CN108403653A - A kind of Nifedipine controlled-release clad sheet and preparation method thereof - Google Patents
A kind of Nifedipine controlled-release clad sheet and preparation method thereof Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
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Abstract
The present invention relates to a kind of Nifedipine controlled-release preparations and preparation method thereof that day takes once.Above-mentioned Nifedipine controlled-release clad sheet, including chip and the dry-method coating layer being wrapped on the inner core and the light shield layer being wrapped on the dry-method coating in drug containing；The interior chip includes following components, in terms of the mass percent for accounting for interior chip total weight：Nifedipine：5~20%；Filler：25~85%；Framework material：20~60%；Lubricant：0.1~2%；The dry-method coating layer includes following components, in terms of the mass percent for accounting for dry-method coating layer gross mass：Nifedipine：1~10%；Framework material：50~90%；Corrosion controlling agent：10~50%；Lubricant：0.1~5%.Prepared its drug release profiles of controlled release clad sheet meet chronopharmacology requirement in serpentine, and timing may be implemented and position release.The present invention provides a kind of preparation method of Nifedipine controlled-release tablet.
Description
Technical field
The invention belongs to technical field of medicine more particularly to a kind of Nifedipine controlled-release tablet that day takes once and its systems
Preparation Method.
Background technology
Hypertension is one of most common angiocardiopathy, is to lead to cardiocerebrovasculaevents events generation, dead (such as brain soldier, hat
Worry, heart failure, kidney failure) important risk factor.China is hypertension big country, and in Hypertensive Population, light moderate is high
Blood pressure Proportion of patients is 89%, wherein mild hypertension 66%, moderate 23%.Mild or moderate hypertension is in China hypertensive patient
Occupy ratio big absolutely, although pressure value is relatively low, it is closely related with cardiocerebrovasculaevents events risk.Hypertension is treated in the market
Drug mainly have diuretics, ACEI, beta-blocker, calcium channel blocker (CCBs).
Nifedipine is first generation dihydropyridine calcium ion antagonist, is mainly used in hypertension, coronary heart disease and the heart and twists
The treatment of pain has become one of the choice drug of the above-mentioned disease of current clinical treatment.The effect of its Pharmacodynamics is retardance
Flow of calcium ions makes to enter intracellular calcium total amount reduction, leads to parteriole smooth muscle relaxation, reduces peripheral resistance and play drop
Pressure acts on.Exclusive use is effective to Mild or moderate hypertension, and effect is suitable with beta-blocker and thiazide diuretic, also
Left ventricular hypertrophy caused by energy reversing hypertension, adverse reaction is light, well-tolerated.It is optional compared with other decompression class drugs
It is intracellular that selecting property inhibits calcium ion to enter through the calcium channel on cell membrane, has expansion blood vessel and negative inotropic action, relaxation blood
Pipe smooth muscle reduces peripheral vascular resistance, to reduce blood pressure, but does not influence brain and coronary artery and renal blood flow, and because
It only inhibits the calcium channel of too open, on the calcium channel to open without influence, therefore will not cause excessively to be depressured.
For the patient with angiocardiopathy, it usually needs Long-term taking medicine, and nifedipine ordinary tablet often needs
Frequent drug administration is wanted, not only making patients bear, but also patient is susceptible to wrong the problem of taking or missing, and influences therapeutic effect.This
Outside, nifedipine ordinary tablet meeting reflectivity causes the adverse reactions such as increased heart rate, activation sympathetic nerve, therefore nitre benzene occur
Gentle controlled release preparation.Controlled release agent type general tolerance in decompression and antianginal therapy is good, can make blood vessel incrementally
Diastole simultaneously avoids reflex sympathetic from activating.
Country's nifedipine sustained-release preparation is broadly divided into four types according to the difference of dosage form, dosage and technique at present
Type：Nifedipine sustained release tablets I, Nifedipine sustained release tablets II, Nifedipine controlled-release tablet, Nifedipine sustained release tablets IV.Import drugs
In predominantly Bayer pharmacy Nifedipine controlled-release tablet (trade name nifedipine), dosage form be osmotic pump controlled release tablet, in vivo
Realize the effect of constant speed Zero order release.
