CN101966164A - Nifedipine sustained release tablet - Google Patents
Nifedipine sustained release tablet Download PDFInfo
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- CN101966164A CN101966164A CN 201010245575 CN201010245575A CN101966164A CN 101966164 A CN101966164 A CN 101966164A CN 201010245575 CN201010245575 CN 201010245575 CN 201010245575 A CN201010245575 A CN 201010245575A CN 101966164 A CN101966164 A CN 101966164A
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Abstract
The invention relates to a nifedipine sustained release tablet and a preparation method thereof. The nifedipine sustained release tablet is characterized by comprising a tablet core and film coating liquid, wherein the tablet core comprises the following components in percentage by mass: 10 to 12 percent of nifedipine (Nif), 6.5 to 7.5 percent of hydroxypropyl methyl cellulose K4M, 45 to 47 percent of lactose, 34 to 35 percent of microcrystalline cellulose, 0.48 to 0.55 percent of lauryl sodium sulfate, a proper amount of 95 percent ethanol and a proper amount of magnesium stearate; and the film coating liquid comprises the following component in percentage by mass: 5.85 to 6.55 percent of Opadry II and 92.86 to 93.82 percent of distilled water. The preparation method comprises the following step of: mixing the nifedipine and polymer by utilizing the imported polymer and dispersion technology to form a hydrophilic matrix tablet so as to fulfill the aim of sustained release. Compared with an ordinary tablet, the sustained release tablet can continuously act for 12 hours relaxatively, is released in a sustained way and has less and slighter adverse reaction.
Description
Technical field
The present invention relates to the medication preparation field, relate in particular to Nifedipine sustained release tablets and preparation method thereof.
Background technology
Nifedipine is
Calcium antagonistIn a kind of, its coronary artery dilator and peripheral arterial effect are the strongest, it is remarkable to suppress the vasospasm effect, is the choice drug of variant angina pectoris, clinical be applicable to prevention and treatment angina pectoris, particularly variant angina pectoris and
Coronary vasospasmDue to angina pectoris.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.The half-life of nifedipine ordinary tablet is lacked (only 1.7h), holds time about 6h, need repeatedly take medicine, and side effect such as easily generation dizziness, flushed face in the afternoon and cardiopalmus.
Summary of the invention
The invention discloses a kind of Nifedipine sustained release tablets and preparation method thereof.Slow releasing tablet is compared with ordinary tablet, acting duration long (12h), and effect relaxes, and discharges slowly, and untoward reaction is few and light.
The present invention adopts following technical scheme for achieving the above object:
Utilize polymer inlet material and dispersion technology that nifedipine and macromolecular material are mixed and make hydrogel matrix tablet, thereby reach the purpose of slow release.
A kind of Nifedipine sustained release tablets is characterized in that: the mass ratio of its each component of prescription raw material is:
The mass ratio of a, each component of label is:
Nifedipine (Nif) 10-12%
Hydroxypropyl emthylcellulose K4M 6.5-7.5%
Lactose 45-47%
Microcrystalline Cellulose (MCC) 34-35%
Sodium lauryl sulphate (SDS) 0.48-0.55%
95% ethanol is an amount of
Magnesium stearate is an amount of
The mass ratio of b, each component of film coating liquid is:
Opadry II 5.85-6.55%
Distilled water 92.86-93.82%.
Described Nifedipine sustained release tablets is characterized in that:
The chemical constitution of described Nifedipine sustained release tablets principal agent composition is as follows:
Molecular formula: C
17H
18N
2O
6
Molecular weight: 346.34.
Described Nifedipine sustained release tablets is characterized in that: the mass ratio of its each component of prescription raw material is:
The mass ratio of a, each component of label is:
Nifedipine Nif 11.6%
Hydroxypropyl emthylcellulose K4M 6.9%
Lactose 46.2%
Microcrystalline Cellulose (MCC) 34.8%
Sodium lauryl sulphate (SDS) 0.5%
95% ethanol is an amount of
Magnesium stearate is an amount of
The mass ratio of b, each component of film coating liquid is:
Opadry II 6.25%
Distilled water 93.75%.
