CN104606145A - Ibuprofen granules and preparation method thereof - Google Patents
Ibuprofen granules and preparation method thereof Download PDFInfo
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- CN104606145A CN104606145A CN201510049631.7A CN201510049631A CN104606145A CN 104606145 A CN104606145 A CN 104606145A CN 201510049631 A CN201510049631 A CN 201510049631A CN 104606145 A CN104606145 A CN 104606145A
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Abstract
The invention discloses ibuprofen granules which are prepared from the following raw materials in parts by weight: 1 part of ibuprofen, 1-100 parts of a filling agent, 1-20 parts of an adhesive, 0.2-10 parts of a thickening agent and 0.1-10 parts of a flavoring agent. The granules are rapidly dissolved in water to form clarified and transparent solution with good taste and are convenient to take, low in content of related substances and high in bioavailability. The invention also discloses a method for preparing the ibuprofen granules. The preparation method is easy to operate, does not need any special equipment and is suitable for industrial production.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, be specifically related to a kind of ibuprofen granule and preparation method thereof.
Background technology
Ibuprofen, chemical name is: 2-methyl-4-(2-methyl-propyl) phenylacetic acid, IUPAC called after: 2-(4-isobutylphenyl) propanoic acid, CAS No.15687-27-1, molecular formula C
13h
18o
2molecular weight 206.28, be NSAID (non-steroidal anti-inflammatory drug) (NSAID), be in the world first for clinical and still widely used ibuprofen class medicine so far, be acknowledged as one of safest medicine in NSAID (non-steroidal anti-inflammatory drug), tool analgesia, antiinflammatory, refrigeration function, its mechanism of action is the synthesis being reduced prostaglandin by the suppression to epoxidase, alleviate the tissue hyperemia because prostaglandin causes, swelling thus, reduce the sensitivity of the peripheral nerve pain sensation, and play refrigeration function by hypothalamus center of body temperature regulation.
Publication number is disclose a kind of arginine ibuprofen tablet and preparation method thereof in the Chinese patent application of CN101390844A, the easy deliquescence of this arginine ibuprofen tablet and failing covers the penetrating odor of medicine, make troubles for taking, especially pediatric pharmaceuticals inconvenience.
Application number be 200310108031.0 Chinese patent application disclose a kind of preparation method of granules containing ibuprofen arginine compositions, wherein have employed the shortcoming that coating steps overcomes the easy moisture absorption of ibuprofen arginine, cover the penetrating odor of of medicine itself, but the step production cycle of more than general granule coatings is long, and cost is high.
Summary of the invention
The invention provides a kind of ibuprofen granule and preparation method thereof, this ibuprofen granule mouthfeel is good, and dissolution is high, and good fluidity, and this preparation method operation is simple, quality controllable and be suitable for suitability for industrialized production.
A kind of ibuprofen granule, be made up of the raw material of following weight portion:
Described filler is made up of sucrose and sodium cyclamate.
In the present invention, using the mixture of sucrose and sodium cyclamate as filler, significantly enhance the dissolution of ibuprofen granule, meanwhile, also effectively improve the mouthfeel of ibuprofen granule, take convenient, be especially applicable to children's and use.
As preferably, described sucrose and the mass ratio of sodium cyclamate are 1:0.3 ~ 3.Proportion is excessive or too smallly all can reduce dissolution, makes mouthfeel become poorer.
As preferably, described ibuprofen granule, be made up of the raw material of following weight portion:
Described binding agent is the one in HPMC K4M, polyvinylpyrrolidone, starch slurry, methylcellulose and Polyethylene Glycol.As preferably, described binding agent is the ethanol water of HPMC K4M or the ethanol water of polyvinylpyrrolidone;
Be 40% ~ 98% for configuring the concentration of volume percent of the ethanol water of described binding agent, in the binding agent obtained, the mass percent concentration of HPMC K4M and polyvinylpyrrolidone is 1% ~ 3%.Parts by weight of raw materials is as the criterion with the aqueous solution of binding agent.The kind of binding agent used and consumption can all produce certain impact to the dissolution of product, mobility and stability.
As preferably, described correctives is at least one in citric acid, aspartame, stevioside, medicinal essence.Because ibuprofen is insoluble solid medicine, mouthfeel hardship is peppery, and dissolubility reduces in an acidic solution, and bitter and peppery feeling weakens.The present invention passes through the cooperation of citric acid, sodium cyclamate and sucrose, the mouthfeel after regulating ibuprofen water-soluble.
