CN104510717B - Olanzapine orally-disintegrating tablet and preparation method thereof - Google Patents
Olanzapine orally-disintegrating tablet and preparation method thereof Download PDFInfo
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- CN104510717B CN104510717B CN201310451237.7A CN201310451237A CN104510717B CN 104510717 B CN104510717 B CN 104510717B CN 201310451237 A CN201310451237 A CN 201310451237A CN 104510717 B CN104510717 B CN 104510717B
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Abstract
The present invention relates to olanzapine orally-disintegrating tablets and preparation method thereof.The disintegration time limited of the oral disintegrating tablet is less than or equal to 10 seconds, it includes: a) Olanzapine of 2% to 15% weight ratio；B) mannitol of 20% to 78% weight ratio；C) microcrystalline cellulose of 10% to 40% weight ratio；D) crospovidone of 1% to 20% weight ratio；E) aspartame of 0.2% to 5% weight ratio；And f) the magnesium stearate of 0.3% to 4% weight ratio.Olanzapine orally-disintegrating tablet of the invention shows as disintegration rate quickly from overall effect, and processing step is simple, at low cost, convenient to take, is suitable for extensive promotion and application.
Description
Technical field
The present invention relates to field of medicine preparations more particularly to olanzapine orally-disintegrating tablet and preparation method thereof.
Background technique
As the extension of average human life and age increase the decline of swallow, oral tablet administration mode becomes
A problem concerned by people.It is estimated that there are about 50% people to tablet is swallowed and capsule is had any problem, drug therapy is affected
Compliance.In paediatrics and old medicine, to can dissolve in water or suspend, can be chewed or can be dissolved rapidly in mouth
Solid pharmaceutical preparation has very big demand, then without the oral flash-dispersion formulations that can be dispersed or dissolved rapidly with water and swallowing act
This demand can be met.This dosage form can be dispersed or dissolved in saliva rapidly after being put into mouth, and drug can pass through oral cavity or food
Mucosal absorption in road, bioavilability is higher than ordinary preparation, and the side effect as caused by first-pass metabolism can also mitigate.
Oral disintegrating tablet, which refers to, is placed on lingual surface the one kind that can be disintegrated into countless particles and sweet mouthfeel in 30 seconds automatically newly
Type pharmaceutical preparation.It since its disintegration rate is fast, absorbs rapidly, and need not drink water after taking medicine, therefore be very suitable to some especial patients
(mental disease, senile dementia, epileptic patient etc.) and old man, child take.It is generallyd use when preparing oral disintegrating tablet both at home and abroad at present
Desivac, mechanography, direct compression method.
Olanzapine is suitable for the acute of schizophrenia and other mental diseases for having serious positive symptom and/or negative symptoms
Phase and the treatment for maintaining the phase, also can be relieved the secondary affective symptom of schizophrenia and related disease.This product is as novel anti-
Antipsychotic drugs have the advantages that long-term efficacy is good and Small side effects, obtain the highly recognition of clinician.
Compared with other technologies (such as desivac, compression moulding), the work of olanzapine orally-disintegrating tablet is prepared using direct tablet compressing technique
Skill is simpler, at low cost, is not required to special production equipment.Insoluble drug dissolution rate can be improved in the technology, usually with flowing
The preferable filler of property, adhesive and disintegrating agent, and it is aided with suitable lubricant and corrigent, mouth good in taste can be obtained and collapse
Piece.Existing direct tablet compressing technique is prepared in olanzapine orally-disintegrating tablet patent, and disintegration time limited is all larger than 10 seconds.
CN101904824 is disclosed " olanzapine orally-disintegrating tablet preparation and preparation method thereof ", selects mannitol and lactose joint
Using as filler, using 35%-74% mannitol and 10%-40% lactose as filler, the microcrystalline cellulose of 0%-10% is as dry
Adhesive, the disintegrating agent of 2%-10%, the corrigent of 0.1%-6%, the lubricant of 0.4%-3%, disintegration time limited was at 15 seconds to 45 seconds.
