CN106890152A - A kind of levo-oxiracetam effervescent tablet in good taste and preparation method thereof - Google Patents
A kind of levo-oxiracetam effervescent tablet in good taste and preparation method thereof Download PDFInfo
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Abstract
A kind of levo-oxiracetam effervescent tablet in good taste, it is characterised in that it is obtained by the supplementary material of following weight proportion：1 part of levo-oxiracetam, 3 ~ 9 parts of tartaric acid, 3 ~ 9 parts of sodium acid carbonate, 0.2 ~ 0.8 part of sodium chloride, 0.3 ~ 1.2 part of Macrogol 6000,4 ~ 10 parts of dextrin, 0.6 ~ 1.5 part of Sucralose, 0.5 ~ 0.9 part of peppermint oil, 0.2 ~ 0.8 part of strawberry essence, volume fraction are 15 ~ 26 parts of 50% ~ 70% ethanol solution；Will not sticking according to levo-oxiracetam effervescent tablet tableting processes obtained in the present invention, finished product aerogenesis is fast, disintegration rate is fast, disintegration time is no more than 30 seconds, and this product is in good taste, easily received by most of patient, while shelf life is 24 months, preparation process is simple is feasible, is worth marketing.
Description
Technical field
The invention mainly relates to pharmaceutical technology field, and in particular to a kind of levo-oxiracetam effervescent tablet in good taste and its system
Preparation Method.
Background technology
Cereboactive drug is a kind of new medicine for central nervous system for promoting study, strengthening memory also known as cereboactive drug.Promote
Intelligence medicine requirement selection index system activates, protects and promotes damaged nerve cell functional rehabilitation in cerebral cortex with selection
Feature.Different from other neurologic agents be a little their above-mentioned effect not by network or olfactory bulb, but directly
Connect and act on cortex.Behavior is neither influenceed, also without calm excitation, therefore such medicine has caused the extensive pass of people
Note and interest, the demand to such medicine are also growing day by day.
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 anoxia class cereboactive drug that synthesized first in 1974 of Italian ISFS.P.A companies
It is exposed to US4118396), it is ring GABOB derivatives, Phosphorylcholine and phosphatidyl ethanolamine can be promoted to synthesize, promote brain generation
Thank, through blood-brain barrier, have stimulation to specific nervous centralis road, intelligence and memory can be improved, to brain blood
Pipe disease, brain trauma, brain tumor, 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 effervescent formulation is primarily present that the easy sticking of tableting processes, finished product aerogenesis are slow, disintegration is slow, mouth
Sense is poor, is difficult the technical problem such as to receive by many patients.
The content of the invention
It is an object of the invention to provide a kind of in good taste, levo-oxiracetam effervescent tablet that disintegration is fast.
Preparation method another object of the present invention is to provide above-mentioned levo-oxiracetam effervescent tablet.
The purpose of the present invention is realized by following technical measures：
A kind of in good taste, levo-oxiracetam effervescent tablet that disintegration is fast, it is characterised in that it is to be with levo-oxiracetam
Raw material, adds a certain amount of acid source, alkali source, adhesive, lubricant, filler, flavouring and is obtained；It is wherein described
Acid source is the one kind in citric acid, tartaric acid, fumaric acid, adipic acid, malic acid；The alkali source is sodium carbonate, carbonic acid
One kind in hydrogen sodium, potassium carbonate, saleratus, calcium carbonate；Described adhesive is water, ethanol, sucrose, starch slurry, paste
One or more in essence, copolyvidone VA64 (PVP/VA64)；The lubricant is talcum powder, magnesium stearate, poly- second
Glycol 4000, Macrogol 6000, stearic acid, calcium stearate, lauryl sodium sulfate, superfine silica gel powder, magnesia, paraffin
In one or more；Filler be starch, lactose, dextrin, Icing Sugar, calcium sulfate, sucrose, mannitol, microcrystalline cellulose,
One or more in glucose, sodium carboxymethylcellulose, sodium chloride；The flavouring is sucrose, maltose, ethyl malt
Phenol, Sucralose, stevia rebaudianum are sweet, sorbierite, mannitol, glucose, aspartame, peppermint oil, strawberry essence, apple fragrant
One or more in any of several broadleaf plants, peach flavor, chocolate essence.
