CN101804042A - Method for preparing prasugrel tablets - Google Patents
Method for preparing prasugrel tablets Download PDFInfo
- Publication number
- CN101804042A CN101804042A CN201010151860A CN201010151860A CN101804042A CN 101804042 A CN101804042 A CN 101804042A CN 201010151860 A CN201010151860 A CN 201010151860A CN 201010151860 A CN201010151860 A CN 201010151860A CN 101804042 A CN101804042 A CN 101804042A
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- preparation
- antioxidant
- prasugrel
- dissolution type
- stomach dissolution
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Abstract
The invention relates to a method for preparing prasugrel tablets. The preparation method comprises the following steps of: preparing a tablet core by tabletting; coating a gastric soluble type antioxidant-containing protective layer on the tablet core; and then coating a gastric soluble type film coat outside the gastric soluble type antioxidant-containing protective layer. In the preparation method, the stability of the prasugrel is ensured by adding an antioxidant layer instead of improving the package, special packaging equipment is not needed and a special deoxidant or dehumidizer is also not required, so the preparation method is simple and convenient.
Description
Technical field
The present invention relates to the preparation method of a kind of preparation of prasugrel preparation, particularly prasugrel tablets.
Background technology
Prasugrel (prasugrel) is to be come and the one or the three oral antiplatelet drug of the common exploitation of company altogether by gift, obtains the drugs approved by FDA listing in 2009, and commodity are by name
Prasugrel is a kind of oral platelet suppressant drug, belongs to anticoagulation medicine, need to be used to the patient of the acute coronary syndrome of percutaneous coronary intervention (pci), comprises the patient that need carry out stent endoprosthesis.
Chinese patent CN 200680020528.9 (publication number CN 101193633) provides a kind of preparation that is encapsulated in the prasugrel in the gas inertia blister package that is not subjected to air and moisture effects.
Chinese patent CN 200780042978.2 (publication number CN 101568339) provide a kind of prasugrel goods, its be included under the normal pressure tablet, caplets, capsule or other solid dosage forms with prasugrel be packaged in air or and the container that do not see through of dampness in.
Summary of the invention
The object of the present invention is to provide a kind of preparation method of prasugrel tablets, the properties of product of acquisition are stable.
The preparation method of prasugrel tablets of the present invention is characterized in that preparing label by tabletting earlier, coats the stomach dissolution type protective layer that contains antioxidant again on label.
Process is as follows:
(1) film-making core: get prasugrel or its pharmaceutical salts and pharmaceutic adjuvant mix homogeneously, on tablet machine, suppress;
(2) coat the stomach dissolution type protective layer that contains antioxidant: get coating material and antioxidant and pharmaceutic adjuvant and be mixed with the stomach dissolution type coating solution, pack anti oxidation layer.
Or:
(1) film-making core: get prasugrel or its pharmaceutical salts and pharmaceutic adjuvant mix homogeneously, on tablet machine, suppress;
(2) compacting contains the stomach dissolution type protective layer of antioxidant: get filler, antioxidant and disintegrating agent and pharmaceutic adjuvant, compacting stomach dissolution type protective layer on the pressed coated machine.
Outside containing the stomach dissolution type protective layer of antioxidant, can also coat the stomach dissolution type film-coat again, get coating material, antiplastering aid and coloring agent pharmaceutic adjuvant and be mixed with the stomach dissolution type coating solution, bag stomach dissolution type film-coat.
Among the present invention:
Filler is selected one or more the arbitrary proportion combination in single water and milk sugar, mannitol, sorbitol, microcrystalline Cellulose and the pregelatinized Starch etc. for use.
Disintegrating agent is selected one or more the arbitrary proportion combination in cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium and the polyvinylpolypyrrolidone etc. for use.
Binding agent is selected one or more the arbitrary proportion combination in hypromellose, hyprolose, polyvidone and the starch etc. for use.
Coating material is selected one or more the arbitrary proportion combination in hypromellose, hyprolose, polyethylene glycol-vinyl alcohol graft copolymer, polyvinyl alcohol, methylcellulose and the ethyl cellulose etc. for use.
Antioxidant is selected one or more the arbitrary proportion combination in vitamin C, propyl gallate, butylated hydroxyanisole and the vitamin E for use.
Antiplastering aid can use Pulvis Talci, coloring agent can select for use ferrum oxide, lemon yellow, carmine and indigo etc. in one or more arbitrary proportion combination.
