CN104606145B - ibuprofen granule and preparation method thereof - Google Patents
ibuprofen granule and preparation method thereof Download PDFInfo
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- CN104606145B CN104606145B CN201510049631.7A CN201510049631A CN104606145B CN 104606145 B CN104606145 B CN 104606145B CN 201510049631 A CN201510049631 A CN 201510049631A CN 104606145 B CN104606145 B CN 104606145B
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Abstract
The invention discloses a kind of ibuprofen granule, is made of the raw material of following parts by weight：1 part of brufen, 1~100 part of filler, 1~20 part of adhesive, 0.2~10 part of thickener, 0.1~10 part of flavouring.The particle dissolves solution rapid, that formation clear is in good taste in water, and easy to take, related material is low, and bioavilability is high.The invention also discloses a kind of preparation method of ibuprofen granule, the preparation method is easy to operate, is not required to any special installation, is adapted to industrialized production.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, and in particular to a kind of ibuprofen granule and preparation method thereof.
Background technology
Brufen, chemical name are：2- methyl -4- (2- methyl-propyls) phenylacetic acid, IUPAC are named as：2-(4-
Isobutylphenyl) propanoic acid, CAS No.15687-27-1, molecular formula C13H18O2, molecular weight 206.28, is
Non-steroidal anti-inflammatory drugs (NSAID), be in the world first be used for clinical and still widely used ibuprofen class medicine so far, it is public
It is considered one of safest medicine in non-steroidal anti-inflammatory drugs, tool analgesia, anti-inflammatory, refrigeration function, its mechanism of action is by right
The suppression of epoxidase and reduce the synthesis of prostaglandin, thus mitigate and congested, swelling organized caused by prostaglandin, reduce week
The sensitiveness of the neural pain sensation is enclosed, and refrigeration function is played by hypothalamus center of body temperature regulation.
A kind of arginine ibuprofen tablet and its system are disclosed in the Chinese patent application of Publication No. CN101390844A
Preparation Method, the easy deliquescence of the arginine ibuprofen tablet and the penetrating odor for failing cover medicine, make troubles, especially to take
It is pediatric pharmaceuticals inconvenience.
The Chinese patent application of Application No. 200310108031.0 discloses one kind and contains ibuprofen arginine composition
Preparation method of granules, wherein employing the shortcomings that coating steps overcome the ibuprofen arginine easy moisture absorption, cover the sheet of medicine
The penetrating odor of body, but step production cycle of coating is long more than general granule, it is of high cost.
The content of the invention
The present invention provides a kind of ibuprofen granule and preparation method thereof, and the ibuprofen granule is in good taste, and dissolution rate is high, and
And good fluidity, the preparation method process is simple, quality controllable and be suitable for industrialized production.
A kind of ibuprofen granule, is made of the raw material of following parts by weight：
The filler is made of sucrose and sodium cyclamate.
In the present invention, filler is used as using the mixture of sucrose and sodium cyclamate, it will be apparent that improve ibuprofen granule
Dissolution rate, meanwhile, the mouthfeel of ibuprofen granule is also effectively improved, takes more convenient, is especially suitable for children's use.
Preferably, the sucrose and the mass ratio of sodium cyclamate are 1：0.3~3.Proportion is excessive or too small
Dissolution rate will be reduced, mouthfeel is become worse.
Preferably, the ibuprofen granule, is made of the raw material of following parts by weight：
The adhesive is HPMC K4M, polyvinylpyrrolidone, starch slurry, methylcellulose and poly- second
One kind in glycol.Preferably, the adhesive is the ethanol water or polyvinylpyrrolidine of HPMC K4M
The ethanol water of ketone；
The concentration of volume percent of ethanol water for configuring described adhesive is 40%~98%, obtained bonding
The mass percent concentration of HPMC K4M and polyvinylpyrrolidone is 1%~3% in agent.Parts by weight of raw materials is with viscous
Subject to the aqueous solution of mixture.The species and dosage of adhesive used can all produce the dissolution rate of product, mobility and stability
Raw certain influence.
