CN105796524A - Aspirin enteric-coated tablet - Google Patents
Aspirin enteric-coated tablet Download PDFInfo
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- CN105796524A CN105796524A CN201610184734.9A CN201610184734A CN105796524A CN 105796524 A CN105796524 A CN 105796524A CN 201610184734 A CN201610184734 A CN 201610184734A CN 105796524 A CN105796524 A CN 105796524A
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- aspirin
- enteric
- parts
- polyvinylpyrrolidone
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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
- A61K31/60—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
-
- 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
-
- 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
-
- 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
- A61K47/16—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
-
- 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
-
- 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
-
- 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
-
- 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
-
- 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
Abstract
The invention relates to an aspirin enteric-coated tablet.The aspirin enteric-coated tablet is characterized by being composed of a tablet core, an isolation wrapping layer and an enteric-coated wrapping layer, wherein the tablet core includes aspirin, calcium phosphate dibasic, D-mannitol, kaolin sodium and L-alanine acid, the isolation wrapping layer includes ethyecellulose and polyethylene glycol monostearate, and the enteric-coated wrapping layer includes polyvinyl acetate phthalate, alginic acid and polyvinylpyrrolidone.The aspirin enteric-coated tablet has the advantages of being small in release quantity in acid, capable of being basically completely released in a buffer solution and the like.
Description
Technical field
The present invention relates to field of medicine preparations, be specifically related to a kind of Aspirin Enteric-coated Tablets and preparation method and application.
Background technology
Aspirin (aspirin), has another name called aspirin, is one of three big classical medicines in history, goes through as one
The antipyretic analgesic that history is long, its effectiveness is the most cheap, remains most widely used antipyretic-antalgic anti-inflammatory agent so far, and
And be the standard preparation comparing and evaluating other drug.Since the sixties in 20th century, pharmacological research shows, aspirin persistency
Inactivation COX-1 activity, suppresses platelet function, and without dosage dependent interaction, extremely low concentration (nmol/L) can be rapidly reached suppression
Effect, i.e. has clear and definite blood coagulation resisting function, such that it is able to as the medicine of pre-preventing thrombosis.Expert advice in primary prevention Ah
Department's woods prolonged application dosage was 75~100mg/ days, and was 75~150mg/ days at the prolonged application dosage of secondary prevention.Nothing
The Genprin that opinion is heavy dose of or low dose of, during life-time service, its major side effects is to stimulate gastrointestinal, solves
The most common method of this problem is to prepare its enteric coated preparation.Meanwhile, aspirin produces trip to damp and hot equal instability, facile hydrolysis
From salicylic acid, hydrolyzate salicylic acid is the principal element that aspirin causes digestive tract to stimulate, and the height of its content is to comment
One of important indicator of valency Genprin quality.In pharmacopeia, in regulation aspirin, salicylic content must not exceed
1.5%.For the above-mentioned character of aspirin, develop the aspirin intestinal that a kind of stability Gao Bingneng discharges in intestinal completely
Molten has vital meaning.
Summary of the invention
It is an object of the invention to provide the Aspirin Enteric-coated Tablets that a kind of stability is high.
Technical scheme: a kind of Aspirin Enteric-coated Tablets, is made up of label, contagion gown layer and enteric coating layer, wherein label bag
Include aspirin, calcium phosphate dibasic anhydrous, D-mannital, Kaolin sodium and ALANINE;Contagion gown layer includes ethyl cellulose
And polyglycol distearate;Enteric coating layer includes polyvinyl acetate phthallate, alginic acid and polyvinylpyrrolidone, its
In the weight portion of each component be: aspirin 40-50 part, calcium phosphate dibasic anhydrous 20-25 part, D-mannital 10-15 part, kaolinite
Soil sodium 10-15 part, ALANINE 2-5 part, ethyl cellulose 20-28 part, polyglycol distearate 6-9 part, phthalic acid
Polyvinyl alcohol ester 12-20 part, alginic acid 5-8 part, polyvinylpyrrolidone 3-5 part.