The preparation method of described Nifedipine sustained release tablets is characterized in that: may further comprise the steps:
(1) lucifuge operation is crossed 120 mesh sieves with raw material, and adjuvant is crossed 80 mesh sieves, and 60-80 ℃ of drying 4 hours is standby;
(2) lactose and the microcrystalline Cellulose with recipe quantity fully mixes, and be standby;
(3) with nifedipine and the abundant mix homogeneously of sodium lauryl sulphate, add hydroxypropyl emthylcellulose K4M, with above-mentioned auxiliary materials and mixing, make binding agent again, system soft material, the wet grain of 24 mesh sieve systems with 95% ethanol;
(4) granule is put into baking oven, 60 ℃ dry about 1.5-2.5 hour, survey its water content 1.2% (the water content requirement is 1%～3%);
(5) 28 mesh sieve granulate add an amount of magnesium stearate mix homogeneously;
(6) lucifuge operation.Get 20 of this product, the accurate title, decided porphyrize, precision takes by weighing in right amount (being equivalent to nifedipine 30mg approximately), puts in the mortar, adds chloroform 2ml and grinds, put in the 100ml measuring bottle with quantitative transfer of dehydrated alcohol gradation, add dehydrated alcohol and be diluted to scale, shake up, filter, precision is measured subsequent filtrate 5ml, puts in the 50ml measuring bottle, be diluted to scale with dehydrated alcohol, shake up,, measure trap at the wavelength place of 333nm according to spectrophotography (two appendix IV of Chinese Pharmacopoeia version in 2000 A).Press C
17H
18N
2O
6Absorptance
Be 140 calculating, promptly.With ZP-35A type tablet machine tabletting, the heavy 86mg of sheet, pressure 5～6kg sees photolysis for fear of principal agent, with 10% Opadry II coating solution coating, coating weightening finish 1～2%, promptly.
[0042] the Nifedipine sustained release tablets acting duration long (12h) of the present invention's production, effect relaxes, and release is slow, and untoward reaction is few and light.
Description of drawings
Fig. 1 is preparation technology's flow chart of Nifedipine sustained release tablets of the present invention.
Fig. 2 is respectively the curve chart of different framework materials to Nifedipine sustained release tablets release measured value with Fig. 3.
Specific embodiments
1, nomenclature of drug
Common name: Nifedipine sustained release tablets
Chemical name: 2,6-dimethyl-4 (2-nitrobenzophenone)-1,4-dihydro-3,5-pyridinedicarboxylic acid dimethyl ester.
English name: Nifedipine Sustained-release Tablets
The Chinese phonetic alphabet: Xiaobendiping Huanshi Pian
2, the chemical constitution of principal agent composition
Molecular formula: C
17H
18N
2O
6
Molecular weight: 346.34
3, naming basis
This product is to be the slow releasing preparation of principal agent with the nifedipine, according to Western medicine nomenclature principle and formulation characteristic, and this product called after Nifedipine sustained release tablets.
4, main research
According to national related drugs research requirement, study of pharmacy work such as preparation prescription screening, quality research, stability test have been carried out.Now main study of pharmacy result is summarized as follows:
1. write out a prescription and technology
Prescription
A, label are formed
Nifedipine (Nif) 10g
Hydroxypropyl emthylcellulose K4M 6g
Lactose 40g
Microcrystalline Cellulose (MCC) 30g
Sodium lauryl sulphate (SDS) 0.5%
95% ethanol is an amount of
Magnesium stearate is an amount of
Make 1000
B, film coating liquid are formed
Opadry II 8g
Distilled water 120ml
Preparation technology
(1) lucifuge operation is crossed 120 mesh sieves with raw material, and adjuvant is crossed 80 mesh sieves, and 60 ℃～80 ℃ dryings 4 hours are standby;
(2) lactose and the microcrystalline Cellulose with recipe quantity fully mixes, and be standby;
(3) with nifedipine and the abundant mix homogeneously of sodium lauryl sulphate, add hydroxypropyl emthylcellulose K4M, with above-mentioned auxiliary materials and mixing, make binding agent again, system soft material, the wet grain of 24 mesh sieve systems with 95% ethanol;
(4) granule is put into baking oven, about 2 hours of 60 ℃ of dryings are surveyed its water content;
(5) 28 mesh sieve granulate add an amount of magnesium stearate mix homogeneously;
(6) behind the assay, with No. 6 stampings, the heavy 86mg of sheet, pressure 5～6kg, with 10% Opadry II coating solution coating, coating weightening finish 1～2%, promptly.
