CN102389423A - Medicinal composition containing ibuprofen sodium salt - Google Patents
Medicinal composition containing ibuprofen sodium salt Download PDFInfo
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- CN102389423A CN102389423A CN2011102667919A CN201110266791A CN102389423A CN 102389423 A CN102389423 A CN 102389423A CN 2011102667919 A CN2011102667919 A CN 2011102667919A CN 201110266791 A CN201110266791 A CN 201110266791A CN 102389423 A CN102389423 A CN 102389423A
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- ibuprofen
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Abstract
The invention relates to a medicinal composition containing ibuprofen sodium salt, which is prepared by taking ibuprofen sodium salt and other one or a plurality of medicinal components as active ingredients, and combing the active ingredients with pharmaceutically appropriate auxiliary materials. The medicinal composition can be made into oral preparations, including conventional tablets, dispersible tablets, sustained release tablets, capsules, sustained release capsules, soft capsules, particles, dry suspension, suspension and the like, and used for symptomatic treatment of being antipyretic, antiphlogistic, analgesic and anti-allergic, and improving sleeping.
Description
Technical field
The present invention is a kind of Pharmaceutical composition that contains the ibuprofen sodium salt, belongs to medical technical field.
Background technology
The wide range that antalgesic relates to, the patient who involves is numerous, feeds through to society and goes up all trades and professions, and existing hundreds of disease is to produce pain in morbidity.In life, pain has been a kind of commonly encountered diseases, and sickness rate is high, and people often take traditional treatment, makes pain can not get radical cure, causes manager and waste of time, and influences patient's life and work.The content that pain comprises is a lot; Add up according to consulting firm; In the 35-50 adult in year; Have about 55% by multiple pain encirclement, optimum recurrent headache, pain in the shoulder and back, waist leg joint pain, soft tissue pain, nervous headache all are common symptons, have its most of diseases certain stage in the course of disease that pain is in various degree arranged.Wherein the pain of obstinate taking place frequently property makes the patient, and especially Advanced Carcinoma Patient nearly all severe pain takes place and makes patient be difficult to restrain oneself, and is very painful, and quality of life receives great infringement and suffers the manager loss
Ibuprofen is effective PG synthetase inhibitors, has antipyretic-antalgic and antiinflammatory action.Be used to sprain, strain, descend pain in the lumbar region pain, scapulohumeral periarthritis, bursitis, tendon and tenosynovitis.Toothache and postoperative pain, rheumatoid arthritis, osteoarthritis and other seronegativities (non-rheumatoid) joint disease.Be used to alleviate moderate pain,, also can be used for alleviating the heating that common cold or influenza cause like arthralgia, myalgia, migraine, headache, toothache, dysmenorrhea, neuralgia.For a long time, ibuprofen sales volume on China's medical market becomes the trend of steady-state growth always, and it becomes four big pillar products on China antipyretic analgesic market together with acetaminophen, aspirin, diclofenac.
Summary of the invention
The present invention is a kind of Pharmaceutical composition that contains Sodium ibuprofen; Be that sodium salt and other one or more medicinal ingredients with ibuprofen are active component; Combine with pharmaceutically suitable adjuvant; Described other medicinal ingredients comprise: pseudoephedrine, chlorphenamine, phenylephrine, acetaminophen, codeine phosphate, oxycodone, ammonia phenol hydrocodone, diphenhydramine etc., and other medicinal ingredients can exist with the pharmaceutical salts form; Comprise hydrochlorate, sulfate, maleate, tartrate, citrate etc.;
Compositions of the present invention can be following compositions: Sodium ibuprofen+pseudoephedrine hydrochloride+chlorphenamine maleate, Sodium ibuprofen+pseudoephedrine hydrochloride, Sodium ibuprofen+PHENYLEPHRINE HYDROCHLORIDE, Sodium ibuprofen+acetaminophen, Sodium ibuprofen+codeine phosphate, Sodium ibuprofen+oxycodone hydrochloride, Sodium ibuprofen+tartaric acid ammonia phenol hydrocodone, Sodium ibuprofen+diphenhydramine citrate etc.;
Described compositions is characterized in that, the unit consumption of ibuprofen sodium salt (in ibuprofen) is 12.5-1000mg, preferred 50-500mg; The unit consumption of other medicinal ingredients is: pseudoephedrine 3.25-240mg, preferred 15-120mg;
Chlorphenamine 0.25-16mg, preferred 1-8mg; Phenylephrine 2.5-40mg, preferred 10-20mg; Acetaminophen 25-1000mg, preferred 100-500mg; Codeine phosphate 2.5-60mg, preferred 10-30mg; Oxycodone 2.5-20mg, preferred 5-10mg; Ammonia phenol hydrocodone 2.5-20mg, preferred 5-10mg; Diphenhydramine 6.25-100mg, preferred 25-50mg;
Compositions of the present invention can be made into oral formulations, comprises ordinary tablet, dispersible tablet, slow releasing tablet, capsule, granule, dry suspension, suspension etc.; Be used for analgesic, antiinflammatory, analgesia, antiallergic and improve the symptomatic treatment of sleep.
