CN104739773A - Dexibuprofen slow release pellet and preparation method thereof - Google Patents
Dexibuprofen slow release pellet and preparation method thereof Download PDFInfo
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- CN104739773A CN104739773A CN201310727476.0A CN201310727476A CN104739773A CN 104739773 A CN104739773 A CN 104739773A CN 201310727476 A CN201310727476 A CN 201310727476A CN 104739773 A CN104739773 A CN 104739773A
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Abstract
The invention discloses a dexibuprofen slow release pellet and a preparation method thereof, and belongs to the field of medicinal preparations. The dexibuprofen slow release pellet comprises 50-80% of dexibuprofen, 0-5% of a slow release material, 0-2.5% of an adhesive, 8.75-47.5% of a filler, and 1.25-6.25% of a disintegrating agent, and all above percentages are based on the total weight of the pellet. The dexibuprofen slow release pellet has the advantages of good stability, stable quality, simple device and process, strong operationality, and suitableness for industrial large scale production. In vitro dissolution test shows that the accumulative release rate within 1h is 10-35%, the accumulative release rate within 2h is 25-55%, the accumulative release rate within 4h is 50-80%, and the accumulative release rate within 7h is 75% or above, so the dexibuprofen slow release pellet has a good release curve.
Description
Technical field
The invention belongs to medical art, be specifically related to a kind of Dexibuprofen sustained-release pellet and preparation method thereof.
Background technology
Ibuprofen is a kind of nonsteroidal antiinflammatory drug, clinically for the long-term treatment of rheumatism atrophic arthritis and osteoarthritis, is also used for the treatment of heating, various moderate pain and inflammation, determined curative effect simultaneously.Ibuprofen is made up of the (S)-ibuprofen of equivalent and left-handed ibuprofen, and research shows, in racemic ibuprofen, (S)-ibuprofen enantiomer is active component, play therapeutical effect, and left-handed ibuprofen enantiomer is non-active ingredient, and relates to potential toxic action.
The (S)-ibuprofen dosage form of current domestic listing mainly contains conventional tablet, capsule, suppository and oral administration mixed suspension etc., because the (S)-ibuprofen half-life is short, need frequent multiple dosing, make troubles to patient, exploitation Dexibuprofen sustained-release preparation, reduce medicining times, reduce the fluctuation of blood drug level peak valley and there is far reaching significance.
(S)-ibuprofen fusing point is lower than raceme ibuprofen (fusing point is 75 DEG C), is 49-53 DEG C, brings larger difficulty to the development of its sustained-release preparation and industrialized great production.Chinese patent CN102293759A discloses a kind of Dex-ibuprofen sustained release tablets preparation and preparation method thereof, medicine is easily caused to melt and produce sticking phenomenon during the large production of slow releasing tablet, cause tablet surface spottiness, related substance raises, and visible tablet is not the desirable dosage form of Dexibuprofen sustained-release preparation, Chinese patent CN101269041A discloses a kind of Dexibuprofen sustained-release dropping pill and preparation method thereof, in drop pill preparation process, medicine easily causes related substance to increase through high temperature melt, Chinese patent CN102228441A and CN102526000A individually discloses a kind of preparation method of Dexibuprofen sustained-release pellet, wherein all based on celphere, by medicine dissolution or be suspended in appropriate solvent, by hydrojet mode to celphere medicine carrying, the release of medicine all adopts coating membrane prosecutor formula to control, its complicated process of preparation, coating membrane Drug controlled release is subject to comparatively multifactor impact (coating weight gain, clothing film integrality, porogen consumption etc.), release difference between easily producing during suitability for industrialized production batch, even produce burst drug release phenomenon, larger difficulty is brought to suitability for industrialized production.
Summary of the invention
The object of the invention is to provide a kind of Dexibuprofen sustained-release pellet.This slow-release micro-pill is compared with ordinary preparation, and drug release is slow, and medicining times reduces, and poisonous side effect of medicine reduces, and improves patient's compliance.
Inventor is according to characteristics such as the diffusion of (S)-ibuprofen, stripping and osmotic pressuries, and by selecting supplementary product kind and consumption thereof, and suitable preparation method designs and improve the rate of release of control (S)-ibuprofen.
Concrete, the invention provides a kind of Dexibuprofen sustained-release pellet, this micropill is grouped into by each one-tenth of following mass percent: the (S)-ibuprofen of 50-80%, the slow-release material of 0-5%, the binding agent of 0-2.5%, the filler of 8.75-47.5%, the disintegrating agent of 1.25-6.25%; Being preferably (S)-ibuprofen is 60-70%, and slow-release material is 1.5-3%, and binding agent is 1-2%, and filler is 17-32%, and disintegrating agent is 1.5-5.5%;
Wherein, described slow-release material is selected from the mixture of one or more in stearic acid, glyceryl monostearate, acrylic resin, ethyl cellulose, hydroxypropyl emthylcellulose; Be preferably stearic acid.
