CN107961223A - A kind of gefarnate tablet composition - Google Patents
A kind of gefarnate tablet composition Download PDFInfo
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- CN107961223A CN107961223A CN201711491139.0A CN201711491139A CN107961223A CN 107961223 A CN107961223 A CN 107961223A CN 201711491139 A CN201711491139 A CN 201711491139A CN 107961223 A CN107961223 A CN 107961223A
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- Prior art keywords
- gefarnate
- recipe quantity
- cornstarch
- sodium
- monohydrogen phosphate
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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
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
-
- 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
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
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- Emergency Medicine (AREA)
- Inorganic Chemistry (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention relates to a kind of gefarnate tablet composition, belong to technical field of medicine.The technical scheme is that：A kind of gefarnate tablet composition, in the composition of unit dose, contain gefarnate 50mg, 40 80mg of cornstarch, 18 30mg of calcium monohydrogen phosphate, 0.8 1.5mg of dodecyl sodium sulfate, 10 18mg of chitosan, 14 25mg of sodium carboxymethylcellulose, 10 18mg of sodium carboxymethyl starch, 0.8 1.5mg of magnesium stearate.The present invention provides a kind of gefarnate tablet composition of stabilization.
Description
Technical field
The present invention relates to a kind of gefarnate tablet composition, belong to technical field of medicine.
Background technology
Gefarnate, Chinese name：[(2E) -3,7- dimethyl-octa -2,6- dialkylenes] (4E, 8E) -5,9,13- trimethyls ten
Four carbon -4,8,12- triolefin acid esters, for treating gastric ulcer and duodenal ulcer, acute and chronic gastritis, colitis, gastrospasm
Deng.
Commercially available gefarnate preparation has two kinds of forms of tablet and injection.Tablet is convenient for carrying and takes, and is adapted to any occasion.
Due to gefarnate bulk pharmaceutical chemicals to be yellowish to yellow transparent oily liquids, during tablet is prepared, it is uneven to there is mixing,
The more difficult qualification of uniformity of dosage units；And during storage, the problem of related material raises.
Therefore it provides it is a kind of it is simple, the gefarnate method for preparing tablet thereof of stable quality is very necessary.
The content of the invention
The object of the present invention is to provide a kind of gefarnate tablet composition of stable quality.
Technical solution：The technical scheme is that：A kind of gefarnate tablet composition, in the composition of unit dose,
Contain gefarnate 50mg, cornstarch 40-80mg, calcium monohydrogen phosphate 18-30mg, dodecyl sodium sulfate 0.8-1.5mg, chitosan
10-18mg, sodium carboxymethylcellulose 14-25mg, sodium carboxymethyl starch 10-18mg, magnesium stearate 0.8-1.5mg.
Currently preferred technical solution is：A kind of gefarnate tablet composition, in the composition of unit dose, contains Ji
Method ester 50mg, cornstarch 46-75mg, calcium monohydrogen phosphate 20-28mg, dodecyl sodium sulfate 0.8-1.5mg, chitosan 12-
16mg, sodium carboxymethylcellulose 16-20mg, sodium carboxymethyl starch 10-15mg, magnesium stearate 0.8-1.5mg.
Currently preferred technical solution is：A kind of gefarnate tablet composition, in the composition of unit dose, contains Ji
Method ester 50mg, cornstarch 68mg, calcium monohydrogen phosphate 25mg, dodecyl sodium sulfate 1.2mg, chitosan 14mg, carboxymethyl cellulose
Plain sodium 18mg, sodium carboxymethyl starch 14mg, magnesium stearate 1.2mg.
In technical solution of the present invention, the addition of dodecyl sodium sulfate, on the one hand improves the dissolution rate of main ingredient, the opposing party
Face improves the stability of main ingredient so that tablet during storage, stablize by related material.
The addition of chitosan, calcium monohydrogen phosphate, has certain booster action to the stability of main ingredient.
The preparation method of the present composition, comprises the following steps：
First step cornstarch, calcium monohydrogen phosphate, dodecyl sodium sulfate, chitosan, sodium carboxymethylcellulose, magnesium stearate point
80 mesh sieves are not crossed.
Second step weighs the gefarnate of recipe quantity, is uniformly mixed with the dodecyl sodium sulfate of recipe quantity, adds four points
One of the sodium carboxymethyl starch of the cornstarch of recipe quantity, the calcium monohydrogen phosphate of half recipe quantity and half recipe quantity mix
Close uniformly, by the use of 45% ethanol as wetting agent, granulation, 30 DEG C of vacuum drying, cross 60 mesh sieves.
Particle obtained by 3rd step second step, is mixed with the cornstarch, calcium monohydrogen phosphate, sodium carboxymethyl starch of remaining recipe quantity
Close uniform, add the chitosan of the recipe quantity of recipe quantity, sodium carboxymethylcellulose is uniformly mixed, by the use of 45% ethanol as soaking
Agent, granulation, 30 DEG C of vacuum drying, cross 40 mesh sieves.
Particle obtained by the 3rd step of 4th step, adds the magnesium stearate of recipe quantity, tabletting.
