CN104434932A - Pharmaceutical composition of clopidogrel hydrogen sulfate and acetylsalicylic acid tablet and preparation method thereof - Google Patents
Pharmaceutical composition of clopidogrel hydrogen sulfate and acetylsalicylic acid tablet and preparation method thereof Download PDFInfo
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- CN104434932A CN104434932A CN201410797659.4A CN201410797659A CN104434932A CN 104434932 A CN104434932 A CN 104434932A CN 201410797659 A CN201410797659 A CN 201410797659A CN 104434932 A CN104434932 A CN 104434932A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/60—Salicylic acid; Derivatives thereof
- A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
- A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/4365—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system having sulfur as a ring hetero atom, e.g. ticlopidine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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Abstract
The invention provides a pharmaceutical composition of clopidogrel hydrogen sulfate and an acetylsalicylic acid tablet and a preparation method thereof, belonging to the field of pharmaceutical preparation. According to the pharmaceutical composition of clopidogrel hydrogen sulfate and the acetylsalicylic acid tablet provided by the invention, F-Melt is added into the formula, so that the flowability of materials is improved and the materials are uniformly mixed; and meanwhile, clopidogrel hydrogen sulfate and the acetylsalicylic acid tablet are respectively pressed into double-layer tablets, so that the two components are prevented from interacting, thereby benefiting the safety of clinical medication and the stability in the storage process.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, be specifically related to a kind of bisulfate clopidogrel aspirin tablet medicament composition and preparation method thereof.
Background technology
Bisulfate clopidogrel, chemistry 2-(2-chlorphenyl)-2-(6,7-dihydro-thiophene is [3,2-c] pyridine-5-base also) acetate hydrogensulfate by name, chemical structural formula is:
Clopidogrel is a kind of anticoagulant, and the activation of the Glycoprotein G Plllb/llla complex optionally suppressing adenosine diphosphate (ADP) (ADP) and its combination of platelet receptor and the ADP of secondary to mediate, therefore can anticoagulant.The platelet aggregation that other agonist is caused by release ADP can also be blocked.
Aspirin and bisulfate clopidogrel all have the effect of anticoagulant, Papillary, anti-platelet activity significantly strengthens, and can be used for treating the disease that causes of platelet aggregation, comprises the disease of the angina pectoris of stability or instability, cardiovascular and cerebrovascular system, its determined curative effect, be confirmed in clinical trial in global multiregion, be the choice drug for the treatment of acute coronary syndrome, the two makes compound preparation, be beneficial to clinical practice, increase the compliance of patient.
The compound preparation listing of existing bisulfate clopidogrel and aspirin at present, but in contact process, there is interaction in these two kinds of compositions.Aspirin facile hydrolysis generates salicylic acid, and soda acid is energy catalytic hydrolysis reaction all, and bisulfate clopidogrel acidity is comparatively strong, contacts and can accelerate salicylic generation, for the impact that Clinical practice security presence is very large with aspirin.In addition, bisulfate clopidogrel, in put procedure, to be degraded into the sour or laevoisomer of clopidogrel thus to lessen the curative effect because of the moisture absorption; Practice also finds, easily sticking occurs, affect product quality and yield in preparation process.
Chinese patent (application number is 00807001.6) discloses a kind of unit dosage forms pharmaceutical composition containing aspirin and clopidogrel hydrogenesulphate.This patent adopts direct compression process or after two kinds of effective ingredient are made granule by comminution granulation in advance, direct mixed pressuring plate.As can be seen here, there is the possibility contacted in bisulfate clopidogrel and aspirin two kinds of active component, easily produces impurity, reduces effect or increase side effect, bringing potential safety hazard to clinical application.
Chinese patent (application number is 201410357824.4) discloses the controlled release preparation of a kind of sulfated compound clopidogrel hydrogen and aspirin, for compound recipe three layers of osmotic pump controlled release tablet, label is made up of the boosting layer of centre and upper and lower two medicine layers, and two medicine layers are respectively bisulfate clopidogrel layer and aspirin layer; Label outsourcing, with semipermeable membrane, the semipermeable membrane of upper and lower two medicine layer positions has small delivery aperture respectively, thus the speed of Drug controlled release.
