CN107753457A - A kind of nifedipine micropore permeation pump clad sheet with expansion label and preparation method thereof - Google Patents
A kind of nifedipine micropore permeation pump clad sheet with expansion label and preparation method thereof Download PDFInfo
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- CN107753457A CN107753457A CN201711012600.XA CN201711012600A CN107753457A CN 107753457 A CN107753457 A CN 107753457A CN 201711012600 A CN201711012600 A CN 201711012600A CN 107753457 A CN107753457 A CN 107753457A
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- Prior art keywords
- nifedipine
- clad sheet
- label
- expansion
- micropore permeation
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Classifications
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- A—HUMAN NECESSITIES
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
-
- 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
-
- A—HUMAN NECESSITIES
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
-
- A—HUMAN NECESSITIES
- 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
- A61K9/28—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
Abstract
The invention belongs to pharmaceutical technology field, specifically a kind of nifedipine micropore permeation pump clad sheet with expansion label and preparation method thereof.Micropore permeation pump clad sheet includes expansion label, and expansion piece wicking surface is followed successively by nifedipine medicated layer and pellicle, and each component part by weight is expansion label：Nifedipine medicated layer：Pellicle=(5~55)：(5~75)：(5~30).Released the drug, and need not punched, mature production technology using the nifedipine micropore permeation pump clad sheet approximation zero order release rate of the label containing expansion prepared by the present invention, can amplified with industrialization.
Description
Technical field
The invention belongs to pharmaceutical technology field, specifically a kind of nifedipine micropore permeation pump with expansion label
Clad sheet and preparation method thereof.
Background technology
Nifedipine (Nifedipine), chemical name：1,4- dihydro -2,6- dimethyl -4- (2- nitrobenzophenones) -3,5-
Pyridinedicarboxylic acid dimethyl ester, it is one kind in calcium ion antagonist, is the choice drug of ariant angina, clinic is applied to pre-
Anti- and treatment coronary disease and angina pectoris, suitable for various types of hypertension, also has good therapeutic effect to intractable, severe hypertension.
Hypertension is one of most common angiocardiopathy in the world today, and cardiovascular and cerebrovascular disease main hazard because
Element.China's Prevalence of Hypertension is about 12%, and existing hyperpietic's number is more than 100,000,000 people, and every year with the speed more than 3,000,000 people
Degree increases.Antihypertensive medicine is currently used in be broadly divided into diuretics, beta-blocker, calcium ion antagonist, act on kidney
Several major classes such as element-hypertensin system medicine, sympatholytic agent.Wherein, calcium ion antagonist is as anti-hypertension one
The status of line drug substance stable, affirmed in 2003 European hypertension prevention and control guides.
Nifedipine ordinary tablet need to taken three times per day, it is impossible to preferably maintain the stabilization of internal blood concentration and daily blood pressure
Steadily.At present, Nifedipine sustained release tablets and controlled release tablet, wherein daily controlled release preparation once is given birth to by Bayer A.G
Production, is 24 hours controlled release preparations close to constant release, and nifedipine and 24 hours keep basically identical rate of release, its body
The correlation of outer release profiles does not decline to a great extent in drug release later stage rate of release up to 0.99, keeps constant speed to release with many 16h
The controlled release preparation put maintains more stable state compared to there is certain advantage per blood pressure in the daytime.
Oral osmotic pump controlled-releasing tablet (OPT) is optimal controlled release formulations for oral administration so far, and it is using osmotic pressure as driving
Power, medicine is set to reach Zero order release.Its advantage has：Extend administration time, reduce administration number of times, reduce adverse reaction frequency
And degree；Releasing the drug, it is small to be influenceed by internal condition such as PH, gastrointestinal motility and food etc., and In vitro-in vivo correlation is preferable, greatly carries
High Drug safety and validity.