Preferably, the flavouring is at least one of citric acid, aspartame, stevioside, medicinal essence.By
It is insoluble solid medicine in brufen, mouthfeel hardship is peppery, and solubility reduces in an acidic solution, and bitter and peppery feeling weakens.The present invention is logical
The cooperation of citric acid, sodium cyclamate and sucrose is crossed, brufen is adjusted and is dissolved in the mouthfeel after water.
Present invention also offers a kind of preparation method of ibuprofen granule, comprise the following steps：
(1) brufen is crossed into 100 mesh sieves, auxiliary material crushed 80 mesh sieves, spare；
(2) filler aqueous solution is obtained by 1/3~1/2 filler is soluble in water；Adhesive is dissolved in ethanol water
In, obtain adhesive ethanol water；
(3) brufen after crushing is added in coating granulator, spray into step (2) obtained filler aqueous solution and
1/3~1/2 adhesive ethanol water, pelletizes, and sieving obtains the master batch of 30~40 mesh；
(4) master batch for obtaining step (3) is returned in coating granulator, continues to spray into remaining filling in step (2)
Agent aqueous solution and adhesive ethanol water, obtain the wet ball of purpose of 18 mesh~30, pellet are obtained after wet ball drying；
(5) pellet and remaining filler powder obtained step (4) is placed in trough type mixing machine and is sufficiently mixed, then
Remaining adhesive ethanol water is added, obtains softwood；
(6) softwood that step (5) obtains, which is placed on oscillating granulator, crosses the granulation of 18 mesh sieves, adds flavouring after dry, mixes
Close and obtain the ibuprofen granule.
In the present invention, the preparation of pellet is obtained by coating pelletizing step twice, is forming 30~40 mesh or so size
First sieved during particle, excessive or too small particle is removed, filler and adhesive is distributed on active ingredient
It is even, the dissolution rate and stability of the ibuprofen granule improved.
Preferably, in step (3), the rotating speed of coating pan is 100~110 revs/min, and the wriggling revolution speed of hydrojet is 10
Rev/min~15 revs/min.Prepare in master batch, the rotating speed of coating pan is kept constant；Wriggling revolution speed is 15 in initial period
Rev/min, when dustless in coating granulator after (about 5~10 minutes), wriggling revolution speed is adjusted to 10 revs/min.At this point it is possible to protect
The particle diameter distribution for the master batch held is more uniform, improves the qualification rate of master batch, and after the stage, material is crossed 40 mesh and 30 mesh
Sieve, obtains the master batch of 30~40 mesh.
Preferably, in step (4), the rotating speed of coating pan is 100~110 revs/min, the wriggling revolution speed of hydrojet for 5 turns/
Divide~10 revs/min.Master batch is returned when preparing pellet in coating pan, it is necessary to further reduce hydrojet speed, obtained pellet
Qualification rate is higher.
Preferably, the temperature of wet ball drying is 50 DEG C~70 DEG C, time of wet ball drying for 2 it is small when~4 it is small when.
The ibuprofen granule：Warm boiled water, 4~8 years old children, one time 0.5 bag；More than 8 years old children and adults, one
Secondary 1 bag, if constant pain or fever, can be spaced 4~6 it is small when repeated drug taking 1 time, 24 are no more than 4 times when small.
The invention has the advantages that：
(1) ibuprofen granule of the present invention stablizes safety, can dissolve quickly, exists with the state of liquid, can alleviate tooth rapidly
Bitterly, dysmenorrhoea, the pain caused by wound (such as：Motional injury), joint and desmalgia, backache, headache, and influenza cause
Fever.
(2) present invention adjusts the thorn of ibuprofen pharmaceutical in itself by filler and adhesive with reference to the specific proportioning of raw material
Swash property smell, and ibuprofen granule is dissolved in the mouthfeel after water, the ibuprofen granule of acquisition dissolves rapid, formation clarification in water
Transparent solution in good taste, easy to take, bioavilability is high, and in good taste and viscosity is medium, it is easier to is received.