Chinese patent (application number is 200810097686.5) discloses a kind of tablet capsule containing clopidogrel hydrogen sulfate salt tablets and aspirin tablet, by respectively bisulfate clopidogrel and aspirin being prepared into the tablet of single component, be filled in same capsule, then separated by blank.But obtained capsule is comparatively large, and it is poor that patient takes compliance.
Summary of the invention
For the problems referred to above, the invention provides a kind of new bisulfate clopidogrel aspirin tablet medicament composition, a kind of preparation method of bisulfate clopidogrel aspirin tablet is provided simultaneously.
For achieving the above object, bisulfate clopidogrel aspirin tablet medicament composition provided by the invention is compound double-layer tablet, and upper and lower two medicine layers are respectively bisulfate clopidogrel layer and aspirin layer.
Further, in bisulfate clopidogrel aspirin tablet medicament composition provided by the invention, bisulfate clopidogrel in the mass ratio of clopidogrel and aspirin for 75:75 or 75:100.
Further, in bisulfate clopidogrel aspirin tablet medicament composition provided by the invention, bisulfate clopidogrel layer is made up of bisulfate clopidogrel, mannitol, microcrystalline Cellulose and F-Melt; Aspirin layer is made up of aspirin, microcrystalline Cellulose and stearic acid.
Further, bisulfate clopidogrel aspirin tablet medicament composition provided by the invention, in per unit preparation, the quality of each component is:
Further, bisulfate clopidogrel aspirin tablet medicament composition provided by the invention, in per unit preparation, the quality of each component is:
Preferably, bisulfate clopidogrel aspirin tablet medicament composition provided by the invention, in per unit preparation, the quality of each component is:
Or, bisulfate clopidogrel aspirin tablet medicament composition provided by the invention, in per unit preparation, the quality of each component is:
Or, bisulfate clopidogrel aspirin tablet medicament composition provided by the invention, in per unit preparation, the quality of each component is:
Or, bisulfate clopidogrel aspirin tablet medicament composition provided by the invention, in per unit preparation, the quality of each component is:
Or, bisulfate clopidogrel aspirin tablet medicament composition provided by the invention, in per unit preparation, the quality of each component is:
Or, bisulfate clopidogrel aspirin tablet medicament composition provided by the invention, in per unit preparation, the quality of each component is:
Or, bisulfate clopidogrel aspirin tablet medicament composition provided by the invention, in per unit preparation, the quality of each component is:
Or, bisulfate clopidogrel aspirin tablet medicament composition provided by the invention, in per unit preparation, the quality of each component is:
Or, bisulfate clopidogrel aspirin tablet medicament composition provided by the invention, in per unit preparation, the quality of each component is:
Or, bisulfate clopidogrel aspirin tablet medicament composition provided by the invention, in per unit preparation, the quality of each component is:
Or, bisulfate clopidogrel aspirin tablet medicament composition provided by the invention, in per unit preparation, the quality of each component is:
Or, bisulfate clopidogrel aspirin tablet medicament composition provided by the invention, in per unit preparation, the quality of each component is:
Or, bisulfate clopidogrel aspirin tablet medicament composition provided by the invention, in per unit preparation, the quality of each component is:
Or, bisulfate clopidogrel aspirin tablet medicament composition provided by the invention, in per unit preparation, the quality of each component is:
Or, bisulfate clopidogrel aspirin tablet medicament composition provided by the invention, in per unit preparation, the quality of each component is:
Or, bisulfate clopidogrel aspirin tablet medicament composition provided by the invention, in per unit preparation, the quality of each component is:
Present invention also offers a kind of preparation method of above-mentioned bisulfate clopidogrel aspirin tablet medicament composition, comprise the following steps:
(1) bisulfate clopidogrel always mixed granule is prepared: the bisulfate clopidogrel of recipe quantity, mannitol, microcrystalline Cellulose are added in material bin with the F-Melt of 50% recipe quantity and mix; Dry granulation; Granulate, sieve number is 24 orders; Add in mixer by the bisulfate clopidogrel granule of preparation, add the F-Melt mixing of surplus, obtained bisulfate clopidogrel is mixed granule always;
(2) aspirin always mixed powder is prepared: the aspirin of recipe quantity, microcrystalline Cellulose and stearic acid are added in material bin and mix, obtained aspirin is mixed powder always;
(3) by bisulfate clopidogrel always mixed granule and aspirin always mixed powder add in two hoppers of bi-layer tablet press respectively, tabletting.
