release layer and the adjuvant mix homogeneously except that magnesium stearate, dry granulation adds magnesium stearate again as the release layer granule; With principal agent in the slow release layer and the adjuvant mix homogeneously except that magnesium stearate, with 70% ethanol system soft material, 16 mesh sieves are granulated, 50 ℃ of dryings, and 16 mesh sieve granulate add magnesium stearate as the slow release layer granule; The double-layer sustained release tablets of this Febuxostat of preparation on bi-layer tablet press.
Embodiment 7: the preparation of Febuxostat slow releasing tablet
Prescription 7:
| Release layer (every) | Slow release layer (every) |
| Febuxostat 60mg HPMC (E30) 20mg | Febuxostat 100mg HPMC (K40M) 85mg mannitol 24mg magnesium stearate 1mg |
Preparation technology: principal agent and adjuvant are crossed 100 mesh sieves respectively.With principal agent in the slow release layer and the adjuvant mix homogeneously except that magnesium stearate, with 70% ethanol system soft material, 16 mesh sieves are granulated, 50 ℃ of dryings, and 16 mesh sieve granulate, tabletting is as slow release layer after the adding magnesium stearate; HPMC water in the release layer is made into 5% solution, principal agent is added wherein and suspendible even; Utilize coating equipment that release layer is wrapped on the slow release layer.
Embodiment 8: the preparation of Febuxostat slow releasing tablet
Prescription 8:
| Release layer (every) | Slow release layer (every) |
| Febuxostat 30mg PVP 20mg PEG400 0.2ml | Febuxostat 50mg ethyl cellulose 84mg microcrystalline Cellulose 30mg magnesium stearate 1mg |
Preparation technology: principal agent and adjuvant are crossed 100 mesh sieves respectively.With principal agent in the slow release layer and the adjuvant mix homogeneously except that magnesium stearate, with 70% ethanol system soft material, 16 mesh sieves are granulated, 50 ℃ of dryings, and 16 mesh sieve granulate, tabletting is as slow release layer after the adding magnesium stearate; PVP in the release layer is made into 10% solution with 75% ethanol, principal agent is added wherein and suspendible even; Utilize coating equipment that release layer is wrapped on the slow release layer.
Embodiment 9: the preparation of Febuxostat slow releasing capsule
Prescription 9:
| Fast release micropill (every) | Slow-release micro-pill (every) |
| Febuxostat 35mg lactose 50mg microcrystalline Cellulose 70mg HPMC (E30) 2mg | Febuxostat 45mg HPMC (K15M) 90mg microcrystalline Cellulose 30mg |
Preparation technology: principal agent and adjuvant are crossed 100 mesh sieves respectively.With the principal agent in the release layer and lactose, microcrystalline Cellulose mix homogeneously, the HPMC water is made into 5% solution as adhesive, prepare fast release micropill with extruding rolling circle equipment; With the principal agent in the slow release layer and lactose, microcrystalline Cellulose mix homogeneously, as adhesive, prepare slow-release micro-pill with extruding rolling circle equipment with 60% ethanol; Two kinds of micropills are wrapped common gastric solubleness film-coat respectively, incapsulate behind the mixing.
Product according to above embodiment preparation can make drug effect rapid through evidence, can keep concentration medicine for a long time again, therefore shows to have reached purpose of the present invention.
Claims (10)
1. the slow releasing preparation of Febuxostat is characterized in that this slow releasing preparation is divided into rapid release and slow release two parts.
2. the slow releasing preparation of Febuxostat according to claim 1, it is characterized in that, this slow releasing preparation can be the double-layer tablet that is pressed into through bi-layer tablet press, or makees the tablet that label, immediate release drug are made outer coating by slow releasing pharmaceutical, or the capsule of being made up of rapid release and slow release two parts medicine.
3. the slow releasing preparation of Febuxostat according to claim 1 is characterized in that, the dosage of Febuxostat in unit formulation is 30mg to 160mg.
4. the slow releasing preparation of Febuxostat according to claim 1 is characterized in that, the dosage of Febuxostat in release layer is 10-80mg, and the dosage in slow release layer is 20-100mg.
5. the slow releasing preparation of Febuxostat according to claim 1 is characterized in that, when with changeing the basket method when measuring in the 900ml pure water of 100rpm at 37 ℃, the dissolution rate in vitro of said preparation is:
Through discharging the Febuxostat of 25-55% (weight) in 1 hour;
Through discharging the Febuxostat of 40-70% (weight) in 2 hours;
Through discharging the Febuxostat of 65-85% (weight) in 6 hours;
Through the Febuxostat of release in 12 hours greater than 85% (weight).
6. the slow releasing preparation of Febuxostat according to claim 5 is characterized in that, when with changeing the basket method when measuring in the 900ml pure water of 100rpm at 37 ℃, the dissolution rate in vitro of said preparation is:
Through discharging the Febuxostat of 35-50% (weight) in 1 hour;
Through discharging the Febuxostat of 45-60% (weight) in 2 hours;
Through discharging the Febuxostat of 70-80% (weight) in 6 hours;
Through the Febuxostat of release in 12 hours greater than 90% (weight).
