CN104306345B - A kind of oral slow-releasing preparation of blonanserin - Google Patents
A kind of oral slow-releasing preparation of blonanserin Download PDFInfo
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- CN104306345B CN104306345B CN201410472636.6A CN201410472636A CN104306345B CN 104306345 B CN104306345 B CN 104306345B CN 201410472636 A CN201410472636 A CN 201410472636A CN 104306345 B CN104306345 B CN 104306345B
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Abstract
The present invention relates to Blonanserin tablet and preparation method thereof, tablet prepared by the present invention can reduce medicining times, maintenance blood concentration is steady, reduce side effect.Wherein, blonanserin and blonanserin mass ratio in common blonanserin component are 70: 30~90: 10 in blonanserin oral formulations component.It is sustained blonanserin component by mass percentage, blonanserin is 15.0~20.0%, starch 20.0~40.0%, sodium alginate 20.0~30.0%, dextrin 10.0~25.0%, magnesium stearate 0.5~0.8%, 50% ethanol 1.0~1.5%, calcium monohydrogen phosphate 3.0~5.0%.
Description
Technical field
The present invention relates to medicine and preparation method thereof, more particularly to a kind of blonanserin oral slow releasing preparation and its preparation
Method.
Background technology
Schizophrenia is a kind of serious, crippling mental illness.Nineteen fifty-three, the medicine of first antipsychotic
Since thing chlorpromazine is clinically applied, have gone through so far more than 50 years.The antipsychotics commercially commonly used at present
It is divided into typical case and the major class of atypia two by receptor blocking effect difference：It is chlorpromazine, haloperole that the former, which represents medicine, is mainly
Dopamine receptor is blocked, has good therapeutic effect to schizoid positive symptom.But the extrapyramidal symptoms (ESP) are common simultaneously,
And it is poor to negative symptoms curative effect；The latter, which represents medicine, Risperidone, Olanzapine, kui gentle ziprasidone and Ziprasidone etc., and a new generation is non-
Classical antipsychotic is improving schizoid positive, negative symptoms and security, tolerance, Extra Pyramidal Syndrome
(EPS) in terms of incidence, hence it is evident that better than Traditional antipsychotics.At present, global anti-schizophrenia pharmaceutical market mainly with
Based on atypia anti-schizophrenia medicine, traditional anti-schizophrenia medicine will be substituted gradually by atypia class.
Blonanserin (Blonanserin) is researched and developed by SUMITOMO CHEMICAL Pharmaceutical Co., Ltd, and in April, 2008 is first in Japan
City.This product is the 5-HT2 acceptors and D2 receptor antagonists of high selectivity, to D1 and adrenaline α 1, H1 histamine receptors and M1
Choline receptor affinity is smaller, and clinic is mainly used in treating atypical mental disease, and the side effect reaction of extrapyramidal system is less, and
With special effect.The double-blind clinical comparative tests in 8 weeks that blonanserin is carried out with haloperole, there is 263 schizophrenia
Patient participates in.8-24mg/d blonanserins are at least effective as 4-12mg/d haloperole, can improve final improvement comprehensively
Series (FGIR) score (two medicines are respectively 61.2% and 51.3% at least moderate improvement rate of patient), extrapyramidal system is not
Good reaction incidence is less (being respectively 52.7% and 75.4%).This product listing preparation includes 2mg, 4mg tablet and 2% powder,
Its standard dose of being grown up is 4mg, and 2 times a day, one after each meal.
However, conventional tablet, powder usually need administration on the one for several times, it is not only inconvenient for use, and blood concentration fluctuation
It is very big, there is " peak valley " phenomenon.When blood concentration is high, it is possible to create side effect, or even poisoning；Can be in treatment valid density one when low
Under, so that curative effect can not be presented.Sustained release preparation then can more enduringly discharge medicine, reduce administration number of times, lower blood medicine dense
Peak valley phenomenon is spent there is provided steady lasting effective blood drug concentration, is reduced toxic side effect, is improved Drug safety and validity.
Therefore, it is necessary to the sustained-release tablet of blonanserin be developed, for clinical demand.
The content of the invention
The present invention, which is provided, can reduce medicining times, maintenance blood concentration is steady, it is oral to reduce a kind of blonanserin of side effect
Preparation, a kind of special blonanserin sustained-release tablet and preparation method thereof.
