CN101259132A - Aspirin dipyridamole sustained-release capsules and production method - Google Patents
Aspirin dipyridamole sustained-release capsules and production method Download PDFInfo
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- CN101259132A CN101259132A CNA2008100239638A CN200810023963A CN101259132A CN 101259132 A CN101259132 A CN 101259132A CN A2008100239638 A CNA2008100239638 A CN A2008100239638A CN 200810023963 A CN200810023963 A CN 200810023963A CN 101259132 A CN101259132 A CN 101259132A
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- dipyridamole
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Abstract
The invention discloses Aspirin-Dipyridomole Sustained-Release Capsules and a production method thereof, the capsule contains an Aspirin film coated tablet and Dipyridomole Sustained-Release pellets, with each Aspirin film coated tablet contains 12.5mg of Aspirin, and the content of Dipyridomole Sustained-Release pellets in each capsule reach 0.1g. The production method comprises the preparing of Aspirin film coated tablet and Dipyridomole Sustained-Release pellets and encapsulation; the production method of the invention is rational, Aspirin is preformed directly from powder, thus controlling salicylic acid in a comparatively low level, which is harmful to human body, , and improving the stability of the medicine. The product of the invention is a medicine used for anti-platelet aggregation and anti-coronary artery dilatation, which is applicable to the sufferers of ischemic stroke that has an attack of transient cerebral ischemia or is caused by thrombus, and can reduce the danger of stroke or recurrence of stroke.
Description
Technical field:
The present invention relates to a kind of medicine.
Background technology:
There is defective in the medicine of existing treatment apoplexy at aspects such as prescriptions, and influence is used and effect.
Summary of the invention:
The object of the present invention is to provide a kind of reasonable recipe, effective aspirin-dipyridomole sustained-release capsule and the production method of treatment apoplexy.
Technical solution of the present invention is:
A kind of aspirin-dipyridomole sustained-release capsule, it is characterized in that: aspirin Film coated tablets and dipyridamole extended-release micropill are housed in the capsule, every aspirin Film coated tablets contains aspirin 12.5mg, and the dipyridamole extended-release micropill contains dipyridamole 0.1g in each capsule.
Every aspirin Film coated tablets is grouped into by the one-tenth of following weight:
Aspirin 12.5mg
Pregelatinized Starch 10～20mg
Microcrystalline Cellulose 20～40mg
Tartaric acid 1～3mg
30 POVIDONE K 30 BP/USP 30 0.5～1.5mg
Hypromellose (HPMC) 0.5～1.5mg
Pulvis Talci 0.3～0.9mg.
The dipyridamole extended-release micropill is grouped into by the one-tenth of following weight in each capsule:
Dipyridamole 100mg
Tartaric acid 20～80mg
Starch 20～40mg
Celluloasun Microcrystallisatum 35～75mg
Hypromellose (HPMC) 4.0～12.0mg
EUDRAGIT L100-55 aqueous dispersion 3.0～9.0mg
Macrogol 4000 1.0～6.0mg
Sodium lauryl sulphate 0.2～2mg
Pulvis Talci 3.0～15.0mg.
