CN106389430B - A kind of felodipine Isosorbide Nitrate compound slow-release tablet and preparation method - Google Patents
A kind of felodipine Isosorbide Nitrate compound slow-release tablet and preparation method Download PDFInfo
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- 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
- 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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- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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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
- A61K9/2072—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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Abstract
The invention discloses a kind of felodipine Isosorbide Nitrate compound slow-release tablets, belong to pharmaceutical technology field.The compound slow-release tablet includes felodipine immediate release section and Isosorbide Nitrate slow-released part, wherein the component of felodipine immediate release section includes: felodipine, diluent, surfactant, disintegrating agent, lubricant, and the component of Isosorbide Nitrate slow-released part includes: Isosorbide Nitrate, slow-release material, diluent, surfactant, lubricant.Preparation method includes stocking up, granulation, whole grain, tabletting.The present invention combines felodipine, Isosorbide Nitrate, reduces pharmaceutic adjuvant dosage to greatest extent, and the effective ratio of drug is high.Realization is lasting in sustained release tablets body of the invention, slowly discharges drug, and blood concentration is steady, and fluctuation is small, to reduce administration frequency, is conducive to patient and takes, and improves patient compliance.
Description
Technical field
The invention belongs to pharmaceutical technology fields, be concretely a kind of felodipine Isosorbide Nitrate compound slow-release tablet and
Preparation method.
Background technique
Hypertension has become " the first killer " of Chinese's health, and there are 1.6 hundred million hypertensive patients in China at present, therefore also referred to as
" Chinese first disease ".Hypertension is suffered from, this section " fuse cord " can cause multiple complications, not know when people will be lighted
Intracorporal some " blasting charge " leads to " huge explosion " for destroying health, threat to life, such as coronary heart disease, myocardial infarction, brain
Angiosis, renal failure etc..Wherein, cerebrovascular disease is most easily to light, endanger maximum one " blasting charge ".It does not control in China
More in hypertensive patient, 70 ~ 80% die of cerebrovascular disease, and 1 ~ 5% dies of coronary heart disease, and 5 ~ 10% die of renal failure.With blood pressure
Normal population is compared, and hypertensive patient's average life span shortens 15 ~ 20 years.Therefore, cardiovascular and cerebrovascular diseases have seriously endangered national health,
Tremendous economic is caused to bear to patient, household and country, the annual cardiovascular and cerebrovascular diseases diagnosis and treatment in estimation China expend 300,000,000,000 RMB.
Decompression and protection target organ (such as heart, brain, kidney) are the two big main purposes for controlling blood pressure from damaging, and on condition that being had
The decompression of effect.
Some researches show that, drug Treatment of Hypertension can effectively prevent cerebrovascular disease, myocardial infarction, heart failure, renal function decline
It exhausts, prevents the further deterioration of high blood pressure.By two or more depressor use in conjunction, can obtain preferable
Efficacy of antihypertensive treatment；Hypertension therapeutic needs Long-term taking medicine, and once needs to take a variety of medicines or repeatedly medication is needed within one day to lead to patient
It is easy to miss compliance of the drug to reduce patient.And individually tableting aid dosage is relatively more, and packing cost is high, therefore
It is the emphasis to study instantly that medication type and medicining times, which how to be reduced, to improve patient dependence.
Summary of the invention
In order to reduce medication type and medicining times to improve patient dependence, the present invention provides a kind of non-
Lip river Horizon Isosorbide Nitrate compound slow-release tablet and preparation method, the compound slow-release tablet organically tie two kinds of drugs
It being combined, the effective ratio of drug is high, and it is convenient to take, so that the medication type for reducing patient improves the medication time of patient
Number.The object of the invention is realized by the following technical solutions:
A kind of felodipine Isosorbide Nitrate compound slow-release tablet, the compound slow-release tablet include felodipine immediate release section and
Isosorbide Nitrate slow-released part, wherein the component and part of felodipine immediate release section include: 5 ~ 10 parts of felodipine,
15 ~ 20 parts of diluent, 0.1 ~ 0.5 part of surfactant, 10 ~ 15 parts of disintegrating agent, 0.5 ~ 1 part of lubricant, Isosorbide Nitrate are slow
The component and part for releasing part includes: 3 ~ 8 parts of Isosorbide Nitrate, 20 ~ 30 parts of slow-release material, 10 ~ 15 parts of diluent, table
0.1 ~ 0.5 part of face activating agent, 0.3 ~ 0.8 part of lubricant.
Further, the object of the invention can also be realized by the following technical scheme:
A kind of felodipine Isosorbide Nitrate compound slow-release tablet, the component and part packet of felodipine immediate release section
It includes: 8 parts of felodipine, 18 parts of diluent, 0.3 part of surfactant, 12 parts of disintegrating agent, 0.7 part of lubricant, Isosorbide Nitrate
The component and part of slow-released part includes: 5 parts of Isosorbide Nitrate, 24 parts of slow-release material, 13 parts of diluent, surface-active
0.4 part of agent, 0.6 part of lubricant.
