CN110384676A - The good dextrorotation oxiracetam capsule and preparation method thereof of stability - Google Patents
The good dextrorotation oxiracetam capsule and preparation method thereof of stability Download PDFInfo
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- CN110384676A CN110384676A CN201910316773.3A CN201910316773A CN110384676A CN 110384676 A CN110384676 A CN 110384676A CN 201910316773 A CN201910316773 A CN 201910316773A CN 110384676 A CN110384676 A CN 110384676A
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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
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- 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
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- 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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
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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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
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- 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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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/08—Antiepileptics; Anticonvulsants
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Abstract
The present invention provides a kind of dextrorotation oxiracetam capsules, using the dextrorotation oxiracetam of particular crystalline form as active constituent, pass through dry granulation process, dextrorotation oxiracetam capsule obtained lists under terms of packing in simulation, through being investigated under high temperature and illumination condition, every quality detecting index is without significant changes, it has good stability, impurity content is few, it is provided simultaneously with preferable dissolution rate, the service efficiency of unit dose is improved, preferentially and the selection that has provided of clinical application for Hospital Drugs, there is very high economic and social 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 capsule that stability is good and its
Preparation method.
Background technique
Dextrorotation oxiracetam is the d-isomer of oxiracetam, research shows that (CN 201610327096.1), in anti-epileptic
There is a special biological activity in field, and dextrorotation oxiracetam bioavilability is high, and toxicity is low, be suitble to be developed further into for
Antiepileptic.Chinese patent CN 201110024526.X discloses a kind of preparation method of dextrorotation oxiracetam, with glycine
Carbethoxy hydrochloride is that raw material reacts under alcoholic solvent and alkaline condition with (R) -4- halogen -3- hydroxy-butyric acid ethyl ester, is washed with inorganic alkoxide
It washs, be concentrated and extracted again, separate and be passed through ammonium hydroxide, be most made afterwards through ion exchange resin, this method effectively reduces object in reaction
The dosage of material reduces costs, while positive effect is also functioned to the yield of reaction.Chinese patent CN
200910076436.8 disclose a kind of using dextrorotation oxiracetam as the solid pharmaceutical preparation of active constituent, and it includes dextrorotation oxiracetams
And dextrorotation oxiracetam granule is made with wet granulation in pharmaceutically acceptable auxiliary material, this method.It is found after researching and analysing,
The quality stability of dextrorotation oxiracetam solid pharmaceutical preparation product disclosed above is poor, during storage, active component content
It significantly reduces, impurity content significantly increases, and is unfavorable for guaranteeing clinical application safety.
Summary of the invention
In order to overcome the drawbacks of the prior art, the present invention provides a kind of dextrorotation oxiracetam capsule.
To achieve the purpose of the present invention, the present invention uses following technical scheme.
A kind of dextrorotation oxiracetam capsule, it is characterised in that: include 60~95 weight in the dextrorotation oxiracetam capsule
Crystal form dextrorotation oxiracetam, 0~35 parts by weight of filler, 2-5 parts by weight lubricant of part；The crystal form dextrorotation is difficult to understand
Draw amide, 2 θ of angle of diffraction be 14.44 ± 0.2 °, 17.12 ± 0.2 °, 18.88 ± 0.2 °, 19.24 ± 0.2 °, 19.78 ±
0.2°、20.66±0.2°、20.84±0.2°、21.18±0.2°、21.82±0.2°、22.94±0.2°、23.24±0.2°、
24.88 ± 0.2 °, 30.46 ± 0.2 °, 31.40 ± 0.2 °, 31.52 ± 0.2 ° have diffraction maximum.
Filler of the present invention is starch, dextrin, lactose, microcrystalline cellulose, sodium carboxymethyl starch, calcium carbonate, sorb
The mixture of one or more of alcohol, mannitol composition.Lubricant of the present invention be magnesium stearate, calcium stearate,
The mixture of one or more of talcum powder and superfine silica gel powder composition.
It further, include the crystal form dextrorotation Aura acyl of 75~90 parts by weight in dextrorotation oxiracetam capsule of the present invention
Amine, 5~30 parts by weight of filler, 2-5 parts by weight lubricant.
The present invention also provides the preparation methods of above-mentioned dextrorotation oxiracetam capsule.
