CN106511305A - L-oxiracetam slow release capsule with high yield and preparation method thereof - Google Patents
L-oxiracetam slow release capsule with high yield and preparation method thereof Download PDFInfo
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- CN106511305A CN106511305A CN201510579834.7A CN201510579834A CN106511305A CN 106511305 A CN106511305 A CN 106511305A CN 201510579834 A CN201510579834 A CN 201510579834A CN 106511305 A CN106511305 A CN 106511305A
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Abstract
The invention provides an L-oxiracetam slow release capsule with high yield. The capsule is characterized in that the capsule is prepared by the following raw auxiliary materials in parts by weight: 1 part of L-oxiracetam, 1.2-2.5 parts of lactose, 2.0-3.0 parts of hydroxypropyl methyl cellulose K4M, 0.6-1.2 parts of carnauba wax, 0.1-0.5 parts of stearyl alcohol, and 2.0-2.5 parts of a polyvinylpyrrolidone K30 ethanol solution whose mass fraction is 5-10%. The L-oxiracetam slow release capsule has low powder layers after particle granulation, the yield of finished products reaches 95% or above, release speed is slow, and release period reaches 12 hours; compared with traditional preparations, the usage frequencies are reduced, and the capsule can be taken one time a day; at the same time, the capsule has good stability, the shelf life reaches 24 months, the preparation technology is simple and feasible, and the capsule is worth market promotion.
Description
Technical field
The invention mainly relates to pharmaceutical technology field, and in particular to a kind of levo-oxiracetam slow releasing capsule of high income and its
Preparation method.
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- pyrroles
Alkyl acetamide, is that (compound is draped over one's shoulders the anti-hypoxia class nootropics that synthesized in 1974 first of Italian ISFS.P.A companies
It is exposed to US4118396), it is ring GABOB derivants, Phosphorylcholine and phosphatidyl ethanolamine synthesis can be promoted, promote brain generation
Thank, through blood brain barrier, have stimulation to specificity nervus centraliss road, intelligence and memory can be improved, to brain blood
Pipe disease, cerebral trauma, cerebroma, intracranial infection, brain degenerative disease etc. also have preferable curative effect, and the drug toxicity pole
It is low, without mutagenesis and carcinogenesis and genotoxicity.Giorgio et al. discloses oxiracetam in US4118396
Chemical constitution and preparation method, Chiodini et al. are disclosed in WO9306826A, and clinical effectiveness proves that S configurations are (left
Rotation) the drug effect of oxiracetam be better than R configurations (dextrorotation), oxiracetam and levo-oxiracetam structure are as follows.
Existing levo-oxiracetam slow releasing capsule is primarily present release and preferably can not control, it is impossible to reach wanting for slow releasing preparation
Ask, after granulate, granule bisque is more, the low technical problem of product yield.
The content of the invention
It is an object of the invention to provide a kind of release is good, high income levo-oxiracetam slow releasing capsule.
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：
A kind of levo-oxiracetam slow releasing capsule of high income, it is characterised in that it be with levo-oxiracetam as raw material,
Add a certain amount of sustained-release matrix material, blocker, lubricant and binding agent to be obtained；Wherein described sustained-release matrix material
For hydroxypropyl methylcellulose, ethyl cellulose, polyethylene, polypropylene, polysiloxanes, Polyethylene oxide, Lactose, Fructose,
One or more in sucrose, mannitol, sodium alginate, agar, chitin, galactose；The blocker is fat
One or more in fat, Cera Flava, Brazil wax, hydrogenated vegetable oil, stearyl alcohol, glyceryl monostearate；It is described
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 Povidone K 30 ethanol solution.
Inventor has found that in research process a certain proportion of hydroxypropyl methylcellulose K4M of selection is collectively constituted with Lactose
Composite slow release framework material, in the Povidone K 30 ethanol solution for adding Brazil wax, octadecanol and certain concentration,
Coordinating specific granulation granulate step, above-mentioned levo-oxiracetam slow releasing capsule release time can caused up to 12 hours,
After granulate, granule bisque is few, and product yield is high, above-mentioned levo-oxiracetam slow releasing capsule, it is characterised in that：Left-handed Austria
1 part of La Xitan, 1.2 parts～2.5 parts of Lactose, hydroxypropyl methylcellulose K4M2.0 part～3.0 part, Brazil wax 0.6
Part～1.2 parts, 0.1 part～0.5 part of octadecanol, mass fraction are 5%～10% 2.0 parts of Povidone K 30 ethanol solution
～2.5 parts；Taking principal agent, sustained-release matrix material and the blocker of recipe quantity, to put co-grinding in mixing mill (complete into fine powder
Portion by No. 5 sieve and can pass through No. 6 sieve amounts must not less than total amount 95%), sieve；Binding agent is added, 18 mesh are used
Sieve mixing granulation, the wet granular by made by are placed in hot-air oven, arrange 40～60 DEG C of temperature, are dried to pellet moisture
≤ 3%, granulate (crosses 24 mesh sieves), standby；Lubricant was crushed into 100 mesh sieves, in adding the granule after granulate,
With three-dimensional motion mixer mixing 10min～20min.
