CN107638415A - Good levo-oxiracetam spansule of a kind of content uniformity and preparation method thereof - Google Patents
Good levo-oxiracetam spansule of a kind of content uniformity and preparation method thereof Download PDFInfo
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- CN107638415A CN107638415A CN201610584161.9A CN201610584161A CN107638415A CN 107638415 A CN107638415 A CN 107638415A CN 201610584161 A CN201610584161 A CN 201610584161A CN 107638415 A CN107638415 A CN 107638415A
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Abstract
A kind of good levo-oxiracetam spansule of content uniformity is made by the supplementary material of following weight proportion：1 part of levo-oxiracetam, 0.8 part ~ 1.5 parts of lactose, 2.2 parts ~ 2.8 parts of HPMC K4M, 0.3 part ~ 0.8 part of Brazil wax, 0.11 part ~ 0.16 part of octadecanol, 0.08 ~ 0.15 part of magnesium stearate, 0.02 ~ 0.09 part of sodium thiosulfate, volume fraction are 50% ~ 70% 2.8 parts ~ 3.5 parts of ethanol solution；Levo-oxiracetam spansule of the present invention has mobility of particle good, particle angle of repose is less than 37 °, and content uniformity is good, and the RSD of mixed process drug content is less than 2%, rate of release is slow, deenergized period is up to 12 hours, meanwhile, this product stability is good, relevant material only increases by 0.05% in shelf life, shelf life is up to 24 months, preparation technology simple possible, is worth marketing.
Description
Technical field
The invention mainly relates to pharmaceutical technology field, and in particular to a kind of levo-oxiracetam spansule and its preparation side
Method.
Background technology
Oxiracetam (S-oxiracetam) is a kind of hydroxy-amino-butyric acid of synthesis (BABOB) cyclic derivatives, the medicine
Listed in 1987 in Italy, the formulation of listing is tablet, 800mg；Capsule, 800mg；Parenteral solution, 1g/5ml.It is domestic at present
Only oxiracetam capsule and parenteral solution listing, and main active used is racemic modification.Ye Lei etc. is in Publication No.
It is obvious to the promoting wakening gone into a coma caused by alcoholism that levo-oxiracetam is mentioned in CN 103735545A patents, and dextrorotation is difficult to understand
La Xitan is not acted on substantially, and the awake effect of above-mentioned rush of levo-oxiracetam is 2 times of racemization Oxiracetam；Levo-oxiracetam
It is notable to the promoting wakening of stupor caused by wound, anesthesia.Peak etc. is opened to drape over one's shoulders in the A of Publication No. CN 103599101 patent
Dew levo-oxiracetam has bright to traumatic brain injury learning and memory in rats cognition dysfunction caused by hydraulic pressure and freely falling body
Aobvious improvement result, its drug effect are far above dextrorotation Oxiracetam.And 200mg/kg levo-oxiracetams and 400mg/kg Auras west
Smooth effect is suitable.Pharmacokinetic study results are shown：Levo-oxiracetam and dextrorotation the Oxiracetam nothing in beasle dog body
Obvious chiral inversion.Beasle dog single intravenous injection gives after left-handed and 2 multiple doses racemization Oxiracetams left-handed Austria in blood plasma
The La Xitan equal no significant difference of main pharmacokinetic parameters.The result of the tests such as safe pharmacology, anxious malicious, long poison show, in equal agent
Under amount is horizontal, levo-oxiracetam is with Oxiracetam to animal subject or the toxicity no significant difference of cell.It is above-mentioned preclinical
Result of study shows that levo-oxiracetam is the main active that drug effect is played in Oxiracetam body, and this product is used alone can
Clinical practice dosage is reduced, reduces potential toxicity.
Existing Oxiracetam oral formulations are primarily present release and can not preferably controlled, it is impossible to reach wanting for sustained release preparation
Ask, drug content uniformity is poor in preparation process, and mobility of particle is bad, and filling loading amount process content uniformity is larger, influences
Dosage, the technical problems such as the relevant material increment of storage process is larger.
The content of the invention
It is an object of the invention to provide the levo-oxiracetam spansule that a kind of release is good, content uniformity is good.
Another object of the present invention is to provide the preparation method of above-mentioned levo-oxiracetam spansule.
