CN110384664A - Dextrorotation oxiracetam enteric coated particles and preparation method thereof - Google Patents
Dextrorotation oxiracetam enteric coated particles and preparation method thereof Download PDFInfo
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- CN110384664A CN110384664A CN201811072545.8A CN201811072545A CN110384664A CN 110384664 A CN110384664 A CN 110384664A CN 201811072545 A CN201811072545 A CN 201811072545A CN 110384664 A CN110384664 A CN 110384664A
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- fluidized bed
- dextrorotation oxiracetam
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- dextrorotation
- bed granulation
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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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- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/08—Antiepileptics; Anticonvulsants
Abstract
The present invention provides a kind of dextrorotation oxiracetam enteric coated particles, using particular crystalline form dextrorotation oxiracetam as active constituent, it is aided with the auxiliary materials fluidized bed granulation methods such as the pregelatinized starch, sodium alginate, cellulose acetate-phthalate of special ratios, obtained dextrorotation oxiracetam particle dissolves out less under one's belt, mainly in intestinal juice be disintegrated release, reduce dextrorotation oxiracetam dissolve out under one's belt brought by drug by gastric acid decomposition and caused by side effect.Preparation method of the present invention is simple, is suitble to industrialized production.
Description
Technical field
The present invention relates to dextrorotation oxiracetam preparations, and in particular to a kind of dextrorotation oxiracetam particle and its preparation side
Method.
Background technique
Oxiracetam is the novel medicine for central nervous system of listing in 1987, can promote study, enhances memory,
Protect damaged nerve cell.It is exactly to improve a variety of cognition dysfunctions, such as gerontal patient that clinically oxiracetam is most common
Cognition dysfunction (POCD), the cerebral injury subsequent neural afunction of Patients with Neurosurgery, epileptic be not after surgery anesthesia
The intellectual damage and improve youngster that the reconstruction of injured cerebral tissue causes with recovery nervous function, slight and moderate Alzheimer's disease
The brain function etc. of virgin cerebral palsy patients.In addition, oxiracetam is also used to treat vascular dementia and acute cerebral infarction.Research
Show that oxiracetam d-isomer (dextrorotation oxiracetam, CAS 68252-28-8) is treated in terms of improving cognition dysfunction
It imitates poor, but has special biological activity in calm, anti-epileptic field, and its toxicity is low, drug safe range is big, is expected to
Substitute as existing high toxicity anti-epileptic class drug.Common oral solid formulation preparation process be first by drug into
Row crushes and sieving, pelletizes after mixing with other components (such as various auxiliary materials), is then prepared according to corresponding preparation type
At capsule or tablet etc..Most of oral solid formulations must be absorbed into blood circulation upon administration, reach certain blood
It can prove effective after concentration.Drug in solid pharmaceutical preparation is before being absorbed, it is necessary to by disintegration and dissolution, then reach specific
Position (such as small intestine) could absorb.Dextrorotation oxiracetam intramolecular contains amido bond, hydrolyzable at carboxylic acid and ammonia or amine, acid,
Alkali, heat can accelerate its hydrolysis.Since dextrorotation oxiracetam is unstable under one's belt, in stomach, the drug residence time prolongs
Long, drug is gradually increased by the amount that gastric acid decomposes, and is reduced so as to cause the enteron aisle effectively amount of absorbing the drug, is caused pharmacological effect not
Stablize, also adds drug safety risk.
Summary of the invention
According to the first aspect of the invention, the purpose of the present invention is providing a kind of enteric dextrorotation oxiracetam particle.
To achieve the purpose of the present invention, the present invention uses following technical scheme.
It is right containing 72-88 part crystal form by weight percentage in dextrorotation oxiracetam particle of the present invention
Revolve oxiracetam, 3-15 parts of pregelatinized starch, 5-10 parts of sodium alginates and 1-10 parts of cellulose acetate-phthalate.