Bisulfate clopidogrel aspirin tablet medicament composition prepared by the present invention has the following advantages:
(1) adding F-Melt in prescription, improve the mobility of material, also can ensure bisulfate clopidogrel layer mix homogeneously steady quality when not using other lubricants, and energy disintegrate rapidly, be conducive to the raising of bioavailability;
(2) bisulfate clopidogrel and aspirin are pressed into double-layer tablet respectively, avoid bisulfate clopidogrel and aspirin interacts, be conducive to the stability in the safety of clinical application and storage process;
(3) technical scheme provided by the invention, efficiently solves the problem of bisulfate clopidogrel granule sticking, improves product appearance character, improves product yield, more can meet industrialized great production demand.
Detailed description of the invention
Below in conjunction with test example and embodiment, the present invention is described in further detail, but not limitation of the present invention, and the equivalent replacement of all any this areas done according to the disclosure of invention, all belongs to protection scope of the present invention.
Embodiment 1: bisulfate clopidogrel aspirin tablet recipe (in 1000)
Preparation method:
(1) bisulfate clopidogrel always mixed granule is prepared: the bisulfate clopidogrel of 97.875g, 60g mannitol, 60g microcrystalline Cellulose are added in material bin with the F-Melt of 2.5g and mix; Dry granulation; Granulate, sieve number is 24 orders; Add in mixer by obtained bisulfate clopidogrel granule, add the F-Melt mixing of 2.5g, obtained bisulfate clopidogrel is mixed granule always;
(2) aspirin always mixed powder is prepared: by the microcrystalline Cellulose of 75g aspirin, 55g and 1.0g stearic acid, add in material bin and mix, obtained aspirin is mixed powder always;
(3) by bisulfate clopidogrel always mixed granule and aspirin always mixed powder join in two hoppers of bi-layer tablet press respectively, tabletting.
Embodiment 2: bisulfate clopidogrel aspirin tablet recipe (in 1000)
Preparation method: with embodiment 1.
Embodiment 3: bisulfate clopidogrel aspirin tablet recipe (in 1000)
Preparation method: with embodiment 1.
Embodiment 4: bisulfate clopidogrel aspirin tablet recipe (in 1000)
Preparation method: with embodiment 1.
Embodiment 5: bisulfate clopidogrel aspirin tablet recipe (in 1000)
Preparation method: with embodiment 1.
Embodiment 6: bisulfate clopidogrel aspirin tablet recipe (in 1000)
Preparation method: with embodiment 1.
Embodiment 7: bisulfate clopidogrel aspirin tablet recipe (in 1000)
Preparation method: with embodiment 1.
Embodiment 8: bisulfate clopidogrel aspirin tablet recipe (in 1000)
Preparation method: with embodiment 1.
Embodiment 9: bisulfate clopidogrel aspirin tablet recipe (in 1000)
Preparation method: with embodiment 1.
Embodiment 10: bisulfate clopidogrel aspirin tablet recipe (in 1000)
Preparation method: with embodiment 1.
Embodiment 11: bisulfate clopidogrel aspirin tablet recipe (in 1000)
Preparation method: with embodiment 1.
Embodiment 12: bisulfate clopidogrel aspirin tablet recipe (in 1000)
Preparation method: with embodiment 1.
Embodiment 13: bisulfate clopidogrel aspirin tablet recipe (in 1000)
Preparation method: with embodiment 1.
Embodiment 14: bisulfate clopidogrel aspirin tablet recipe (in 1000)
Preparation method: with embodiment 1.
Embodiment 15: bisulfate clopidogrel aspirin tablet recipe (in 1000)
Preparation method: with embodiment 1.
Embodiment 16: bisulfate clopidogrel aspirin tablet recipe (in 1000)
Preparation method: with embodiment 1.
Comparative formulation: prescription and the technique of reference Chinese patent (application number is 00807001.6) embodiment 1 prepare Comparative formulation, specification: bisulfate clopidogrel/aspirin 75mg/75mg.
Test example 1: quality research is tested
Get the embodiment of the present invention 1,2,6,7 sample, investigate respectively bisulfate clopidogrel in each embodiment always mixed granule and aspirin always mix the mixing uniformity of powder and observe appearance character and the yield situation of tablet, result of the test is as shown in table 1 Yu table 2.