A kind of felodipine Isosorbide Nitrate compound slow-release tablet, diluent include starch, microcrystalline cellulose, in mannitol
At least one.
A kind of felodipine Isosorbide Nitrate compound slow-release tablet, surfactant include sucrose ester, fatty acid sorbitan,
At least one of polysorbate.
A kind of felodipine Isosorbide Nitrate compound slow-release tablet, disintegrating agent include sodium carboxymethyl starch, low-substituted hydroxypropyl
At least one of base cellulose, crosslinked polyvinylpyrrolidone.
A kind of felodipine Isosorbide Nitrate compound slow-release tablet, lubricant include magnesium stearate, superfine silica gel powder, talcum powder
At least one of.
A kind of felodipine Isosorbide Nitrate compound slow-release tablet, slow-release material include alginate, chitosan
At least one of.
The present invention also provides a kind of preparation methods of felodipine Isosorbide Nitrate compound slow-release tablet, including walk as follows
It is rapid:
1) it stocks up, the component and part according to a kind of felodipine Isosorbide Nitrate compound slow-release tablet is standby
Material, wherein felodipine crushing sieves with 100 mesh sieve, and Isosorbide Nitrate crushed 120 meshes, and diluent, collapses surfactant
Solution agent, lubricant, slow-release material crushed 80 meshes respectively；
2) it pelletizes, felodipine, diluent, surfactant, disintegrating agent, the uniform wet granulation of mix lubricant is obtained non-
Lip river Horizon immediate release section particle, Isosorbide Nitrate, diluent, surfactant, lubricant, slow-release material is uniformly mixed wet
Method is pelletized to obtain Isosorbide Nitrate slow-released part particle；
3) particle obtained by step 2 is crossed 20 ~ 40 mesh sieves by whole grain respectively；
4) tabletting, by particle obtained by step 3) by the tabletting of high speed bi-layer tablet press, specification be every containing felodipine 2 ~
5mg, 5 ~ 10mg of Isosorbide Nitrate.
Further, a kind of preparation method of felodipine Isosorbide Nitrate compound slow-release tablet of the invention can also be by
Following technical scheme is realized:
Drying equipment used in the step 2 granulation step is fluidized bed, felodipine immediate release section technological parameter are as follows: into
Air temperature is 55 ~ 60 DEG C, and temperature of charge is 45 ~ 50 DEG C, and leaving air temp is 35 ~ 40 DEG C；Isosorbide Nitrate slow-released part technique
Parameter are as follows: inlet air temperature is 50 ~ 55 DEG C, and temperature of charge is 40 ~ 50 DEG C, and leaving air temp is 35 ~ 40 DEG C.
The present invention also provides a kind of purposes of felodipine Isosorbide Nitrate compound slow-release tablet, and the sustained release tablets are for height
The drug therapy of blood pressure.
Beneficial effects of the present invention
1) present invention combines two kinds of drug felodipines, Isosorbide Nitrate, subtracts to greatest extent
Pharmaceutic adjuvant dosage is lacked, the effective ratio of drug is high, can be used for treating hypertension.Realized in sustained release tablets body of the invention persistently,
Slowly release drug, blood concentration is steady, fluctuate it is small, to reduce administration frequency, be conducive to patient and take, improve patient according to
From property.By the concentration of control active drug ingredient in blood to maintain drug effect, reduces drug release and reach peak number, to trouble
There are also certain protections for the internal organs of person.
2) although the present invention is to use customary adjuvant, but two kinds of drugs can be combined together carry out tabletting well
And release.
3) present invention process is simple, green, is easy to amplify metaplasia production, and cost is relatively low, advantageously reduces product price.Institute
Compound slow-release tablet is obtained to carry, is convenient to take.
4) auxiliary material is organically combined with bulk pharmaceutical chemicals well and is carried out granulation and tabletting by the present invention, and obtained sustained release tablets are slow
Release that part release rate is steady, and immediate release section is up-to-standard, through quality research and study on the stability, the related object of sustained release tablets of the invention
Matter, content etc. meet regulation.
Detailed description of the invention
Fig. 1 is the embodiment of the present invention 1 ~ 3 gained felodipine Isosorbide Nitrate compound slow-release tablet release (%) curve
Figure.
Series 1 is the release profiles of embodiment 1 in figure, 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, as it will be easily appreciated by one skilled in the art that real
It applies specific material proportion, process conditions and its result described in example and is merely to illustrate the present invention without that should will not limit
The present invention described in detail in claims.
Embodiment 1
A kind of felodipine Isosorbide Nitrate compound slow-release tablet, the compound slow-release tablet include felodipine immediate release section and
Isosorbide Nitrate slow-released part, wherein the component and part of felodipine immediate release section includes 5 parts of felodipine, starch
15 parts, 0.1 part of sucrose ester, 10 parts of sodium carboxymethyl starch, 0.5 part of magnesium stearate, the component of Isosorbide Nitrate slow-released part and
Parts by weight include 3 parts of Isosorbide Nitrate, 20 parts of sodium alginate, 10 parts of starch, 0.1 part of fatty acid sorbitan, superfine silica gel powder
0.3 ~ 0.8 part.