The specific embodiment
Following Sodium ibuprofen specification is all in ibuprofen
Embodiment 1 tablet
The supplementary material title | Consumption |
Sodium ibuprofen dihydrate | 200g |
Pseudoephedrine hydrochloride | 30g |
Microcrystalline Cellulose | 86g |
Lactose | 26.6g |
Sodium carboxymethyl cellulose | 9.0g |
Hydroxypropyl cellulose | 6.0g |
Magnesium stearate | 2.4g |
Purified water | In right amount |
Technology: get above-mentioned each crude drug, pulverize separately is crossed 80 mesh sieves, and is subsequent use; Each adjuvant is crossed 60 mesh sieves respectively, and is subsequent use; Except that magnesium stearate, get each supplementary material respectively, mix homogeneously adds suitable quantity of water system soft material, and 18 orders are granulated, 60 degree fluid bed dryings, 24 order granulate add magnesium stearate, mix homogeneously, tabletting.
Embodiment 2 capsules
The supplementary material title | Consumption |
Sodium ibuprofen dihydrate | 200g |
Pseudoephedrine hydrochloride | 30g |
Chlorphenamine maleate | 2g |
Microcrystalline Cellulose | 40.4g |
Sodium carboxymethyl cellulose | 9.2g |
Hydroxypropyl cellulose | 4.0g |
Silicon dioxide | 4.6g |
Magnesium stearate | 1.8g |
Purified water | In right amount |
Technology: get above-mentioned each crude drug, pulverize separately is crossed 80 mesh sieves, and is subsequent use; Each adjuvant is crossed 60 mesh sieves respectively, and is subsequent use; Except that silicon dioxide, magnesium stearate, get each supplementary material respectively, mix homogeneously adds suitable quantity of water system soft material, and 18 orders are granulated, 60 ℃ of dryings, 24 order granulate add silicon dioxide, magnesium stearate, behind the mix homogeneously, insert in the capsulae vacuus, promptly get.
Embodiment 3: chewable tablet
The supplementary material title | Consumption |
Sodium ibuprofen dihydrate | 100g |
Diphenhydramine | 25g |
Lactose | 50g |
Cross-linking sodium carboxymethyl cellulose | 20g |
PVP?K30 | 2g |
PEG?6000 | 50g |
Citric acid | 50g |
Microcrystalline Cellulose PH-101 | 200g |
Low-substituted hydroxypropyl cellulose | 20g |
Sucralose | 1g |
The powder orange flavor | 12g |
Mannitol | 50g |
Castor oil hydrogenated | 5g |
Coating powder | In right amount |
Preparation technology:
1.PVP be dissolved in an amount of water;
2. with lactose, Sodium ibuprofen, cross-linking sodium carboxymethyl cellulose and 150 gram microcrystalline Cellulose mix homogeneously;
3. the aqueous solution that adds PVP is granulated, and carries out drying in 60 degree; Granulate, subsequent use;
4. get diphenhydramine, microcrystalline Cellulose 50 grams, mannitol, citric acid, low-substituted hydroxypropyl cellulose mix homogeneously, add entry system soft material, granulate, and dry, granulate, subsequent use;
5. with step 3 and step 4 two parts granule mixing, add PEG 6000, sucralose, powder orange flavor, castor oil hydrogenated mix homogeneously, tabletting, coating promptly gets.
Embodiment 4: granule
The supplementary material title | Consumption |
Sodium ibuprofen dihydrate | 150g |
Zinc gluconate | 100g |
Chlorphenamine maleate | 2g |
Sucrose | 80g |
Essence | In right amount |
Technology: get above-mentioned each crude drug, pulverize separately is crossed 80 mesh sieves, and is subsequent use; Each adjuvant is crossed 60 mesh sieves respectively, and is subsequent use; , get each supplementary material respectively, mix homogeneously adds suitable quantity of water system soft material, and 18 orders are granulated, 60 ℃ of dryings, 20 order granulate, packing promptly gets.