Binding agent is selected from the mixture of one or more in polyvidone, hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose.
Filler is selected from the mixture of one or more in microcrystalline Cellulose, starch, sucrose, lactose, Polyethylene Glycol; Wherein be preferably microcrystalline Cellulose, sucrose or both mixture.
Disintegrating agent is selected from the mixture of one or more in cross-linked polyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, interlinkage sodium carboxymethyl cellulose.
Experiment proves, the proportioning of the selection of adjuvant, adjuvant and medicine, all can have influence on release and pharmaceutical preparation stability in longer-term storage of medicine.Technical solution of the present invention is on the basis of experience lot of experiments, above-mentioned supplementary product kind and consumption thereof are filtered out, meet the slow-release function of (S)-ibuprofen, can ensure that the long-time stability of Dexibuprofen sustained-release pellet are compared with traditional slow releasing preparation prescription simultaneously, a unique distinction of the present invention is the selection of disintegrating agent kind and consumption, inventor finds in research process: can improve by preferably suitable disintegrating agent kind and consumption the shortcoming that the release of drug release later stage delays excessively, can ensure that medicine to discharge by predetermined rate of releasing drug and to ensure that final drug release is complete in conjunction with suitable slow-release material.
The molding of tradition micropill realizes mainly through selecting the good adjuvant of balling-up, and drug content of the present invention is higher, the consumption of adjuvant is less, and (S)-ibuprofen itself becomes ball poor, so one of difficult point that micropill molding is Dexibuprofen sustained-release pellet to be prepared, the present invention increases main cohesive force by the binding agent that dextrorotation is suitable, impels micropill molding.
Another object of the present invention is the preparation method providing above-mentioned Dexibuprofen sustained-release pellet, and this preparation method comprises the steps:
1) by (S)-ibuprofen, slow-release material, binding agent, filler, disintegrating agent mix homogeneously, make soft material, then soft material is obtained wet granular;
2) by round as a ball in rolling circle equipment for step 1 gained wet granular, (S)-ibuprofen micropill is obtained;
3) gained (S)-ibuprofen micropill in step 2 is dry in less than 50 DEG C, then sieve is got particle diameter and is less than 14 object pillers, and get product Dexibuprofen sustained-release pellet.
Wherein, in step 1), wet granular preparation method is preferably but be not limited to sieve granulate or stir and granulate; More preferably sieve granulation, excessively 30-60 mesh sieve, more preferably crosses 30-40 mesh sieve;
Step 2) described in rolling circle equipment can be the round as a ball and high-speed stirred shearing equipment of centrifugal granulating spheronizator, coating pan, be preferably centrifugal granulating spheronizator.
In step 3), the baking temperature of (S)-ibuprofen micropill drying is preferably 25-40 DEG C.Preferred piller particle diameter is 14-40 order.
The preparation of wet granular described in step 1 belongs to the preparation method be familiar with in the industry, by high-shearing granulation, wave granulation of sieving, fluidized-bed spray granulation come.Compared with extrusion-spheronization pelletizing technique, described employing wet granular spheronization is prepared micropill and material can be avoided to produce high temperature through extruding and make principal agent melt the generation of phenomenon.The preparation that wet granular spheronization is used for low melting point substance micropill is one of another innovative point of the present invention.
Gained Dexibuprofen sustained-release pellet of the present invention can encapsulated preparation Dexibuprofen slow-release capsule, also can prepare Dex-ibuprofen sustained release tablets agent by the mode of compaction of pellet.
Compared with prior art, technical scheme of the present invention has following beneficial effect:
1) Dexibuprofen sustained-release pellet of technical solution of the present invention achieves medicine and obtains slow releasing, and patient consumes's number of times reduces, and improves patient's compliance.
2) slow releasing preparation technique of the present invention avoids in medicine production process and melts, and ensure that drug quality.
3) technical solution of the present invention technique is simple and easy to control, with low cost, technique favorable reproducibility, is applicable to the large production of technology.
4) technical solution of the present invention also has an excellent characteristics, be exactly the long-time stability of that Dexibuprofen sustained-release pellet provided by the invention are good, total its related substances is low, laevoisomer does not detect.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is described in further detail, but the non-scope being only limitted to these embodiments of scope of the present invention, undeclared part is prior art.
