CN102091051A - Allopurinol dual-release preparation and preparation method thereof - Google Patents
Allopurinol dual-release preparation and preparation method thereof Download PDFInfo
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- CN102091051A CN102091051A CN2009102423245A CN200910242324A CN102091051A CN 102091051 A CN102091051 A CN 102091051A CN 2009102423245 A CN2009102423245 A CN 2009102423245A CN 200910242324 A CN200910242324 A CN 200910242324A CN 102091051 A CN102091051 A CN 102091051A
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Abstract
The invention relates to an allopurinol dual-release preparation and a preparation method thereof, which is characterized in that the dual-release preparation consists of a quick-release part and a slow-release part, wherein the ratio of the base allopurinol contained in the quick-release part to the base allopurinol contained in the slow-release part is 1:1 to 1:24. The invention belongs to the technical field of medicine preparation and aims at providing the allopurinol dual-release preparation with good patient compliance and small side effect and the preparation method thereof, wherein the allopurinol dual-release preparation has the advantages of taking effect quickly and maintaining effective blood concentration stably. The dual-release preparation can not only be used for reducing the side effect on the gastrointestinal tract, but also decreasing the administration times of a patient and adverse effect and promoting the patient compliance.
Description
Technical field
The present invention relates to two delivery formulations of a kind of allopurinol and preparation method thereof, it is characterized in that described pair of delivery formulations is to be made of immediate release section and slow-released part, wherein to contain the proportion of principal agent allopurinol be 1 for immediate release section and slow-released part: 1-1: 24.Belong to the pharmaceutical preparations technology field.
Background technology
Allopurinol (Allpurinol), chemical constitution are 1H-pyrazolo [3,4-d] pyrimidine-4-alcohol.Allopurinol is white or off-white color crystalline powder; Almost odorless is tasteless.Atomic molten in water or ethanol, insoluble in ether or chloroform; In alkaline solution, dissolve.Allopurinol is uniquely can suppress the synthetic medicine of uric acid at present, itself and metabolite oxypurinol are by suppressing the activity of xanthine oxidase, stoping hypoxanthine and xanthine metabolism is uric acid, make the uric acid content in blood and the urine be reduced to the following level of dissolubility, thereby prevent that uric acid from forming crystallization deposition in joint and hetero-organization thereof, also helps the in-house uric acid crystal of gout patient to dissolve again.Allopurinol can also synthesizing by purine new in the effect inhibition body to hypoxanthine-guanine monophosphate nucleic acid conversion enzyme.The oral back of allopurinol absorbs fully in gastrointestinal tract, is activated oxypurinol at the liver intracellular metabolite, the both can not and protein binding.The half-life of allopurinol is 1～3 hour, discharges by kidney with oxypurinol.
Domestic existing listing allopurinol is conventional tablet at present, need take 1～3 general every day, and can not the effective gout blood drug level of held stationary, and action time is short, need adhere to medicining times and dosage for a long time, just can reach therapeutic effect, ordinary tablet blood drug level peak value fluctuation degree is big in addition, easily produces untoward reaction.In view of there is above deficiency in ordinary tablet, in order better to control allopurinol blood drug level, guarantee clinical efficacy, reduce medicining times, improve compliance, the two delivery formulations of allopurinol have been developed in the generation of reduction untoward reaction.
Beneficial effect
1, the two delivery formulations of allopurinol have been developed its advantage, improve the deficiency of common formulations, because of it is made up of immediate release section and slow-released part, the rapid stripping of allopurinol in the immediate release section of oral back, reach effective blood drug concentration, quick acting, slow-released part then slowly discharges, and can remain valid in a long time, stable blood concentration, and drug effect was kept 12-24 hour.
2, can reduce medicine to the gastrointestinal side effect.The conventional formulation dose is big, and is big to GI irritation, makes slow releasing preparation and can reduce side effect.
3, pharmaceutical release time is obviously prolonged, therefore reduced medicining times, improve patient compliance, abirritate and untoward reaction.