Present invention also offers a kind of preparation method of ibuprofen granule, comprise the following steps:
(1) ibuprofen is crossed 100 mesh sieves, 80 mesh sieves pulverized by adjuvant, for subsequent use;
(2) filler aqueous solution is obtained by soluble in water for the filler of 1/3 ~ 1/2; Binding agent is dissolved in ethanol water, obtains binding agent ethanol water;
(3) ibuprofen after pulverizing is joined in coating granulator, spray into the binding agent ethanol water of filler aqueous solution that step (2) obtains and 1/3 ~ 1/2, granulate, sieve and obtain 30 ~ 40 object master batches;
(4) master batch that step (3) obtains is turned back in coating granulator, continue to spray into remaining filler aqueous solution and binding agent ethanol water in step (2), obtain 18 order ~ 30 objects to wet ball, after wet ball drying, obtain micropill;
(5) micropill step (4) obtained and remaining filler powder are placed in trough type mixing machine and fully mix, and then add remaining binding agent ethanol water, obtain soft material;
(6) soft material that step (5) obtains is placed on oscillating granulator and crosses 18 mesh sieves granulations, adds correctives, be mixed to get described ibuprofen granule after drying.
In the present invention, the preparation of micropill obtains through twice coating pelletizing step, first sieve when the granule of formation 30 ~ 40 order left and right size, excessive or too small granule is removed, filler and binding agent are evenly distributed on active component, improve dissolution and the stability of the ibuprofen granule obtained.
As preferably, in step (3), the rotating speed of coating pan is 100 ~ 110 revs/min, and the peristaltic pump rotating speed of hydrojet is 10 revs/min ~ 15 revs/min.Prepare in master batch, the rotating speed of coating pan keeps constant; Peristaltic pump rotating speed is 15 revs/min at initial period, after dustless in coating granulator (about 5 ~ 10 minutes), and peristaltic pump rotational speed regulation to 10 rev/min.Now, the particle size distribution of the master batch obtained can be kept comparatively even, improve the qualification rate of master batch, after this stage terminates, material is crossed 40 orders and 30 mesh sieves, obtain 30 ~ 40 object master batches.
As preferably, in step (4), the rotating speed of coating pan is 100 ~ 110 revs/min, and the peristaltic pump rotating speed of hydrojet is 5 revs/min ~ 10 revs/min.Returned by master batch in coating pan when preparing micropill, need to reduce hydrojet speed further, the qualification rate of the micropill obtained is higher.
As preferably, the temperature of wet ball drying is 50 DEG C ~ 70 DEG C, and the time of wet ball drying is 2 hours ~ 4 hours.
Described ibuprofen granule: warm boiled water, 4 ~ 8 years old child, one time 0.5 bag; More than 8 years old children and adults, one time 1 bag, if constant pain or heating, can 4 ~ 6 hours repeated drug takings in interval 1 time, 24 hours are no more than 4 times.
Tool of the present invention has the following advantages:
(1) ibuprofen granule stability and safety of the present invention, can dissolve very soon, exist with the state of liquid, toothache, dysmenorrhea, the pain (such as: motional injury) caused because of wound, joint and desmodynia, backache, headache can be alleviated rapidly, and the heating that influenza causes.
(2) the present invention is by filler and binding agent, specific proportioning in conjunction with raw material regulates the penetrating odor of ibuprofen pharmaceutical itself, and ibuprofen granule water-soluble after mouthfeel, the ibuprofen granule obtained dissolves rapidly, forms the good solution of clear mouthfeel in water, be convenient to take, bioavailability is high, and mouthfeel is good and viscosity is medium, is more easily accepted.
(3) the present invention is with order of addition and make female ball, invests step 2) better improve mouthfeel and the penetrating odor of ibuprofen, be easier to patient and accept, improve compliance.
(4) preparation technology of the present invention is simple, and controlled, equipment that need not be special, cost-saving, shortened process, is suitable for suitability for industrialized production.
Detailed description of the invention
Embodiment 1
Ibuprofen is crossed 100 mesh sieves, sucrose, HPMC K4M, sodium cyclamate and steviosin glycosides cross 80 mesh sieves after pulverizing, for subsequent use.
Take the raw material of following recipe quantity:
(1) 6.1kg sucrose and 6.1kg sodium cyclamate are dissolved in 100kg boiling water, stir, be mixed with filler aqueous solution; HPMC K4M is dissolved in the ethanol water of 50% (volume percent content), stirs, be mixed with 1% HPMC K4M 50% ethanol water 4.5kg, for subsequent use;
(2) getting ibuprofen 1.70kg joins in coating granulator; start main frame; arranging rotating speed is 110 revs/min, sprays filler aqueous solution and 1.5kg 1% HPMC K4M 50% ethanol water of step (1) gained, peristaltic pump rotating speed 15 revs/min simultaneously; after dustless in comminutor; open cover observe and the hydrojet speed that slows down to 10 revs/min, until after producing master batch, release material; and material is crossed 40 orders and 30 mesh sieves, obtain 30 order ~ 40 object master batches.