Inventor has found that selection suitable supplementary product kind, specific supplementary material consumption proportion relation are matched somebody with somebody in research process
Close special processing method, can cause above-mentioned levo-oxiracetam effervescent tablet tableting processes will not sticking, and finished product has
Have the advantages that in good taste, aerogenesis is fast, it is fast to be disintegrated；Above-mentioned levo-oxiracetam effervescent tablet in good taste, it is characterised in that
It is obtained by the supplementary material of following weight proportion：1 part of levo-oxiracetam, 3~9 parts of tartaric acid, sodium acid carbonate 3~9
Part, 0.2~0.8 part of sodium chloride, 0.3~1.2 part of Macrogol 6000,4~10 parts of dextrin, 0.6~1.5 part of Sucralose,
0.5~0.9 part of peppermint oil, 0.2~0.8 part of strawberry essence, volume fraction are 15~26 parts of 50%~70% ethanol solution；Take
The dextrin of recipe quantity is placed in milling, and the purified water of the quality such as addition, mixing of milling adds recipe quantity in operating process
Peppermint oil and strawberry essence, continue to mill 10~20 minutes, take out, and are placed in air dry oven, set 40 DEG C of drying temperature
~50 DEG C of dryings to moisture takes out less than 3%, is placed in Universalpulverizer, adds levo-oxiracetam, the winestone of recipe quantity
Acid, Sucralose, co-grinding collect mixed-powder after crossing 100 mesh sieves, and mixed-powder is placed in wet granulator
Adhesive is added, starts granulator (installing 18 mesh nylon mesh), granulation obtains sour phase particle, standby；Take recipe quantity
Sodium acid carbonate, sodium chloride mixing, are placed in Universalpulverizer and crush, and mixed-powder is collected after crossing 100 mesh sieves, standby；
The Macrogol 6000 of recipe quantity is heated into fusing, 40~45 DEG C of fusion temperature is set, after Macrogol 6000 melts,
The mixed-powder of above-mentioned sodium acid carbonate and sodium chloride is added, is uniformly mixed, be placed in Universalpulverizer after cooling, powder
It is broken, it is placed in after 100 mesh sieves excessively and adhesive is added in wet granulator, start granulator (installing 18 mesh nylon mesh), system
Grain, obtains alkali phase particle, standby.
Further, in order to accelerate the disintegration time of levo-oxiracetam effervescent tablet so that finished product taste more preferably, a kind of mouth
The levo-oxiracetam effervescent tablet felt, it is characterised in that it is obtained by the supplementary material of following weight proportion：Left-handed Austria
1 part of La Xitan, 4~7 parts of tartaric acid, 4~7 parts of sodium acid carbonate, 0.4~0.6 part of sodium chloride, Macrogol 6000 0.6~0.9
Part (sodium chloride: Macrogol 6000=2: 3), 6~9 parts of dextrin, 0.7~1.0 part of Sucralose, peppermint oil 0.6~0.8
Part, 0.3~0.6 part of strawberry essence, volume fraction are 18~23 parts of 50%~70% ethanol solution；The dextrin for taking recipe quantity is put
In milling, the purified water of the quality such as addition, mixing of milling adds the peppermint oil of recipe quantity and strawberry fragrant in operating process
Essence, continues to mill 10~20 minutes, takes out, and is placed in air dry oven, sets 45 DEG C of dryings of drying temperature low to moisture
Taken out in 3%, be placed in Universalpulverizer, add levo-oxiracetam, tartaric acid, the Sucralose of recipe quantity, mixing
Crush, mixed-powder is collected after crossing 100 mesh sieves, mixed-powder is placed in adhesive is added in wet granulator, start system
Grain machine (installs 18 mesh nylon mesh), and granulation obtains sour phase particle, standby；The sodium acid carbonate of recipe quantity, sodium chloride is taken to mix
Close, be placed in Universalpulverizer and crush, mixed-powder is collected after crossing 100 mesh sieves, it is standby；By the polyethylene glycol of recipe quantity
6000 heating fusings, set 42 DEG C of fusion temperature, after after Macrogol 6000 fusing, add above-mentioned sodium acid carbonate and chlorine
Change the mixed-powder of sodium, be uniformly mixed, be placed in Universalpulverizer after cooling, crush, be placed in after crossing 100 mesh sieves
Adhesive is added in wet granulator, starts granulator (installing 18 mesh nylon mesh), granulation obtains alkali phase particle, standby.
Supplementary material needed for above-mentioned, is well known to those skilled in the art, and in the market is commercially available.