According to its design feature, Oros can be divided into elementary osmotic pump and (the also known as push-pull infiltration of more chamber osmotic pumps
Pump) two classes.Wherein elementary osmotic pump piece is the first generation product of osmotic pump controlled release tablet, and the medicine for being only applicable to dissolve in water is (logical
Normal solubility is 5-30g/100ml), label includes medicine and penetrating agent, the pellicle of one layer of controlled release of outsourcing, is then existed with laser
A small delivery aperture is opened on label coating membrane, the moisture in oral rear intestines and stomach enters label by pellicle, forms medicine
Saturated solution or suspension, the dissolving of Thief zone auxiliary material, makes big permeable pressure head inside and outside film be present, by decoction with constant speed in addition
Rate extrudes release hole, and its discharge is equal with penetrating into the water in film, until label medicine is molten most.More chamber osmotic pumps are main
Suitable for being insoluble in water or having the medicine of incompatibility.Its label is made up of double-deck or three-layer tablet.In label by medicine, have
The hydrophilic polymer of osmotic pressure activity and one layer of other auxiliary materials composition are medicated layer；Other one layer of label is gathered by hydrophily
Compound, osmotic pressure accelerator and other auxiliary materials composition, are properly termed as boosting layer.Pellicle is surrounded by outside label, and in pellicle
Both sides it is unilateral on open one or several release holes, medicine is connected by release hole with external environment.When osmotic pump tablet enter it is water-based
During environment, moisture enters label by release hole and pellicle, and medicine is partly dissolved or is suspended in the presence of permeation enhancers
In water, discharged in the presence of osmotic pressure from small delivery aperture, meanwhile, volume is swollen after the hydrophilic polymer water suction in boosting layer
It is swollen, certain impetus is produced from release hole release to medicine.
Indicate whether to punch osmotic pumps being divided into there are hole osmotic pumps (Elementary Osmotic according to osmotic pump preparation
Pump, abbreviation EOP) and micropore permeation pump (Micro-Porous Osmotic Pump, abbreviation MPOP or Porousity
Osmotic Pump abbreviation POP).EOP opens one or more release holes in dosage surface, on the one hand aperture wants so small that can to keep away
Exempt from the uncontrolled release of medicine, on the other hand there is the pressure for being enough to prevent piece in-core that will be big to increase.Typical Representative is nitre benzene
Horizon osmotic pumps, Indomethacin osmotic pump tablet etc..The machine drilling of early stage is not suitable for the big production of mechanization, and caused
The coating membrane breakage rate of releasing drug flat by osmotic pumps are influenceed；Laser boring mode, but laser boring are commonly used in industrial production at present
Be possible to film calcination or aperture is differed, and when the duct that releases the drug is less, it is oral after duct be easily blocked and cause in intestines and stomach
Random drug release.The malpractice for the Indomethacin osmotic pump tablet that the eighties occurs, that is, it is the Indomethacin of high concentration from releasing
Medicine hole comes out, and causes local drug concentration too high in alimentary canal, to stimulation caused by alimentary canal breast film.MPOP is in coating membrane
Pore-foaming agent is added, improves the permeability of film.This coating membrane surface does not have aperture, the sponge that drug solution is formed by pore-foaming agent
Micropore on shape film discharges.Pore-foaming agent can strengthen the pliability of film to a certain extent, and make osmotic pump preparation
Preparation technology simplifies, and decreases the excitant caused by local drug concentration caused by single release hole is too high.Therefore,
This preparation has broad application prospects.Typical Representative is potassium chloride osmotic pump tablet etc., is provided to study similar osmotic pump tablet
Certain theoretical reference.
It is but domestic at present there is not yet any technology report on the nifedipine micro hole seep irrigation with expansion label
Road.
The content of the invention
It is an object of the invention to provide a kind of nifedipine micropore permeation pump clad sheet with expansion label and its preparation
Method.
To achieve the above object, the present invention use technical scheme for：
A kind of nifedipine micropore permeation pump clad sheet with expansion label, micropore permeation pump clad sheet include expansion piece
Core, expansion piece wicking surface are followed successively by nifedipine medicated layer and pellicle, and each component part by weight is expansion label：Nifedipine
Medicated layer：Pellicle=(5~55)：(5~75)：(5~30).
It is described to be made up of expansion label swelling agent, filler, lubricant；Each component part by weight is swelling agent：Filling
Agent：Lubricant=(20~90)：(1~45)：(1~15).
The swelling agent is selected from polyoxyethylene, hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, marine alga
One or more in sour sodium；The filler in microcrystalline cellulose, lactose, mannitol, sucrose, starch, dextrin one
Kind is several；One or more of the lubricant in talcum powder, magnesium stearate, superfine silica gel powder, sodium stearyl fumarate.
The nifedipine medicated layer is made up of nifedipine, adhesive, osmotic pressure regulator, filler, lubricant；Respectively
Composition weight ratio is nifedipine：Adhesive：Osmotic pressure regulator：Filler：Lubricant=(10~90)：(1~15)：(1
~45)：(10~30)：(1~15).
