CN102908324A - Apixaban tablet - Google Patents
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- CN102908324A CN102908324A CN2012104344682A CN201210434468A CN102908324A CN 102908324 A CN102908324 A CN 102908324A CN 2012104344682 A CN2012104344682 A CN 2012104344682A CN 201210434468 A CN201210434468 A CN 201210434468A CN 102908324 A CN102908324 A CN 102908324A
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Abstract
The invention discloses an Apixaban tablet, which comprises the following components in parts: 1 part of Apixaban, 10-20 parts of water-soluble carrier material, 30-60 parts of filling agent, 5-10 parts of disintegrating agent and 5-10 parts of glidant. The Apixaban tablet provided by the invention improves the deficiencies in the prior art that the extracorporeal dissolution rate and the bioavailability is low. The preparation method of the Apixaban tablet disclosed by the invention is simple to operate, has good reproducibility, and is suitable for large-scale production. The Apixaban tablet is mainly used for the anti-thrombosis purpose.
Description
Technical field
The invention belongs to medical technical field, be specifically related to a kind of Eliquis sheet and preparation method thereof.
Background technology
Eliquis is the direct Xa factor inhibitor of a kind of new oral, and chemical formula is 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxo-piperidine-1-yl) phenyl]-4,5,6,7-tetrahydrochysene-1H-pyrazolo [3,4-c] pyridine-3-carboxamide.Molecular formula is C
25H
25N
5O
4, molecular weight is 459.50.Structural formula is as follows:
Cardiovascular and cerebrovascular disease is take its high incidence, high relapse rate, high disability rate, high mortality as characteristics serious threat people ' s health.China just has 1 people to suffer from cardiovascular and cerebrovascular disease among per 5 adults at present, just have 1 people to die from cardiovascular and cerebrovascular disease average per 10 seconds, annual number because of cerebrovascular disease death accounts for 22.5% of dead sum, and sickness rate is still in ascendant trend year by year, according to the prediction of Ministry of Public Health, the number of the infected of China's cardiovascular and cerebrovascular disease more than 40 years old also will increase 2-3 doubly in 20 years futures.Cardio-cerebral vascular disease patient is again because of its high disability rate, can not recover fully after causing most patients ill, and different sequela is arranged, and has a strong impact on Quality of Life.Thrombosis is that a kind of intravascular space is narrow, blood thromboembolism and the inaccessible common vascular conditions that causes of blood circulation.Phlebothrombosis mainly causes pulmonary infarction, and arterial thrombus will cause myocardial infarction, apoplexy, acute coronary syndrome and Peripheral arteral disease, the serious threat mankind's health.
Antithrombotic drug can be divided into by its mechanism of action: antiplatelet drug; Anticoagulant; Thrombolytic Drugs.The classification of existing anticoagulation medicine mainly contains 1. thrombin inhibitor a. Xa factor inhibitor indirectly indirectly, sulphur reaches liver certain herbaceous plants with big flowers sodium, the direct Xa factor inhibitor of 0ctaparine (the III phase is clinical) b., razaxaban, Eliquis, edoxaban, Otamixaban; 2. directly thrombin inhibitor comprises hirudin, lepirudin 023 ludon, bivalirudin, argatroban, dabigatran etcxilate etc.; 3. vitamin k antagonist: warfarin; 4. heparin class.Conventional medicament acts on IIa and Xa factor two places, the sales volume of domestic Low molecular heparin is at present with the highest in the veriety, but because the restriction of route of administration and the untoward reaction such as hemorrhage, novel medicine oral, that act on the Xa factor inhibitor will be expected to become new succedaneum.Eliquis is the new oral anticoagulant of the 3rd listing after dabigatran etcxilate, razaxaban.Its gone through in Europe to prevent to accept to select a time hip joint or replacement knee in arthroplasty patient's venous thromboembolism sexual behavior part.According to the clinical studies show before external a large amount of listings, Eliquis is that first is presented in the medicine that the main terminal point events incidence such as apoplexy, hemorrhage and mortality rate clearly reduces in these three kinds of anticoagulant, shows the significant advantage that surmounts other two chief competitor dabigatrans and razaxaban.Undoubtedly, the ultimate aim of new oral anticoagulant is to replace existing traditional anticoagulant, to treat the prevention of established venous thromboembolism (VTE) and Patients With Atrial Fibrillation arterial thrombosis.The mechanism of action of research take Eliquis as representative is more novel, clinical effectiveness is more remarkable and the oral anticoagulation of less adverse effect will become the from now on emphasis of research and development gradually.