(3) pot that 30 order ~ 40 object master batches put into coating granulator is got; continue to spray into remaining filler aqueous solution and 1% HPMC K4M 50% ethanol water in step (2); peristaltic pump rotating speed 8 revs/min; obtain 18 order ~ 30 objects to wet ball; the ball that 18 order-30 objects wet puts into hot air circulation drying oven 60 DEG C of dryings, obtains micropill.
(4) get step (3) gained micropill and remaining 12.2g sucrose and 12.2g sodium cyclamate and be placed in 10L-trough type mixing machine mixing 25 minutes.
(5), after end to be mixed, remaining 3.0kg 1% HPMC K4M 50% ethanol water configured slowly is added soft material processed.
(6) soft material is placed in and oscillating granulator crosses 18 orders granulates, dry, add steviosin glycosides 2.4kg, mixing, subpackage and get final product.
Embodiment 2
Ibuprofen is crossed 100 mesh sieves, sucrose, polyvinylpyrrolidone etc. cross 80 sieves after pulverizing, for subsequent use.
Take the raw material of following recipe quantity:
(1) 5.1kg sucrose and 10.1kg sodium cyclamate are dissolved in boiling water, stir, be mixed with filler aqueous solution; Polyvinylpyrrolidone is dissolved in 50% ethanol water, stirs, be mixed with 3% polyvinylpyrrolidone 50% ethanol water 5.1kg, for subsequent use;
(2) getting ibuprofen 2.50kg joins in coating granulator; start main frame; arranging rotating speed is 110 revs/min, sprays step (1) gained filler aqueous solution and polyvinylpyrrolidine ethanol water simultaneously, peristaltic pump rotating speed 15 revs/min; after dustless in comminutor; open cover observe and the hydrojet speed that slows down to 10 revs/min, until after producing master batch, release material; and material is crossed 40 orders and 30 mesh sieves, obtain 30 order-40 object master batches.
(3) pot that 30 order-40 object master batches put into coating granulator is got; spray into remaining filler aqueous solution and polyvinylpyrrolidone ethanol water in step (2); obtain 18 order-30 objects to wet ball; the ball that 18 order-30 objects wet puts into hot air circulation drying oven 60 DEG C of dryings, obtains micropill.
(4) get step (3) gained micropill and remaining 10.2kg sucrose and 20.2kg sodium cyclamate and be placed in 10L-trough type mixing machine mixing 25 minutes;
(5), after end to be mixed, the remaining polyvinylpyrrolidone configuring 2/3 is slowly added soft material processed;
(6) soft material is placed in and oscillating granulator crosses 18 orders granulates, dry, add citric acid 3.6kg, mixing, subpackage and get final product.
Embodiment 3
Ibuprofen is crossed 100 mesh sieves respectively, and sucrose, polyvinylpyrrolidone etc. cross 80 sieves after pulverizing, for subsequent use.
Take the raw material of following recipe quantity:
(1) 10.1kg sucrose and 5.1kg sodium cyclamate are dissolved in boiling water, stir, dissolve and be mixed with filler aqueous solution; Polyvinylpyrrolidone is dissolved in ethanol water and stirs, be mixed with aqueous povidone solution 5.7kg, for subsequent use;
(2) getting ibuprofen 3.50kg joins in coating granulator; start main frame; arranging rotating speed is 110 revs/min, sprays step (1) gained filler aqueous solution and polyvinylpyrrolidone ethanol water simultaneously, peristaltic pump rotating speed 15 revs/min; after dustless in comminutor; open cover observe and the hydrojet speed that slows down to 10 revs/min, until after producing master batch, release material; and material is crossed 40 orders, 30 mesh sieves, obtain 30 order-40 object master batches.
(3) pot that 30 order-40 object master batches put into coating granulator is got; spray into remaining filler aqueous solution and polyvinylpyrrolidone ethanol water in step (2); obtain 18 order-30 objects to wet ball; the ball that 18 order-30 objects wet puts into hot air circulation drying oven 60 DEG C of dryings, obtains micropill.