Preparation technology's note
Nifedipine is its effective ingredient.The surfactant sodium lauryl sulphate is solubilizing agent, and hydroxypropyl emthylcellulose K4M is the framework material of slow releasing tablet, and lactose and microcrystalline Cellulose are filler.Magnesium stearate is a lubricant.Coating solution Opadry II has moistureproof and certain interception.
See photolysis for fear of principal agent, its operating process is lucifuge.For principal agent is fully dissolved, raw material is crossed 160 mesh sieves, and fully mixes with the solubilizing agent sodium lauryl sulphate, and is even in order to make medicament contg, and adjuvant is all crossed 100 mesh sieves.
2. prescription screening requirement
This product is a slow releasing tablet, according to the relevant requirements of 2000 editions appendix IA of Chinese Pharmacopoeia, detections such as slow releasing tablet uniformity, release is investigated, and notes outward appearance, hardness, weight differential, the content of preparation, the ease for operation and the repeatability of technology simultaneously.
3. prescription screening
Prescription screening is carried out in requirement according to 2000 editions tablet general rules of Chinese Pharmacopoeia, and mainly investigating index is release, forms to determine satisfactory prescription.
This experiment is carried out single factor to sustained-release tablet recipe and is investigated under conditions such as stator weight, facility for granulating, tablet machine parameter, temperature and humidity.
Different framework materials is to the influence to the slow releasing tablet release of the influence of slow releasing tablet release and identical slow-release material different amounts
The different framework material of table 1 is to the influence of Nifedipine sustained release tablets release
After more than pressing the recipe quantity mixing, be that binding agent 30 mesh sieves are granulated, dash for No. 6 with 95% ethanol, hardness 3.5kg, the heavy 86mg/ sheet of sheet is surveyed its release by the quality standard method.
Conclusion: from above release result, the release when E-50LV10mg and K4M5mg is the fastest as can be seen, but compressibility is not fine.
Different binding agents are to the influence of Nifedipine sustained release tablets release
The different binding agents of table 2 are to the influence of Nifedipine sustained release tablets release
After more than pressing the recipe quantity mixing, granulate with different binding agent 30 mesh sieves, dash for No. 6, sheet weight 4kg surveys its release by the quality standard method.
Conclusion: by the release result, 95% alcohol granulation discharges the fastest as can be seen.Different filleies are to the influence of Nifedipine sustained release tablets release
The different filleies of table 3 are to the influence of Nifedipine sustained release tablets release
After more than pressing the recipe quantity mixing, granulate with same binder 30 mesh sieves, dash for No. 6, sheet weight 4kg surveys its release by the quality standard method.
Conclusion: two kinds of filleies compare, and lactose is obviously fast than microcrystalline Cellulose to the release of principal agent, but is not fine with the lactose compressibility only, mix by a certain percentage so consider lactose and microcrystalline Cellulose.
Brief summary: it is K4M that above prescription is tentatively drafted slow-release material, and filler is lactose and microcrystalline Cellulose, but principal agent discharged deficiency in 8 hours, because of principal agent is an insoluble drug, so further screen solubilizing agent and change preparation technology.
Different solubilizing agents are to the investigation of nifedipine dissolubility
The different solubilizing agents of table 4 are to the influence of nifedipine dissolubility
Conclusion: above result shows that Tween 80 is best to the solubilizing effect of principal agent, but Tween 80 has interference to principal agent near 237nm, so select 0.5% SDS.
The investigation of Different Preparation
Method one: above prescription preparation all forms with the direct mixed pelletization of powder;
Method two: with nifedipine and the abundant mix homogeneously of sodium lauryl sulphate, add hydroxypropyl emthylcellulose K4M, with adjuvant lactose and microcrystalline Cellulose mixing, make binding agent with 95% ethanol again, the system soft material is granulated No. 6 stampings with adequate amount of ethanol 30 mesh sieves.
The influence of the different preparation methoies of table 5 to discharging
Conclusion: method two obviously is better than method one to the release of principal agent
The influence of the filler slow releasing tablet release of different proportion
The influence that the filler of table 6 different proportion discharges Nifedipine sustained release tablets
Conclusion: the different proportion filler relatively, when lactose: MCC be 6: 1 and lactose: MCC when being 5: 2 principal agent discharge the soonest, consider from economic angle, select lactose and microcrystalline Cellulose by 5: 2 o'clock, tablet hardness and discharge and all can reach requirement.