Summary of the invention
One object of the present invention is to provide the two delivery formulations of allopurinol that a kind of good patient compliance, side effect are little, can quick acting can keep steady effective blood drug concentration again lastingly.
Another object of the present invention is to provide the preparation method of the two delivery formulations of a kind of allopurinol.
The present invention relates to the two delivery formulations of a kind of allopurinol, it is characterized in that described pair of delivery formulations is to be made of immediate release section and slow-released part, wherein to contain the proportion of principal agent allopurinol be 1 for immediate release section and slow-released part: 1-1: 24, and immediate release section contains principal agent allopurinol and disintegrating agent, diluent, binding agent, lubricant; Slow-released part contains principal agent allopurinol and slow-release material, diluent, binding agent, lubricant.
Of the present invention pair of delivery formulations, it is characterized in that immediate release section is by weight percentage in the described pair of delivery formulations: allopurinol accounts for 15%～75%, and preferred 25%～65%; Diluent accounts for 5%～50%, and preferred 15%～40%; Disintegrating agent accounts for 5%～50%, and preferred 10%～40%; Binding agent 0.5%～15%, preferred 2%～10%; Lubricant accounts for 0.01%～3.0%.
Of the present invention pair of delivery formulations is characterized in that slow-released part by weight percentage in the described pair of delivery formulations: allopurinol 30%～80%, preferred 30%～70%; Slow-release material accounts for 5%～40%, and preferred 10%～25%; Diluent 5%～30%, preferred 10%～20%; Binder constitutes 1%～10%, preferred 3%～8%; Lubricant accounts for 0.1%～3.0%.
Of the present invention pair of delivery formulations, it is characterized in that described slow-release material is selected from one or more in hypromellose, hydroxypropyl cellulose, sodium alginate, sodium carboxymethyl cellulose, polyvidone, copolyvidone, POLYPROPYLENE GLYCOL, ethyl cellulose, hydroxyethyl-cellulose, polyacrylic resin base polymer, stearic acid, the Brazil wax, preferred hydroxypropyl methylcellulose.
Of the present invention pair of delivery formulations, it is characterized in that described diluent is selected from one or more in microcrystalline Cellulose, mannitol, starch, Icing Sugar, pregelatinized Starch, low-substituted hydroxypropyl cellulose, Polyethylene Glycol, the ethanol, preferably microcrystalline cellulose.
Of the present invention pair of delivery formulations, it is characterized in that described disintegrating agent is selected from one or more in crospolyvinylpyrrolidone, polyvidone, polyvinylpolypyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, starch, the cross-linking sodium carboxymethyl cellulose, preferred carboxymethyl starch sodium, starch.
Of the present invention pair of delivery formulations, it is characterized in that described binding agent is selected from that polyvidone, copolyvidone, hypromellose, starch, carboxymethyl starch are received, in the ethyl cellulose, polyacrylic resin base polymer one or more, preferred polyvidone.
Of the present invention pair of delivery formulations is characterized in that described lubricant agent is selected from one or more in magnesium stearate, calcium stearate, hard fumaric acid sodium, micropowder silica gel, Pulvis Talci, month pure magnesium sulfate of extension, preferred magnesium stearate.
Of the present invention pair of delivery formulations is characterized in that comprising and is prepared as follows step:
(1) immediate-release granules preparation: allopurinol was pulverized 80 mesh sieves, standby; Take by weighing allopurinol, disintegrating agent, binding agent, the diluent of recipe quantity, mix homogeneously adds suitable quantity of water, carries out wet granulation, the 16 mesh sieves granulate that wet, and 50 ℃ of oven dry, 20 mesh sieve granulate, calculated yield adds magnesium stearate, and mixing is standby.
(2) slow-releasing granules preparation: allopurinol was pulverized 80 mesh sieves, standby; Take by weighing allopurinol, slow-release material, the diluent of recipe quantity, mix homogeneously adds the soft material that makes with binding agent, carries out wet granulation, the 16 mesh sieves granulate that wet, and 50 ℃ of oven dry, 20 mesh sieve granulate, calculated yield adds magnesium stearate, and mixing is standby.