Aforementioned patents disclose olanzapine orally-disintegrating tablet preparation prescriptions and preparation method thereof, and are with direct powder compression work
Skill preparation, but it does not optimize screening to dry adhesives and disintegrating agent ratio, and disintegration time limited is long, patient medication compliance
Difference.
Summary of the invention
In order to solve the above-mentioned technical problems, the present invention provides a kind of olanzapine orally-disintegrating tablets and preparation method thereof.
Technical solution of the present invention is as follows: using mannitol as filler in prescription, microcrystalline cellulose as dry adhesives,
Crospovidone directly mixes pressure with Olanzapine as lubricant as corrigent, magnesium stearate as disintegrating agent, aspartame
Piece.
The present invention provides a kind of olanzapine orally-disintegrating tablet, disintegration time limited is less than or equal to 10 seconds.With weight ratio meter, it includes
Following ingredient:
A) Olanzapine of 2% to 15% weight ratio；
B) mannitol of 20% to 78% weight ratio；
C) microcrystalline cellulose of 10% to 40% weight ratio；
D) crospovidone of 1% to 20% weight ratio；
E) aspartame of 0.2% to 5% weight ratio；With
F) magnesium stearate of 0.3% to 4% weight ratio.
Wherein weight ratio is the ratio between each component and composition total weight.
Preferably, the oral disintegrating tablet includes:
A) Olanzapine of 3% to 12% weight ratio；
B) mannitol of 25% to 78% weight ratio；
C) microcrystalline cellulose of 12% to 35% weight ratio；
D) crospovidone of 3% to 12% weight ratio；
E) aspartame of 0.2% to 2% weight ratio；With
F) magnesium stearate of 0.5% to 3% weight ratio.
It is furthermore preferred that it is 25% to 78%, preferably 30% to 78% that mannitol, which accounts for the ratio of total weight of tablet, in the tablet.Institute
The particle diameter distribution for stating mannitol is preferably 50% partial size lower than 100 μm, and 90% partial size is lower than 250 μm.
Preferably, the ratio that microcrystalline cellulose accounts for total weight of tablet in the tablet is 12% to 35%, preferably 12% to 32%；
The microcrystalline cellulose particle diameter distribution is preferably 50% partial size lower than 150 μm, and 90% partial size is lower than 250 μm.Using such partial size
After can be preferably uniformly mixed with other auxiliary materials especially mannitol, to play the role of better molding.And inventor
It is surprised to find that it has significant impact to preparation disintegration time limited.
Further, the ratio that crospovidone accounts for total weight of tablet in the tablet is 3% to 12%, preferably 3% to 9%.
The crospovidone particle diameter distribution is preferably 50% partial size lower than 90 μm, and 90% partial size is lower than 150 μm.
Inventor has surprisingly found that by many experiments, when preparing olanzapine orally-disintegrating tablet using technique of direct powder compression,
Parteck deltaM is as filler, and as dry adhesives, crospovidone XL is used as to be collapsed microcrystalline cellulose PH102 or Type102
Agent is solved, had not only guaranteed that powder had good mobility and compressibility, but also guarantee that tablet has cracking disintegration time limited.
The object of the invention is also to provide a kind of methods for preparing the olanzapine orally-disintegrating tablet, and powder is used directly to press
Blade technolgy, the specific steps are as follows:
1) main ingredient Olanzapine and aspartame difference is finely ground, it sieves with 100 mesh sieve, weighs recipe quantity, the two is uniformly mixed；
2) by microcrystalline cellulose, crospovidone and mannitol respectively cross 60 meshes, weigh respectively according to quantity, and in order according to
In the secondary hybrid medicine being added in step 1), mix；
3) magnesium stearate of recipe quantity is added into hybrid medicine obtained in step 2, is sieved, mixes, carries out intermediate
Content detection, after determining slice weight, using the tabletting of direct tablet compressing technology to get.
