CN102125531A - Nifedipine sustained-release tablet - Google Patents
Nifedipine sustained-release tablet Download PDFInfo
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- CN102125531A CN102125531A CN2010100272582A CN201010027258A CN102125531A CN 102125531 A CN102125531 A CN 102125531A CN 2010100272582 A CN2010100272582 A CN 2010100272582A CN 201010027258 A CN201010027258 A CN 201010027258A CN 102125531 A CN102125531 A CN 102125531A
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- nifedipine
- sustained release
- release tablets
- blocker
- nifedipine sustained
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Abstract
The invention provides a nifedipine sustained-release tablet which contains a physiological effective dose of nifedipine and release blocker and a pharmaceutically acceptable excipient, wherein the nifedipine is dispersed in the release blocker; the release blocker is selected from macromolecular substances which can be swelled in water, such as hydroxypropyl methyl cellulose, sodium alginate, carboxymethyl cellulose, methyl cellulose and xanthan gum, and the amount of the used release blocker is 5-30 percent of the weight of the sustained-release tablet; and the nifedipine sustained-release tablet contains 15-30mg of nifedipine and also contains several of filler, a disintegrating agent, a surfactant, an adhesive, a lubricant and a glidant as the excipient. The nifedipine sustained-release tablet can be used for treating hypertension and angina pectoris.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, be specifically related to slow releasing tablet of a kind of nifedipine and preparation method thereof.
Background technology
Nifedipine, English name nifedipine is a kind of in the calcium antagonist, its molecular structure such as figure below.Nifedipine has stronger coronary artery dilator and peripheral arterial effect, can significantly suppress vasospasm, be the choice drug of variant angina pectoris, clinically be applicable to angina pectoris due to prevention and treatment angina pectoris, particularly variant angina pectoris and the coronary vasospasm.Be applicable to various types of hypertension, intractable, severe hypertension are also had better curative effect.Owing to can reduce afterload, the intractable congestive heart failure also there is good efficacy, be suitable for for a long time and take.In addition, also be applicable to the angina pectoris patient who suffers from the respiratory tract obstruction disease, its curative effect is better than beta-blocker.
Nifedipine is a kind of fugitive calcium antagonist, the very fast peak value that in blood plasma, reaches it behind the oral or sublingual administration, make the whole body small artery rapidly expansion cause blood pressure drops.Because nifedipine has the effect of Rapid Expansion blood vessel, so part patient side reaction such as can occur having a headache, blush.Certain this side reaction individual variation is very big, and most people feel slightly can stand, but also has the violent or face's flushing of a few peoples' excuse pain to be impatient at and have to use instead the depressor of other types.
The nifedipine preparation that uses mainly contains tablet, capsule, spray at present.Ordinary preparation needs administration in a day at least 3 times, and the side effect that can not avoid arteriolar in short-term rapid expansion to cause.By the physiological disposition of preparation means change nifedipine,, improve the compliance of patient's medication, with significant for improving its clinical efficacy.
Summary of the invention
The invention provides a kind of Nifedipine sustained release tablets, its drug release rate is stable, can reduce medicining times, improves patient's the compliance of taking medicine.
The present invention further provides the preparation method of Nifedipine sustained release tablets.
The present invention also provides the application of Nifedipine sustained release tablets aspect preparation hypertension and angina drug.
The present invention is achieved through the following technical solutions:
Nifedipine sustained release tablets of the present invention contains the nifedipine of physiology effective dose and discharges blocker, and the excipient that pharmaceutically is suitable for, and wherein, nifedipine is scattered in and discharges in the blocker.
Nifedipine sustained release tablets of the present invention contains nifedipine 15-30mg.
Nifedipine sustained release tablets of the present invention discharge blocker be selected from can be in water swollen polymer substance.For example hydroxypropyl emthylcellulose, sodium alginate, sodium carboxymethyl cellulose, methylcellulose, xanthan gum.Discharge the 5-30% that the blocker consumption accounts for slow releasing tablet weight.
Nifedipine sustained release tablets of the present invention also comprises the excipient that pharmaceutically is suitable for, for example several mixture of filler, disintegrating agent, surfactant, binding agent, lubricant and fluidizer.
