CN106511311A - Levo-oxiracetam sustained-release capsule with good particle mobility and preparation method of levo-oxiracetam sustained-release capsule - Google Patents
Levo-oxiracetam sustained-release capsule with good particle mobility and preparation method of levo-oxiracetam sustained-release capsule Download PDFInfo
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Abstract
The invention provides a levo-oxiracetam sustained-release capsule with good particle mobility. The levo-oxiracetam sustained-release capsule with good particle mobility is characterized by being prepared from the following raw materials and auxiliary materials in parts by weight: 1 part of levo-oxiracetam, 1.2-1.6 parts of lactose, 1.0-1.5 parts of hydroxypropyl methyl cellulose K4M, 0.8-1.3 parts of hydroxypropyl methyl cellulose K15M, 0.6-1.0 part of carnauba wax, 0.05-0.12 part of stearyl alcohol, 0.06-0.11 part of magnesium stearate, and 1.6-2.2 parts of ethanol solution with the volume fraction being 50-80 %. The levo-oxiracetam sustained-release capsule with good particle mobility prepared by adopting the method provided the invention has good release uniformity, the release degrees RSD at the different time points among different samples are smaller than 6%, the release speed is low, the release period is as long as 12h, therefore, compared with the traditional preparation, the product provided by the invention has the advantages that the administration times can be reduced, only once of administration is needed each day, the particle mobility is good, the repose angle is smaller than 37 degrees, meanwhile, the product is good in stability, the shelf life is 24 months, the preparation process is simple and feasible, and the product is suitable for market promotion.
Description
Technical field
The invention mainly relates to pharmaceutical technology field, and in particular to a kind of good levo-oxiracetam slow release glue of mobility of particle
Capsule and preparation method thereof.
Background technology
Nootropics are that a kind of promotion learns also known as cereboactive drug, the new medicine for central nervous system of memory reinforcing.Promote
Intelligence medicine requires selection in cerebral cortex, with selection activation, protection and promotion damaged nerve cell functional rehabilitation
Feature.Different from other neurologic agents be a little their above-mentioned effect not by reticular system or olfactory bulb, but directly
Connect and act on cortex.Behavior is affected neither, also without calm excitation, therefore such medicine has caused the extensive pass of people
Note and interest, also grow with each passing day to the demand of such medicine.
Oxiracetam (oxiracetam, CAS No.：62613-82-5) chemical entitled 4- hydroxyls -2- OXo-1-pyrrolidine second
Amide, is that (compound is disclosed in the anti-hypoxia class nootropics that synthesized in 1974 first of Italian ISFS.P.A companies
US4118396), it is ring GABOB derivants, Phosphorylcholine and phosphatidyl ethanolamine synthesis can be promoted, promote brain metabolism,
Through blood brain barrier, have stimulation to specificity nervus centraliss road, intelligence and memory can be improved, to cerebrovascular,
Cerebral trauma, cerebroma, intracranial infection, brain degenerative disease etc. also have preferable curative effect, and the drug toxicity is extremely low, nothing
Mutagenesis and carcinogenesis and genotoxicity.Giorgio et al. discloses the chemistry knot of oxiracetam in US4118396
Structure and preparation method, Chiodini et al. are disclosed in WO9306826A, and clinical effectiveness proves S configurations (left-handed)
The drug effect of oxiracetam is better than R configurations (dextrorotation), and oxiracetam and levo-oxiracetam structure are as follows.
It is bad that existing levo-oxiracetam is primarily present mobility of particle, and filling loading amount process content uniformity is larger, release
Can not preferably control, it is impossible to reach the requirement of slow releasing preparation, differ greatly with the release of different samples in batch product, lead
Cause the technical problems such as product quality variance is larger.
The content of the invention
It is an object of the invention to provide a kind of good levo-oxiracetam slow releasing capsule of mobility of particle.
Another object of the present invention is to provide the preparation method of above-mentioned levo-oxiracetam slow releasing capsule.