Be widely used in clinical treatment however as the concept of chronopharmacology in recent years and division of day and night pharmacodynamics, people by
Gradually recognize " biorhythmic " this concept.Biorhythmic is the essential characteristic of human life activity, i.e., among one day
Internal physiological activity or biochemical process can with the time present circadian changes, such as under normal circumstances human blood-pressure on 1st
Among to will appear two peak values be respectively early 10 points and at dusk 6 points.Simultaneously because the content of hormone in vivo secretion, plasma protein
Etc. factors variation, the process of absorption, transhipment, metabolism and the excretion of drug can be influenced to a certain extent, to be related to medicine
The drug effect of object.Therefore, development is based on chronopharmacology principle, and meeting the circadian time schedule system of body biorhythmic becomes very
It is necessary.Due to the typical division of day and night property disease such as such as hypertension, the state of " two peaks, one paddy " is will appear in 24 hours (in morning 2
~3 points are minimum, and blood pressure increases rapidly after early morning gets up), it is at early morning so as to cause the high-incidence season of angiocardiopathy.It passes at this time
The constant speed Zero order release of controlled release form such as osmotic pump tablet in meaning of uniting it is not necessary to, patient is with greater need for can be occurred frequently in disease
Phase faster plays the drug of drug effect.Based on above-mentioned reason, it is proposed that this concept of multiphase medicine-releasing system, wherein more typical
Dosage form be exactly clad sheet according to the present invention.Clad sheet is made of drug containing label and one or more layers barrier layer, wherein shielding
Barrier layer typically serves to adjust the effect of release, can choose whether drug containing according to demand；Drug containing label can also select as needed
For slow-release or quick-releasing type.Since the composition and ratio of label and block layer are all very flexible, a variety of release may be implemented in clad sheet
Medicine behavior, such as bimodal pattern, impulse type and time lagged type, fully meet the needs of various disease.Compared with traditional penetration pumps piece, keep away
Exempting from the use of acetone and other organic solvent, preparation process includes mainly granulation and tabletting in addition, is not related to the operations such as laser boring,
Technical difficulty is low, is convenient for industrialized production.
Invention content
The purpose of the present invention is to provide a kind of Nifedipine controlled-release clad sheet and preparation method thereof, nitre provided by the invention
Benzene Horizon controlled release tablet composition is simple, is easy to industrialized production.It is easy to morning morbidity otherwise for this division of day and night property disease of hypertension
The characteristics of, the release profiles of the clad sheet realize first slow rear fast release in vivo in ' S ' type, can be quick in the disease high-incidence season
Drug release, to reach preferable curative effect.
The present invention provides a kind of Nifedipine controlled-release tablet, including drug containing inner core and the dry-method coating that is wrapped on the inner core
Layer.Controlled release tablet by oral administration after, light shield layer dissolving, internal controlled release clad sheet is exposed.External dry-method coating in the gastrointestinal tract
Layer slowly releases the drug with the corrosion of skeleton, and inner core starts to realize very fast release after external coatings corrosion is to specific degrees.It is logical
Formulation is crossed, dry-method coating layer corrosion speed is controlled, realizes the quick release of specific time and position.
The inner core includes following components, in terms of the mass percent for accounting for interior chip total weight：
Nifedipine：5~20%；
Filler：25~85%；
Framework material：20~60%；
Lubricant：0.1~2%.
The dry-method coating layer includes following components, in terms of the mass percent for accounting for dry-method coating layer gross mass：
Nifedipine：1~10%；
Framework material：50~90%；
Corrosion controlling agent：10~50%；
Lubricant：0.1~5%.
Preferably, the nifedipine is nifedipine micro mist；
The grain size of the nifedipine micro mist is 5~30 μm.