The present invention solve the technical scheme that is used of above-mentioned technical problem for：A kind of blonanserin oral formulations, this is oral
Preparation is mixed with prescription ratio and formed for the sustained release pellet and plain particles component being made up of sustained release blonanserin component；
Blonanserin and blonanserin mass ratio in common blonanserin component in above-mentioned blonanserin oral formulations component
For 70: 30~90: 10；Preferably, blonanserin and blonanserin mass ratio in common blonanserin component are 80: 20 in component
~85: 10；It is highly preferred that blonanserin and blonanserin mass ratio in common blonanserin component are 82: 18 in component.
Above-mentioned sustained release blonanserin component by mass percentage, blonanserin be 15.0~20.0%, starch 20.0~
40.0%th, sodium alginate 20.0~30.0%, dextrin 10.0~25.0%, magnesium stearate 0.5~0.8%, 50% ethanol 1.0~
1.5%, calcium monohydrogen phosphate 3.0~5.0%.
Preferably, by mass percentage, blonanserin is 18.0%, starch to above-mentioned sustained release blonanserin component
34.0%th, sodium alginate 24.0%, dextrin 20.0%, magnesium stearate 0.8%, 50% ethanol 1.2%, calcium monohydrogen phosphate 2.0%.
By mass percentage, blonanserin is that 20.0~30.0%, starch is to above-mentioned plain particles blonanserin component
50~70%, PVP 1.5~2.0%, low-substituted hydroxypropyl methylcellulose be 3.5~4.5%, magnesium stearate be 0.2~
0.35%.
Above-mentioned plain particles blonanserin component by mass percentage, blonanserin be 25.0%, starch be 68.8%,
PVP 1.7%, low-substituted hydroxypropyl methylcellulose are that 4.2%, magnesium stearate is 0.3%.
Above-mentioned blonanserin sustained release preparation, a diameter of 200 μm~800 μm of sustained release pellet, preferably sustained release pellet is straight
Footpath is 300 μm~700 μm, more preferably a diameter of 400 μm~600 μm of sustained release pellet；In plain particles blonanserin component extremely
Few 65% mixture of powders granularity is 100 μm~300 μm, and preferably at least 80% mixture of powders granularity is 100 μm~300
μm。
Present invention also offers a kind of preparation method of blonanserin sustained release preparation, this method comprises the following steps：
1), by sustained release blonanserin constituent mass percentages, blonanserin 18.0%, starch 34.0%, marine alga are weighed
Sour sodium 24.0%, dextrin 20.0% fully mixes, adds recipe quantity magnesium stearate 0.8%, 50% ethanol 1.2%, phosphoric acid hydrogen
Calcium 2.0%, continues well mixed, plus suitable quantity of water prepares softwood；
2), by plain particles blonanserin constituent mass percentages, it is that 25.0%, starch is to weigh cloth blonanserin
68.8%th, PVP 1.7%, low-substituted hydroxypropyl methylcellulose are that 4.2%, magnesium stearate is 0.3%, add blonanserin and delay
Micropill is released, is well mixed, it is tabletted, produce blonanserin sustained release preparation.
In the R＆D process to blonanserin medicine, inventor is had found, common Blonanserin tablet is released in human body
Put too fast, haemoconcentration fluctuation is larger, does not reach good clinical therapeutic efficacy.It is right according to conventional sustained release agent preparation method
A variety of different slow-release materials (such as ethyl cellulose, polymethacrylates, hydroxypropyl methylcellulose, carbomer) are combined
Attempt, Blonanserin tablet is prepared into conventional sustained-release tablet.However, it was found that sustained-release tablet is still difficult to not reach treatment and released
Put the requirement of speed.The physics that this is mainly to blonanserin medicine in itself is related with chemical property, the difficulty of such as blonanserin
Dissolubility matter.
In order to reach the requirement for the treatment of rate of release, the slow-releasing granules of blonanserin, plain particles are mixed and made by trial
Piece agent.By the Integrated Selection to the proportioning between slow-release material and other auxiliary materials and slow-release material, it is determined for compliance with requiring
Prescription.Meanwhile, by the investigation of long-time stability, finally determine the optimal prescription of blonanserin sustained-release tablet.
Compared with prior art, blonanserin sustained release preparation of the invention is the sustained release being made up of sustained release blonanserin component
Micropill and plain particles blonanserin component are mixed the tablet of compacting in prescription ratio, in pH5.5 acetate buffer
In, burst size is 25~35% in 2 hours；6 hours burst sizes are 55~65%；8 hours burst sizes are up to more than 70%.And should
Sustained release preparation drug release rule has more reappearance and uniformity, can reduce medicining times, maintenance blood concentration is steady, extends and effectively kills
Bacteria concentration holds time, reduces side effect and can faster reach effective blood drug concentration compared to existing sustained release preparation, and can reduce
Feed influence, realizes that segmentation is taken.