(4) get step (3) gained micropill and remaining 20.2kg sucrose and 10.2kg sodium cyclamate and be placed in 10L-trough type mixing machine mixing 25 minutes;
(5), after end to be mixed, the remaining polyvinylpyrrolidone ethanol water configuring 2/3 is slowly added soft material processed;
(6) soft material is placed in and oscillating granulator crosses 18 orders granulates, dry, add aspartame 4.2kg, mixing, subpackage and get final product.
Embodiment 4
Ibuprofen is crossed 100 mesh sieves respectively, and sucrose, HPMC K4M etc. cross 80 sieves after pulverizing, for subsequent use.
Take the raw material of following recipe quantity:
(1) 11.2kg sucrose and 5.6kg sodium cyclamate are dissolved in boiling water, stir, dissolve and be mixed with filler aqueous solution; Hypromellose is dissolved in ethanol stir, dissolves and be mixed with 1% HPMC K4M 50% ethanol water 6.0kg, for subsequent use;
(2) getting ibuprofen 4.70kg joins in coating granulator; start main frame; arranging rotating speed is 110 revs/min, sprays step (1) gained filler aqueous solution and 1% HPMC K4M 50% ethanol water, peristaltic pump rotating speed 15 revs/min simultaneously; after dustless in comminutor; open cover observe and the hydrojet speed that slows down to 10 revs/min, until after producing master batch, release material; and material is crossed 40 orders and 30 mesh sieves, obtain 30 order-40 object master batches.
(3) pot that 30 order ~ 40 object master batches put into coating granulator is got; spray into remaining filler aqueous solution and 1% HPMC K4M 50% ethanol water in step (2); obtain 18 order-30 objects to wet ball; the ball that 18 order-30 objects wet puts into hot air circulation drying oven 60 DEG C of dryings, obtains micropill.
(4) get step (3) gained micropill and remaining 22.4kg sucrose and 11.2kg sodium cyclamate and be placed in 10L-trough type mixing machine mixing 25 minutes;
(5), after end to be mixed, remaining 1% HPMC K4M 50% ethanol water configuring 2/3 is slowly added soft material processed;
(6) soft material is placed in and oscillating granulator crosses 18 orders granulates, dry, add steviosin glycosides 4.5kg, mixing, subpackage and get final product.
Comparative example 1
Except in prescription with sucrose, remaining operation with embodiment 1.
Comparative example 2
Except not adding sodium cyclamate in prescription, remaining operation is with embodiment 1.
Comparative example 3
Ibuprofen is crossed 100 mesh sieves respectively, and sucrose, HPMC K4M cross 80 sieves after pulverizing, for subsequent use.
Take the raw material of following recipe quantity:
(1) 12.2kg sucrose is dissolved in boiling water, stirs, dissolve and be mixed with aqueous sucrose solution; Hypromellose is dissolved in ethanol stir, dissolves and be mixed with 1% HPMC K4M 50% ethanol water 4.5kg, for subsequent use;
(2) get ibuprofen 1.70kg, sucrose 24.4kg is placed in 10L-trough type mixing machine mixing 25 minutes;
(3), after end to be mixed, 1% HPMC K4M 50% ethanol water configured slowly is added soft material processed;
(4) soft material is placed in and oscillating granulator crosses 18 orders granulates, dry, add steviosin glycosides 2.4kg, mixing, subpackage and get final product.
Comparative example 4
Ibuprofen is crossed 100 mesh sieves respectively, and sucrose, HPMC K4M cross 80 sieves after pulverizing, for subsequent use.
Take the raw material of following recipe quantity:
(1) 15.2kg sodium cyclamate is dissolved in boiling water, stirs, dissolve and be mixed with sodium cyclamate aqueous solution; Polyvinylpyrrolidone is dissolved in ethanol stir, dissolves and be mixed with polyvinylpyrrolidone ethanol water 5.1kg, for subsequent use;
(2) get ibuprofen 2.50kg, remaining sodium cyclamate is placed in 10L-trough type mixing machine mixing 25 minutes;
(3), after end to be mixed, the remaining polyvinylpyrrolidone configured slowly is added soft material processed;
(4) soft material is placed in and oscillating granulator crosses 18 orders granulates, dry, add citric acid 3.6kg, mixing, subpackage and get final product.
Ibuprofen granule embodiment 1 ~ 4 and comparative example 1 ~ 4 obtained respectively carries out quality inspection by Chinese Pharmacopoeia version in 2010 two attached I rules of preparations IN, and concrete assay is as table 1;
Table 1
From above assay, every regulation (Chinese Pharmacopoeia version in 2010 two attached I rules of preparations IN) relevant under ibuprofen granule indices of the present invention meets granule item, as mobility, mouthfeel, melting, content all conform with the regulations, embodiment 1 ~ 4 first makes the micropill of filler and binding agent parcel, make granule again, mouthfeel is good, and comparative example 1 ~ 4, mouthfeel is micro-peppery, therefore reliability and the controllability of the inventive method are described, simple to operate, be suitable for suitability for industrialized production.
