CN106955272A - A kind of levo-oxiracetam aseptic powdery of injection and preparation method thereof - Google Patents
A kind of levo-oxiracetam aseptic powdery of injection and preparation method thereof Download PDFInfo
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- CN106955272A CN106955272A CN201610195054.7A CN201610195054A CN106955272A CN 106955272 A CN106955272 A CN 106955272A CN 201610195054 A CN201610195054 A CN 201610195054A CN 106955272 A CN106955272 A CN 106955272A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/4015—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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Abstract
A kind of levo-oxiracetam aseptic powdery of injection, it is made by the supplementary material of following weight percents：Levo-oxiracetam 56% ~ 63%, L serines 18% ~ 23%, mannitol 12% ~ 18%, polyethylene glycol 2000 3% ~ 7%, methionine 3% ~ 8%;It is smaller according to impurity level increase in injection levo-oxiracetam aseptic powdery produced by the present invention its preparation process, whole preparation process impurity only increases phenomenon of the 0.02%, product without drying shrinkage and bubbling, finished product has solid shape, good stability, impurity is less than 0.25% in shelf life, and shelf life is up to 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 injection and its preparation
Method.
Background technology
It is a kind of promotion study that cereboactive drug, which is also known as cereboactive drug, strengthens the new medicine for central nervous system of memory.Cereboactive drug
Thing requires selection index system in cerebral cortex, with selection activation, protection and the feature for promoting damaged nerve cell functional rehabilitation.With
Other neurologic agents it is different be a little their above-mentioned effect not by network or olfactory bulb, but directly act on cortex.
Behavior is neither influenceed, also without calm excitation, therefore such medicine has caused the extensive concern and interest of people, to such medicine
The demand of thing is also growing day by day.
Oxiracetam (oxiracetam, CAS No.：62613-82-5) chemical entitled Esomeprazole,
The anti anoxia class cereboactive drug (compound is disclosed in US4118396) synthesized first in 1974 for Italian ISFS.P.A companies,
It is ring GABOB derivatives, Phosphorylcholine and phosphatidyl ethanolamine can be promoted to synthesize, promotes brain metabolism, it is right through blood-brain barrier
Specific nervous centralis road has stimulation, can improve intelligence and memory, to cerebrovascular disease, brain trauma, brain tumor, encephalic
Infection, brain degenerative disease etc. also have preferable curative effect, and the drug toxicity is extremely low, no mutagenesis and carcinogenesis and reproduction
Toxicity.Giorgio et al. discloses the chemical constitution and preparation method of Oxiracetam, Chiodini et al. in US4118396
Disclosed in WO9306826A, it is (right that clinical effectiveness proves that the drug effect of the Oxiracetam of S configurations (left-handed) is better than R configurations
Rotation), Oxiracetam and levo-oxiracetam structure are as follows.
Existing injection levo-oxiracetam aseptic powdery its be primarily present the increase of preparation process impurity substantially, be difficult to be formed skeleton,
Easily there is drying shrinkage and bubbling phenomenon, finished product is without solid shape, and product stability is poor, the problems such as shelf life is short.
The content of the invention
It is an object of the invention to provide it is a kind of with solid form, good stability, shelf life length injection levo-oxiracetam
Aseptic powdery.
Another object of the present invention is to provide the preparation method of above-mentioned injection levo-oxiracetam aseptic powdery.
The purpose of the present invention is realized by following technical measures：
The levo-oxiracetam aseptic powdery of a kind of injection, it is characterised in that it is by the supplementary material system of following weight percents
：Levo-oxiracetam 55%~65%, additives 30%~45%, wherein the additives be sucrose, trehalose, mannitol,
Lactose, glucose, maltose, glucan, albumin, polyethylene glycol, glycerine, Serine, vitamin C, thio sulphur
One in sour sodium, methionine, sodium glutamate, alanine, glycine, methyl amimoacetic acid, phosphate, acetate, citrate
Plant or a variety of.
Inventor has found in research process, selects specific additives species, coordinates specific supplementary material consumption proportion relation,
It may be such that above-mentioned injection levo-oxiracetam aseptic powdery is smaller in preparation process impurity level increase, be less prone to drying shrinkage and bubbling
Phenomenon, finished product has solid shape, easily forms skeleton, and shelf life can extend, above-mentioned injection levo-oxiracetam
Aseptic powdery, it is characterised in that it is made by the supplementary material of following weight percents：Levo-oxiracetam 56%~63%, L-
Serine 18%~23%, mannitol 12%~18%, polyethylene glycol 2000 3%~7%, methionine 3%~8%.
Most preferably, above-mentioned injection levo-oxiracetam aseptic powdery, it is characterised in that it is by following weight percents
Supplementary material is made：Levo-oxiracetam 58%~61%, Serine 19%~22%, mannitol 13%~16%, polyethylene glycol 2000
4%~6%, methionine 3%~6%.