The release research method of technical solution of the present invention gained Dexibuprofen sustained-release pellet is as follows:
Get this product, according to dissolution method (Chinese Pharmacopoeia version in 2010 two annex XC first methods), ［ potassium dihydrogen phosphate 68.05g is got with phosphate buffer, hydro-oxidation sodium liquid (1mol/L) 56ml, be diluted with water to 1000ml, shake up, survey pH value and should be 6.0 ± 0.05 900ml is solvent, rotating speed is 30 turns per minute, operates in accordance with the law, through 1,2,4 and 7 hour, respectively get solution 5ml, and supplement the phosphate buffer of identical temperature same volume simultaneously, filter, precision measures subsequent filtrate 20 μ l, injection liquid chromatography record chromatogram; Another precision takes (S)-ibuprofen reference substance 15mg, puts in 50ml measuring bottle, adds methanol 2ml and makes dissolving, be diluted to scale, shake up and be measured in the same method by release medium.Calculate the stripping quantity of Dexibuprofen sustained-release pellet at different time respectively.This product every should be more than 10 ~ 35%, 25 ~ 55%, 50 ~ 80% and 75% of labelled amount 1,2,4 respectively mutually with 7 little stripping quantities constantly, all should conform with the regulations.
Above-mentioned detection liquid phase chromatogram condition used is:
Take octadecylsilane chemically bonded silica as filler, with acetonitrile-0.02mol/L potassium dihydrogen phosphate (pH3.0,47:53) for mobile phase; Determined wavelength 264nm; Column temperature: 25 DEG C; Flow velocity: 1.0ml/min.
Assay: chromatographic condition take octadecylsilane chemically bonded silica as filler; Mobile phase is acetonitrile-0.02mol/L potassium dihydrogen phosphate (pH3.0,47:53); Determined wavelength 264nm; Column temperature is 25 DEG C; Flow velocity 1.0ml/min; Sample size: 20ul, measures according to high performance liquid chromatography (Chinese Pharmacopoeia version in 2010 two annex VD), and this product should be 90 ~ 110% of labelled amount containing (S)-ibuprofen.
Determination of related substances: by chromatographic condition under assay item, measure according to high performance liquid chromatography (Chinese Pharmacopoeia version in 2010 two annex VD), this product impurity must not be greater than 1.0%
Laevoisomer: chromatographic condition chiral chromatographic column (CHIRALCEL OD-H, 250mm × 4.6mm, 5um), with normal hexane-ethanol-trifluoroacetic acid (39:1:0.1) for mobile phase, determined wavelength 264nm, flow velocity 0.8ml/min.Measure according to high performance liquid chromatography (Chinese Pharmacopoeia version in 2010 two annex VD), this product laevoisomer must not be greater than 0.5%
Embodiment 1
By following proportioning, prepare Dexibuprofen sustained-release pellet:
(S)-ibuprofen and auxiliary materials and mixing is taken by recipe quantity, add 10% ethanol water 80ml soft material, sieve series wet granular crossed by soft material, and wet granular is round as a ball in centrifugal granulating spheronizator obtains (S)-ibuprofen micropill, and (S)-ibuprofen micropill is drying to obtain Dexibuprofen sustained-release pellet under 40 DEG C of conditions.
Embodiment 2
By following proportioning, prepare Dexibuprofen sustained-release pellet:
(S)-ibuprofen and auxiliary materials and mixing is taken by recipe quantity, add purified water 100ml soft material, sieve series wet granular crossed by soft material, and wet granular is round as a ball in coating pan obtains (S)-ibuprofen micropill, and (S)-ibuprofen micropill is drying to obtain Dexibuprofen sustained-release pellet under 35 DEG C of conditions.
Embodiment 3
By following proportioning, prepare Dexibuprofen sustained-release pellet:
(S)-ibuprofen and auxiliary materials and mixing is taken by recipe quantity, add purified water 110ml soft material, sieve series wet granular crossed by soft material, and wet granular is round as a ball in centrifugal granulating spheronizator obtains (S)-ibuprofen micropill, and (S)-ibuprofen micropill is drying to obtain Dexibuprofen sustained-release pellet under 30 DEG C of conditions.
Embodiment 4
By following proportioning, prepare Dexibuprofen sustained-release pellet:
(S)-ibuprofen and auxiliary materials and mixing is taken by recipe quantity, add purified water 80ml soft material, sieve series wet granular crossed by soft material, and wet granular is round as a ball in centrifugal granulating spheronizator obtains (S)-ibuprofen micropill, and (S)-ibuprofen micropill is drying to obtain Dexibuprofen sustained-release pellet under 40 DEG C of conditions.