Eliquis is water insoluble, has the shortcoming that dissolution velocity is slow, dissolution in vitro is low, bioavailability is low, the impact certain on being absorbed with of medicine.In order to improve the dissolution of Eliquis, generally adopt the method that in prescription, adds the exhibiting high surface activating agent, although the method can increase the dissolution of Eliquis, the exhibiting high surface activating agent brings a large amount of toxic and side effects to human body.Thereby seek the dissolution that a kind of nontoxic method increases Eliquis, the method that improves Eliquis is extremely urgent.
Summary of the invention
The purpose of this invention is to provide a kind of good absorbing, the high and Ah piperazine's sheet that utilize modern solid dispersion technology preparation of bioavailability.The present invention also provides a kind of preparation method of above-mentioned Eliquis tablet preparation.
At first the present invention passes through solid dispersion technology, reduced the Eliquis particle diameter, make Eliquis and Polyethylene Glycol form colloidal solution, thereby solve the defective that prior art exists, improve dissolution rate and the dissolubility of medicine, increase drug absorption, improve bioavailability, thereby the therapeutical effect of medicine is given full play to.Secondly adopt a certain amount of Polyethylene Glycol among the present invention, thereby avoided employed magnesium stearate in the routine prescription, increased the stability of Eliquis prescription and the risk of impurity degraded.Moreover the present invention adopts powder direct compression technology, compares with conventional wet granule compression tablet technology, reduced production technology; improved production efficiency; be convenient to large-scale production, and powder direct compression technology is identical with wet granule compression tablet to the requirement of equipment, is convenient to industrialized great production.
As follows for solving the problems of the technologies described above the technical solution used in the present invention:
A kind of Eliquis sheet is counted by weight, and the Eliquis sheet comprises following composition: 1 part of Eliquis; 10～20 parts of water-solubility carrier materials: 30～60 parts of filleies; 5～10 parts of disintegrating agents; 5～10 parts of fluidizer.The specification of Eliquis sheet is 2.5mg.The water-solubility carrier material is polyethylene glycol 6000, and filler is microcrystalline Cellulose, and disintegrating agent is polyvinylpolypyrrolidone, and fluidizer is micropowder silica gel.
The Eliquis sheet prepares by the following method:
(1) take by weighing the polyethylene glycol 6000 of recipe quantity, 60 ℃ are heated to melting;
(2) Eliquis that takes by weighing recipe quantity joins under the low rate mixing condition in the fused mass that step (1) makes, vigorous stirring after all adding, and low rate mixing is 200～400r/min, vigorous stirring is 10000～20000r/min;
(3) the fused mass rapid cooling curing 2h under-20 ℃ condition that step (2) is obtained;
(4) the 0 ℃ of pulverizing of solidfied material and mistake 80 mesh sieves that step (3) are obtained; Ground product obtains the Eliquis solid dispersion in 20 ℃ of drying under reduced pressure 4h;
(5) the Eliquis solid dispersion that step (4) is obtained and the microcrystalline Cellulose of recipe quantity; Polyvinylpolypyrrolidone; Micropowder silica gel mix homogeneously direct compression makes the Eliquis sheet.
Advantage of the present invention is: select water-solubility carrier material and solid to disperse technology of preparing, dissolution rate and the dissolubility of medicine have not only been improved, thereby increase drug absorption and bioavailability, and the water-solubility carrier material has the rapid release effect, drug release is accelerated, and drug effect speed is accelerated.The present invention is simple to operate, and favorable reproducibility is easy to realize a large amount of productions.