The present invention is using mannitol as filler, and microcrystalline cellulose is as dry adhesives, and crospovidone is as disintegration
Agent, aspartame is as corrigent, and magnesium stearate is as lubricant, by above-mentioned specific preparation prescription, in conjunction with to each component
The screening of best prescription content, it is surprisingly found by the inventors that, the effect of Olanzapine Tablets of the present invention on the whole shows as disintegration rate
Quickly, good mouthfeel, the quality of the pharmaceutical preparations are stablized.
Commercially available olanzapine orally-disintegrating tablet is yellow freeze-drying tablet, and preparation process uses desivac, equipment needed for the technology and
Operating cost is high, and batch is limited, and the operating time is long, and tablet thickness about 1mm, bad mechanical strength is not amenable to common aluminum plastic packet
Dress.The present invention prepares olanzapine orally-disintegrating tablet using technique of direct powder compression, and technical process is simple, is produced using conventional tablet
Equipment can produce, at low cost, with short production cycle, and mechanical strength is good, and final product quality is stablized, and it is surprising that originally
It invents conventional tablet obtained and is but remarkably improved the dissolution rate of property drug hard to tolerate with a thickness of the thickness 3mm of conventional formulation,
Disintegration rate is even better than freeze-drying tablet.Preparation method processing step of the invention is simple, at low cost, consumes energy low, with short production cycle,
It is suitable for extensive promotion and application.
Specific embodiment
In order to better illustrate the present invention and its acquired effect, come furtherly below in conjunction with specific embodiment
It is bright.But the scope of the present invention is not limited to the concrete scheme of embodiment.
Embodiment 1:
Preparation: conventional tablet pharmaceutical equipment production can be used in the dosage form, and is prepared with direct tablet compressing technique, specific to prepare
Method is as follows: sieving with 100 mesh sieve main ingredient Olanzapine and aspartame are finely ground respectively, weighs recipe quantity, the two is uniformly mixed.It is micro-
Crystalline cellulose, crospovidone and mannitol cross 60 meshes respectively, weigh respectively according to quantity and sequentially add above-mentioned mix in order
It is mixed in composite medicine, the magnesium stearate of recipe quantity is then added, sieving mixes, and intermediates content detection is carried out, after determining slice weight
Using the tabletting of direct tablet compressing technology to get.
Embodiment 2:
Preparation: conventional tablet pharmaceutical equipment production can be used in the dosage form, and is prepared with direct tablet compressing technique, specific to prepare
Method is as follows: sieving with 100 mesh sieve main ingredient Olanzapine and aspartame are finely ground respectively, weighs recipe quantity, the two is uniformly mixed.It is micro-
Crystalline cellulose, crospovidone and mannitol cross 60 meshes respectively, weigh respectively according to quantity and sequentially add above-mentioned mix in order
It is mixed in composite medicine, the magnesium stearate of recipe quantity is then added, sieving mixes, and intermediates content detection is carried out, after determining slice weight
Using the tabletting of direct tablet compressing technology to get.
Embodiment 3:
Preparation: conventional tablet pharmaceutical equipment production can be used in the dosage form, and is prepared with direct tablet compressing technique, specific to prepare
Method is as follows: sieving with 100 mesh sieve main ingredient Olanzapine and aspartame are finely ground respectively, weighs recipe quantity, the two is uniformly mixed.It is micro-
Crystalline cellulose, crospovidone and mannitol cross 60 meshes respectively, weigh respectively according to quantity and sequentially add above-mentioned mix in order
It is mixed in composite medicine, the magnesium stearate of recipe quantity is then added, sieving mixes, and intermediates content detection is carried out, after determining slice weight
Using the tabletting of direct tablet compressing technology to get.