The purpose of the present invention is realized by following technical measures：
The good levo-oxiracetam slow releasing capsule of a kind of mobility of particle, it is characterised in that it is to be with levo-oxiracetam
Raw material, adds a certain amount of sustained-release matrix material, blocker, lubricant and binding agent and is obtained；Wherein described slow release bone
Frame material be hydroxypropyl methylcellulose, ethyl cellulose, polyethylene, polypropylene, polysiloxanes, Polyethylene oxide, Lactose,
One or more in Fructose, sucrose, mannitol, sodium alginate, agar, chitin, galactose；The retardance
Agent is fat, Cera Flava, Brazil wax, hydrogenated vegetable oil, stearyl alcohol, one or more in glyceryl monostearate；
The lubricant is magnesium stearate, Pulvis Talci, silicon dioxide, one or more in octadecanol；Adhesive therefor is
Ethanol solution, starch slurry, sucrose solution, water, any one in polyvidone ethanol solution.
Inventor had found in research process, selects a certain proportion of hydroxypropyl methylcellulose K4M, hydroxypropyl methylcellulose
Plain K15M and Lactose collectively constitute composite slow release framework material, add Brazil wax, octadecanol, magnesium stearate and
The ethanol solution of certain concentration, then coordinate specific processing step, above-mentioned levo-oxiracetam slow releasing capsule granule can be caused
Good fluidity, release are good, and good with the release uniformity between batch product difference sample, and above-mentioned mobility of particle is good
Levo-oxiracetam slow releasing capsule, it is characterised in that：1 part of levo-oxiracetam, 1.2 parts～1.6 parts of Lactose, hydroxypropyl
0.8 part～1.3 parts of 1.0 parts～1.5 parts of methylcellulose K4M, hydroxypropyl methylcellulose K15M, Brazil wax 0.6
Part～1.0 parts, 0.05 part～0.12 part of octadecanol, 0.06～0.11 part of magnesium stearate, volume fraction is 50%～80%
1.6 parts～2.2 parts of ethanol solution；Principal agent, sustained-release matrix material and the blocker for taking recipe quantity is put in mixing mill and is mixed
Conjunction is ground into fine powder (all sieve by No. 5 and can must not be less than the 95% of total amount by the amount of No. 6 sieves), sieves；Add
Binding agent, with 18 mesh sieve mixing granulations, the wet granular by made by, is placed in hot-air oven, arranges 40 DEG C～60 DEG C of temperature,
It is dried to pellet moisture≤3%, granulate (crosses 24 mesh sieves), standby；Lubricant was crushed into 100 mesh sieves, was added whole
In granule after grain, with three-dimensional motion mixer mixing 10min～20min.
Further, in order that levo-oxiracetam slow releasing capsule difference sample room release uniformity is more preferable, particle flow
Property more preferably, above-mentioned levo-oxiracetam slow releasing capsule, it is characterised in that：1 part of levo-oxiracetam, Lactose 1.3 parts～1.5
Part, 1.2 parts～1.5 parts of hydroxypropyl methylcellulose K4M, 0.9 part～1.1 parts of hydroxypropyl methylcellulose K15M, cohune
0.7 part～0.8 part of palmitic acid wax, 0.06 part～0.09 part of octadecanol, 0.08～0.11 part of magnesium stearate, volume fraction is
1.8 parts～2.1 parts of 50%～70% ethanol solution；Principal agent, sustained-release matrix material and the blocker for taking recipe quantity puts mixing
In pulverizer, co-grinding (is all sieved by No. 5 and can must not be less than the 95% of total amount by the amount of No. 6 sieves) into fine powder,
Sieve；Binding agent is added, with 18 mesh sieve mixing granulations, the wet granular by made by, is placed in hot-air oven, temperature is set
40 DEG C～60 DEG C of degree, is dried to pellet moisture≤3%, and granulate (crosses 24 mesh sieves), standby；Lubricant was crushed into 100
Mesh sieve, in adding the granule after granulate, with three-dimensional motion mixer mixing 10min～20min；
The preparation method of the good levo-oxiracetam slow releasing capsule of a kind of mobility of particle, it is characterised in that it is by as follows
Obtained in step：
1. supplementary material pre-treatment：Principal agent, sustained-release matrix material and the blocker for taking recipe quantity puts mixing in mixing mill
Be ground into fine powder (all sieve by No. 5 and the 95% of total amount can must not be less than by the amount of No. 6 sieves), sieve；
2. pelletize：Binding agent is added, with 18 mesh sieve mixing granulations, the wet granular by made by, is placed in hot-air oven,
40～60 DEG C of temperature is set, is dried to pellet moisture≤3%, granulate (crosses 24 mesh sieves), standby；
3. total mixed：Lubricant was crushed into 100 mesh sieves, in adding the granule after granulate, was mixed with three-dimensional motion mixer
1 0min～20min；
4. fill：Filled with fully-automatic capsule filler, adjust loading amount 0.5g/ grain, whole filling process need to control relatively wet
Degree is below 50%；
5. aluminum-plastic packaged：Aluminium-plastic bubble plate packing machine subpackage is used, per plate 10, operation room relative humidity have to be lower than 50%；
6. outsourcing is obtained final product.
