CN106389430A - Felodipine and isosorbide dinitrate compound sustained-release tablet and preparation method thereof - Google Patents
Felodipine and isosorbide dinitrate compound sustained-release tablet and preparation method thereof Download PDFInfo
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- CN106389430A CN106389430A CN201610787959.3A CN201610787959A CN106389430A CN 106389430 A CN106389430 A CN 106389430A CN 201610787959 A CN201610787959 A CN 201610787959A CN 106389430 A CN106389430 A CN 106389430A
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- felodipine
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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
-
- 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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
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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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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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
- A61K9/2072—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
Abstract
The invention discloses a felodipine and isosorbide dinitrate compound sustained-release tablet, and belongs to the technical field of medicines. The compound sustained-release tablet consists of a felodipine sustained-release part and an isosorbide dinitrate sustained-release part, wherein the felodipine sustained-release part consists of the following components: felodipine, a diluent, a surfactant, a disintegrant and a lubricant; and the isosorbide dinitrate sustained-release part consists of the following components: isosorbide dinitrate, a sustained-release material, a diluent, a surfactant and alubricant. A preparation method comprises steps of preparing materials, preparing granules, straightening the granules and tabletting the granules. The compound sustained-release tablet provided by the invention, by organically combining the felodipine and the isosorbide dinitrate, can reduce the dosage of pharmaceutical adjuvants to the greatest extent and increase the effective proportions of medicines. With the application of the sustained-release tablet provided by the invention, the durable and slow release of the medicines is achieved, and the sustained-release tablet is stable in blood concentration and light in fluctuation, so that the sustained-release tablet can reduce an administration frequency, bring about benefits for patients to take the sustained-release tablet and improve the compliance of the patients.
Description
Technical field
The invention belongs to pharmaceutical technology field, be concretely a kind of felodipine sorbide nitrate compound slow-release tablet and
Preparation method.
Background technology
Hypertension has become as " first killer " of Chinese's health, and China has 1.6 hundred million hyperpietics at present, therefore also referred to as
" Chinese first disease ".Suffer from hypertension, this section " fuse cord " can cause multiple complications, do not know when will light people
Certain internal " blasting charge ", leads to one to destroy health, " huge explosion " of threat to life, such as coronary heart disease, myocardial infarction, brain
Angiopathy, renal failure etc..Wherein, cerebrovascular is " blasting charge " the most easily lighting, endangering maximum.China does not control
In hyperpietic more, 70 ~ 80% die from cerebrovascular, and 1 ~ 5% dies from coronary heart disease, and 5 ~ 10% die from renal failure.With blood pressure
Normal population is compared, and hyperpietic's average life shortens 15 ~ 20 years.Therefore, cardiovascular and cerebrovascular disease serious harm national health,
Cause tremendous economic to bear to patient, household and country, estimate that China's annual cardiovascular and cerebrovascular disease diagnosis and treatment expend 300,000,000,000 RMB.
Blood pressure lowering and protection target organ（As the heart, brain, kidney etc.）It is the two big main purposes controlling blood pressure from infringement, and premise has been by
The blood pressure lowering of effect.
There are some researches show, medicine Treatment of Hypertension can effectively prevent and treat cerebrovascular, myocardial infarction, heart failure, renal function decline
Exhaust, stop the deterioration further of hypertension.By two kinds or two or more depressor use in conjunction, can obtain preferably
Efficacy of antihypertensive treatment；Hypertension therapeutic needs Long-term taking medicine, and once needs to take multiple medicines or need within one day repeatedly medication to lead to patient
Easily miss medicine thus reducing the compliance of patient.And individually tableting aid consumption is relatively many, packing cost is high, therefore
How to reduce medication species and medicining times thus improving the emphasis that patient dependence is for instantly studying.