A kind of production method of aspirin-dipyridomole sustained-release capsule is characterized in that: comprise the following steps:
(1) preparation aspirin Film coated tablets:
A) aspirin, tartaric acid pulverize separately are also crossed 100 mesh sieves, pregelatinized Starch, dimension crystalline cellulose are crossed 100 mesh sieves, equivalent dilution method mix homogeneously is pressed in tartaric acid, pregelatinized Starch, get Pulvis Talci again and above-mentioned mixing of materials is even, and 2 times 60 eye mesh screens of mistake, by every specification tabletting that contains aspirin 12.5mg, get the plain sheet of aspirin;
B) 30 POVIDONE K 30 BP/USP 30 is added dehydrated alcohol and make its dissolving, add Pulvis Talci and make the suspension that contains Pulvis Talci 2g, 30 POVIDONE K 30 BP/USP 30 5g in every 100ml alcohol, as No. 1 coating solution; Other gets hypromellose, adds 85% ethanol and makes its dissolving, adds Pulvis Talci and makes the suspension that contains Pulvis Talci 2g, hypromellose (HPMC) 5g in every 100ml85% ethanol liquid, as No. 2 coating solutions; The plain sheet of aspirin is placed in the coating pan, regulate coating pan angle and revolution, under the blowing hot-air drying, with No. 1 coating solution coating, until plain sheet weightening finish 2～3%; After treating the tablet drying, continue under these conditions with No. 2 coating solution coatings, weightening finish 2～3%, after the coated tablet drying, stand-by;
The consumption of above-mentioned each component is grouped into by the one-tenth of following weight by every aspirin Film coated tablets and carries out proportioning:
Aspirin 12.5mg
Pregelatinized Starch 10～20mg
Microcrystalline Cellulose 20～40mg
Tartaric acid 1～3mg
30 POVIDONE K 30 BP/USP 30 0.5～1.5mg
Hypromellose (HPMC) 0.5～1.5mg
Pulvis Talci 0.3～0.9mg.
(2) preparation dipyridamole extended-release micropill:
A) get microcrystalline Cellulose, make binding agent, be equipped with celphere with rotation coating pelletizing mechanism with 5% hypromellose (HPMC) aqueous solution; With dipyridamole, tartaric acid, starch pulverize separately, cross behind 100～160 mesh sieves fully mix homogeneously, get mixed powder, and with mixed powder through rotation coating pelletizing machine, with contain 5% hypromellose (HPMC), 2% talcous aqueous suspension is made binding agent, above-mentioned celphere is made the pastille micropill, 40 ℃ of oven dry, standby;
B) get above-mentioned pastille micropill, carry out coating with 10% EUDRAGIT L100-55 aqueous dispersion, contain Macrogol 4000, sodium lauryl sulphate and Pulvis Talci in the 10% EUDRAGIT L100-55 aqueous dispersion, behind the coating, 40 ℃ of oven dry, standby;
The consumption of above-mentioned each component is grouped into by the one-tenth of following weight by dipyridamole extended-release micropill in each capsule and uses:
Dipyridamole 100mg
Tartaric acid 20～80mg
Starch 20～40mg
Celluloasun Microcrystallisatum 35～75mg
Hypromellose (HPMC) 4.0～12.0mg
EUDRAGIT L100-55 aqueous dispersion 3.0～9.0mg
Macrogol 4000 1.0～6.0mg
Sodium lauryl sulphate 0.2～2mg
Pulvis Talci 3.0～15.0mg.
(3) capsule preparation:
Aspirin Film coated tablets and dipyridamole extended-release micropill that step (1) is obtained are loaded in the same capsule, get product;
Comprise a slice aspirin Film coated tablets in each capsule, the dipyridamole extended-release micropill contains dipyridamole 0.1g in each capsule.
Reasonable recipe of the present invention, aspirin adopts direct powder compression, makes harmful salicylic acid be controlled at lower level, has increased medicine stability.Product of the present invention is antiplatelet aggregation and coronary artery expansion medicine, is applicable to the ischemic cerebral stroke patients due to existing transient ischemic attack or the thrombosis, reduces the danger that apoplexy or apoplexy are sent out again.
Model case:
1, the king so-and-so, the man, people from Xiamen, Fujian, 2 years apoplexy history was used product of the present invention 1 year, physical condition obviously improves, and does not send out again.
2, Miao so-and-so, the man, people from Nantong, 3 years apoplexy history uses product of the present invention a year surplus, physical condition obviously improves, and does not send out again.
The invention will be further described below in conjunction with embodiment.