The purpose of the present invention is realized by following technical measures：
A kind of good levo-oxiracetam spansule of content uniformity, it is characterised in that it include levo-oxiracetam,
Sustained-release matrix material, retarding agent, lubricant, adhesive, stabilizer；Wherein described sustained-release matrix material is hydroxypropyl methylcellulose
Element, ethyl cellulose, polyethylene, polypropylene, polysiloxanes, polyoxyethylene, lactose, fructose, sucrose, mannitol, alginic acid
One or more in sodium, agar, chitin, galactolipin；The retarding agent is fat, beeswax, Brazil wax, hydrogenated vegetable
One or more in oil, stearyl alcohol, glycerin monostearate；The lubricant be magnesium stearate, talcum powder, silica,
One or more in octadecanol；Adhesive therefor is ethanol solution, starch slurry, sucrose solution, water, PVP ethanol solution
Any of Deng；The stabilizer is vitamin C, methionine, sodium thiosulfate, citric acid, tartaric acid, cysteine,
One or more in glutathione.
Inventor is in research process discovery, specific supplementary material species and supplementary material consumption proportion relation, then coordinates spy
Determine processing step, be remarkably improved the content uniformity of levo-oxiracetam spansule, extend levo-oxiracetam sustained release glue
Release time of capsule, and mobility of particle is good, filling process content uniformity is more stable, the relevant material increment of storage process also compared with
It is small, above-mentioned levo-oxiracetam spansule, it is characterised in that it is made by the supplementary material of following weight proportion：Left-handed Austria
1 part of La Xitan, 0.8 part~1.5 parts of lactose, 2.2 parts~2.8 parts of HPMC K4M, 0.3 part of Brazil wax~
0.8 part, 0.11 part~0.16 part of octadecanol, 0.08~0.15 part of magnesium stearate, 0.02~0.09 part of sodium thiosulfate, volume
Fraction is 50%~70% 2.8 parts~3.5 parts of ethanol solution；By levo-oxiracetam with 3~7 times amount water be dissolved into it is molten
Liquid, it is standby；Lactose, HPMC K4M, Brazil wax, the sodium thiosulfate of recipe quantity are taken, adds left-handed Aura west
The smooth aqueous solution, is stirred 10min~15min, is placed in air dry oven, sets 40 DEG C~60 DEG C of temperature, dries to moisture
≤ 3%, take out, be placed in co-grinding in mixing mill into fine powder (all by No. 5 sieves and can must not by No. 6 amounts sieved
Less than total amount 95%), sieving；Ethanol solution is added, with 18 mesh sieve mixing granulations, by manufactured wet granular, is placed in hot blast baking
In case, 40 DEG C~60 DEG C of temperature is set, dried to pellet moisture≤3%, whole grain (crosses 24 mesh sieves), standby；By octadecanol, firmly
Fatty acid magnesium crushed 100 mesh sieves, add in the particle after whole grain, with three-dimensional motion mixer mixing 10min~20min.
In order to further improve particle circulation so that filling process loading amount is more stable, a kind of levo-oxiracetam sustained release
Capsule, it is characterised in that it is made by the supplementary material of following weight proportion：1 part of levo-oxiracetam, lactose 1.1 parts~1.3
Part, 2.3 parts~2.5 parts of HPMC K4M, 0.5 part~0.7 part of Brazil wax, octadecanol 0.12 part~0.15
Part, 0.10~0.13 part of magnesium stearate, 0.03~0.06 part of sodium thiosulfate, volume fraction is 50%~70% ethanol solution
2.9 parts~3.3 parts；Levo-oxiracetam is dissolved into solution with the water of 3~7 times of amounts, it is standby；Take lactose, the hydroxypropyl of recipe quantity
Methylcellulose K4M, Brazil wax, sodium thiosulfate, add the levo-oxiracetam aqueous solution, be stirred 10min~
15min, it is placed in air dry oven, 40 DEG C~60 DEG C of temperature is set, dries to moisture≤3%, take out, be placed in mixing mill
Middle co-grinding (is all sieved by No. 5 into fine powder and can must not be less than the 95% of total amount by the amounts of No. 6 sieves), sieving；Add
Ethanol solution, with 18 mesh sieve mixing granulations, manufactured wet granular is placed in hot-air oven, 40 DEG C~60 DEG C of temperature is set, done
It is dry standby to pellet moisture≤3%, whole grain (24 mesh sieves excessively)；Octadecanol, magnesium stearate were crushed into 100 mesh sieves, added whole
In particle after grain, with three-dimensional motion mixer mixing 10min~20min.