In the drug containing inner core, the filler include one kind in sucrose, mannitol, lactose, pregelatinized starch or
It is several；
The framework material includes one or more of hypromellose, hydroxypropyl cellulose, polyoxyethylene；
The lubricant includes the one or more in talcum powder, magnesium stearate, superfine silica gel powder.
Preferably, the filler accounts for the 30~70% of the drug containing inner core total weight；
The framework material accounts for the 25~55% of the drug containing inner core total weight；
The lubricant accounts for the 0.2~10% of the drug containing inner core total weight.
In the dry-method coating layer, the framework material includes hypromellose, hydroxypropyl cellulose, polyoxy second
One or more of alkene and povidone；
The corrosion controlling agent includes one or more of ethyl cellulose, acrylic resin copolymer and povidone；
The lubricant includes one or more of talcum powder, magnesium stearate, superfine silica gel powder.
Preferably, the framework material accounts for the 60~85% of the dry-method coating layer total weight；
The corrosion controlling agent accounts for the 10~45% of the dry-method coating layer total weight；
The lubricant accounts for 0.5~3% of weight in the dry-method coating layer.
Preferably, the mass ratio of the drug containing inner core and the dry-method coating layer is 1: (2~20).
Preferably, the Nifedipine controlled-release tablet further includes the light shield layer being wrapped on controlled release clad sheet, coating weight gain 2
~10%.
The present invention provides a kind of preparation method of Nifedipine controlled-release tablet, includes the following steps：
A it pelletizes after) mixing 5~20% nifedipine, 25~85% filler, 20~60% framework material,
And by particle obtained and 0.1~2% mix lubricant, obtain drug containing inner sandwich layer material；
It is made after 1~10% nifedipine, 50~90% framework material and 10~50% corrosion controlling agent are mixed
Grain, and by particle obtained and 0.1~5% mix lubricant, obtain dry-method coating layer material；
B) by the step A) in drug containing inner sandwich layer material carry out tabletting obtain internal layer label；
C) by the step A) in dry-method coating layer material and the step B) in internal layer label carry out secondary tabletting, obtain
Clad sheet；
D) using coating solution to the step C) obtained clad sheet is coated, obtain coating tablet, the coating solution packet
Include filmogen and solvent.
It is an object of the present invention to provide a kind of controlled release cored tablet preparation, tablet was slowly released before this in gastrointestinal tract
It puts, by controlling time and the degree of outer layer bulk erosion, to the time of chip quick release and position in control.By with
The combination of chronopharmacology and pharmacodynamics is improved common CONTROLLED RELEASE OSMOTIC pump piece, improves drug release profiles, reach better
Curative effect.
It is a further object of the present invention to provide a kind of compositions simply, and preparation process simplicity is with being easy to the nitre benzene of industrialized production
Flat controlled release tablet and preparation method thereof.From production efficiency angle, preparation method of the present invention related only to granulation and
Tabletting, technological process is simple, and production takes low to cost-effective raising efficiency.Compare osmotic pump preparation such as patent
Preparation flow disclosed in CN100563638C and CN101310712B is it is found that outside granulation that the invention is related to and tablet forming technique
Further comprise laser boring, organic solvent coating.Preparation method of the present invention mainly uses dry-method coating technology, production
Time is short, high degree of automation, due to hardly using solvent in whole process, so being asked without safety and environmental protection etc.
Topic.
Above-mentioned purpose and other purposes can realize that the present invention relates to oral administration solid controlled release form, the dosage forms by virtue of this invention
Including 0.5~20% weight nifedipine, vitro release (uses Chinese Pharmacopoeia four 0931 dissolution rates of general rule of version in 2015
With drug release determination method the second method release device, rotating speed 100rpm, dissolution medium is 37 DEG C of 6.8 (phosphate-buffereds of 900mL pH
Liquid) be 2 hours after cumulative release after 10~30%, 4 hours cumulative release discharge after 25~50%, 8 hours be no less than 65%, 12
Release no less than 80% after hour.