Further, in order that granule bisque is less after levo-oxiracetam slow releasing capsule granulate, product yield is higher,
Above-mentioned levo-oxiracetam slow releasing capsule, it is characterised in that：1 part of levo-oxiracetam, 1.5 parts～2.0 parts of Lactose, hydroxyl
Third 2.3 parts of methylcellulose K4M～2.7 parts, 0.8 part～1.1 parts of Brazil wax, 0.3 part～0.5 part of octadecanol,
Mass fraction is 7%～9% 2.1 parts～2.3 parts of Povidone K 30 ethanol solution；Take principal agent, the sustained-release matrix of recipe quantity
During material and blocker put mixing mill, co-grinding (all sieves and can pass through the amount of No. 6 sieves into fine powder by No. 5
Must not be less than total amount 95%), sieve；Binding agent is added, with 18 mesh sieve mixing granulations, the wet granular by made by, is put
In hot-air oven, 40～60 DEG C of temperature is set, is dried to pellet moisture≤3%, granulate (crosses 24 mesh sieves), standby；
Lubricant was crushed into 100 mesh sieves, in adding the granule after granulate, with three-dimensional motion mixer mixing 10min～20min；
The preparation method of the levo-oxiracetam slow releasing capsule of a kind of high income, it is characterised in that it is to make as follows
：
1. supplementary material pre-treatment：Principal agent, sustained-release matrix material and the blocker for taking recipe quantity puts mixing in mixing mill
Fine powder (amount that No. 6 sieves are all sieved and can passed through by No. 5 must not be less than the 95% of total amount) is ground into, is sieved；
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
10min～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：
After levo-oxiracetam slow releasing capsule of the present invention has granule granulate, bisque is few, product yield up to more than 95%, releases
Put speed slow, deenergized period is up to 12 hours, therefore this product can be reduced compared with conventional formulation and take number of times, take once a day
；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 levo-oxiracetam slow releasing capsule of high income, is obtained according to the following steps：
| Composition | Consumption |
| Levo-oxiracetam | 1 part |
| Lactose | 1.5 part |
| Hydroxypropyl methylcellulose K4M | 2.3 part |
| Brazil wax | 0.8 part |
| Octadecanol | 0.3 part |
| Magnesium stearate | 0.01 part |
| 9% Povidone K 30 ethanol solution | 2.1 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
Fine powder (amount that No. 6 sieves are all sieved and can passed through by No. 5 must not be less than the 95% of total amount) is ground into, is sieved；
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
10min～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：Yield is calculated
1. test material：Gained finished product in 1 preparation process of embodiment
2. test method：With quality obtained by the quality and finished product of inventory, product yield is calculated；
3. result of the test：See the table below
| Name of product | Inventory | Packaging material weight | Finished weight | Yield |
| Embodiment 1 | 500.8g | 28.3g | 506.5g | 95.7% |
4. conclusion (of pressure testing)：Can be seen that product yield is up to 95.7% by upper table result of the test.
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 X the second methods of D), 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, the requirement of slow releasing preparation can be met.