Embodiment
With reference to embodiment, the present invention will be further described.Release requirement of experiment of the present invention is：In pH5.5 vinegar
In phthalate buffer, Cumulative release amount is 25~35% in 2 hours；6 hours Cumulative release amounts are 55~65%；Add up within 8 hours
Burst size is up to more than 70%.
Embodiment 1：
(1) it is sustained blonanserin micropill prescription
(2) common blonanserin micropill prescription
Prepare tablet mixing recipe quantity
| Ingredient names | Consumption (g) |
| It is sustained blonanserin micropill | 136.00 |
| Common blonanserin micropill | 29.85 |
| Altogether | 165.85 |
It is pressed into 470.
By the specific preparation method of above prescription：
1) blonanserin in sustained release blonanserin micropill prescription, starch, are weighed, sodium alginate, dextrin, is sufficiently mixed, after
The continuous magnesium stearate, 50% ethanol, calcium monohydrogen phosphate for adding recipe quantity is well mixed, and granulation is standby；
2) each supplementary material, is weighed by plain particles blonanserin component recipe quantity, the sustained release blonanserin of recipe quantity is added
Particle, is well mixed, tabletting produces blonanserin sustained release preparation.
Using Chinese Pharmacopoeia two methods of annex XC first of version in 2010, using pH5.5 acetate buffers 1000ml as dissolution
Medium, rotating speed is 100r/min, determines release, as a result as follows：
| Time (h) | 2 | 4 | 6 | 8 | 12 |
| Cumulative release amount (%) | 30.1 | 51.2 | 60.5 | 75.1 | 99.6 |
The sustained release preparation of the present invention is multiple-unit preparation, in pH5.5 acetate buffer, and accumulative in 2 hours is released
It is high-volume 30.1%, 6 hours Cumulative release amounts are 60.5%；8 hours Cumulative release amounts are up to 75.1%, and meeting release experiment will
Ask..Sustained release preparation drug release rule has more reappearance and uniformity, can reduce medicining times, maintenance blood concentration is steady, extend
Effective bacteriocidal concentration holds time, reduces side effect and can faster reach effective blood drug concentration, and energy compared to existing sustained release preparation
Reduction feed influence, realizes that segmentation is taken.
The foregoing is only presently preferred embodiments of the present invention, be not intended to limit the invention, it is all the present invention spirit and
Within principle, any modification, equivalent substitution and improvements made etc. should be included in the scope of the protection.
Embodiment 2：
Prepared according to the release sustaining component prescription of embodiment 1 and common ingredients prescription, prepare tablet mixing recipe quantity：
| Ingredient names | Consumption (g) |
| It is sustained blonanserin micropill | 80.00 |
| Common blonanserin micropill | 20.00 |
| Altogether | 100.00 |
It is pressed into 250.
By the specific preparation method of above prescription：
1) blonanserin in sustained release blonanserin micropill prescription, starch, are weighed, sodium alginate, dextrin, is sufficiently mixed, after
The continuous magnesium stearate, 50% ethanol, calcium monohydrogen phosphate for adding recipe quantity is well mixed, and granulation is standby；
2) each supplementary material, is weighed by plain particles blonanserin component recipe quantity, the sustained release blonanserin of recipe quantity is added
Particle, is well mixed, tabletting produces blonanserin sustained release preparation.
Embodiment 3：
(1) it is sustained blonanserin micropill prescription
(2) common blonanserin micropill prescription
Prepare tablet mixing recipe quantity
| Ingredient names | Consumption (g) |
| It is sustained blonanserin micropill | 132.68 |
| Common blonanserin micropill | 33.17 |
| Altogether | 165.85 |
It is pressed into 470.
By the specific preparation method of above prescription：
1) blonanserin in sustained release blonanserin micropill prescription, starch, are weighed, sodium alginate, dextrin, is sufficiently mixed, after
The continuous magnesium stearate, 50% ethanol, calcium monohydrogen phosphate for adding recipe quantity is well mixed, and granulation is standby；
2) each supplementary material, is weighed by plain particles blonanserin component recipe quantity, the sustained release blonanserin of recipe quantity is added
Particle, is well mixed, tabletting produces blonanserin sustained release preparation.