Embodiment 5: slow releasing tablet
The supplementary material title | Consumption |
Sodium ibuprofen | 200g |
Pseudoephedrine hydrochloride | 30g |
Lactose | 70g |
Microcrystalline Cellulose | 85g |
HPMC?K4M | 10g |
Silicon dioxide | 2g |
Magnesium stearate | 2g |
Technology: get above-mentioned each crude drug, pulverize separately is crossed 80 mesh sieves, and is subsequent use; Each adjuvant is crossed 60 mesh sieves respectively, and is subsequent use; Except that silicon dioxide, magnesium stearate, get each supplementary material respectively, with equivalent incremental method mix homogeneously, add 90% ethanol system soft material, 18 mesh sieves are granulated, 60 ℃ of oven dry, 24 mesh sieve granulate.Add colloidal silica, magnesium stearate, mix homogeneously, tabletting.
Embodiment 6: to the refrigeration function of rat
Get some of sD rats, body weight (150 ± 20) g.Choose 60 of the rat of body temperature in 36.6 ℃~38.3 ℃, male and female half and half are divided into 6 groups at random; Every group 10, be respectively model contrast, ibuprofen group, Sodium ibuprofen group, acetaminophen group, ibuprofen+acetaminophen group, Sodium ibuprofen+acetaminophen group, each organizes equal gastric infusion; 1 day 1 time continuous 3d, fasting 12h before experiment freely drinks water; The same day was surveyed body temperature 2 times in experiment, at a distance from 2h 1 time, selected the temperature difference to be no more than 0.3 ℃ 40 of qualified rats; After the last administration at once in rat back subcutaneous injection dry yeast (15%) suspension 10mL/kg, then in 2,6,10h measures anus temperature value, comparison between organizing.The result shows that with respect to matched group, each treatment group all has certain refrigeration function, but the action effect of Sodium ibuprofen+acetaminophen is more obvious.See table 1
Table 1 pair dry yeast causes the influence of rat fever
Embodiment 7: to the antiinflammatory action of mice
Get 40 of KM kind mices; Male and female half and half; Body weight 18-22g; Be divided into 4 groups at random: be respectively model contrast (drug administration by injection), arginine+ibuprofen (drug administration by injection) group, arginine+ibuprofen (gastric infusion) group, arginine+ibuprofen (auris dextra topical administration), ibuprofen (gastric infusion) group, 10 every group, 1 day 1 time continuous 3d.Behind the last administration 45min, be coated with xylene 0.05mL/ in the mouse right ear two sides and only cause swollenly, left ear is not painted with normal ear; Mice is put to death in the cervical vertebra dislocation behind the 45min, lays disk in same area respectively with the 9mm card punch, weighs; Calculate swelling degree, inhibitory rate of intumesce, compare between organizing.
The result shows that with respect to matched group, each treatment group all has tangible antiinflammatory action, and ibuprofen+arginic compound injection group effect is more remarkable, sees table 2.
Table 2 xylol causes the antiinflammatory action of mice ear
Embodiment 8: to the analgesic activity of mice
Get 40 of KM kind mices, male and female half and half, body weight 18-22g is divided into 7 groups at random, 10 every group.Be respectively model contrast, Sodium ibuprofen+codeine phosphate group, ibuprofen+codeine phosphate group, Sodium ibuprofen+oxycodone hydrochloride group, ibuprofen+oxycodone hydrochloride group, Sodium ibuprofen+tartaric acid ammonia phenol hydrocodone group, ibuprofen+tartaric acid ammonia phenol hydrocodone group.Behind the administration 45min, each Mus lumbar injection 0.6% acetum 0.1mL/10g.The mouse writhing reaction times that occurs in the observation 15min is calculated the analgesia suppression ratio, compares between organizing.The result shows that with respect to each positive controls, each compound pain effect that exists with the Sodium ibuprofen salt form is more remarkable.See table 3
Table 3 medicine is to the inhibitory action of mice acetic acid property writhing response
Embodiment 9: to the mitigation of Cavia porcellus nose allergic symptom
40 of Cavia porcelluss make sensitinogen with the 10%TDI olive oil solution, the slow collunarium of micro sample adding appliance.Modeling process is divided into sensitization and excited for two phases.The sensitization phase: model group collunarium every day 1 time, 7d continuously.Stimulating phase: since 9d, collunarium is 1 time next day of changing into, excites 4 times, altogether 8d.The modeling time is 15d altogether.
