CN106692072A - L-oxiracetam sterile powder with good stability and preparation method thereof - Google Patents
L-oxiracetam sterile powder with good stability and preparation method thereof Download PDFInfo
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- CN106692072A CN106692072A CN201510456710.XA CN201510456710A CN106692072A CN 106692072 A CN106692072 A CN 106692072A CN 201510456710 A CN201510456710 A CN 201510456710A CN 106692072 A CN106692072 A CN 106692072A
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- oxiracetam
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Abstract
An L-oxiracetam sterile powder with good stability is characterized by being prepared from raw materials and auxiliary materials including L-oxiracetam, L-serine, mannitol, polyethylene glycol and phenol through steps of concentration, dilution, freeze-drying and capping. By the preparation method, the prepared L-oxiracetam sterile powder for injection and with good stability has a fixed shape, has no dry shrinkage or bubbling phenomenon during the freeze-drying preparation process, has good product homogeneity with consistent characteristics of the upper and lower layers, meets the requirements of sterility test, and has less impurity with total impurity of lower than 0.21%. The preparation method is beneficial to raise drug use safety and reduce adverse drug reaction. By the preparation method, product stability is good and shelf life reaches a length of 24 months.
Description
Technical field
The invention mainly relates to pharmaceutical technology field, and in particular to a kind of levo-oxiracetam aseptic powdery of good stability and
Its preparation method.
Background technology
Oxiracetam (S-oxiracetam) is a kind of 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 nerve cell
Recover, improve the mnemonic learning function of disturbance of intelligence patient, and medicine in itself without direct vasoactive, also without in
Pivot excitation, the influence to ability of learning and memory is a kind of lasting facilitation.
Oxiracetam (oxiracetam, CAS No.：62613-82-5) chemical entitled 4- hydroxyls -2- OXo-1-pyrrolidine second
Acid amides, is that (compound is disclosed in the anti anoxia class cereboactive drug that synthesized first in 1974 of Italian ISFS.P.A companies
US4118396), it is ring GABOB derivatives, Phosphorylcholine and phosphatidyl ethanolamine can be promoted to synthesize, promotes brain metabolism,
Through blood-brain barrier, have stimulation to specific nervous centralis road, intelligence and memory can be improved, to cerebrovascular disease,
Brain trauma, brain tumor, intracranial infection, brain degenerative disease etc. also have preferable curative effect, and the drug toxicity is extremely low, nothing
Mutagenesis and carcinogenesis and genotoxicity.Giorgio et al. discloses the chemistry knot of Oxiracetam in US4118396
Structure and preparation method, Chiodini et al. are disclosed in WO9306826A, and clinical effectiveness proves S's configurations (left-handed)
The drug effect of Oxiracetam is better than R configurations (dextrorotation), and Oxiracetam and levo-oxiracetam structure are as follows.
Existing levo-oxiracetam aseptic powdery its be primarily present without solid shape, be difficult to be formed skeleton, easily there is drying shrinkage and
Bubbling phenomenon, product homogeneity is bad, and levels proterties is inconsistent, and stability is poor, and shelf life is short, and steriling test does not conform to
The problems such as lattice.
The content of the invention
It is an object of the invention to provide a kind of levo-oxiracetam long with solid form, good stability, shelf life without
Bacterium powder end.
Preparation method another object of the present invention is to provide the good levo-oxiracetam aseptic powdery of aforementioned stable.
The purpose of the present invention is realized by following technical measures：
A kind of levo-oxiracetam aseptic powdery of good stability, it is characterised in that it be with levo-oxiracetam as raw material,
A certain amount of excipient is added to be obtained；Wherein described excipient be sucrose, trehalose, mannitol, lactose, glucose,
Maltose, glucan, albumin, polyethylene glycol, glycerine, Serine, sodium glutamate, alanine, glycine,
One or more in methyl amimoacetic acid, phosphate, acetate, citrate.