The ibuprofen granule that embodiment 1 and comparative example 1 ~ 4 obtain respectively is carried out influence factor's experiment investigation result:
Table 2 ibuprofen granule high temperature (60 DEG C) is tested
Table 3 ibuprofen granule high humidity (92.5%) is tested
Table 4 ibuprofen granule exposure experiments to light
Result shows granule moisture absorption caking under relative humidity 92.5% condition, and under hot conditions, related substance slightly raises, and illumination is on this quality without impact, and under the same terms, the stability of the product of comparative example 4 is poorer simultaneously.
Claims (10)
1. an ibuprofen granule, is characterized in that, is made up of the raw material of following weight portion:
Described filler is made up of sucrose and sodium cyclamate.
2. ibuprofen granule according to claim 1, is characterized in that, described sucrose and the mass ratio of sodium cyclamate are 1:0.3 ~ 3.
3. ibuprofen granule according to claim 1, is characterized in that, is made up of the raw material of following weight portion:
4. the ibuprofen granule according to any one of claims 1 to 3, is characterized in that, described binding agent is the ethanol water of HPMC K4M or the ethanol water of polyvinylpyrrolidone.
5. the ibuprofen granule according to any one of claims 1 to 3, is characterized in that, described correctives is at least one in citric acid, aspartame, stevioside and medicinal essence.
6. a preparation method for the ibuprofen granule as described in any one of Claims 1 to 5, is characterized in that, comprises the following steps:
(1) ibuprofen is crossed 100 mesh sieves, 80 mesh sieves pulverized by adjuvant, for subsequent use;
(2) filler aqueous solution is obtained by soluble in water for the filler of 1/3 ~ 1/2; Binding agent is dissolved in ethanol water, obtains binding agent ethanol water;
(3) ibuprofen after pulverizing is joined in coating granulator, spray into the binding agent ethanol water of filler aqueous solution that step (2) obtains and 1/3 ~ 1/2, granulate, sieve and obtain 30 ~ 40 object master batches;
(4) master batch that step (3) obtains is turned back in coating granulator, continue to spray into remaining filler aqueous solution and binding agent ethanol water in step (2), obtain 18 order ~ 30 objects to wet ball, after wet ball drying, obtain micropill;
(5) micropill step (4) obtained and remaining filler powder are placed in trough type mixing machine and fully mix, and then add remaining binding agent ethanol water, obtain soft material;
(6) soft material that step (5) obtains is placed on oscillating granulator and crosses 18 mesh sieves granulations, adds correctives, be mixed to get described ibuprofen granule after drying.
7. the preparation method of ibuprofen granule according to claim 6, is characterized in that, in step (3), the rotating speed of coating pan is 100 ~ 110 revs/min, and the peristaltic pump rotating speed for hydrojet is 10 revs/min ~ 15 revs/min.
8. the preparation method of ibuprofen granule according to claim 7, is characterized in that, peristaltic pump rotating speed after 5 ~ 10 minutes 15 revs/min of hydrojets, is reduced to 10 revs/min and carried out hydrojet.
9. the preparation method of ibuprofen granule according to claim 6, is characterized in that, in step (4), the rotating speed of coating pan is 100 ~ 110 revs/min, and the peristaltic pump rotating speed for hydrojet is 5 revs/min ~ 10 revs/min.
10. the preparation method of ibuprofen granule according to claim 9, is characterized in that, the temperature of wet ball drying is 50 DEG C ~ 70 DEG C, and the time of wet ball drying is 2 hours ~ 4 hours.
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN112137966A (en) * | 2020-10-28 | 2020-12-29 | 哈药集团技术中心 | Ibuprofen granule and preparation method thereof |
CN115581673A (en) * | 2022-10-28 | 2023-01-10 | 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 |
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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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- 2015-01-30 CN CN201510049631.7A patent/CN104606145B/en active Active
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
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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 |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN112137966A (en) * | 2020-10-28 | 2020-12-29 | 哈药集团技术中心 | Ibuprofen granule and preparation method thereof |
CN115581673A (en) * | 2022-10-28 | 2023-01-10 | 浙江康恩贝制药股份有限公司 | Ibuprofen granule and preparation method thereof |
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 |
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