The Cavia porcellus that modeling is successful is divided into 7 groups at random; Difference model blank group (O), Sodium ibuprofen+pseudoephedrine hydrochloride+chlorphenamine maleate group (A), ibuprofen+pseudoephedrine hydrochloride+chlorphenamine maleate group (A0), Sodium ibuprofen+pseudoephedrine hydrochloride group (B), ibuprofen+pseudoephedrine hydrochloride group (B0), Sodium ibuprofen+PHENYLEPHRINE HYDROCHLORIDE group (C), ibuprofen+PHENYLEPHRINE HYDROCHLORIDE group (C0); Each organizes equal gastric infusion, and the blank group is irritated the normal saline that stomach gives equivalent.More than each treated animal excite at every turn the back 1h give the corresponding treatment medicine, observe 30min after the administration behind the 2h.Observation item comprises: the number of times that scratches, and the sneeze number of times, the thin nasal discharge degree, each treated animal becomes mold process and typical case's performance.The symptom and sign standards of grading: number of times scratches: gently scratch nose several times, remember 1 fen; Scratching nasal surface portion is more than, and scouring everywhere, remembers 2 fens.Sneeze: remember 1 fen for 1~3, remember 2 fens for 410, note is 3 minutes more than 11.Thin nasal discharge: flow to prenaris note 1 minute, flow between prenaris and the lower lip and remember 2 fens, thin nasal discharge is had one's face covered with and is remembered 3 fens.Between 2 standards, use 0.5 minute mark.Above each item all adopts the stack scoring method, and it is invalid that total points then was regarded as Drug therapy above 5 minutes.
Result: see rhinitis classical symptoms such as significantly scratching appears in the blank model group of table 4, sneeze, nasal discharge increase, nasal obstruction.Each compound recipe group can significantly reduce these sniffles; With respect to each positive controls, each is remarkable relatively with the therapeutic effect of the compound recipe that the Sodium ibuprofen salt form exists, so compound recipe of the present invention is the treatment rhinitis; Especially allergic rhinitis, effective curative of the relevant sniffle of flu.
Table 4 treatment finishes back animal dead number, symptom and sign scoring, typical case's performance
Claims (8)
1. a Pharmaceutical composition that contains Sodium ibuprofen is characterized in that, is that sodium salt and other one or more medicinal ingredients with ibuprofen are active component, combines with pharmaceutically suitable adjuvant.
2. the described compositions of claim 1 is characterized in that, described other medicinal ingredients comprise: pseudoephedrine, chlorphenamine, phenylephrine, acetaminophen, codeine phosphate, oxycodone, ammonia phenol hydrocodone, diphenhydramine etc.
3. the described compositions of claim 2 is characterized in that, other medicinal ingredients can exist with the pharmaceutical salts form; Comprise hydrochlorate, sulfate, maleate, tartrate, citrate etc.
4. the described compositions of claim 1; It is characterized in that, can be following compositions: Sodium ibuprofen+pseudoephedrine hydrochloride+chlorphenamine maleate, Sodium ibuprofen+pseudoephedrine hydrochloride, Sodium ibuprofen+PHENYLEPHRINE HYDROCHLORIDE, Sodium ibuprofen+acetaminophen, Sodium ibuprofen+codeine phosphate, Sodium ibuprofen+oxycodone hydrochloride, Sodium ibuprofen+tartaric acid ammonia phenol hydrocodone, Sodium ibuprofen+diphenhydramine citrate.
5. prescription requires 1 described compositions, it is characterized in that, the unit consumption of ibuprofen sodium salt (in ibuprofen) is 12.5-1000mg, preferred 50-500mg.
6. the described compositions of claim 1 is characterized in that, the unit consumption of other medicinal ingredients is:
Pseudoephedrine 3.25-240mg, preferred 15-120mg;
Chlorphenamine 0.25-16mg, preferred 1-8mg;
Phenylephrine 2.5-40mg, preferred 10-20mg;
Acetaminophen 25-1000mg, preferred 100-500mg;
Codeine phosphate 2.5-60mg, preferred 10-30mg;
Oxycodone 2.5-20mg, preferred 5-10mg;
Ammonia phenol hydrocodone 2.5-20mg, preferred 5-10mg;
Diphenhydramine 6.25-100mg, preferred 25-50mg.
7. the described compositions of claim 1 is characterized in that, can be made into oral formulations, comprises ordinary tablet, dispersible tablet, slow releasing tablet, capsule, granule, dry suspension, suspension etc.
8. the described compositions of claim 1,, antiinflammatory, analgesia, antiallergic analgesic and improve the purposes in the sleep medicine in preparation.