Because prasugrel character is extremely unstable, meet water capacity facile hydrolysis, meet the easy oxidation of oxygen, therefore in Chinese patent CN200680020528.9, prasugrel made tablet after the bag film-coat be packaged in oxygen flow gas not and or the container of dampness in, to keep the stable of prasugrel.Chinese patent CN 200780042978.2 then directly indicate this tablet need under the protection of noble gas under the normal pressure, be packaged in oxygen flow gas not and or the container of dampness in.
Preparation method of the present invention is by adding the stability that anti oxidation layer guarantees prasugrel, rather than reaches the stable purpose of prasugrel by improving packing, does not need special packaging facilities, does not need to add special oxygen scavenger or dehumidizer, and is simple and convenient.
The specific embodiment
The invention will be further described below in conjunction with embodiment.
Embodiment 1
The preparation method of prasugrel tablets is as follows:
A: the preparation of prasugrel sheet
Hydrochloric acid prasugrel 5.49g
Hypromellose 15g
Mannitol 78g
Cross-linking sodium carboxymethyl cellulose 12g
Microcrystalline Cellulose 27g
Magnesium stearate 3.5g
Make 1000 altogether
It is dry respectively to get pharmaceutic adjuvants such as hypromellose, cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose and magnesium stearate, take by weighing hydrochloric acid prasugrel, hypromellose, mannitol, cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose by recipe quantity, mixing, add magnesium stearate again, mixing, tabletting.
B: the coating that contains the stomach dissolution type protective layer of antioxidant
Prescription:
Kollicoat?IR 110g
BHA 10
Pulvis Talci 70g
Titanium dioxide 20g
95% ethanol (V/V) 600g
Purified water 1190g
Get the BHA of recipe quantity, add 95% ethanol (V/V), stir and make its dissolving, behind the adding purified water mixing, add Kollicoat IR, Pulvis Talci and titanium dioxide more successively, stir evenly the back as coating solution.Get the tablet of prasugrel, place coating machine (BGB-5B type, Pharmaceutical Equipment Factory, Wenzhou City), the temperature of control air inlet is 75～85 ℃, and the control air inlet is pressed and is 0.3MPa, and the control strip temperature remains on 34～40 ℃, and the rotating speed of control coating machine is 6～10rpm.Weightening finish is about 5%.
C: bag stomach dissolution type film-coat
Prescription:
Kollicoat?IR 110g
Kollicoat?Protect 50g
Pulvis Talci 70g
Titanium dioxide 20g
Purified water 1190g
Get the purified water of recipe quantity, add Kollicoat IR, Kollicoat Protect, Pulvis Talci and titanium dioxide successively, stir evenly the back as coating solution.Get the above-mentioned tablet that has comprised the antioxidant protective layer, place coating machine (BGB-5B type, Pharmaceutical Equipment Factory, Wenzhou City); the temperature of control air inlet is 75～85 ℃; the control air inlet is pressed and is 0.3MPa, and the control strip temperature remains on 36～42 ℃, and the rotating speed of control coating machine is 6～10rpm.Weightening finish is about 2%.
Embodiment 2
The preparation method of prasugrel tablets is as follows:
A: the preparation of prasugrel sheet
Hydrochloric acid prasugrel 5.49g
Hypromellose 15g
Mannitol 78g
Cross-linking sodium carboxymethyl cellulose 12g
Microcrystalline Cellulose 27g
Magnesium stearate 3.5g
Make 1000 altogether
It is dry respectively to get pharmaceutic adjuvants such as hypromellose, cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose and magnesium stearate, take by weighing hydrochloric acid prasugrel, hypromellose, mannitol, cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose by recipe quantity, mixing, add magnesium stearate again, mixing, tabletting.
B: contain the compacting of the stomach dissolution type protective layer of antioxidant
Prescription:
Kollicoat?IR 110g
BHA 10
Pulvis Talci 70g
Titanium dioxide 20g
95% ethanol (V/V) 600g
Purified water 1190g
Get the BHA of recipe quantity, add 95% ethanol (V/V), stir and make its dissolving, behind the adding purified water mixing, add Kollicoat IR, Pulvis Talci and titanium dioxide more successively, stir evenly the back as coating solution.Get the tablet of prasugrel, place coating machine (BGB-5B type, Pharmaceutical Equipment Factory, Wenzhou City), the temperature of control air inlet is 75～85 ℃, and the control air inlet is pressed and is 0.3MPa, and the control strip temperature remains on 34～40 ℃, and the rotating speed of control coating machine is 6～10rpm.Weightening finish is about 5%.
