CN201426858Y - Clopidogrel hydrogen shlfate and aspirin double-layer tablet - Google Patents
Clopidogrel hydrogen shlfate and aspirin double-layer tablet Download PDFInfo
- Publication number
- CN201426858Y CN201426858Y CN2009200151275U CN200920015127U CN201426858Y CN 201426858 Y CN201426858 Y CN 201426858Y CN 2009200151275 U CN2009200151275 U CN 2009200151275U CN 200920015127 U CN200920015127 U CN 200920015127U CN 201426858 Y CN201426858 Y CN 201426858Y
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- aspirin
- clopidogrel
- double
- layer
- layer tablet
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Abstract
The utility model relates to a double-layer tablet, which comprises an aspirin sustained-release tablet layer and a copidogrel hydrogen shlfate rapid-release tablet. The utility model has simple preparation process, is convenient for patients to take and has accurate dose.
Description
Technical field
This utility model relates to a kind of dosage form structure, is specifically related to a kind of Clopidogrel Hydrogensulfate aspirin double-layer tablet, belongs to field of pharmaceutical preparations.
Background technology
The heart, cerebrovascular disease are the most serious diseases that threatens human body health in the world today, and its sickness rate surpasses tumor and leaps to the first, and the antithrombotic reagent of long usefulness has aspirin, indobufen, ticlopidine, clopidogrel etc. in the market.Aspirin is widely used in treatment coronary atherosclerotic heart disease and ischemic cerebrovascular as medicament for resisting platelet aggregation clinically because of low price.Clopidogrel is the accumulative potent inhibitor of a kind of ADP induced platelet; it is by the blocking-up adp receptor; suppress Fibrinogen with it platelet receptor (being glycoprotein GPIIb/IIIa) thus combine platelet aggregation always; multinomial clinical research proves; clopidogrel has early stage and long-term protective effect to atherosclerosis thrombosis stroke disease patient; this class patient comprises unstable angina pectoris, myocardial infarction, ischemic cerebral apoplexy is medium in early days, and its toleration, clinical efficacy all are better than aspirin.But clopidogrel resolves into clopidogrel acid easily, and this can influence the drug effect of clopidogrel.
For the advantage on the anti-platelet aggregation drug effect in conjunction with aspirin and clopidogrel better, the report of external existing aspirin and clopidogrel drug combination has also been obtained curative effect preferably, experimental study shows, clopidogrel and aspirin coupling, biologically active pdgf is obviously received inhibition, platelet-leukocyte microgranule forms and reduces, the danger of acute coronary syndrome is reduced greatly, aspirin does not significantly increase the bleeding time that clopidogrel causes, do not change inductive anticoagulant effect, and clopidogrel can strengthen the inhibitory action of aspirin to the inductive platelet aggregation of collagen protein by ADP.
But, for share aspirin and clopidogrel/Clopidogrel Hydrogensulfate, all be to use two kinds of preparation unit to take respectively in the prior art, this is unfavorable for that the patient takes, and it is also higher to take time unit's treatment cost, dosage control is comparatively inconvenience also.
Summary of the invention
The purpose of this utility model provides that a kind of patient of being beneficial to takes and taking dose double-layer tablet accurately, and this double-layer tablet comprises two kinds of unit lamellas that rate of release is different, is respectively aspirin sustained release tablet layer 1 and Clopidogrel Hydrogensulfate rapid release lamella 2.
In this utility model preparation, aspirin sustained release tablet layer 1 comprises acceptable excipient in the aspirin for the treatment of effective dose and the pharmacy, wherein contain slow releasing agent in the excipient at least, filler, lubricant, adhesive, described slow releasing agent can be a low-substituted hydroxypropyl cellulose, ethyl cellulose, acrylic resin, in chitosan or the xanthan gum any one or multiple, described filler can be a microcrystalline Cellulose, lactose, in the starch any one, described lubricant can be a magnesium stearate, in the differential silica gel any one, described binding agent can be polyvidones, polyvinylpyrrolidone, gelatin, in the hydroxypropyl cellulose any one.