(3) with order of addition and female ball is made in the present invention, and investing step 2) preferably improves mouthfeel and the stimulation of brufen
Property smell, it is easier to patient receive, improve compliance.
(4) preparation process of the present invention is simple, controllable, cost-effective woth no need to special equipment, shortens technological process, fits
In industrialized production.
Embodiment
Embodiment 1
Brufen is crossed into 100 mesh sieves, sucrose, HPMC K4M, sodium cyclamate and Steviosin glycosides cross 80 mesh after crushing
Sieve, it is spare.
Weigh the raw material of following recipe quantity：
(1) 6.1kg sucrose and 6.1kg sodium cyclamates are dissolved in 100kg boiling water, stirred evenly, be configured to filler water
Solution；HPMC K4M is dissolved in the ethanol water of 50% (volume percent content), stirs evenly, is configured to 1%
HPMC K4M 50% ethanol water 4.5kg, it is spare；
(2) take brufen 1.70kg to be added in coating granulator, start host, it is 110 revs/min to set rotating speed, at the same time
50% ethanol water of filler aqueous solution and 1% HPMC K4Ms of 1.5kg obtained by step (1) is sprayed, peristaltic pump turns
15 revs/min of speed, after dustless in comminutor, open cover and observes and slow down hydrojet speed to 10 revs/min, until producing master batch
Afterwards, material is released, and material is crossed into 40 mesh and 30 mesh sieves, obtains the master batch of the mesh of 30 mesh~40.
(3) take the master batch of the mesh of 30 mesh~40 to be put into the pot of coating granulator, continue to spray into remaining filling in step (2)
50% ethanol water of agent aqueous solution and 1% HPMC K4M, 8 revs/min of wriggling revolution speed, obtains the purpose of 18 mesh~30
Wet ball, is put into 60 DEG C of dryings in hot air circulation drying oven, up to pellet by the wet ball of -30 purpose of 18 mesh.
(4) pellet obtained by step (3) and remaining 12.2g sucrose and 12.2g sodium cyclamates is taken to be placed in the mixing of 10L- groove profiles
Mixed 25 minutes in machine.
(5) it is after to be mixed, remaining 3.0kg 1% HPMC K4M, 50% ethanol configured is water-soluble
Liquid is slowly added to softwood processed.
(6) softwood is placed on oscillating granulator and crosses the granulation of 18 mesh, it is dry, Steviosin glycosides 2.4kg is added, is mixed, packing
To obtain the final product.
Embodiment 2
Brufen is crossed after 100 mesh sieves, sucrose, polyvinylpyrrolidone etc. crush and crosses 80 sieves, it is spare.
Weigh the raw material of following recipe quantity：
(1) 5.1kg sucrose and 10.1kg sodium cyclamates are dissolved in boiling water, stirred evenly, be configured to filler aqueous solution；
Polyvinylpyrrolidone is dissolved in 50% ethanol water, is stirred evenly, is configured to 3% polyvinylpyrrolidone, 50% ethanol
Aqueous solution 5.1kg, it is spare；
(2) take brufen 2.50kg to be added in coating granulator, start host, it is 110 revs/min to set rotating speed, at the same time
Filler aqueous solution and polyvinylpyrrolidine ethanol water obtained by step (1) are sprayed, 15 revs/min of wriggling revolution speed, treats comminutor
It is interior it is dustless after, open cover and observe and slow down hydrojet speed to 10 revs/min, after producing master batch, releasing material, and by thing
Expect 40 mesh and 30 mesh sieves, and obtain the master batch of -40 mesh of 30 mesh.
