CN101869555A - Nifedipine controlled -release tablet and preparation technology thereof - Google Patents
Nifedipine controlled -release tablet and preparation technology thereof Download PDFInfo
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- CN101869555A CN101869555A CN200910130968A CN200910130968A CN101869555A CN 101869555 A CN101869555 A CN 101869555A CN 200910130968 A CN200910130968 A CN 200910130968A CN 200910130968 A CN200910130968 A CN 200910130968A CN 101869555 A CN101869555 A CN 101869555A
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Abstract
The invention provides a nifedipine controlled -release tablet and a preparation technology thereof. The preparation is a dual-layer tablet jointly pressed by a medicine containing layer and a propelling layer, the medicine release rate of the nifedipine is kept to be stable in a body, the concentration of plasma drug capable of effectively reducing blood pressure is continuously kept, and thereby the time of pressure reducing effect is prolonged. Through controlling the prescription and the technological parameters of the nifedipine controlled-release tablet, the common problem that the dual-layer tablet is cracked after the dual-layer tablet is placed for a long time, the appearance of the prepared nifedipine controlled-release tablet is good, the upper layer and the lower layer of the tablet are tightly combined, and the good appearance and the stable medicine release rate can be always kept even though under the impacts of external temperature and external humidity. The invention has the advantages that the preparation method is simple, the used raw materials and auxiliary materials can be obtained easily, the industrialized production can be realized and the application prospect is very good.
Description
Technical field
The invention provides a kind of preparation method that contains the two-layer release-controlled tablet of nifedipine, said preparation is made up of medicated layer and promoting layer, wraps contagion gown, release-controlled film successively, play drug release hole, wraps film-coat at last.
Background technology
Nifedipine (Nifedipine) is a dihydropyridine type calcium antagonists, alternative suppresses the transmembrane transport that calcium ion enters myocardial cell and smooth muscle cell, and suppresses calcium ion storehouse in the cell and discharge, and does not change the plasma calcium ion concentration.Its coronary artery dilator and peripheral arterial effect are the strongest, and it is remarkable to suppress the vasospasm effect, is the choice drug of variant angina pectoris, is applicable to various types of hypertension, and 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.At present, the recommended line medicine that is used for the blood pressure lowering treatment of calcium ion antagonist, extensive use clinically and effect are remarkable.
Nifedipine has multiple dosage form listing such as ordinary tablet, slow releasing tablet, controlled release tablet at present, its controlled release form is produced by Bayer A.G, commodity " visiing together new " by name, after this launch, show many advantages: the 1) coronary artery of diastole normal blood supply district and ischemic region simultaneously, antagonism coronary vasospasm spontaneous or that ergometrine brings out increases sending of coronary vasospasm patient cardiac muscle oxygen, removes and the prevention coronary vasospasm; 2) can suppress myocardial contraction, reduce myocardial metabolism, reduce myocardial oxygen consumption; 3) energy diastole Peripheral resistance blood vessel reduces Peripheral resistance, and systolic pressure and diastolic pressure are reduced, and alleviates cardiac afterload; 4) can continue to keep the plasma drug level of effective blood pressure lowering, the hypotensive effect time obviously prolongs, and has eliminated the drug plasma peak concentration, does not activate heart rate, does not increase catecholamine levels, and untoward reaction obviously reduces.
The result of the 5th census shows that China's aging process is obviously accelerated, and the senile disease problem is also remarkable day by day.In the end of the year 2005, China 65 years old and above aging population surpass 100,000,000 people first, account for 7.69% of country's total population; 60 years old and above population are 1.44 hundred million people, account for 11.03% of country's total population.The senile hypertension patient's of China absolute quantity occupies first of the whole world, the prevalence of critical above hypertension is 13.58% among the crowd, nineteen ninety, population markization prevalence was 11.26%, national resident's nutrition in 2002 and investigation of health conditions data show that the prevalence of China adult hypertension is 18.8%.Hypertension is the chronic lifelong disease of sickness rate height, disability rate height, course of disease length, and the patient often needs lifelong treatment.In case ill, its quality of life will have going down in various degree, therefore, develop this medicine, all be significant from protecting the health of people, creating on the economic and social benefit.
The Nifedipine controlled-release tablet sheet of our development, it is the double-layer tablet that is pressed into jointly by medicated layer and promoting layer, guaranteed that nifedipine keeps stable rate of releasing drug and blood drug level in vivo, by prescription and control of process parameters, solved the problem of the ubiquitous postpone generation sliver of a specified duration of double-layer tablet, the Nifedipine controlled-release tablet that makes not only outward appearance is good, and two-layer up and down combination is tight, under the influence of extraneous humiture, can remain good surface appearance and stable rate of releasing drug.This product preparation method is simple, and used supplementary material is easy to get, and is suitable for the big production of industry, has good application prospects.
