CN106511302A - Levorotatory oxiracetam slow-release capsule with good releasing rate uniformity and preparation method thereof - Google Patents
Levorotatory oxiracetam slow-release capsule with good releasing rate uniformity and preparation method thereof Download PDFInfo
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Abstract
A levorotatory oxiracetam slow-release capsule with good releasing rate uniformity is characterized in that the levorotatory oxiracetam slowly-released capsule is prepared from the following raw materials in parts by weight: 1 part of levorotatory oxiracetam, 1.2 to 1.7 parts of lactin, 0.8 to 1.6 parts of hydroxypropylmethylcellulose K4M, 1.1 to 2.0 parts of hydroxypropylmethylcellulose K15M, 0.3 to 0.8 part of brazil palm wax, 0.05 to 0.2 part of stearyl alcohol, and 2.1 to 2.8 parts of ethanol solution with the volume fraction of 50 to 70%; the levorotatory oxiracetam slow-release capsule prepared according to the preparation method provided by the invention has a good releasing uniformity, each time point releasing rate RSD (Relative Standard Deviation) among different samples is less than 5%, releasing speed is slow, the releasing period can reach 12 hours, and thus medicine taking times of the levorotatory oxiracetam slowly-released capsule can be reduced to once a day through comparing with traditional preparations, main drug content uniformity is good, the RSD of the main drug content is less than 1% during a mixing process; meanwhile, the levorotatory oxiracetam slow-release capsule is good in stability, the shelf-life can reach 24 months, a preparation process is simple and feasible, and the capsule is worth market popularizing.
Description
Technical field
The invention mainly relates to pharmaceutical technology field, and in particular to a kind of levo-oxiracetam slow releasing capsule and its preparation side
Method.
Background technology
Oxiracetam (S-oxiracetam) is a kind of the hydroxy-amino-butyric acid of synthesis (BABOB) cyclic derivatives, only
For central nervous system, cerebral cortex, Hippocampus are mainly distributed on, have activation, protection or promote the function of neurocyte
Recover, improve the mnemonic learning function of disturbance of intelligence patient, and medicine does not have direct vasoactive in itself, in also not having
Pivot excitation, the impact to ability of learning and memory are a kind of lasting facilitations.
In 1987 in Italy's listing, the dosage form of listing is tablet to the medicine, 800mg；Capsule, 800mg；Injection,
5ml∶1g.It is domestic at present to there was only oxiracetam capsule and injection listing, and main active used is racemic modification.
The rush that Ye Lei etc. goes into a coma caused by mentioning levo-oxiracetam to alcoholism in 103735545 A patents of Publication No. CN
Effect of waking up is obvious, and dextrorotation oxiracetam is not acted on substantially, and the above-mentioned rush of levo-oxiracetam wakes up effect for racemization Aura
Western smooth 2 times；Levo-oxiracetam is notable to the promoting wakening of stupor caused by wound, anesthesia.Zhang Feng etc. is in Publication No.
Levo-oxiracetam is disclosed in the patent of 103599101 A of CN to traumatic brain injury rat caused by hydraulic pressure and freely falling body
Learning and memory cognitive dysfunction improves significantly, and its drug effect is far above dextrorotation oxiracetam.And 200mg/kg
Levo-oxiracetam is suitable with the effect of 400mg/kg oxiracetams.Pharmacokinetic study results show：Left-handed Aura
Western smooth and dextrorotation oxiracetam is in beasle dog body without obvious chiral inversion.Beasle dog single intravenous injection gives left-handed and 2
After the racemization oxiracetam of multiple dose in blood plasma levo-oxiracetam the equal no significant difference of main pharmacokinetic parameters.Safe medicine
The result of the tests such as reason, anxious malicious, long poison show that, under isodose level, levo-oxiracetam is with oxiracetam to tested
The toxicity no significant difference of animal or cell.Above-mentioned preclinical result of study shows that levo-oxiracetam is oxiracetam
The main active of drug effect is played in vivo, this product is used alone can reduce Clinical practice dosage, reduce potential poison secondary anti-
Should.