Description of drawings: Fig. 1: Eliquis sheet stripping curve figure.
The specific embodiment
For a better understanding of the present invention, below by the description to the invention preferred embodiment, explain in detail the present invention, but do not limit in any form the present invention.
Embodiment 1
Present embodiment provides 10000 Eliquis sheets of preparation, and (specification is: the 2.5mg/ sheet) prescription and preparation method are as follows
(1) take by weighing the polyethylene glycol 6000 of recipe quantity, 60 ℃ are heated to melting;
(2) Eliquis that takes by weighing recipe quantity joins under the low rate mixing condition in the fused mass that step (1) makes, vigorous stirring after all adding, and low rate mixing is 200～400r/min, vigorous stirring is 10000～20000r/min;
(3) the fused mass rapid cooling curing 2h under-20 ℃ condition that step (2) is obtained;
(4) the 0 ℃ of pulverizing of solidfied material and mistake 80 mesh sieves that step (3) are obtained; Ground product obtains the Eliquis solid dispersion in 20 ℃ of drying under reduced pressure 4h;
(5) the Eliquis solid dispersion that step (4) is obtained and the microcrystalline Cellulose of recipe quantity; Polyvinylpolypyrrolidone; Micropowder silica gel mix homogeneously direct compression makes the Eliquis sheet.
Embodiment 2
Present embodiment provides 10000 Eliquis sheets of preparation, and (specification is: the 2.5mg/ sheet) prescription and preparation method are as follows
(1) take by weighing the polyethylene glycol 6000 of recipe quantity, 60 ℃ are heated to melting;
(2) Eliquis that takes by weighing recipe quantity joins under the low rate mixing condition in the fused mass that step (1) makes, vigorous stirring after all adding, and low rate mixing is 200～400r/min, vigorous stirring is 10000～20000r/min;
(3) the fused mass rapid cooling curing 2h under-20 ℃ condition that step (2) is obtained;
(4) the 0 ℃ of pulverizing of solidfied material and mistake 80 mesh sieves that step (3) are obtained; Ground product obtains the Eliquis solid dispersion in 20 ℃ of drying under reduced pressure 4h;
(5) the Eliquis solid dispersion that step (4) is obtained and the microcrystalline Cellulose of recipe quantity; Polyvinylpolypyrrolidone; Micropowder silica gel mix homogeneously direct compression makes the Eliquis sheet.
Embodiment 3
Present embodiment provides 10000 Eliquis sheets of preparation, and (specification is: the 2.5mg/ sheet) prescription and preparation method are as follows
(1) take by weighing the polyethylene glycol 6000 of recipe quantity, 60 ℃ are heated to melting;
(2) Eliquis that takes by weighing recipe quantity joins under the low rate mixing condition in the fused mass that step (1) makes, vigorous stirring after all adding, and low rate mixing is 200～400r/min, vigorous stirring is 10000～20000r/min;
(3) the fused mass rapid cooling curing 2h under-20 ℃ condition that step (2) is obtained;
(4) the 0 ℃ of pulverizing of solidfied material and mistake 80 mesh sieves that step (3) are obtained; Ground product obtains the Eliquis solid dispersion in 20 ℃ of drying under reduced pressure 4h;
(5) the Eliquis solid dispersion that step (4) is obtained and the microcrystalline Cellulose of recipe quantity; Polyvinylpolypyrrolidone; Micropowder silica gel mix homogeneously direct compression makes the Eliquis sheet.
Embodiment 4
Present embodiment provides 10000 Eliquis sheets of preparation, and (specification is: the 2.5mg/ sheet) prescription and preparation method are as follows
(1) take by weighing the polyethylene glycol 6000 of recipe quantity, 60 ℃ are heated to melting;
(2) Eliquis that takes by weighing recipe quantity joins under the low rate mixing condition in the fused mass that step (1) makes, vigorous stirring after all adding, and low rate mixing is 200～400r/min, vigorous stirring is 10000～20000r/min;
(3) the fused mass rapid cooling curing 2h under-20 ℃ condition that step (2) is obtained;
(4) the 0 ℃ of pulverizing of solidfied material and mistake 80 mesh sieves that step (3) are obtained; Ground product obtains the Eliquis solid dispersion in 20 ℃ of drying under reduced pressure 4h;
(5) the Eliquis solid dispersion that step (4) is obtained and the microcrystalline Cellulose of recipe quantity; Polyvinylpolypyrrolidone; Micropowder silica gel mix homogeneously direct compression makes the Eliquis sheet.
