CN109432023A - A kind of ibuprofen arginine tablet and preparation method thereof - Google Patents
A kind of ibuprofen arginine tablet and preparation method thereof Download PDFInfo
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- CN109432023A CN109432023A CN201811567394.3A CN201811567394A CN109432023A CN 109432023 A CN109432023 A CN 109432023A CN 201811567394 A CN201811567394 A CN 201811567394A CN 109432023 A CN109432023 A CN 109432023A
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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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
- A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
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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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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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
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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Abstract
The invention discloses a kind of ibuprofen arginine tablets and preparation method thereof, ibuprofen arginine microparticle is prepared using centrifugal granulating method, and processing is coated by capsule core of ibuprofen arginine microparticle, the shortcomings that overcoming the ibuprofen arginine easy moisture absorption covers the penetrating odor of drug itself；Using silica auxiliary acrylic resin pharmaceutical carrier as coating material, brufen coated granule is prepared, the dissolution of brufen is accelerated, the bitter taste of brufen can be covered；Using the ibuprofen granule powder after coating as tabletting powder in the present invention, cooperate softwood processed with auxiliary material, tablet is prepared through granulation, tabletting again, compared with the process of the prior art, the ibuprofen arginine tablet of the method for the present invention preparation has dissolution rate high, the advantages that stability is good, and bioavilability is high, is not easy the moisture absorption.
Description
Technical field
The invention belongs to technical field of medicine, and in particular to a kind of ibuprofen arginine tablet and preparation method thereof.
Background technique
Brufen is that clinically common Nonsteroidal anti-inflammatory, antalgesic, analgesic activity are significant.Brufen is practically insoluble in
Water, the pharmacokinetic parameters Tmax value (time for reaching maximum plasma concentration) of tablet are 1.5-2 hours, are worked relatively slow.
Ibuprofen arginine is brufen soluble derivative, and it is water soluble quick-acting that the dosage form of report, which has syrup and granule,
Preparation increases body absorption rate.But although syrup and granule can reach quick-acting, the problem is that acrid flavour is peppery, disease
People's poor resistance.
Onset time, T are shortened compared with Genpril by tablet made of raw material of arginine IbuprofenmaxValue is
0.5 hour.Due to not being aqueous solution compared with arginine Ibuprofen syrup and granule, so there is no pungent sense when medication,
Increase the tolerance of patient.In addition, arginine ibuprofen tablet production, storage and patient carry, take than arginine cloth
Ibuprofen syrup and granule are convenient, and additive of tablet and preparation packaging are also simply inexpensive compared with other preparations.
But according to the prior art, it is very difficult that ibuprofen arginine is made into solid pharmaceutical preparation, especially be made granule and
When tablet, one side moisture absorption phenomenon is very serious, on the other hand makes to be made into specific dosage form due to irritating smell and is limited
System.
Hot-melt extruded (Hot Melt Extrusion, HME) technology is the extrusion by single screw rod or twin-screw, by raw material
Medicine, carrier material mix simultaneously, melt molding, and due to its strong mixing and shear action, drug and carrier material are by multiphase
State switchs to single phase, is present in drug in carrier material with molecular state.
Summary of the invention
In view of the above shortcomings of the prior art, the purpose of the present invention is to provide a kind of ibuprofen arginine tablet and systems
Preparation Method, the ibuprofen arginine tablet being prepared are not easy the moisture absorption, effectively improve the solubility of brufen, improve curative effect, together
When can cover the bitter taste of brufen, increase the tolerance of patient.
In order to achieve the above objectives, the invention adopts the following technical scheme:
A kind of ibuprofen arginine tablet prepares ibuprofen arginine microparticle using centrifugal granulating method, and with cloth Lip river
Fragrant arginine microparticle is capsule core, using silica auxiliary acrylic resin pharmaceutical carrier as coating material, prepares brufen packet
Clothing particle, then formed through soft material granulation, tabletting；
The partial size of the ibuprofen arginine microparticle is in 0.25~0.45mm.
Further, the ibuprofen arginine tablet mixes system with auxiliary material using brufen coated granule as tabletting powder
It is prepared at softwood, then through granulation, tabletting；The auxiliary material includes one of adhesive, disintegrating agent, lubricant or a variety of mixed
It closes.