Be applicable to that filler of the present invention is selected from starch, amylum pregelatinisatum, dextrin, sucrose, lactose, fructose, glucose, xylitol, mannitol, microcrystalline Cellulose, calcium carbonate, magnesium carbonate, calcium phosphate, calcium hydrogen phosphate, calcium sulfate, magnesium oxide, aluminium hydroxide, carboxymethylcellulose calcium, sodium carboxymethyl cellulose.Preferred sugar alcohols, amylum pregelatinisatum, calcium phosphate, calcium hydrogen phosphate, calcium sulfate, microcrystalline Cellulose.Be applicable to that disintegrating agent of the present invention is selected from cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, low substituted hydroxy-propyl methylcellulose, be applicable to that surfactant of the present invention is selected from one or more the combination of following material: tween 80, poloxamer.Be applicable to that binding agent of the present invention is selected from one or more the combination of following material: water, ethanol, hypromellose.Be applicable to that lubricant of the present invention is selected from one or more the combination of following material: stearic acid, calcium stearate, magnesium stearate, zinc stearate, Pulvis Talci, glyceryl monostearate, glyceryl palmitostearate, Stepanol MG, Polyethylene Glycol, stearyl fumarate are applicable to that fluidizer of the present invention is selected from one or more the combination of following material: silica sol, Powderd cellulose, magnesium trisilicate, Pulvis Talci.
The preparation method of Nifedipine sustained release tablets of the present invention may further comprise the steps:
(1), crosses 80 mesh sieves with all the other excipient pulverize separately of nifedipine;
(2) with nifedipine and release blocker mix homogeneously; Alcoholic solution with polyvinylpyrrolidone K29/30 is granulated, and drying is with 14 mesh sieve granulate;
(3) with all the other excipient mix homogeneously mutually;
(4) with the tablet machine tabletting.
Nifedipine sustained release tablets of the present invention can be used for preparing the medicine of relevant diseases such as treatment hypertension or angina pectoris.
The present invention is further detailed explanation below in conjunction with embodiment.Embodiment provides by way of example, is not construed as limiting the invention.
The specific embodiment
Embodiment 1
Nifedipine 15g
Lactose 30g
PVP?k29/32 10g
Low-substituted hydroxypropyl methylcellulose 30g
Sodium alginate 60g
Magnesium stearate 4g
Preparation:, cross 80 mesh sieves with all the other excipient pulverize separately of nifedipine; With nifedipine and sodium alginate mix homogeneously; Alcoholic solution with PVP K29/30 is granulated, and drying is with 14 mesh sieve granulate; With all the other excipient mix homogeneously mutually; Tabletting.
Embodiment 2
Nifedipine 30g
Lactose 40g
PVP?k29/32 10g
Cross-linked pvp 34g
Hydroxypropyl emthylcellulose 50g
Magnesium stearate 6g
Preparation:, cross 80 mesh sieves with all the other excipient pulverize separately of nifedipine; With nifedipine and hydroxypropyl emthylcellulose mix homogeneously; Alcoholic solution with PVP K29/30 is granulated, and drying is with 14 mesh sieve granulate; With all the other excipient mix homogeneously mutually; Tabletting.
Claims (10)
1. Nifedipine sustained release tablets is characterized in that, contain the nifedipine of physiology effective dose and discharge blocker, and the excipient that pharmaceutically is suitable for, wherein, nifedipine is scattered in and discharges in the blocker.
2. Nifedipine sustained release tablets as claimed in claim 1 is characterized in that, described nifedipine content is 15-30mg.
3. Nifedipine sustained release tablets as claimed in claim 1 is characterized in that, described release blocker be selected from can be in water swollen polymer substance.
4. Nifedipine sustained release tablets as claimed in claim 1 is characterized in that, described release blocker is selected from hydroxypropyl emthylcellulose, sodium alginate, sodium carboxymethyl cellulose, methylcellulose, xanthan gum.
5. Nifedipine sustained release tablets as claimed in claim 1 is characterized in that, described release blocker consumption accounts for the 5-30% of slow releasing tablet weight.
6. Nifedipine sustained release tablets as claimed in claim 1 is characterized in that, the described excipient that pharmaceutically is suitable for is selected from several mixture of filler, disintegrating agent, surfactant, binding agent, lubricant and fluidizer.
7. Nifedipine sustained release tablets as claimed in claim 6, it is characterized in that described filler is selected from starch, amylum pregelatinisatum, dextrin, sucrose, lactose, fructose, glucose, xylitol, mannitol, microcrystalline Cellulose, calcium carbonate, magnesium carbonate, calcium phosphate, calcium hydrogen phosphate, calcium sulfate, magnesium oxide, aluminium hydroxide, carboxymethylcellulose calcium, sodium carboxymethyl cellulose.Preferred sugar alcohols, amylum pregelatinisatum, calcium phosphate, calcium hydrogen phosphate, calcium sulfate, microcrystalline Cellulose.
8. Nifedipine sustained release tablets as claimed in claim 6, it is characterized in that, described disintegrating agent is selected from cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, low substituted hydroxy-propyl methylcellulose, and described surfactant is selected from one or more the combination of following material: tween 80, poloxamer.