Summary of the invention
The invention provides the preparation method of the reliable and stable treatment hypertension drug of a kind of preparation technology's simple possible, curative effect.
This product is made up of medicated layer and promoting layer, and wraps contagion gown and controlled release film coat successively, and is aging, play drug release hole, wraps film-coat at last and makes.
The medicated layer of this two-layer release-controlled tablet is made up of a certain amount of nifedipine and hydrophilic gel framework material, penetrating agent, binding agent, lubricant, and wherein, the consumption of nifedipine is 10mg-90mg; The hydrophilic gel framework material is hypromellose, methylcellulose, sodium carboxymethyl cellulose, polyvidone, alginate, chitosan, carbomer etc., wherein preferred hypromellose K100LV, and consumption is 2-40%, preferred 3-10%; Penetrating agent is a polyoxyethylene, and the outflow from drug release hole plays a driving role to principal agent in the medicated layer, consumption 5-50%, preferred 10-30%; Binding agent is polyvidone (K30) alcoholic solution or its aqueous solution, polyethylene glycol 6000, Macrogol 4000, preferred polyvidone (K30) aqueous solution, and binder concn is 5-50%, preferred 10-35%; Lubricant is stearic acid, magnesium stearate, Pulvis Talci, micropowder silica gel, preferred magnesium stearate, and consumption is 0.01-1%.
Promoting layer is made up of a certain amount of penetrating agent, diluent, coloring agent, lubricant, wherein, penetrating agent is a polyoxyethylene, consumption 3-60%, preferred 15-35%, diluent is carboxymethyl starch sodium, crosslinked carboxymethyl fecula sodium, hypromellose, preferred hypromellose, consumption is 2-20%, and preferable amount is 5-15%; Add a certain amount of sodium chloride simultaneously, for coyote hole provides constant osmotic pressure, consumption 0.5-5%, preferred 1-3%; Coloring agent is selected iron oxide red for use, consumption 0.1-2%, preferred 0.5-1%; Lubricant is stearic acid, magnesium stearate, Pulvis Talci, micropowder silica gel, and preferred magnesium stearate, consumption is 0.01-1%.
Concrete technology of preparing scheme is as follows:
Medicated layer preparation: prepare 30 POVIDONE K 30 BP/USP 30 aqueous solutions earlier, treat its all nifedipine (high speed dispersor running status) of dissolving back additional proportion amount, high speed dispersion makes it form the aqueous dispersion solution of stable uniform, takes the spray-dired mode of aqueous dispersion solution to prepare the pastille complex; With this pastille complex successively and polyoxyethylene (WSR N～80), hypromellose K100LV CR mix homogeneously, use dry granulation again, cross 24 mesh sieves after, add a certain amount of magnesium stearate and carry out always mixing, standby behind the mix homogeneously.
Promoting layer preparation: get polyoxyethylene (WSR 303), hypromellose E10M CR, sodium chloride (100 order), iron oxide red, magnesium stearate and carry out always mixing, standby behind the mix homogeneously;
Tablet press: get the medicated layer and the promoting layer material of mix homogeneously, the compacting of adopting the 8.5mm scrobicula to rush in capable double-layer tablet.
Plain sheet after the compacting will carry out the coating of contagion gown layer earlier, and its material is hydroxypropyl cellulose, sodium carboxymethyl cellulose and polyvidone, preferred hydroxypropyl cellulose (EF level), consumption 2-15%, preferred 3-10%.The preparation of contagion gown liquid: under the ethanol stirring, add hydroxypropyl cellulose (EF level), treat that its solid content is standby after all dissolving; Bag contagion gown operation: the double-layer tablet that pressure makes is carried out contagion gown and is packed, and coating process control material bed tempertaure is 45 ± 2 ℃, and the coating weightening finish is counted 2.0% (w/w) by plain sheet label and got final product.