Inventor has found to select Serine, mannitol, poly- second in composition described above in research process by many experiments
Glycol 2000 constitutes Composite excipient, adds a certain amount of phenol, coordinates specific preparation method, can make an above-mentioned left side
Rotation Oxiracetam aseptic powdery has solid shape, easily forms skeleton, is less prone to drying shrinkage and bubbling phenomenon, and homogeneity is good,
Product levels proterties is consistent, aseptic to meet the requirements, and can make shelf life extension；The good left-handed Aura of aforementioned stable
Western smooth aseptic powdery, it is characterised in that it is by levo-oxiracetam, Serine, mannitol, polyethylene glycol, benzene
Phenol is supplementary material, with concentrated compounding, dilute match somebody with somebody, freeze-drying, rolls lid step and be prepared；Wherein described concentrated compounding step is to locate
The supplementary material of side's amount is placed in container, adds the sterilized water for injection stirring of 5 times of weight portions of levo-oxiracetam, after dissolving,
The needle-use activated carbon of mass fraction 0.1% is added, 30min is stirred, is then filtered with 0.45 micrometer Millipore filter membrane, collected
Filtrate；It is dilute with step be to adding sterilized water for injection in filtrate to recipe quantity, with hydrochloric acid or NaOH adjust pH to
7.0, then with 0.22 micron of miillpore filter aseptic filtration, take that filtrate is filling after the assay was approved to be sub-packed in sterile glass vials
In；Heat conduction oil temperature is refrigerated to -40 DEG C by freeze-drying step for quick, keeps constant temperature 60 minutes, is risen with 5 DEG C/h
Temperature keeps constant temperature 80 minutes to -10 DEG C, is being quickly cooled to -40 DEG C, cryostat 120 minutes；Then vacuumize dry
It is dry, it is warming up to 10 DEG C/h, -10 DEG C of constant temperature 150 minutes；0 DEG C, 0 DEG C of 300 points of constant temperature are warming up to 4 DEG C/h
Clock；10 DEG C are warming up to 5 DEG C/h, 10 DEG C of constant temperature 240 minutes is warming up to 30 DEG C, 30 DEG C of constant temperature with 10 DEG C/h
60 minutes, while preceding case vacuum drop reaches 10Pa/10 timesharing, freeze and terminate.
The good levo-oxiracetam aseptic powdery of most preferred aforementioned stable, it is characterised in that it is by following weight hundred
The supplementary material of ratio is divided to be obtained：Levo-oxiracetam 54%~57%, Serine 17%~21%, mannitol 22%~25%,
Polyethylene glycol 2000 2%~4%, phenol 0.1%~0.5%；The supplementary material of recipe quantity is placed in container, left-handed Austria is added
The sterilized water for injection stirring of 5 times of weight portions of La Xitan, after dissolving, adds the needle-use activated carbon of mass fraction 0.1%,
Stirring 30min, is then filtered with 0.45 micrometer Millipore filter membrane, collects filtrate, and sterilized water for injection is added extremely in filtrate
Recipe quantity, pH to 7.0 is adjusted with hydrochloric acid or NaOH, then with 0.22 micron of miillpore filter aseptic filtration, is taken
Filtrate is filling after the assay was approved to be sub-packed in sterile glass vials.
A kind of preparation method of the levo-oxiracetam aseptic powdery of good stability is worthy of careful study, it is characterised in that it is by such as
Obtained in lower step：
1. concentrated compounding：The levo-oxiracetam of recipe quantity, excipient are placed in container, 5 times of weights of levo-oxiracetam are added
The sterilized water for injection stirring of part is measured, after dissolving, the needle-use activated carbon of mass fraction 0.5% is added, stirred
30min is mixed, is then filtered with 0.45 micrometer Millipore filter membrane, collect filtrate, it is standby；
2. it is dilute to match somebody with somebody：To sterilized water for injection to recipe quantity is added in filtrate, pH is adjusted to 7.0 with hydrochloric acid or NaOH,
Then with 0.22 micron of miillpore filter aseptic filtration, take that filtrate is qualified rear filling to be sub-packed in sterile glass
It is standby in bottle；
3. freeze-drying：It is quick that heat conduction oil temperature is refrigerated to -40 DEG C, constant temperature is kept 60 minutes, with 5 DEG C/h of intensifications
To -10 DEG C, constant temperature is kept 80 minutes, be quickly cooled to -40 DEG C, cryostat 120 minutes.