Embodiment 4:
Preparation: conventional tablet pharmaceutical equipment production can be used in the dosage form, and is prepared with direct tablet compressing technique, specific to prepare
Method is as follows: sieving with 100 mesh sieve main ingredient Olanzapine and aspartame are finely ground respectively, weighs recipe quantity, the two is uniformly mixed.It is micro-
Crystalline cellulose, crospovidone and mannitol cross 60 meshes respectively, weigh respectively according to quantity and sequentially add above-mentioned mix in order
It is mixed in composite medicine, the magnesium stearate of recipe quantity is then added, sieving mixes, and intermediates content detection is carried out, after determining slice weight
Using the tabletting of direct tablet compressing technology to get.
Embodiment 5:
Preparation: conventional tablet pharmaceutical equipment production can be used in the dosage form, and is prepared with direct tablet compressing technique, specific to prepare
Method is as follows: sieving with 100 mesh sieve main ingredient Olanzapine and aspartame are finely ground respectively, weighs recipe quantity, the two is uniformly mixed.It is micro-
Crystalline cellulose, crospovidone and mannitol cross 60 meshes respectively, weigh respectively according to quantity and sequentially add above-mentioned mix in order
It is mixed in composite medicine, the magnesium stearate of recipe quantity is then added, sieving mixes, and intermediates content detection is carried out, after determining slice weight
Using the tabletting of direct tablet compressing technology to get.
Embodiment 6:
Preparation: conventional tablet pharmaceutical equipment production can be used in the dosage form, and is prepared with direct tablet compressing technique, specific to prepare
Method is as follows: sieving with 100 mesh sieve main ingredient Olanzapine and aspartame are finely ground respectively, weighs recipe quantity, the two is uniformly mixed.It is micro-
Crystalline cellulose, crospovidone and mannitol cross 60 meshes respectively, weigh respectively according to quantity and sequentially add above-mentioned mix in order
It is mixed in composite medicine, the magnesium stearate of recipe quantity is then added, sieving mixes, and intermediates content detection is carried out, after determining slice weight
Using the tabletting of direct tablet compressing technology to get.
Experimental example 1, disintegration time mensuration
The disintegration time limited of each embodiment, friability, tablet hardness, the test bit of dissolution rate are as follows:
From the above-mentioned all data measured: using oral disintegrating tablet made from this method, disintegration time limited less than 10 seconds, firmly
Spend 3-5kg/cm2, less than 0.5%, 5min, the dissolution rate in 0.1N HCL solution is greater than 90% to friability.
Experimental example 2, compared with commercially available thin slice tablet disintegration time limit
The present invention is compared with commercially available closest to preparation disintegration effect, wherein comparative example composition are as follows:
The comparing result of disintegration time limited is as follows:
| Embodiment | Preparation thickness | Disintegration time limited |
| Embodiment 1 | 3mm | 8.6s |
| Embodiment 2 | 3mm | 7.5s |
| Embodiment 3 | 3mm | 5.3s |
| Embodiment 4 | 3mm | 7.2s |
| Embodiment 5 | 3mm | 6.5s |
| Embodiment 6 | 3mm | 7.8s |
| Comparative example | 1mm | 9.2s |
It can be seen that conventional tablet of the present invention from above-mentioned testing result and can reach close with sheet preparation and even preferably collapse
Solve speed.
Experimental example 3, factors influencing:
By embodiment 1, into embodiment 6, olanzapine tablet finished product is placed in surface plate, (opposite in high temperature (60 DEG C) high humidity
Humidity 92.5%) under the conditions of investigated, specifically, respectively by sample be placed in 60 DEG C of insulating boxs,
In the lighting box of 92.5% environment of relative humidity and 4500LX, each embodiment influence factor result is as follows:
Experimental example 4, compared with CN101904824 preparation disintegration time limited
Comparative example:
According to method described in CN101904824, inventor has carried out comparative test, and prescription is as follows:
Preparation: by Olanzapine, filler, adhesive, disintegrating agent, corrigent sieving mixing, being then added lubricant total mix,
Olanzapine orally-disintegrating tablet is made in final direct tablet compressing.
