CN104306346B - A kind of sustained release preparation of blonanserin and preparation method thereof - Google Patents
A kind of sustained release preparation of blonanserin and preparation method thereof Download PDFInfo
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- CN104306346B CN104306346B CN201410472696.8A CN201410472696A CN104306346B CN 104306346 B CN104306346 B CN 104306346B CN 201410472696 A CN201410472696 A CN 201410472696A CN 104306346 B CN104306346 B CN 104306346B
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Abstract
The present invention relates to a kind of blonanserin sustained release preparation and preparation method thereof, the slow-releasing granules and common ingredients that the Blonanserin tablet is made up of sustained release component are mixed with prescription ratio to be formed, and the release sustaining component is 75: 25~80: 20 with common ingredients mass ratio；Its release sustaining component mainly includes 8.00~12.0% blonanserins, 15.0~20.0% hydroxypropyl methylcelluloses, 15.0~25.0% sodium carboxymethylcelluloses etc. by mass percentage, and common ingredients mainly include 8.00~12.0% blonanserins, 30.0~50.0% lactose etc. by mass percentage；Tablet prepared by the present invention can reduce medicining times, maintenance blood concentration is steady, reduce side effect.
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 75: 25~80: 20；Preferably, blonanserin and blonanserin mass ratio in common blonanserin component are 78 in component:
22。
By mass percentage, blonanserin is that 8.00~12.0%, hydroxypropyl is fine to above-mentioned sustained release blonanserin component
Dimension element 15.0~20.0%, sodium carboxymethylcellulose 15.0~25.0%, lactose 20.0~30.0%, Icing Sugar 10.0~
15.0%th, 17% starch slurry 5.00~10.0%, magnesium stearate 0.50~2.00%, calcium monohydrogen phosphate 3.0~5.0%.
Preferably, by mass percentage, blonanserin is that 10.0%, hydroxypropyl is fine to above-mentioned sustained release blonanserin component
Dimension element 15.0%, sodium carboxymethylcellulose 18.8%, lactose 28.0%, Icing Sugar 15.0%, 17% starch slurry 8.00%, phosphoric acid hydrogen
Calcium 4.00%, magnesium stearate 1.00%.
By mass percentage, blonanserin is that 8.00~12.0%, lactose is to above-mentioned plain particles blonanserin component
30.0~50.0%, 17% starch slurry 20.0~30.0%, mannitol 10.0~15.0%, PVP 1.5~2.0%, carboxylic first
Base sodium starch 2.00~8.0%, magnesium stearate are 0.50~1.50%.
Above-mentioned plain particles blonanserin component by mass percentage, blonanserin be 10.0%, lactose be 45.0%,
17% starch slurry 25.0%, mannitol 12.0%, PVP 1.80%, sodium carboxymethyl starch 5.20%, magnesium stearate are
1.00%.
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
μ m。
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, it is 10.0%, HPMC to weigh blonanserin
15.0%th, sodium carboxymethylcellulose 18.8%, lactose 28.0%, Icing Sugar 15.0%, 17% starch slurry 8.00%, are fully mixed,
Recipe quantity calcium monohydrogen phosphate 4.00%, magnesium stearate 1.00% are added, continues well mixed, plus suitable quantity of water prepares softwood；
2), by plain particles blonanserin constituent mass percentages, it is that 10.0%, lactose is to weigh blonanserin
45.0%th, 17% starch slurry 25.0%, mannitol 12.0%, PVP 1.80%, sodium carboxymethyl starch 5.20%, magnesium stearate
For 1.00%, blonanserin slow-releasing granules are added, are 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 (polymethacrylates, hydroxypropyl methylcellulose, carbomer etc.) are combined trial, by Bu Nanse
Forest tract agent is prepared into conventional sustained-release tablet.However, it was found that sustained-release tablet is still difficult to the requirement for not reaching treatment rate of release.
The physics that this is mainly to blonanserin medicine in itself is related with chemical property, the indissoluble property of such as blonanserin.
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 pH 5.5 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%.Due to mouth
The effective blood drug concentration kept in human body after clothes in alimentary canal by program release medicine, stabilization persistently, therefore with treatment
Imitate, drug effect length, Small side effects, few and easy to use clothes for patients number of times the advantages of；And due to the selection of material so that medicine
It is cheap, taken beneficial to common patient.