Then drying is vacuumized, is warming up to 10 DEG C/h, -10 DEG C of constant temperature 150 minutes；With 4 DEG C/
Hour is warming up to 0 DEG C, 0 DEG C of constant temperature 300 minutes；10 DEG C, 10 DEG C of perseverances are warming up to 5 DEG C/h
Temperature 240 minutes, 30 DEG C are warming up to 10 DEG C/h, 30 DEG C of constant temperature 60 minutes, while preceding case
Vacuum drop reaches 10Pa/10 timesharing, freezes and terminates.
4. lid is rolled：Aluminium-plastic combined cover needs once purged sterilizing, drying, then carries out rolling lid, obtains final product.
The present invention has following beneficial effect：
The levo-oxiracetam aseptic powdery of good stability of the present invention has solid shape, in lyophilized preparation process without drying shrinkage
With the phenomenon of bubbling, product homogeneity is good, and levels proterties is consistent, and steriling test meets the requirements, and this product impurity is few,
Its total impurities is less than 0.21%, is conducive to improving the security that medicine is used, and reduces adverse drug reaction, product stability
Good, shelf life is up to 24 months.
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 aseptic powdery of good stability, is obtained according to the following steps：
| Composition | Consumption |
| Levo-oxiracetam | 100g |
| Serine | 38g |
| Mannitol | 41g |
| Polyethylene glycol 2000 | 5g |
| Phenol | 0.5g |
It is made 1000 bottles
Preparation process：
1. concentrated compounding：The levo-oxiracetam of recipe quantity, excipient are placed in container, 5 times of weights of levo-oxiracetam are added
The sterilized water for injection stirring of part is measured, after dissolving, the needle-use activated carbon of mass fraction 0.5% is added, stirred
30min is mixed, is then filtered with 0.45 micrometer Millipore filter membrane, collect filtrate, it is standby；
2. it is dilute to match somebody with somebody：To sterilized water for injection to recipe quantity is added in filtrate, pH is adjusted to 7.0 with hydrochloric acid or NaOH,
Then with 0.22 micron of miillpore filter aseptic filtration, take that filtrate is qualified rear filling to be sub-packed in sterile glass
It is standby in bottle；
3. freeze-drying：It is quick that heat conduction oil temperature is refrigerated to -40 DEG C, constant temperature is kept 60 minutes, with 5 DEG C/h of intensifications
To -10 DEG C, constant temperature is kept 80 minutes, be quickly cooled to -40 DEG C, cryostat 120 minutes.
Then drying is vacuumized, is warming up to 10 DEG C/h, -10 DEG C of constant temperature 150 minutes；With 4 DEG C/
Hour is warming up to 0 DEG C, 0 DEG C of constant temperature 300 minutes；10 DEG C, 10 DEG C of perseverances are warming up to 5 DEG C/h
Temperature 240 minutes, 30 DEG C are warming up to 10 DEG C/h, 30 DEG C of constant temperature 60 minutes, while preceding case
Vacuum drop reaches 10Pa/10 timesharing, freezes and terminates.
4. lid is rolled：Aluminium-plastic combined cover needs once purged sterilizing, drying, then carries out rolling lid, obtains final product.
Embodiment 2
A kind of levo-oxiracetam aseptic powdery of good stability, is obtained according to the following steps：
| Composition | Consumption |
| Levo-oxiracetam | 100g |
| Serine | 31g |
| Mannitol | 39g |
| Polyethylene glycol 2000 | 5g |
| Phenol | 0.5 |
It is made 1000 bottles
Preparation process：Preparation technology according to embodiment 1 is obtained.
Embodiment 3
A kind of levo-oxiracetam aseptic powdery of good stability, is obtained according to the following steps：
| Composition | Consumption |
| Levo-oxiracetam | 100g |
| Serine | 35g |
| Mannitol | 42g |
| Polyethylene glycol 2000 | 4g |
| Phenol | 0.6g |
It is made 1000 bottles
Preparation process：Preparation technology according to embodiment 1 is obtained.