Embodiment 5
Conventional method prepares 10000 Eliquis sheets, and (specification is: the 2.5mg/ sheet) prescription and preparation method are as follows
(1) polyvidone that takes by weighing recipe quantity adds water and makes 2% aqueous solution, and is for subsequent use as binding agent;
(2) take by weighing Eliquis, lactose, the microcrystalline Cellulose mix homogeneously of recipe quantity, add binding agent 30 orders and granulate 60 ℃ of dry 2h, 30 order granulate; Get intermediate compound I;
(3) take by weighing micropowder silica gel, crosslinked carboxymethyl fecula sodium, magnesium stearate and the intermediate compound I mix homogeneously of recipe quantity, tabletting makes the Eliquis sheet.
Embodiment 6
Eliquis sheet (embodiment 1,2,3,4,5) cumulative in vitro dissolution determination:
The dissolution experimental technique is as follows: get this product according to dissolution method (two appendix XC the second methods of Chinese Pharmacopoeia version in 2010), take hydrochloric acid solution (9 → 1000) 900ml as solvent, rotating speed is 50r/min, in accordance with the law operation, respectively at 5min, 5min, 15min, 30min, 45min, get solution 10ml, filter, get subsequent filtrate 3ml and place the 100ml measuring bottle, be diluted to scale with mobile phase, shake up, filter, as need testing solution.Adopt the octadecylsilane chemically bonded silica chromatographic column; Take the 10mM ammonium acetate: acetonitrile (65: 35) is as mobile phase; Flow velocity is per minute 1.0ml; The detection wavelength is 280nm; Column temperature is 25 ℃, by the stripping quantity of external standard method with every of calculated by peak area.The cumulative in vitro dissolution sees the following form.
| ? | 5min | 10min | 15min | 30min | 45min |
| Embodiment 1 | 68％ | 82％ | 95％ | 97％ | 96％ |
| Embodiment 2 | 71％ | 79％ | 92％ | 95％ | 96％ |
| Embodiment 3 | 69％ | 86％ | 94％ | 95％ | 94％ |
| Embodiment 4 | 65％ | 64％ | 95％ | 96％ | 97％ |
| Embodiment 5 | 12％ | 18％ | 23％ | 27％ | 25％ |
Claims (7)
1. an Eliquis sheet is characterized in that, counts by weight, and described Eliquis sheet comprises following composition: 1 part of Eliquis; 10～20 parts of water-solubility carrier materials; 30～60 parts of filleies; 5～10 parts of disintegrating agents; 5～10 parts of fluidizer.
2. Eliquis sheet according to claim 1 is characterized in that, the specification of described Eliquis sheet is 2.5mg.
3. Eliquis sheet according to claim 1 is characterized in that, described water-solubility carrier material is polyethylene glycol 6000.
4. Eliquis sheet according to claim 1 is characterized in that, described filler is microcrystalline Cellulose.
5. Eliquis sheet according to claim 1 is characterized in that, described disintegrating agent is polyvinylpolypyrrolidone.