C: bag stomach dissolution type film-coat
Prescription:
Kollicoat?IR 110g
Kollicoat?Protect 50g
Pulvis Talci 70g
Titanium dioxide 20g
Purified water 1190g
Get the purified water of recipe quantity, add Kollicoat IR, Kollicoat Protect, Pulvis Talci and titanium dioxide successively, stir evenly the back as coating solution.Get the above-mentioned tablet that has comprised the antioxidant protective layer, place coating machine (BGB-5B type, Pharmaceutical Equipment Factory, Wenzhou City); the temperature of control air inlet is 75～85 ℃; the control air inlet is pressed and is 0.3MPa, and the control strip temperature remains on 36～42 ℃, and the rotating speed of control coating machine is 6～10rpm.Weightening finish is about 2%.
Embodiment 3
The preparation method of prasugrel tablets prepares label by tabletting earlier, coats the stomach dissolution type protective layer that contains antioxidant again on label, and concrete operations are as follows:
(1) film-making core: get prasugrel or its pharmaceutical salts and pharmaceutic adjuvant mix homogeneously, on tablet machine, suppress;
(2) coat the stomach dissolution type protective layer that contains antioxidant: get coating material and antioxidant and pharmaceutic adjuvant and be mixed with the stomach dissolution type coating solution, pack anti oxidation layer.
Or
(1) film-making core: get prasugrel or its pharmaceutical salts and pharmaceutic adjuvant mix homogeneously, on tablet machine, suppress;
(2) compacting contains the stomach dissolution type protective layer of antioxidant: get filler, antioxidant and disintegrating agent and pharmaceutic adjuvant, compacting stomach dissolution type protective layer on the pressed coated machine.
Can also outside containing the stomach dissolution type protective layer of antioxidant, coat the stomach dissolution type film-coat again.
Get coating material, antiplastering aid and coloring agent pharmaceutic adjuvant and be mixed with the stomach dissolution type coating solution, bag stomach dissolution type film-coat, wherein:
Filler is selected one or more the arbitrary proportion combination in single water and milk sugar, mannitol, sorbitol, microcrystalline Cellulose and the pregelatinized Starch for use.
Disintegrating agent is selected one or more the arbitrary proportion combination in cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium and the polyvinylpolypyrrolidone for use.
Binding agent is selected one or more the arbitrary proportion combination in hypromellose, hyprolose, polyvidone and the starch for use.
Coating material is selected one or more the arbitrary proportion combination in hypromellose, hyprolose, polyethylene glycol-vinyl alcohol graft copolymer, polyvinyl alcohol, methylcellulose and the ethyl cellulose for use.
Antioxidant is selected one or more the arbitrary proportion combination in vitamin C, propyl gallate, butylated hydroxyanisole and the vitamin E for use.
Embodiment 4
The preparation method of prasugrel tablets prepares label by tabletting earlier, coats the stomach dissolution type protective layer that contains antioxidant again on label, and concrete operations are as follows:
(1) film-making core: get prasugrel or its pharmaceutical salts and pharmaceutic adjuvant mix homogeneously, on tablet machine, suppress;
(2) coat the stomach dissolution type protective layer that contains antioxidant: get coating material and antioxidant and pharmaceutic adjuvant and be mixed with the stomach dissolution type coating solution, pack anti oxidation layer.
Can also outside containing the stomach dissolution type protective layer of antioxidant, coat the stomach dissolution type film-coat again.
Get coating material, antiplastering aid and coloring agent pharmaceutic adjuvant and be mixed with the stomach dissolution type coating solution, bag stomach dissolution type film-coat, wherein:
Filler selects for use mannitol and sorbitol to meromict.
Disintegrating agent is selected cross-linking sodium carboxymethyl cellulose and 2: 1 mixed of carboxymethyl starch sodium weight for use.
Binding agent selects for use hypromellose and starch to meromict.
Coating material selects for use weight portions such as hypromellose, hyprolose and polyvinyl alcohol to mix.
Antioxidant selects for use vitamin C and vitamin E to meromict.
Embodiment 5
The preparation method of prasugrel tablets prepares label by tabletting earlier, coats the stomach dissolution type protective layer that contains antioxidant again on label, and concrete operations are as follows:
(1) film-making core: get prasugrel or its pharmaceutical salts and pharmaceutic adjuvant mix homogeneously, on tablet machine, suppress;
(2) compacting contains the stomach dissolution type protective layer of antioxidant: get filler, antioxidant and disintegrating agent and pharmaceutic adjuvant, compacting stomach dissolution type protective layer on the pressed coated machine.
Can also outside containing the stomach dissolution type protective layer of antioxidant, coat the stomach dissolution type film-coat again.
Get coating material, antiplastering aid and coloring agent pharmaceutic adjuvant and be mixed with the stomach dissolution type coating solution, bag stomach dissolution type film-coat, wherein:
Filler selects for use single water and milk sugar and pregelatinized Starch to meromict.