Described Aspirin Enteric-coated Tablets, ethyl cellulose and the weight of polyglycol distearate in described contagion gown layer
Proportioning is 3:1.
Described Aspirin Enteric-coated Tablets, wherein polyvinyl acetate phthallate, alginic acid and polyvinylpyrrolidone
Weight proportion be 3:2:1.
Described Aspirin Enteric-coated Tablets, the weight portion of the most each component is: aspirin 50 parts, calcium phosphate dibasic anhydrous 20
Part, D-mannital 15 parts, 10 parts of Kaolin sodium, ALANINE 5 parts, ethyl cellulose 24 parts, polyglycol distearate 8
Part, polyvinyl acetate phthallate 12 parts, alginic acid 8 parts, polyvinylpyrrolidone 4 parts.
The enteric coatel tablets of the present invention are additionally added in the middle of label and enteric coating layer one layer of contagion gown layer, by increasing capacitance it is possible to increase activity becomes
Dividing the stability of aspirin, inventor selects ethyl cellulose and polyglycol distearate conduct by substantial amounts of testing sieve
The coating material of contagion gown layer.
Employing polyvinyl acetate phthallate creative in the present invention, alginic acid and polyvinylpyrrolidone are as intestinal
Molten coating material, makes enteric coatel tablets substantially completely discharge under intestinal environment.
Enteric coatel tablets of the present invention can use the tabletting of this area routine, packaging technique to prepare.By the aspirin of formula ratio, nothing
Water calcium hydrogen phosphate, D-mannital and ALANINE cross 100 mesh sieves, add ethanol in proper amount solution, pelletize, and are dried, and cross 20 mesh sieves,
Add Kaolin sodium, mix homogeneously, tabletting, obtain label;By molten to ethyl cellulose and the polyglycol distearate of formula ratio
In ethanol in proper amount, as sealing coat coating material, coating on label, increase weight 10-20%;By the phthalic acid of formula ratio
Polyvinyl alcohol ester, alginic acid and polyvinylpyrrolidone are dissolved in appropriate ethanol, as enteric-coating material, enteric coated,
Weightening finish 20-30%, obtains the Aspirin Enteric-coated Tablets of the present invention.
Detailed description of the invention
Form by the following examples, is described in further detail the foregoing of the present invention again, but should be by this
Being interpreted as that the scope of the above-mentioned theme of the present invention is only limitted to Examples below, all technology realized based on foregoing of the present invention are equal
Belong to the scope of the present invention.
Embodiment 1:
Preparation method: the aspirin of formula ratio, calcium phosphate dibasic anhydrous, D-mannital and ALANINE are crossed 100 mesh
Sieve, adds ethanol in proper amount solution, pelletizes, and is dried, and crosses 20 mesh sieves, adds Kaolin sodium, mix homogeneously, tabletting, obtains label;Will
The ethyl cellulose of formula ratio and polyglycol distearate are dissolved in ethanol in proper amount, as sealing coat coating material, at label
Upper coating, increase weight 10-20%;The polyvinyl acetate phthallate of formula ratio, alginic acid and polyvinylpyrrolidone are dissolved in
In appropriate ethanol, as enteric-coating material, enteric coated, increase weight 20-30%, obtains the aspirin enteric-coated of the present invention
Sheet.
Embodiment 2:
Preparation method: the aspirin of formula ratio, calcium phosphate dibasic anhydrous, D-mannital and ALANINE are crossed 100 mesh
Sieve, adds ethanol in proper amount solution, pelletizes, and is dried, and crosses 20 mesh sieves, adds Kaolin sodium, mix homogeneously, tabletting, obtains label;Will
The ethyl cellulose of formula ratio and polyglycol distearate are dissolved in ethanol in proper amount, as sealing coat coating material, at label
Upper coating, increase weight 10-20%;The polyvinyl acetate phthallate of formula ratio, alginic acid and polyvinylpyrrolidone are dissolved in
In appropriate ethanol, as enteric-coating material, enteric coated, increase weight 20-30%, obtains the aspirin enteric-coated of the present invention
Sheet.