The preparation method of dextrorotation oxiracetam capsule of the present invention, using following steps: adjusting the work of dry granulating machine
Skill parameter: 10~20MPa of hydraulic system pressure, host speed regulation≤25Hz, 10~15Hz of straight feeding frequency, vertical feeding frequency
10~18Hz crushed 60 meshes；It weighs crystal form dextrorotation oxiracetam and filler is uniformly mixed, with through dry granulating machine
It pelletizes, gained particle is cooled to 20 DEG C after 50-75 DEG C of dry 30~60min with bottom discharge, is then mixed with lubricant
It closes uniformly, filling capsulae vacuus both obtained.
The utility model has the advantages that
The present invention provides a kind of dextrorotation oxiracetam capsule, with the dextrorotation oxiracetam of particular crystalline form be activity at
Point, by dry granulation process, the filling capsule of obtained dry particl, content uniformity is small, while dissolvent residual is not present, and effectively protects
Demonstrate,prove clinical efficacy；Dextrorotation oxiracetam capsule of the present invention is in the case where simulation lists terms of packing, through being investigated under high temperature and illumination condition,
Every quality detecting index has good stability without significant changes, and impurity content is few, is provided simultaneously with preferable dissolution rate, improves
The service efficiency of unit dose, preferentially and the selection that has provided of clinical application for Hospital Drugs, have it is very high it is economical with
And social effect.Preparation method of the present invention is simple, is suitble to industrialized production.
Definition
Dextrorotation oxiracetam capsule of the present invention is used for the treatment of epilepsy, including but not limited to cortical epilepsy, traumatic
Epilepsy, secondary generalized epileptic, complex partial seizure.
The cortical epilepsy refers to that lesion is classified as in the classification of international epilepsy in a kind of corticocerebral epilepsy
Symptom epilepsy belongs to and positions related (focal) epilepsy syndromes.In international classification, the relevant epilepsy of cortex epilepsy is sorted out
It is the partial epilepsy without consciousness decline for simple partial seizures.The cortical epilepsy is classified as temporal-lobe epilepsy, top
Leaf epilepsy or occipital aphasia epilepsy.
The traumatic epilepsy is a kind of intractable epilepsy, broadly, can be divided into two kinds of epilepsies, i.e. Early epilepsy and evening
Phase epilepsy.Early epilepsy is as being not real epilepsy by caused by fainting from fear in wound latter week greatly caused by brain stimulation.
In contrast, advanced stage epilepsy is by caused real epilepsy after wound one or more weeks.Most of wound epilepsies are in cortex
It is considered as the typical example of partial epilepsy caused by the formation of trauma damage part lesion.
The secondary generalized epileptic is symptom related with intractable epilepsy, is a seed type of part breaking-out, table
It now seeks peace EEG Characteristics for Comprehensive Clinical, observes neuronal excitation in electroencephalogram, show have at one of cerebral hemisphere
Limit the epileptic attack starting of part.Secondary generalized epileptic starting is divided into simple partial seizure (without the loss of consciousness) or complexity portion
Distribution work (is lost) consciously, and induces convulsions by the secondary general whole body that develops to.Its cardinal symptom is twitch, such as tetanic
Property spasm, atonic seizure epilepsy or Myoclonic seizures.
Complex partial seizures are symptoms related with intractable epilepsy, refer to the partial seizure that band sickens for consciousness,
And it is analogous to commonly referred to as psychomotor class epilepsy or epilepsy relevant to temporal epilepsy.It is multiple in international classification draft
Hetero moiety breaking-out is defined as the epilepsy that band sickens for consciousness, and electroencephalogram unilateral or bilateral is discharged during showing as epilepsy, can attribution
It is spread in lesion or in temples or in preceding temples.
Dextrorotation oxiracetam capsule of the present invention is used for the treatment of epilepsy, can be according to the clinical manifestation situation of epilepsy and its
He shares antiepileptic, including Topiramate, carbamazepine, Oxcarbazepine, phenytoinum naticum, Lamotrigine, Zonisamide, non-ammonia
Ester, ethymal, valproic acid, Levetiracetam etc..
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
30mg dextrorotation oxiracetam is dissolved in 2mL normal propyl alcohol, 50 DEG C of heating, filtering obtains supersaturated solution, this is molten
Liquid sealing is placed on cooling crystallization 15 hours under -17 DEG C of environment, is separated by filtration, dry under the conditions of 65 DEG C, relative humidity are 10%
Dry 4h or so obtains colourless sand shaped crystal for obtained dextrorotation oxiracetam crystal and carries out powder diffraction experiment: test equipment
Condition: room temperature test, test condition are as follows: with Cu Ka are carried out using BrukerD2PHASER powder diffractometerFor
Light source, voltage 30kV, electric current 10mA test 0.014 ° of step-length, scanning speed 0.1s/step, 5-40 ° of scanning range (2 θ).Through
Detection, embodiment 1 prepare dextrorotation oxiracetam crystal, 2 θ of angle of diffraction be 14.44 ± 0.2 °, 17.12 ± 0.2 °,
18.88±0.2°、19.24±0.2°、19.78±0.2°、20.66±0.2°、20.84±0.2°、21.18±0.2°、21.82
±0.2°、22.94±0.2°、23.24±0.2°、24.88±0.2°、30.46±0.2°、31.40±0.2°、31.52±
0.2 ° has diffraction maximum.