Disintegrating agent is selected cross-linking sodium carboxymethyl cellulose for use.
Binding agent selects for use hypromellose and polyvidone to meromict.
Coating material selects for use hypromellose and hyprolose weight to mix at 2: 1.
Antioxidant is selected vitamin E for use.
Embodiment 6
The preparation method of prasugrel tablets prepares label by tabletting earlier, coats the stomach dissolution type protective layer that contains antioxidant again on label, and concrete operations are as follows:
(1) film-making core: get prasugrel or its pharmaceutical salts and pharmaceutic adjuvant mix homogeneously, on tablet machine, suppress;
(2) coat the stomach dissolution type protective layer that contains antioxidant: get coating material and antioxidant and pharmaceutic adjuvant and be mixed with the stomach dissolution type coating solution, pack anti oxidation layer.
Can also outside containing the stomach dissolution type protective layer of antioxidant, coat the stomach dissolution type film-coat again.
Get coating material, antiplastering aid and coloring agent pharmaceutic adjuvant and be mixed with the stomach dissolution type coating solution, bag stomach dissolution type film-coat, wherein:
Filler is selected mannitol, sorbitol and 3: 2: 1 mixed of microcrystalline Cellulose weight ratio for use.
Disintegrating agent selects for use cross-linking sodium carboxymethyl cellulose and carboxymethyl starch sodium weight to mix at 2: 1.
Binding agent selects for use hypromellose and polyvidone to meromict.
Coating material selects for use hypromellose and hyprolose weight to meromict.
Antioxidant selects for use part by weight such as vitamin C, propyl gallate, butylated hydroxyanisole and vitamin E to mix.
Claims (10)
1. the preparation method of a prasugrel tablets is characterized in that preparing label by tabletting earlier, coats the stomach dissolution type protective layer that contains antioxidant again on label.
2. the preparation method of prasugrel tablets according to claim 1 is characterized in that:
(1) film-making core: get prasugrel or its pharmaceutical salts and pharmaceutic adjuvant mix homogeneously, on tablet machine, suppress;
(2) coat the stomach dissolution type protective layer that contains antioxidant: get coating material and antioxidant and pharmaceutic adjuvant and be mixed with the stomach dissolution type coating solution, pack anti oxidation layer.
3. the preparation method of prasugrel tablets according to claim 1 is characterized in that:
(1) film-making core: get prasugrel or its pharmaceutical salts and pharmaceutic adjuvant mix homogeneously, on tablet machine, suppress;
(2) compacting contains the stomach dissolution type protective layer of antioxidant: get filler, antioxidant and disintegrating agent and pharmaceutic adjuvant, compacting stomach dissolution type protective layer on the pressed coated machine.
4. according to the preparation method of claim 1,2 or 3 described prasugrel tablets, it is characterized in that: outside containing the stomach dissolution type protective layer of antioxidant, coat the stomach dissolution type film-coat again.
5. according to the preparation method of claim 1,2 or 3 described prasugrel tablets, it is characterized in that: get coating material, antiplastering aid and coloring agent pharmaceutic adjuvant and be mixed with the stomach dissolution type coating solution, bag stomach dissolution type film-coat.
6. according to the preparation method of claim 1,2 or 3 described prasugrel tablets, it is characterized in that: filler is selected one or more the arbitrary proportion combination in single water and milk sugar, mannitol, sorbitol, microcrystalline Cellulose and the pregelatinized Starch for use.
7. according to the preparation method of claim 1,2 or 3 described prasugrel tablets, it is characterized in that: disintegrating agent is selected one or more the arbitrary proportion combination in cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium and the polyvinylpolypyrrolidone for use.
8. according to the preparation method of claim 1,2 or 3 described prasugrel tablets, it is characterized in that: binding agent is selected one or more the arbitrary proportion combination in hypromellose, hyprolose, polyvidone and the starch for use.
9. according to the preparation method of claim 1,2 or 3 described prasugrel tablets, it is characterized in that: coating material is selected one or more the arbitrary proportion combination in hypromellose, hyprolose, polyethylene glycol-vinyl alcohol graft copolymer, polyvinyl alcohol, methylcellulose and the ethyl cellulose for use.