Disintegration time mensuration: taking this product 6, according to method (Chinese Pharmacopoeia 2010 under disintegration time limited detection method tablet item
Two Ⅹ A of annex of version) it checks, the time of block is not left using on mesh as the disintegration time of this product.
Experimental result: preparing resulting tablet when hardness is 3-5kg/cm2 according to CN101904824 experiment prescription,
Disintegration time limited is 28 seconds, and hardness is in 1-3kg/cm2When, disintegration time limited is 21 seconds, and friability is greater than 1%.
By above-mentioned experiment it is found that being disintegrated according to the resulting olanzapine orally-disintegrating tablet of CN101904824 and gained tablet of the present invention
Time limit significant difference, and olanzapine orally-disintegrating tablet is suitable for mental patient, disintegration rate is faster, and absorption is faster, therefore this hair
Bright products obtained therefrom has better curative effect to patient.
Note: the percentage of each component is weight percentage in invention formulation prescription.
Claims (3)
1. a kind of olanzapine orally-disintegrating tablet, which is characterized in that its disintegration time limited is less than or equal to 10 seconds,
It includes:
A) Olanzapine of 2% to 15% weight ratio；
B) mannitol of 20% to 78% weight ratio；
C) microcrystalline cellulose of 10% to 40% weight ratio；
D) crospovidone of 1% to 20% weight ratio；
E) aspartame of 0.2% to 5% weight ratio；With
F) magnesium stearate of 0.3% to 4% weight ratio；
50% partial size of the mannitol is lower than 100 μm, and 90% partial size is lower than 250 μm；50% partial size of the microcrystalline cellulose
Lower than 150 μm, 90% partial size is lower than 250 μm；50% partial size of the crospovidone is lower than 90 μm, and 90% partial size is lower than 150 μ
m。
2. olanzapine orally-disintegrating tablet according to claim 1, which is characterized in that it includes:
A) Olanzapine of 3% to 12% weight ratio；
B) mannitol of 25% to 78% weight ratio；
C) microcrystalline cellulose of 12% to 35% weight ratio；
D) crospovidone of 3% to 12% weight ratio；
E) aspartame of 0.2% to 2% weight ratio；With
F) magnesium stearate of 0.5% to 3% weight ratio.
3. a kind of method for preparing olanzapine orally-disintegrating tablet described in any one of -2 according to claim 1, which is characterized in that it is adopted
With technique of direct powder compression, specific steps are as follows:
1) main ingredient Olanzapine and aspartame difference is finely ground, it sieves with 100 mesh sieve, weighs recipe quantity, the two is uniformly mixed；
2) microcrystalline cellulose, crospovidone and mannitol are crossed into 60 meshes respectively, weighed respectively according to quantity, and is successively added in order
Enter in the hybrid medicine into step 1), mixes；
3) magnesium stearate of recipe quantity is added into hybrid medicine obtained in step 2), is sieved, mixes, carries out intermediates content
Detection, after determining slice weight, using the tabletting of direct tablet compressing technology to get.
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106389362A (en) * | 2016-08-31 | 2017-02-15 | 安徽省润生医药股份有限公司 | Olanzapine orally disintegrating tablet and preparation method thereof |
| CN108261399A (en) * | 2016-12-30 | 2018-07-10 | 江苏豪森药业集团有限公司 | Olanzapine oral disnitegration tablet and preparation method thereof |
| CN108926543A (en) * | 2017-05-26 | 2018-12-04 | 万全万特制药江苏有限公司 | A kind of Olanzapine oral disnitegration tablet and preparation method thereof |
| CN108498472B (en) * | 2018-06-28 | 2021-03-16 | 苏州盛达药业有限公司 | Olanzapine tablet and preparation method thereof |
| CN113730365A (en) * | 2021-08-10 | 2021-12-03 | 杭州新诺华医药有限公司 | Olanzapine orally disintegrating tablet and preparation method thereof |
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