Content of the invention
In order to reduce medication species and medicining times thus improving patient dependence, the invention provides a kind of non-
Lip river Horizon sorbide nitrate compound slow-release tablet and preparation method, two kinds of medicines are organically combined by this compound slow-release tablet
Together, the effective ratio of medicine is high, and taking convenience, thus the medication species reducing patient improves the medicining times of patient.This
Goal of the invention is realized by technical scheme below：
A kind of felodipine sorbide nitrate compound slow-release tablet, this compound slow-release tablet includes felodipine immediate release section and nitric acid
Soquad slow-released part, the wherein component of felodipine immediate release section and parts by weight include：5 ~ 10 parts of felodipine, dilution
15 ~ 20 parts of agent, 0.1 ~ 0.5 part of surfactant, 10 ~ 15 parts of disintegrating agent, 0.5 ~ 1 part of lubricant, sorbide nitrate slow release portion
The component divided and parts by weight include：Live in 3 ~ 8 parts of sorbide nitrate, 20 ~ 30 parts of slow-release material, 10 ~ 15 parts of diluent, surface
0.1 ~ 0.5 part of agent of property, 0.3 ~ 0.8 part of lubricant.
Further, the object of the invention can also be realized by technical scheme below：
A kind of felodipine sorbide nitrate compound slow-release tablet, the component of felodipine immediate release section and parts by weight include：
8 parts of felodipine, 18 parts of diluent, 0.3 part of surfactant, 12 parts of disintegrating agent, 0.7 part of lubricant, sorbide nitrate delays
Release the component of part and parts by weight include：5 parts of sorbide nitrate, 24 parts of slow-release material, 13 parts of diluent, surfactant
0.4 part, 0.6 part of lubricant.
A kind of felodipine sorbide nitrate compound slow-release tablet, diluent include starch, Microcrystalline Cellulose, in Mannitol
At least one.
A kind of felodipine sorbide nitrate compound slow-release tablet, surfactant include sucrose ester, fatty acid sorbitan,
At least one in Polysorbate.
A kind of felodipine sorbide nitrate compound slow-release tablet, disintegrating agent includes carboxymethyl starch sodium, low-substituted hydroxypropyl
At least one in base cellulose, crospolyvinylpyrrolidone.
A kind of felodipine sorbide nitrate compound slow-release tablet, lubricant includes magnesium stearate, micropowder silica gel, Pulvis Talci
In at least one.
A kind of felodipine sorbide nitrate compound slow-release tablet, slow-release material includes alginate, chitosan
In at least one.
Present invention also offers a kind of preparation method of felodipine sorbide nitrate compound slow-release tablet, walk including following
Suddenly：
1）Get the raw materials ready, component and parts by weight according to a kind of described felodipine sorbide nitrate compound slow-release tablet are got the raw materials ready,
Wherein, felodipine pulverized 100 mesh sieves, and sorbide nitrate pulverized 120 mesh sieves, diluent, surfactant, disintegrate
Agent, lubricant, slow-release material pulverized 80 mesh sieves respectively；
2）Pelletize, by felodipine, diluent, surfactant, disintegrating agent, mix lubricant uniform wet granulation get Fei Luo ground
Flat immediate release section granule, by sorbide nitrate, diluent, surfactant, lubricant, slow-release material mix homogeneously wet method system
Grain obtains sorbide nitrate slow-released part granule；
3）Granulate, by step 2）Gained granule crosses 20 ~ 40 mesh sieve granulate respectively；
4）Tabletting, by step 3）Gained granule pass through high speed bi-layer tablet press tabletting, specification be every contain felodipine 2 ~ 5mg,
Sorbide nitrate 5 ~ 10mg.
Further, a kind of preparation method of felodipine sorbide nitrate compound slow-release tablet of the present invention can also be by
Technical scheme below is realized：
Described step 2）Drying equipment used by granulation step is fluid bed, and felodipine immediate release section technological parameter is：Enter pathogenic wind-warm
Spend for 55 ~ 60 DEG C, temperature of charge is 45 ~ 50 DEG C, leaving air temp is 35 ~ 40 DEG C；Sorbide nitrate slow-released part technological parameter
For：Inlet temperature is 50 ~ 55 DEG C, and temperature of charge is 40 ~ 50 DEG C, and leaving air temp is 35 ~ 40 DEG C.
Present invention also offers a kind of purposes of felodipine sorbide nitrate compound slow-release tablet, this slow releasing tablet is used for high
The Drug therapy of blood pressure.
Beneficial effects of the present invention
1）Two kinds of drug felodipines, sorbide nitrates are combined by the present invention, decrease to greatest extent
Pharmaceutic adjuvant consumption, the effective ratio of medicine is high, can be used for treating hypertension.Realize in the slow releasing tablet body of the present invention persistently, slowly
Release medicine, steadily, fluctuation is little, thus reducing administration frequency, is conducive to patient to take for blood drug level, improves patient compliance
Property.By controlling active drug composition concentration in blood to maintain drug effect, reducing drug release and reaching peak number of times, to patient
Internal organs also have certain protection.
