CN105796524B - A kind of aspirin enteric coated tablet - Google Patents
A kind of aspirin enteric coated tablet Download PDFInfo
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- CN105796524B CN105796524B CN201610184734.9A CN201610184734A CN105796524B CN 105796524 B CN105796524 B CN 105796524B CN 201610184734 A CN201610184734 A CN 201610184734A CN 105796524 B CN105796524 B CN 105796524B
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/60—Salicylic acid; Derivatives thereof
- A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
- A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
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Abstract
The present invention relates to a kind of aspirin enteric coated tablets, which is characterized in that is made of label, barrier layer and enteric coating layer, wherein label includes aspirin, calcium phosphate dibasic anhydrous, D-mannital, kaolin sodium and l-Alanine；Barrier layer includes ethyl cellulose and polyethylene glycol stearate；Enteric coating layer includes polyvinyl acetate phthallate, alginic acid and polyvinylpyrrolidone, which has many advantages, such as that burst size is small in acid, can substantially completely discharge in buffer.
Description
Technical field
The present invention relates to field of medicine preparations, and in particular to a kind of aspirin enteric coated tablet and preparation method and application.
Background technique
Aspirin (aspirin) also known as acetylsalicylic acid are one of three big classical drugs in history, go through as one kind
The long analgesic-antipyretic of history, effectiveness is obviously cheap, is so far still most widely used antipyretic-antalgic anti-inflammatory agent, and
It and is the standard preparation for comparing and evaluating other drugs.Since the 1960s, pharmacological research shows aspirin persistence
COX-1 activity is inactivated, platelet function, no dosage dependent interaction are inhibited, extremely low concentration (nmol/L) can be rapidly reached inhibition
Effect has specific blood coagulation resisting function, so as to the drug as pre- preventing thrombosis.Expert advice in primary prevention Ah
Taking charge of woods prolonged application dosage is 75~100mg/ days, and is 75~150mg/ days in the prolonged application dosage of secondary prevention.Nothing
By large dosage or low dose of Genprin, its major side effects is the stimulation to gastrointestinal tract when used for a long time, is solved
The most common method of this problem is to prepare its enteric coated preparations.Meanwhile aspirin is to damp and hot unstable, facile hydrolysis generation trip
From salicylic acid, hydrolysate salicylic acid is the principal element that aspirin causes alimentary canal to stimulate, and the height of its content is to comment
One of the important indicator of valence Genprin quality.Salicylic content must not exceed in regulation aspirin in pharmacopeia
1.5%.For the above-mentioned property of aspirin, a kind of aspirin intestines that stability Gao Bingneng discharges completely in enteron aisle are developed
Molten has vital meaning.
Summary of the invention
The purpose of the present invention is to provide a kind of aspirin enteric coated tablets that stability is high.
Technical solution: a kind of aspirin enteric coated tablet is made of, wherein label packet label, barrier layer and enteric coating layer
Include aspirin, calcium phosphate dibasic anhydrous, D-mannital, kaolin sodium and l-Alanine；Barrier layer includes ethyl cellulose
And polyethylene glycol stearate；Enteric coating layer includes polyvinyl acetate phthallate, alginic acid and polyvinylpyrrolidone,
The parts by weight of middle each component are as follows: 40-50 parts of aspirin, 20-25 parts of calcium phosphate dibasic anhydrous, 10-15 parts of D-mannital, kaolinite
Native sodium 10-15 parts, 2-5 parts of l-Alanine, 20-28 parts of ethyl cellulose, 6-9 parts of polyethylene glycol stearate, phthalic acid
12-20 parts of polyvinyl alcohol ester, 5-8 parts of alginic acid, 3-5 parts of polyvinylpyrrolidone.
The aspirin enteric coated tablet, the weight of ethyl cellulose and polyethylene glycol stearate in the barrier layer
Proportion is 3:1.
The aspirin enteric coated tablet, wherein polyvinyl acetate phthallate, alginic acid and polyvinylpyrrolidone
Weight proportion be 3:2:1.
The aspirin enteric coated tablet, wherein parts by weight of each component are as follows: 50 parts of aspirin, calcium phosphate dibasic anhydrous 20
Part, 15 parts of D-mannital, 10 parts of kaolin sodium, 5 parts of l-Alanine, 24 parts of ethyl cellulose, polyethylene glycol stearate 8
Part, 12 parts of polyvinyl acetate phthallate, 8 parts of alginic acid, 4 parts of polyvinylpyrrolidone.