(3) with the granule mix homogeneously of (1) and (2) preparation, directly encapsulated, promptly get slow releasing capsule.
(4) granule that (1) is made adds a side hopper of putting double-deck sheeting equipment, starts tablet machine, the heavy and hardness (0-5kg) of adjustment sheet; The granule that (2) are made adds the opposite side hopper of putting double-deck sheeting equipment again, and the heavy and hardness of adjustment sheet is suppressed continuously, promptly gets double-layer sustained release tablets.
Description of drawings
The slow releasing capsule release curve chart that Fig. 1 makes for embodiment 1-5
Fig. 2 is put the line chart of writing music for the double-layer sustained release tablets that embodiment 1-5 makes
The specific embodiment
Embodiment 1:
Immediate release section
Allopurinol 50g
Microcrystalline Cellulose 101 20g
Starch 30g
30 POVIDONE K 30 BP/USP 30 3g
Magnesium stearate 0.5g
Slow-released part
Allopurinol 200g
Hypromellose K100LV 40g
Microcrystalline Cellulose 101 50g
30 POVIDONE K 30 BP/USP 30 15g
Magnesium stearate 0.8g
Make 1000 slices/
Preparation method:
(1) immediate-release granules preparation: allopurinol was pulverized 80 mesh sieves, standby; Take by weighing allopurinol, starch, 30 POVIDONE K 30 BP/USP 30, the microcrystalline Cellulose 101 of recipe quantity, mix homogeneously adds suitable quantity of water, carries out wet granulation, the 16 mesh sieves granulate that wet, and 50 ℃ of oven dry, 20 mesh sieve granulate, calculated yield adds magnesium stearate, and mixing is standby.
(2) slow-releasing granules preparation: allopurinol was pulverized 80 mesh sieves, standby; Take by weighing allopurinol, microcrystalline Cellulose 101, the hypromellose K100LV of recipe quantity, mix homogeneously, it is an amount of to add 20% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution, carries out wet granulation, the 16 mesh sieves granulate that wets, 50 ℃ of oven dry, 20 mesh sieve granulate, calculated yield, add magnesium stearate, mix, standby.
(3) with the granule mix homogeneously of (1) and (2) preparation, directly encapsulated, promptly get slow releasing capsule.
(4) granule that (1) is made adds a side hopper of putting double-deck sheeting equipment, starts tablet machine, the heavy and hardness (0-5kg) of adjustment sheet; The granule that (2) are made adds the opposite side hopper of putting double-deck sheeting equipment again, and the heavy and hardness of adjustment sheet is suppressed continuously, promptly gets double-layer sustained release tablets.
Embodiment 2:
Immediate release section:
Allopurinol 50g
Microcrystalline Cellulose 101 25g
Starch 26g
30 POVIDONE K 30 BP/USP 30 3.7g
Magnesium stearate 0.5g
Slow-released part
Allopurinol 200g
Hypromellose K4M 25g
Hypromellose E5 26g
Microcrystalline Cellulose 101 45g
30 POVIDONE K 30 BP/USP 30 15g
Magnesium stearate 0.8g
Make 1000 slices/
Preparation method: with embodiment 1.
Embodiment 3:
Immediate release section:
Allopurinol 125g
Microcrystalline Cellulose 101 38g
Carboxymethyl starch sodium 23g
30 POVIDONE K 30 BP/USP
3012g
Magnesium stearate 1g
Slow-released part:
Allopurinol 125g
Hydroxypropyl methylcellulose K100LV 55g
Microcrystalline Cellulose 101 40g
30 POVIDONE K 30 BP/USP
3015g
Magnesium stearate 1g
Make 1000 slices/altogether
Preparation method: with embodiment 1.