The present invention has following beneficial effect：
A kind of good levo-oxiracetam slow releasing capsule of mobility of particle of the present invention has release uniformity good, different samples it
Between each time point release RSD be respectively less than 6%, rate of release is slow, and deenergized period is up to 12 hours, therefore this product is more traditional
Preparation can be reduced and take number of times, take once a day, and mobility of particle is good, and not sub- angle is less than 37 °；Meanwhile, this
Product good stability, shelf life are up to 24 months, and preparation process is simple is feasible, are worth marketing.
Specific embodiment
The present invention is specifically described below by embodiment, it is necessary to it is pointed out here that be that following examples are served only for
The present invention is further described, it is impossible to be interpreted as limiting the scope of the invention, without departing substantially from spirit of the invention
In the case of essence, the modification made to the inventive method, step or condition or replacement belong to the scope of the present invention.
Embodiment 1
A kind of good levo-oxiracetam slow releasing capsule of mobility of particle, is obtained according to the following steps：
| Composition | Consumption |
| Levo-oxiracetam | 1 part |
| Lactose | 1.3 part |
| Hydroxypropyl methylcellulose K4M | 1.2 part |
| Hydroxypropyl methylcellulose K15M | 0.9 part |
| Brazil wax | 0.7 part |
| Octadecanol | 0.06 part |
| Magnesium stearate | 0.08 part |
| 60% ethanol solution | 1.8 part |
Make 1000
Preparation process：
1. supplementary material pre-treatment：Principal agent, sustained-release matrix material and the blocker for taking recipe quantity puts mixing in mixing mill
Be ground into fine powder (all sieve by No. 5 and the 95% of total amount can must not be less than by the amount of No. 6 sieves), sieve；
2. pelletize：Binding agent is added, with 18 mesh sieve mixing granulations, the wet granular by made by, is placed in hot-air oven,
40～60 DEG C of temperature is set, is dried to pellet moisture≤3%, granulate (crosses 24 mesh sieves), standby；
3. total mixed：Lubricant was crushed into 100 mesh sieves, in adding the granule after granulate, was mixed with three-dimensional motion mixer
1 0min～20min；
4. fill：Filled with fully-automatic capsule filler, adjust loading amount 0.5g/ grain, whole filling process need to control relatively wet
Degree is below 50%；
5. aluminum-plastic packaged：Aluminium-plastic bubble plate packing machine subpackage is used, per plate 10, operation room relative humidity have to be lower than 50%；
6. outsourcing is obtained final product.
In order to be better understood from the present invention, the beneficial of invention medicine is expanded on further below by way of stability test of the present invention
Effect, rather than limitation of the present invention.
Test one：Particle flow performance is determined
1. test material：Sample after the completion of always mixing in 1 preparation process of embodiment
2. test method：After the completion of embodiment 1 is always mixed, respectively in the upper, middle and lower of three-dimensional motion mixer, each point point
Angle of repose is not measured by sampling, its mobility is judged；
3. result of the test：
4. conclusion (of pressure testing)：Can be seen that by upper table result of the test, three measurements are respectively less than 37 ° angle of repose, show particle flow
Property is good.