One layer of barrier layer is additionally added in enteric coatel tablets of the invention among label and enteric coating layer, can increase activity at
Divide the stability of aspirin, inventor filters out ethyl cellulose and polyethylene glycol stearate conduct through a large number of experiments
The coating material of barrier layer.
Creative use polyvinyl acetate phthallate in the present invention, alginic acid and polyvinylpyrrolidone are as intestines
Molten coating material discharges enteric coatel tablets substantially completely under intestinal environment.
The tabletting of this field routine, packaging technique preparation can be used in enteric coatel tablets of the present invention.By the aspirin of formula ratio, nothing
Water calcium monohydrogen phosphate, the pure and mild l-Alanine of D-MANNOSE sieve with 100 mesh sieve, and ethanol in proper amount solution is added, and pelletize, dry, cross 20 meshes,
Kaolin sodium is added, is uniformly mixed, tabletting is to get label；The ethyl cellulose of formula ratio and polyethylene glycol stearate is molten
It in ethanol in proper amount, as spacer layer coating material, is coated on label, increase weight 10-20%；By the phthalic acid of formula ratio
Polyvinyl alcohol ester, alginic acid and polyvinylpyrrolidone are dissolved in suitable ethyl alcohol, enteric coated as enteric-coating material,
20-30% increase weight to get aspirin enteric coated tablet of the invention.
Specific embodiment
Form by the following examples is described in further detail above content of the invention again, but should not be by this
The range for being interpreted as the above-mentioned theme of the present invention is only limitted to example below, and all technologies realized based on above content of the present invention are equal
Belong to the scope of the present invention.
Embodiment 1:
Preparation method: by the aspirin of formula ratio, calcium phosphate dibasic anhydrous, the pure and mild l-Alanine of D-MANNOSE crosses 100 mesh
Ethanol in proper amount solution is added in sieve, pelletizes, dry, crosses 20 meshes, and kaolin sodium is added, and is uniformly mixed, tabletting is to get label；It will
The ethyl cellulose and polyethylene glycol stearate of formula ratio are dissolved in ethanol in proper amount, as spacer layer coating material, in label
Upper coating, increase weight 10-20%；By the polyvinyl acetate phthallate of formula ratio, alginic acid and polyvinylpyrrolidone are dissolved in
Enteric coated as enteric-coating material in suitable ethyl alcohol, the 20-30% that increases weight is to get of the invention aspirin enteric-coated
Piece.
Embodiment 2:
Preparation method: by the aspirin of formula ratio, calcium phosphate dibasic anhydrous, the pure and mild l-Alanine of D-MANNOSE crosses 100 mesh
Ethanol in proper amount solution is added in sieve, pelletizes, dry, crosses 20 meshes, and kaolin sodium is added, and is uniformly mixed, tabletting is to get label；It will
The ethyl cellulose and polyethylene glycol stearate of formula ratio are dissolved in ethanol in proper amount, as spacer layer coating material, in label
Upper coating, increase weight 10-20%；By the polyvinyl acetate phthallate of formula ratio, alginic acid and polyvinylpyrrolidone are dissolved in
Enteric coated as enteric-coating material in suitable ethyl alcohol, the 20-30% that increases weight is to get of the invention aspirin enteric-coated
Piece.
Embodiment 3
Preparation method: by the aspirin of formula ratio, calcium phosphate dibasic anhydrous, the pure and mild l-Alanine of D-MANNOSE crosses 100 mesh
Ethanol in proper amount solution is added in sieve, pelletizes, dry, crosses 20 meshes, and kaolin sodium is added, and is uniformly mixed, tabletting is to get label；It will
The ethyl cellulose and polyethylene glycol stearate of formula ratio are dissolved in ethanol in proper amount, as spacer layer coating material, in label
Upper coating, increase weight 10-20%；By the polyvinyl acetate phthallate of formula ratio, alginic acid and polyvinylpyrrolidone are dissolved in
Enteric coated as enteric-coating material in suitable ethyl alcohol, the 20-30% that increases weight is to get of the invention aspirin enteric-coated
Piece.
