CN108498471A - A kind of eszopiclone composition - Google Patents
A kind of eszopiclone composition Download PDFInfo
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- CN108498471A CN108498471A CN201810301888.0A CN201810301888A CN108498471A CN 108498471 A CN108498471 A CN 108498471A CN 201810301888 A CN201810301888 A CN 201810301888A CN 108498471 A CN108498471 A CN 108498471A
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- eszopiclone
- monohydrogen phosphate
- calcium monohydrogen
- microcrystalline cellulose
- magnesium stearate
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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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- 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
- A61P25/20—Hypnotics; Sedatives
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Abstract
The present invention relates to a kind of eszopiclone compositions and preparation method thereof, belong to technical field of medicine.The technical scheme is that a kind of eszopiclone tablet composition, in the composition of unit dose, contain：1 3mg of eszopiclone, 40 87mg of microcrystalline cellulose, 8 12mg of calcium monohydrogen phosphate, 3 5mg of croscarmellose sodium, 10 30mg of colloidal silicon dioxide, 10 20mg of oiliness auxiliary material, 1.4 2mg of magnesium stearate.Technical solution of the present invention stablized, the eszopiclone tablet composition of safety.
Description
Technical field
The present invention relates to a kind of eszopiclone compositions and preparation method thereof, belong to pharmaceutical technology field.
Background technology
Eszopiclone（Esopiclone）It is the quick short-acting Non-benzodiazepine developed by Sepracor companies of the U.S.
Sedative hypnotics are the dextrorotation individual isomer of zopiclone, for short-term and chronic insomnia treatment.Therefore this product is more
The zopiclone of listing has the advantages such as curative effect is strong, toxicity is low.U.S. FDA approval listing is obtained in December, 2004.
The difficult soluble substance of eszopiclone, is practically insoluble in water, and commercially available eszopiclone piece specification is 1,2 and 3mg tri-
Specification.Because the specification of product is smaller, uniformity of dosage units is not easy up to standard in prepared tablet；Because eszopiclone is insoluble in water,
The problem of there is the product dissolution data poor reproducibilities of different batches in tablet.
Application No. is 201010158069.9 Chinese patents in order to solve the problems, such as uniformity of dosage units, have been used in prescription certain
The grain size of the auxiliary materials such as disintegrant, dextrin, starch, lactose, microcrystalline cellulose, the hydroxypropylcellulose of amount, wherein eszopiclone is
50μm-250μm.201410188249.X Chinese patents are by the granularity of control eszopiclone, and then dry powder blend, is directly pressed
The mode of piece, dissolution rate is unstable between solving the problems, such as uniformity of dosage units and criticizing.The above patent exists eszopiclone powder
It is broken to and needs granularity and mixed process, thin material is caused to be spread into air, entire preparation section is filled with right assistant gram
Grand specific bitter taste.
Experiment finds that during preparing eszopiclone tablet, requirement of the tablet to prescription is extremely stringent, otherwise institute
The tablet of preparation can be in reduction trend with the extension of resting period, dissolution rate during storage；Related substance becomes in raising
Gesture.In order to solve the above problem, Chinese patent 200910247360,200910247348,201210577011,
201110180034, it takes and Eszopiclone is dissolved in the acid solution containing acidulant, drug containing Acidic Liquid is made；Later,
Basifier, auxiliary material and the drug containing Acidic Liquid are uniformly mixed, wet granulation is carried out.At mechanical crushing
Pollution caused by reason, while solving the stability problem during tablet storage.But due to its take it is molten with acid solution
Solution, then the mode with basic auxiliary by pH value adjustment back, extends the energy expenditure in preparation process and preparation process.
Invention content
Goal of the invention：In view of the deficiencies of the prior art, the present invention provides a kind of stable quality, the right sides of uniformity of dosage units qualification
Zopiclone tablet composition；And the uniform diffusion of bulk pharmaceutical chemicals in production process is solved, to reach uniformity of dosage units difficulty up to standard
Topic.
Technical solution：
The technical scheme is that a kind of eszopiclone tablet composition, in the composition of unit dose, contain：Right assistant
Clone 1-3mg, microcrystalline cellulose 40-87mg, calcium monohydrogen phosphate 8-12mg, croscarmellose sodium 3-5mg, colloidal state dioxy
SiClx 10-30mg, oiliness auxiliary material 10-20mg, magnesium stearate 1.4-2mg.