Description of the drawings
In order to more clearly explain the embodiment of the invention or the technical proposal in the existing technology, below to embodiment or existing
Attached drawing is briefly described needed in technology description.
Fig. 1 is 1 Nifedipine controlled-release clad sheet release profiles of embodiment
Fig. 2 is 2 Nifedipine controlled-release clad sheet release profiles of embodiment
Fig. 3 is 3 Nifedipine controlled-release clad sheet release profiles of embodiment
Fig. 4 is 4 Nifedipine controlled-release clad sheet release profiles of embodiment
Fig. 5 is 5 Nifedipine controlled-release clad sheet release profiles of embodiment
Fig. 6 is 6 Nifedipine controlled-release clad sheet release profiles of embodiment
Fig. 7 is 7 Nifedipine controlled-release clad sheet release profiles of embodiment
Fig. 8 is 8 Nifedipine controlled-release clad sheet release profiles of embodiment
Fig. 9 is 9 Nifedipine controlled-release clad sheet release profiles of embodiment
Specific implementation mode
Embodiment 1
Prescription (1000 amounts)：
Interior chip：
Dry-method coating layer：
Light shield layer：
Opadry 04F140000 25g
Water 225g
Preparation process：According to above-mentioned prescription, by each component of each component of inner sandwich layer and dry-method coating layer, (lubricant removes
It mixes 20min respectively outside), uses 50% ethyl alcohol softwood processed respectively.Gained softwood is crossed into the granulation of 30 sieves, it is dry under the conditions of 50 DEG C
Dry whole grain is carried out after 30min.Inner sandwich layer and coatings particle respectively with the mix lubricant 5min of recipe quantity.Using 5mm circles
Flat bevel grinding has pressed internal core piece, hardness 3kg/cm2；Clad sheet, hardness 14kg/cm are suppressed using 9mm circle scrobicula grinding tools2。
In clad sheet outsourcing thin film clothing, Nifedipine controlled-release clad sheet is obtained, light shield layer coating fluid solid content is
10%, piece bed tempertaure is 40 DEG C, and the coating weight gain of light shield layer is 4%.
Controlled release tablet that the present embodiment obtains is determined in the pH6.8 phosphate buffers containing 1% lauryl sodium sulfate
Drug release behavior, the results are shown in Figure 1.
Embodiment 2
Prescription (1000 amounts)：
Interior chip：
Dry-method coating layer：
Light shield layer：
Opadry 04F140000 25g
Water 225g
Preparation process：According to above-mentioned prescription, by each component of each component of inner sandwich layer and dry-method coating layer, (lubricant removes
It mixes 20min respectively outside), uses 95% ethyl alcohol softwood processed respectively.Gained softwood is crossed into the granulation of 30 sieves, it is dry under the conditions of 50 DEG C
Dry whole grain is carried out after 30min.Inner sandwich layer and coatings particle respectively with the mix lubricant 5min of recipe quantity.Using 6mm circles
Scrobicula grinding tool pressed internal core piece, hardness 3kg/cm2；Clad sheet, hardness 10kg/cm are suppressed using 9mm circle scrobicula grinding tools2。
Finally in clad sheet outsourcing thin film clothing, Nifedipine controlled-release clad sheet is obtained, light shield layer is coated fluid solid content
It is 10%, piece bed tempertaure is 40 DEG C, and the coating weight gain of light shield layer is 4%.
Controlled release tablet that the present embodiment obtains is determined in the pH6.8 phosphate buffers containing 1% lauryl sodium sulfate
Drug release behavior, the results are shown in Figure 2.
Embodiment 3
Prescription (1000 amounts)：
Interior chip：
Dry-method coating layer：
Light shield layer：
Opadry 04F140000 25g
Water 225g
Preparation process：With embodiment 2
Controlled release tablet that the present embodiment obtains is determined in the pH6.8 phosphate buffers containing 1% lauryl sodium sulfate
Drug release behavior, the results are shown in Figure 3.