Embodiment 4:
Immediate release section:
Allopurinol 100g
Microcrystalline Cellulose 101 35g
Starch 15g
30 POVIDONE K 30 BP/USP
3010g
Magnesium stearate 0.8g
Slow-released part:
Allopurinol 150g
Hydroxypropyl methylcellulose K4M 45g
Hydroxypropyl methylcellulose E5 26g
Microcrystalline Cellulose 101 48g
30 POVIDONE K 30 BP/USP
3016g
Magnesium stearate 1g
Make 1000 slices/altogether
Preparation method: with embodiment 1.
Embodiment 5:
Immediate release section:
Allopurinol 25g
Microcrystalline Cellulose 101 15g
Carboxymethyl starch sodium 20g
30 POVIDONE K 30 BP/USP 30 3g
Magnesium stearate 0.5g
Slow-released part
Allopurinol 225g
Hypromellose K4M 48g
Hypromellose E5 27g
Microcrystalline Cellulose 101 50g
30 POVIDONE K 30 BP/USP 30 18g
Magnesium stearate 1g
Make 1000 slices/
Preparation method: with embodiment 1.
Embodiment 6:
Immediate release section:
Allopurinol 12.5g
Microcrystalline Cellulose 101 12g
Carboxymethyl starch sodium 17g
30 POVIDONE K 30 BP/USP 30 2.5g
Magnesium stearate 0.5g
Slow-released part
Allopurinol 237.5g
Hypromellose K100LV 60g
Microcrystalline Cellulose 101 45g
30 POVIDONE K 30 BP/USP 30 15g
Magnesium stearate 1g
Make 1000 slices/
Preparation method: with embodiment 1.
Embodiment 7:
Release layer prescription (by 1000):
Allopurinol 10g
Microcrystalline Cellulose 101 20g
Starch 10g
30 POVIDONE K 30 BP/USP 30 3g
Magnesium stearate 0.5g
Slow release layer prescription (by 1000)
Allopurinol 240g
Hypromellose K4M 36g
Hypromellose E5 28g
Microcrystalline Cellulose 101 50g
30 POVIDONE K 30 BP/USP 30 15g
Magnesium stearate 0.8g
Make 1000
Preparation method: with embodiment 1.
In order to investigate release in vitro effect of the present invention, according to drug release determination method (two appendix X of Chinese Pharmacopoeia version in 2005 D, first method), adopting dissolution first subtraction unit, is solvent with the hydrochloric acid solution 900ml of 0.1mol/L, and rotating speed is that per minute 75 changes, operation in accordance with the law, at 1 hour, get solution 10ml when 4 hours and 8 hours respectively, filter, and instant release medium of in stripping rotor, replenishing equal volume, uniform temp, subsequent filtrate diluted as need testing solution carry out drug release determination.
Test records slow releasing capsule that embodiment 1-5 makes and discharges and the results are shown in Table 1, and double-layer sustained release tablets discharges and the results are shown in Table 2.
The slow releasing capsule release result of the test that table 1 embodiment 1-5 makes
| 1 |
4 |
8 hours | |
| Embodiment 1 | 31.5％ | 63.5％ | 94.0 |
| Embodiment | |||
| 2 | 30.4％ | 61.4％ | 92.2％ |
| Embodiment 3 | 36.5％ | 55.3％ | 87.4 |
| Embodiment | |||
| 4 | 34.8％ | 53.7％ | 88.9％ |
| Embodiment 5 | 20.1％ | 48.9％ | 83.1％ |
Double-layer sustained release tablets degree of the putting result of the test that table 2 embodiment 1-5 makes
| 1 |
4 |
8 hours | |
| Embodiment 1 | 28.3％ | 60.4％ | 90.2 |
| Embodiment | |||
| 2 | 27.8％ | 58.9％ | 89.5％ |
| Embodiment 3 | 32.9％ | 51.8％ | 84.7％ |
| |
30.8％ | 51.7％ | 83.9％ |
| Embodiment 5 | 18.1％ | 45.9％ | 79.1％ |
Claims (7)
1. two delivery formulations of an allopurinol, it is characterized in that described pair of delivery formulations is to be made of immediate release section and slow-released part, wherein to contain the proportion of principal agent allopurinol be 1 for immediate release section and slow-released part: 1-1: 24, and immediate release section contains principal agent allopurinol and disintegrating agent, diluent, binding agent, lubricant; Slow-released part contains principal agent allopurinol and slow-release material, diluent, binding agent, lubricant.