And then carrying out the coating of controlled release film coat layer, its material is cellulose acetate, ethyl cellulose, polymethacrylates, preferred cellulose acetate (398-3), consumption 1-10%, preferred 2-8%. Plasticizer is selected polyethylene glycol 1500, dibutyl sebacate for use, and consumption is: 0.1-1%.The preparation of release-controlled film coating solution: under acetone gentle agitation state, add cellulose acetate (398-3), polyethylene glycol 1500, dibutyl sebacate successively, stop to stir after the solid content adding finishes, treat that its solid content is standby after all dissolving; Release-controlled film coating operation: clean feed flow pipeline and spray gun with ethanol and acetone successively, getting the sheet stock that has wrapped contagion gown carries out release-controlled film and packs, the coating process does not need the heating of material bed, and the weightening finish of control coating is counted 21.0% (w/w) by plain sheet label and got final product, with acetone cleaning spray gun and pipeline; Wearing out of release-controlled film: get the sheet stock that has wrapped release-controlled film and be positioned in 40 ℃ of baking ovens, aging 12-24 hour.
After having wrapped film-coat, need make drug release hole on tablet, its forging method is: take out aging good tablet, utilize laser-beam drilling machine to make drug release hole in medicated layer central authorities, the aperture is (500 ± 30) μ m.
Wrap the thin film clothing at last, material is elected as: Opadry II 85G 64998PINK, its consumption is: 10-25%.The preparation of film-coat liquid: under the water stirring, add II85G 64998PINK, stirred at least 45 minutes, treat that it forms homogeneous dispersion liquid, standby; Bag film-coat operation: clean feed flow pipeline and spray gun with ethanol and water successively, get the sheet stock that wrap release-controlled film and carry out release-controlled film and pack, coating process control material bed tempertaure is 40 ± 3 ℃, controls the coating 5%-6% (w/w) that presses the coating sheet stock that increases weight and gets final product.
Advantages such as preparation of the present invention has that the active component rate of release is stable, outward appearance good, taking convenience, absorption is fast, bioavailability is high, determined curative effect, quality controllable and side effect are little.
The specific embodiment
Embodiment 1:
The Nifedipine controlled-release tablet prescription
1.1, medicated layer prescription:
Nifedipine 30.0g
30 POVIDONE K 30 BP/USP 30 40.0g
Polyoxyethylene (WSR N～80) 30.0g
Hypromellose K100 LV CR 50.0g
Magnesium stearate 1.0g
1.2, promoting layer prescription
Polyoxyethylene (WSR 303) 35.0g
Hypromellose E10M CR 35.0g
Sodium chloride 7.0g
Iron oxide red 2.0g
Magnesium stearate 0.7g
Make 1000
1.3, contagion gown prescription:
Hydroxypropyl cellulose (EF level) 4.5g
Ethanol 87.5g
Be used for 1000 coating tablets
1.4, controlled release clothing prescription:
Cellulose acetate (398-3) 50.0g
Polyethylene glycol 1500 8.0g
Dibutyl sebacate 5.0g
Acetone 1200g
Be used for 1000 coating tablets
1.5, film-coat prescription:
Opadry II85G64998PINK 17.5g
Water 82.5g
Be used for 1000 coating tablets
Embodiment 2:
The Nifedipine controlled-release tablet prescription
2.1, medicated layer prescription:
Nifedipine 30.0g
30 POVIDONE K 30 BP/USP 30 45.0g
Polyoxyethylene (WSR N～80) 45.0g
Hypromellose K100 LV CR 30.0g
Magnesium stearate 1.0g
2.2, promoting layer prescription
Polyoxyethylene (WSR 303) 48.0g
Hypromellose E10M CR 24.0g
Sodium chloride 5.0g
Iron oxide red 2.0g
Magnesium stearate 0.7g
Make 1000
2.3, contagion gown prescription:
Hydroxypropyl cellulose (EF level) 4.0g
Ethanol 85.0g
Be used for 1000 coating tablets
2.4, controlled release clothing prescription:
Cellulose acetate (398-3) 45.0g
Polyethylene glycol 1500 5.0g
Dibutyl sebacate 5.0g
Acetone 1200g
Be used for 1000 coating tablets
2.5, film-coat prescription:
Opadry II85G 64998PINK 20g
Water 80g
Be used for 1000 coating tablets
Embodiment 3:
The Nifedipine controlled-release tablet prescription
3.1, medicated layer prescription:
Nifedipine 30.0g
30 POVIDONE K 30 BP/USP 30 55.0g
Polyoxyethylene (WSR N～80) 30.0g
Hypromellose K100LV CR 25.0g
Magnesium stearate 1.0g
3.2, promoting layer prescription
Polyoxyethylene (WSR 303) 44.0g
Hypromellose E10M CR 28.0g
Sodium chloride 5.0g
Ferrum oxide 2.0g
Magnesium stearate 0.7g
Make 1000
3.3, contagion gown prescription:
Hydroxypropyl cellulose (EF level) 4.6g
Ethanol 87.4g
Be used for 1000 coating tablets
3.4, controlled release clothing prescription:
Cellulose acetate (398-3) 55.0g
Polyethylene glycol 1500 8.0g
Dibutyl sebacate 3.0g
Acetone 1200g
Be used for 1000 coating tablets
3.5, film-coat prescription:
Opadry II85G 64998PINK 12.5g
Water 87.5g
Be used for 1000 coating tablets
Claims (8)
1. a resisting hypertension and angina drug with control-release function exists with the form of double-layer coating plate.