The preparation method of the good levo-oxiracetam spansule of a kind of content uniformity, it is characterised in that it is by such as
Made from lower step：
1. supplementary material pre-treatment：Levo-oxiracetam main ingredient is dissolved into solution with the water of 3~7 times of amounts, it is standby；Take prescription
Sustained-release matrix material, retarding agent, the stabilizer of amount, the levo-oxiracetam aqueous solution is added, 10min~15min is stirred, puts
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 mixed powder in mixing mill
It is broken into fine powder (all sieved by No. 5 and can must not be less than the 95% of total amount by the amounts of No. 6 sieves), sieving；
2. granulation：Adhesive is added, with 18 mesh sieve mixing granulations, manufactured wet granular is placed in hot-air oven, is set
40 DEG C~60 DEG C of temperature, dry to pellet moisture≤3%, whole grain (crosses 18 mesh sieves), standby；
It is 3. total mixed：Lubricant be crushed into 100 mesh sieves, add in the particle after whole grain, mixed with three-dimensional motion mixer
10min~20min；
4. filling：Filled with fully-automatic capsule filler, adjust loading amount 0.5g/ grains, whole filling process need to control relatively
Humidity is below 50%；
It is 5. aluminum-plastic packaged：Dispensed with aluminium-plastic bubble plate packing machine, per plate 10, operation room relative humidity have to be lower than 50%；
6. outsourcing produces.
The present invention has following beneficial effect：
Levo-oxiracetam spansule of the present invention has that mobility of particle is good, and particle angle of repose is less than 37 °, and content is uniform
Property it is good, the RSD of mixed process drug content is less than 2%, and rate of release is slow, is up to 12 hours deenergized period, therefore this product is more traditional
Preparation can reduce and take number, take once a day；Meanwhile this product stability is good, relevant material only increases in shelf life
0.05%, shelf life is up to 24 months, preparation technology simple possible, is worth marketing.
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 only used
It is further described in the present invention, it is impossible to limiting the scope of the invention is interpreted as, without departing substantially from spirit of the invention
In the case of essence, the modifications or substitutions made to the inventive method, step or condition belong to the scope of the present invention.
Embodiment 1
A kind of good levo-oxiracetam spansule of content uniformity, is made according to the following steps：
Preparation process：
1. supplementary material pre-treatment：Levo-oxiracetam is dissolved into solution with the water of 3~7 times of amounts, it is standby；Take recipe quantity
Lactose, HPMC K4M, Brazil wax, sodium thiosulfate, the levo-oxiracetam aqueous solution is added, is stirred
10min~15min, it is placed in air dry oven, 40 DEG C~60 DEG C of temperature is set, dries to moisture≤3%, take out, be placed in mixed
Close co-grinding in pulverizer (all to sieve by No. 5 into fine powder and can must not be less than the 95% of total amount by the amounts of No. 6 sieves), mistake
Sieve；
2. granulation：Ethanol solution is added, with 18 mesh sieve mixing granulations, manufactured wet granular is placed in hot-air oven, if
40 DEG C~60 DEG C of temperature is put, is dried to pellet moisture≤3%, whole grain (crosses 24 mesh sieves), standby；
It is 3. total mixed：Octadecanol, magnesium stearate were crushed into 100 mesh sieves, adds in the particle after whole grain, uses three-dimensional motion
Mixer mixing 10min~20min；
4. filling：Filled with fully-automatic capsule filler, adjust loading amount 0.5g/ grains, whole filling process need to control relatively
Humidity is below 50%；
It is 5. aluminum-plastic packaged：Dispensed with aluminium-plastic bubble plate packing machine, per plate 10, operation room relative humidity have to be lower than 50%；
6. outsourcing produces.
In order to be better understood from the present invention, having for invention medicine is expanded on further below by way of stability test of the present invention
Beneficial effect, rather than limitation of the present invention.