Preparation method of the present invention, for the stabilization of the stabilization of uniformity of dosage units, and tablet, has certain positive
Effect.
Beneficial effect：The present invention provides a kind of gefarnate tablet composition of stabilization, present composition content are uniform
Degree, dissolution rate can meet standard requirement, and the stable quality during storage.
Embodiment 1,
Gefarnate 50g, cornstarch 40g, calcium monohydrogen phosphate 18g, dodecyl sodium sulfate 1.5g, chitosan 10g, carboxymethyl cellulose
Plain sodium 14g, sodium carboxymethyl starch 18g, magnesium stearate 0.8g, preparation method prepares 1000 as described in technical solution.
Embodiment 2, gefarnate 50g, cornstarch 80g, calcium monohydrogen phosphate 30g, dodecyl sodium sulfate 0.8g, chitosan
18g, sodium carboxymethylcellulose 25g, sodium carboxymethyl starch 10g, magnesium stearate 1.5g, as described in technical solution prepared by preparation method
1000.
Embodiment 3, gefarnate 50g, cornstarch 68g, calcium monohydrogen phosphate 25g, dodecyl sodium sulfate 1.2g, chitosan
14g, sodium carboxymethylcellulose 18g, sodium carboxymethyl starch 14g, magnesium stearate 1.2g, as described in technical solution prepared by preparation method
1000.
The prescription of reference examples 1, embodiment 3, cuts dodecyl sodium sulfate, and corresponding weight is supplemented by cornstarch, tool
Body is as follows：
Gefarnate 50g, cornstarch 69.2g, calcium monohydrogen phosphate 25g, chitosan 14g, sodium carboxymethylcellulose 18g, carboxymethyl form sediment
Powder sodium 14g, magnesium stearate 1.2g, 1000 are prepared by following preparation methods.
First step cornstarch, calcium monohydrogen phosphate, chitosan, sodium carboxymethylcellulose, magnesium stearate cross 80 mesh sieves respectively.
Second step weighs the gefarnate of recipe quantity, adds cornstarch, the half prescription of a quarter recipe quantity
The calcium monohydrogen phosphate of amount and the sodium carboxymethyl starch of half recipe quantity are uniformly mixed, by the use of 45% ethanol as wetting agent, granulation,
30 DEG C of vacuum drying, cross 60 mesh sieves.
Particle obtained by 3rd step second step, is mixed with the cornstarch, calcium monohydrogen phosphate, sodium carboxymethyl starch of remaining recipe quantity
Close uniform, add the chitosan of the recipe quantity of recipe quantity, sodium carboxymethylcellulose is uniformly mixed, by the use of 45% ethanol as soaking
Agent, granulation, 30 DEG C of vacuum drying, cross 40 mesh sieves.
Particle obtained by the 3rd step of 4th step, adds the magnesium stearate of recipe quantity, tabletting.
The prescription of reference examples 2, embodiment 3, cuts chitosan and calcium monohydrogen phosphate, and corresponding weight is supplemented by cornstarch, specifically
It is as follows：
Gefarnate 50g, cornstarch 107g, dodecyl sodium sulfate 1.2g, sodium carboxymethylcellulose 18g, sodium carboxymethyl starch
14g, magnesium stearate 1.2g, 1000 are prepared by following preparation methods.
First step cornstarch, dodecyl sodium sulfate, sodium carboxymethylcellulose, magnesium stearate cross 80 mesh sieves respectively.
Second step weighs the gefarnate of recipe quantity, is uniformly mixed with the dodecyl sodium sulfate of recipe quantity, adds four points
One of cornstarch, the sodium carboxymethyl starch of half recipe quantity of recipe quantity be uniformly mixed, be used as wetting by the use of 45% ethanol
Agent, granulation, 30 DEG C of vacuum drying, cross 60 mesh sieves.
Particle obtained by 3rd step second step, cornstarch, sodium carboxymethyl starch with remaining recipe quantity are uniformly mixed, then
The sodium carboxymethylcellulose for adding the recipe quantity of recipe quantity is uniformly mixed, and wetting agent, granulation, 30 DEG C of vacuum are used as by the use of 45% ethanol
It is dry, cross 40 mesh sieves.
Particle obtained by the 3rd step of 4th step, adds the magnesium stearate of recipe quantity, tabletting.
The prescription of reference examples 3, embodiment 3, one-step method granulation are specific as follows：
Gefarnate 50g, cornstarch 68g, calcium monohydrogen phosphate 25g, dodecyl sodium sulfate 1.2g, chitosan 14g, carboxymethyl cellulose
Plain sodium 18g, sodium carboxymethyl starch 14g, magnesium stearate 1.2g, 1000 are prepared by following preparation methods.
First step cornstarch, calcium monohydrogen phosphate, dodecyl sodium sulfate, chitosan, sodium carboxymethylcellulose, stearic acid
Magnesium crosses 80 mesh sieves respectively.