In eszopiclone tablet composition of the present invention, the oiliness auxiliary material is selected from polyoxy hydrogenated castor oil, lecithin, spits
One or more of temperature 80, polyethylene glycol 400, glycerine, poloxamer, preferably lecithin, Tween 80, polyethylene glycol 400.
Preferably, a kind of eszopiclone tablet composition in the composition of unit dose, contains：Eszopiclone 1-3mg,
Microcrystalline cellulose 58-72mg, calcium monohydrogen phosphate 8-12mg, croscarmellose sodium 3-5mg, colloidal silicon dioxide 15-25mg,
Oiliness auxiliary material 14-18mg, magnesium stearate 1.5-1.8mg.
Preferably, a kind of eszopiclone tablet composition in the composition of unit dose, contains：Eszopiclone 2mg, it is micro-
Crystalline cellulose 58mg, calcium monohydrogen phosphate 10mg, croscarmellose sodium 3mg, colloidal silicon dioxide 15mg, oiliness auxiliary material
14mg, magnesium stearate 1.8mg.
Preferably, a kind of eszopiclone tablet composition in the composition of unit dose, contains：Eszopiclone 2mg, it is micro-
Crystalline cellulose 72mg, calcium monohydrogen phosphate 12mg, croscarmellose sodium 5mg, colloidal silicon dioxide 25mg, oiliness auxiliary material
18mg, magnesium stearate 1.5mg.
Preferably, a kind of eszopiclone tablet composition in the composition of unit dose, contains：Eszopiclone 2mg, it is micro-
Crystalline cellulose 65mg, calcium monohydrogen phosphate 10mg, croscarmellose sodium 4mg, colloidal silicon dioxide 20mg, oiliness auxiliary material
16mg, magnesium stearate 1.6mg.
Preferably, eszopiclone composition of the present invention contains in the composition of unit dose：Eszopiclone 1mg, it is micro-
Crystalline cellulose 70mg, calcium monohydrogen phosphate 10mg, croscarmellose sodium 4mg, colloidal silicon dioxide 18mg, glycerine 10mg, firmly
Fatty acid magnesium 2mg.
Preferably, eszopiclone composition of the present invention contains in the composition of unit dose：Eszopiclone 2mg, it is micro-
Crystalline cellulose 58mg, calcium monohydrogen phosphate 8-12mg, croscarmellose sodium 3mg, colloidal silicon dioxide 20mg, PEG400
15mg, magnesium stearate 2mg.
Preferably, eszopiclone composition of the present invention contains in the composition of unit dose：Eszopiclone 3mg, it is micro-
Crystalline cellulose 47mg, calcium monohydrogen phosphate 10mg, croscarmellose sodium 3mg, colloidal silicon dioxide 25mg, lecithin 20mg,
Magnesium stearate 2mg.
The preparation method of eszopiclone tablet composition of the present invention, eszopiclone and one or more kinds of oiliness is auxiliary
Material is uniformly mixed, then mix and is adsorbed with colloidal silicon dioxide, then after being mixed with auxiliary materials such as microcrystalline celluloses, progress tabletting or
Person fills capsule.The problem of this solution solves the small dimension medicament contg uniformitys, while avoiding raw material in production process
Spread the bitter taste generated.
The preparation method of eszopiclone piece of the present invention, includes the following steps：
Requirement of the first step to supplementary material granularity：Eszopiclone sieves with 100 mesh sieve, other solid adjuvant materials cross 80 mesh sieve；
The eszopiclone of second step recipe quantity is added in oiliness auxiliary material, is uniformly mixed；
The calcium monohydrogen phosphate of the colloidal silicon dioxide of recipe quantity, half recipe quantity is added to mixing obtained by second step by third step
In uniform object, it is uniformly mixed；
At uniformly mixed object and microcrystalline cellulose, croscarmellose sodium, remaining half obtained by 4th step third step
The calcium monohydrogen phosphate just measured is uniformly mixed.
Magnesium stearate is added after mixing in the material of the 4th step of 5th step, tabletting.
Advantageous effect：Active constituent is dispersed in oiliness auxiliary material by technical solution of the present invention first, is disperseed with oiliness auxiliary material
Active constituent is dissolved, colloidal silicon dioxide and calcium monohydrogen phosphate is then used to adsorb oiliness auxiliary material.Prescription of the present invention is rationally matched
5, in conjunction with the preparation method while playing cladding, indiffusion smell to active component, also the stability of slice, thin piece is played
Obvious action.