2）Although the present invention is to adopt customary adjuvant, but two kinds of medicines can be combined together well and carry out tabletting
And release.
3）Present invention process is simple, green is produced it is easy to amplify metaplasia, and cost is relatively low, advantageously reduces product price.Institute
Compound slow-release tablet carry, taking convenience.
4）Adjuvant is organically combined with crude drug and is pelletized and tabletting by the present invention well, and the slow releasing tablet obtaining is delayed
Release part release rate steadily, immediate release section is up-to-standard, through quality research and study on the stability, the relevant thing of slow releasing tablet of the present invention
Matter, content etc. meet regulation.
Brief description
Fig. 1 is embodiments of the invention 1 ~ 3 gained felodipine sorbide nitrate compound slow-release tablet release（%）Curve
Figure.
In figure series 1 is the release profiles of embodiment 1, and series 2 is the release profiles of embodiment 2, and series 3 is embodiment 3
Release profiles.
Specific embodiment
According to following embodiments, the present invention may be better understood.However, it is as it will be easily appreciated by one skilled in the art that real
Apply the specific material proportion described by example, process conditions and its result be merely to illustrate the present invention and not should also without limitation on
The present invention described in detail in claims.
Embodiment 1
A kind of felodipine sorbide nitrate compound slow-release tablet, this compound slow-release tablet includes felodipine immediate release section and nitric acid
Soquad slow-released part, the wherein component of felodipine immediate release section and parts by weight include 5 parts of felodipine, starch 15
Part, 0.1 part of sucrose ester, 10 parts of carboxymethyl starch sodium, 0.5 part of magnesium stearate, the component of sorbide nitrate slow-released part and weight
Amount number includes 3 parts of sorbide nitrate, 20 parts of sodium alginate, 10 parts of starch, 0.1 part of fatty acid sorbitan, micropowder silica gel 0.3
~ 0.8 part.
A kind of preparation method of felodipine sorbide nitrate compound slow-release tablet, comprises the steps：
1）Get the raw materials ready, component and parts by weight according to a kind of described felodipine sorbide nitrate compound slow-release tablet are got the raw materials ready,
Wherein, felodipine pulverized 100 mesh sieves, and sorbide nitrate pulverized 120 mesh sieves, starch, sucrose ester, carboxymethyl starch
80 mesh sieves were pulverized in sodium, magnesium stearate, sodium alginate, fatty acid sorbitan, micropowder silica gel respectively；
2）Pelletize, by felodipine, starch, sucrose ester, carboxymethyl starch sodium, magnesium stearate mix homogeneously wet granulation get Fei Luo
Horizon immediate release section granule, will be wet to sorbide nitrate, starch, sodium alginate, fatty acid sorbitan, micropowder silica gel mix homogeneously
Method is pelletized to obtain sorbide nitrate slow-released part granule；
3）Granulate, by step 2）Gained granule crosses 20 mesh sieve granulate respectively；
4）Tabletting, by step 3）Gained granule passes through high speed bi-layer tablet press tabletting, and specification is every 2mg containing felodipine, nitre
Sour Soquad 5mg.
Usage and dosage：Oral 2 times a day, 1 ~ 2 every time.
Embodiment 2
A kind of felodipine sorbide nitrate compound slow-release tablet, this compound slow-release tablet includes felodipine immediate release section and nitric acid
Soquad slow-released part, the wherein component of felodipine immediate release section and parts by weight include 10 parts of felodipine, starch 10
Part, 10 parts of Microcrystalline Cellulose, 0.2 part of fatty acid sorbitan, 0.3 part of Polysorbate, 15 parts of low-substituted hydroxypropyl cellulose, micropowder
1 part of silica gel, the component of sorbide nitrate slow-released part and parts by weight include 8 parts of sorbide nitrate, 10 parts of potassium alginate,
20 parts of chitosan, 15 parts of Mannitol, 0.5 part of Polysorbate, 0.3 part of micropowder silica gel, 0.5 part of Pulvis Talci.