2. described pair of delivery formulations of claim 1, it is characterized in that immediate release section is by weight percentage in the described pair of delivery formulations: allopurinol accounts for 15%～75%, and preferred 25%～65%; Diluent accounts for 5%～50%, and preferred 15%～40%; Disintegrating agent accounts for 5%～50%, and preferred 10%～40%; Binding agent 0.5%～15%, preferred 2%～10%; Lubricant accounts for 0.01%～3.0%.
3. described pair of delivery formulations of claim 1 is characterized in that slow-released part by weight percentage in the described pair of delivery formulations: allopurinol 30%～80%, preferred 30%～70%; Slow-release material accounts for 5%～40%, and preferred 10%～25%; Diluent 5%～30%, preferred 10%～20%; Binder constitutes 1%～10%, preferred 3%～8%; Lubricant accounts for 0.1%～3.0%.
4. described pair of delivery formulations of claim 1-3 is characterized in that:
Described slow-release material is selected from one or more in hypromellose, hydroxypropyl cellulose, sodium alginate, sodium carboxymethyl cellulose, polyvidone, copolyvidone, POLYPROPYLENE GLYCOL, ethyl cellulose, hydroxyethyl-cellulose, polyacrylic resin base polymer, stearic acid, the Brazil wax, preferred hydroxypropyl methylcellulose.
Described diluent is selected from one or more in microcrystalline Cellulose, mannitol, starch, Icing Sugar, pregelatinized Starch, low-substituted hydroxypropyl cellulose, Polyethylene Glycol, the ethanol, preferably microcrystalline cellulose.
Described disintegrating agent is selected from one or more in crospolyvinylpyrrolidone, polyvidone, polyvinylpolypyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, starch, the cross-linking sodium carboxymethyl cellulose, preferred carboxymethyl starch sodium, starch.
Described binding agent is selected from that polyvidone, copolyvidone, hypromellose, starch, carboxymethyl starch are received, in the ethyl cellulose, polyacrylic resin base polymer one or more, preferred polyvidone.
Described lubricant agent is selected from one or more in magnesium stearate, calcium stearate, hard fumaric acid sodium, micropowder silica gel, Pulvis Talci, month pure magnesium sulfate of extension, preferred magnesium stearate.
5. described pair of delivery formulations of claim 1-4 is characterized in that calculating by weight, and it consists of:
6. described pair of delivery formulations of claim 1-4 is characterized in that calculating by weight, and it consists of:
7. described pair of delivery formulations of claim 1-6 is characterized in that comprising and is prepared as follows step:
(1) immediate-release granules preparation: allopurinol was pulverized 80 mesh sieves, standby; Take by weighing allopurinol, disintegrating agent, binding agent, the diluent of recipe quantity, mix homogeneously adds suitable quantity of water, carries out wet granulation, the 16 mesh sieves granulate that wet, and 50 ℃ of oven dry, 20 mesh sieve granulate, calculated yield adds magnesium stearate, and mixing is standby.
(2) slow-releasing granules preparation: allopurinol was pulverized 80 mesh sieves, standby; Take by weighing allopurinol, slow-release material, the diluent of recipe quantity, mix homogeneously adds the soft material that makes with binding agent, carries out wet granulation, the 16 mesh sieves granulate that wet, and 50 ℃ of oven dry, 20 mesh sieve granulate, calculated yield adds magnesium stearate, and mixing is standby.
(3) with the granule mix homogeneously of (1) and (2) preparation, directly encapsulated, promptly get slow releasing capsule.
