CN103127022B - A kind of compound medicine-releasing system of Allopurinol and preparation method thereof - Google Patents
A kind of compound medicine-releasing system of Allopurinol and preparation method thereof Download PDFInfo
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- CN103127022B CN103127022B CN201110387589.1A CN201110387589A CN103127022B CN 103127022 B CN103127022 B CN 103127022B CN 201110387589 A CN201110387589 A CN 201110387589A CN 103127022 B CN103127022 B CN 103127022B
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Abstract
The present invention relates to compound medicine-releasing system of a kind of Allopurinol and preparation method thereof, belong to field of pharmaceutical preparations, it is included into speed controlled-release administrating system, the compound medicine-releasing system is composited by slow release layer and release layer through suppressing twice, slow release layer and quick-release layer weight ratio are 0.1: 5 50: 1, wherein Allopurinol release layer content with its slow release layer content weight ratio be 0.1: 5 10: 1, this compound medicine-releasing system has had the functional characteristics of common drug quick-release and sustained release concurrently, greatly improve the compliance of patient's medication, avoid the too high or too low fluctuation of blood concentration, it is easy to use, and the medicine-releasing system, its release performance reaches good homogeneity, and release characteristic is basically identical in different dissolution mediums.
Description
Technical field
The present invention relates to compound medicine-releasing system of Allopurinol and preparation method thereof, belong to field of pharmaceutical preparations.
Background technology
Allopurinol is xanthine alcohol oxidase inhibitor, comes into National essential drugs list, to treat the one of gout
Line medicine, Chinese Pharmacopoeia version in 2010 has also been recorded.Allopurinol and its metabolin oxypurinol can suppress xanthine oxidase,
By suppressing the activity of xanthine oxidase, hypoxanthine synthesis uric acid, reduction blood and urine uric acid concentration are reduced, urine is prevented
Acid forms crystallization deposition in joint and its hetero-organization, it helps the uric acid in gout patients tissue newly dissolves, and is anti-analgesic
Wind acute attack curative effect more definite medicine.
Allopurinol orally easily absorbs, and can absorb 80%-90% from intestines and stomach, can reach blood peak concentration of drug within 2-6 hours, partly decline
Phase is 1-3 hours, and common Allopurinol conventional tablet in the market, ordinary tablet one is taken 2-3 times day by day, take number of times compared with
It is many, bring many inconvenience to patient, with reference to gout have compared with the long gap phase disease feature and need long-term treatment feature,
We for Allopurinol in the urgent need to finding a kind of rapid-action, and safety can greatly improve patient compliance, medicine system easy to use
Agent.
The content of the invention
One of goal of the invention of the present invention to provide a kind of compound medicine-releasing system of Allopurinol, the compound medicine-releasing system by
Slow release layer and release layer are constituted, and Allopurinol is distributed in slow release layer and release layer according to a certain percentage, certain ratio mentioned here
Example is 0.1: 5-50: 1, preferably 0.5: 5-1: 1, slow release layer and quick-release layer weight ratio are 0.1: 1-50: 1, and preferably 0.5: 1-10: 1.
The two of the goal of the invention of the present invention is provide a kind of preparation method of the compound medicine-releasing system of Allopurinol, and its feature exists
In, prepare release layer when, Allopurinol first mixes with disperse matrix, crushes, sieved, then with other auxiliary material mixing granulations, its mesh
Be to prepare solid dispersions, improve solubility of the Allopurinol in water, more symbol and immediate release profile.
The slow release layer preparation method of described compound medicine-releasing system includes the step for mixing active component and pharmaceutic adjuvant
Suddenly, then pelletize, dry, whole grain, prepared slow release layer is sustained-release matrix layer.
The release layer of described compound medicine-releasing system includes solid dispersions, and the solid dispersions are by Allopurinol and disperse
Matrix is constituted, and disperse matrix is the carrier material of solid dispersions, and medicine high degree of dispersion in carrier material, carrier material promotees
Enter the dissolution of medicine, disperse matrix is selected from Macrogol 4000 and 6000, PVP, PLURONICS F87, carbomer, polyoxy second
Alkene, carbopol, citric acid, chitosan, preferably Macrogol 4000 and 6000, PLURONICS F87, citric acid.Allopurinol with
The weight ratio of disperse matrix is 1: 1-10, preferably 1: 4-8.