Supplementary material needed for above-mentioned, is well known to those skilled in the art, in the market is commercially available.
The preparation method of the levo-oxiracetam aseptic powdery of a kind of injection, it is characterised in that it is obtained as follows：
1. concentrated compounding：The levo-oxiracetam of recipe quantity, additives are placed in container, 10 times of parts by weight of levo-oxiracetam are added
Sterilized water for injection stirring, after dissolving, add mass fraction 0.1% needle-use activated carbon, stir 30min,
Then filtered with 0.45 micrometer Millipore filter membrane, collect filtrate, it is standby；
2. dilute match somebody with somebody：Sterilized water for injection is added into filtrate to 1000 times of filtrate volume, pH is adjusted with hydrochloric acid or NaOH
To 7.0, 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 it is sterile
It is standby in vial；
3. freeze-drying：The above-mentioned decoction being sub-packed in sterile glass vials is put in freeze drier, rapidly temperature is refrigerated to
- 40 DEG C, whole process is kept for 180 minutes, then vacuumizes drying, -10 DEG C are warming up to 15 DEG C/h,
- 10 DEG C of constant temperature are kept for 120 minutes；0 DEG C is warming up to 5 DEG C/h, 0 DEG C of constant temperature 320 minutes；With 5 DEG C/
Hour is warming up to 10 DEG C, 10 DEG C of constant temperature 240 minutes, and 30 DEG C, 30 DEG C of constant temperature are warming up to 10 DEG C/h
60 minutes, while preceding case vacuum drop reaches 10Pa/10 timesharing, freeze and terminate；
4. roll lid：Aluminium-plastic combined cover needs once purged sterilizing, drying, then carries out rolling lid, produces.
The present invention has following beneficial effect：
Impurity level increase is smaller in injection levo-oxiracetam aseptic powdery preparation process of the present invention, and whole preparation process impurity is only
There is increase by 0.02%, phenomenon of the product without drying shrinkage and bubbling, finished product impurity in solid shape, good stability, shelf life to be less than
0.25%, shelf life is up to 24 months.
Embodiment
The present invention is specifically described below by embodiment, it is necessary to it is pointed out here that be following examples be served only for this
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 and essence
In the case of, 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 injection levo-oxiracetam aseptic powdery, is made according to the following steps：
Preparation process：
1. concentrated compounding：The levo-oxiracetam of recipe quantity, additives are placed in container, 10 times of parts by weight of levo-oxiracetam are added
Sterilized water for injection stirring, after dissolving, add mass fraction 0.1% needle-use activated carbon, stir 30min,
Then filtered with 0.45 micrometer Millipore filter membrane, collect filtrate, it is standby；
2. dilute match somebody with somebody：Sterilized water for injection is added into filtrate to 1000 times of filtrate volume, pH is adjusted with hydrochloric acid or NaOH
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
It is standby in sterile glass vials；
3. freeze-drying：The above-mentioned decoction being sub-packed in sterile glass vials is put in freeze drier, rapidly by temperature
Degree is refrigerated to -40 DEG C, and whole process is kept for 180 minutes, then vacuumizes drying, with
15 DEG C/h are warming up to -10 DEG C, and -10 DEG C of constant temperature are kept for 120 minutes；With 5 DEG C/h
It is warming up to 0 DEG C, 0 DEG C of constant temperature 320 minutes；10 DEG C, 10 DEG C are warming up to 5 DEG C/h
Constant temperature 240 minutes, 30 DEG C are warming up to 10 DEG C/h, 30 DEG C of constant temperature 60 minutes,
Case vacuum drop reaches 10Pa/10 timesharing before simultaneously, freezes and terminates；
4. roll lid：Aluminium-plastic combined cover needs once purged sterilizing, drying, then carries out rolling lid, produces.
In order to be better understood from the present invention, the beneficial effect of invention medicine is expanded on further below by way of stability test of the present invention,
Rather than limitation of the present invention.
Experiment one：A kind of levo-oxiracetam aseptic powdery stability experiment of injection of the present invention
Experiment material：
The Oxiracetam aseptic powdery sample of injection：It is made for embodiment 1
Acceleration study method：The Oxiracetam aseptic powdery of injection made from embodiment 1 is packed by listing, Acceleration study is put
In case, certain time 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, visible foreign matters, pH, relevant material, content, sterility test
Accelerated test stability is recorded：
Acceleration study result shows：Acceleration sample in June is suitable with the every Testing index quality of 0 month sample, shows that this product accelerates real
Test June, quality keeps stable, and this product stability is preferable.