Comparative example 1:
Preparation method: by the aspirin of formula ratio, calcium phosphate dibasic anhydrous, the pure and mild l-Alanine of D-MANNOSE crosses 100 mesh
Ethanol in proper amount solution is added in sieve, pelletizes, dry, crosses 20 meshes, and kaolin sodium is added, and is uniformly mixed, tabletting is to get label；It will
The ethyl cellulose and polyethylene glycol stearate of formula ratio are dissolved in ethanol in proper amount, as spacer layer coating material, in label
Upper coating, increase weight 10-20%；By the polyvinyl acetate phthallate of formula ratio, alginic acid and polyvinylpyrrolidone are dissolved in
Enteric coated as enteric-coating material in suitable ethyl alcohol, the 20-30% that increases weight is to get of the invention aspirin enteric-coated
Piece.
Comparative example 2:
Preparation method: by the aspirin of formula ratio, calcium phosphate dibasic anhydrous, the pure and mild l-Alanine of D-MANNOSE crosses 100 mesh
Ethanol in proper amount solution is added in sieve, pelletizes, dry, crosses 20 meshes, and kaolin sodium is added, and is uniformly mixed, tabletting is to get label；It will
The ethyl cellulose and polyethylene glycol stearate of formula ratio are dissolved in ethanol in proper amount, as spacer layer coating material, in label
Upper coating, increase weight 10-20%；By the polyvinyl acetate phthallate of formula ratio, alginic acid and polyvinylpyrrolidone are dissolved in
Enteric coated as enteric-coating material in suitable ethyl alcohol, the 20-30% that increases weight is to get of the invention aspirin enteric-coated
Piece.
Comparative example 3:
Preparation method: by the aspirin of formula ratio, calcium phosphate dibasic anhydrous, the pure and mild l-Alanine of D-MANNOSE crosses 100 mesh
Ethanol in proper amount solution is added in sieve, pelletizes, dry, crosses 20 meshes, and kaolin sodium is added, and is uniformly mixed, tabletting is to get label；It will
The ethyl cellulose and polyethylene glycol stearate of formula ratio are dissolved in ethanol in proper amount, as spacer layer coating material, in label
Upper coating, increase weight 10-20%；The Opadry of formula ratio is dissolved in suitable ethyl alcohol, as enteric-coating material, packet enteric
Clothing, the 20-30% that increases weight is to get aspirin enteric coated tablet of the invention.
4 aspirin enteric coated tablet dissolution test of embodiment
1, acid in burst size measuring method: respectively Example and comparative example preparation enteric coatel tablets sample, according to
The second method of drug release determination method measures in 2010 editions annex of Chinese Pharmacopoeia, is that dissolution is situated between with the hydrochloric acid solution 600ml of 0.lmol/L
Matter, revolving speed are 100 turns per minute, operate according to methods, through 2 hours, take solution 10ml, filter, take subsequent filtrate as test solution；
Aspirin reference substance is taken, accurately weighed, acetate methanol solution on the rocks, which dissolves and dilutes to be made in every lml, contains the molten of 4.25 μ g
Liquid, as reference substance solution.According to the method measurement under content determination item, and calculate the burst size of aspirin.
2, in buffer burst size measuring method: in acid burst size measurement item under solution in continuously add 37 DEG C
0.2mol/L sodium radio-phosphate,P-32 solution mixes, with 2mol/L hydrochloric acid solution or 2mol/L sodium hydroxide solution adjust the pH value of solution to
6.8 ± 0.05, continue dissolution 15 minutes, take solution 10ml, filters, take subsequent filtrate as test solution；Another precision weigh Ah
It is appropriate to take charge of a woods reference substance, it is accurately weighed, the solution for being made and containing 22 μ g in every 1ml is dissolved and diluted with glacial acetic acid methanol solution,
As aspirin reference substance solution；According to the method measurement under content determination item, and calculates aspirin and discharged in buffer
Amount.
The release experimental result of 1 aspirin enteric coated tablet of table
| Embodiment | Burst size (weight %) in acid | Burst size (weight %) in buffer |
| Embodiment 1 | 0.09 | 99.26 |
| Embodiment 2 | 0.15 | 99.48 |
| Embodiment 3 | 0.13 | 98.42 |
| Comparative example 1 | 2.8 | 92.89 |
| Comparative example 2 | 3.5 | 90.72 |
| Comparative example 3 | 1.9 | 93.43 |
It can be seen that present invention selection polyvinyl acetate phthallate, alginic acid and polyethylene from the test result of table 1
Pyrrolidones as enteric coating, than use polyvinyl acetate phthallate and polyvinylpyrrolidone, use alginic acid and
Polyvinylpyrrolidone and exclusive use Opadry have burst size and higher buffer burst size in lower acid.I.e. originally
The burst size in acid of aspirin enteric coated tablet prepared by inventive embodiments is small, substantially completely discharges in buffer.