Second step weighs the gefarnate of recipe quantity, is uniformly mixed with the dodecyl sodium sulfate of recipe quantity, adds prescription
Cornstarch, calcium monohydrogen phosphate, the sodium carboxymethyl starch of amount are uniformly mixed, and add chitosan, the carboxymethyl cellulose of recipe quantity
Sodium is uniformly mixed, and by the use of 45% ethanol as wetting agent, granulation, 30 DEG C of vacuum drying, cross 40 mesh sieves.
3rd step youngster walks gained particle, adds the magnesium stearate of recipe quantity, tabletting.
Test example 1, respectively Example 1-3 and the product of reference examples 4, respectively take 10, HPLC analysis detections are each at random
The content of active ingredient in tablet, the labelled content of active component content and active ingredient in more each tablet, calculates standard
Deviation RSD, data record and table 1.
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Reference examples 3 | |
| Average content, % | 99.98 | 99.99 | 100.01 | 99.92 |
| RSD, % | 0.8 | 0.9 | 0.8 | 3.68 |
The uniformity of dosage units of batch is tested in 99.98% -100.01% scope.For the tablet of all batches, RSD (phases
To standard deviation, represented with the percentage of value) it is less than 2%, it means that and the content uniformity of tablet is high.And test example
RSD be up to 3.68.Illustrate preparation method of the present invention, be effective for improving uniformity of dosage units.
Test example 2 distinguishes each 100 of the product of Example 1-3 and reference examples 1-3, aluminum-plastic packaged, is placed in constant temperature and humidity
In case, 30 DEG C, relative humidity 65%, stores December.Measure stores preceding and the 12nd the end of month related content of material respectively（Efficient liquid
Phase chromatography）, and the appearance of piece is observed, data record and table 2.
2 data of table illustrate prescription of the present invention, are to have for stable tablet in the related content of material and appearance of the process of storage China
Effect.
Preparation method of the present invention, appearance and related content of material for stable tablet have certain positive effect.
Claims (4)
1. a kind of gefarnate tablet composition, it is characterised in that in the composition of unit dose, contain gefarnate 50mg, corn
Starch 40-80mg, calcium monohydrogen phosphate 18-30mg, dodecyl sodium sulfate 0.8-1.5mg, chitosan 10-18mg, carboxymethyl cellulose
Plain sodium 14-25mg, sodium carboxymethyl starch 10-18mg, magnesium stearate 0.8-1.5mg.
2. according to gefarnate tablet composition described in claim 1, it is characterised in that in the composition of unit dose, contain Ji
Method ester 50mg, cornstarch 46-75mg, calcium monohydrogen phosphate 20-28mg, dodecyl sodium sulfate 0.8-1.5mg, chitosan 12-
16mg, sodium carboxymethylcellulose 16-20mg, sodium carboxymethyl starch 10-15mg, magnesium stearate 0.8-1.5mg.
3. according to gefarnate tablet composition described in claim 1, it is characterised in that in the composition of unit dose, contain Ji
Method ester 50mg, cornstarch 68mg, calcium monohydrogen phosphate 25mg, dodecyl sodium sulfate 1.2mg, chitosan 14mg, carboxymethyl cellulose
Plain sodium 18mg, sodium carboxymethyl starch 14mg, magnesium stearate 1.2mg.
4. the preparation method of gefarnate tablet composition described in claim 1, it is characterised in that comprise the following steps：
First step cornstarch, calcium monohydrogen phosphate, dodecyl sodium sulfate, chitosan, sodium carboxymethylcellulose, magnesium stearate point
80 mesh sieves are not crossed；
Second step weighs the gefarnate of recipe quantity, is uniformly mixed with the dodecyl sodium sulfate of recipe quantity, adds a quarter
The sodium carboxymethyl starch mixing of the cornstarch of recipe quantity, the calcium monohydrogen phosphate of half recipe quantity and half recipe quantity is equal
Even, by the use of 45% ethanol as wetting agent, granulation, 30 DEG C of vacuum drying, cross 60 mesh sieves；
Particle obtained by 3rd step second step, mixes with the cornstarch, calcium monohydrogen phosphate, sodium carboxymethyl starch of remaining recipe quantity
It is even, add the chitosan of the recipe quantity of recipe quantity, sodium carboxymethylcellulose is uniformly mixed, wetting agent, system are used as by the use of 45% ethanol
Grain, 30 DEG C of vacuum drying, crosses 40 mesh sieves；
Particle obtained by the 3rd step of 4th step, adds the magnesium stearate of recipe quantity, tabletting.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711491139.0A CN107961223A (en) | 2017-12-30 | 2017-12-30 | A kind of gefarnate tablet composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711491139.0A CN107961223A (en) | 2017-12-30 | 2017-12-30 | A kind of gefarnate tablet composition |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN107961223A true CN107961223A (en) | 2018-04-27 |
Family
ID=61993911
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201711491139.0A Withdrawn CN107961223A (en) | 2017-12-30 | 2017-12-30 | A kind of gefarnate tablet composition |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN107961223A (en) |
-
2017
- 2017-12-30 CN CN201711491139.0A patent/CN107961223A/en not_active Withdrawn
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| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| WW01 | Invention patent application withdrawn after publication |
Application publication date: 20180427 |
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| WW01 | Invention patent application withdrawn after publication |