In the release layer of described compound medicine-releasing system solid dispersions preparation method include fusion method, it is solvent method, molten
Agent-fusion method, polishing, freeze-drying, preferred molten method, solvent-fusion method, most preferably polishing, polishing.
Described compound medicine-releasing system, it is characterised in that in addition to main ingredient, immediate release section contains following auxiliary material：
1. suitable diluent, in an amount of from the 20%-90% of immediate release section；
2. suitable disperse matrix, in an amount of from the 20%-90% of immediate release section；
3. suitable disintegrant, in an amount of from the 2%-10% of immediate release section；
4. suitable adhesive, in an amount of from 1%-10%；
5. suitable colouring agent, in an amount of from the 0.5%-3% of immediate release section；
6. suitable lubricant, in an amount of from the 0.5%-5% of immediate release section；
Described compound medicine-releasing system, it is characterised in that in addition to main ingredient, slow-released part contains following auxiliary material：
1. suitable diluent, in an amount of from the 10%-60% of slow-released part；
2. suitable skeletal matrix, in an amount of from the 1%-20% of slow-released part；
3. suitable adhesive, in an amount of from 1%-10%；
4. suitable solubilizer, in an amount of from the 0.5%-5% of slow-released part；
5. suitable lubricant, in an amount of from the 0.5%-5% of slow-released part.
The auxiliary material that above-mentioned compound medicine-releasing system is included, described skeletal matrix is selected from ethyl cellulose, hydroxypropyl fiber
Element, hydroxypropyl methylcellulose, sodium carboxymethylcellulose, stearic acid, octadecyl alcolol, preferably hydroxypropylcellulose, hydroxypropyl methylcellulose；It is described
Diluent is selected from lactose, starch, Icing Sugar, dextrin, microcrystalline cellulose, citric acid, mannitol, sorbierite, calcium monohydrogen phosphate, sulfuric acid
Calcium, sodium chloride, sodium acid carbonate, preferably lactose, microcrystalline cellulose, citric acid, sodium chloride, sodium acid carbonate；The solubilizer is selected from
Dodecyl sodium sulfate, Tween-80, polysorbate60, polysorbate40, preferably are selected from dodecyl sodium sulfate, Tween-80；Described adhesive
Selected from starch slurry, polyvinylpyrrolidone, hydroxypropylcellulose, hydroxypropyl methylcellulose, methylcellulose, gelatin, polyethylene glycol
4000th, Macrogol 6000, preferably polyvinylpyrrolidone, hydroxypropylcellulose；Described disperse matrix is selected from polyethylene glycol
4000 and 6000, PVP, PLURONICS F87, carbomer, polyoxyethylene, carbopol, citric acid, chitosan, preferably poly- second
Glycol 4000 and 6000, PLURONICS F87, citric acid, preferred Macrogol 4000 and 6000, PLURONICS F87, lemon
Acid；The disintegrant is selected from dried starch, PVPP, Ac-Di-Sol, low-substituted hydroxypropyl cellulose, preferably
PVPP, Ac-Di-Sol.
The compound medicine-releasing system of Allopurinol, it is characterised in that its slow release layer and release layer are made up of following ingredients respectively：
The drug release determination condition, according to drug release determination method (two methods of annex XD first of Chinese Pharmacopoeia version in 2010),
Dissolution medium is selected from distilled water, simulated intestinal fluid, simulated gastric fluid, preferably pH8.0 buffer solutions, simulated gastric fluid；Medium volume 900ml,
37 DEG C of temperature；Rotating speed 50-100r/min, preferably 75r/min.Preparation method：
1. the preparation of slow release layer particle
Supplementary material is first crossed into 120 mesh sieves respectively, the wherein larger auxiliary material of particle first crushes re-sieving, then weighs prescription respectively
Auxiliary material beyond the Allopurinol and lubricant of amount, using equivalent pass interpretation of the law it is well mixed after, add the adhesive containing solubilizer
Softwood processed, after being pelletized with 20 mesh sieves, wet granular is put in 60 DEG C of convection ovens and dried 2 hours, dries after finishing, and takes out, 20 mesh sieves
Whole grain, and add magnesium stearate and always mix, drug content is determined, it is determined that layer weight.