Embodiment 1. eszopiclone 1mg, microcrystalline cellulose 40mg, calcium monohydrogen phosphate 8mg, croscarmellose sodium 3mg, glue
State silica 30mg, Tween 80 10mg, magnesium stearate 1.4mg.1000 are prepared according to preparation method described in technical solution part
Piece.There is no the bitter taste of eszopiclone to occur during film-making, in air.
Embodiment 2. eszopiclone 3mg, microcrystalline cellulose 87mg, calcium monohydrogen phosphate 12mg, croscarmellose sodium 5mg,
Colloidal silicon dioxide 10mg, polyethylene glycol 400 20mg, magnesium stearate 2mg.According to preparation method system described in technical solution part
It is 1000 standby.There is no the bitter taste of eszopiclone to occur during film-making, in air.
Embodiment 3. eszopiclone 2mg, microcrystalline cellulose 72mg, calcium monohydrogen phosphate 9mg, croscarmellose sodium 3mg, glue
State silica 25mg, lecithin 14mg, magnesium stearate 1.5mg.1000 are prepared according to preparation method described in technical solution part
Piece.There is no the bitter taste of eszopiclone to occur during film-making, in air.
Embodiment 4. eszopiclone 2mg, microcrystalline cellulose 58mg, calcium monohydrogen phosphate 10mg, croscarmellose sodium 3mg,
Colloidal silicon dioxide 15mg, glycerine 18mg, magnesium stearate 1.8mg.1000 are prepared according to preparation method described in technical solution part
Piece.There is no the bitter taste of eszopiclone to occur during film-making, in air.
Embodiment 5. eszopiclone 2mg, microcrystalline cellulose 65mg, calcium monohydrogen phosphate 10mg, croscarmellose sodium 4mg,
Colloidal silicon dioxide 20mg, Tween 80 10mg, magnesium stearate 1.6mg.It is prepared according to preparation method described in technical solution part
1000.There is no the bitter taste of eszopiclone to occur during film-making, in air.
Embodiment 6. eszopiclone 2mg, microcrystalline cellulose 58mg, calcium monohydrogen phosphate 10mg, croscarmellose sodium 3mg,
Colloidal silicon dioxide 20mg, polyethylene glycol 400 10mg, lecithin 8mg, magnesium stearate 2mg.Described in technical solution part
Preparation method prepares 1000.There is no the bitter taste of eszopiclone to occur during film-making, in air.
Embodiment 7. eszopiclone 2mg, microcrystalline cellulose 70mg, calcium monohydrogen phosphate 10mg, croscarmellose sodium 4mg,
Colloidal silicon dioxide 18mg, Tween 80 15mg, magnesium stearate 1.6mg.It is prepared according to preparation method described in technical solution part
1000.There is no the bitter taste of eszopiclone to occur during film-making, in air.
Reference examples 1（Prescription is not added with calcium monohydrogen phosphate and oil components with reference to embodiment 7）
Eszopiclone 2mg, microcrystalline cellulose 70mg, croscarmellose sodium 4mg, colloidal silicon dioxide 18mg are stearic
Sour magnesium 1.6mg.1000 are prepared by following preparation methods, has the bitter taste of eszopiclone to occur during film-making, in air.
First step eszopiclone sieves with 100 mesh sieve, other solid adjuvant materials cross 80 mesh sieve；
The eszopiclone of second step recipe quantity is uniformly mixed with the colloidal silicon dioxide of recipe quantity, and microcrystalline cellulose is added, hands over
Join sodium carboxymethylcellulose to be uniformly mixed.
Third walks second step resulting material and magnesium stearate is added, and is uniformly mixed, tabletting.
Reference examples 2（Prescription is with reference to embodiment 7）
Eszopiclone 2mg, microcrystalline cellulose 70mg, calcium monohydrogen phosphate 10mg, croscarmellose sodium 4mg, colloidal state dioxy
SiClx 18mg, Tween 80 15mg, magnesium stearate 1.6mg.1000 are prepared according to preparation method described in technical solution part.It presses
Following preparation methods prepare 1000, have the bitter taste of eszopiclone to occur during film-making, in air.