Further, the disintegrating agent is selected from low-substituted hydroxypropyl cellulose, microcrystalline cellulose, crospovidone, crosslinking
One of sodium carboxymethylcellulose is a variety of.
Further, the lubricant is selected from one of stearic acid, superfine silica gel powder, talcum powder or a variety of.
The invention also discloses the preparation methods of above-mentioned ibuprofen arginine tablet, including following preparation step:
(1) granulation capsule core: being placed in centrifugation pellet processing machine for suitable arginine Ibuprofen, be then turned on centrifugation pellet processing machine,
And -80% ethanol of 0.5% PVP K30 is sprayed, centrifugal granulator is carried out, by the arginine Ibuprofen capsule core prepared at 40 DEG C
At a temperature of be dried, and sieved with 40 mesh, 60 mesh screens, it is micro- to the arginine Ibuprofen between 60 mesh to collect 40 mesh
Ball, as capsule core；
(2) preparation of brufen coated granule:
Using silica, acrylic resin pharmaceutical carrier as coating material, pelletize through hot-melt extruded；
Brufen bulk pharmaceutical chemicals and coating material being taken, with 1:(1.2-1.5) ratio of (ω/ω) is uniformly mixed, with step (1)
Arginine Ibuprofen capsule core after mixing, is added in the loading hopper of hot-melt extruded instrument, and preheating heats mini-extruder extrusion instrument extremely before feeding
Set temperature is 80-85 DEG C, sets screw speed as 30-60r/min；
Fusant is squeezed out after squeezing out by head die hole with form of strips, is cooled to room temperature, and is crushed, and brufen coating is obtained
Particle；
(3) softwood is prepared:
The brufen coated granule for taking step (2) to prepare is uniformly mixed with disintegrating agent, adds adhesive softwood；
(4) granulation, tabletting:
Softwood obtained by step (3) is pelletized, 16 meshes are crossed, and crosses 14 mesh whole grains after drying, by particle after whole grain with
Lubricant is added in mixing machine, and tabletting is after mixing to get the ibuprofen arginine tablet.
Further, the mass ratio of ibuprofen arginine capsule core and coating material is in the brufen coated granule
(1.5-2): 1.
Further, the mass ratio in the coating material between silica and acrylic resin pharmaceutical carrier is 1:
(3-5)。
The present invention has the beneficial effect that:
(1) present invention prepares ibuprofen arginine microparticle using centrifugal granulating method, and with ibuprofen arginine micro-
Grain is the shortcomings that capsule core is coated processing, overcomes the ibuprofen arginine easy moisture absorption, the penetrating odor of cover drug itself.
(2) using silica auxiliary acrylic resin pharmaceutical carrier as coating material, brufen coated granule, a side are prepared
Face silica has porous structure and polymolecularity, has extremely strong adsorption capacity to drug, so that brufen is easily adsorbed to
Inside, while the silicone hydroxyl (- SiOH) of particle surface has very strong affinity to water, and can with there are the ends such as-OH ,-NH
The molecule of group forms intermolecular hydrogen bonding and accelerates brufen so as to improve the mobility of brufen coated granule powder
Dissolution；Anionic group in another aspect ibuprofen molecule and the cation group in acrylic resin pharmaceutical carrier molecule with
Hydrogenbond can cover the bitter taste of brufen.
(3) processing of Genpril is mostly using brufen/arginine Ibuprofen bulk pharmaceutical chemicals and auxiliary material in the prior art
Mixing is coated processing after granulation, tabletting again, and using the ibuprofen granule powder after coating as tabletting in the present invention
Powder cooperates softwood processed with auxiliary material, then prepares tablet through granulation, tabletting, compared with the process of the prior art, this hair
The ibuprofen arginine tablet of bright method preparation has dissolution rate high, and stability is good, and bioavilability is high, and it is excellent to be not easy moisture absorption etc.
Point.
Specific embodiment
The present invention is further explained with reference to embodiments, but is not intended to limit the contents of the present invention.