Long-term experiment method：Injection Oxiracetam aseptic powdery made from embodiment 1 is packed by listing, the long-term case that keeps sample is put
In, certain time 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：Character, visible foreign matters, pH, relevant material, content, sterility test
Long term test stability is recorded：
Long term test shows：This product long term test 24 months characters, visible foreign matters, pH value, relevant material, content and nothings
Bacterium checks that indices, without significant changes, meet every relevant regulations of production quality standard draft.This product long term test
24 months steady qualities, 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 preparation process of injection of the present invention is on the increased influence of impurity
1. experiment material：
The levo-oxiracetam aseptic powdery sample of injection：Prepared by embodiment 1.
The levo-oxiracetam aseptic powdery control sample of injection：To lack the sample of methionine, its preparation technology is with implementation
Example 1.
2. experimental method：In the preparation process of embodiment 1, sampled respectively before and after preparing, detect that it, about material, is investigated and prepared
Process is to the influence about material.Meanwhile, the prescription for lacking methionine is taken as control prescription, by the preparation side of embodiment 1
Prepared by method, sampling detects it about material equally before and after preparing, and investigates preparation process to the influence about material.
3. experimental result see the table below：
4. experiment conclusion：The prescription of embodiment 1, the relevant material increase of preparation process is only 0.02%, hence it is evident that better than control sample.
Embodiment 2
A kind of injection levo-oxiracetam aseptic powdery, is made according to the following steps：
Preparation process：Preparation technology according to embodiment 1 is made.
By the test method of embodiment 1, stability test investigation, preparation process influence experiment increased on impurity are carried out respectively,
The sample stability result of the test of embodiment 2 shows to accelerate sample quality stabilization in June, long-term 24 months steady qualities, therefore this product has
Minimum 24 months of effect phase.The influence increased on impurity of the preparation process of embodiment 2 is test result indicate that this product product in preparation process
Impurity incrementss are smaller, meet product requirement.
Embodiment 3
A kind of injection levo-oxiracetam aseptic powdery, is made according to the following steps：
Preparation process：Preparation technology according to embodiment 1 is made.
By the test method of embodiment 1, stability test investigation, preparation process influence experiment increased on impurity are carried out respectively,
The sample stability result of the test of embodiment 3 shows to accelerate sample quality stabilization in June, long-term 24 months steady qualities, therefore this product has
Minimum 24 months of effect phase.The influence increased on impurity of the preparation process of embodiment 3 is test result indicate that this product product in preparation process
Impurity incrementss are smaller, meet product requirement.
Embodiment 4-6：A kind of injection levo-oxiracetam aseptic powdery, is prepared, preparation side by the supplementary material of following weight
Method be the same as Example 1：
Preparation process：Preparation technology according to embodiment 1 is made.
By the test method of embodiment 1, the sample obtained by embodiment 4,5,6 carries out stability test investigation, preparation respectively
Process influence experiment increased on impurity, the sample stability result of the test of embodiment 4,5,6 shows that acceleration sample quality in June is steady
It is fixed, long-term 24 months steady qualities, therefore minimum 24 months of this product term of validity.The preparation process of embodiment 4,5,6 increases to impurity
Plus influence test result indicate that this product product impurity incrementss in preparation process are smaller, meet product requirement.
Claims (3)
1. the levo-oxiracetam aseptic powdery of a kind of injection, it is characterised in that it is made by the supplementary material of following weight percents：Levo-oxiracetam about 56% ~ 63%, Serine about 18% ~ 23%, mannitol about 12% ~ 18%, polyethylene glycol 2000 about 3% ~ 7%, methionine about 3% ~ 8%.
2. the levo-oxiracetam aseptic powdery of a kind of injection as claimed in claim 1, it is characterised in that it is made by the supplementary material of following weight percents：Levo-oxiracetam 58% ~ 61%, Serine 19% ~ 22%, mannitol 13% ~ 16%, polyethylene glycol 2000 4% ~ 6%, methionine 3% ~ 6%.
3. a kind of 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, additives are placed in container, the sterilized water for injection stirring of 10 times of parts by weight of levo-oxiracetam are added, 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, filtrate is collected, it is standby；
B. it is dilute to match somebody with somebody：Sterilized water for injection is added into filtrate to 1000 times of filtrate volume, 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. it is freeze-dried：The above-mentioned decoction being sub-packed in sterile glass vials is put in freeze drier, temperature -40 DEG C are refrigerated to rapidly, whole process is kept for 180 minutes, then vacuumizes drying, -10 DEG C are warming up to 15 DEG C/h, -10 DEG C of constant temperature are kept for 120 minutes；0 DEG C is warming up to 5 DEG C/h, 0 DEG C of constant temperature 320 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, produces.
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| US20040067986A1 (en) * | 2002-10-04 | 2004-04-08 | Nathan Sassover | Neuro-degenerative inhibitor, neuro-endocrine modulator, and neuro-cerebral metabolism enhancer |
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