Experiment one：Particle flow performance determines
1. test material：Sample after the completion of always being mixed in the preparation process of embodiment 1
2. test method：After the completion of embodiment 1 is always mixed, distinguish respectively in the upper, middle and lower of three-dimensional motion mixer, each point
Angle of repose is measured by sampling, judges its mobility；
3. result of the test：
4. conclusion (of pressure testing)：It can be seen that by upper table result of the test, measure angle of repose three times and be respectively less than 37 °, show particle flow
Property is good.Experiment two：Content uniformity
4. test material：Sample after the completion of always being mixed in the preparation process of embodiment 1
5. test method：Embodiment 1 is always mixed complete 15 minutes after, respectively the upper, middle and lower of three-dimensional motion mixer, a left side,
The right separately sampled 5g of each point, content detection is carried out according to content assaying method, the content RSD of each sample point is calculated, evaluates whether to mix
Close uniform；
6. result of the test：
4. conclusion (of pressure testing)：It can be seen that by upper table result of the test, this product content uniformity is good, and RSD is less than 2%
Experiment three：Drug release determination
1. test material：The test specimen of Example 1
2. test method：Spansule obtained above is taken as sample, according to release inspection technique (Chinese Pharmacopoeia 2010 editions
Two the second methods of annex X D), using the device of the method for dissolution method second, using water 900ml as dissolution medium, rotating speed is every
100 turns of minute, operate in accordance with the law, through 1,2,4,6,8,12 hour, take release solution 10ml, filtered with 0.45 μm of miillpore filter,
Subsequent filtrate is taken as need testing solution, and supplements dissolution medium 10ml in process container in time.Another precision weighs left-handed Aura
Western smooth reference substance about 10mg is put in 25ml measuring bottles, is dissolved with water and is diluted to scale, shaken up, as reference substance solution.Essence respectively
It is close to measure above-mentioned reference substance solution and each 20 μ l of need testing solution, determined according to the chromatographic condition of assay.Calculate every
Release (refers to Accumulation dissolution).
3. result of the test：The measurement result of the release of spansule sample of the present invention see the table below
4. conclusion (of pressure testing)：Levo-oxiracetam spansule main ingredient levo-oxiracetam discharges into slow, release time length
Up to 12 hours, the requirement of sustained release preparation can be met.
Experiment four：A kind of good levo-oxiracetam spansule stability experiment of content uniformity of the present invention
Experiment material：
Levo-oxiracetam spansule：It is made for embodiment 1.
Acceleration study method：Levo-oxiracetam spansule made from embodiment 1 is packed by listing, puts Acceleration study
In case, certain time sampling, investigation project is tested.
Acceleration study temperature：40±2℃
Humidity：RH75% ± 5%
Investigate the time：0th, 1,2,3, June
Inspection target：
Character, moisture, relevant material, release, content, microbial limit
Accelerated test stability records：
Acceleration study result shows：Acceleration sample in June is suitable with 0 month sample items Testing index quality, shows that this product adds
Speed is tested June, and quality keeps stable, and this product stability is preferable.
Long-term experiment method：Levo-oxiracetam spansule made from embodiment 1 is packed by listing, puts and keeps sample for a long time
In case, certain time sampling, investigation project is tested.
Acceleration study temperature：25±2℃
Humidity：RH60% ± 10%
Investigate the time：0th, 3,6,9,12,18,24 months
Character, moisture, relevant material, release, content, microbial limit
Long term test stability records：
Long term test shows：24 months characters of this product long term test, moisture, relevant material, release, content, microorganism
Limit meets every relevant regulations of production quality standard draft without significant changes.24 lunar geology of this product long term test
Amount is stable, impurity increment only 0.05%, therefore minimum 24 months of this product term of validity, and long term test is still during investigation is continued.
Embodiment 2
A kind of good levo-oxiracetam spansule of content uniformity, is made according to the following steps：
Preparation process：It is made according to the preparation technology of embodiment 1.Tested by the test method of embodiment 1, angle of repose knot
Fruit shows this product good fluidity, and angle of repose is less than 36 °, and content uniformity test result shows that this product content uniformity is good, and RSD is small
In 1%, drug release determination result of the test shows that levo-oxiracetam was up to 12 hours, can met in slowly release, release time
The requirement of sustained release preparation, stability test result show that acceleration sample quality in June is stable, and impurity increment is 0.04%, long-term by 24
Individual month steady quality, impurity increment is 0.05%, therefore this product term of validity at least 24 months.