(3) take the master batch of -40 mesh of 30 mesh to be put into the pot of coating granulator, spray into remaining filler water in step (2)
Solution and polyvinylpyrrolidone ethanol water, obtain the wet ball of -30 purpose of 18 mesh, and the wet ball of -30 purpose of 18 mesh is put into hot wind
60 DEG C of dryings in cyclic drying case, up to pellet.
(4) pellet obtained by step (3) and remaining 10.2kg sucrose and 20.2kg sodium cyclamates is taken to be placed in 10L- groove profiles and mix
Mixed 25 minutes in conjunction machine；
(5) after to be mixed, the polyvinylpyrrolidone of remaining configuration 2/3 is slowly added to softwood processed；
(6) softwood is placed on oscillating granulator and crosses the granulation of 18 mesh, it is dry, citric acid 3.6kg, mixing are added, packing is
.
Embodiment 3
Brufen is crossed respectively after 100 mesh sieves, sucrose, polyvinylpyrrolidone etc. crush and cross 80 sieves, it is spare.
Weigh the raw material of following recipe quantity：
(1) 10.1kg sucrose and 5.1kg sodium cyclamates are dissolved in boiling water, stirred evenly, dissolving is configured to filler water
Solution；Polyvinylpyrrolidone is dissolved in ethanol water and is stirred evenly, is configured to aqueous povidone solution
5.7kg, it is spare；
(2) take brufen 3.50kg to be added in coating granulator, start host, it is 110 revs/min to set rotating speed, at the same time
Filler aqueous solution and polyvinylpyrrolidone ethanol water obtained by step (1) are sprayed, 15 revs/min of wriggling revolution speed, waits to be granulated
In machine it is dustless after, open cover observe and slow down hydrojet speed to 10 revs/min, after producing master batch, release material, and general
Material crosses 40 mesh, 30 mesh sieves, obtains the master batch of -40 mesh of 30 mesh.
(3) take the master batch of -40 mesh of 30 mesh to be put into the pot of coating granulator, spray into remaining filler water in step (2)
Solution and polyvinylpyrrolidone ethanol water, obtain the wet ball of -30 purpose of 18 mesh, and the wet ball of -30 purpose of 18 mesh is put into hot wind
60 DEG C of dryings in cyclic drying case, up to pellet.
(4) pellet obtained by step (3) and remaining 20.2kg sucrose and 10.2kg sodium cyclamates is taken to be placed in 10L- groove profiles and mix
Mixed 25 minutes in conjunction machine；
(5) after to be mixed, the polyvinylpyrrolidone ethanol water of remaining configuration 2/3 is slowly added to make
Softwood；
(6) softwood is placed on oscillating granulator and crosses the granulation of 18 mesh, it is dry, aspartame 4.2kg is added, is mixed, packing
To obtain the final product.
Embodiment 4
Brufen is crossed respectively after 100 mesh sieves, sucrose, HPMC K4M etc. crush and cross 80 sieves, it is spare.
Weigh the raw material of following recipe quantity：
(1) 11.2kg sucrose and 5.6kg sodium cyclamates are dissolved in boiling water, stirred evenly, dissolving is configured to filler water
Solution；Hydroxypropyl methylcellulose is dissolved in ethanol to stir evenly, it is water-soluble that dissolving is configured to 1% HPMC K4M, 50% ethanol
Liquid 6.0kg, it is spare；
(2) take brufen 4.70kg to be added in coating granulator, start host, it is 110 revs/min to set rotating speed, at the same time
50% ethanol water of filler aqueous solution and 1% HPMC K4M obtained by spray step (1), 15 turns of wriggling revolution speed/
Point, after dustless in comminutor, open cover and observe and slow down hydrojet speed to 10 revs/min, after producing master batch, release
Material, and material is crossed into 40 mesh and 30 mesh sieves, obtain the master batch of -40 mesh of 30 mesh.