A kind of specific embodiment: preparation method of ibuprofen arginine tablet, the specific steps are as follows:
(1) granulation capsule core: being placed in centrifugation pellet processing machine for suitable arginine Ibuprofen, be then turned on centrifugation pellet processing machine,
And -80% ethanol of 0.5% PVP K30 is sprayed, centrifugal granulator is carried out, by the arginine Ibuprofen capsule core prepared at 40 DEG C
At a temperature of be dried, and sieved with 40 mesh, 60 mesh screens, it is micro- to the arginine Ibuprofen between 60 mesh to collect 40 mesh
Ball, as capsule core；
(2) preparation of brufen coated granule:
Using silica, acrylic resin pharmaceutical carrier as coating material, pelletize through hot-melt extruded；The silica with
Mass ratio between acrylic resin pharmaceutical carrier is 1:(3-5)；
Brufen bulk pharmaceutical chemicals and coating material being taken, with 1:(1.2-1.5) ratio of (ω/ω) is uniformly mixed, with step (1)
Arginine Ibuprofen capsule core after mixing, is added in the loading hopper of hot-melt extruded instrument, and preheating heats mini-extruder extrusion instrument extremely before feeding
Set temperature is 80-85 DEG C, sets screw speed as 30-60r/min；By head die hole with form of strips after fusant extrusion
It squeezes out, is cooled to room temperature, crush, obtain brufen coated granule；
The mass ratio of ibuprofen arginine capsule core and coating material is (1.5-2) in the brufen coated granule: 1.
(3) softwood is prepared:
The brufen coated granule for taking step (2) to prepare is uniformly mixed with disintegrating agent, adds adhesive softwood；It is described
Disintegrating agent is selected from one of low-substituted hydroxypropyl cellulose, microcrystalline cellulose, crospovidone, croscarmellose sodium
Or it is a variety of；
(4) granulation, tabletting:
Softwood obtained by step (3) is pelletized, 16 meshes are crossed, and crosses 14 mesh whole grains after drying, by particle after whole grain with
Lubricant is added in mixing machine, and the lubricant is selected from one of stearic acid, superfine silica gel powder, talcum powder or a variety of；Mixing is equal
Tabletting is after even to get the ibuprofen arginine tablet.
Embodiment 1:
The preparation of every 1000 arginine ibuprofen tablets, the specific steps are as follows:
(1) granulation capsule core: weighing 200g arginine Ibuprofen and be placed in centrifugation pellet processing machine, be then turned on centrifugation pellet processing machine,
And -80% ethanol of 0.5% PVP K30 is sprayed, centrifugal granulator is carried out, by the arginine Ibuprofen capsule core prepared at 40 DEG C
At a temperature of be dried, and sieved with 40 mesh, 60 mesh screens, it is micro- to the arginine Ibuprofen between 60 mesh to collect 40 mesh
Ball, as capsule core；
(2) preparation of brufen coated granule:
25g silica, 75g acrylic resin pharmaceutical carrier are weighed as coating material, is pelletized through hot-melt extruded；
It weighs 130g brufen bulk pharmaceutical chemicals and coating material is uniformly mixed, then is mixed with step (1) arginine Ibuprofen capsule core
It after closing uniformly, is added in the loading hopper of hot-melt extruded instrument, preheating hot melt mini-extruder extrusion instrument to set temperature is 82 DEG C before feeding, setting
Screw speed is 35r/min；Fusant is squeezed out after squeezing out by head die hole with form of strips, is cooled to room temperature, and is crushed, is obtained
Brufen coated granule；
(3) softwood is prepared:
Brufen coated granule and 12g low-substituted hydroxypropyl cellulose, the 28g microcrystalline cellulose for taking step (2) to prepare are mixed
It closes uniformly, rotating speed of agitator 24 turns/min, mixing time 30min, 150g cornstarch is added by several times in material upon mixing
Slurry, and 40min is stirred in timing, and softwood is made；
(4) granulation, tabletting:
Softwood obtained by step (3) is pelletized, crosses 16 meshes, and under the conditions of 50 DEG C of ± 5 DEG C of temperature, dry 25 ±
5min crosses 14 mesh whole grains after dry, and particle detections moisture must not cross 3.0% after whole grain；
Particle after whole grain and 28g lubricant talcum powder are added in mixing machine, tabletting is after mixing to get the cloth Lip river
Fragrant arginine tablets.