The prescription screening brief summary: according to above prescription screening, and by a large amount of previous experiments results as can be known:
(1) dissimilar framework material to the influence of slow releasing tablet release is in proper order:
K4M＞CMC-Na＞K100LV＞E50LV
(2) when slow-release material is identical, the big more obstruction that slow releasing tablet is discharged of proportion is big more
K4M：10mg＞K4M：5mg
(3) different types of binding agent has remarkable difference to the release of slow releasing tablet, and ethanol has facilitation than other binding agent to the release of slow releasing tablet
(4) different filler has remarkable difference to the release of slow releasing tablet.
Tablet hardness is to the influence of drug release
After same prescription adopted different compression force tablettings, the hardness that obtains tablet was respectively 4kg, 5kg, 6kg, the results are shown in Table 7.
The influence that table 7 different hardness discharges Nifedipine sustained release tablets
Conclusion: when tablet hardness is 4kg, 5kg, principal agent discharges and is more or less the same during 6kg.Multiple factors such as comprehensive Nifedipine sustained release tablets coating, selecting the hardness of slow releasing tablet is 5～6kg.
The craft screening brief summary:
(1) system of selection two pelletizing press sheets
(2) tablet hardness is controlled at 5～6kg
5, quality research work
[character] according to the character of test specimen and commercially available product, this product character fixed " be Film coated tablets, remove displaing yellow behind the film-coat ".
[content limit] is with reference to the standard WS of State Food and Drug Administration
1-(X-056)-content limit of 2004Z Nifedipine sustained release tablets (I) regulation, and with reference to the result to three batch sample assays of quality research, regulation this product contains nifedipine (C
17H
18N
2O
6) should be 90.0%～110.0% of labelled amount
[discriminating] is according to the standard WS of State Food and Drug Administration
1-(X-056)-and 2004Z, recorded chemical discriminating and spectrum and differentiated.Sample is three batches on inspection, and is all up to specification.
[inspection]
Related substance is with reference to the standard WS of State Food and Drug Administration
1-(X-056)-and the method for 2004Z, we have investigated the influence of the sample size of sample to chromatographic peak profile again, and impurity A and impurity B content assaying method have been carried out methodological study again.On this basis, my method in the draft of settling the standard is used for the mensuration of Nifedipine sustained release tablets related substance.Sample is three batches on inspection, and is all up to specification.
Release is with reference to the standard WS of State Food and Drug Administration
1-(X-056)-method of 2004Z, we have carried out methodological study to assay method again, and to the release homogeneity of grinding sample certainly and rate of release is studied and commercially available product relatively, basically identical.Sample is three batches on inspection, and is all up to specification.
Uniformity of dosage units is because the specification of this product is 10mg, according to the regulation under two appendix uniformity of dosage units of Chinese Pharmacopoeia version in 2000 item, the coupon agent content uniformity in accordance with the law.Sample is three batches on inspection, and is all up to specification.
[assay] on the experimental basis of interference, linearity, precision and the response rate of investigation method, we adopt the content of determined by ultraviolet spectrophotometry nifedipine.Through 3 batches of sample surveys, all up to specification.(seeing data numbering 10 for details).
[study on the stability] stability test is the result show: high temperature does not have obvious influence to the stability of Nifedipine sustained release tablets, and high humidity can make the heavy obviously increase of the sheet of this product, and the illumination nifedipine easily decomposes, to photo-labile.Behind the coating high humidity environment there is the certain protection effect.Therefore, the holding conditions of this product should be: lucifuge, drying, the shady and cool airtight preservation in place; But the effect duration of accelerated test result's preliminary forecasting this product is 2 years; The result that long term test kept sample 6 months shows that this product is stable, and test is still in process.
6, overall merit
Nifedipine sustained release tablets is that the nifedipine crude drug adds suitable adjuvant, the tablet that the rational technology of warp is made.Through study on the stability and related detection, the quality standard of being formulated (content, character, discriminating, release etc.) can be controlled the quality of medicine well.
My company's product Nifedipine sustained release tablets, specification 10mg, quality standard: WS1-(X-056)-2004Z, the cardio-cerebralvascular medication, be applicable to chronic stable angina pectoris (angina of effort), vasospasm type angina pectoris (Prinzmetal ' s angina pectoris, variant angina pectoris), essential hypertension is the essential drugs of treatment in the world that country and World Health Organization (WHO) confirm.