Embodiment 4：
(1) it is sustained blonanserin micropill prescription
(2) common blonanserin micropill prescription
Prepare tablet mixing recipe quantity
| Ingredient names | Consumption (g) |
| It is sustained blonanserin micropill | 136.00 |
| Common blonanserin micropill | 29.85 |
| Altogether | 165.85 |
It is pressed into 470.
By the specific preparation method of above prescription：
1) blonanserin in sustained release blonanserin micropill prescription, starch, are weighed, sodium alginate, dextrin, is sufficiently mixed, after
The continuous magnesium stearate, 50% ethanol, calcium monohydrogen phosphate for adding recipe quantity is well mixed, and granulation is standby；
2) each supplementary material, is weighed by plain particles blonanserin component recipe quantity, the sustained release blonanserin of recipe quantity is added
Particle, is well mixed, tabletting produces blonanserin sustained release preparation.
Embodiment 5：Blonanserin is sustained monolithic
Prescription：
It is pressed into 350.
By the specific preparation method of above prescription：Blonanserin in prescription, starch, sodium alginate, dextrin is weighed to be sufficiently mixed,
The magnesium stearate, 50% ethanol, calcium monohydrogen phosphate for continuously adding recipe quantity are well mixed, and granulation, tabletting is produced.
Embodiment 6：The common monolithic of blonanserin
Prescription：
It is pressed into 75.
By the specific preparation method of above prescription：Blonanserin, starch, PVP, low-substituted hydroxypropyl first are weighed according to prescription
Base cellulose, magnesium stearate, are well mixed, tabletting produces blonanserin sustained release preparation.
Embodiment 7：
Beneficial effects of the present invention are verified below by way of experiment：
Verification experimental verification：Blonanserin oral formulations embodiment 1 is contrasted with the vitro release of embodiment 5 and 6.
Using Chinese Pharmacopoeia two methods of annex XC first of version in 2010, using pH5.5 acetate buffers 1000ml as dissolution
Medium, rotating speed is 100r/min, and at the appointed time point sampling, is measured with high performance liquid chromatograph, each preparation is determined respectively
Vitro release.As a result table below is seen.
| Time (h) | 2 | 4 | 6 | 8 | 12 |
| The Cumulative release amount of embodiment 1 (%) | 30.1 | 51.2 | 60.5 | 75.1 | 99.6 |
| The Cumulative release amount of embodiment 5 (%) | 30.1 | 64.8 | 90.7 | 99.5 | 99.6 |
| The Cumulative release amount of embodiment 6 (%) | 15.5 | 26.9 | 46.1 | 55.4 | 58.3 |
As a result show：The Cumulative release amount of preparation prepared by the embodiment of the present invention 1 in 2 hours is 30.1%, is tired out within 6 hours
It is 60.5% to count burst size, and Cumulative release amount is 75.1% within 8 hours, meets release requirement of experiment；And system prepared by embodiment 5
Rate of release is too fast in vitro for agent, and Cumulative release amount is 90.7% within 6 hours, more than 70%, and preparation prepared by embodiment 6 then discharges
Speed is excessively slow, and Cumulative release amount is 46.1% within 6 hours, less than 55%,；Embodiment 5 and embodiment 6 do not meet release experiment
It is required that.
Embodiment 8：
Illustrated below by way of experiment checking blonanserin slow-releasing granules of the present invention, blonanserin conventional tablet prescription is touched
Rope process.Prescription LZ1：(1) it is sustained blonanserin micropill prescription
(2) common blonanserin micropill prescription
Prescription LZ2：(1) it is sustained blonanserin micropill prescription
(2) common blonanserin micropill prescription
Prescription LZ3：
(1) it is sustained blonanserin micropill prescription
(2) common blonanserin micropill prescription
Sustained release agent A：The blonanserin preparation prepared according to embodiment 1；
Sustained release agent B：The blonanserin preparation prepared according to prescription LZ1；
Sustained release agent C：The blonanserin preparation prepared according to prescription LZ2；
Sustained release agent D：The blonanserin preparation prepared according to prescription LZ3.