Embodiment 2:
The preparation of every 1000 arginine ibuprofen tablets, the specific steps are as follows:
(1) granulation capsule core: weighing 200g arginine Ibuprofen and be placed in centrifugation pellet processing machine, be then turned on centrifugation pellet processing machine,
And -80% ethanol of 0.5% PVP K30 is sprayed, centrifugal granulator is carried out, by the arginine Ibuprofen capsule core prepared at 40 DEG C
At a temperature of be dried, and sieved with 40 mesh, 60 mesh screens, it is micro- to the arginine Ibuprofen between 60 mesh to collect 40 mesh
Ball, as capsule core；
(2) preparation of brufen coated granule:
25g silica, 75g acrylic resin pharmaceutical carrier are weighed as coating material, is pelletized through hot-melt extruded；
It weighs 130g brufen bulk pharmaceutical chemicals and coating material is uniformly mixed, then is mixed with step (1) arginine Ibuprofen capsule core
It after closing uniformly, is added in the loading hopper of hot-melt extruded instrument, preheating hot melt mini-extruder extrusion instrument to set temperature is 82 DEG C before feeding, setting
Screw speed is 35r/min；Fusant is squeezed out after squeezing out by head die hole with form of strips, is cooled to room temperature, and is crushed, is obtained
Brufen coated granule；
(3) softwood is prepared:
The brufen coated granule for taking step (2) to prepare is uniformly mixed with 18g crospovidone, 23g microcrystalline cellulose, is stirred
Mix 24 turns/min of paddle revolving speed, 150g corn starch liquid, and timing is added in material upon mixing in mixing time 30min by several times
40min is stirred, softwood is made；
(4) granulation, tabletting:
Softwood obtained by step (3) is pelletized, crosses 16 meshes, and under the conditions of 50 DEG C of ± 5 DEG C of temperature, dry 25 ±
5min crosses 14 mesh whole grains after dry, and particle detections moisture must not cross 3.0% after whole grain；
Particle after whole grain and 16g stearic acid, 24g superfine silica gel powder are added in mixing machine, tabletting is after mixing to get institute
State ibuprofen arginine tablet.
Embodiment 3:
The preparation of every 1000 arginine ibuprofen tablets, the specific steps are as follows:
(1) granulation capsule core: weighing 200g arginine Ibuprofen and be placed in centrifugation pellet processing machine, be then turned on centrifugation pellet processing machine,
And -80% ethanol of 0.5% PVP K30 is sprayed, centrifugal granulator is carried out, by the arginine Ibuprofen capsule core prepared at 40 DEG C
At a temperature of be dried, and sieved with 40 mesh, 60 mesh screens, it is micro- to the arginine Ibuprofen between 60 mesh to collect 40 mesh
Ball, as capsule core；
(2) softwood is directly prepared:
25g silica, 75g acrylic resin pharmaceutical carrier are weighed, then weighs 130g brufen bulk pharmaceutical chemicals and is uniformly mixed,
It is uniformly mixed again with step (1) arginine Ibuprofen capsule core, obtains mixing medicine, for use；
Mixing medicine is taken to be uniformly mixed with 12g low-substituted hydroxypropyl cellulose, 28g microcrystalline cellulose, 24 turns of rotating speed of agitator/
150g corn starch liquid is added in material upon mixing by several times by min, mixing time 30min, and 40min is stirred in timing, is made
Softwood；
(3) granulation, tabletting:
Softwood obtained by step (2) is pelletized, crosses 16 meshes, and under the conditions of 50 DEG C of ± 5 DEG C of temperature, dry 25 ±
5min crosses 14 mesh whole grains after dry, and particle detections moisture must not cross 3.0% after whole grain；
Particle after whole grain and 28g lubricant talcum powder are added in mixing machine, tabletting is after mixing to get the cloth Lip river
Fragrant arginine tablets.
Embodiment 4: testing result
By embodiment 1-3, arginine Ibuprofen piece obtained presses Chinese Pharmacopoeia two annex progress quality of version in 2010 respectively
It examines, specific examination table 1.
Disintegration time refers to the ifs vitro disintegration time, specifically using 37 DEG C of water as medium, when investigating the ifs vitro disintegration of oral disintegrating tablet
Between.
Porosity test: in Example 1-3 gained tablet horizontalization ware, 5 are placed under the conditions of room temperature relative humidity is 80%
It, and compared in the investigation of sampling in 3,5 days.