Claims (2)
1. a kind of aspirin enteric coated tablet, which is characterized in that be made of label, barrier layer and enteric coating layer, wherein label packet
Include aspirin, calcium phosphate dibasic anhydrous, D-mannital, kaolin sodium and l-Alanine；Barrier layer includes ethyl cellulose
And polyethylene glycol stearate；Enteric coating layer includes polyvinyl acetate phthallate, alginic acid and polyvinylpyrrolidone,
The parts by weight of middle each component are as follows: 40-50 parts of aspirin, 20-25 parts of calcium phosphate dibasic anhydrous, 10-15 parts of D-mannital, kaolinite
Native sodium 10-15 parts, 2-5 parts of l-Alanine, 20-28 parts of ethyl cellulose, 6-9 parts of polyethylene glycol stearate, phthalic acid
12-20 parts of polyvinyl alcohol ester, 5-8 parts of alginic acid, 3-5 parts of polyvinylpyrrolidone, in the barrier layer ethyl cellulose and
The weight proportion of polyethylene glycol stearate is 3:1, wherein polyvinyl acetate phthallate, alginic acid and polyvinylpyrrolidine
The weight proportion of ketone is 3:2:1.
2. aspirin enteric coated tablet described in claim 1, which is characterized in that the wherein parts by weight of each component are as follows: aspirin
50 parts, 20 parts of calcium phosphate dibasic anhydrous, 15 parts of D-mannital, 10 parts of kaolin sodium, 5 parts of l-Alanine, 24 parts of ethyl cellulose,
8 parts of polyethylene glycol stearate, 12 parts of polyvinyl acetate phthallate, 8 parts of alginic acid, 4 parts of polyvinylpyrrolidone.
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| CN201610184734.9A CN105796524B (en) | 2016-03-29 | 2016-03-29 | A kind of aspirin enteric coated tablet |
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| CN201610184734.9A CN105796524B (en) | 2016-03-29 | 2016-03-29 | A kind of aspirin enteric coated tablet |
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| CN105796524A CN105796524A (en) | 2016-07-27 |
| CN105796524B true CN105796524B (en) | 2019-01-01 |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008140459A1 (en) * | 2007-05-16 | 2008-11-20 | Fmc Corporation | Solid form |
| CN101352412A (en) * | 2008-09-17 | 2009-01-28 | 青岛六和药业有限公司 | Intestinal-lysis non-steroidal antipyretic-antalgic anti-inflammatory agent and preparation thereof |
| CN102641254A (en) * | 2012-05-07 | 2012-08-22 | 山东新华制药股份有限公司 | Preparation method of aspirin enteric-coated sustained-release preparation |
| CN104069085A (en) * | 2014-06-26 | 2014-10-01 | 合肥今越制药有限公司 | Aspirin enteric sustained-release capsule and preparation method thereof |
| CN104800183A (en) * | 2015-04-14 | 2015-07-29 | 南京多宝生物科技有限公司 | Aspirin enteric-coated tablet as well as preparation method and application thereof |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8574625B2 (en) * | 2007-05-30 | 2013-11-05 | Wockhardt Ltd. | Tablet dosage form |
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2016
- 2016-03-29 CN CN201610184734.9A patent/CN105796524B/en active Active
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008140459A1 (en) * | 2007-05-16 | 2008-11-20 | Fmc Corporation | Solid form |
| CN101352412A (en) * | 2008-09-17 | 2009-01-28 | 青岛六和药业有限公司 | Intestinal-lysis non-steroidal antipyretic-antalgic anti-inflammatory agent and preparation thereof |
| CN102641254A (en) * | 2012-05-07 | 2012-08-22 | 山东新华制药股份有限公司 | Preparation method of aspirin enteric-coated sustained-release preparation |
| CN104069085A (en) * | 2014-06-26 | 2014-10-01 | 合肥今越制药有限公司 | Aspirin enteric sustained-release capsule and preparation method thereof |
| CN104800183A (en) * | 2015-04-14 | 2015-07-29 | 南京多宝生物科技有限公司 | Aspirin enteric-coated tablet as well as preparation method and application thereof |
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