The specific embodiment:
(1) preparation aspirin Film coated tablets:
A) aspirin, tartaric acid pulverize separately are also crossed 100 mesh sieves, pregelatinized Starch, dimension crystalline cellulose are crossed 100 mesh sieves, equivalent dilution method mix homogeneously is pressed in tartaric acid, pregelatinized Starch, get Pulvis Talci again and above-mentioned mixing of materials is even, and 2 times 60 eye mesh screens of mistake, by every specification tabletting that contains aspirin 12.5mg, get the plain sheet of aspirin;
B) 30 POVIDONE K 30 BP/USP 30 is added dehydrated alcohol and make its dissolving, add Pulvis Talci and make the suspension that contains Pulvis Talci 2g, 30 POVIDONE K 30 BP/USP 30 5g in every 100ml ethanol, as No. 1 coating solution; Other gets hypromellose, adds 85% ethanol and makes its dissolving, adds Pulvis Talci and makes the suspension that contains Pulvis Talci 2g, hypromellose (HPMC) 5g in every 100ml85% ethanol liquid, as No. 2 coating solutions; The plain sheet of aspirin is placed in the coating pan, regulate coating pan angle and revolution, under the blowing hot-air drying, with No. 1 coating solution coating, until plain sheet weightening finish 2～3%; After treating the tablet drying, continue under these conditions with No. 2 coating solution coatings, weightening finish 2～3%, after the coated tablet drying, stand-by;
The consumption of above-mentioned each component is grouped into by the one-tenth of following weight by every aspirin Film coated tablets and carries out proportioning:
Aspirin 12.5mg
Pregelatinized Starch 10～20mg
Microcrystalline Cellulose 20～40mg
Tartaric acid 1～3mg
30 POVIDONE K 30 BP/USP 30 0.5～1.5mg
Hypromellose (HPMC) 0.5～1.5mg
Pulvis Talci 0.3～0.9mg.
(2) preparation dipyridamole extended-release micropill:
A) get microcrystalline Cellulose, make binding agent, be equipped with celphere with rotation coating pelletizing mechanism with 5% hypromellose (HPMC) aqueous solution; With dipyridamole, tartaric acid, starch pulverize separately, cross behind 100～160 mesh sieves fully mix homogeneously, get mixed powder, and with mixed powder through rotation coating pelletizing machine, with contain 5% hypromellose (HPMC), 2% talcous aqueous suspension is made binding agent, above-mentioned celphere is made the pastille micropill, 40 ℃ of oven dry, standby;
B) get above-mentioned pastille micropill, carry out coating with 10% EUDRAGIT L100-55 aqueous dispersion, contain Macrogol 4000, sodium lauryl sulphate and Pulvis Talci in the 10% EUDRAGIT L100-55 aqueous dispersion, behind the coating, 40 ℃ of oven dry, standby;
The consumption of above-mentioned each component is grouped into by the one-tenth of following weight by dipyridamole extended-release micropill in each capsule and carries out proportioning:
Dipyridamole 100mg
Tartaric acid 20～80mg
Starch 20～40mg
Celluloasun Microcrystallisatum 35～75mg
Hypromellose (HPMC) 4.0～12.0mg
EUDRAGIT L100-55 aqueous dispersion 3.0～9.0mg
Macrogol 4000 1.0～6.0mg
Sodium lauryl sulphate 0.2～2mg
Pulvis Talci 3.0～15.0mg.
(3) capsule preparation:
Aspirin Film coated tablets and dipyridamole extended-release micropill that step (1) is obtained are loaded in the same capsule, get product; Comprise a slice aspirin Film coated tablets in each capsule, the dipyridamole extended-release micropill contains dipyridamole 0.1g in each capsule.Adopt No. 1 capsule.
Claims (5)
1, a kind of aspirin-dipyridomole sustained-release capsule, it is characterized in that: aspirin Film coated tablets and dipyridamole extended-release micropill are housed in the capsule, every aspirin Film coated tablets contains aspirin 12.5mg, and the dipyridamole extended-release micropill in each capsule contains dipyridamole 0.1g.
2, aspirin-dipyridomole sustained-release capsule according to claim 1 is characterized in that: every aspirin Film coated tablets is grouped into by the one-tenth of following weight:
Aspirin 12.5mg
Pregelatinized Starch 10～20mg
Microcrystalline Cellulose 20～40mg
Tartaric acid 1～3mg
30 POVIDONE K 30 BP/USP 30 0.5～1.5mg
Hypromellose (HPMC) 0.5～1.5mg
Pulvis Talci 0.3～0.9mg.