(3) take the master batch of the mesh of 30 mesh~40 to be put into the pot of coating granulator, spray into remaining filler water in step (2)
50% ethanol water of solution and 1% HPMC K4M, obtains the wet ball of -30 purpose of 18 mesh, by the wet ball of -30 purpose of 18 mesh
60 DEG C of dryings in hot air circulation drying oven are put into, up to pellet.
(4) pellet obtained by step (3) and remaining 22.4kg sucrose and 11.2kg sodium cyclamates is taken to be placed in 10L- groove profiles and mix
Mixed 25 minutes in conjunction machine；
(5) after to be mixed, 1% HPMC K4M, 50% ethanol water of remaining configuration 2/3 is delayed
It is slow to add softwood processed；
(6) softwood is placed on oscillating granulator and crosses the granulation of 18 mesh, it is dry, Steviosin glycosides 4.5kg is added, is mixed, packing
To obtain the final product.
Comparative example 1
Except not adding sucrose in prescription, remaining operation is the same as embodiment 1.
Comparative example 2
Except not adding sodium cyclamate in prescription, remaining operation is the same as embodiment 1.
Comparative example 3
Brufen is crossed into 100 mesh sieves respectively, sucrose, HPMC K4M cross 80 sieves after crushing, spare.
Weigh the raw material of following recipe quantity：
(1) 12.2kg sucrose is dissolved in boiling water, stirred evenly, dissolving is configured to aqueous sucrose solution；By hypromellose
Element is dissolved in ethanol and stirs evenly, and dissolving is configured to 1% HPMC K4M 50% ethanol water 4.5kg, spare；
(2) take brufen 1.70kg, sucrose 24.4kg to be placed in 10L- trough type mixing machines to mix 25 minutes；
(3) after to be mixed, 1% HPMC K4M, 50% ethanol water configured is slowly added to make
Softwood；
(4) softwood is placed on oscillating granulator and crosses the granulation of 18 mesh, it is dry, Steviosin glycosides 2.4kg is added, is mixed, packing
To obtain the final product.
Comparative example 4
Brufen is crossed into 100 mesh sieves respectively, sucrose, HPMC K4M cross 80 sieves after crushing, spare.
Weigh the raw material of following recipe quantity：
(1) 15.2kg sodium cyclamates are dissolved in boiling water, stirred evenly, dissolving is configured to sodium cyclamate aqueous solution；Will be poly-
Vinylpyrrolidone is dissolved in ethanol and stirs evenly, and dissolving is configured to polyvinylpyrrolidone ethanol water 5.1kg, spare；
(2) brufen 2.50kg is taken, remaining sodium cyclamate is placed in 10L- trough type mixing machines and mixes 25 minutes；
(3) after to be mixed, the remaining polyvinylpyrrolidone configured is slowly added to softwood processed；
(4) softwood is placed on oscillating granulator and crosses the granulation of 18 mesh, it is dry, citric acid 3.6kg, mixing are added, packing is
.
Ibuprofen granule made from embodiment 1~4 and the difference of comparative example 1~4 is pressed into two attached I of Chinese Pharmacopoeia version in 2010
Rules of preparations IN carries out quality inspection, specific inspection result such as table 1；
Table 1
Inspection result more than, ibuprofen granule indices of the present invention meet items related under granule item
Provide (the Chinese Pharmacopoeia attached I rules of preparations IN of version two in 2010), as mobility, mouthfeel, melting, content meet regulation,
Embodiment 1~4 is first formed with the pellet of filler and adhesive parcel, then particle is made, in good taste, and comparative example 1~4, mouth
Feel micro- peppery, therefore illustrate the reliability and controllability of the method for the present invention, it is easy to operate, it is suitable for industrialized production.
Ibuprofen granule made from embodiment 1 and the difference of comparative example 1~4 is subjected to influence factor experiment investigation result：
(60 DEG C) experiments of 2 ibuprofen granule high temperature of table
3 ibuprofen granule high humidity (92.5%) of table is tested
4 ibuprofen granule exposure experiments to light of table
The result shows that particle moisture absorption is lumpd under the conditions of relative humidity 92.5%, related material slightly rises under hot conditions
Height, illumination on this quality without influence, while under the same terms the product of comparative example 4 stability it is worse.