Existing levo-oxiracetam slow releasing preparation is primarily present release and preferably can not control, it is impossible to reach wanting for slow releasing preparation
Ask, differ greatly with the release of different samples in batch product, cause product quality variance larger, in product preparation process
Poor etc. the technical problem of drug content uniformity.
The content of the invention
It is an object of the invention to provide a kind of release uniformity is good, good stability 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：
The good levo-oxiracetam slow releasing capsule of a kind of release uniformity, 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 collectively constitutes composite slow release framework material with Lactose, adds Brazil wax, octadecanol and certain concentration
Ethanol solution, then coordinate specific supplementary material pre-treating method, when above-mentioned levo-oxiracetam slow releasing capsule can be caused to discharge
Between be up to 12 hours, and good with the release uniformity between batch product difference sample, in product preparation process, principal agent contains
Amount uniformity is good, the good levo-oxiracetam slow releasing capsule of above-mentioned release uniformity, it is characterised in that：Levo-oxiracetam
1 part, 1.2 parts～1.7 parts of Lactose, 0.8 part～1.6 parts of hydroxypropyl methylcellulose K4M, hydroxypropyl methylcellulose K15M 1.1
Part～2.0 parts, 0.3 part～0.8 part of Brazil wax, 0.05 part～0.2 part of octadecanol, volume fraction are 50%～70%
2.1 parts～2.8 parts of ethanol solution；It is by levo-oxiracetam with the water dissolution of 3～7 times of amounts into solution, standby；Take prescription
The sustained-release matrix material of amount, blocker, add levo-oxiracetam aqueous solution, stirring mixing 10min～15min to be placed in
In air dry oven, 40 DEG C～60 DEG C of temperature is set, is dried to moisture≤3%, is taken out, be placed in mixing mill and mix
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, obtain final product.
Further, in order that levo-oxiracetam slow releasing capsule difference sample room release uniformity is more preferable, sample size
Uniformity is more preferable, above-mentioned levo-oxiracetam slow releasing capsule, it is characterised in that：1 part of levo-oxiracetam, Lactose 1.3
Part～1.5 parts, 1.0 parts～1.3 parts of hydroxypropyl methylcellulose K4M, 1.5 parts～1.8 parts of hydroxypropyl methylcellulose K15M,
0.5 part～0.7 part of Brazil wax, 0.08 part～0.18 part of octadecanol, volume fraction is 50%～70% ethanol solution
2.3 parts～2.7 parts；It is by levo-oxiracetam principal agent with the water dissolution of 3～7 times of amounts into solution, standby；Take the slow of recipe quantity
Framework material, blocker is released, adds levo-oxiracetam aqueous solution, stirring mixing 10min～15min to be placed in air blast and do
In dry case, 40 DEG C～60 DEG C of temperature is set, is dried to moisture≤3%, take out, be placed in mixing mill co-grinding into
Fine powder (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), is sieved, is obtained final product.