Claims (4)
1. Nifedipine sustained release tablets is characterized in that: mass ratio of its each component of prescription raw material is:
The mass ratio of a, each component of label is:
Nifedipine (Nif) 10-12%
Hydroxypropyl emthylcellulose K4M 6.5-7.5%
Lactose 45-47%
Microcrystalline Cellulose (MCC) 34-35%
Sodium lauryl sulphate (SDS) 0.48-0.55%
95% ethanol is an amount of
Magnesium stearate is an amount of
The mass ratio of b, each component of film coating liquid is:
Opadry II 5.85-6.55%
Distilled water 92.86-93.82%.
2. Nifedipine sustained release tablets according to claim 1 is characterized in that:
The chemical constitution of described Nifedipine sustained release tablets principal agent composition is as follows:
Molecular formula: C
17H
18N
2O
6
Molecular weight: 346.34.
3. Nifedipine sustained release tablets according to claim 1 is characterized in that: the mass ratio of its each component of prescription raw material is:
The mass ratio of a, each component of label is:
Nifedipine Nif 11.6%
Hydroxypropyl emthylcellulose K4M 6.9%
Lactose 46.2%
Microcrystalline Cellulose (MCC) 34.8%
Sodium lauryl sulphate (SDS) 0.5%
95% ethanol is an amount of
Magnesium stearate is an amount of
The mass ratio of b, each component of film coating liquid is:
Opadry II 6.25%
Distilled water 93.75%.
4. the preparation method of Nifedipine sustained release tablets according to claim 1 is characterized in that: may further comprise the steps:
(1) lucifuge operation is crossed 120 mesh sieves with raw material, and adjuvant is crossed 80 mesh sieves, and 60-80 ℃ of drying 4 hours is standby;
(2) lactose and the microcrystalline Cellulose with recipe quantity fully mixes, and be standby;
(3) with nifedipine and the abundant mix homogeneously of sodium lauryl sulphate, add hydroxypropyl emthylcellulose K4M, with above-mentioned auxiliary materials and mixing, make binding agent again, system soft material, the wet grain of 24 mesh sieve systems with 95% ethanol;
(4) granule is put into baking oven, 60 ℃ dry about 1.5-2.5 hour, survey its amount 1.2% (the water content requirement is 1%～3%);
(5) 28 mesh sieve granulate add an amount of magnesium stearate mix homogeneously;
(6) lucifuge operation.Get 20 of this product, the accurate title, decided porphyrize, precision takes by weighing in right amount (being equivalent to nifedipine 30mg approximately), puts in the mortar, adds chloroform 2ml and grinds, put in the 100ml measuring bottle with quantitative transfer of dehydrated alcohol gradation, add dehydrated alcohol and be diluted to scale, shake up, filter, precision is measured subsequent filtrate 5ml, puts in the 50ml measuring bottle, be diluted to scale with dehydrated alcohol, shake up,, measure trap at the wavelength place of 333nm according to spectrophotography (two appendix IV of Chinese Pharmacopoeia version in 2000 A).Press C
17H
18N
2O
6Absorptance
Be 140 calculating, promptly.With ZP-35A type tablet machine tabletting, the heavy 86mg of sheet, pressure 5～6kg sees photolysis for fear of principal agent, with 10% Opadry II coating solution coating, coating weightening finish 1～2%, promptly.
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| CN 201010245575 CN101966164A (en) | 2010-07-28 | 2010-07-28 | Nifedipine sustained release tablet |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102429874A (en) * | 2011-12-06 | 2012-05-02 | 沈阳药科大学 | Nifedipine framework sustained-release pellets and preparation method and application thereof |
| 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 |
| CN104257621A (en) * | 2014-09-15 | 2015-01-07 | 河南润弘本草制药有限公司 | Film coating liquid for stroke rejuvenation tablet and preparation method of film coating liquid |
| 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 |
| 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 |
| CN111643473A (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 preparation method thereof |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102429874A (en) * | 2011-12-06 | 2012-05-02 | 沈阳药科大学 | Nifedipine framework sustained-release pellets and preparation method and application thereof |
| 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 |
| CN104257621A (en) * | 2014-09-15 | 2015-01-07 | 河南润弘本草制药有限公司 | Film coating liquid for stroke rejuvenation tablet and preparation method of film coating liquid |
| CN104257621B (en) * | 2014-09-15 | 2017-01-11 | 河南润弘本草制药有限公司 | Film coating liquid for stroke rejuvenation tablet and preparation method of film coating liquid |
| 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 |
| 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 |
| CN111643473A (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 preparation method thereof |
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Application publication date: 20110209 |