Above-mentioned dextrorotation oxiracetam particle, wherein the dextrorotation oxiracetam of the crystal form uses Cu-K α spoke
It penetrates, obtained X-ray powder diffraction spectrum is 12.6 ± 0.2 °, 14.04 ± 0.2 °, 15.1 in 2 θ of angle of diffraction in 2 θ of angle of reflection
±0.2°、16.66±0.2°、17.54±0.2°、19.42±0.2°、20.68±0.2°、21±0.2°、22.16±0.2°、
23.46±0.2°、25.36±0.2°、26.08±0.2°、26.5±0.2°、30.26±0.2°、30.46±0.2°、30.96
There is diffraction maximum at ± 0.2 °, 31.28 ± 0.2 °.
The preparation method of the dextrorotation oxiracetam of crystal form described above, using following steps:
Dextrorotation oxiracetam is sealed with concentration 30mg/mL-70mg/mL dissolution, is in temperature with ethyl acetate
The 20-32 DEG C of speed with 200-350r/min stirs 22-25h, and filtrate is stood volatilization crystallization, crystal collected, in 40- by filtering
75 DEG C, relative humidity be 15-30% under conditions of dry 3-6h, obtain the dextrorotation oxiracetam of crystal form.
According to the second aspect of the invention, the purpose of the present invention is to provide the preparations of above-mentioned dextrorotation oxiracetam particle
Method.In order to effectively guarantee the quality of dextrorotation oxiracetam particle, while relatively low cost is kept, the present invention selects
Fluidized bed granulation method, it is main referring in particular to medicinal fluidised bed granulator JB/T20014-2011 and Higher Education Publishing House Pan Wei tri-
Compile 2006 editions " industrial pharmacy ".It is found in research, dextrorotation oxiracetam particle is prepared using fluid-bed marumerization method
Defect is equally existed, technology controlling and process is bad to make material powders be not easy to reach fluidized state, cause plug nozzle and filter bag, together
When may also result in particle obtained and have color spot or partial size bigger than normal, be unevenly distributed, to influence the dissolution and absorption of drug.
The preparation method of dextrorotation oxiracetam particle of the present invention, including stock and fluidized bed granulation step, it is special
Sign is: in the fluidized bed granulation, the atomizing pressure of fluidized bed is 1.5~3.0bar, the hydrojet speed of fluidized bed is 5~
15g/min, inlet air temperature when fluidized bed granulation are 25~80 DEG C；Intake volume when fluidized bed granulation is 25~82m3/h。
Inventor also found that before fluidized bed granulation is hydrojet, dry material is vulnerable to electrostatic and is adhered to fluidisation
In bed wall and on filter bag, these materials sticked cannot participate in pelletizing, and the uniformity of particle and yield is caused to receive influence.
In above-mentioned fluidized bed granulation, the atomizing pressure of fluidized bed is 1.5~2.8bar, the hydrojet speed of fluidized bed is 6~
12g/min, inlet air temperature when fluidized bed granulation are 35~62 DEG C；Intake volume when fluidized bed granulation is 35~65m3/h；
The drying carries out in a fluidized bed, and inlet air temperature when described dry is 32~78 DEG C, and intake volume when dry is 22~
65m3/ h, dry time are 25~80min；The coating solution is the cellulose acetate-phthalate solution of 3%-20%,
In terms of quality volumn concentration g/mL.
Above-mentioned drying carries out in a fluidized bed, and inlet air temperature when described dry is 40~65 DEG C, air inlet wind when dry
Amount is 30~60m3/ h, dry time are 30~60min.
The preparation method of dextrorotation oxiracetam particle of the present invention, using following steps:
(1) it stocks up: weighing each supplementary material by recipe quantity, wherein the dextrorotation oxiracetam raw material and pregelatinated of crystal form
Starch, sodium alginate cross 80 meshes respectively；
(2) dextrorotation oxiracetam raw material, the pregelatinated of crystal form fluidized bed granulation: are added in fluidised bed granulator
Starch and sodium alginate, air inlet mixing, spray into coating liquor, under conditions of lasting air inlet by the way of top spray or side spray
Mixing, drying, obtain dextrorotation oxiracetam particle；In the fluidized bed granulation atomizing pressure of fluidized bed be 1.5~
2.8bar, the hydrojet speed of fluidized bed are 6~12g/min, and inlet air temperature when fluidized bed granulation is 35~62 DEG C；Fluidized bed system
Intake volume when grain is 35~65m3/h；The drying carries out in a fluidized bed, inlet air temperature when described dry be 40~
70 DEG C, intake volume when dry is 30~60m3/ h, dry time are 30~60min；The coating solution is 3%-10%
Cellulose acetate-phthalate solution, in terms of quality volumn concentration g/mL.