Embodiment 3
Preparation method: the aspirin of formula ratio, calcium phosphate dibasic anhydrous, D-mannital and ALANINE are crossed 100 mesh
Sieve, adds ethanol in proper amount solution, pelletizes, and is dried, and crosses 20 mesh sieves, adds Kaolin sodium, mix homogeneously, tabletting, obtains label;Will
The ethyl cellulose of formula ratio and polyglycol distearate are dissolved in ethanol in proper amount, as sealing coat coating material, at label
Upper coating, increase weight 10-20%;The polyvinyl acetate phthallate of formula ratio, alginic acid and polyvinylpyrrolidone are dissolved in
In appropriate ethanol, as enteric-coating material, enteric coated, increase weight 20-30%, obtains the aspirin enteric-coated of the present invention
Sheet.
Comparative example 1:
Preparation method: the aspirin of formula ratio, calcium phosphate dibasic anhydrous, D-mannital and ALANINE are crossed 100 mesh
Sieve, adds ethanol in proper amount solution, pelletizes, and is dried, and crosses 20 mesh sieves, adds Kaolin sodium, mix homogeneously, tabletting, obtains label;Will
The ethyl cellulose of formula ratio and polyglycol distearate are dissolved in ethanol in proper amount, as sealing coat coating material, at label
Upper coating, increase weight 10-20%;The polyvinyl acetate phthallate of formula ratio, alginic acid and polyvinylpyrrolidone are dissolved in
In appropriate ethanol, as enteric-coating material, enteric coated, increase weight 20-30%, obtains the aspirin enteric-coated of the present invention
Sheet.
Comparative example 2:
Preparation method: the aspirin of formula ratio, calcium phosphate dibasic anhydrous, D-mannital and ALANINE are crossed 100 mesh
Sieve, adds ethanol in proper amount solution, pelletizes, and is dried, and crosses 20 mesh sieves, adds Kaolin sodium, mix homogeneously, tabletting, obtains label;Will
The ethyl cellulose of formula ratio and polyglycol distearate are dissolved in ethanol in proper amount, as sealing coat coating material, at label
Upper coating, increase weight 10-20%;The polyvinyl acetate phthallate of formula ratio, alginic acid and polyvinylpyrrolidone are dissolved in
In appropriate ethanol, as enteric-coating material, enteric coated, increase weight 20-30%, obtains the aspirin enteric-coated of the present invention
Sheet.
Comparative example 3:
Preparation method: the aspirin of formula ratio, calcium phosphate dibasic anhydrous, D-mannital and ALANINE are crossed 100 mesh
Sieve, adds ethanol in proper amount solution, pelletizes, and is dried, and crosses 20 mesh sieves, adds Kaolin sodium, mix homogeneously, tabletting, obtains label;Will
The ethyl cellulose of formula ratio and polyglycol distearate are dissolved in ethanol in proper amount, as sealing coat coating material, at label
Upper coating, increase weight 10-20%;The Opadry of formula ratio is dissolved in appropriate ethanol, as enteric-coating material, bag enteric
Clothing, increase weight 20-30%, obtains the Aspirin Enteric-coated Tablets of the present invention.
Embodiment 4 Aspirin Enteric-coated Tablets dissolution test
1, the assay method of burst size in acid: the enteric coatel tablets sample that respectively prepared by Example and comparative example, according to
In 2010 editions annex of Chinese Pharmacopoeia, drug release determination method the second method measures, and is situated between with the hydrochloric acid solution 600ml of 0.lmol/L for dissolution
Matter, rotating speed is 100 turns per minute, operates in accordance with the law, through 2 hours, takes solution 10ml, filters, takes subsequent filtrate as need testing solution;
Taking aspirin reference substance, accurately weighed, acetate methanol solution on the rocks dissolves and dilutes to make and contains the molten of 4.25 μ g in every lml
Liquid, as reference substance solution.Measure according to the method under assay item, and calculate the burst size of aspirin.