Embodiment 5
By following proportioning, prepare Dexibuprofen sustained-release pellet:
(S)-ibuprofen and auxiliary materials and mixing is taken by recipe quantity, add purified water 65ml soft material, sieve series wet granular crossed by soft material, and wet granular stirs round as a ball (S)-ibuprofen micropill in high shear agitation machine, and (S)-ibuprofen micropill is drying to obtain Dexibuprofen sustained-release pellet under 40 DEG C of conditions.
Checking embodiment
Quality testing is carried out to embodiment 1 ~ 5 gained Dexibuprofen sustained-release pellet, carry out temperature 25 DEG C simultaneously, relative humidity 60% ± 10% long term test and temperature 40 DEG C, each 6 months of the accelerated test of relative humidity 75% ± 5%, detecting the change of each quality index, is matched group according to group experiment gained Dexibuprofen sustained-release dropping pill of first in detailed description of the invention in CN101269041A.The data obtained is as follows:
Table 1.0 day sample detection result
From " 0 day sample detection result ", Dexibuprofen sustained-release pellet related substance of the present invention is lower, and release is steady.
Table 2.25 DEG C, relative humidity 60% ± 10% long term test 6 months sample detection results
Table 3.40 DEG C, relative humidity 75% ± 5% accelerated test 6 months sample detection results
Have each embodiment sample quality result of study visible, each index all conforms with the regulations, and through long-term and accelerated test 6 months, the change of sample related substance, content, laevoisomer and release was all not obvious, interpret sample steady quality, reliable.
Claims (10)
1. a Dexibuprofen sustained-release pellet, it is characterized in that: this micropill is grouped into by each one-tenth of following mass percent: the (S)-ibuprofen of 50-80%, the slow-release material of 0-5%, the binding agent of 0-2.5%, the filler of 8.75-47.5%, the disintegrating agent of 1.25-6.25%;
Wherein, described slow-release material is selected from the mixture of one or more in stearic acid, glyceryl monostearate, acrylic resin, ethyl cellulose, hydroxypropyl emthylcellulose;
Binding agent is selected from the mixture of one or more in polyvidone, hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose;
Filler is selected from the mixture of one or more in microcrystalline Cellulose, starch, sucrose, lactose, Polyethylene Glycol;
Disintegrating agent is selected from the mixture of one or more in cross-linked polyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, interlinkage sodium carboxymethyl cellulose.
2. a kind of Dexibuprofen sustained-release pellet as claimed in claim 1, it is characterized in that: this micropill is grouped into by each one-tenth of following mass percent: (S)-ibuprofen is 60-70%, slow-release material is 1.5-3%, and binding agent is 1-2%, filler is 17-32%, and disintegrating agent is 1.5-5.5%.
3. a kind of Dexibuprofen sustained-release pellet as claimed in claim 1, is characterized in that: described slow-release material is stearic acid.
4. a kind of Dexibuprofen sustained-release pellet as claimed in claim 1, is characterized in that: filler is microcrystalline Cellulose, sucrose or both mixture.
5. the preparation method of Dexibuprofen sustained-release pellet according to the arbitrary claim of claim 1-4, is characterized in that, comprise following steps:
1) by (S)-ibuprofen, slow-release material, binding agent, filler, disintegrating agent mix homogeneously, make soft material, then soft material is obtained wet granular;
2) by round as a ball in rolling circle equipment for step 1) gained wet granular, (S)-ibuprofen micropill is obtained;
3) by step 2) in gained (S)-ibuprofen micropill dry in less than 50 DEG C, then sieve and get particle diameter and be less than 14 order pillers, get product Dexibuprofen sustained-release pellet.
6. the preparation method of Dexibuprofen sustained-release pellet according to claim 5, is characterized in that, in step 1), soft material is granulated for sieving or stirred and granulates.
7. the preparation method of Dexibuprofen sustained-release pellet according to claim 6, is characterized in that, in step 1), soft material is granulation of sieving, and crosses 30-60 mesh sieve.
8. the preparation method of Dexibuprofen sustained-release pellet according to claim 7, is characterized in that, in step 1), soft material is granulation of sieving, and crosses 30-40 mesh sieve.
9. the preparation method of Dexibuprofen sustained-release pellet according to claim 5, is characterized in that, in step 3), the baking temperature of (S)-ibuprofen micropill drying is 25-40 DEG C.
10. the preparation method of Dexibuprofen sustained-release pellet according to claim 5, is characterized in that, in step 3), the particle diameter of piller is 14-30 order.