Claims (6)
1. a kind of ibuprofen granule, it is characterised in that be made of the raw material of following parts by weight：
1 part of brufen
12.6 parts~18.24 parts of filler
0.1 part~10 parts of flavouring
1 part~2.04 parts of adhesive
The filler is made of sucrose and sodium cyclamate, and the mass ratio of the sucrose and sodium cyclamate is 1：0.3~3；
The adhesive is the ethanol water of HPMC K4M or the ethanol water of polyvinylpyrrolidone；
The preparation method of the ibuprofen granule, comprises the following steps：
（1）Brufen is crossed into 100 mesh sieves, auxiliary material crushed 80 mesh sieves, spare；
（2）Filler aqueous solution is obtained by 1/3 ~ 1/2 filler is soluble in water；By HPMC K4M or polyethylene pyrrole
Pyrrolidone is dissolved in ethanol water, obtains the ethanol water of HPMC K4M or the ethanol of polyvinylpyrrolidone
Aqueous solution；
（3）Brufen after crushing is added in coating granulator, sprays into step（2）Obtained filler aqueous solution and 1/3 ~
The ethanol water of 1/2 HPMC K4M or the ethanol water of polyvinylpyrrolidone, pelletize, sieve
To the master batch of 30 ~ 40 mesh；
（4）By step（3）Obtained master batch is returned in coating granulator, continues to spray into step（3）In remaining filler water
The ethanol water of the ethanol water or polyvinylpyrrolidone of solution and HPMC K4M, obtains the purpose of 18 mesh ~ 30
Wet ball, pellet is obtained after wet ball drying；
（5）By step（4）Obtained pellet and remaining filler powder is placed in trough type mixing machine and is sufficiently mixed, and then adds
The ethanol water of remaining HPMC K4M or the ethanol water of polyvinylpyrrolidone, obtain softwood；
（6）Step（5）Obtained softwood, which is placed on oscillating granulator, crosses the granulation of 18 mesh sieves, adds flavouring after dry, mixes
To the ibuprofen granule.
2. ibuprofen granule according to claim 1, it is characterised in that the flavouring for citric acid, aspartame,
At least one of stevioside and medicinal essence.
3. ibuprofen granule according to claim 1, it is characterised in that step（3）In, the rotating speed of coating pan for 100 ~
110 revs/min, the wriggling revolution speed for hydrojet is 10 revs/min ~ 15 revs/min.
4. ibuprofen granule according to claim 3, it is characterised in that wriggling revolution speed is in 15 revs/min of 5 ~ 10 points of hydrojets
Zhong Hou, is reduced to 10 revs/min of progress hydrojets.
5. ibuprofen granule according to claim 1, it is characterised in that step（4）In, the rotating speed of coating pan for 100 ~
110 revs/min, the wriggling revolution speed for hydrojet is 5 revs/min ~ 10 revs/min.
6. ibuprofen granule according to claim 1, it is characterised in that the temperature of wet ball drying is 50 DEG C~70 DEG C, wet
Ball drying time for 2 it is small when~4 it is small when.
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| CN115581673B (en) * | 2022-10-28 | 2024-02-02 | 浙江康恩贝制药股份有限公司 | Ibuprofen granule and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101491676A (en) * | 2008-01-22 | 2009-07-29 | 沈阳华泰药物研究有限公司 | Ibuprofen compositions |
| CN101856331A (en) * | 2010-05-20 | 2010-10-13 | 海南新中正制药有限公司 | Arginine (s)-ibuprofen granules and preparation method thereof |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101491676A (en) * | 2008-01-22 | 2009-07-29 | 沈阳华泰药物研究有限公司 | Ibuprofen compositions |
| CN101856331A (en) * | 2010-05-20 | 2010-10-13 | 海南新中正制药有限公司 | Arginine (s)-ibuprofen granules and preparation method thereof |
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