First step eszopiclone sieves with 100 mesh sieve, other solid adjuvant materials cross 80 mesh sieve；
The eszopiclone of second step recipe quantity is uniformly mixed with the colloidal silicon dioxide of recipe quantity, and microcrystalline cellulose is added, hands over
Join sodium carboxymethylcellulose to be uniformly mixed.
Third walks second step resulting material and magnesium stearate is added, and is uniformly mixed, tabletting.
Reference examples 3（Prescription is with reference to embodiment 6）
Eszopiclone 2mg, microcrystalline cellulose 58mg, croscarmellose sodium 3mg, colloidal silicon dioxide 20mg, poly- second
Glycol 400 10mg, lecithin 8mg, magnesium stearate 2mg.The preparation method with reference to described in reference examples 1 prepares 1000, film-making process
In, there is the bitter taste of eszopiclone to occur in air.
Reference examples 4（Prescription is with reference to embodiment 6）
Eszopiclone 2mg, microcrystalline cellulose 58mg, calcium monohydrogen phosphate 10mg, croscarmellose sodium 3mg, colloidal state dioxy
SiClx 20mg, magnesium stearate 2mg.The preparation method with reference to described in reference examples 1 prepares 1000, during film-making, there is the right side in air
The bitter taste of zopiclone occurs.
Test example 1：According to the Determination of Content Uniformity method of States Pharmacopoeia specifications, the production of embodiment 1-7 and reference examples 1-4 are measured respectively
As a result the uniformity of dosage units of product is recorded in table 1.
1 uniformity of dosage units result of table
1 data of table illustrate that embodiment 1-7 products obtained therefrom uniformity of dosage units is better than reference examples 1-4, illustrates that technical solution of the present invention obtains
Obtained the highly uniform eszopiclone tablet of content.
Test example 2：According to the stability test assay method of States Pharmacopoeia specifications, respectively by the product of embodiment 1-7, reference examples 1-4,
Aluminum-plastic packaged respectively, it is 60 DEG C to be placed in temperature, in the climatic chamber that relative humidity is 75%, respectively at the 30th day, 60 days, 90
It takes out, and detects the related substance and dissolution rate of sample, is recorded in respectively in table 2 and table 3.
Table 2 is in relation to substance-measuring result
2 data of table explanation, the addition of oiliness auxiliary material and calcium monohydrogen phosphate, in conjunction with distinctive preparation method, for Tablets
Play extraordinary stabilization result.
3 dissolution results of table
3 data of table illustrate that the sample prepared by embodiment 1-7 is placed 3 months under the conditions of accelerated test, in relation to content of material without
It rises appreciably, dissolution rate is without being substantially reduced；And the sample prepared by reference examples 1-4 is placed 3 months under the conditions of accelerated test, is had
It closes content of material to rise appreciably, dissolution rate has in apparent downward trend.
Claims (10)
1. a kind of eszopiclone tablet composition, characterized in that in the composition of unit dose, contain eszopiclone 1-
3mg, microcrystalline cellulose 40-87mg, calcium monohydrogen phosphate 8-12mg, croscarmellose sodium 3-5mg, colloidal silicon dioxide 10-
30mg, oiliness auxiliary material 10-20mg, magnesium stearate 1.4-2mg, the oiliness auxiliary material are selected from polyoxy hydrogenated castor oil, lecithin, spit
One or more of temperature 80, polyethylene glycol 400, glycerine, poloxamer.
2. according to eszopiclone tablet composition described in claim 1, characterized in that the oiliness auxiliary material be selected from lecithin,
Tween 80, polyethylene glycol 400.
3. according to eszopiclone tablet composition described in claim 1, characterized in that in the composition of unit dose, contain
Eszopiclone 1-3mg, microcrystalline cellulose 58-72mg, calcium monohydrogen phosphate 8-12mg, croscarmellose sodium 3-5mg, colloidal state
Silica 1 5-25mg, oiliness auxiliary material 14-18mg, magnesium stearate 1.5-1.8mg.
4. according to eszopiclone tablet composition described in claim 1, characterized in that in the composition of unit dose, contain
Eszopiclone 2mg, microcrystalline cellulose 58mg, calcium monohydrogen phosphate 10mg, croscarmellose sodium 3mg, colloidal silicon dioxide
15mg, oiliness auxiliary material 14mg, magnesium stearate 1.8mg.