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| CN105935445A (en) * | 2016-03-28 | 2016-09-14 | 赤峰赛林泰药业有限公司 | 2-(-4-isobutylphenyl)propionic acid dextrogyre-containing pharmaceutical composition and preparation method thereof |
| CN106511280A (en) * | 2016-12-20 | 2017-03-22 | 南京康川济医药科技有限公司 | Ibuprofen slow-releasing dry suspension and preparation method thereof |
| CN106727393A (en) * | 2016-12-26 | 2017-05-31 | 浙江工业大学 | A kind of sustained release preparations of ibuprofen containing grid internal structure and preparation method thereof |
| CN110123769A (en) * | 2019-05-24 | 2019-08-16 | 北京悦康科创医药科技股份有限公司 | A kind of ibuprofen slow-release piller and preparation method thereof |
| CN110755396A (en) * | 2019-12-06 | 2020-02-07 | 北京悦康科创医药科技股份有限公司 | Ibuprofen sustained-release pellet and preparation method thereof |
| CN110859809A (en) * | 2019-12-17 | 2020-03-06 | 卓和药业集团有限公司 | Pharmaceutical composition and preparation method thereof |
| CN111135146A (en) * | 2018-11-05 | 2020-05-12 | 珠海润都制药股份有限公司 | Ibuprofen sustained-release pellet and preparation method thereof |
| CN113181127A (en) * | 2021-05-07 | 2021-07-30 | 苏州康恒研新药物技术有限公司 | Preparation method of dapoxetine hydrochloride pellet tablets |
| CN113546049A (en) * | 2021-04-30 | 2021-10-26 | 贵州汉方药业有限公司 | Flexible pill medicine adhesive and flexible pill prepared by using same |
| CN115120575A (en) * | 2022-07-01 | 2022-09-30 | 云鹏医药集团有限公司 | Preparation method of ibuprofen sustained-release capsule |
| CN115702883A (en) * | 2021-08-05 | 2023-02-17 | 上海博志研新药物技术有限公司 | Ibuprofen pharmaceutical composition, preparation method and application thereof |
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| CN105935445B (en) * | 2016-03-28 | 2019-02-01 | 赤峰赛林泰药业有限公司 | Pharmaceutical composition and preparation method thereof containing 2- (- 4- isobutyl phenenyl) propionic acid dextrogyre |
| CN105935445A (en) * | 2016-03-28 | 2016-09-14 | 赤峰赛林泰药业有限公司 | 2-(-4-isobutylphenyl)propionic acid dextrogyre-containing pharmaceutical composition and preparation method thereof |
| CN106511280A (en) * | 2016-12-20 | 2017-03-22 | 南京康川济医药科技有限公司 | Ibuprofen slow-releasing dry suspension and preparation method thereof |
| CN106511280B (en) * | 2016-12-20 | 2019-03-29 | 南京康川济医药科技有限公司 | A kind of ibuprofen slow-release dry suspensoid agent and preparation method thereof |
| CN106727393A (en) * | 2016-12-26 | 2017-05-31 | 浙江工业大学 | A kind of sustained release preparations of ibuprofen containing grid internal structure and preparation method thereof |
| CN111135146A (en) * | 2018-11-05 | 2020-05-12 | 珠海润都制药股份有限公司 | Ibuprofen sustained-release pellet and preparation method thereof |
| CN110123769A (en) * | 2019-05-24 | 2019-08-16 | 北京悦康科创医药科技股份有限公司 | A kind of ibuprofen slow-release piller and preparation method thereof |
| CN110755396A (en) * | 2019-12-06 | 2020-02-07 | 北京悦康科创医药科技股份有限公司 | Ibuprofen sustained-release pellet and preparation method thereof |
| CN110859809A (en) * | 2019-12-17 | 2020-03-06 | 卓和药业集团有限公司 | Pharmaceutical composition and preparation method thereof |
| CN113546049A (en) * | 2021-04-30 | 2021-10-26 | 贵州汉方药业有限公司 | Flexible pill medicine adhesive and flexible pill prepared by using same |
| CN113181127A (en) * | 2021-05-07 | 2021-07-30 | 苏州康恒研新药物技术有限公司 | Preparation method of dapoxetine hydrochloride pellet tablets |
| CN115702883A (en) * | 2021-08-05 | 2023-02-17 | 上海博志研新药物技术有限公司 | Ibuprofen pharmaceutical composition, preparation method and application thereof |
| CN115120575A (en) * | 2022-07-01 | 2022-09-30 | 云鹏医药集团有限公司 | Preparation method of ibuprofen sustained-release capsule |
| CN115120575B (en) * | 2022-07-01 | 2023-05-30 | 云鹏医药集团有限公司 | Preparation method of ibuprofen sustained-release capsule |
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