9. Nifedipine sustained release tablets as claimed in claim 6 is characterized in that, described binding agent is selected from one or more the combination of following material: water, ethanol, hypromellose.
10. Nifedipine sustained release tablets as claimed in claim 6, it is characterized in that, described lubricant is selected from one or more the combination of following material: stearic acid, calcium stearate, magnesium stearate, zinc stearate, Pulvis Talci, glyceryl monostearate, glyceryl palmitostearate, Stepanol MG, Polyethylene Glycol, stearyl fumarate, described fluidizer are selected from one or more the combination of following material: silica sol, Powderd cellulose, magnesium trisilicate, Pulvis Talci.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010100272582A CN102125531A (en) | 2010-01-12 | 2010-01-12 | Nifedipine sustained-release tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010100272582A CN102125531A (en) | 2010-01-12 | 2010-01-12 | Nifedipine sustained-release tablet |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102125531A true CN102125531A (en) | 2011-07-20 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2010100272582A Pending CN102125531A (en) | 2010-01-12 | 2010-01-12 | Nifedipine sustained-release tablet |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102657648A (en) * | 2012-05-08 | 2012-09-12 | 张俊萍 | Drug for treating hypertension and preparation method thereof |
| CN102846575A (en) * | 2012-10-10 | 2013-01-02 | 德州德药制药有限公司 | Nifedipine sustained release tablet and preparation method thereof |
| CN103349651A (en) * | 2013-07-29 | 2013-10-16 | 德州博诚制药有限公司 | Nifedipine sustained release tablet and preparation method thereof |
| CN104940938A (en) * | 2015-07-15 | 2015-09-30 | 山东司邦得制药有限公司 | Montmorillonite compound slow-release preparation, nifedipine sustained release tablet and preparation method and application thereof |
| CN106344531A (en) * | 2016-10-31 | 2017-01-25 | 浙江为康制药有限公司 | Nifedipine controlled-release tablet composition and preparation method thereof |
| CN107569465A (en) * | 2017-06-26 | 2018-01-12 | 安徽永生堂药业有限责任公司 | A kind of Nifedipine sustained release tablets and preparation method thereof |
| CN111643467A (en) * | 2020-07-28 | 2020-09-11 | 华润双鹤利民药业（济南）有限公司 | Nifedipine sustained release tablet and production process thereof |
| CN111643468A (en) * | 2020-07-28 | 2020-09-11 | 华润双鹤利民药业（济南）有限公司 | Nifedipine sustained release preparation and preparation thereof |
-
2010
- 2010-01-12 CN CN2010100272582A patent/CN102125531A/en active Pending
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102657648A (en) * | 2012-05-08 | 2012-09-12 | 张俊萍 | Drug for treating hypertension and preparation method thereof |
| CN102846575A (en) * | 2012-10-10 | 2013-01-02 | 德州德药制药有限公司 | Nifedipine sustained release tablet and preparation method thereof |
| CN102846575B (en) * | 2012-10-10 | 2014-08-27 | 德州德药制药有限公司 | Nifedipine sustained release tablet and preparation method thereof |
| CN103349651A (en) * | 2013-07-29 | 2013-10-16 | 德州博诚制药有限公司 | Nifedipine sustained release tablet and preparation method thereof |
| CN103349651B (en) * | 2013-07-29 | 2014-08-27 | 德州博诚制药有限公司 | Nifedipine sustained release tablet and preparation method thereof |
| CN104940938A (en) * | 2015-07-15 | 2015-09-30 | 山东司邦得制药有限公司 | Montmorillonite compound slow-release preparation, nifedipine sustained release tablet and preparation method and application thereof |
| CN106344531A (en) * | 2016-10-31 | 2017-01-25 | 浙江为康制药有限公司 | Nifedipine controlled-release tablet composition and preparation method thereof |
| CN106344531B (en) * | 2016-10-31 | 2019-07-30 | 浙江为康制药有限公司 | A kind of Nifedipine controlled-release tablet composition and preparation method thereof |
| CN107569465A (en) * | 2017-06-26 | 2018-01-12 | 安徽永生堂药业有限责任公司 | A kind of Nifedipine sustained release tablets and preparation method thereof |
| CN111643467A (en) * | 2020-07-28 | 2020-09-11 | 华润双鹤利民药业（济南）有限公司 | Nifedipine sustained release tablet and production process thereof |
| CN111643468A (en) * | 2020-07-28 | 2020-09-11 | 华润双鹤利民药业（济南）有限公司 | Nifedipine sustained release preparation and preparation thereof |
| CN111643467B (en) * | 2020-07-28 | 2022-06-07 | 华润双鹤利民药业（济南）有限公司 | Nifedipine sustained release tablet and production process thereof |
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Application publication date: 20110720 |