The preparation method of the good levo-oxiracetam slow releasing capsule of a kind of release uniformity, it is characterised in that it is by as follows
Obtained in step：
1. supplementary material pre-treatment：It is by levo-oxiracetam with the water dissolution of 3～7 times of amounts into solution, standby；Take recipe quantity
Sustained-release matrix material, blocker, add levo-oxiracetam aqueous solution, stirring mixing 10min～15min to be placed in air blast
In drying baker, 40 DEG C～60 DEG C of temperature is set, is dried to moisture≤3%, is taken out, be placed in co-grinding in mixing mill
(all sieved by No. 5 and the 95% of total amount can must not be less than by the amount of No. 6 sieves) into fine powder, 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 DEG C～60 DEG C of temperature is set, is dried to pellet moisture≤3%, granulate (crosses 18 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：
Levo-oxiracetam slow releasing capsule of the present invention has release uniformity good, each time point release between different samples
RSD is respectively less than 5%, and rate of release is slow, and deenergized period is up to 12 hours, therefore this product can be reduced compared with conventional formulation and take secondary
Number, takes once a day, and drug content uniformity is good, and the RSD of mixed process drug content is less than 1%；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 release uniformity, is obtained according to the following steps：
| Composition | Consumption |
| Levo-oxiracetam | 1 part |
| Lactose | 1.3 part |
| Hydroxypropyl methylcellulose K4M | 1.0 part |
| Hydroxypropyl methylcellulose K15M | 1.5 part |
| Brazil wax | 0.5 part |
| Octadecanol | 0.08 part |
| 70% ethanol solution | 2.3 part |
Make 1000
Preparation process：
1. supplementary material pre-treatment：It is by levo-oxiracetam with the water dissolution of 3～7 times of amounts into solution, standby；Take recipe quantity
Sustained-release matrix material, blocker, add levo-oxiracetam aqueous solution, stirring mixing 10min～15min to be placed in air blast
In drying baker, 40 DEG C～60 DEG C of temperature is set, is dried to moisture≤3%, is taken out, be placed in co-grinding in mixing mill
(all sieved by No. 5 and the 95% of total amount can must not be less than by the amount of No. 6 sieves) into fine powder, 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 DEG C～60 DEG C of temperature is set, is dried to pellet moisture≤3%, granulate (crosses 18 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：Content uniformity
1. test material：Sample after the completion of always mixing in 1 preparation process of embodiment
2. test method：Embodiment 1 it is total it is mixed complete 15 minutes after, respectively the upper, middle and lower of three-dimensional motion mixer,
The separately sampled 5g of left and right each point, carries out content detection according to content assaying method, calculates the content of each sample point
RSD, evaluates whether mix homogeneously；
3. result of the test：
4. conclusion (of pressure testing)：Can be seen that by upper table result of the test, this product content uniformity is good, RSD is less than 1%
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, quite, each time point RSD of release is respectively less than 5% to different sample room release behaviors.
Test three：A kind of good levo-oxiracetam slow releasing capsule stability experiment of release uniformity 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 release uniformity, is obtained according to the following steps：
| Composition | Consumption |
| Levo-oxiracetam | 1 part |
| Lactose | 1.5 part |
| Carboxylic the third methylcellulose K4M | 1.3 part |
| Carboxylic the third methylcellulose K15M | 1.8 part |
| Brazil wax | 0.7 part |
| Octadecanol | 0.18 part |
| 70% ethanol solution | 2.7 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 and sample stability test, drug release determination result of the test shows levo-oxiracetam in slow release, during release
Between be up to 12 hours, release RSD of different time points each sample is respectively less than 5%, and each point content uniformity RSD is equal
Less than 1%, stability test result shows to accelerate June sample quality stable, long-term 24 months steady qualities, therefore this product
At least 24 months effect duration.
Embodiment 3
A kind of good levo-oxiracetam slow releasing capsule of release uniformity, is obtained according to the following steps：
| Composition | Consumption |
| Levo-oxiracetam | 1 part |
| Lactose | 1.4 part |
| Carboxylic the third methylcellulose K4M | 1.2 part |
| Carboxylic the third methylcellulose K15M | 1.7 part |
| Brazil wax | 0.6 part |
| Octadecanol | 0.12 part |
| 70% ethanol solution | 2.5 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 and sample stability test, drug release determination result of the test shows levo-oxiracetam in slow release, during release
Between be up to 12 hours, release RSD of different time points each sample is respectively less than 5%, and each point content uniformity RSD is equal
Less than 1%, stability test result shows to accelerate June sample quality stable, long-term 24 months steady qualities, therefore this product
At least 24 months effect duration.
Embodiment 4-6：A kind of good levo-oxiracetam slow releasing capsule of release uniformity, 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 and sample stability test, 4,5,6 drug release determination result of the test of embodiment shows levo-oxiracetam in slow
On The Drug Release, release time are up to 12 hours, and release RSD of different time points each sample is respectively less than 5%, embodiment 4,
5th, 6 each point content uniformities RSD are respectively less than 1%, and 4,5,6 stability test result of embodiment shows to accelerate 6 lunar samples
Quality is stable, long-term 24 months steady qualities, therefore at least 24 months this product effect duration.