2, the assay method of burst size in buffer: continuously add 37 DEG C in the solution under burst size measures item in acid
0.2mol/L sodium radio-phosphate,P-32 solution, mixing, regulate the pH value of solution extremely with 2mol/L hydrochloric acid solution or 2mol/L sodium hydroxide solution
6.8 ± 0.05, continue dissolution 15 minutes, take solution 10ml, filter, take subsequent filtrate as need testing solution;Another precision weigh Ah
Department's woods reference substance is appropriate, accurately weighed, dissolves with glacial acetic acid methanol solution and dilutes and makes the solution containing 22 μ g in every 1ml,
As aspirin reference substance solution;Measure according to the method under assay item, and calculate aspirin and discharge in buffer
Amount.
The release experimental result of table 1 Aspirin Enteric-coated Tablets
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 |
From the result of the test of table 1 it can be seen that the present invention selects polyvinyl acetate phthallate, alginic acid and polyethylene
Ketopyrrolidine as enteric coating, than use polyvinyl acetate phthallate and polyvinylpyrrolidone, use alginic acid and
Polyvinylpyrrolidone and be used alone Opadry there is burst size and higher buffer burst size in lower acid.I.e. originally
Aspirin Enteric-coated Tablets prepared by inventive embodiments burst size in acid is little, substantially completely discharges in buffer.
Claims (4)
1. an Aspirin Enteric-coated Tablets, it is characterised in that be made up of label, contagion gown layer and enteric coating layer, wherein label bag
Include aspirin, calcium phosphate dibasic anhydrous, D-mannital, Kaolin sodium and ALANINE;Contagion gown layer includes ethyl cellulose
And polyglycol distearate;Enteric coating layer includes polyvinyl acetate phthallate, alginic acid and polyvinylpyrrolidone, its
In the weight portion of each component be: aspirin 40-50 part, calcium phosphate dibasic anhydrous 20-25 part, D-mannital 10-15 part, kaolinite
Soil sodium 10-15 part, ALANINE 2-5 part, ethyl cellulose 20-28 part, polyglycol distearate 6-9 part, phthalic acid
Polyvinyl alcohol ester 12-20 part, alginic acid 5-8 part, polyvinylpyrrolidone 3-5 part.
2. the Aspirin Enteric-coated Tablets described in claim 1, it is characterised in that ethyl cellulose and poly-second in described contagion gown layer
The weight proportion of glycol stearate is 3:1.
3. the Aspirin Enteric-coated Tablets described in claim 1, it is characterised in that wherein polyvinyl acetate phthallate, Sargassum
The weight proportion of acid and polyvinylpyrrolidone is 3:2:1.
4. the Aspirin Enteric-coated Tablets described in claim 1, it is characterised in that the weight portion of the most each component is: aspirin
50 parts, calcium phosphate dibasic anhydrous 20 parts, D-mannital 15 parts, 10 parts of Kaolin sodium, ALANINE 5 parts, ethyl cellulose 24 parts,
Polyglycol distearate 8 parts, polyvinyl acetate phthallate 12 parts, alginic acid 8 parts, polyvinylpyrrolidone 4 parts.
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Citations (6)
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 |
US20150079170A1 (en) * | 2007-05-30 | 2015-03-19 | Girish Kumar Jain | Novel tablet dosage form |
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 |
-
2016
- 2016-03-29 CN CN201610184734.9A patent/CN105796524B/en active Active
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2008140459A1 (en) * | 2007-05-16 | 2008-11-20 | Fmc Corporation | Solid form |
US20150079170A1 (en) * | 2007-05-30 | 2015-03-19 | Girish Kumar Jain | Novel tablet dosage 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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