Dextrorotation Aura acyl of the crystal form dextrorotation oxiracetam to prepare embodiment 2-4 is obtained using 1 method of embodiment
Amine capsule.
Embodiment 2
Prescription: 75 parts, 10 parts microcrystalline celluloses of dextrorotation oxiracetam of the crystal form of reference 1 method of embodiment preparation,
12 parts of sodium carboxymethyl starches, 3 parts of magnesium stearates.
Using following steps: the technological parameter of dry granulating machine: hydraulic system pressure 20MPa is adjusted, host adjusts the speed 20Hz,
Straight feeding frequency 10Hz, vertical feeding frequency 18Hz crushed 60 meshes；Weigh crystal form dextrorotation oxiracetam and crystallite
Cellulose, sodium carboxymethyl starch are uniformly mixed, and are pelletized with through dry granulating machine, by gained particle in 50 DEG C of dry 60min
After be cooled to 20 DEG C with bottom discharge, be then uniformly mixed with magnesium stearate, filling capsulae vacuus is both.
Embodiment 3
Prescription: referring to dextrorotation oxiracetam 90 parts, 5 parts medicinal calcium carbonates, 5 of the crystal form of 1 method of embodiment preparation
Part superfine silica gel powder.
Using following steps: the technological parameter of dry granulating machine: hydraulic system pressure 10MPa is adjusted, host adjusts the speed 22Hz,
Straight feeding frequency 15Hz, vertical feeding frequency 12Hz crushed 60 meshes；Weigh crystal form dextrorotation oxiracetam and medicinal
Calcium carbonate be uniformly mixed, pelletized with through dry granulating machine, gained particle is cooled to after 75 DEG C of dry 40min 20 DEG C with
Then bottom discharge is uniformly mixed with superfine silica gel powder, filling capsulae vacuus both obtained.
Embodiment 4
Prescription: 82 parts, 15 portions mannitol of dextrorotation oxiracetam, 3 parts of cunnings referring to the crystal form of 1 method of embodiment preparation
Mountain flour.
Using following steps: the technological parameter of dry granulating machine: hydraulic system pressure 17MPa is adjusted, host adjusts the speed 25Hz,
Straight feeding frequency 13Hz, vertical feeding frequency 16Hz crushed 60 meshes；Weigh crystal form dextrorotation oxiracetam and filling
Agent is uniformly mixed, and is pelletized with through dry granulating machine, and gained particle is cooled to 20 DEG C or less after 62 DEG C of dry 48min and is gone out
Material, then uniform with mix lubricant, filling capsulae vacuus both obtained.
Embodiment 5
The study on the stability of product of the present invention
Dextrorotation oxiracetam capsule made from method using the embodiment of the present invention 2, respectively at 60 DEG C of high temperature, RH92.5%
It places, is sampled respectively at 5 days, 10 days, detection, and compared with 0 day under the conditions of intensity of illumination 4500Lx ± 500Lx, experiment knot
Fruit see the table below 1.
The study on the stability of 1 embodiment of table, 2 product
Judging from the experimental results, capsule sample of the present invention, under the conditions of commercially available back, under high temperature and illumination condition,
Its character, related substance, content have no significant change, and illustrate more stable under hot conditions, while photostability is preferable；This hair
Bright sample is placed under conditions of high humidity, and related substance has certain variation, it should be noted that moisture-proof.
Referring to embodiment 5, the dextrorotation oxiracetam capsule product stability of embodiment 3-4 preparation is investigated, is existed as the result is shown
Under the conditions of commercially available back, under high temperature and illumination condition, character, related substance, content have no significant change；Sample is in high humidity
Under the conditions of place, related substance has certain variation, it should be noted that moisture-proof.