The utility model has the advantages that
The present invention provides a kind of dextrorotation oxiracetam particles, with particular crystalline form dextrorotation oxiracetam (anti-
12.6 ± 0.2 ° of firing angle, 14.04 ± 0.2 °, 15.1 ± 0.2 °, 16.66 ± 0.2 °, 17.54 ± 0.2 °, 19.42 ± 0.2 °,
20.68±0.2°、21±0.2°、22.16±0.2°、23.46±0.2°、25.36±0.2°、26.08±0.2°、26.5±
Have diffraction maximum at 0.2 °, 30.26 ± 0.2 °, 30.46 ± 0.2 °, 30.96 ± 0.2 °, 31.28 ± 0.2 °) it is active constituent, it is auxiliary
The auxiliary materials fluidized bed granulation methods such as pregelatinized starch, sodium alginate, cellulose acetate-phthalate with special ratios are made
Dextrorotation oxiracetam particle dissolve out under one's belt it is less, mainly in intestinal juice be disintegrated release, reduce dextrorotation oxiracetam and exist
In stomach dissolve out brought by drug by gastric acid decompose and caused by side effect.The present invention passes through pregelatinized starch, sodium alginate, neighbour
The reasonable compatibility of the auxiliary materials such as Cellulose Acetate Phthalate and active constituent dextrorotation oxiracetam, the enteric coated particles of preparation are in intestines
Hydrophilic gel is formed in liquid, while dextrorotation oxiracetam and intestinal mucosa exposure concentration are small during release, and drug release speed
Degree is gentle lasting, to significantly improve curative effect of medication and bioavilability.The present invention prepares dextrorotation hydroxyl oxygen with fluidized bed coating
Pyrrole vinegar amine enteric coated particles, by the control of the series of parameters such as air blast flux, atomization gas pressure, effective solution fluidized bed system
Material powders are not easy to reach fluidized state during grain, and plug nozzle and filter bag and particle obtained is caused to have color spot or grain
The technical issues of diameter is bigger than normal, is unevenly distributed, the fluid bed granulate fine uniform of preparation, hardness are moderate.Preparation method of the present invention
Simply, material used, equipment are field of pharmaceutical preparations conventional equipment, while the material being more toxic is not used, economic and environment-friendly,
It is suitble to large-scale promotion.
Specific embodiment
The present invention is specifically described below by embodiment, it is necessary to which indicated herein is that following embodiment is only used
In invention is further explained, it should not be understood as limiting the scope of the invention, person skilled in art can
To make some nonessential modifications and adaptations to the present invention according to aforementioned present invention content.The preparation process of crystal form of the present invention
In, it is filtered into conventional solid-liquid separate mode known in the art.
Embodiment 1
It by dextrorotation oxiracetam with 30mg/mL ethyl acetate stirring and dissolving, seals, is 20-25 DEG C in temperature
24-25h is stirred with the speed of 200-250r/min, it is 70-75 in temperature that filtrate is stood volatilization crystallization, collects crystal by filtering
DEG C, relative humidity dry 4-5h under conditions of being 20-25% collects crystallization.Powder diffraction measurement is carried out to the crystallization of collection
(XRPD): test equipment condition: carrying out room temperature test, test condition are as follows: with Cu using Bruker D2PHASER powder diffractometer
KaFor light source, voltage 30kV, electric current 10mA test 0.014 ° of step-length, scanning speed 0.1s/step, scan model
Enclose 5-40 ° (2 θ).Through detecting, 2 θ of angle of diffraction be 12.6 ± 0.2 °, 14.04 ± 0.2 °, 15.1 ± 0.2 °, 16.66 ±
0.2°、17.54±0.2°、19.42±0.2°、20.68±0.2°、21±0.2°、22.16±0.2°、23.46±0.2°、
25.36±0.2°、26.08±0.2°、26.5±0.2°、30.26±0.2°、30.46±0.2°、30.96±0.2°、31.28
There is diffraction maximum at ± 0.2 °.