Embodiment
With reference to embodiment, the present invention will be further described.Release requirement of experiment of the present invention is：PH's 5.5
In acetate buffer, Cumulative release amount is 25~35% in 2 hours；6 hours Cumulative release amounts are 55~65%；Tire out within 8 hours
Burst size is counted 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 | 78.00 |
| Common blonanserin micropill | 22.00 |
| Altogether | 100.00 |
It is pressed into 280.
By the specific preparation method of above prescription：
1), by sustained release blonanserin constituent mass percentages, blonanserin, HPMC, carboxymethyl are weighed
Sodium cellulosate, lactose, Icing Sugar, 17% starch slurry, are fully mixed, and add recipe quantity calcium monohydrogen phosphate, magnesium stearate, continue to mix
Uniformly, plus suitable quantity of water prepares softwood；
2), by plain particles blonanserin constituent mass percentages, weigh that blonanserin is, lactose is, 17% starch
Slurry, mannitol, PVP, sodium carboxymethyl starch, magnesium stearate are to add blonanserin slow-releasing granules, are well mixed, are pressed into
Piece, produces blonanserin sustained release preparation.
Using Chinese Pharmacopoeia two methods of annex XC first of version in 2010, using the acetate buffer 1000ml of pH 5.5 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 (%) | 28.1 | 46.2 | 64.5 | 85.8 | 99.7 |
The sustained release preparation of the present invention is multiple-unit preparation, in pH 5.5 acetate buffer, and accumulative in 2 hours is released
It is high-volume 28.1%, 6 hours Cumulative release amounts are 64.5%；8 hours Cumulative release amounts are up to 85.8%, 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.
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 | 75.00 |
| Common blonanserin micropill | 25.00 |
| Altogether | 100.00 |
It is pressed into 280.
By the specific preparation method of above prescription：
1), by sustained release blonanserin constituent mass percentages, blonanserin, HPMC, carboxymethyl are weighed
Sodium cellulosate, lactose, Icing Sugar, 17% starch slurry, are fully mixed, and add recipe quantity calcium monohydrogen phosphate, magnesium stearate, continue to mix
Uniformly, plus suitable quantity of water prepares softwood；
2), by plain particles blonanserin constituent mass percentages, weigh that blonanserin is, lactose is, 17% starch
Slurry, mannitol, PVP, sodium carboxymethyl starch, magnesium stearate are to add blonanserin slow-releasing granules, are well mixed, are pressed into
Piece, produces blonanserin sustained release preparation.
Embodiment 3：
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 280.
By the specific preparation method of above prescription：
1), by sustained release blonanserin constituent mass percentages, blonanserin, HPMC, carboxymethyl are weighed
Sodium cellulosate, lactose, Icing Sugar, 17% starch slurry, are fully mixed, and add recipe quantity calcium monohydrogen phosphate, magnesium stearate, continue to mix
Uniformly, plus suitable quantity of water prepares softwood；
2), by plain particles blonanserin constituent mass percentages, weigh that blonanserin is, lactose is, 17% starch
Slurry, mannitol, PVP, sodium carboxymethyl starch, magnesium stearate are to add blonanserin slow-releasing granules, are well mixed, are pressed into
Piece, 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 | 78.00 |
| Common blonanserin micropill | 22.00 |
| Altogether | 100.00 |
It is pressed into 280.
By the specific preparation method of above prescription：
1), by sustained release blonanserin constituent mass percentages, blonanserin, HPMC, carboxymethyl are weighed
Sodium cellulosate, lactose, Icing Sugar, 17% starch slurry, are fully mixed, and add recipe quantity calcium monohydrogen phosphate, magnesium stearate, continue to mix
Uniformly, plus suitable quantity of water prepares softwood；
2), by plain particles blonanserin constituent mass percentages, weigh that blonanserin is, lactose is, 17% starch
Slurry, mannitol, PVP, sodium carboxymethyl starch, magnesium stearate are to add blonanserin slow-releasing granules, are well mixed, are pressed into
Piece, produces blonanserin sustained release preparation.
Embodiment 5：Blonanserin is sustained monolithic
Prescription：
It is pressed into 200.
By the specific preparation method of above prescription：Weigh blonanserin, HPMC, sodium carboxymethylcellulose, breast
Sugar, Icing Sugar, 17% starch slurry, are fully mixed, and add recipe quantity calcium monohydrogen phosphate, magnesium stearate, continue well mixed, granulation,
Tabletting is produced.