Embodiment 3
A kind of good levo-oxiracetam spansule of content uniformity, is made according to the following steps：
Preparation process：It is made according to the preparation technology of embodiment 1.Tested by the test method of embodiment 1, angle of repose knot
Fruit shows this product good fluidity, and angle of repose is less than 38 °, and content uniformity test result shows that this product content uniformity is good, and RSD is small
In 2%, drug release determination result of the test shows that levo-oxiracetam was up to 12 hours, can met in slowly release, release time
The requirement of sustained release preparation, stability test result show that acceleration sample quality in June is stable, and impurity increment is 0.05%, long-term by 24
Individual month steady quality, impurity increment is 0.05%, therefore this product term of validity at least 24 months.
Embodiment 4-6：The levo-oxiracetam spansule that a kind of content has allowed, by the supplementary material system of following weight
Standby and obtain, preparation method is the same as embodiment 1：
It is made according to the preparation technology of embodiment 1.Tested by the test method of embodiment 1, the angle of repose of embodiment 4,5,6
As a result this product good fluidity is shown, angle of repose is respectively smaller than 35 °, 38 °, 36 °, the content uniformity test result of embodiment 4,5,6
Show that this product content uniformity is good, RSD is respectively smaller than 2%, 2%, 1%, and the drug release determination result of the test of embodiment 4,5,6 shows
Levo-oxiracetam is up to 12 hours in slowly release, release time, can meet the requirement of sustained release preparation, embodiment 4,5,
6 stability test results show that acceleration sample quality in June is stable, and impurity increment is respectively 0.04%, 0.05%, 0.04%, long
24 months phases steady quality, impurity increment are respectively 0.05%, 0.05%, 0.04%, therefore this product term of validity at least 24 months.
Claims (3)
1. the good levo-oxiracetam spansule of a kind of content uniformity, it is characterised in that it is by following weight proportion
Supplementary material is made：About 1 part of levo-oxiracetam, about 0.8 part ~ 1.5 parts of lactose, HPMC K4M about 2.2 parts ~ 2.8
Part, about 0.3 part ~ 0.8 part of Brazil wax, about 0.11 part ~ 0.16 part of octadecanol, about 0.08 ~ 0.15 part of magnesium stearate are thio
About 0.02 ~ 0.09 part of sodium sulphate, volume fraction are 50% ~ 70% about 2.8 parts ~ 3.5 parts of ethanol solution；Levo-oxiracetam is used
The water of 3 ~ 7 times of amounts is dissolved into solution, standby；Take lactose, HPMC K4M, Brazil wax, the thio sulphur of recipe quantity
Sour sodium, the levo-oxiracetam aqueous solution is added, 10min ~ 15min is stirred, is placed in air dry oven, 40 DEG C of temperature is set
~ 60 DEG C, dry to moisture≤3%, take out, be placed in mixing mill co-grinding into fine powder（All sieve and can lead to by No. 5
The 95% of total amount must not be less than by crossing the amount of No. 6 sieves）, sieving；Add ethanol solution, with 18 mesh sieve mixing granulations, will made of wet
Grain, is placed in hot-air oven, sets 40 DEG C ~ 60 DEG C of temperature, dries to pellet moisture≤3%, whole grain（Cross 24 mesh sieves）, it is standby；Will
Octadecanol, magnesium stearate crushed 100 mesh sieves, added in the particle after whole grain, with three-dimensional motion mixer mixing 10min ~
20min。
2. levo-oxiracetam spansule as claimed in claim 1, it is characterised in that it is by the original of following weight proportion
Auxiliary material is made：1 part of levo-oxiracetam, 1.1 parts ~ 1.3 parts of lactose, 2.3 parts ~ 2.5 parts of HPMC K4M, cohune
0.5 part ~ 0.7 part of palmitic acid wax, 0.12 part ~ 0.15 part of octadecanol, 0.10 ~ 0.13 part of magnesium stearate, sodium thiosulfate 0.03 ~ 0.06
Part, volume fraction is 50% ~ 70% 2.9 parts ~ 3.3 parts of ethanol solution；By levo-oxiracetam with 3 ~ 7 times amount water be dissolved into it is molten
Liquid, it is standby；Lactose, HPMC K4M, Brazil wax, the sodium thiosulfate of recipe quantity are taken, adds left-handed Aura west
The smooth aqueous solution, is stirred 10min ~ 15min, is placed in air dry oven, 40 DEG C ~ 60 DEG C of temperature of setting, and drying to moisture≤
3%, take out, be placed in mixing mill co-grinding into fine powder（All sieve and be able to must not be less than by the amounts of No. 6 sieves by No. 5
The 95% of total amount）, sieving；Ethanol solution is added, with 18 mesh sieve mixing granulations, manufactured wet granular is placed in hot-air oven,
40 DEG C ~ 60 DEG C of temperature is set, dried to pellet moisture≤3%, whole grain（Cross 24 mesh sieves）, it is standby；By octadecanol, magnesium stearate
100 mesh sieves are crushed, are added in the particle after whole grain, with three-dimensional motion mixer mixing 10min ~ 20min.