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 DEG C of soil
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 DEG C of soil
Humidity：RH60% ± 10%
The investigation time：0th, 3,6,9,12,18 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 levo-oxiracetam slow releasing capsule, is obtained according to the following steps：
| Composition | Consumption |
| Levo-oxiracetam | 1 part |
| Lactose | 2.0 part |
| Carboxylic the third methylcellulose K4M | 2.7 part |
| Brazil wax | 1.1 part |
| Octadecanol | 0.5 part |
| 8% Povidone K 30 ethanol solution | 2.3 part |
Make 1000
Preparation process：It is obtained according to the preparation technology of embodiment 1.By the test method of embodiment 1, yield meter is carried out respectively
Calculate, drug release determination and sample stability are tested, yield result of calculation shows that product yield is up to 96.1%, release
Determination test result shows that levo-oxiracetam slow releasing capsule, in slow release, is up to 12 hours, can meet release time
The requirement of slow releasing preparation, stability test result show 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 levo-oxiracetam slow releasing capsule, is obtained according to the following steps：
| Composition | Consumption |
| Levo-oxiracetam | 1 part |
| Lactose | 1.8 part |
| Carboxylic the third methylcellulose K4M | 2.5 part |
| Brazil wax | 0.9 part |
| Octadecanol | 0.3 part |
| 8% Povidone K 30 ethanol solution | 2.2 part |
Make 1000
Preparation process：It is obtained according to the preparation technology of embodiment 1.By the test method of embodiment 1, yield meter is carried out respectively
Calculate, drug release determination and sample stability are tested, yield result of calculation shows that product yield is up to 95.3%, release
Determination test result shows that levo-oxiracetam slow releasing capsule, in slow release, is up to 12 hours, can meet release time
The requirement of slow releasing preparation, stability test result show 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 levo-oxiracetam slow releasing capsule, is prepared by the supplementary material of following weight, and preparation method is same
Embodiment 1：
It is obtained according to the preparation technology of embodiment 1.By the test method of embodiment 1, yield calculating, release are carried out respectively
Determine and sample stability test, 4,5,6 yield of embodiment is respectively 95.9%, 96.2%, 95.1%, embodiment
4th, 5,6 drug release determination result of the tests show that levo-oxiracetam slow releasing capsule, in slow release, is up to 12 release time
Hour, the requirement of slow releasing preparation can be met, 4,5,6 stability test result of embodiment shows to accelerate June sample quality
It is stable, long-term 24 months steady qualities, therefore at least 24 months this product effect duration.
Claims (3)
1. the levo-oxiracetam slow releasing capsule of a kind of high income, it is characterised in that it is obtained by the supplementary material and step of following weight proportion：1 part of levo-oxiracetam, 1.2 parts ~ 2.5 parts of Lactose, hydroxypropyl methylcellulose K4M2.0 part ~ 3.0 part, 0.6 part ~ 1.2 parts of Brazil wax, 0.1 part ~ 0.5 part of octadecanol, mass fraction are 5% ~ 10% 2.0 parts ~ 2.5 parts of Povidone K 30 ethanol solution；Take recipe quantity principal agent, sustained-release matrix material and blocker put mixing mill in co-grinding into fine powder（The amount that No. 6 sieves are all sieved and can passed through by No. 5 must not be less than the 95% of total amount）, sieve；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；Lubricant was crushed into 100 mesh sieves, in adding the granule after granulate, with three-dimensional motion mixer mixing 10min ~ 20min.
2. levo-oxiracetam slow releasing capsule as claimed in claim 1, it is characterised in that it is obtained by the supplementary material and step of following weight proportion：About 1 part of levo-oxiracetam, about 1.5 parts ~ 2.0 parts of Lactose, about 2.3 parts ~ 2.7 parts of hydroxypropyl methylcellulose K4M, 0.8 part ~ 1.1 parts of Brazil wax, about 0.3 part ~ 0.5 part of octadecanol, mass fraction are 7% ~ 9% about 2.1 parts ~ 2.3 parts of Povidone K 30 ethanol solution；Take recipe quantity principal agent, sustained-release matrix material and blocker put mixing mill in co-grinding into fine powder（The amount that No. 6 sieves are all sieved and can passed through by No. 5 must not be less than the 95% of total amount）, sieve；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；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 levo-oxiracetam slow releasing capsule of a kind of high income 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（The amount that No. 6 sieves are all sieved and can passed through by No. 5 must not be less than the 95% of total amount）, 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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510579834.7A CN106511305A (en) | 2015-09-11 | 2015-09-11 | L-oxiracetam slow release capsule with high yield and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510579834.7A CN106511305A (en) | 2015-09-11 | 2015-09-11 | L-oxiracetam slow release capsule with high yield and preparation method thereof |
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| CN106511305A true CN106511305A (en) | 2017-03-22 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201510579834.7A Withdrawn CN106511305A (en) | 2015-09-11 | 2015-09-11 | L-oxiracetam slow release capsule with high yield and preparation method thereof |
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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 CN201510579834.7A patent/CN106511305A/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 |
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