A kind of preparation method of levo-oxiracetam effervescent tablet in good taste, it is characterised in that it is prepared as follows
's：
1. the dextrin for taking recipe quantity is placed in and mills, and the purified water of quality, mixing of milling, addition in operating process such as adds
The peppermint oil and strawberry essence of recipe quantity, continue to mill 10~20 minutes, take out, and are placed in air dry oven, set dry
Dry temperature 45 C drying to moisture takes out less than 3%, is placed in Universalpulverizer, the levo-oxiracetam of addition recipe quantity,
Tartaric acid, Sucralose, co-grinding collect mixed-powder after crossing 100 mesh sieves, and mixed-powder is placed in into wet granulation
Adhesive is added in machine, starts granulator (installing 18 mesh nylon mesh), granulation obtains sour phase particle, standby；
2. sodium acid carbonate, the sodium chloride mixing of recipe quantity are taken, is placed in Universalpulverizer and is crushed, collected after crossing 100 mesh sieves
Mixed-powder, it is standby；The Macrogol 6000 of recipe quantity is heated into fusing, 42 DEG C of fusion temperature is set, poly- second two is treated
After alcohol 6000 melts, the mixed-powder of above-mentioned sodium acid carbonate and sodium chloride is added, be uniformly mixed, be placed in after cooling
In Universalpulverizer, crush, be placed in after 100 mesh sieves excessively and adhesive is added in wet granulator, start granulator and (install
18 mesh nylon mesh), granulation obtains alkali phase particle, standby；
3. in sour phase wet granular, alkali phase wet granular being put into air dry oven respectively, 40 DEG C~50 DEG C of design temperature, control
Relative humidity is less than 30%, starts drying；Particle situation is observed at any time, and drying time is 120~150 minutes, it is ensured that
Grain moisture≤2%；
4. whole grain, sub-sieve：Sour phase particle is mixed with alkali phase particle and is placed in crushing and pelletizing machine, with 20 mesh sieve whole grains,
Below 25 DEG C of environment temperature of control, relative humidity is below 30%；
5. compressing tablet：Tablet press machine pressure, adjustment sheet weight are set, compressing tablet is controlled below 25 DEG C of environment temperature, relative humidity
Less than 30%；
6. bag in：Packed with Aluminium-coating Packer with levo-oxiracetam effervescent tablet, set packing specification as 6 sheet panels, controlled
Below 25 DEG C of environment temperature, below 30%, packaging is obtained final product relative humidity.
The present invention has following beneficial effect：
A kind of levo-oxiracetam effervescent tablet tableting processes in good taste of the present invention will not sticking, finished product aerogenesis is fast, disintegration speed
Degree is fast, and disintegration time is no more than 30 seconds, and this product is in good taste, is easily received by most of patient, while shelf life
It is 24 months, preparation process is simple is feasible, is 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 or replacement made to the inventive method, step or condition belong to the scope of the present invention.
Embodiment 1
A kind of levo-oxiracetam effervescent tablet in good taste, is obtained according to the following steps：
Preparation process：
1. the dextrin for taking recipe quantity is placed in and mills, and the purified water of quality, mixing of milling, addition in operating process such as adds
The peppermint oil and strawberry essence of recipe quantity, continue to mill 10~20 minutes, take out, and are placed in air dry oven, set dry
Dry temperature 45 C drying to moisture takes out less than 3%, is placed in Universalpulverizer, the levo-oxiracetam of addition recipe quantity,
Tartaric acid, Sucralose, co-grinding collect mixed-powder after crossing 100 mesh sieves, and mixed-powder is placed in into wet granulation
Adhesive is added in machine, starts granulator (installing 18 mesh nylon mesh), granulation obtains sour phase particle, standby；
2. sodium acid carbonate, the sodium chloride mixing of recipe quantity are taken, is placed in Universalpulverizer and is crushed, collected after crossing 100 mesh sieves
Mixed-powder, it is standby；The Macrogol 6000 of recipe quantity is heated into fusing, 42 DEG C of fusion temperature is set, poly- second two is treated
After alcohol 6000 melts, the mixed-powder of above-mentioned sodium acid carbonate and sodium chloride is added, be uniformly mixed, be placed in after cooling
In Universalpulverizer, crush, be placed in after 100 mesh sieves excessively and adhesive is added in wet granulator, start granulator and (install
18 mesh nylon mesh), granulation obtains alkali phase particle, standby；
3. in sour phase wet granular, alkali phase wet granular being put into air dry oven respectively, 40 DEG C~50 DEG C of design temperature, control
Relative humidity is less than 30%, starts drying；Particle situation is observed at any time, and drying time is 120~150 minutes, it is ensured that
Grain moisture≤2%；
4. whole grain, sub-sieve：Sour phase particle is mixed with alkali phase particle and is placed in crushing and pelletizing machine, with 20 mesh sieve whole grains,
Below 25 DEG C of environment temperature of control, relative humidity is below 30%；
5. compressing tablet：Tablet press machine pressure, adjustment sheet weight are set, compressing tablet is controlled below 25 DEG C of environment temperature, relative humidity
Less than 30%；
6. bag in：Packed with Aluminium-coating Packer with levo-oxiracetam effervescent tablet, set packing specification as 6 sheet panels, controlled
Below 25 DEG C of environment temperature, below 30%, packaging is obtained final product relative humidity.