Test two：Drug release determination
1. test material：1 test specimen of Example
2. test method：Slow releasing capsule obtained above is taken as sample, according to release inspection technique (Chinese Pharmacopoeia 2010 editions two
Portion's annex the second methods of XD), using the device of the second method of dissolution method, with water 900ml as release medium, turn
Speed is 100 turns per minute, is operated in accordance with the law, and Jing 1,2,4,6,8,12 hours takes release solution 10ml, is used
0.45 μm of microporous filter membrane filtration, takes subsequent filtrate as need testing solution, and the supplementary release in process container in time
Medium 10ml.Another precision weighs levo-oxiracetam reference substance about 10mg and puts in 25ml measuring bottles, with water dissolution and dilute
Release to scale, shake up, as reference substance solution.Precision measures above-mentioned reference substance solution and need testing solution is each respectively
20 μ l, determine according to the chromatographic condition of assay.Calculate the release (referring to Accumulation dissolution) of per.
3. result of the test：The measurement result of the release of slow releasing capsule sample of the present invention see the table below
4. conclusion (of pressure testing)：Levo-oxiracetam slow releasing capsule principal agent levo-oxiracetam is up to 12 into slow release, release time
Hour, quite, each time point RSD of release is respectively less than 6% to different sample room release behaviors.
Test three：A kind of levo-oxiracetam slow releasing capsule stability experiment of the present invention
Experiment material：
Levo-oxiracetam slow releasing capsule：It is obtained for embodiment 1.
Acceleration study method：By levo-oxiracetam slow releasing capsule obtained in embodiment 1 by listing packaging, Acceleration study is put
In case, certain hour sampling is tested to investigation project.
Acceleration study temperature：40±2℃
Humidity：RH75% ± 5%
The investigation time：0th, 1,2,3, June
Inspection target：
Character, moisture, relevant material, release, content, microbial limit
Accelerated test stability is recorded：
Acceleration study result shows：Accelerate June sample suitable with 0 month sample items Testing index quality, show that this product adds
Speed experiment June, quality keep stable, and this product stability is preferable.
Long-term experiment method：By levo-oxiracetam slow releasing capsule obtained in embodiment 1 by listing packaging, put and keep sample for a long time
In case, certain hour sampling is tested to investigation project.
Acceleration study temperature：25±2℃
Humidity：RH60% ± 10%
The investigation time：0th, 3,6,9,12,18,24 months
Character, moisture, relevant material, release, content, microbial limit
Long term test stability is recorded：
Long term test shows：It is 24 months character of this product long term test, moisture, relevant material, release, content, micro-
Biological limit without significant changes, meets every relevant regulations of production quality standard draft.This product long term test 24
Individual month steady quality, therefore this product effect duration is minimum 24 months, long term test is still during continuing to investigate.
Embodiment 2
A kind of good levo-oxiracetam slow releasing capsule of mobility of particle, is obtained according to the following steps：
| Composition | Consumption |
| Levo-oxiracetam | 1 part |
| Lactose | 1.5 part |
| Carboxylic the third methylcellulose K4M | 1.5 part |
| Carboxylic the third methylcellulose K15M | 1.1 part |
| Brazil wax | 0.8 part |
| Octadecanol | 0.09 part |
| Magnesium stearate | 0.11 part |
| 70% ethanol solution | 2.1 part |
Make 1000
Preparation process：It is obtained according to the preparation technology of embodiment 1.By the test method of embodiment 1, release is carried out respectively
Determine, stop sub- angle measure and sample stability test, drug release determination result of the test shows levo-oxiracetam in slow
Release, release time are up to 12 hours, and release RSD of different time points each sample is respectively less than 5%, three measurements
Angle of repose is respectively less than 37 °, illustrates that mobility of particle is good, and stability test result shows to accelerate June sample quality stable,
Long-term 24 months steady qualities, therefore at least 24 months this product effect duration.