A kind of preparation method of felodipine sorbide nitrate compound slow-release tablet, comprises the steps：
1）Get the raw materials ready, component and parts by weight according to a kind of described felodipine sorbide nitrate compound slow-release tablet are got the raw materials ready,
Wherein, felodipine pulverized 100 mesh sieves, and sorbide nitrate pulverized 120 mesh sieves, starch, Microcrystalline Cellulose, fatty acid mountain
Pears are smooth, Polysorbate, low-substituted hydroxypropyl cellulose, micropowder silica gel, potassium alginate, chitosan, Mannitol, Pulvis Talci
Pulverized 80 mesh sieves respectively；
2）Pelletize, by felodipine, starch, Microcrystalline Cellulose, fatty acid sorbitan, Polysorbate, low substituted hydroxy-propyl fiber
Element, micropowder silica gel mix homogeneously wet granulation obtain felodipine immediate release section granule, by sorbide nitrate, potassium alginate, take off
Chitosan, Mannitol, Polysorbate, micropowder silica gel, Pulvis Talci mix homogeneously wet granulation obtain sorbide nitrate slow release
Partial particulate；
3）Granulate, by step 2）Gained granule crosses 30 mesh sieve granulate respectively；
4）Tabletting, by step 3）Gained granule passes through high speed bi-layer tablet press tabletting, and specification is every 3mg containing felodipine, nitre
Sour Soquad 8mg.
Usage and dosage：Oral 2 times a day, 1 ~ 2 every time.
Embodiment 3
A kind of felodipine sorbide nitrate compound slow-release tablet, this compound slow-release tablet includes felodipine immediate release section and nitric acid
Soquad slow-released part, the wherein component of felodipine immediate release section and parts by weight include 8 parts of felodipine, microcrystalline cellulose
Element 8 parts, 10 parts of Mannitol, 0.3 part of Polysorbate, 5 parts of low-substituted hydroxypropyl cellulose, 7 parts of crospolyvinylpyrrolidone,
0.3 part of micropowder silica gel, 0.4 part of Pulvis Talci, the component of sorbide nitrate slow-released part and parts by weight include Isosorbide
5 parts of ester, 24 parts of chitosan, 3 parts of starch, 10 parts of Microcrystalline Cellulose, 0.4 part of fatty acid sorbitan, magnesium stearate 0.6
Part.
A kind of preparation method of felodipine sorbide nitrate compound slow-release tablet, comprises the steps：
1）Get the raw materials ready, component and parts by weight according to a kind of described felodipine sorbide nitrate compound slow-release tablet are got the raw materials ready,
Wherein, felodipine pulverized 100 mesh sieves, and sorbide nitrate pulverized 120 mesh sieves, Microcrystalline Cellulose, Mannitol, poly- Pyrusussuriensiss
Ester, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, micropowder silica gel, Pulvis Talci, chitosan, starch, fat
Fat acid Pyrusussuriensiss are smooth, magnesium stearate pulverized 80 mesh sieves respectively；
2）Pelletize, by felodipine Microcrystalline Cellulose, Mannitol, Polysorbate, low-substituted hydroxypropyl cellulose, crosslinked polyethylene
Ketopyrrolidine, micropowder silica gel, Pulvis Talci mix homogeneously wet granulation obtain felodipine immediate release section granule, by Isosorbide
Ester, chitosan, starch, Microcrystalline Cellulose, fatty acid sorbitan, that magnesium stearate mix homogeneously wet granulation obtains nitric acid is different
Pyrusussuriensiss ester slow-released part granule；
3）Granulate, by step 2）Gained granule crosses 40 mesh sieve granulate respectively；
4）Tabletting, by step 3）Gained granule passes through high speed bi-layer tablet press tabletting, and specification is every 5mg containing felodipine, nitre
Sour Soquad 10mg.
Usage and dosage：Oral 2 times a day, 1 ~ 2 every time.
Embodiment 4
The compound slow-release tablet friability of the present invention checks
According to《Chinese Pharmacopoeia》2015 editions（Four）0923 tablet friability inspection technique checks.
Instrument：Friability tester.
Method：If piece takes dry tablet for 0.65g or following person so as to gross weight is about 6.5 g again；Piece is great to be taken in 0.65g person
Blow away the powder coming off, precise weighing with hair-dryer for 10, put in cylinder, rotate 100 times.Take out, remove powder with method, accurate
Weigh, less loss weight must not cross 1%, and must not detect fracture, cracking and the piece pulverized.This test is normally only made 1 time.As less loss
When weight is more than 1%, should recheck 2 times, the average less loss weight of 3 times must not cross 1 %, and must not detect fracture, cracking and pulverizing
Piece.