Experiment one：Disintegration time limited
1. test material：10, effervescent tablet sample obtained in Example 1, check disintegration time limited.
2. determination method：Test sample 10 is taken, is respectively placed in conical flask, add purified water 50ml, record effervescent tablet to collapse
Solution required time completely.
3. result of the test：Disintegration time limited inspection result see the table below：
| Sample number into spectrum | 1# | 2# | 3# | 4# | 5# |
| Disintegration time (s) | 19 | 21 | 20 | 23 | 26 |
| Sample number into spectrum | 6# | 7# | 8# | 9# | 10# |
| Disintegration time | 21 | 23 | 26 | 19 | 22 |
4. conclusion (of pressure testing)：From upper table result of the test, the levo-oxiracetam Effervescent tablet disintegration time is respectively less than 30s.
Experiment two：Stability experiment
Experiment material：
Levo-oxiracetam effervescent tablet：For embodiment 1 is obtained.
Acceleration study method：Levo-oxiracetam effervescent tablet obtained in embodiment 1 is packed by listing, Acceleration study case is put
In, certain hour sampling is tested to investigation project.
Acceleration study temperature：40±2℃
Acceleration study humidity：RH75% ± 5%
The investigation time：0th, 1,2,3, June
Inspection target：Proterties, tablet weight variation, disintegration time limited, relevant material, 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 keeps stabilization, and this product stability is preferable.
Long-term experiment method：Levo-oxiracetam effervescent tablet obtained in embodiment 1 is packed by listing, the long-term case that keeps sample is put
In, certain hour sampling is tested to investigation project.
Long-term experiment temperature：25±2℃
Long-term experiment humidity：RH60% ± 10%
The investigation time：0th, 3,6,9,12,18,24 months
Inspection target：Proterties, tablet weight variation, disintegration time limited, relevant material, content, microbial limit
Long term test stability is recorded：
Long term test shows：24 months proterties of this product long term test, tablet weight variation, disintegration time limited, relevant material, contain
Amount, microbial limit without significant changes, meet every relevant regulations of production quality standard draft.This product is long-term
24 months steady qualities of experiment, therefore minimum 24 months of this product term of validity, long term test is still during continuing to investigate.
Experiment three：Taste, mouthfeel market survey
A kind of levo-oxiracetam effervescent tablet in good taste of the present invention is by specific supplementary material compatibility, by multiple seasoning
It is made, with excellent taste, taste is fragrant and sweet, can be received by many patients.
Method：The people of crowd 1000 of random selection more than 10 years old, carries out taste trial test, will now taste result statistics as follows
Table：
Levo-oxiracetam effervescent tablet taste application form
| It is very good | Preferably | Typically | Difference |
| 621 | 173 | 128 | 78 |
It can be seen from taste tastes market survey, this product is easy to be received by many patients, according to incompletely statistics, feels taste
Road is extraordinary to account for the 62.1% of whole crowd, feel taste it is relatively good account for 17.3%, feel taste it is general account for 12.8%,
Think that distasteful accounts for 7.8%.Therefore this product have it is in good taste, easily the characteristics of received by many patients colony.
Embodiment 2
A kind of levo-oxiracetam effervescent tablet in good taste, is obtained according to the following steps：
Preparation process：Preparation technology according to embodiment 1 is obtained.By the test method of embodiment 1, when being disintegrated respectively
Limit is checked, stability test and mouthfeel are investigated, and disintegration time limited inspection result shows that this product disintegration rate is fast, disintegration time
Less than 30 seconds, stability test result showed to accelerate June sample quality stable, long-term 24 months steady qualities, therefore this
The product term of validity at least 24 months, the survey showed that this product is in good taste for mouthfeel, is easily received by many patients.