One or more of the described adhesive in hydroxypropyl methylcellulose, hydroxypropyl cellulose, PVP；The infiltration
Press conditioning agent be selected from sucrose, lactose, glucose, mannitol, sorbierite, fructose, sodium chloride, potassium chloride, sodium sulphate, sodium phosphate,
One or more in sodium dihydrogen phosphate；The filler is selected from microcrystalline cellulose, starch and its derivative, cyclodextrin, sweet dew
One or more in alcohol, lactose, sucrose.
The pellicle is made up of cellulose, plasticizer, pore-foaming agent；Each component part by weight is cellulose：Plasticizer：Cause
Hole agent=(10~50)：(1~25)：(1~25).
The cellulose is selected from cellulose acetate or ethyl cellulose；The plasticizer is selected from glycerine, propane diols, poly- second two
One or more in alcohol, triethyl citrate, diethyl phthalate, glyceric acid triethyl, castor oil；The pore-foaming agent
One or more in sucrose, lactose, mannitol, polyethylene glycol, hydroxypropyl methylcellulose, hydroxypropyl cellulose, PVP.
The preparation method with the nifedipine micropore permeation pump clad sheet for expanding label：
A) swelling agent, filler, mix lubricant are pressed into expansion label according to the above ratio；
B) according to the above ratio by nifedipine and adhesive, osmotic pressure regulator, filler, mix lubricant, Ran Houyu
The nifedipine clad sheet containing expansion label is made by clad sheet tablet press machine in above-mentioned acquisition expansion label mixing；
C) plasticizer, pore-foaming agent and cellulose are dissolved in into organic solvent-aqueous solution to enter above-mentioned nifedipine medicine-containing particle
Row coating, is made the nifedipine micropore permeation pump clad sheet with expansion label.
Advantage for present invention：
Present invention incorporates two-chamber osmotic pump and micropore permeation pump, expanding material is pressed into the label of clad sheet, then
Nifedipine raw material and relevant auxiliary materials with slightly solubility are pressed into the clad sheet containing expansion label on clad sheet tablet press machine, then
Give clad sheet bag one layer of semi-transparent clothing film containing pore-foaming agent, it is not necessary to be punched again to coating tablet.By moisture after gained preparation oral
The micropore formed by pore-foaming agent enters medicine layer, and medicine layer forms suspension in the presence of the auxiliary material such as moisture and penetrating agent,
Some drugs suspension can be discharged by micropore.When moisture penetration medicine layer contacts expansion label, expanding material meets water
Expansion, starts to promote remaining drug suspension to discharge.Because there is many micropores on pellicle, it will not produce and be similar to
The situation that EOP is blocked on the gastrointestinal tract, it is not easy to produce drug accumulation.
The preparation of the present invention can discharge active medicine nifedipine with the rate of releasing drug of approximately constant, and be not situated between
The influence of the factors such as matter environmental pH, gastrointestinal peristalsis and food, there is preferable In vitro-in vivo correlation, normal oral can be avoided
Blood concentration fluctuation caused by preparation, medicining times are reduced, are greatly enhanced Drug safety, validity and compliance.
Brief description of the drawings：
Fig. 1 is the nifedipine micropore permeation pump clad sheet schematic diagram with expansion label provided in an embodiment of the present invention.
Fig. 2 is that each embodiment nifedipine micropore permeation pump clad sheet provided in an embodiment of the present invention is visitd newly with commercial preparation
With drug release patterns figure in the ph 6.8 media.
Embodiment
Following examples are that the present invention is further described, without limiting the scope of the present invention.
Invention formulation can discharge nifedipine with the rate of releasing drug of approximately constant.Mainly by expansion label, nitre benzene
The micropore permeation pump clad sheet that Horizon medicated layer and pellicle are formed.It is micro- that the invention further relates to the nifedipine with expansion label
The preparation method of hole osmotic pump tablet, first compacting expansion label, parcel expansion label is then suppressed using clad sheet tablet press machine
Nifedipine clad sheet, finally carry out semi-transparent film coating.Using the nifedipine micropore of the label containing expansion prepared by the present invention
Osmotic pumps clad sheet approximation zero order release rate releases the drug, and need not punch, mature production technology, can be amplified with industrialization.