3. the preparation method of levo-oxiracetam spansule as claimed in claim 1 or 2, it is characterised in that it is by such as
Made from lower step：
A. supplementary material pre-treatment：Levo-oxiracetam main ingredient is dissolved into solution with the water of 3 ~ 7 times of amounts, it is standby；Take recipe quantity
Sustained-release matrix material, retarding agent, stabilizer, the levo-oxiracetam aqueous solution is added, 10min ~ 15min is stirred, is placed in drum
In wind drying box, 40 DEG C ~ 60 DEG C of temperature is set, dried to moisture≤3%, is taken out, is placed in mixing mill co-grinding into thin
Powder（All sieved by No. 5 and can must not be less than the 95% of total amount by the amounts of No. 6 sieves）, sieving；
B. pelletize：Adhesive is added, with 18 mesh sieve mixing granulations, manufactured wet granular is placed in hot-air oven, temperature is set
40 DEG C ~ 60 DEG C, dry to pellet moisture≤3%, whole grain（Cross 18 mesh sieves）, it is standby；
C. it is total mixed：Lubricant be crushed into 100 mesh sieves, added in the particle after whole grain, with three-dimensional motion mixer mixing 10min
~20min；
D. fill：Filled with fully-automatic capsule filler, adjust loading amount 0.5g/ grains, whole filling process need to control relative humidity
Below 50%；
E. it is aluminum-plastic packaged：Dispensed with aluminium-plastic bubble plate packing machine, per plate 10, operation room relative humidity have to be lower than 50%；
F. outsourcing produces.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610584161.9A CN107638415A (en) | 2016-07-22 | 2016-07-22 | Good levo-oxiracetam spansule of a kind of content uniformity and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610584161.9A CN107638415A (en) | 2016-07-22 | 2016-07-22 | Good levo-oxiracetam spansule of a kind of content uniformity and preparation method thereof |
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| Publication Number | Publication Date |
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| CN107638415A true CN107638415A (en) | 2018-01-30 |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102617437A (en) * | 2012-04-10 | 2012-08-01 | 南京优科生物医药研究有限公司 | Novel crystal formations of levogyration oxiracetam and preparation method thereof |
| CN102670527A (en) * | 2012-05-28 | 2012-09-19 | 南京优科生物医药研究有限公司 | Freeze-dried powder injection of L-oxiracetam and process for preparing freeze-dried powder injection |
| 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 |
-
2016
- 2016-07-22 CN CN201610584161.9A patent/CN107638415A/en not_active Withdrawn
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102617437A (en) * | 2012-04-10 | 2012-08-01 | 南京优科生物医药研究有限公司 | Novel crystal formations of levogyration oxiracetam and preparation method thereof |
| CN102670527A (en) * | 2012-05-28 | 2012-09-19 | 南京优科生物医药研究有限公司 | Freeze-dried powder injection of L-oxiracetam and process for preparing freeze-dried powder injection |
| 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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Application publication date: 20180130 |
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| WW01 | Invention patent application withdrawn after publication |