Experimental method：
Using Chinese Pharmacopoeia two methods of annex XC first of version in 2010, using pH5.5 acetate buffers 1000ml as dissolution
Medium, rotating speed is 100r/min, and at the appointed time point sampling, is measured with high performance liquid chromatograph, cloth is determined respectively each slow
The vitro release of release formulation.As a result table below is seen.
| Time (h) | 2 | 4 | 6 | 8 | 12 |
| Sustained release agent A Cumulative release amounts (%) | 30.1 | 51.2 | 60.5 | 75.1 | 99.6 |
| Sustained release agent B Cumulative release amounts (%) | 20.1 | 90.5 | 98.7 | 99.0 | 99.3 |
| Sustained release agent C Cumulative release amounts (%) | 14.4 | 30.0 | 46.2 | 50.1 | 62.3 |
| Sustained release agent D Cumulative release amounts (%) | 15.3 | 24.5 | 29.6 | 33.2 | 35.2 |
As a result show：Cumulative release amount of the sustained release preparation A (embodiment 1) of the present invention in 2 hours is 30.1%, 6 hours
Cumulative release amount is 60.5%, and Cumulative release amount is 75.1% within 8 hours, meets release requirement of experiment；And sustained release preparation B is in body
Outer rate of release is too fast, and Cumulative release amount is 90.5% within 4 hours, more than 70%；Then rate of release excessively delays by sustained release preparation C, D
Slowly, 6 hours Cumulative release amounts are respectively 46.2%, 29.6%, and sustained release preparation B, C, D do not meet release requirement of experiment.
Claims (4)
1. a kind of Blonanserin tablet, the slow-releasing granules being made up of release sustaining component and common ingredients be mixed with prescription ratio and
Into the release sustaining component is 90 with common ingredients mass ratio:10~70:30, its prescription is as follows：
A release sustaining component prescriptions are：
B common ingredients prescriptions are：
Each component sum is 100% in common ingredients prescription.
2. Blonanserin tablet according to claim 1, the slow-releasing granules being made up of release sustaining component and common ingredients by
Square ratio, which is mixed with, to be formed, and blonanserin mass ratio is 80 in the blonanserin and common ingredients in the release sustaining component:20
~85:10.
3. Blonanserin tablet according to claim 2, the slow-releasing granules being made up of release sustaining component and common ingredients by
Square ratio, which is mixed with, to be formed, and blonanserin mass ratio is 82 in the blonanserin and common ingredients in the release sustaining component:18.
4. the preparation method of the Blonanserin tablet according to any one of claim 1-3, it is characterised in that the preparation
Method is as follows：Blonanserin, starch, sodium alginate, the dextrin in release sustaining component prescription are taken, is sufficiently mixed, continuously adds prescription
The magnesium stearate of amount, 50% ethanol, calcium monohydrogen phosphate are well mixed, and granulation obtains being sustained blonanserin particle, standby；By common group
Divide recipe quantity to weigh each supplementary material, add the sustained release blonanserin particle of recipe quantity, be well mixed, tabletting produces blonanserin
Sustained release preparation.
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| CN104306345B true CN104306345B (en) | 2017-07-21 |
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| CN102078321A (en) * | 2010-12-31 | 2011-06-01 | 泰州万全医药科技有限公司 | Blonanserin-containing medicinal composition and preparation method thereof |
| CN102240270A (en) * | 2010-05-13 | 2011-11-16 | 丽珠医药集团股份有限公司 | Blonanserin tablet and preparation method thereof |
| WO2012020301A2 (en) * | 2010-08-10 | 2012-02-16 | Lupin Limited | Oral controlled release pharmaceutical compositions of blonanserin |
| CN103381209A (en) * | 2012-05-03 | 2013-11-06 | 贵州大学 | Hawthorne leaf total-flavones sustained-release preparation and preparation method thereof |
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2014
- 2014-09-11 CN CN201410472636.6A patent/CN104306345B/en active Active
Patent Citations (5)
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| CN101868228A (en) * | 2007-11-21 | 2010-10-20 | 大日本住友制药株式会社 | Orally disintegrating tablet |
| CN102240270A (en) * | 2010-05-13 | 2011-11-16 | 丽珠医药集团股份有限公司 | Blonanserin tablet and preparation method thereof |
| WO2012020301A2 (en) * | 2010-08-10 | 2012-02-16 | Lupin Limited | Oral controlled release pharmaceutical compositions of blonanserin |
| CN102078321A (en) * | 2010-12-31 | 2011-06-01 | 泰州万全医药科技有限公司 | Blonanserin-containing medicinal composition and preparation method thereof |
| CN103381209A (en) * | 2012-05-03 | 2013-11-06 | 贵州大学 | Hawthorne leaf total-flavones sustained-release preparation and preparation method thereof |
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