Embodiment 4
Prescription (1000 amounts)：
Interior chip：
Dry-method coating layer：
Light shield layer：
Opadry 04F140000 25g
Water 225g
Preparation process：With embodiment 2
Controlled release tablet that the present embodiment obtains is determined in the pH6.8 phosphate buffers containing 1% lauryl sodium sulfate
Drug release behavior, the results are shown in Figure 4.
Embodiment 5
Prescription (1000 amounts)：
Interior chip：
Dry-method coating layer：
Light shield layer：
Opadry 04F140000 25g
Water 225g
Preparation process：With embodiment 2
Controlled release tablet that the present embodiment obtains is determined in the pH6.8 phosphate buffers containing 1% lauryl sodium sulfate
Drug release behavior, the results are shown in Figure 5.
Embodiment 6
Prescription (1000 amounts)：
Interior chip：
Dry-method coating layer：
Light shield layer：
Opadry 04F140000 25g
Water 225g
Preparation process：According to above-mentioned prescription, by each component of each component of inner sandwich layer and dry-method coating layer, (lubricant removes
It mixes 20min respectively outside), uses 50% ethyl alcohol softwood processed respectively.Gained softwood is crossed into the granulation of 30 sieves, it is dry under the conditions of 50 DEG C
Dry whole grain is carried out after 30min.Inner sandwich layer and coatings particle respectively with the mix lubricant 5min of recipe quantity.Using 6mm circles
Flat bevel grinding has pressed internal core piece, hardness 3kg/cm2；Clad sheet, hardness 12kg/cm are suppressed using 9mm circle scrobicula grinding tools2。
Finally in clad sheet outsourcing thin film clothing, Nifedipine controlled-release clad sheet is obtained, light shield layer is coated fluid solid content
It is 10%, piece bed tempertaure is 40 DEG C, and the coating weight gain of light shield layer is 4%.
The present invention determines the controlled release tablet that the present embodiment obtains and is released in 1% sodium dodecyl sulfate solution that pH is 6.8
Medicine behavior, the results are shown in Figure 6.
Embodiment 7
Inner core prescription：With 6 prescription of embodiment
Dry-method coating layer：
Light shield layer：
Opadry 04F140000 25g
Water 225g
Preparation process：With embodiment 1
Controlled release tablet that the present embodiment obtains is determined in the pH6.8 phosphate buffers containing 1% lauryl sodium sulfate
Drug release behavior, the results are shown in Figure 7.
Comparative example 1
Prescription (1000 amounts)：
Interior chip：
Preparation process：It is above-mentioned to be uniformly mixed with equal increments method, it prepares adhesive using Tween 80 and pelletizes.It will be obtained
The use of 6mm circular flat bevel grindings tool compressed tablets weight is 50mg, hardness 3kg/cm after particle is mixed with magnesium stearate2Interior chip.
Dry-method coating layer：
Light shield layer：
Opadry 04F140000 25g
Water 225g
Preparation process：With embodiment 2
Controlled release tablet that the present embodiment obtains is determined in the pH6.8 phosphate buffers containing 1% lauryl sodium sulfate
Drug release behavior, the results are shown in Figure 8.
Comparative example 2
Inner core tablet recipe：With 3 inner core tablet recipe of embodiment
Dry-method coating layer：
Light shield layer：
Opadry 04F140000 25g
Water 225g
Preparation process：With embodiment 1
Controlled release tablet that the present embodiment obtains is determined in the pH6.8 phosphate buffers containing 1% lauryl sodium sulfate
Drug release behavior, the results are shown in Figure 9.