2. the preparation of release layer particle
The Allopurinol for first weighing recipe quantity is mixed with a part of diluent, crushes 120 mesh sieves, adds remaining diluent,
Using equivalent pass interpretation of the law it is well mixed after, add and contain colouring agent adhesive softwood, after the granulation of 20 mesh sieves, wet granular puts 60
Dry 1.5 hours, dried after finishing in DEG C convection oven, take out, 20 mesh sieve whole grains, and add magnesium stearate and always mix, determine master
Medicine content, it is determined that layer weight.
3. the preparation of compound medicine-releasing system
First slow release layer particle is placed in a loading hopper of bi-layer tablet press, first with less pressure precompressed and adjust to
Required first synusia weight, then release layer particle is placed in another loading hopper of the bi-layer tablet press, it is total needed for pressurizeing and adjusting
After piece weight, adjust after slice, thin piece hardness 40-80N, monitoring parameter stability, you can continuous tabletting.
4. compound medicine-releasing system dissolution is determined
Using Chinese Pharmacopoeia version annex XC the second subtraction units of dissolution method (slurry processes) in 2010, respectively with distilled water,
Simulated intestinal fluid, simulated gastric fluid, pH8.0 buffer solutions, 900ml is dissolution medium, and rotating speed 75r/min is operated in accordance with the law, 1 hour, 4
Hour, 8 hours, 12 hours separately sampled 10ml, filtration, and corresponding dissolution medium is supplemented into stripping rotor, precision draws continuous filter
Liquid 2ml, puts in 25ml measuring bottles, plus corresponding dissolution medium is fixed to scale, shakes up.According to AAS (Chinese Pharmacopoeia version in 2010
Two annex IVA), trap is determined at 250nm wavelength, by the absorption coefficient of AllopurinolFor 571 calculate every
The cumulative release amount of different time.This product 1 hour, 4 hours, 8 hours, the burst size of 12 hours be respectively labelled amount 10%-
30%th, 30%-60%, 60-90%, more than 90%, all should meet regulation.
Brief description of the drawings
Homogeneity curve map is discharged in Fig. 1 Allopurinol sustained-release double-layer tablet simulated gastric fluids
Add up release homogeneity curve map in the slow double-layer tablets simulated intestinal fluid of Fig. 2 Allopurinols
Add up release homogeneity curve map in Fig. 3 Allopurinol sustained-release double-layer tablet distilled water
Add up release homogeneity curve map in Fig. 4 Allopurinol sustained-release double-layer tablet pH8.0 buffer solutions
Fig. 5 Allopurinols sustained-release double-layer tablet Cumulative release profile figure in different dissolution mediums
Embodiment
With reference to embodiment, the present invention is described further, but is not any limitation of the invention.
Embodiment 1
The compound medicine-releasing system of Allopurinol
Prescription (1000)
Preparation method：
1. the preparation of slow release layer particle
Supplementary material is first crossed into 120 mesh sieves respectively, the wherein larger auxiliary material of particle first crushes re-sieving, then weighs prescription respectively
Allopurinol, HPMC, lactose, the sodium chloride of amount, using equivalent pass interpretation of the law it is well mixed after, add appropriate dissolved with telling
95% ethanol solution softwood of 5% PVP K30 of temperature -80, with 20 mesh sieve extrusion granulators, wet granular puts 60 DEG C of convection ovens
Middle drying 2 hours, is dried after finishing, and is taken out, 20 mesh sieve whole grains, and adds the magnesium stearate of dry particl gross weight 1%, and mixing is equal
It is even, drug content is determined, it is determined that layer weight.