Embodiment 6
Product of the present invention content uniformity is investigated
Measuring method: referring to the detection method inspection under 2015 editions annex capsule items of Chinese Pharmacopoeia in relation to content uniformity
Survey, take test sample 10, accurately weighed weight, pours out content (must not lose softgel shell) respectively, hard capsule softgel shell brushed with small or
Other suitable apparatus are wiped only, and accurately weighed softgel shell weight, finds out the tolerant loading amount of every intragranular respectively.Every loading amount and labelled amount
Compare (all labelled amounts are indicated with certain component amount, should be compared with average loading amount), and content uniformity should surpass within 10%
Content uniformity limit must not be more than 2 out, and must not have 1 times of 1 overrun.The dextrorotation Aura acyl of embodiment 2-4 preparation
Amine capsule content uniformity result see the table below 2.
The content uniformity of 2 embodiment 2-4 product of table is investigated
| Embodiment 2 | Embodiment 3 | Embodiment 4 | |
| Content uniformity (%) | 2.3% | 2.4% | 2.1% |
From the point of view of 2 result of table, dextrorotation oxiracetam capsule content uniformity of the present invention is not higher than 2.5%.
Claims (6)
1. a kind of dextrorotation oxiracetam capsule, it is characterised in that: include 60~95 parts by weight in the dextrorotation oxiracetam capsule
Crystal form dextrorotation oxiracetam, 0~35 parts by weight of filler, 2-5 parts by weight lubricant；The crystal form dextrorotation Aura
Amide, in angle of diffraction 2θ is14.44±0.2°、17.12±0.2°、18.88±0.2°、19.24±0.2°、19.78±
0.2°、20.66±0.2°、20.84±0.2°、21.18±0.2°、21.82±0.2°、22.94±0.2°、23.24±0.2°、
24.88 ± 0.2 °, 30.46 ± 0.2 °, 31.40 ± 0.2 °, 31.52 ± 0.2 ° have diffraction maximum.
2. dextrorotation oxiracetam capsule as described in claim 1, it is characterised in that: the filler is starch, dextrin, cream
The mixing of one or more of sugar, microcrystalline cellulose, sodium carboxymethyl starch, calcium carbonate, sorbierite, mannitol composition
Object.
3. dextrorotation oxiracetam capsule as described in claim 1, it is characterised in that: the lubricant is magnesium stearate, tristearin
The mixture of one or more of sour calcium, talcum powder and superfine silica gel powder composition.
4. dextrorotation oxiracetam capsule as described in claim 1, it is characterised in that: include in the dextrorotation oxiracetam capsule
Crystal form dextrorotation oxiracetam, 0~35 parts by weight of filler, the 2-5 parts by weight lubricant of 60~95 parts by weight；The crystallization
Form dextrorotation oxiracetam, in angle of diffraction 2θ is14.44±0.2°、17.12±0.2°、18.88±0.2°、19.24±
0.2°、19.78±0.2°、20.66±0.2°、20.84±0.2°、21.18±0.2°、21.82±0.2°、22.94±0.2°、
23.24 ± 0.2 °, 24.88 ± 0.2 °, 30.46 ± 0.2 °, 31.40 ± 0.2 °, 31.52 ± 0.2 ° have diffraction maximum；The filling
Agent is one or both of starch, dextrin, lactose, microcrystalline cellulose, sodium carboxymethyl starch, calcium carbonate, sorbierite, mannitol
The mixture of composition described above；The lubricant is one or both of magnesium stearate, calcium stearate, talcum powder and superfine silica gel powder
The mixture of composition described above.
5. dextrorotation oxiracetam capsule as claimed in claim 4, it is characterised in that: wrapped in the dextrorotation oxiracetam capsule
Crystal form dextrorotation oxiracetam, 5~30 parts by weight of filler, 2-5 parts by weight lubricant containing 75~90 parts by weight.
6. the preparation method of dextrorotation oxiracetam capsule as described in any one in claim 1-5, using following steps: adjusting dry
The technological parameter of method granulator: 10~20MPa of hydraulic system pressure, host speed regulation≤25Hz, straight feeding 10~15Hz of frequency,
Vertical feeding 10~18Hz of frequency, crushed 60 meshes；It weighs crystal form dextrorotation oxiracetam and filler is uniformly mixed, use
It pelletizes through dry granulating machine, gained particle is cooled to 20 DEG C with bottom discharge, so after 50-75 DEG C of dry 30~60min
Uniform with mix lubricant afterwards, filling capsulae vacuus both obtained.
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| CN2018103577767 | 2018-04-20 | ||
| CN201810357776 | 2018-04-20 |
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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 |
-
2019
- 2019-04-19 CN CN201910316773.3A patent/CN110384676A/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 |
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