Embodiment 4-6：The levo-oxiracetam aseptic powdery of a kind of good stability, by the supplementary material preparation of following weight
, preparation method is with embodiment 1：
| Embodiment | Levo-oxiracetam | Serine | Mannitol | Polyethylene glycol 2000 | Phenol |
| 4 | 100g | 36g | 43g | 4g | 0.7g |
| 5 | 100g | 35g | 41g | 5g | 0.5g |
| 6 | 100g | 33g | 43g | 4g | 0.6g |
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.
Experiment one：A kind of levo-oxiracetam aseptic powdery stability experiment of good stability of the present invention
Experiment material：
The Oxiracetam aseptic powdery sample of injection：For embodiment 1 is obtained
Acceleration study method：The Oxiracetam aseptic powdery of injection obtained in embodiment 1 is packed by listing, acceleration is put
In experimental box, 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：Proterties, visible foreign matters, pH, relevant material, content, sterility test
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：Injection Oxiracetam aseptic powdery obtained in embodiment 1 is packed by listing, is put and is stayed for a long time
In sample 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
Inspection target：Proterties, visible foreign matters, pH, relevant material, content, sterility test
Long term test stability is recorded：
Long term test shows：24 months proterties of this product long term test, visible foreign matters, pH value, relevant material, content with
And sterility test indices meet every relevant regulations of production quality standard draft without significant changes.This product
24 months steady qualities of long term test, therefore minimum 24 months of this product shelf life, long term test is still during continuing to investigate.
Experiment two：A kind of levo-oxiracetam aseptic powdery antibacterial ability experiment of good stability of the present invention
1. test objective：Investigate the antibacterial ability of levo-oxiracetam aseptic powdery.
2. test method：Sample and control sample (being obtained by the preparation method of embodiment 1) each 20 obtained by Example 1
Bottle, be placed under natural conditions after open bottle cover (25 DEG C ± 5 DEG C of temperature, relative humidity 70% ± 10%) place 15 days,
Sampled respectively at 0 day, 5 days, 10 days, 15 days, each time point takes 5 bottles, enters according to version Chinese Pharmacopoeia in 2010
Row Sterility testing, sample preparation prescription see the table below：
| Prescription title | Levo-oxiracetam | Serine | Mannitol | Polyethylene glycol 2000 | Phenol |
| Control sample | 100g | 37g | 40g | 5g | - |
3. result of the test：
4. conclusion：The antibacterial ability of the sample of embodiment 1 is better than control sample.
Claims (3)
1. the levo-oxiracetam aseptic powdery of a kind of good stability, it is characterised in that it is the Serine by levo-oxiracetam, mannitol, and polyethylene glycol, phenol is supplementary material, with concentrated compounding, dilute match somebody with somebody, freeze-drying, rolls lid step and be prepared；Wherein described concentrated compounding step is that the supplementary material of recipe quantity is placed in container, the sterilized water for injection stirring of 5 times of weight portions of levo-oxiracetam is added, after dissolving, add the needle-use activated carbon of mass fraction 0.1%, stirring 30min, is then filtered with 0.45 micrometer Millipore filter membrane, collects filtrate；Dilute is, to adding sterilized water for injection to recipe quantity in filtrate, pH to 7.0 being adjusted with hydrochloric acid or NaOH, then with 0.22 micron of miillpore filter aseptic filtration, to take that filtrate is filling after the assay was approved to be sub-packed in sterile glass vials with step；Heat conduction oil temperature is refrigerated to -40 DEG C by freeze-drying step for quick, keeps constant temperature 60 minutes, and -10 DEG C are warming up to 5 DEG C/h, keeps constant temperature 80 minutes, is being quickly cooled to -40 DEG C, cryostat 120 minutes；Then drying is vacuumized, is warming up to 10 DEG C/h, -10 DEG C of constant temperature 150 minutes；0 DEG C is warming up to 4 DEG C/h, 0 DEG C of constant temperature 300 minutes；10 DEG C are warming up to 5 DEG C/h, 10 DEG C of constant temperature 240 minutes is warming up to 30 DEG C with 10 DEG C/h, 30 DEG C of constant temperature 60 minutes, while preceding case vacuum drop reaches 10Pa/10 timesharing, is freezed and terminated.