Embodiment 1
Prescription (1000)：
Preparation technology (referring to Fig. 1)：
1st, the preparation of label is expanded：
The polyoxyethylene -301, lactose T80, hydroxypropyl methylcellulose E5 of recipe quantity are weighed in micro-mixer mixing 10min,
2min is remixed after adding magnesium stearate, diameter 6mm, 30~40N of hardness scrobicula piece are suppressed using ZP-19 rotary pelleting machines
Core.
2nd, the preparation of nifedipine clad sheet
Lucifuge operates, and weighs the nifedipine of recipe quantity, hydroxypropyl methylcellulose E5, sodium chloride, lactose T80 in miniature mixing
10min is mixed in device, 2min is remixed after adding magnesium stearate, it is then using ZPW20 clad sheets tablet press machine that above-mentioned acquisition is swollen
Swollen label is pressed into diameter 8.5mm, 60~80N of hardness scrobicula piece with nifedipine medicated layer.
3rd, semi-transparent film coating
Coating solution is prepared according to pellicle coating fluid prescription, above-mentioned clad sheet is coated on high-efficiency coating pot, is controlled
25~30 DEG C of temperature of charge processed, coating weight gain 15%.After coating terminates, product dries 6h at 40 DEG C, obtains nifedipine micropore
Osmotic pumps clad sheet.
Embodiment 2
Prescription (1000)：
Preparation technology：
1st, the preparation of label is expanded：
Polyoxyethylene-the coagulant, microcrystalline cellulose PH102, hydroxypropyl methylcellulose E5 of recipe quantity are weighed miniature mixed
Clutch mixes 10min, and 2min is remixed after adding magnesium stearate, and diameter 6mm, hardness 30 are suppressed using ZP-19 rotary pelleting machines
~40N scrobicula label.
2nd, the preparation of nifedipine clad sheet
Lucifuge operates, weigh the nifedipine of recipe quantity, hydroxypropyl methylcellulose E5, sodium chloride, microcrystalline cellulose PH102,
Mannitol mixes 10min in micro-mixer, 2min is remixed after adding magnesium stearate, then using ZPW20 clad sheet pressures
Above-mentioned acquisition is expanded piece machine into label and nifedipine medicated layer is pressed into diameter 8.5mm, 60~80N of hardness scrobicula piece.
3rd, semi-transparent film coating
Coating solution is prepared according to pellicle coating fluid prescription, above-mentioned clad sheet is coated on high-efficiency coating pot, is controlled
25~30 DEG C of temperature of charge processed, coating weight gain 15%.After coating terminates, product dries 6h at 40 DEG C, obtains nifedipine micropore
Osmotic pumps clad sheet.
Embodiment 3
Prescription (10000)：
Preparation technology：
1st, the preparation of label is expanded：
The polyoxyethylene -301, lactose T80, hydroxypropyl cellulose SSL of recipe quantity are weighed in blender mixing 15min, is added
2min is remixed after entering talcum powder, diameter 6mm, 30~40N of hardness scrobicula label are suppressed using ZP-19 rotary pelleting machines.
2nd, the preparation of nifedipine clad sheet
Lucifuge operates, and weighs the nifedipine of recipe quantity, hydroxypropyl cellulose SSL, sodium chloride, lactose T80 in blender
Middle mixing 15min, 2min is remixed after adding talcum powder, then using ZPW20 clad sheets tablet press machine by above-mentioned acquisition expansion piece
Core is pressed into diameter 8.5mm, 60~80N of hardness scrobicula piece with nifedipine medicated layer.
3rd, semi-transparent film coating
Coating solution is prepared according to pellicle coating fluid prescription, above-mentioned clad sheet is coated on high-efficiency coating pot, is controlled
30~35 DEG C of temperature of charge processed, coating weight gain 20%.After coating terminates, product dries 6h at 40 DEG C, obtains nifedipine micropore
Osmotic pumps clad sheet.
Embodiment 4
Prescription (10000)：
Preparation technology：
1st, the preparation of label is expanded：
Hydroxypropyl methylcellulose K100M, polyoxyethylene -301, starch, lactose T80, the PVP K30 for weighing recipe quantity are mixing
Clutch mixes 15min, and 2min is remixed after adding superfine silica gel powder, and diameter 6mm, hardness 30 are suppressed using ZP-19 rotary pelleting machines
~40N scrobicula label.