6. Eliquis sheet according to claim 1 is characterized in that, described fluidizer is micropowder silica gel.
7. described Eliquis sheet according to claim 1～6, it is characterized in that: described Eliquis sheet prepares by the following method:
(1) take by weighing the polyethylene glycol 6000 of recipe quantity, 60 ℃ are heated to melting;
(2) Eliquis that takes by weighing recipe quantity joins under the low rate mixing condition in the fused mass that step (1) makes, vigorous stirring after all adding, and low rate mixing is 200～400r/min, vigorous stirring is 10000～20000r/min;
(3) the fused mass rapid cooling curing 2h under-20 ℃ condition that step (2) is obtained;
(4) the 0 ℃ of pulverizing of solidfied material and mistake 80 mesh sieves that step (3) are obtained; Ground product obtains the Eliquis solid dispersion in 20 ℃ of drying under reduced pressure 4h;
(5) the Eliquis solid dispersion that step (4) is obtained and the microcrystalline Cellulose of recipe quantity, polyvinylpolypyrrolidone, micropowder silica gel mix homogeneously direct compression make the Eliquis sheet.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012104344682A CN102908324A (en) | 2012-10-31 | 2012-10-31 | Apixaban tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012104344682A CN102908324A (en) | 2012-10-31 | 2012-10-31 | Apixaban tablet |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102908324A true CN102908324A (en) | 2013-02-06 |
Family
ID=47607065
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2012104344682A Pending CN102908324A (en) | 2012-10-31 | 2012-10-31 | Apixaban tablet |
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| CN (1) | CN102908324A (en) |
Cited By (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103830199A (en) * | 2014-03-24 | 2014-06-04 | 重庆东得医药科技有限公司 | Medicine preparation containing apixaban and preparation method of medicine preparation |
| CN104095823A (en) * | 2014-07-08 | 2014-10-15 | 成都克莱蒙医药科技有限公司 | Method for preparing Apixaban tablets |
| CN104382874A (en) * | 2014-11-21 | 2015-03-04 | 哈尔滨圣吉药业股份有限公司 | Apixaban sustained-release tablets and preparation method thereof |
| CN104721156A (en) * | 2013-12-18 | 2015-06-24 | 山东新时代药业有限公司 | Rivaroxaban-containing tablets |
| CN104721142A (en) * | 2013-12-18 | 2015-06-24 | 山东新时代药业有限公司 | Rivaroxaban solid dispersion and preparation method thereof |
| CN105534939A (en) * | 2015-12-29 | 2016-05-04 | 郑州大明药物科技有限公司 | Dabigatran etexilate mesylate oral solid preparation and preparation method thereof |
| CN105832672A (en) * | 2016-05-06 | 2016-08-10 | 杭州容立医药科技有限公司 | Preparation method and application of solid dispersoid |
| CN105997883A (en) * | 2016-05-06 | 2016-10-12 | 杭州容立医药科技有限公司 | Solid dispersion and preparation method and application thereof |
| CN106913528A (en) * | 2015-12-25 | 2017-07-04 | 中美华世通生物医药科技（武汉）有限公司 | Eliquis micropill and preparation method thereof |
| EP3243505A1 (en) * | 2016-05-13 | 2017-11-15 | Zaklady Farmaceutyczne Polpharma SA | A pharmaceutical composition comprising amorphous apixaban |
| CN108096205A (en) * | 2018-02-27 | 2018-06-01 | 南京正科医药股份有限公司 | A kind of Apixaban tablet and preparation method thereof |
| CN108186577A (en) * | 2018-03-09 | 2018-06-22 | 武汉工程大学 | A kind of razaxaban solid dispersions and preparation method thereof and preparation |
| CN108553441A (en) * | 2018-06-08 | 2018-09-21 | 北京阳光诺和药物研究有限公司 | A kind of Apixaban tablet and preparation method thereof |
| US10537524B2 (en) | 2016-01-12 | 2020-01-21 | North & South Brother Pharmacy Investment Company Limited | Apixaban solid composition and preparation method thereof |