2. levo-oxiracetam aseptic powdery as claimed in claim 1, it is characterised in that it is obtained by the supplementary material of following weight percents：Levo-oxiracetam 54% ~ 57%, Serine 17% ~ 21%, mannitol 22% ~ 25%, polyethylene glycol 2000 2% ~ 4%, phenol 0.1% ~ 0.5%；The supplementary material of recipe quantity is placed in container, add the sterilized water for injection stirring of 5 times of weight portions of levo-oxiracetam, after dissolving, the needle-use activated carbon of mass fraction 0.1% is added, stir 30min, then filtered with 0.45 micrometer Millipore filter membrane, filtrate is collected, to sterilized water for injection to recipe quantity is added in filtrate, pH to 7.0 is adjusted with hydrochloric acid or NaOH, then with 0.22 micron of miillpore filter aseptic filtration, take that filtrate is filling after the assay was approved to be sub-packed in sterile glass vials.
3. the preparation method of injection levo-oxiracetam aseptic powdery as claimed in claim 1 or 2, it is characterised in that it is obtained as follows：
A. concentrated compounding：The levo-oxiracetam of recipe quantity, excipient are placed in container, the sterilized water for injection stirring of 5 times of weight portions of levo-oxiracetam are added, after dissolving, the needle-use activated carbon of mass fraction 0.5% is added, 30min is stirred, is then filtered with 0.45 micrometer Millipore filter membrane, filtrate is collected, it is standby；
B. it is dilute to match somebody with somebody：To adding sterilized water for injection to recipe quantity in filtrate, pH to 7.0 is adjusted with hydrochloric acid or NaOH, then with 0.22 micron of miillpore filter aseptic filtration, take filtrate it is qualified it is rear it is filling be sub-packed in sterile glass vials, it is standby；
C. freeze-drying：It is quick that heat conduction oil temperature is refrigerated to -40 DEG C, keep constant temperature 60 minutes, -10 DEG C are warming up to 5 DEG C/h, keep constant temperature 80 minutes, it is being quickly cooled to -40 DEG C, cryostat 120 minutes；Then drying is vacuumized, is warming up to 10 DEG C/h, -10 DEG C of constant temperature 150 minutes；0 DEG C is warming up to 4 DEG C/h, 0 DEG C of constant temperature 300 minutes；10 DEG C are warming up to 5 DEG C/h, 10 DEG C of constant temperature 240 minutes is warming up to 30 DEG C with 10 DEG C/h, 30 DEG C of constant temperature 60 minutes, while preceding case vacuum drop reaches 10Pa/10 timesharing, is freezed and terminated；
D. lid is rolled：Aluminium-plastic combined cover needs once purged sterilizing, drying, then carries out rolling lid, obtains final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510456710.XA CN106692072A (en) | 2015-07-30 | 2015-07-30 | L-oxiracetam sterile powder with good stability and preparation method thereof |
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| CN201510456710.XA CN106692072A (en) | 2015-07-30 | 2015-07-30 | L-oxiracetam sterile powder with good stability and preparation method thereof |
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| CN106692072A true CN106692072A (en) | 2017-05-24 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201510456710.XA Pending CN106692072A (en) | 2015-07-30 | 2015-07-30 | L-oxiracetam sterile powder with good stability and preparation method thereof |
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| Country | Link |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101766597A (en) * | 2008-12-31 | 2010-07-07 | 北京利乐生制药科技有限公司 | Injection preparation with levo-oxiracetam as active component |
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- 2015-07-30 CN CN201510456710.XA patent/CN106692072A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101766597A (en) * | 2008-12-31 | 2010-07-07 | 北京利乐生制药科技有限公司 | Injection preparation with levo-oxiracetam as active component |
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Effective date of registration: 20170824 Address after: 400042 Chongqing city Yubei District Qinye Road No. 9 Applicant after: Chongqing Runze Pharmaceutical Co., Ltd. Address before: 400030 Chongqing city Shapingba District Yubei Road No. 50 of No. 13-15-6A Applicant before: DONGZE PHARMACEUTICAL SCIENCE AND TECHNOLOGY CO., LTD. |
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