7. the slow releasing preparation of Febuxostat according to claim 1 is characterized in that, also contains the lubricant of the wetting agent of disintegrating agent, 1-15% of filler, the 1-15% of 20-90% or binding agent, 0.1-5% in the described release layer.
8. the slow releasing preparation of Febuxostat according to claim 5, it is characterized in that the filler in the described release layer comprises one or more the mixture in starch and derivant thereof, inorganic salt (calcium sulfate, calcium hydrogen phosphate etc.), the polyhydric alcohol (as mannitol, sorbitol, xylitol and sucrose etc.); Disintegrating agent comprises one or more the mixture in cellulose and derivant thereof, carboxymethyl starch sodium, the crospolyvinylpyrrolidone.
9. the slow releasing preparation of Febuxostat according to claim 1 is characterized in that, also contains the lubricant of the wetting agent of filler, 1-15% of slow-release material, the 5-45% of 30-80% or binding agent, 0.1-5% in the described slow release layer.
10. the slow releasing preparation of Febuxostat according to claim 9, it is characterized in that described slow-release material comprises one or more the mixture in hydroxypropyl emthylcellulose, hydroxypropyl cellulose, methylcellulose, ethyl cellulose, carboxymethyl cellulose, carbomer, xanthan gum, polyacrylic resin class, alginates, stearic acid, stearyl alcohol, Brazil wax, the tristerin.
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| WO2011158870A1 (en) * | 2010-06-16 | 2011-12-22 | 帝人ファーマ株式会社 | Controlled release nucleated tablet |
| WO2011162390A1 (en) * | 2010-06-25 | 2011-12-29 | 帝人ファーマ株式会社 | Sustained-release therapeutic agent for hypertension and renal dysfunction |
| CN101773498B (en) * | 2009-12-30 | 2012-06-20 | 青岛黄海制药有限责任公司 | Preparation method of oral slow/controlled-release preparation containing febuxostat |
| CN102552197A (en) * | 2011-12-28 | 2012-07-11 | 辰欣药业股份有限公司 | Tablet containing febuxostat and preparation method of the tablet |
| CN102614146A (en) * | 2012-04-28 | 2012-08-01 | 杭州朱养心药业有限公司 | Method for preparing febuxostat tablet and febuxostat tablet |
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| CN102973530A (en) * | 2012-12-14 | 2013-03-20 | 贵州信邦制药股份有限公司 | Febuxostat double-layer enteric-coated tablet and preparation method thereof |
| JP2013528651A (en) * | 2010-06-16 | 2013-07-11 | タケダ ファーマシューティカルズ ユー．エス．エー． インコーポレイティド | Novel controlled release dosage forms of xanthine oxidoreductase inhibitors or xanthine oxidase inhibitors |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101291656A (en) * | 2005-08-18 | 2008-10-22 | 帝人制药株式会社 | Preparation with accurate dose-dividing function |
-
2009
- 2009-09-29 CN CN200910093378A patent/CN101658505A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101291656A (en) * | 2005-08-18 | 2008-10-22 | 帝人制药株式会社 | Preparation with accurate dose-dividing function |
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| CN102917696B (en) * | 2010-06-01 | 2015-04-01 | 韩国联合制药株式会社 | Aceclofenac slow-release preparation providing an optimum pharmacological clinical effect when administered once a day |
| CN102917696A (en) * | 2010-06-01 | 2013-02-06 | 韩国联合制药株式会社 | Aceclofenac slow-release preparation providing an optimum pharmacological clinical effect when administered once a day |
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| CN102552197A (en) * | 2011-12-28 | 2012-07-11 | 辰欣药业股份有限公司 | Tablet containing febuxostat and preparation method of the tablet |
| CN102614145B (en) * | 2012-04-28 | 2013-05-01 | 杭州朱养心药业有限公司 | Stable febuxostat tablet and preparation method thereof |
| CN102614145A (en) * | 2012-04-28 | 2012-08-01 | 杭州朱养心药业有限公司 | Stable febuxostat tablet and preparation method thereof |
| CN102614146A (en) * | 2012-04-28 | 2012-08-01 | 杭州朱养心药业有限公司 | Method for preparing febuxostat tablet and febuxostat tablet |
| CN102973530A (en) * | 2012-12-14 | 2013-03-20 | 贵州信邦制药股份有限公司 | Febuxostat double-layer enteric-coated tablet and preparation method thereof |
| CN102973530B (en) * | 2012-12-14 | 2016-08-03 | 贵州信邦制药股份有限公司 | A kind of febuxostat double-layer enteric coated tablet and preparation method thereof |
| CN110214008A (en) * | 2017-06-14 | 2019-09-06 | 江苏恒瑞医药股份有限公司 | A kind of Febustat controlled release composition and preparation method thereof |
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