2. the preparation of release layer particle
The Allopurinol for first weighing recipe quantity is mixed with citric acid, and high speed disintegrator crosses 120 mesh sieves after crushing, then at addition
Microcrystalline cellulose, the Ac-Di-Sol 6g of side's amount, using equivalent pass interpretation of the law it is well mixed after, addition contains colouring agent
10% PVP K30 80% ethanol solution softwood, after 20 mesh sieve extrusion granulators, wet granular is put in 60 DEG C of convection ovens
Dry 1.5 hours, dry after finishing, take out, 20 mesh sieve whole grains, and add magnesium stearate and 4g crosslinking carboxylics that dry particl weighs 1%
Sodium carboxymethylcellulose pyce, is well mixed, and drug content is determined, it is determined that layer weight.
3. the preparation of compound medicine-releasing system
First slow release layer particle is placed in a loading hopper of bi-layer tablet press, first with less pressure precompressed and adjust to
Required first synusia weight, then release layer particle is placed in another loading hopper of the bi-layer tablet press, it is total needed for pressurizeing and adjusting
After piece weight, adjust after slice, thin piece hardness 40-80N, monitoring parameter stability, you can continuous tabletting.
4. compound Allopurinol medicine-releasing system dissolution is determined
Using Chinese Pharmacopoeia version annex XC the second subtraction units of dissolution method (slurry processes) in 2010, respectively with distilled water,
Simulated intestinal fluid, simulated gastric fluid, pH8.0 buffer solutions, 900ml is dissolution medium, and rotating speed 75r/min is operated in accordance with the law, 1 hour, 4
Hour, 8 hours, 12 hours separately sampled 10ml, filtration, and corresponding dissolution medium is supplemented into stripping rotor, precision draws continuous filter
Liquid 2ml, puts in 25ml measuring bottles, plus corresponding dissolution medium is fixed to scale, shakes up.According to AAS (Chinese Pharmacopoeia version in 2010
Two annex IVA), trap is determined at 250nm wavelength, by the absorption coefficient of AllopurinolFor 571 calculate every
The cumulative release amount of different time.This product 1 hour, 4 hours, 8 hours, the burst size of 12 hours be respectively labelled amount 10%-
30%th, 30%-60%, 60-90%, more than 90%, all should meet regulation.
Allopurinol is sustained compound medicine-releasing system dissolution determination result in different dissolution mediums and see the table below 1-4.
It is plotted against time with each accumulative releasing degree, obtains the compound medicine-releasing system of Allopurinol release in different medium equal
One linearity curve figure (see accompanying drawing 1-4), it is seen that compound medicine-releasing system preparation process of the invention is stable, is released in various dissolution mediums
Put homogeneity preferably, SD ＜ 3；With each in different medium average cumulative release be plotted against time, obtain Allopurinol compound
Cumulative release profile figure in medicine-releasing system difference dissolution medium (see accompanying drawing 5), it is seen that slice, thin piece release has in different dissolution mediums
Certain difference, but meet regulation.
The compound medicine-releasing system of the Allopurinol of table 1 release tables of data in simulated gastric fluid
The compound medicine-releasing system of the Allopurinol of table 2 release tables of data in simulated intestinal fluid
The compound medicine-releasing system of the Allopurinol of table 3 release tables of data in water
The compound medicine-releasing system of the Allopurinol of table 4 release tables of data in pH8.0 buffer solutions
Embodiment 2
The compound medicine-releasing system of Allopurinol
Prescription (1000)
Preparation method：
1. the preparation of slow release layer particle
Supplementary material is first crossed into 120 mesh sieves respectively, the wherein larger auxiliary material of particle first crushes re-sieving, then weighs prescription respectively
Allopurinol, HPMC, lactose, the sodium chloride of amount, using equivalent pass interpretation of the law it is well mixed after, add appropriate dissolved with telling
80% ethanol solution softwood of 5% PVP K30 of temperature -80,20 mesh sieve extrusion granulators, wet granular is put in 60 DEG C of convection ovens
Dry 2 hours, dry after finishing, take out, 20 mesh sieve whole grains, and add the magnesium stearate of dry particl gross weight 1%, be well mixed,
Drug content is determined, it is determined that layer weight.