In this utility model preparation, Clopidogrel Hydrogensulfate slow release lamella 2 comprises acceptable excipient in the Clopidogrel Hydrogensulfate for the treatment of effective dose and the pharmacy, wherein contain filler, disintegrating agent, lubricant and binding agent in the excipient at least, described filler can be crystalline cellulose element, lactose, starch and composition thereof, described disintegrating agent can be microcrystalline Cellulose, the low hydroxypropyl cellulose that replaces, sucrose, polyvinylpyrrolidone, sodium starch glycollate and composition thereof, in described disintegrating agent, polyvinylpyrrolidone preferably; Described adhesive can be any one in polyvidone, polyvinylpyrrolidone, gelatin, the hydroxypropyl cellulose, and described lubricant can be magnesium stearate or differential silica gel.
In this utility model, every amount that contains aspirin can be 25-75mg, is preferably 25 or 50mg, and every middle sulfur acid clopidogrel is 25-100mg, is preferably 50 or 75mg.
When preparing double-layer tablet of the present invention, prepare earlier the granule of each lamella successively, be pressed into double-layer tablet then promptly.
Pharmacological testing research
Double-layer tablet and independent Clopidogrel Hydrogensulfate, aspirin are to containing arachidonic hematoblastic agglutination.
Animal: 40 male rats, body weight are in the scope of 250-300g;
Dosage: aspirin 3mg/kg.d
-1, Clopidogrel Hydrogensulfate 9mg/kg.d
-1Double-layer tablet of the present invention (aspirin+Clopidogrel Hydrogensulfate) is (3+9) mg/kg.d
-1, successive administration 10 days, after last day of administration administration 2 hours, use the isoflurane anesthesia rat, and collect blood sample from abdominal aortic and put in the plastic tube that fills Gansu, with centrifugal 10 minutes of resulting blood sample, obtain containing hematoblastic blood plasma with centrifuge.Test, each test contain hematoblastic blood plasma rising tone by the arachidonic acid coagulation, the results are shown in following table
Table 1 is at external agglutination to rat platelet
| The treatment group | Coagulation degree % behind the interpolation 1mM olefin(e) acid |
| Matched group | ?93.8±4.2 |
| The Clopidogrel Hydrogensulfate group | ?82.6±10.7 |
| The aspirin group | ?77.3±12.6 |
| Double-layer tablet group of the present invention | ?52.6±14.4 * |
From last table result as can be known, double-layer tablet group of the present invention obviously is better than a kind of among both of independent use to hematoblastic agglutination.
Description of drawings
Fig. 1 is a front view of the present utility model.
Specific embodiment
Aspirin sustained release tablet layer prescription (every content)
Aspirin 25.0mg
Hydroxypropyl emthylcellulose 70.0mg
Starch 50.0mg
Polyvidone 12.0mg
Differential silica gel 2.0g
70% ethanol is an amount of
Gross weight 159mg
Clopidogrel Hydrogensulfate fast-release tablet prescription (every content)
Clopidogrel Hydrogensulfate 75mg
Crospolyvinylpyrrolidone 50mg
Microcrystalline Cellulose 50mg
Polyvidone 10mg
Magnesium stearate 2mg
70% ethanol is an amount of
Gross weight 187mg
Get aspirin, Clopidogrel Hydrogensulfate is crossed 100 mesh sieves respectively, starch, microcrystalline Cellulose, hydroxypropyl emthylcellulose, polyvidone is crossed 100 mesh sieves respectively, standby, dispose 1000 sample recipe quantities, get the aspirin of getting of recipe quantity, hydroxypropyl emthylcellulose, starch, stearic acid, mix homogeneously, and cross 60 mesh sieves, and be adhesive with the polyvidone that is dissolved in an amount of 70% the ethanol, join in the said mixture, be mixed with soft material, cross 16 mesh sieves and granulate, 60 ℃ of granules dry 2 hours down take out and add micropowder silica gel 2.0g and mix, cross 18 mesh sieve granulate, get aspirin layer granule; Other gets Clopidogrel Hydrogensulfate, polyvinylpyrrolidone, the polyvidone mix homogeneously of recipe quantity, crosses 100 mesh sieves, is binding agent with the polyvidone that is dissolved in 70% ethanol, be mixed with soft material, cross 16 mesh sieves and granulate, granule is dry under 60 ℃, takes out to add the micropowder silica gel mix homogeneously, cross 18 mesh sieve granulate, get Clopidogrel Hydrogensulfate layer granule, two kinds of granules are pressed into double-layer tablet up and down, wherein one deck is an aspirin sustained release tablet layer 1, another layer is a Clopidogrel Hydrogensulfate rapid release lamella 2, promptly.