| CN112791057A (en) * | 2021-02-07 | 2021-05-14 | 齐飞 | Slow release preparation containing edoxaban and preparation method thereof |
| WO2021095048A1 (en) * | 2019-11-13 | 2021-05-20 | Unison Pharmaceuticals Pvt. Ltd. | Orally disintegrating pharmaceutical compositions of apixaban |
| WO2023115593A1 (en) * | 2021-12-26 | 2023-06-29 | 浙江海正药业股份有限公司 | Apixaban tablet and preparation process therefor |
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| WO2011106478A2 (en) * | 2010-02-25 | 2011-09-01 | Bristol-Myers Squibb Company | Apixaban formulations |
| CN102058889A (en) * | 2010-11-05 | 2011-05-18 | 王定豪 | Dispersible tablet containing anticoagulants and application thereof |
| CN102727454A (en) * | 2012-05-25 | 2012-10-17 | 成都中医药大学附属医院 | Evodiamine dispersion tablets and preparation method thereof |
Cited By (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104721156A (en) * | 2013-12-18 | 2015-06-24 | 山东新时代药业有限公司 | Rivaroxaban-containing tablets |
| CN104721142A (en) * | 2013-12-18 | 2015-06-24 | 山东新时代药业有限公司 | Rivaroxaban solid dispersion and preparation method thereof |
| CN104721142B (en) * | 2013-12-18 | 2020-04-28 | 山东新时代药业有限公司 | Rivaroxaban solid dispersion and preparation method thereof |
| CN103830199A (en) * | 2014-03-24 | 2014-06-04 | 重庆东得医药科技有限公司 | Medicine preparation containing apixaban and preparation method of medicine preparation |
| CN104095823A (en) * | 2014-07-08 | 2014-10-15 | 成都克莱蒙医药科技有限公司 | Method for preparing Apixaban tablets |
| CN104382874A (en) * | 2014-11-21 | 2015-03-04 | 哈尔滨圣吉药业股份有限公司 | Apixaban sustained-release tablets and preparation method thereof |
| CN106913528A (en) * | 2015-12-25 | 2017-07-04 | 中美华世通生物医药科技（武汉）有限公司 | Eliquis micropill and preparation method thereof |
| CN105534939A (en) * | 2015-12-29 | 2016-05-04 | 郑州大明药物科技有限公司 | Dabigatran etexilate mesylate oral solid preparation and preparation method thereof |
| US10537524B2 (en) | 2016-01-12 | 2020-01-21 | North & South Brother Pharmacy Investment Company Limited | Apixaban solid composition and preparation method thereof |
| CN105997883A (en) * | 2016-05-06 | 2016-10-12 | 杭州容立医药科技有限公司 | Solid dispersion and preparation method and application thereof |
| CN105832672A (en) * | 2016-05-06 | 2016-08-10 | 杭州容立医药科技有限公司 | Preparation method and application of solid dispersoid |
| EP3243505A1 (en) * | 2016-05-13 | 2017-11-15 | Zaklady Farmaceutyczne Polpharma SA | A pharmaceutical composition comprising amorphous apixaban |
| CN108096205A (en) * | 2018-02-27 | 2018-06-01 | 南京正科医药股份有限公司 | A kind of Apixaban tablet and preparation method thereof |
| CN108186577A (en) * | 2018-03-09 | 2018-06-22 | 武汉工程大学 | A kind of razaxaban solid dispersions and preparation method thereof and preparation |
| CN108553441A (en) * | 2018-06-08 | 2018-09-21 | 北京阳光诺和药物研究有限公司 | A kind of Apixaban tablet and preparation method thereof |
| CN108553441B (en) * | 2018-06-08 | 2019-11-08 | 北京阳光诺和药物研究有限公司 | A kind of Apixaban tablet and preparation method thereof |
| WO2021095048A1 (en) * | 2019-11-13 | 2021-05-20 | Unison Pharmaceuticals Pvt. Ltd. | Orally disintegrating pharmaceutical compositions of apixaban |
| CN112791057A (en) * | 2021-02-07 | 2021-05-14 | 齐飞 | Slow release preparation containing edoxaban and preparation method thereof |
| CN112791057B (en) * | 2021-02-07 | 2022-03-18 | 齐飞 | Slow release preparation containing edoxaban and preparation method thereof |
| WO2023115593A1 (en) * | 2021-12-26 | 2023-06-29 | 浙江海正药业股份有限公司 | Apixaban tablet and preparation process therefor |
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Application publication date: 20130206 |