10. according to the preparation method of claim 1,2 or 3 described prasugrel tablets, it is characterized in that: antioxidant is selected one or more the arbitrary proportion combination in vitamin C, propyl gallate, butylated hydroxyanisole and the vitamin E for use.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201010151860A CN101804042A (en) | 2010-04-16 | 2010-04-16 | Method for preparing prasugrel tablets |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201010151860A CN101804042A (en) | 2010-04-16 | 2010-04-16 | Method for preparing prasugrel tablets |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101804042A true CN101804042A (en) | 2010-08-18 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201010151860A Pending CN101804042A (en) | 2010-04-16 | 2010-04-16 | Method for preparing prasugrel tablets |
Country Status (1)
| Country | Link |
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| CN (1) | CN101804042A (en) |
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102440970A (en) * | 2010-10-13 | 2012-05-09 | 山东新时代药业有限公司 | Prasugrel hydrobromide tablets and preparation method thereof |
| CN102784097A (en) * | 2011-05-20 | 2012-11-21 | 无锡万全医药技术有限公司 | Stable prasugrel hydrobromide solid preparation and preparation method thereof |
| CN103717209A (en) * | 2012-04-02 | 2014-04-09 | 埃吉斯药物股份公开有限公司 | Prasugrel-containing immediate release stable oral pharmaceutical compositions |
| CN105310989A (en) * | 2014-07-03 | 2016-02-10 | 重庆安格龙翔医药科技有限公司 | Prasugrel oxalate tablet and preparation method of same |
| CN105435237A (en) * | 2015-12-17 | 2016-03-30 | 河南润弘制药股份有限公司 | Prasugrel hydrochloride pharmaceutical composition, tablets and preparation method of tablets |
| CN111714458A (en) * | 2019-03-18 | 2020-09-29 | 上海复星星泰医药科技有限公司 | Sustained-release particles of prasugrel hydrochloride, preparation containing same and preparation method thereof |
| CN115517366A (en) * | 2022-11-02 | 2022-12-27 | 宝健（北京）生物技术有限公司 | Spirulina tablet for shortening disintegration time and slowing attenuation of beta-carotene and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101193625A (en) * | 2005-06-10 | 2008-06-04 | 武田药品工业株式会社 | Sugar-coated tablet |
| US20090281136A1 (en) * | 2008-05-08 | 2009-11-12 | Sandeep Mhetre | Prasugrel pharmaceutical formulations |
-
2010
- 2010-04-16 CN CN201010151860A patent/CN101804042A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101193625A (en) * | 2005-06-10 | 2008-06-04 | 武田药品工业株式会社 | Sugar-coated tablet |
| US20090281136A1 (en) * | 2008-05-08 | 2009-11-12 | Sandeep Mhetre | Prasugrel pharmaceutical formulations |
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102440970A (en) * | 2010-10-13 | 2012-05-09 | 山东新时代药业有限公司 | Prasugrel hydrobromide tablets and preparation method thereof |
| CN102440970B (en) * | 2010-10-13 | 2014-06-04 | 山东新时代药业有限公司 | Prasugrel hydrobromide tablets and preparation method thereof |
| CN102784097A (en) * | 2011-05-20 | 2012-11-21 | 无锡万全医药技术有限公司 | Stable prasugrel hydrobromide solid preparation and preparation method thereof |
| CN103717209A (en) * | 2012-04-02 | 2014-04-09 | 埃吉斯药物股份公开有限公司 | Prasugrel-containing immediate release stable oral pharmaceutical compositions |
| CN103717209B (en) * | 2012-04-02 | 2017-07-18 | 埃吉斯药物私人有限公司 | The combination of oral medication of the stabilization containing prasugrel of quick-release |
| CN105310989A (en) * | 2014-07-03 | 2016-02-10 | 重庆安格龙翔医药科技有限公司 | Prasugrel oxalate tablet and preparation method of same |
| CN105435237A (en) * | 2015-12-17 | 2016-03-30 | 河南润弘制药股份有限公司 | Prasugrel hydrochloride pharmaceutical composition, tablets and preparation method of tablets |
| CN105435237B (en) * | 2015-12-17 | 2018-12-28 | 河南润弘制药股份有限公司 | A kind of prasugrel hydrochloride pharmaceutical composition, tablet and preparation method thereof |
| CN111714458A (en) * | 2019-03-18 | 2020-09-29 | 上海复星星泰医药科技有限公司 | Sustained-release particles of prasugrel hydrochloride, preparation containing same and preparation method thereof |
| CN115517366A (en) * | 2022-11-02 | 2022-12-27 | 宝健（北京）生物技术有限公司 | Spirulina tablet for shortening disintegration time and slowing attenuation of beta-carotene and preparation method thereof |
| CN115517366B (en) * | 2022-11-02 | 2024-04-02 | 宝健（北京）生物技术有限公司 | A spirulina tablet for shortening disintegration time and relieving beta-carotene attenuation, and its preparation method |
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Application publication date: 20100818 |