Embodiment 2
It by dextrorotation oxiracetam with 70mg/mL ethyl acetate stirring and dissolving, seals, is 12-15 DEG C in temperature
20-30h is stirred with the speed of 200-250r/min, it is 55-60 in temperature that filtrate is stood volatilization crystallization, collects crystal by filtering
DEG C, relative humidity dry 3-4h under conditions of being 10-20% collects crystallization.It is tested referring to the method for embodiment 1, as a result
The crystallization of dextrorotation oxiracetam and embodiment 1 for showing the preparation of embodiment 2 are the phase isomorphism.
Embodiment 3
It by dextrorotation oxiracetam with 21mg/mL ethyl acetate stirring and dissolving, seals, is 25-30 DEG C in temperature
22-25h is stirred with the speed of 150-200r/min, it is 65-70 in temperature that filtrate is stood volatilization crystallization, collects crystal by filtering
DEG C, relative humidity dry 4-5h under conditions of being 15-20% collects crystallization.It is tested referring to the method for embodiment 1, as a result
The crystallization of dextrorotation oxiracetam and embodiment 1 for showing the preparation of embodiment 3 are the phase isomorphism.
Embodiment 4
Crystal form dextrorotation oxiracetam prepared by embodiment 1 is placed on monocrystal silicon sample platform, by it by 30 DEG C
80 DEG C are heated to, respectively in 35,45,55,65,75 DEG C of progress powder x-ray diffraction measurements, test result is shown, knot of the present invention
Crystalline form dextrorotation oxiracetam does not occur crystal phenomenon between 30 DEG C -80 DEG C, it is seen that crystal form dextrorotation hydroxyl oxygen of the present invention
Pyrrole vinegar amine high-temperature stability is good, and high temperature will not cause crystal transfer.
Embodiment 5
Prescription: it forms sediment referring to 80 parts, 10 parts pregelatinateds of dextrorotation oxiracetam of the crystal form of 1 method of embodiment preparation
Powder, 5 parts of sodium alginates, 4 parts of cellulose acetate-phthalates.
Preparation method: (1) stocking up: weighing each supplementary material by recipe quantity, and wherein the dextrorotation oxiracetam of crystal form is former
Material and filler cross 80 meshes respectively；(2) pelletize: the dextrorotation oxiracetam that crystal form is added in fluidised bed granulator is former
Material, pregelatinized starch and sodium alginate, air inlet mixing, spray into coating liquor, in the item of lasting air inlet by the way of top spray
It is mixed under part, is dry, obtaining dextrorotation oxiracetam particle；The atomizing pressure of fluidized bed is in the fluidized bed granulation
1..8bar, the hydrojet speed of fluidized bed is 10g/min, and inlet air temperature when fluidized bed granulation is 45 DEG C；When fluidized bed granulation
Intake volume is 45m3/h；The drying carries out in a fluidized bed, and inlet air temperature when described dry is 55 DEG C, when dry into
Wind air quantity is 50m3/ h, dry time are 50min；The cellulose acetate-phthalate acetone that the coating solution is 10% is molten
Liquid, in terms of quality volumn concentration g/mL.
Embodiment 6
Prescription: it forms sediment referring to 72 parts, 10 parts pregelatinateds of dextrorotation oxiracetam of the crystal form of 2 method of embodiment preparation
Powder, 10 parts of sodium alginates, 6 parts of cellulose acetate-phthalates.