2. the preparation of release layer particle
The Allopurinol for first weighing recipe quantity is mixed with Macrogol 4000, and high speed disintegrator crosses 120 mesh sieves after crushing, then
Add microcrystalline cellulose, the PVPP 6g of recipe quantity, using equivalent pass interpretation of the law it is well mixed after, addition contains colouring agent
75% ethanol solution softwood of 10% PVP K30, after 20 mesh sieve extrusion granulators, wet granular is put in 60 DEG C of convection ovens and done
Dry 1.5 hours, dry after finishing, take out, 20 mesh sieve whole grains, and add magnesium stearate and the poly- dimension of 4g crosslinkings that dry particl weighs 1%
Ketone, is well mixed, and drug content is determined, it is determined that layer weight.
3. the preparation of compound medicine-releasing system
First slow release layer particle is placed in a loading hopper of bi-layer tablet press, first with less pressure precompressed and adjust to
Required first synusia weight, then release layer particle is placed in another loading hopper of the bi-layer tablet press, it is total needed for pressurizeing and adjusting
After piece weight, adjust after slice, thin piece hardness 40-80N, monitoring parameter stability, you can continuous tabletting.
Embodiment 3
The compound medicine-releasing system of Allopurinol
Prescription (1000)
Preparation method：
1. the preparation of slow release layer particle
Supplementary material is first crossed into 120 mesh sieves respectively, the wherein larger auxiliary material of particle first crushes re-sieving, then weighs prescription respectively
Allopurinol, HPMC, lactose, the dextrin of amount, using equivalent pass interpretation of the law it is well mixed after, add appropriate dissolved with telling
60% ethanol solution softwood of 8% PVP K30 of temperature -80,20 mesh sieve extrusion granulators, wet granular is put in 60 DEG C of convection ovens
Dry 2 hours, dry after finishing, take out, 20 mesh sieve whole grains, and add the magnesium stearate of dry particl gross weight 0.5%, mixing is equal
It is even, drug content is determined, it is determined that layer weight.
2. the preparation of release layer particle
The Allopurinol for first weighing recipe quantity is mixed with PLURONICS F87, and high speed disintegrator crosses 120 mesh sieves after crushing, then
Add lactose, the low-substituted hydroxypropyl cellulose 6g of recipe quantity, using equivalent pass interpretation of the law it is well mixed after, addition contains colouring agent
After 20% ethanol solution softwood of 2% hydroxypropyl methylcellulose, 20 mesh sieve extrusion granulators, wet granular is put in 60 DEG C of convection ovens and done
Dry 1.5 hours, dry after finishing, take out, 20 mesh sieve whole grains, and add magnesium stearate and the poly- dimension of 4g crosslinkings that dry particl weighs 1%
Ketone, is well mixed, and drug content is determined, it is determined that layer weight.
3. the preparation of compound medicine-releasing system
First slow release layer particle is placed in a loading hopper of bi-layer tablet press, first with less pressure precompressed and adjust to
Required first synusia weight, then release layer particle is placed in another loading hopper of the bi-layer tablet press, it is total needed for pressurizeing and adjusting
After piece weight, adjust after slice, thin piece hardness 40-80N, monitoring parameter stability, you can continuous tabletting.