2nd, the preparation of nifedipine clad sheet
Lucifuge operates, and weighs the nifedipine of recipe quantity, PVP K30, potassium chloride, mannitol, mixes in a mixer
15min, 2min is remixed after adding talcum powder, above-mentioned acquisition is then expanded by label and nitre using ZPW20 clad sheets tablet press machine
Benzene Horizon medicated layer is pressed into diameter 8.5mm, 50~70N of hardness scrobicula piece.
3rd, semi-transparent film coating
Coating solution is prepared according to pellicle coating fluid prescription, above-mentioned clad sheet is coated on high-efficiency coating pot, is controlled
25~30 DEG C of temperature of charge processed, coating weight gain 20%.After coating terminates, product dries 6h at 40 DEG C, obtains nifedipine micropore
Osmotic pumps clad sheet.
Embodiment 5
Prescription (10000)：
Preparation technology：
1st, the preparation of label is expanded：
The hydroxypropyl methylcellulose K100M, copolyvidone S630, lactose T80 of recipe quantity are weighed in blender mixing 15min,
2min is remixed after adding superfine silica gel powder, diameter 6mm, 30~40N of hardness scrobicula piece are suppressed using ZP-19 rotary pelleting machines
Core.
2nd, the preparation of nifedipine clad sheet
Lucifuge operates, and weighs the nifedipine of recipe quantity, PVP K30, sodium chloride, mannitol, lactose T80 in blender
Middle mixing 15min, 2min is remixed after adding magnesium stearate, is then expanded using ZPW20 clad sheets tablet press machine by above-mentioned
Label is pressed into diameter 8.5mm, 50~70N of hardness scrobicula piece with nifedipine medicated layer.
3rd, semi-transparent film coating
Coating solution is prepared according to pellicle coating fluid prescription, above-mentioned clad sheet is coated on high-efficiency coating pot, is controlled
25~30 DEG C of temperature of charge processed, coating weight gain 20%.After coating terminates, product dries 8h at 40 DEG C, obtains nifedipine micropore
Osmotic pumps clad sheet.
Embodiment 6
Dissolution determination
Lucifuge operates, and takes above-described embodiment that formulation samples are made, (2015 editions pharmacopeia are led to drug release determination method by dissolution rate
Then 0,931 second method), slice, thin piece is put into small Metal net basket (Japanese sinper), solvent is 1% lauryl sodium sulfate
Phosphate-citron acid buffering (pH=6.8) 900ml, rotating speed are 100 turns per minute, are operated in accordance with the law, through 4,8,12,16,20 and 24
Hour take filtrate appropriate respectively, separately take nifedipine reference substance about 18mg, it is accurately weighed in 50ml brown measuring bottles, add mixed liquor
I dissolves and is diluted to scale, and precision measures 5ml into 25ml brown measuring bottles, is diluted to scale with mixed liquor II, shakes up.
Chromatographic condition：It is filler with octadecylsilane chemically bonded silica, adds guard column, acetonitrile-methanol-water (20：30：
50) it is mobile phase, Detection wavelength 265nm, number of theoretical plate is calculated by nifedipine peak should be not less than 5000.
Above-mentioned solution takes 10 μ l, injects liquid chromatograph, determines peak area in accordance with the law, calculated with external standard method in every test sample
Different time nifedipine content, the stripping quantity of this product every at 4,8,12,16,20 and 24 hours (referring to table 1 and Fig. 2).Sample
The stripping quantity of product every at 4,12 and 24 hours, should be the 5%~17% of labelled amount respectively, more than 43%~80%, and 85%.
Accumulation dissolution calculation formula：
Xi schools=Xi+ (X1+X2+......+Xi) V2/V1
V1 is dissolution medium cumulative volume, and for V2 to supplement volume after every sub-sampling, Xi is the actually measured percentage of ith
Dissolution rate.
Table 1
From table 1 and Fig. 2, the nifedipine micro hole seep irrigation with expansion label produced by the present invention can reach
Similar stripping curve is ground with original.
Claims (8)
- A kind of 1. nifedipine micropore permeation pump clad sheet with expansion label, it is characterised in that:Micropore permeation pump clad sheet Expansion label is included, expansion piece wicking surface is followed successively by nifedipine medicated layer and pellicle, and each component part by weight is expansion piece Core：Nifedipine medicated layer：Pellicle=(5~55)：(5~75)：(5~30).
- 2. the nifedipine micropore permeation pump clad sheet with expansion label as described in claim 1, it is characterised in that：It is described It is made up of expansion label swelling agent, filler, lubricant；Each component part by weight is swelling agent：Filler：Lubricant= (20~90)：(1~45)：(1~15).