2. the two-layer release-controlled tablet of claim 1 is that pastille composite layer and promoting layer are granulated respectively, and mixed pressuring plate is made double-layer tablet then, wraps contagion gown and controlled release film coat successively, and is aging, play drug release hole, wraps film-coat at last and makes.
3. the two-layer release-controlled tablet medicated layer in the claim 2 is made up of a certain amount of nifedipine and hydrophilic gel framework material, penetrating agent, binding agent, lubricant, and wherein, the consumption of nifedipine is 10mg-90mg; The hydrophilic gel framework material is hypromellose, methylcellulose, sodium carboxymethyl cellulose, polyvidone, alginate, chitosan, carbomer etc., wherein preferred hypromellose K100LV, and consumption is 2-40%, preferred 3-10%; Penetrating agent is a polyoxyethylene, and the outflow from drug release hole plays a driving role to principal agent in the medicated layer, consumption 5-50%, preferred 10-30%; Binding agent is polyvidone (K30) alcoholic solution or its aqueous solution, polyethylene glycol 6000, Macrogol 4000, preferred polyvidone (K30) aqueous solution, and binder concn is 5-50%, preferred 10-35%; Lubricant is stearic acid, magnesium stearate, Pulvis Talci, micropowder silica gel, and preferred magnesium stearate, consumption is 0.01-1%.
Promoting layer is made up of a certain amount of penetrating agent, diluent, lubricant, coloring agent, wherein, penetrating agent is a polyoxyethylene, consumption 3-60%, preferred 15-35%, diluent is carboxymethyl starch sodium, crosslinked carboxymethyl fecula sodium, hypromellose, preferred hypromellose, consumption is 2-20%, and preferable amount is 5-15%; Add a certain amount of sodium chloride simultaneously, for coyote hole provides constant osmotic pressure, consumption 0.5-5%, preferred 1-3%; Coloring agent is selected iron oxide red for use, consumption 0.1-2%, preferred 0.5-1%; Lubricant is stearic acid, magnesium stearate, Pulvis Talci, micropowder silica gel, and preferred magnesium stearate, consumption is 0.01-1%.
4. the preparation method of the two-layer release-controlled tablet of claim 2, its technology is:
Supplementary material is handled: raw material carries out micronization processes, and getting particle diameter is that the following fine powder of 10 μ m is standby; Sodium chloride is beaten powder handle, it is standby to cross 100 mesh sieves.
Medicated layer preparation: prepare 30 POVIDONE K 30 BP/USP 30 aqueous solutions earlier, treat its all nifedipine (high speed dispersor running status) of dissolving back additional proportion amount, high speed dispersion makes it form the aqueous dispersion solution of stable uniform, takes the spray-dired mode of aqueous dispersion solution to prepare the pastille complex; With this pastille complex successively and polyoxyethylene (WSR N～80), hypromellose K100LV CR mix homogeneously, use dry granulation again, cross 24 mesh sieves after, add a certain amount of magnesium stearate and carry out always mixing, standby behind the mix homogeneously.
Promoting layer preparation: get polyoxyethylene (WSR 303), hypromellose E10M CR, sodium chloride (100 order), iron oxide red, magnesium stearate and carry out always mixing, standby behind the mix homogeneously;
Tablet press: get the medicated layer and the promoting layer material of mix homogeneously, the compacting of adopting the 8.5mm scrobicula to rush in capable double-layer tablet.
5. the coating material of the contagion gown layer of claim 2 is hydroxypropyl cellulose, sodium carboxymethyl cellulose and polyvidone, preferred hydroxypropyl cellulose (EF level), consumption 2-15%, preferred 3-10%.
Its art for coating is:
A, the preparation of contagion gown liquid: under the ethanol stirring, add hydroxypropyl cellulose (EF level), treat that its solid content is standby after all dissolving.
B, bag contagion gown operation: the double-layer tablet that pressure makes is carried out contagion gown and is packed, and coating process control material bed tempertaure is 45 ± 2 ℃, and the coating weightening finish is counted 2.0% (w/w) by plain sheet label and got final product.