Result：Embodiments of the invention 1-3 gained sample all meets regulation through friability test inspection.
Embodiment 5
The release inspection of the present invention
According to Chinese Pharmacopoeia 2015 editions（Four）0931 dissolution and drug release determination method second method, with 0.3% cetyl three
Methyl bromide amine phosphate buffer（pH6.5）500ml is medium, and rotating speed is 100 revs/min, operates in accordance with the law.Measure respectively
The release of sample obtained by embodiment 1-3.Each sample all samples in 1h, 2h, 4h, 8h, is detected by HPLC, Isosorbide
Ester release（%）Result is shown in Fig. 1.
Conclusion：The felodipine sorbide nitrate compound sustained-released film vitro release result of the present invention shows this slow release
Piece has slow Slow release, and steadily, fluctuate drug level little feature.
Embodiment 6
The pharmacodynamic analysis of the present invention：
Hypotensive activity to Hypertensive Rats, spontaneous hypertensive rat (SHR) male using 20 ~ 26 week old is big
Mus, are equally divided into four groups, every group 10, and single dose, with compound dose oral administration respectively, detects its hypotensive effect.By I
Type big rat-tail pressure heart rate measurement instrument measures big rat-tail pressure, and folk prescription single oral dose administration felodipine 0.2mg/kg/d, nitric acid are different
Pyrusussuriensiss ester 0.5mg/kg/d；Compound recipe single oral dose administration felodipine 0.2mg/kg/d, sorbide nitrate 0.5mg/kg/
D, sorbide nitrate is quick releasing formulation；Compound recipe single oral dose administration felodipine 0.2mg/kg/d, sorbide nitrate
0.5mg/kg/d, wherein sorbide nitrate make slow release layer.Folk prescription single dose sorbide nitrate needs multiple dosing, right
Venous pressure effectiveness comparison is good, and systolic pressure can reduce by 25.65 ~ 28.55mmHg, and diastolic pressure reduces by 8.79 ~ 11.56mmHg, year
Survival rate is 70.4%, though felodipine belongs to long-acting drug, only good to arterial pressure effect, systolic pressure can reduce by 27.35 ~
32.45mmHg, diastolic pressure reduce by 18.26 ~ 21.53mmHg, year survival rate be 72.3%；Compound dose oral administration blood pressure lowering
Effect is low lasting, and maximum reducing comes across 4 ~ 5h after administration, and systolic pressure can reduce by 34.26 ~ 39.48mmHg, diastole pressure drop
Low 32.46 ~ 37.32mmHg, year survival rate be 86.9%, antihypertensive effect is good, and substantially increases the existence of medication Mus
Rate.
The above is the preferred embodiment of the present invention, its object is to allow person skilled in the art understand the present invention
Content is simultaneously carried out it is noted that for those skilled in the art, without departing from the principle of the invention
Under the premise of, some improvements and modifications can also be made, these improvements and modifications are also considered as protection scope of the present invention.
Claims (10)
1. a kind of felodipine sorbide nitrate compound slow-release tablet is it is characterised in that this compound slow-release tablet includes felodipine
Immediate release section and sorbide nitrate slow-released part, the wherein component of felodipine immediate release section and parts by weight include：Non- Lip river
5 ~ 10 parts of Horizon, 15 ~ 20 parts of diluent, 0.1 ~ 0.5 part of surfactant, 10 ~ 15 parts of disintegrating agent, 0.5 ~ 1 part of lubricant, nitric acid
The component of Soquad slow-released part and parts by weight include：3 ~ 8 parts of sorbide nitrate, 20 ~ 30 parts of slow-release material, diluent
10 ~ 15 parts, 0.1 ~ 0.5 part of surfactant, 0.3 ~ 0.8 part of lubricant.
2. a kind of felodipine sorbide nitrate compound slow-release tablet it is characterised in that the component of felodipine immediate release section and
Parts by weight include：8 parts of felodipine, 18 parts of diluent, 0.3 part of surfactant, 12 parts of disintegrating agent, 0.7 part of lubricant, nitre
The component of sour Soquad slow-released part and parts by weight include：5 parts of sorbide nitrate, 24 parts of slow-release material, diluent 13
Part, 0.4 part of surfactant, 0.6 part of lubricant.