Mixing uniformity investigation method: in the upper left corner of mixer upper surface, the lower right corner and intermediate point, the intermediate point in intermediate layer, the lower left corner of lower surface, the upper right corner and intermediate point sample, measure the content of each sample point bisulfate clopidogrel and aspirin respectively, calculate the RSD% of 7 groups of assay results.
Table 1 embodiment of the present invention and Comparative formulation mixing uniformity are investigated
Table 2 embodiment of the present invention sample appearance character and yield are investigated
Yield computing formula: yield=total tablet weight/inventory × 100%
Result shows, in various embodiments of the present invention sample, bisulfate clopidogrel granule and aspirin granule mixing uniformity are investigated RSD% and be all not more than 0.2%, is far smaller than the limit of 2.0% of standard regulation, mix homogeneously.In tableting processes, all there is not sticking phenomenon in embodiment of the present invention sample, plain sheet complete appearance, any surface finish, and yield is all more than 85%, meets industrialized great production requirement.
Test example 2 influence factor tests
Get the embodiment of the present invention 1,2,6,7 sample and Comparative formulation sample, at high temperature (60 DEG C), high humidity (25 DEG C, RH92.5%) place 10 days under, illumination (4500 ± 500LX) condition, related substance, content, dissolution determination is carried out respectively at sampling in the 0th day, 10 days, investigate sample mass change situation under these conditions, result of the test is see table 3.
Dissolution investigation method: with pH2.0 buffer 1000ml for dissolution medium, measure according to " Chinese Pharmacopoeia " version in 2010 two annex X C dissolution method second methods, in 15 minutes time, get solution appropriate, adopt HPLC method to measure the content of bisulfate clopidogrel and aspirin respectively.
Table 3 embodiment of the present invention compares with Comparative formulation influence factor test mass
Result shows, 0 day time, embodiment of the present invention sample and Comparative formulation sample size are without obvious difference, but the dissolution of Comparative formulation sample is starkly lower than the present embodiment sample, and related substance is apparently higher than embodiment of the present invention sample.
Placing after 10 days under high temperature (60 DEG C) condition, compared with 0 day, all there is not significant change in embodiment of the present invention sample dissolution, content, and clopidogrel acid, laevoisomer and total impurities amount slightly increase; And Comparative formulation sample salicylic acid, clopidogrel are sour, laevoisomer and total impurities amount obviously increase, and the related substance amount of embodiment of the present invention sample under being significantly greater than the same terms; Comparative formulation content obviously declines, and dissolution rate obviously slows down.
Placing after 10 days under high humidity (25 DEG C, RH92.5%) condition, compared with 0 day, all there is not significant change in embodiment of the present invention sample size, and the acid of salicylic acid, clopidogrel, laevoisomer and total impurities amount slightly increase; And Comparative formulation sample salicylic acid, clopidogrel are sour, laevoisomer and total impurities amount obviously increase, and the related substance amount of embodiment of the present invention sample under being significantly greater than the same terms; Comparative formulation content obviously declines, and dissolution rate obviously slows down.
Place after 10 days under illumination (4500 ± 500LX) condition, the embodiment of the present invention is compared with 0 day, and indices all significant change does not occur; And Comparative formulation sample salicylic acid, clopidogrel are sour, laevoisomer and total impurities amount obviously increase, and the related substance amount of embodiment of the present invention sample under being significantly greater than the same terms; Comparative formulation content slightly declines.
As can be seen from the above results, embodiment of the present invention sample is all significantly better than Comparative formulation sample in related substance, dissolution etc., and stability comparatively prior art significantly improves.
Known by above-mentioned result of the test, the bisulfate clopidogrel aspirin tablet medicament composition adopting prescription of the present invention and technique to prepare, F-Melt is added in prescription, improve the mobility of material, also bisulfate clopidogrel layer mix homogeneously steady quality can be ensured when not using other lubricants, and energy disintegrate rapidly, be conducive to the raising of bioavailability; Double-layer tablet is pressed into respectively with aspirin powder again by after bisulfate clopidogrel granule coating, the contact of isolated bisulfate clopidogrel and aspirin effectively, avoid between medicine and interact, be conducive to the stability in the safety of clinical application and storage process; And, adopt this technique to prepare bisulfate clopidogrel aspirin tablet, efficiently solve the problem of clopidogrel sticking, improve product appearance character, improve product yield, more can meet industrialized great production requirement.