5. according to eszopiclone tablet composition described in claim 1, characterized in that in the composition of unit dose, contain
Eszopiclone 2mg, microcrystalline cellulose 72mg, calcium monohydrogen phosphate 12mg, croscarmellose sodium 5mg, colloidal silicon dioxide
25mg, oiliness auxiliary material 18mg, magnesium stearate 1.5mg.
6. according to eszopiclone tablet composition described in claim 1, characterized in that in the composition of unit dose, contain
Eszopiclone 2mg, microcrystalline cellulose 65mg, calcium monohydrogen phosphate 10mg, croscarmellose sodium 4mg, colloidal silicon dioxide
20mg, oiliness auxiliary material 16mg, magnesium stearate 1.6mg.
7. according to eszopiclone tablet composition described in claim 1, characterized in that in the composition of unit dose, contain
Eszopiclone 1mg, microcrystalline cellulose 70mg, calcium monohydrogen phosphate 10mg, croscarmellose sodium 4mg, colloidal silicon dioxide
18mg, glycerine 10mg, magnesium stearate 2mg.
8. according to eszopiclone tablet composition described in claim 1, characterized in that in the composition of unit dose, contain
Eszopiclone 2mg, microcrystalline cellulose 58mg, calcium monohydrogen phosphate 8-12mg, croscarmellose sodium 3mg, colloidal silica
Silicon 20mg, PEG400 15mg, magnesium stearate 2mg.
9. according to the preparation method of eszopiclone tablet composition described in claim 1, characterized in that by eszopiclone with
One or more kinds of oiliness auxiliary materials are uniformly mixed, then are uniformly mixed with colloidal silicon dioxide and calcium monohydrogen phosphate, then with microcrystalline cellulose
The auxiliary materials such as element are uniformly mixed, and then carry out tabletting.
10. according to the preparation method of eszopiclone tablet composition described in claim 1, characterized in that include the following steps：
Requirement of the first step to supplementary material granularity：Eszopiclone sieves with 100 mesh sieve, other solid adjuvant materials cross 80 mesh sieve；
The eszopiclone of second step recipe quantity is added in oiliness auxiliary material, is uniformly mixed；
The calcium monohydrogen phosphate of the colloidal silicon dioxide of recipe quantity, half recipe quantity is added to mixed obtained by second step by third step
It closes in uniform object, is uniformly mixed；
At uniformly mixed object and microcrystalline cellulose, croscarmellose sodium, remaining half obtained by 4th step third step
The calcium monohydrogen phosphate just measured is uniformly mixed；
Magnesium stearate is added after mixing in the material of the 4th step of 5th step, tabletting.
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| CN201810301888.0A CN108498471A (en) | 2018-04-04 | 2018-04-04 | A kind of eszopiclone composition |
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| CN201810301888.0A CN108498471A (en) | 2018-04-04 | 2018-04-04 | A kind of eszopiclone composition |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112089697A (en) * | 2020-10-23 | 2020-12-18 | 迪沙药业集团有限公司 | Levofloxacin hydrochloride composition |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102727452A (en) * | 2011-04-01 | 2012-10-17 | 成都康弘药业集团股份有限公司 | Eszopiclone-containing particle and its preparation method |
| CN102846538A (en) * | 2011-06-27 | 2013-01-02 | 上海中西制药有限公司 | Sedative hypnotic pharmaceutical preparation and its preparation method |
| CN104706615A (en) * | 2014-05-07 | 2015-06-17 | 迪沙药业集团有限公司 | Pharmaceutical composition |
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2018
- 2018-04-04 CN CN201810301888.0A patent/CN108498471A/en active Pending
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|---|---|---|---|---|
| CN102727452A (en) * | 2011-04-01 | 2012-10-17 | 成都康弘药业集团股份有限公司 | Eszopiclone-containing particle and its preparation method |
| CN102846538A (en) * | 2011-06-27 | 2013-01-02 | 上海中西制药有限公司 | Sedative hypnotic pharmaceutical preparation and its preparation method |
| CN104706615A (en) * | 2014-05-07 | 2015-06-17 | 迪沙药业集团有限公司 | Pharmaceutical composition |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112089697A (en) * | 2020-10-23 | 2020-12-18 | 迪沙药业集团有限公司 | Levofloxacin hydrochloride composition |
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Application publication date: 20180907 |