3. a kind of felodipine sorbide nitrate compound slow-release tablet according to claim 1 is it is characterised in that diluent
Including at least one in starch, Microcrystalline Cellulose, Mannitol.
4. a kind of felodipine sorbide nitrate compound slow-release tablet according to claim 1 is it is characterised in that live in surface
Property agent includes sucrose ester, fatty acid sorbitan, at least one in Polysorbate.
5. a kind of felodipine sorbide nitrate compound slow-release tablet according to claim 1 is it is characterised in that disintegrating agent
Including at least one in carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone.
6. a kind of felodipine sorbide nitrate compound slow-release tablet according to claim 1 is it is characterised in that lubricant
Including at least one in magnesium stearate, micropowder silica gel, Pulvis Talci.
7. a kind of felodipine sorbide nitrate compound slow-release tablet according to claim 1 is it is characterised in that slow release material
Material includes alginate, at least one in chitosan.
8. a kind of preparation method of felodipine sorbide nitrate compound slow-release tablet is it is characterised in that comprise the steps：
1）Get the raw materials ready, according to a kind of group of the felodipine sorbide nitrate compound slow-release tablet described in any one of claim 1 ~ 7
Point and parts by weight get the raw materials ready, wherein, felodipine pulverized 100 mesh sieves, and sorbide nitrate pulverized 120 mesh sieves, diluent,
Surfactant, disintegrating agent, lubricant, slow-release material pulverized 80 mesh sieves respectively；
2）Pelletize, by felodipine, diluent, surfactant, disintegrating agent, mix lubricant uniform wet granulation get Fei Luo ground
Flat immediate release section granule, by sorbide nitrate, diluent, surfactant, lubricant, slow-release material mix homogeneously wet method system
Grain obtains sorbide nitrate slow-released part granule；
3）Granulate, by step 2）Gained granule crosses 20 ~ 40 mesh sieve granulate respectively；
4）Tabletting, by step 3）Gained granule pass through high speed bi-layer tablet press tabletting, specification be every contain felodipine 2 ~ 5mg,
Sorbide nitrate 5 ~ 10mg.
9. the preparation method of a kind of felodipine sorbide nitrate compound slow-release tablet according to claim 8, its feature
It is, described step 2）Drying equipment used by granulation step is fluid bed, and felodipine immediate release section technological parameter is：Enter pathogenic wind-warm
Spend for 55 ~ 60 DEG C, temperature of charge is 45 ~ 50 DEG C, leaving air temp is 35 ~ 40 DEG C；Sorbide nitrate slow-released part technological parameter
For：Inlet temperature is 50 ~ 55 DEG C, and temperature of charge is 40 ~ 50 DEG C, and leaving air temp is 35 ~ 40 DEG C.
10. a kind of purposes of felodipine sorbide nitrate compound slow-release tablet is it is characterised in that this slow releasing tablet is used for hypertension
Drug therapy.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112315961A (en) * | 2020-11-29 | 2021-02-05 | 北京康立生医药技术开发有限公司 | Marxitemtan isosorbide dinitrate sustained-release capsule |
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| US20100068267A1 (en) * | 1999-10-29 | 2010-03-18 | Nitromed, Inc. | Compositions for treating vascular diseases characterized by nitric oxide insufficiency |
| US20070098791A1 (en) * | 2005-10-31 | 2007-05-03 | Rekhi Gurvinder S | Controlled release compositions comprising a combination of isosorbide dinitrate and hydralazine hydrochloride |
| CN103655508A (en) * | 2013-12-24 | 2014-03-26 | 合肥立方制药股份有限公司 | Double-medicament-layer isosorbide mononitrate osmotic pump controlled release tablet and preparation method thereof |
| CN104146947A (en) * | 2014-07-30 | 2014-11-19 | 上海新亚药业闵行有限公司 | Anti-hypertensive medicinal preparation and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112315961A (en) * | 2020-11-29 | 2021-02-05 | 北京康立生医药技术开发有限公司 | Marxitemtan isosorbide dinitrate sustained-release capsule |
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| Publication number | Publication date |
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| CN106389430B (en) | 2018-12-25 |
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