Claims (6)
1. a kind of Allopurinol medicine-releasing system, it is characterized in that the medicine-releasing system is compound medicine-releasing system, by slow release layer and release layer
Be composited through suppressing twice, in simulated gastric fluid, simulated intestinal fluid, distilled water and pH8.0 buffer solutions have immediate release profile and
Sustained releasing character, described slow release layer and quick-release layer weight ratio is 0.5: 1-10: 1, and Allopurinol is delaying in the content of release layer with it
The content weight ratio for releasing layer is 0.1: 5-10: 1；The release layer includes solid dispersions, the solid dispersions by Allopurinol and
Disperse matrix is constituted, and Allopurinol is 1: 10-1: 1 with disperse matrix part by weight；Described slow release layer and release layer are respectively under
Arrange each composition composition：
Wherein described skeletal matrix is selected from hydroxypropylcellulose, hydroxypropyl methylcellulose；The diluent is selected from lactose, microcrystalline cellulose
Element, sodium chloride, sodium acid carbonate；The solubilizer is selected from dodecyl sodium sulfate, Tween-80；Described adhesive is selected from polyethylene
Pyrrolidones, hydroxypropylcellulose；Described disperse matrix be selected from Macrogol 4000 and 6000, PLURONICS F87, carbomer,
Citric acid；The disintegrant is selected from PVPP, Ac-Di-Sol.
2. the Allopurinol medicine-releasing system described in claim 1, it is characterised in that slow release layer and release layer are respectively by following each composition
Composition：
3. the Allopurinol medicine-releasing system described in claim 1 or 2, it is characterised in that release characteristic has the homogeneity of height, releases
The SD ＜ 3 for degree of putting.
4. the Allopurinol medicine-releasing system described in claim 3, it is characterised in that release characteristic has in different dissolution mediums
The homogeneity of height, the SD ＜ 3 of release.
5. the Allopurinol medicine-releasing system described in claim 1 or 2, it is characterised in that under the conditions of common drug release determination, this product
1 hour, 4 hours, 8 hours, the burst size of 12 hours be respectively the 5%-30% of labelled amount, 30%-60%, 60%-90%,
More than 90%.
6. the preparation method of the Allopurinol medicine-releasing system described in claim 1 or 2, it is characterised in that release layer Allopurinol is first with dividing
Dissipate matrix mixing, crush, sieving is mixed with diluent, pelletized again.
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| CN201110387589.1A CN103127022B (en) | 2011-11-23 | 2011-11-23 | A kind of compound medicine-releasing system of Allopurinol and preparation method thereof |
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| CN103127022B true CN103127022B (en) | 2017-08-18 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107823160B (en) * | 2017-12-02 | 2020-04-14 | 广东世信药业有限公司 | Solid dispersion preparation for resisting gout and preparation method thereof |
| CN111281902A (en) * | 2018-12-06 | 2020-06-16 | 常州高新技术产业开发区三维工业技术研究所有限公司 | Application of lithocarpus litseifolius or active extract thereof |
| CN111735786A (en) * | 2020-07-02 | 2020-10-02 | 无锡紫杉药业有限公司 | Allopurinol quality detection method |
Citations (4)
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|---|---|---|---|---|
| US5773031A (en) * | 1996-02-27 | 1998-06-30 | L. Perrigo Company | Acetaminophen sustained-release formulation |
| CN1739522A (en) * | 2004-12-17 | 2006-03-01 | 范敏华 | Slowly releasing allopurinol tablet and its prepn |
| CN101836967A (en) * | 2010-05-17 | 2010-09-22 | 中国药科大学 | Dihydroartemisinine bilayer tablet and preparation method thereof |
| CN102091051A (en) * | 2009-12-14 | 2011-06-15 | 北京科信必成医药科技发展有限公司 | Allopurinol dual-release preparation and preparation method thereof |
-
2011
- 2011-11-23 CN CN201110387589.1A patent/CN103127022B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5773031A (en) * | 1996-02-27 | 1998-06-30 | L. Perrigo Company | Acetaminophen sustained-release formulation |
| CN1739522A (en) * | 2004-12-17 | 2006-03-01 | 范敏华 | Slowly releasing allopurinol tablet and its prepn |
| CN102091051A (en) * | 2009-12-14 | 2011-06-15 | 北京科信必成医药科技发展有限公司 | Allopurinol dual-release preparation and preparation method thereof |
| CN101836967A (en) * | 2010-05-17 | 2010-09-22 | 中国药科大学 | Dihydroartemisinine bilayer tablet and preparation method thereof |
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