Embodiment 3
A kind of good levo-oxiracetam slow releasing capsule of mobility of particle, is obtained according to the following steps：
| Composition | Consumption |
| Levo-oxiracetam | 1 part |
| Lactose | 1.4 part |
| Carboxylic the third methylcellulose K4M | 1.3 part |
| Carboxylic the third methylcellulose K15M | 1.0 part |
| Brazil wax | 0.7 part |
| Octadecanol | 0.08 part |
| Magnesium stearate | 0.09 part |
| 60% ethanol solution | 2.0 part |
Make 1000
Preparation process：It is obtained according to the preparation technology of embodiment 1.By the test method of embodiment 1, release is carried out respectively
Determine, stop sub- angle measure and sample stability test, drug release determination result of the test shows levo-oxiracetam in slow
Release, release time are up to 12 hours, and release RSD of different time points each sample is respectively less than 5%, three measurements
Angle of repose is respectively less than 37 °, illustrates that mobility of particle is good, and stability test result shows to accelerate June sample quality stable,
Long-term 24 months steady qualities, therefore at least 24 months this product effect duration.
Embodiment 4-6：A kind of good levo-oxiracetam slow releasing capsule of mobility of particle, by the supplementary material preparation of following weight
, preparation method is with embodiment 1：
Preparation process：It is obtained according to the preparation technology of embodiment 1.By the test method of embodiment 1, release is carried out respectively
Determine, stop sub- angle measure and sample stability test, 4,5,6 drug release determination result of the test of embodiment shows left-handed
Oxiracetam was up to 12 hours in slow release, release time, and release RSD of different time points each sample is respectively less than
5%, the measurement of embodiment 4,5,6 three times is respectively less than 37 ° angle of repose, illustrates that mobility of particle is good, embodiment 4,5,
6 stability test results show to accelerate June sample quality stable, long-term 24 months steady qualities, thus this product valid until
It is few 24 months.
Claims (3)
1. the good levo-oxiracetam slow releasing capsule of a kind of mobility of particle, it is characterised in that it be by following weight proportion supplementary material and step be obtained：About 1 part of levo-oxiracetam, about 1.2 parts ~ 1.6 parts of Lactose, about 1.0 parts ~ 1.5 parts of hydroxypropyl methylcellulose K4M, about 0.8 part ~ 1.3 parts of hydroxypropyl methylcellulose K15M, about 0.6 part ~ 1.0 parts of Brazil wax, about 0.05 part ~ 0.12 part of octadecanol, 0.06 ~ 0.11 part of magnesium stearate, volume fraction are 50% ~ 80% about 1.6 parts ~ 2.2 parts of ethanol solution；Take recipe quantity principal agent, sustained-release matrix material and blocker put mixing mill in co-grinding into fine powder（All sieved by No. 5 and the 95% of total amount can must not be less than by the amount of No. 6 sieves）, sieve；Binding agent is added, with 18 mesh sieve mixing granulations, the wet granular by made by, is placed in hot-air oven, 40 DEG C ~ 60 DEG C of temperature is set, be dried to pellet moisture≤3%, granulate（Cross 24 mesh sieves）, it is standby；Lubricant was crushed into 100 mesh sieves, in adding the granule after granulate, with three-dimensional motion mixer mixing 10min ~ 20min.
2. the levo-oxiracetam slow releasing capsule of good fluidity as claimed in claim 1, it is characterised in that it be by following weight proportion supplementary material and step be obtained：1 part of levo-oxiracetam, 1.3 parts ~ 1.5 parts of Lactose, 1.2 parts ~ 1.5 parts of hydroxypropyl methylcellulose K4M, 0.9 part ~ 1.1 parts of hydroxypropyl methylcellulose K15M, 0.7 part ~ 0.8 part of Brazil wax, 0.06 part ~ 0.09 part of octadecanol, 0.08 ~ 0.11 part of magnesium stearate, volume fraction are 50% ~ 70% 1.8 parts ~ 2.1 parts of ethanol solution；Take recipe quantity principal agent, sustained-release matrix material and blocker put mixing mill in co-grinding into fine powder（All sieved by No. 5 and the 95% of total amount can must not be less than by the amount of No. 6 sieves）, sieve；Binding agent is added, with 18 mesh sieve mixing granulations, the wet granular by made by, is placed in hot-air oven, 40 DEG C ~ 60 DEG C of temperature is set, be dried to pellet moisture≤3%, granulate（Cross 24 mesh sieves）, it is standby；Lubricant was crushed into 100 mesh sieves, in adding the granule after granulate, with three-dimensional motion mixer mixing 10min ~ 20min.