3, aspirin-dipyridomole sustained-release capsule according to claim 1 and 2 is characterized in that: the dipyridamole extended-release micropill in each capsule is grouped into by the one-tenth of following weight:
Dipyridamole 100mg
Tartaric acid 20～80mg
Starch 20～40mg
Celluloasun Microcrystallisatum 35～75mg
Hypromellose (HPMC) 4.0～12.0mg
EUDRAGIT L100-55 aqueous dispersion 3.0～9.0mg
Macrogol 4000 1.0～6.0mg
Sodium lauryl sulphate 0.2～2mg
Pulvis Talci 3.0～15.0mg.
4, a kind of production method of aspirin-dipyridomole sustained-release capsule is characterized in that: comprise the following steps:
(1) preparation aspirin Film coated tablets:
A) aspirin, tartaric acid pulverize separately are also crossed 100 mesh sieves, pregelatinized Starch, dimension crystalline cellulose are crossed 100 mesh sieves, equivalent dilution method mix homogeneously is pressed in tartaric acid, pregelatinized Starch, get Pulvis Talci again and above-mentioned mixing of materials is even, and 2 times 60 eye mesh screens of mistake, by every specification tabletting that contains aspirin 12.5mg, get the plain sheet of aspirin;
B) 30 POVIDONE K 30 BP/USP 30 is added dehydrated alcohol and make its dissolving, add Pulvis Talci and make the suspension that contains Pulvis Talci 2g, 30 POVIDONE K 30 BP/USP 30 5g in every 100ml ethanol, as No. 1 coating solution; Other gets hypromellose, adds 85% ethanol and makes its dissolving, adds Pulvis Talci and makes the suspension that contains Pulvis Talci 2g, hypromellose (HPMC) 5g in every 100ml85% ethanol liquid, as No. 2 coating solutions; The plain sheet of aspirin is placed in the coating pan, regulate coating pan angle and revolution, under the blowing hot-air drying, with No. 1 coating solution coating; After treating the tablet drying, continue under these conditions with No. 2 coating solution coatings, after the coated tablet drying, stand-by;
The consumption of above-mentioned each component is grouped into by the one-tenth of following weight by every aspirin Film coated tablets and carries out proportioning:
Aspirin 12.5mg
Pregelatinized Starch 10～20mg
Microcrystalline Cellulose 20～40mg
Tartaric acid 1～3mg
30 POVIDONE K 30 BP/USP 30 0.5～1.5mg
Hypromellose (HPMC) 0.5～1.5mg
Pulvis Talci 0.3～0.9mg.
(2) preparation dipyridamole extended-release micropill:
A) get microcrystalline Cellulose, make binding agent, be equipped with celphere with rotation coating pelletizing mechanism with 5% hypromellose (HPMC) aqueous solution; With dipyridamole, tartaric acid, starch pulverize separately, cross behind 100～160 mesh sieves fully mix homogeneously, get mixed powder, and with mixed powder through rotation coating pelletizing machine, with contain 5% hypromellose (HPMC), 2% talcous aqueous suspension is made binding agent, above-mentioned celphere is made the pastille micropill, 40 ℃ of oven dry, standby;
B) get above-mentioned pastille micropill, carry out coating with 10% EUDRAGIT L100-55 aqueous dispersion, contain Macrogol 4000, sodium lauryl sulphate and Pulvis Talci in the 10% EUDRAGIT L100-55 aqueous dispersion, behind the coating, 40 ℃ of oven dry, standby;
The consumption of above-mentioned each component is grouped into by the one-tenth of following weight by dipyridamole extended-release micropill in each capsule and carries out proportioning:
Dipyridamole 100mg
Tartaric acid 20～80mg
Starch 20～40mg
Celluloasun Microcrystallisatum 35～75mg
Hypromellose (HPMC) 4.0～12.0mg
EUDRAGIT L100-55 aqueous dispersion 3.0～9.0mg
Macrogol 4000 1.0～6.0mg
Sodium lauryl sulphate 0.2～2mg
Pulvis Talci 3.0～15.0mg.