(4) granule that (1) is made adds a side hopper of putting double-deck sheeting equipment, starts tablet machine, the heavy and hardness (0-5kg) of adjustment sheet; The granule that (2) are made adds the opposite side hopper of putting double-deck sheeting equipment again, and the heavy and hardness of adjustment sheet is suppressed continuously, promptly gets double-layer sustained release tablets.
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Cited By (8)
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| CN102579408A (en) * | 2012-03-19 | 2012-07-18 | 河南中帅医药科技发展有限公司 | Doxycycline hydrochloride dual-release preparation and preparation method thereof |
| CN102727558A (en) * | 2012-07-04 | 2012-10-17 | 重庆市中药研究院 | Tripterygium Hypoglaucum Hutch root extract, and bi-layer extended release tablet and application thereof |
| CN105272984A (en) * | 2014-06-23 | 2016-01-27 | 北京新天宇科技开发有限公司 | Parazole [3,4-d]pyrimidine-4-one derivative, and preparation method and applications thereof |
| CN106822907A (en) * | 2016-12-29 | 2017-06-13 | 山东达因海洋生物制药股份有限公司 | A kind of two-phase delivery formulations containing racecadotril and preparation method thereof |
| CN103127022B (en) * | 2011-11-23 | 2017-08-18 | 常州善美药物研究开发中心有限公司 | A kind of compound medicine-releasing system of Allopurinol and preparation method thereof |
| CN107260708A (en) * | 2016-04-09 | 2017-10-20 | 厦门恩成制药有限公司 | A kind of dual-release preparation of Betahistine or its salt and preparation method thereof |
| CN113081989A (en) * | 2021-03-29 | 2021-07-09 | 海南普利制药股份有限公司 | Allopurinol sustained release tablet |
| CN113318092A (en) * | 2021-06-10 | 2021-08-31 | 黑龙江澳利达奈德制药有限公司 | Allopurinol sustained-release capsule |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN100500155C (en) * | 2004-12-17 | 2009-06-17 | 范敏华 | Slowly releasing allopurinol tablet and its preparation |
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| CN103127022B (en) * | 2011-11-23 | 2017-08-18 | 常州善美药物研究开发中心有限公司 | A kind of compound medicine-releasing system of Allopurinol and preparation method thereof |
| CN102579408A (en) * | 2012-03-19 | 2012-07-18 | 河南中帅医药科技发展有限公司 | Doxycycline hydrochloride dual-release preparation and preparation method thereof |
| CN102579408B (en) * | 2012-03-19 | 2013-06-05 | 河南中帅医药科技发展有限公司 | Doxycycline hydrochloride dual-release preparation and preparation method thereof |
| CN102727558A (en) * | 2012-07-04 | 2012-10-17 | 重庆市中药研究院 | Tripterygium Hypoglaucum Hutch root extract, and bi-layer extended release tablet and application thereof |
| CN105272984A (en) * | 2014-06-23 | 2016-01-27 | 北京新天宇科技开发有限公司 | Parazole [3,4-d]pyrimidine-4-one derivative, and preparation method and applications thereof |
| CN105272984B (en) * | 2014-06-23 | 2019-06-14 | 湘北威尔曼制药股份有限公司 | Pyrazolo [3,4-d] pyrimidin-4-one-derivatives, preparation method and application |
| CN107260708A (en) * | 2016-04-09 | 2017-10-20 | 厦门恩成制药有限公司 | A kind of dual-release preparation of Betahistine or its salt and preparation method thereof |
| CN106822907A (en) * | 2016-12-29 | 2017-06-13 | 山东达因海洋生物制药股份有限公司 | A kind of two-phase delivery formulations containing racecadotril and preparation method thereof |
| CN113081989A (en) * | 2021-03-29 | 2021-07-09 | 海南普利制药股份有限公司 | Allopurinol sustained release tablet |
| CN113318092A (en) * | 2021-06-10 | 2021-08-31 | 黑龙江澳利达奈德制药有限公司 | Allopurinol sustained-release capsule |
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