Claims (1)
1, a kind of Clopidogrel Hydrogensulfate aspirin double-layer tablet is characterized in that comprising aspirin sustained release tablet layer (1) and Clopidogrel Hydrogensulfate rapid release lamella (2).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009200151275U CN201426858Y (en) | 2009-07-06 | 2009-07-06 | Clopidogrel hydrogen shlfate and aspirin double-layer tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009200151275U CN201426858Y (en) | 2009-07-06 | 2009-07-06 | Clopidogrel hydrogen shlfate and aspirin double-layer tablet |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN201426858Y true CN201426858Y (en) | 2010-03-24 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2009200151275U Expired - Lifetime CN201426858Y (en) | 2009-07-06 | 2009-07-06 | Clopidogrel hydrogen shlfate and aspirin double-layer tablet |
Country Status (1)
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102058550A (en) * | 2010-12-30 | 2011-05-18 | 江苏亚邦强生药业有限公司 | Clopidogrel bisulfate tablet and preparation method thereof |
| CN104367582A (en) * | 2014-05-20 | 2015-02-25 | 南京海纳医药科技有限公司 | Tablet containing clopidogrel sulfate and aspirin active compositions and preparation method thereof |
| CN104434932A (en) * | 2014-12-18 | 2015-03-25 | 成都苑东药业有限公司 | Pharmaceutical composition of clopidogrel hydrogen sulfate and acetylsalicylic acid tablet and preparation method thereof |
| CN104523710A (en) * | 2014-12-30 | 2015-04-22 | 石药集团欧意药业有限公司 | Compound clopidogrel hydrogen sulphate and aspirin double-layer tablet and preparation method thereof |
-
2009
- 2009-07-06 CN CN2009200151275U patent/CN201426858Y/en not_active Expired - Lifetime
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102058550A (en) * | 2010-12-30 | 2011-05-18 | 江苏亚邦强生药业有限公司 | Clopidogrel bisulfate tablet and preparation method thereof |
| CN102058550B (en) * | 2010-12-30 | 2016-04-27 | 江苏亚邦强生药业有限公司 | Clopidogrel bisulfate tablet and preparation method thereof |
| CN104367582A (en) * | 2014-05-20 | 2015-02-25 | 南京海纳医药科技有限公司 | Tablet containing clopidogrel sulfate and aspirin active compositions and preparation method thereof |
| CN104434932A (en) * | 2014-12-18 | 2015-03-25 | 成都苑东药业有限公司 | Pharmaceutical composition of clopidogrel hydrogen sulfate and acetylsalicylic acid tablet and preparation method thereof |
| CN104434932B (en) * | 2014-12-18 | 2017-05-24 | 成都苑东生物制药股份有限公司 | Pharmaceutical composition of clopidogrel hydrogen sulfate and acetylsalicylic acid tablet and preparation method thereof |
| CN104523710A (en) * | 2014-12-30 | 2015-04-22 | 石药集团欧意药业有限公司 | Compound clopidogrel hydrogen sulphate and aspirin double-layer tablet and preparation method thereof |
| CN104523710B (en) * | 2014-12-30 | 2018-05-25 | 石药集团欧意药业有限公司 | A kind of bisulfate clopidogrel aspirin Composite Double synusia and preparation method thereof |
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| CX01 | Expiry of patent term |
Granted publication date: 20100324 |
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| DD01 | Delivery of document by public notice |
Addressee: Guan Yi Document name: Notification of Expiration of Patent Right Duration |
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Addressee: Gao Dan Document name: Notification of Passing Examination on Formalities |