Preparation method: (1) stocking up: weighing each supplementary material by recipe quantity, and wherein the dextrorotation oxiracetam of crystal form is former
Material and filler cross 80 meshes respectively；(2) pelletize: the dextrorotation oxiracetam that crystal form is added in fluidised bed granulator is former
Material, pregelatinized starch and sodium alginate, air inlet mixing, spray into coating liquor, in the item of lasting air inlet by the way of side spray
It is mixed under part, is dry, obtaining dextrorotation oxiracetam particle；The atomizing pressure of fluidized bed is in the fluidized bed granulation
1.5bar, the hydrojet speed of fluidized bed are 6g/min, and inlet air temperature when fluidized bed granulation is 35 DEG C；When fluidized bed granulation into
Wind air quantity is 35m3/h；The drying carries out in a fluidized bed, and inlet air temperature when described dry is 40 DEG C, air inlet when dry
Air quantity is 30m3/ h, dry time are 30min；The cellulose acetate-phthalate solution that the coating solution is 5%, with matter
Measure volumn concentration g/mL meter.
Embodiment 7
Prescription: 88 parts, 3 parts pregelatinized starch of dextrorotation oxiracetam of the crystal form of reference 3 method of embodiment preparation,
5 parts of sodium alginates, 3 parts of cellulose acetate-phthalates.
Preparation method: (1) stocking up: weighing each supplementary material by recipe quantity, and wherein the dextrorotation oxiracetam of crystal form is former
Material and filler cross 80 meshes respectively；(2) pelletize: the dextrorotation oxiracetam that crystal form is added in fluidised bed granulator is former
Material, pregelatinized starch and sodium alginate, air inlet mixing, spray into coating liquor, in the item of lasting air inlet by the way of top spray
It is mixed under part, is dry, obtaining dextrorotation oxiracetam particle；The atomizing pressure of fluidized bed is in the fluidized bed granulation
2.8bar, the hydrojet speed of fluidized bed are 12g/min, and inlet air temperature when fluidized bed granulation is 62 DEG C；When fluidized bed granulation
Intake volume is 65m3/h；The drying carries out in a fluidized bed, and inlet air temperature when described dry is 70 DEG C, when dry into
Wind air quantity is 60m3/ h, dry time are 60min；The cellulose acetate-phthalate solution that the coating solution is 3%, with
Quality volumn concentration g/mL meter.
Embodiment 8
Releasing result is investigated: referring to the relevant regulations of version Chinese Pharmacopoeia in 2015, by the dextrorotation hydroxyl oxygen pyrrole vinegar of embodiment 5-7
Amine particle, respectively loaded in HDPE bottles, seals, in 25 DEG C ± 2 DEG C of temperature, 60% ± 10% condition of relative humidity according to a certain amount of
After lower placement 24 months, the acid-resistant strength after detection 0.1M HCl acidproof two hours (passes through medicament contg in acidproof rear enteric coated particles
Verifying) and 6.8 buffer of pH in 30min release, test result is as follows table 1.
1 acid-resistant strength of table and releasing result are investigated
5-7 of the embodiment of the present invention preparation dextrorotation oxiracetam particle 25 DEG C ± 2 DEG C of temperature, relative humidity 60% ±
Content and the release result of 30min change unobvious, the release of 30min compared with 0 day after placing 24 months under the conditions of 10%
Degree is greater than 80%, illustrates that dextrorotation oxiracetam particle acid-resistant strength of the present invention is strong, drug release rate has good stability.
Claims (6)
1. a kind of dextrorotation oxiracetam particle, it is characterised in that: containing with weight hundred in the dextrorotation oxiracetam particle
Divide 72-88 part crystal form dextrorotation oxiracetam, 3-15 parts of pregelatinized starch, 5-10 parts of sodium alginates and 1-10 than meter
The cellulose acetate-phthalate of part；The dextrorotation oxiracetam of the crystal form is radiated using Cu-K α, obtained X-
Ray powder diffraction spectrum is in 2 θ of angle of reflection in angle of diffraction 2θFor 12.6 ± 0.2 °, 14.04 ± 0.2 °, 15.1 ± 0.2 °, 16.66
±0.2°、17.54±0.2°、19.42±0.2°、20.68±0.2°、21±0.2°、22.16±0.2°、23.46±0.2°、
25.36±0.2°、26.08±0.2°、26.5±0.2°、30.26±0.2°、30.46±0.2°、30.96±0.2°、31.28
There is diffraction maximum at ± 0.2 °.