- 3. there is the nifedipine micropore permeation pump clad sheet of expansion label as described in claim 2, it is characterised in that：It is described swollen Swollen dose of one kind in polyoxyethylene, hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, sodium alginate or It is several；One or more of the filler in microcrystalline cellulose, lactose, mannitol, sucrose, starch, dextrin；The profit One or more of the lubrication prescription in talcum powder, magnesium stearate, superfine silica gel powder, sodium stearyl fumarate.
- 4. there is the nifedipine micropore permeation pump clad sheet of expansion label as described in claim 1, it is characterised in that：The nitre Benzene Horizon medicated layer is made up of nifedipine, adhesive, osmotic pressure regulator, filler, lubricant；Each component part by weight is Nifedipine：Adhesive：Osmotic pressure regulator：Filler：Lubricant=(10~90)：(1~15)：(1~45)：(10~ 30)：(1~15).
- 5. there is the nifedipine micropore permeation pump clad sheet of expansion label as described in claim 4, it is characterised in that：It is described viscous One or more of the mixture in hydroxypropyl methylcellulose, hydroxypropyl cellulose, PVP；The osmotic pressure regulator is selected from sugarcane In sugar, lactose, glucose, mannitol, sorbierite, fructose, sodium chloride, potassium chloride, sodium sulphate, sodium phosphate, sodium dihydrogen phosphate It is one or more of；The filler is in microcrystalline cellulose, starch and its derivative, cyclodextrin, mannitol, lactose, sucrose One or more.
- 6. there is the nifedipine micropore permeation pump clad sheet of expansion label as described in claim 1, it is characterised in that：Described half Permeable membrane is made up of cellulose, plasticizer, pore-foaming agent；Each component part by weight is cellulose：Plasticizer：Pore-foaming agent=(10~ 50)：(1~25)：(1~25).
- 7. there is the nifedipine micropore permeation pump clad sheet of expansion label as described in claim 5, it is characterised in that：The fibre Dimension element is selected from cellulose acetate or ethyl cellulose；The plasticizer is selected from glycerine, propane diols, polyethylene glycol, lemon triethylenetetraminehexaacetic acid One or more in ester, diethyl phthalate, glyceric acid triethyl, castor oil；The pore-foaming agent is selected from sucrose, breast One or more in sugar, mannitol, polyethylene glycol, hydroxypropyl methylcellulose, hydroxypropyl cellulose, PVP.
- 8. having the preparation method of the nifedipine micropore permeation pump clad sheet of expansion label described in a kind of claim 1, it is special Sign is：A) swelling agent, filler, mix lubricant are pressed into expansion label according to the above ratio；B) according to the above ratio by nifedipine and adhesive, osmotic pressure regulator, filler, mix lubricant, then with it is above-mentioned Obtain expansion label mixing and the nifedipine clad sheet containing expansion label is made by clad sheet tablet press machine；C) plasticizer, pore-foaming agent and cellulose are dissolved in into organic solvent-aqueous solution to wrap above-mentioned nifedipine medicine-containing particle Clothing, the nifedipine micropore permeation pump clad sheet with expansion label is made.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111184699A (en) * | 2020-04-09 | 2020-05-22 | 河北大学 | Nifedipine controlled release capsule and preparation method thereof |
| CN114767872A (en) * | 2022-03-21 | 2022-07-22 | 则正(上海)生物科技有限公司 | Application of polacrilin potassium in preparation of osmotic pump boosting layer, nifedipine osmotic pump tablet and preparation method |
| 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 |
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| US6485748B1 (en) * | 1997-12-12 | 2002-11-26 | Andrx Pharmaceuticals, Inc. | Once daily pharmaceutical tablet having a unitary core |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111184699A (en) * | 2020-04-09 | 2020-05-22 | 河北大学 | Nifedipine controlled release capsule and preparation method thereof |
| CN114767872A (en) * | 2022-03-21 | 2022-07-22 | 则正(上海)生物科技有限公司 | Application of polacrilin potassium in preparation of osmotic pump boosting layer, nifedipine osmotic pump tablet and preparation method |
| CN114767872B (en) * | 2022-03-21 | 2023-08-22 | 则正(上海)生物科技有限公司 | Application of polacrilin potassium in preparation of osmotic pump boosting layer, nifedipine osmotic pump tablet and preparation method |
| 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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