(3) capsule preparation:
Aspirin Film coated tablets and dipyridamole extended-release micropill that step (1) is obtained are loaded in the same capsule, get product;
5, the production method of aspirin-dipyridomole sustained-release capsule according to claim 4 is characterized in that: comprise a slice aspirin Film coated tablets in each capsule, the dipyridamole extended-release micropill in every capsules contains dipyridamole 0.1g.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008100239638A CN101259132B (en) | 2008-04-15 | 2008-04-15 | Aspirin dipyridamole sustained-release capsules and production method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008100239638A CN101259132B (en) | 2008-04-15 | 2008-04-15 | Aspirin dipyridamole sustained-release capsules and production method |
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| CN101259132B CN101259132B (en) | 2010-09-08 |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102058558A (en) * | 2010-12-14 | 2011-05-18 | 张瑞琛 | Method for preparing aspirin dipyridamole double-layer tablets |
| CN102266301A (en) * | 2011-07-27 | 2011-12-07 | 蚌埠丰原涂山制药有限公司 | Nonsteroidal anti-inflammatory tablet and preparation method thereof |
| CN101732279B (en) * | 2008-11-26 | 2012-01-25 | 上海信谊百路达药业有限公司 | Aspirin enteric coated tablet with low content of free salicylic acid and preparation process thereof |
| CN102836135A (en) * | 2012-09-18 | 2012-12-26 | 沈阳奥吉娜药业有限公司 | Aspirin enteric-coated tablet and preparation process thereof |
| CN105106225A (en) * | 2015-09-10 | 2015-12-02 | 石家庄市智同医药科技有限公司 | Compound dipyridamole and aspirin tablet and preparation method thereof |
| CN109528668A (en) * | 2018-12-20 | 2019-03-29 | 华中药业股份有限公司 | Acetylsalicylic acid tablet and preparation method thereof |
| CN116650444A (en) * | 2023-07-31 | 2023-08-29 | 国药集团川抗制药有限公司 | Tacrolimus slow-release drug and preparation method thereof |
-
2008
- 2008-04-15 CN CN2008100239638A patent/CN101259132B/en not_active Expired - Fee Related
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101732279B (en) * | 2008-11-26 | 2012-01-25 | 上海信谊百路达药业有限公司 | Aspirin enteric coated tablet with low content of free salicylic acid and preparation process thereof |
| CN102058558A (en) * | 2010-12-14 | 2011-05-18 | 张瑞琛 | Method for preparing aspirin dipyridamole double-layer tablets |
| CN102266301A (en) * | 2011-07-27 | 2011-12-07 | 蚌埠丰原涂山制药有限公司 | Nonsteroidal anti-inflammatory tablet and preparation method thereof |
| CN102836135A (en) * | 2012-09-18 | 2012-12-26 | 沈阳奥吉娜药业有限公司 | Aspirin enteric-coated tablet and preparation process thereof |
| CN102836135B (en) * | 2012-09-18 | 2014-11-26 | 沈阳奥吉娜药业有限公司 | Aspirin enteric-coated tablet and preparation process thereof |
| CN105106225A (en) * | 2015-09-10 | 2015-12-02 | 石家庄市智同医药科技有限公司 | Compound dipyridamole and aspirin tablet and preparation method thereof |
| CN109528668A (en) * | 2018-12-20 | 2019-03-29 | 华中药业股份有限公司 | Acetylsalicylic acid tablet and preparation method thereof |
| CN116650444A (en) * | 2023-07-31 | 2023-08-29 | 国药集团川抗制药有限公司 | Tacrolimus slow-release drug and preparation method thereof |
| CN116650444B (en) * | 2023-07-31 | 2023-10-31 | 国药集团川抗制药有限公司 | Tacrolimus slow-release drug and preparation method thereof |
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| CN101259132B (en) | 2010-09-08 |
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