3. the preparation method of the good levo-oxiracetam slow releasing capsule of a kind of mobility of particle as claimed in claim 1 or 2, it is characterised in that it is obtained as follows：
A. supplementary material pre-treatment：Take recipe quantity principal agent, sustained-release matrix material and blocker put mixing mill in co-grinding into fine powder（All sieved by No. 5 and the 95% of total amount can must not be less than by the amount of No. 6 sieves）, sieve；
B. pelletize：Binding agent is added, with 18 mesh sieve mixing granulations, the wet granular by made by, is placed in hot-air oven, 40 ~ 60 DEG C of temperature is set, be dried to pellet moisture≤3%, granulate（Cross 24 mesh sieves）, it is standby；
C. it is total mixed：Lubricant was crushed into 100 mesh sieves, in adding the granule after granulate, with three-dimensional motion mixer mixing 10min ~ 20min；
D. fill：Filled with fully-automatic capsule filler, adjust loading amount 0.5g/ grain, whole filling process need to control relative humidity below 50%；
E. it is aluminum-plastic packaged：Aluminium-plastic bubble plate packing machine subpackage is used, per plate 10, operation room relative humidity have to be lower than 50%；
F. outsourcing is obtained final product.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510579960.2A CN106511311A (en) | 2015-09-11 | 2015-09-11 | Levo-oxiracetam sustained-release capsule with good particle mobility and preparation method of levo-oxiracetam sustained-release capsule |
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|---|---|---|---|
| CN201510579960.2A CN106511311A (en) | 2015-09-11 | 2015-09-11 | Levo-oxiracetam sustained-release capsule with good particle mobility and preparation method of levo-oxiracetam sustained-release capsule |
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| CN106511311A true CN106511311A (en) | 2017-03-22 |
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| CN201510579960.2A Withdrawn CN106511311A (en) | 2015-09-11 | 2015-09-11 | Levo-oxiracetam sustained-release capsule with good particle mobility and preparation method of levo-oxiracetam sustained-release capsule |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109692167A (en) * | 2017-10-23 | 2019-04-30 | 重庆润泽医药有限公司 | The pharmaceutical composition and preparation method thereof for treating cognition dysfunction |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1993006826A1 (en) * | 1991-10-08 | 1993-04-15 | Smithkline Beecham Farmaceutici S.P.A. | Composition comprising s-oxiracetame for use as nootropic |
| CN102249975A (en) * | 2010-05-21 | 2011-11-23 | 重庆润泽医疗器械有限公司 | (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide crystal form I and preparation method and application thereof |
| CN103599083A (en) * | 2013-12-06 | 2014-02-26 | 重庆东泽医药科技发展有限公司 | Levo-oxiracetam slow-release tablet and preparation method thereof |
-
2015
- 2015-09-11 CN CN201510579960.2A patent/CN106511311A/en not_active Withdrawn
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1993006826A1 (en) * | 1991-10-08 | 1993-04-15 | Smithkline Beecham Farmaceutici S.P.A. | Composition comprising s-oxiracetame for use as nootropic |
| CN102249975A (en) * | 2010-05-21 | 2011-11-23 | 重庆润泽医疗器械有限公司 | (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide crystal form I and preparation method and application thereof |
| CN103599083A (en) * | 2013-12-06 | 2014-02-26 | 重庆东泽医药科技发展有限公司 | Levo-oxiracetam slow-release tablet and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109692167A (en) * | 2017-10-23 | 2019-04-30 | 重庆润泽医药有限公司 | The pharmaceutical composition and preparation method thereof for treating cognition dysfunction |
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Application publication date: 20170322 |