2. dextrorotation oxiracetam particle as described in claim 1, it is characterised in that: the dextrorotation hydroxyl oxygen pyrrole of the crystal form
Vinegar amine, which is adopted, to be prepared by the following steps: being covered dextrorotation oxiracetam with concentration 30mg/mL-70mg/mL dissolution with ethyl acetate
Sealing is that the 20-32 DEG C of speed with 200-350r/min stirs 22-25h in temperature, and filtrate is stood volatilization crystallization, received by filtering
Collect crystal, in 40-75 DEG C, relative humidity to dry 3-6h under conditions of 15-30%, obtains the dextrorotation hydroxyl oxygen pyrrole vinegar of crystal form
Amine.
3. the preparation method of dextrorotation oxiracetam particle as claimed in claim 1 or 2, including stock, fluidized bed granulation and total
Mixed and filling step, it is characterised in that: in the fluidized bed granulation, the atomizing pressure of fluidized bed is 1.5~3.0bar, fluidized bed
Hydrojet speed be 5~15g/min, inlet air temperature when fluidized bed granulation is 25~80 DEG C；Air inlet wind when fluidized bed granulation
Amount is 25~82m3/h。
4. the preparation method of dextrorotation oxiracetam particle as claimed in claim 3, it is characterised in that: the fluidized bed granulation
In, the atomizing pressure of fluidized bed is 1.5~2.8bar, and the hydrojet speed of fluidized bed is 6~12g/min, when fluidized bed granulation
Inlet air temperature is 35~62 DEG C；Intake volume when fluidized bed granulation is 35~65m3/h；The drying carries out in a fluidized bed,
Inlet air temperature when described dry is 32~78 DEG C, and intake volume when dry is 22~65m3/ h, the dry time be 25~
80min；The coating solution is the cellulose acetate-phthalate solution of 5%-20%, in terms of quality volumn concentration g/mL.
5. the preparation method of dextrorotation oxiracetam particle as claimed in claim 4, it is characterised in that: the drying is in fluidized bed
Middle progress, inlet air temperature when dry are 40~65 DEG C, and intake volume when dry is 30~60m3/ h, dry time are 30
~60min.
6. the preparation method of dextrorotation oxiracetam particle as claimed in claim 1 or 2, using following steps:
(1) it stocks up: weighing each supplementary material by recipe quantity, wherein the dextrorotation oxiracetam raw material of crystal form and pregelatinated form sediment
Powder, sodium alginate cross 80 meshes respectively；
(2) it pelletizes: dextrorotation oxiracetam raw material, pregelatinized starch and the seaweed of crystal form being added in fluidised bed granulator
Sour sodium, air inlet mixing, sprays into coating liquor by the way of top spray or side spray, mixes under conditions of lasting air inlet, is dry,
Obtain dextrorotation oxiracetam particle；The atomizing pressure of fluidized bed is 1.5~2.8bar in the fluidized bed granulation, fluidized bed
Hydrojet speed is 6~12g/min, and inlet air temperature when fluidized bed granulation is 35~62 DEG C；Intake volume when fluidized bed granulation
For 35~65m3/h；The drying carries out in a fluidized bed, and inlet air temperature when described dry is 40~70 DEG C, when dry into
Wind air quantity is 30~60m3/ h, dry time are 30~60min；The phthalic acid acetic acid that the coating solution is 3%-10% is fine
Plain solution is tieed up, in terms of quality volumn concentration g/mL.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2018103577930 | 2018-04-20 | ||
| CN201810357793 | 2018-04-20 |
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| CN110384664A true CN110384664A (en) | 2019-10-29 |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN102603607A (en) * | 2011-01-21 | 2012-07-25 | 重庆润泽医疗器械有限公司 | Preparation method of (R)-oxiracetam |
-
2018
- 2018-09-14 CN CN201811072545.8A patent/CN110384664A/en not_active Withdrawn
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN102603607A (en) * | 2011-01-21 | 2012-07-25 | 重庆润泽医疗器械有限公司 | Preparation method of (R)-oxiracetam |
Non-Patent Citations (1)
| Title |
|---|
| 袁利杰等: "HPLC 法测定奥拉西坦原料及其注射剂中奥拉西坦的含量和有关物质", 《中国药师》 * |
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Application publication date: 20191029 |
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