Claims (3)
1. the good levo-oxiracetam slow releasing capsule of a kind of release uniformity, 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 ~ 1.7 parts of Lactose, about 0.8 part ~ 1.6 parts of hydroxypropyl methylcellulose K4M, about 1.1 parts ~ 2.0 parts of hydroxypropyl methylcellulose K15M, 0.3 part ~ 0.8 part of Brazil wax, about 0.05 part ~ 0.2 part of octadecanol, volume fraction are 50% ~ 70% 2.1 parts ~ 2.8 parts of ethanol solution；It is by levo-oxiracetam with the water dissolution of 3 ~ 7 times of amounts into solution, standby；Take sustained-release matrix material, the blocker of recipe quantity, add levo-oxiracetam aqueous solution, stirring mixing 10min ~ 15min to be placed in air dry oven, 40 DEG C ~ 60 DEG C of temperature is set, be dried to moisture≤3%, take out, co-grinding is placed in mixing mill 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, obtain final product.
2. levo-oxiracetam slow releasing capsule 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, 1.0 parts ~ 1.3 parts of hydroxypropyl methylcellulose K4M, 1.5 parts ~ 1.8 parts of hydroxypropyl methylcellulose K15M, 0.5 part ~ 0.7 part of Brazil wax, 0.08 part ~ 0.18 part of octadecanol, volume fraction are 50% ~ 70% 2.3 parts ~ 2.7 parts of ethanol solution；It is by levo-oxiracetam principal agent with the water dissolution of 3 ~ 7 times of amounts into solution, standby；Take sustained-release matrix material, the blocker of recipe quantity, add levo-oxiracetam aqueous solution, stirring mixing 10min ~ 15min to be placed in air dry oven, 40 DEG C ~ 60 DEG C of temperature is set, be dried to moisture≤3%, take out, co-grinding is placed in mixing mill 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, obtain final product.
3. the preparation method of levo-oxiracetam slow releasing capsule as claimed in claim 1 or 2, it is characterised in that it is obtained as follows：
A. supplementary material pre-treatment：It is by levo-oxiracetam with the water dissolution of 3 ~ 7 times of amounts into solution, standby；Sustained-release matrix material, the blocker of recipe quantity is taken, adds levo-oxiracetam aqueous solution, stirring mixing 10min ~ 15min to be placed in air dry oven, 40 DEG C ~ 60 DEG C of temperature is set, be dried to moisture≤3%, take out, co-grinding is into fine powder in putting mixing mill（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 DEG C ~ 60 DEG C of temperature is set, be dried to pellet moisture≤3%, granulate（Cross 18 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 Autocapsulefillingmachine, 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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| CN201510577273.7A CN106511302B (en) | 2015-09-11 | 2015-09-11 | Levalsartan sustained-release capsule with good release uniformity and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510577273.7A CN106511302B (en) | 2015-09-11 | 2015-09-11 | Levalsartan sustained-release capsule with good release uniformity and preparation method thereof |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103301114A (en) * | 2012-03-07 | 2013-09-18 | 辽宁亿灵科创生物医药科技有限公司 | Oxiracetam medicinal composition, 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 |
| WO2014087367A2 (en) * | 2012-12-09 | 2014-06-12 | Mahesh Kandula | Compositions and methods for the treatment of neurological diseases and its associated complications |
-
2015
- 2015-09-11 CN CN201510577273.7A patent/CN106511302B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103301114A (en) * | 2012-03-07 | 2013-09-18 | 辽宁亿灵科创生物医药科技有限公司 | Oxiracetam medicinal composition, and preparation method and application thereof |
| WO2014087367A2 (en) * | 2012-12-09 | 2014-06-12 | Mahesh Kandula | Compositions and methods for the treatment of neurological diseases and its associated complications |
| 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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