Claims (10)
1. a kind of Nifedipine controlled-release tablet, including chip, dry-method coating layer, light shield layer in drug containing；
The interior chip includes following components, in terms of the mass percent for accounting for interior chip total weight：
Nifedipine：5~20%；
Filler：25~85%；
Framework material：20~60%；
Lubricant：0.1~2%；
The dry-method coating layer includes following components, in terms of the mass percent for accounting for dry-method coating layer gross mass：
Nifedipine：1~10%；
Framework material：50~90%；
Corrosion controlling agent：10~50%；
Lubricant：0.1~5%；
The light shield layer film coating includes filmogen and solvent, and the mass ratio of the filmogen and solvent is (5~20):
100。
2. Nifedipine controlled-release tablet according to claim 1, which is characterized in that the nifedipine is micronized medicine,
The nifedipine grain size is 5~30 μm.
3. Nifedipine controlled-release tablet according to claim 1, which is characterized in that ectonexine drug containing ratio is (0.3~2): 1.
4. Nifedipine controlled-release tablet according to claim 1, which is characterized in that in the drug containing in chip, the filling
Agent includes one or more of sucrose, mannitol, lactose, microcrystalline cellulose, starch, pregelatinized starch；
The framework material includes hypromellose, hydroxypropyl cellulose, polyoxyethylene, acrylic resin, ethyl cellulose
One or more of element；
The lubricant includes one or more of talcum powder, magnesium stearate, superfine silica gel powder.
5. Nifedipine controlled-release tablet according to claim 1, it is characterised in that the filler accounts for chip in the drug containing
The 30~70% of gross weight；
The framework material accounts for 25~55% of chip total weight in the drug containing；
The lubricant accounts for 0.2~10% of chip total weight in the drug containing.
6. Nifedipine controlled-release tablet according to claim 1, which is characterized in that in the dry-method coating layer, the skeleton
Material includes one or more of hypromellose, hydroxypropyl cellulose, polyoxyethylene and povidone；
The corrosion controlling agent includes one or more of ethyl cellulose, acrylic resin copolymer and povidone；
The lubricant includes one or more of talcum powder, magnesium stearate, superfine silica gel powder.
7. Nifedipine controlled-release tablet according to claim 1, which is characterized in that the framework material accounts for the dry-method coating
The 60~85% of layer total weight；
The corrosion controlling agent accounts for the 10~45% of the dry-method coating layer total weight
The lubricant accounts for 0.5~3% of weight in the dry-method coating layer.
8. Nifedipine controlled-release tablet according to claim 1, which is characterized in that chip and the dry method packet in the drug containing
The mass ratio of clothing layer is 1: (2~20).
9. Nifedipine controlled-release tablet according to claim 1, which is characterized in that the light shield layer film coating weightening is 2
~10%.
10. a kind of preparation method of Nifedipine controlled-release tablet, includes the following steps：
A it pelletizes after) mixing 5~20% nifedipine, 25~85% filler, 20~60% framework material, and will
Particle obtained and 0.1~2% mix lubricant, obtain drug containing inner sandwich layer material；
It pelletizes after 1~10% nifedipine, 50~90% framework material and 10~50% corrosion controlling agent are mixed, and
By particle obtained and 0.1~5% mix lubricant, dry-method coating layer material is obtained；
B) by the step A) in drug containing inner sandwich layer material carry out tabletting obtain internal layer label；
C) by the step A) in dry-method coating layer material and the step B) in internal layer label carry out secondary tabletting, obtain cored
Piece；
D) using coating solution to the step C) obtained clad sheet is coated, coating tablet is obtained, the coating solution includes into
Membrane material and solvent.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810234448.8A CN108403653A (en) | 2018-03-16 | 2018-03-16 | A kind of Nifedipine controlled-release clad sheet and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810234448.8A CN108403653A (en) | 2018-03-16 | 2018-03-16 | A kind of Nifedipine controlled-release clad sheet and preparation method thereof |
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ID=63133106
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| CN201810234448.8A Pending CN108403653A (en) | 2018-03-16 | 2018-03-16 | A kind of Nifedipine controlled-release clad sheet and preparation method thereof |
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|---|---|
| CN (1) | CN108403653A (en) |
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