Embodiment 3
A kind of levo-oxiracetam effervescent tablet in good taste, is obtained according to the following steps：
Preparation process：Preparation technology according to embodiment 1 is obtained.By the test method of embodiment 1, when being disintegrated respectively
Limit is checked, stability test and mouthfeel are investigated, and disintegration time limited inspection result shows that this product disintegration rate is fast, disintegration time
Less than 30 seconds, stability test result showed to accelerate June sample quality stable, long-term 24 months steady qualities, therefore this
The product term of validity at least 24 months, the survey showed that this product is in good taste for mouthfeel, is easily received by many patients.
Embodiment 4-6：A kind of levo-oxiracetam effervescent tablet in good taste, is prepared by the supplementary material of following weight,
Preparation method is with embodiment 1：
Preparation process：Preparation technology according to embodiment 1 is obtained.By the test method of embodiment 1, embodiment 4,5,6
Prepared sample carries out the investigation of disintegration time limited inspection, stability test and mouthfeel, the disintegration time limited of embodiment 4,5,6 respectively
Inspection result shows that this product disintegration rate is fast, and disintegration time is less than 30 seconds, the stability test result of embodiment 4,5,6
Show to accelerate June sample quality stabilization, long-term 24 months steady qualities, therefore this product term of validity at least 24 months, implement
The survey showed that this product is in good taste for the mouthfeel of example 4,5,6, is easily received by many patients.
Claims (3)
1. a kind of levo-oxiracetam effervescent tablet in good taste, it is characterised in that it is obtained by the supplementary material of following weight proportion：1 part of levo-oxiracetam, 3 ~ 9 parts of tartaric acid, 3 ~ 9 parts of sodium acid carbonate, 0.2 ~ 0.8 part of sodium chloride, 0.3 ~ 1.2 part of Macrogol 6000,4 ~ 10 parts of dextrin, 0.6 ~ 1.5 part of Sucralose, 0.5 ~ 0.9 part of peppermint oil, 0.2 ~ 0.8 part of strawberry essence, volume fraction are 15 ~ 26 parts of 50% ~ 70% ethanol solution；The dextrin for taking recipe quantity is placed in and mills; the purified water of the quality such as addition; mill mixing; the peppermint oil and strawberry essence of recipe quantity are added in operating process; continue to mill 10 ~ 20 minutes; take out; it is placed in air dry oven; set 40 DEG C ~ 50 DEG C dryings of drying temperature to moisture to be taken out less than 3%, be placed in Universalpulverizer, add levo-oxiracetam, tartaric acid, the Sucralose of recipe quantity; co-grinding; mixed-powder is collected after crossing 100 mesh sieves, mixed-powder is placed in adhesive is added in wet granulator, start granulator（18 mesh nylon mesh are installed）, granulation obtains sour phase particle, standby；Sodium acid carbonate, the sodium chloride mixing of recipe quantity are taken, is placed in Universalpulverizer and is crushed, mixed-powder is collected after crossing 100 mesh sieves, it is standby；The Macrogol 6000 of recipe quantity is heated into fusing; 40 ~ 45 DEG C of fusion temperature of setting; after after Macrogol 6000 fusing; add the mixed-powder of above-mentioned sodium acid carbonate and sodium chloride; it is uniformly mixed, is placed in Universalpulverizer after cooling, crushes; cross after 100 mesh sieves to be placed in and adhesive is added in wet granulator, start granulator（18 mesh nylon mesh are installed）, granulation obtains alkali phase particle, standby.
2. levo-oxiracetam effervescent tablet as claimed in claim 1, it is characterised in that it is obtained by the supplementary material of following weight proportion：1 part of levo-oxiracetam, 4 ~ 7 parts of tartaric acid, 4 ~ 7 parts of sodium acid carbonate, 0.4 ~ 0.6 part of sodium chloride, 0.6 ~ 0.9 part of Macrogol 6000,（Sodium chloride：Macrogol 6000=2:3）, 6 ~ 9 parts of dextrin, 0.7 ~ 1.0 part of Sucralose, 0.6 ~ 0.8 part of peppermint oil, 0.3 ~ 0.6 part of strawberry essence, volume fraction be 18 ~ 23 parts of 50% ~ 70% ethanol solution；The dextrin for taking recipe quantity is placed in and mills; the purified water of the quality such as addition; mill mixing; the peppermint oil and strawberry essence of recipe quantity are added in operating process; continue to mill 10 ~ 20 minutes; take out; it is placed in air dry oven; set 45 DEG C of dryings of drying temperature to moisture to be taken out less than 3%, be placed in Universalpulverizer, add levo-oxiracetam, tartaric acid, the Sucralose of recipe quantity; co-grinding; mixed-powder is collected after crossing 100 mesh sieves, mixed-powder is placed in adhesive is added in wet granulator, start granulator（18 mesh nylon mesh are installed）, granulation obtains sour phase particle, standby；Sodium acid carbonate, the sodium chloride mixing of recipe quantity are taken, is placed in Universalpulverizer and is crushed, mixed-powder is collected after crossing 100 mesh sieves, it is standby；The Macrogol 6000 of recipe quantity is heated into fusing; 42 DEG C of fusion temperature of setting; after after Macrogol 6000 fusing; add the mixed-powder of above-mentioned sodium acid carbonate and sodium chloride; it is uniformly mixed, is placed in Universalpulverizer after cooling, crushes; cross after 100 mesh sieves to be placed in and adhesive is added in wet granulator, start granulator（18 mesh nylon mesh are installed）, granulation obtains alkali phase particle, standby.