Claims (10)
1. a bisulfate clopidogrel aspirin tablet medicament composition, is characterized in that, this pharmaceutical composition is compound double-layer tablet, and upper and lower two medicine layers are respectively bisulfate clopidogrel layer and aspirin layer.
2. bisulfate clopidogrel aspirin tablet medicament composition according to claim 1, is characterized in that, bisulfate clopidogrel in the mass ratio of clopidogrel and aspirin for 75:75 or 75:100.
3. bisulfate clopidogrel aspirin tablet medicament composition according to claim 2, it is characterized in that, in this pharmaceutical composition, bisulfate clopidogrel layer is made up of bisulfate clopidogrel, mannitol, microcrystalline Cellulose and F-Melt; Aspirin layer is made up of aspirin, microcrystalline Cellulose and stearic acid.
4. bisulfate clopidogrel aspirin tablet medicament composition according to claim 3, is characterized in that, in per unit preparation, the quality of each component is:
5. bisulfate clopidogrel aspirin tablet medicament composition according to claim 4, is characterized in that, in per unit preparation, the quality of each component is:
6. bisulfate clopidogrel aspirin tablet medicament composition according to claim 4, is characterized in that, in per unit preparation, the quality of each component is:
7. bisulfate clopidogrel aspirin tablet medicament composition according to claim 4, is characterized in that, in per unit preparation, the quality of each component is:
8. bisulfate clopidogrel aspirin tablet medicament composition according to claim 4, is characterized in that, in per unit preparation, the quality of each component is:
9. bisulfate clopidogrel aspirin tablet medicament composition according to claim 4, is characterized in that, in per unit preparation, the quality of each component is:
10. a preparation method for the bisulfate clopidogrel aspirin tablet medicament composition described in any one of claim 1 ~ 9, is characterized in that, comprise the following steps:
(1) bisulfate clopidogrel always mixed granule is prepared: the bisulfate clopidogrel of recipe quantity, mannitol, microcrystalline Cellulose are added in material bin with the F-Melt of 50% recipe quantity and mix; Dry granulation; Granulate, sieve number is 24 orders; Add in mixer by the bisulfate clopidogrel granule of preparation, add the F-Melt mixing of surplus, obtained bisulfate clopidogrel is mixed granule always;
(2) aspirin always mixed powder is prepared: the aspirin of recipe quantity, microcrystalline Cellulose and stearic acid are added in material bin and mix, obtained aspirin is mixed powder always;
(3) by bisulfate clopidogrel always mixed granule and aspirin always mixed powder add in two hoppers of bi-layer tablet press respectively, tabletting.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410797659.4A CN104434932B (en) | 2014-12-18 | 2014-12-18 | Pharmaceutical composition of clopidogrel hydrogen sulfate and acetylsalicylic acid tablet and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410797659.4A CN104434932B (en) | 2014-12-18 | 2014-12-18 | Pharmaceutical composition of clopidogrel hydrogen sulfate and acetylsalicylic acid tablet and preparation method thereof |
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| CN104434932B CN104434932B (en) | 2017-05-24 |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1359294A (en) * | 1999-04-30 | 2002-07-17 | 圣诺菲-合成实验室公司 | Pharmaceutical composition in unit form containing acetylsalcylic acid and clopidogrel |
| CN101632647A (en) * | 2008-07-21 | 2010-01-27 | 北京迈劲医药科技有限公司 | Preparation method for compound preparation comprising aspirin and alkaline drugs |
| CN201426858Y (en) * | 2009-07-06 | 2010-03-24 | 沈阳亿灵医药科技有限公司 | Clopidogrel hydrogen shlfate and aspirin double-layer tablet |
-
2014
- 2014-12-18 CN CN201410797659.4A patent/CN104434932B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1359294A (en) * | 1999-04-30 | 2002-07-17 | 圣诺菲-合成实验室公司 | Pharmaceutical composition in unit form containing acetylsalcylic acid and clopidogrel |
| CN101632647A (en) * | 2008-07-21 | 2010-01-27 | 北京迈劲医药科技有限公司 | Preparation method for compound preparation comprising aspirin and alkaline drugs |
| CN201426858Y (en) * | 2009-07-06 | 2010-03-24 | 沈阳亿灵医药科技有限公司 | Clopidogrel hydrogen shlfate and aspirin double-layer tablet |
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