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Cited By (13)
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CN102920691A (en) * | 2012-10-23 | 2013-02-13 | 中美天津史克制药有限公司 | Compound sustained-release capsule containing ibuprofen and pseudo ephedrine |
CN103768060A (en) * | 2014-01-26 | 2014-05-07 | 悦康药业集团有限公司 | Compound tablet of ibuprofen, pseudoephedrine hydrochloride and chlorpheniramine maleate |
CN103787958A (en) * | 2014-03-10 | 2014-05-14 | 悦康药业集团有限公司 | Chlorpheniramine maleate compound and pharmaceutical composition thereof |
CN104251889A (en) * | 2013-06-26 | 2014-12-31 | 深圳海王药业有限公司 | Method for determining content of three components comprising phenylephrine hydrochloride, chlorphenamine maleate and ibuprofen in compound cold treatment tablet |
CN104983732A (en) * | 2015-05-28 | 2015-10-21 | 华润三九医药股份有限公司 | Allergy and congestion relief and preparation method thereof |
US9492444B2 (en) | 2013-12-17 | 2016-11-15 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
CN106324162A (en) * | 2015-06-17 | 2017-01-11 | 深圳海王药业有限公司 | High performance liquid chromatography-time-of-flight mass spectrometry method for identifying degradation product in compound cold treatment medicine based on heart-cutting technology |
US9707184B2 (en) | 2014-07-17 | 2017-07-18 | Pharmaceutical Manufacturing Research Services, Inc. | Immediate release abuse deterrent liquid fill dosage form |
CN107929247A (en) * | 2016-10-13 | 2018-04-20 | 长春海悦药业股份有限公司 | That quick tablet composition of a kind of cloth Lip river feritin and preparation method thereof |
US10172797B2 (en) | 2013-12-17 | 2019-01-08 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
US10195153B2 (en) | 2013-08-12 | 2019-02-05 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded immediate release abuse deterrent pill |
WO2019240755A1 (en) * | 2018-06-11 | 2019-12-19 | Wellesley Pharmaceuticals, Llc | Pharmaceutical compositions and methods for weight loss |
US10959958B2 (en) | 2014-10-20 | 2021-03-30 | Pharmaceutical Manufacturing Research Services, Inc. | Extended release abuse deterrent liquid fill dosage form |
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CN104251889B (en) * | 2013-06-26 | 2016-06-01 | 深圳海王药业有限公司 | The measuring method of Phenylephrine Hydrochloride, chlorpheniramine maleate and Ibuprofen BP/EP three kinds of component contents in compound flu tablet |
CN104251889A (en) * | 2013-06-26 | 2014-12-31 | 深圳海王药业有限公司 | Method for determining content of three components comprising phenylephrine hydrochloride, chlorphenamine maleate and ibuprofen in compound cold treatment tablet |
US10639281B2 (en) | 2013-08-12 | 2020-05-05 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded immediate release abuse deterrent pill |
US10195153B2 (en) | 2013-08-12 | 2019-02-05 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded immediate release abuse deterrent pill |
US10172797B2 (en) | 2013-12-17 | 2019-01-08 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
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CN103787958A (en) * | 2014-03-10 | 2014-05-14 | 悦康药业集团有限公司 | Chlorpheniramine maleate compound and pharmaceutical composition thereof |
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US9707184B2 (en) | 2014-07-17 | 2017-07-18 | Pharmaceutical Manufacturing Research Services, Inc. | Immediate release abuse deterrent liquid fill dosage form |
US10959958B2 (en) | 2014-10-20 | 2021-03-30 | Pharmaceutical Manufacturing Research Services, Inc. | Extended release abuse deterrent liquid fill dosage form |
CN104983732B (en) * | 2015-05-28 | 2018-05-04 | 华润三九医药股份有限公司 | A kind of cloth Lip river feritin that quick and preparation method thereof |
CN104983732A (en) * | 2015-05-28 | 2015-10-21 | 华润三九医药股份有限公司 | Allergy and congestion relief and preparation method thereof |
CN106324162B (en) * | 2015-06-17 | 2018-04-27 | 深圳海王医药科技研究院有限公司 | High performance liquid chromatography-flight time mass spectrum method for combined use of catabolite in a kind of technical appraisement compound cold drug based on heartcut |
CN106324162A (en) * | 2015-06-17 | 2017-01-11 | 深圳海王药业有限公司 | High performance liquid chromatography-time-of-flight mass spectrometry method for identifying degradation product in compound cold treatment medicine based on heart-cutting technology |
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Application publication date: 20120328 |