3. the preparation method of levo-oxiracetam effervescent tablet as claimed in claim 1 or 2, it is characterised in that it is obtained as follows：
A. the dextrin for taking recipe quantity is placed in and mills; the purified water of the quality such as addition; mill mixing; the peppermint oil and strawberry essence of recipe quantity are added in operating process; continue to mill 10 ~ 20 minutes; take out; it is placed in air dry oven; set 45 DEG C of dryings of drying temperature to moisture to be taken out less than 3%, be placed in Universalpulverizer, add levo-oxiracetam, tartaric acid, the Sucralose of recipe quantity; co-grinding; mixed-powder is collected after crossing 100 mesh sieves, mixed-powder is placed in adhesive is added in wet granulator, start granulator（18 mesh nylon mesh are installed）, granulation obtains sour phase particle, standby；
B. sodium acid carbonate, the sodium chloride mixing of recipe quantity are taken, is placed in Universalpulverizer and is crushed, mixed-powder is collected after crossing 100 mesh sieves, it is standby；The Macrogol 6000 of recipe quantity is heated into fusing; 42 DEG C of fusion temperature of setting; after after Macrogol 6000 fusing; add the mixed-powder of above-mentioned sodium acid carbonate and sodium chloride; it is uniformly mixed, is placed in Universalpulverizer after cooling, crushes; cross after 100 mesh sieves to be placed in and adhesive is added in wet granulator, start granulator（18 mesh nylon mesh are installed）, granulation obtains alkali phase particle, standby；
C. in sour phase wet granular, alkali phase wet granular being put into air dry oven respectively, 40 DEG C ~ 50 DEG C of design temperature, control relative humidity is less than 30%, starts drying；Particle situation is observed at any time, and drying time is 120 ~ 150 minutes, it is ensured that pellet moisture≤2%；
D. whole grain, sub-sieve:Sour phase particle is mixed with alkali phase particle and is placed in crushing and pelletizing machine, with 20 mesh sieve whole grains, below 25 DEG C of environment temperature of control, relative humidity is below 30%；
E. compressing tablet：Tablet press machine pressure, adjustment sheet weight are set, compressing tablet is controlled below 25 DEG C of environment temperature, and relative humidity is below 30%；
F. interior bag：Packed with Aluminium-coating Packer with levo-oxiracetam effervescent tablet, set packing specification as 6 sheet panels, below 25 DEG C of environment temperature of control, below 30%, packaging is obtained final product relative humidity.
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2044216A5 (en) * | 1969-05-12 | 1971-02-19 | Ile De France | Effervescent tablets prepd by aqueous - granulation |
| CN101766596A (en) * | 2009-01-04 | 2010-07-07 | 北京润德康医药技术有限公司 | Solid preparation with dextro-oxiracetam as active component |
| CN101766595A (en) * | 2008-12-31 | 2010-07-07 | 北京利乐生制药科技有限公司 | Solid preparation with levo-oxiracetam as active component |
| 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 |
-
2015
- 2015-12-17 CN CN201510945507.9A patent/CN106890152A/en not_active Withdrawn
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2044216A5 (en) * | 1969-05-12 | 1971-02-19 | Ile De France | Effervescent tablets prepd by aqueous - granulation |
| CN101766595A (en) * | 2008-12-31 | 2010-07-07 | 北京利乐生制药科技有限公司 | Solid preparation with levo-oxiracetam as active component |
| CN101766596A (en) * | 2009-01-04 | 2010-07-07 | 北京润德康医药技术有限公司 | Solid preparation with dextro-oxiracetam as active component |
| 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 |
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