6. the coating material of the controlled release film coat layer of claim 2 is cellulose acetate, ethyl cellulose, polymethacrylates, preferred cellulose acetate (398-3), consumption 1-10%, preferred 2-8%., plasticizer is polyethylene glycol 1500, dibutyl sebacate, consumption is: 0.1-1%.
Its art for coating is:
The preparation of a, release-controlled film coating solution: under acetone gentle agitation state, add cellulose acetate (398-3), polyethylene glycol 1500, dibutyl sebacate successively, stop to stir after the solid content adding finishes, treat that its solid content is standby after all dissolving.
B, release-controlled film coating operation: clean feed flow pipeline and spray gun with ethanol and acetone successively, getting the sheet stock that has wrapped contagion gown carries out release-controlled film and packs, the coating process does not need the heating of material bed, and the weightening finish of control coating is counted 21.0% (w/w) by plain sheet label and got final product, with acetone cleaning spray gun and pipeline.
C, release-controlled film wear out: get the sheet stock that has wrapped release-controlled film and be positioned in 40 ℃ of baking ovens, aging 12-24 hour.
7. the forging method of the drug release hole of claim 2 is: take out aged tablet, utilize laser-beam drilling machine to make drug release hole in medicated layer central authorities, the aperture is (500 ± 30) μ m.
8. the material of the film-coat layer of claim 2 is elected as: Opadry II85G64998PINK, its consumption is: 10-25%.
Its art for coating is:
The preparation of a, film-coat liquid: under the water stirring, add II85G 64998PINK, stirred at least 45 minutes, treat that it forms homogeneous dispersion liquid, standby.
B, bag film-coat operation: clean feed flow pipeline and spray gun with ethanol and water successively, get the sheet stock that wrap release-controlled film and carry out release-controlled film and pack, coating process control material bed tempertaure is 40 ± 3 ℃, controls the coating 5%-6% (w/w) that presses the coating sheet stock that increases weight and gets final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910130968A CN101869555A (en) | 2009-04-21 | 2009-04-21 | Nifedipine controlled -release tablet and preparation technology thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910130968A CN101869555A (en) | 2009-04-21 | 2009-04-21 | Nifedipine controlled -release tablet and preparation technology thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101869555A true CN101869555A (en) | 2010-10-27 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200910130968A Pending CN101869555A (en) | 2009-04-21 | 2009-04-21 | Nifedipine controlled -release tablet and preparation technology thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102512394A (en) * | 2011-12-15 | 2012-06-27 | 浙江泰利森药业有限公司 | Nifedipine sustained release tablets and preparation process thereof |
| CN109172534A (en) * | 2018-10-23 | 2019-01-11 | 迪沙药业集团有限公司 | A kind of Nifedipine slow release tablet composition |
| CN112870175A (en) * | 2019-11-29 | 2021-06-01 | 江苏先声药业有限公司 | Nifedipine composition and preparation method thereof |
| CN115192538A (en) * | 2022-08-02 | 2022-10-18 | 沈阳信康药物研究有限公司 | Pressed coated nifedipine sustained release tablet and preparation method thereof |
-
2009
- 2009-04-21 CN CN200910130968A patent/CN101869555A/en active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102512394A (en) * | 2011-12-15 | 2012-06-27 | 浙江泰利森药业有限公司 | Nifedipine sustained release tablets and preparation process thereof |
| CN102512394B (en) * | 2011-12-15 | 2013-10-23 | 浙江泰利森药业有限公司 | Nifedipine sustained release tablets and preparation process thereof |
| CN109172534A (en) * | 2018-10-23 | 2019-01-11 | 迪沙药业集团有限公司 | A kind of Nifedipine slow release tablet composition |
| CN109172534B (en) * | 2018-10-23 | 2020-08-07 | 迪沙药业集团有限公司 | Nifedipine sustained-release tablet composition |
| CN112870175A (en) * | 2019-11-29 | 2021-06-01 | 江苏先声药业有限公司 | Nifedipine composition and preparation method thereof |
| CN112870175B (en) * | 2019-11-29 | 2023-09-01 | 江苏先声药业有限公司 | Nifedipine composition and preparation method thereof |
| CN115192538A (en) * | 2022-08-02 | 2022-10-18 | 沈阳信康药物研究有限公司 | Pressed coated nifedipine sustained release tablet and preparation method thereof |
| CN115192538B (en) * | 2022-08-02 | 2023-09-15 | 沈阳信康药物研究有限公司 | Compression-coated nifedipine sustained-release tablet and preparation method thereof |
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Application publication date: 20101027 |