1 testing result of table
Without Cotton seeds in embodiment 3, used coating material directly with brufen bulk pharmaceutical chemicals, brufen essence ammonia
Sour pellet directly mixes softwood processed, is processed into tablet, as shown in table 1, the arginine ibuprofen tablet and reality of embodiment 1-2 preparation
The tablet for applying the preparation of example 3 is compared, and is not easy suction and is shown, moisture protection is obvious preferably.
Claims (7)
1. a kind of ibuprofen arginine tablet, which is characterized in that ibuprofen arginine microparticle is prepared using centrifugal granulating method,
And using ibuprofen arginine microparticle as capsule core, using silica auxiliary acrylic resin pharmaceutical carrier as coating material, preparation
Brufen coated granule, then formed through soft material granulation, tabletting；
The partial size of the ibuprofen arginine microparticle is in 0.25~0.45mm.
2. a kind of ibuprofen arginine tablet according to claim 1, which is characterized in that the ibuprofen arginine tablet
Using brufen coated granule as tabletting powder, it is mixed and made into softwood with auxiliary material, then be prepared through granulation, tabletting；The auxiliary material
Including one of adhesive, disintegrating agent, lubricant or a variety of mixing.
3. a kind of ibuprofen arginine tablet according to claim 2, which is characterized in that the disintegrating agent is selected from low substitution
One of hydroxypropyl cellulose, microcrystalline cellulose, crospovidone, croscarmellose sodium are a variety of.
4. a kind of ibuprofen arginine tablet according to claim 2, which is characterized in that the lubricant is selected from tristearin
One of acid, superfine silica gel powder, talcum powder are a variety of.
5. a kind of preparation method of the ibuprofen arginine tablet as described in claim 1-4 is any, which is characterized in that including as follows
Preparation step:
(1) granulation capsule core: suitable arginine Ibuprofen is placed in centrifugation pellet processing machine, is then turned on centrifugation pellet processing machine, and spray
- 80% ethanol of 0.5% PVP K30 is spilt, centrifugal granulator is carried out, by the arginine Ibuprofen capsule core prepared in 40 DEG C of temperature
Under be dried, and sieved with 40 mesh, 60 mesh screens, collect 40 mesh to the arginine Ibuprofen pellet between 60 mesh, make
For capsule core；
(2) preparation of brufen coated granule:
Using silica, acrylic resin pharmaceutical carrier as coating material, pelletize through hot-melt extruded；
Brufen bulk pharmaceutical chemicals and coating material being taken, with 1:(1.2-1.5) ratio of (ω/ω) is uniformly mixed, with the smart ammonia of step (1)
Ibuprofen acid capsule core after mixing, is added in the loading hopper of hot-melt extruded instrument, and preheating hot melt mini-extruder extrusion instrument is extremely set before feeding
Temperature is 80-85 DEG C, sets screw speed as 30-60r/min；
Fusant is squeezed out after squeezing out by head die hole with form of strips, is cooled to room temperature, and is crushed, and brufen coating is obtained
Grain；
(3) softwood is prepared:
The brufen coated granule for taking step (2) to prepare is uniformly mixed with disintegrating agent, adds adhesive softwood；
(4) granulation, tabletting:
Softwood obtained by step (3) is pelletized, 16 meshes are crossed, and crosses 14 mesh whole grains after drying, by particle after whole grain and lubrication
Agent is added in mixing machine, and tabletting is after mixing to get the ibuprofen arginine tablet.
6. a kind of preparation method of ibuprofen arginine tablet according to claim 5, which is characterized in that the brufen
The mass ratio of ibuprofen arginine capsule core and coating material is (1.5-2) in coated granule: 1.
7. a kind of preparation method of ibuprofen arginine tablet according to claim 5, which is characterized in that the coating material
Mass ratio in material between silica and acrylic resin pharmaceutical carrier is 1:(3-5).
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| CN201811567394.3A CN109432023A (en) | 2018-12-21 | 2018-12-21 | A kind of ibuprofen arginine tablet and preparation method thereof |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1528278A (en) * | 2003-10-15 | 2004-09-15 | 杭州容立医药科技有限公司 | Method for preparing composition granules containing ibuprofen amino guanidyl valeric acid |
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2018
- 2018-12-21 CN CN201811567394.3A patent/CN109432023A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1528278A (en) * | 2003-10-15 | 2004-09-15 | 杭州容立医药科技有限公司 | Method for preparing composition granules containing ibuprofen amino guanidyl valeric acid |
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