Embodiment 6：The common monolithic of blonanserin
Prescription：
It is pressed into 50.
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 the acetate buffer 1000ml of pH 5.5 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 (%) | 28.1 | 46.2 | 64.5 | 85.8 | 99.7 |
| The Cumulative release amount of embodiment 5 (%) | 14.5 | 26.5 | 40.2 | 64.3 | 66.8 |
| The Cumulative release amount of embodiment 6 (%) | 50.3 | 80.1 | 89.8 | 99.1 | 99.6 |
As a result show：The Cumulative release amount of preparation prepared by the embodiment of the present invention 1 in 2 hours is 28.1%, is tired out within 6 hours
It is 64.5% to count burst size, and Cumulative release amount is 85.8% within 8 hours, meets release requirement of experiment；And system prepared by embodiment 5
Rate of release is excessively slow in vitro for agent, and 6 hours Cumulative release amounts are less than 55%, preparation then rate of release prepared by embodiment 6
Too fast, 4 hours Cumulative release amounts more than 70% and discharge also unstable；It is real that embodiment 5 and embodiment 6 do not meet release
Test requirement.
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
Prescription LZ4 (hydroxypropyl methylcellulose consumptions: sodium carboxymethylcellulose consumption=1: 1)：
(1) it is sustained blonanserin micropill prescription
(2) common blonanserin micropill prescription
Prescription LZ5 (hydroxypropyl methylcellulose consumptions: sodium carboxymethylcellulose consumption=1: 2)：
(1) it is sustained blonanserin micropill prescription
(2) common blonanserin micropill prescription
Above prescription is prepared into sustained-release tablet according to the preparation method of embodiment 1.
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；
Sustained release agent E：The blonanserin preparation prepared according to prescription LZ4；
Sustained release agent F：The blonanserin preparation prepared according to prescription LZ5；
Experimental method：
Using Chinese Pharmacopoeia two methods of annex XC first of version in 2010, using the acetate buffer 1000ml of pH 5.5 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 (%) | 28.1 | 46.2 | 64.5 | 85.8 | 99.7 |
| 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 |
| Sustained release agent E Cumulative release amounts (%) | 20.1 | 45.2 | 55.8 | 60.1 | 62.4 |
| Sustained release agent F Cumulative release amounts (%) | 26.2 | 39.3 | 46.7 | 55.2 | 58.9 |
As a result show：The Cumulative release amount of preparation prepared by sustained release preparation A (embodiment 1) of the present invention in 2 hours is
28.1%, 6 hours Cumulative release amounts are 64.5%, and Cumulative release amount is 85.8% within 8 hours, meets release requirement of experiment；And
Rate of release is too fast in vitro by sustained release preparation B, and Cumulative release amount is 90.5% within 4 hours, and Cumulative release amount is more than 70%；Sustained release system
C, D6 hours Cumulative release amounts of agent are respectively 50.1%, 33.2%, and Cumulative release amount is less than 55%；Sustained release agent E, sustained release agent F8 are small
When Cumulative release amount be respectively 62.4%, 58.9%, Cumulative release amount is less than 70%；From above experimental result, sustained release system
The rate of release of agent B, C, D, E, F in vitro is undesirable.
Claims (3)
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 75: 25~80: 20 with common ingredients mass ratio, and 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 78: 22 in the blonanserin and common ingredients in the release sustaining component.
3. the preparation method of Blonanserin tablet according to claim 1 or 2, it is characterised in that the preparation method is such as
Under：By sustained release blonanserin constituent mass percentages, weigh blonanserin, HPMC, sodium carboxymethylcellulose,
Lactose, Icing Sugar, 17% starch slurry, are fully mixed, and add recipe quantity calcium monohydrogen phosphate, magnesium stearate, continue well mixed, plus suitable
Amount water prepares softwood, and granulation obtains blonanserin slow-releasing granules；Based on common ingredients mass percent, blonanserin, breast are weighed
Sugar, 17% starch slurry, mannitol, PVP, sodium carboxymethyl starch, magnesium stearate, add blonanserin slow-releasing granules, and mixing is equal
It is even, it is tabletted, produce blonanserin sustained release preparation.
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