A kind of preparation method of felodipine Isosorbide Nitrate compound slow-release tablet, includes the following steps:
1) it stocks up, the component and part according to a kind of felodipine Isosorbide Nitrate compound slow-release tablet is standby
Material, wherein felodipine crushing sieves with 100 mesh sieve, and Isosorbide Nitrate crushed 120 meshes, and starch, sucrose ester, carboxymethyl form sediment
Powder sodium, magnesium stearate, sodium alginate, fatty acid sorbitan, superfine silica gel powder crushed 80 meshes respectively；
2) it pelletizes, felodipine, starch, sucrose ester, sodium carboxymethyl starch, magnesium stearate is uniformly mixed wet granulation and obtained
Felodipine immediate release section particle mixes Isosorbide Nitrate, starch, sodium alginate, fatty acid sorbitan, superfine silica gel powder equal
Even wet granulation obtains Isosorbide Nitrate slow-released part particle；
3) particle obtained by step 2 is crossed 20 mesh sieves by whole grain respectively；
4) tabletting, by particle obtained by step 3) by the tabletting of high speed bi-layer tablet press, specification is every and contains felodipine
2mg, Isosorbide Nitrate 5mg.
Usage and dosage: it takes orally 2 times a day, 1 ~ 2 every time.
Embodiment 2
A kind of felodipine Isosorbide Nitrate compound slow-release tablet, the compound slow-release tablet include felodipine immediate release section and
Isosorbide Nitrate slow-released part, wherein the component and part of felodipine immediate release section includes 10 parts of felodipine, forms sediment
10 parts of powder, 10 parts of microcrystalline cellulose, 0.2 part of fatty acid sorbitan, 0.3 part of polysorbate, 15 parts of low-substituted hydroxypropyl cellulose,
1 part of superfine silica gel powder, the component and part of Isosorbide Nitrate slow-released part includes 8 parts of Isosorbide Nitrate, potassium alginate
10 parts, 20 parts of chitosan, 15 parts of mannitol, 0.5 part of polysorbate, 0.3 part of superfine silica gel powder, 0.5 part of talcum powder.
A kind of preparation method of felodipine Isosorbide Nitrate compound slow-release tablet, includes the following steps:
1) it stocks up, the component and part according to a kind of felodipine Isosorbide Nitrate compound slow-release tablet is standby
Material, wherein felodipine crushing sieves with 100 mesh sieve, and Isosorbide Nitrate crushed 120 meshes, starch, microcrystalline cellulose, fat
Sour sorb is smooth, polysorbate, low-substituted hydroxypropyl cellulose, superfine silica gel powder, potassium alginate, chitosan, mannitol, cunning
Mountain flour crushed 80 meshes respectively；
2) it pelletizes, by felodipine, starch, microcrystalline cellulose, fatty acid sorbitan, polysorbate, low substituted hydroxy-propyl
Cellulose, superfine silica gel powder are uniformly mixed wet granulation and obtain felodipine immediate release section particle, by Isosorbide Nitrate, alginic acid
Potassium, chitosan, mannitol, polysorbate, superfine silica gel powder, talcum powder are uniformly mixed wet granulation and obtain Isosorbide Nitrate
Slow-released part particle；
3) particle obtained by step 2 is crossed 30 mesh sieves by whole grain respectively；
4) tabletting, by particle obtained by step 3) by the tabletting of high speed bi-layer tablet press, specification is every and contains felodipine
3mg, Isosorbide Nitrate 8mg.
Usage and dosage: it takes orally 2 times a day, 1 ~ 2 every time.
Embodiment 3
A kind of felodipine Isosorbide Nitrate compound slow-release tablet, the compound slow-release tablet include felodipine immediate release section and
Isosorbide Nitrate slow-released part, wherein the component and part of felodipine immediate release section includes 8 parts of felodipine, crystallite
8 parts of cellulose, 10 parts of mannitol, 0.3 part of polysorbate, 5 parts of low-substituted hydroxypropyl cellulose, crosslinked polyvinylpyrrolidone 7
Part, 0.3 part of superfine silica gel powder, 0.4 part of talcum powder, the component and part of Isosorbide Nitrate slow-released part include the different mountain of nitric acid
5 parts of pear 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 Isosorbide Nitrate compound slow-release tablet, includes the following steps:
1) it stocks up, the component and part according to a kind of felodipine Isosorbide Nitrate compound slow-release tablet is standby
Material, wherein felodipine crushing sieves with 100 mesh sieve, and Isosorbide Nitrate crushed 120 meshes, and microcrystalline cellulose, gathers mannitol
Sorb ester, low-substituted hydroxypropyl cellulose, crosslinked polyvinylpyrrolidone, superfine silica gel powder, talcum powder, chitosan, shallow lake
Powder, fatty acid sorbitan, magnesium stearate crushed 80 meshes respectively；
2) it pelletizes, felodipine microcrystalline cellulose, mannitol, polysorbate, low-substituted hydroxypropyl cellulose, crosslinking is poly-
Vinylpyrrolidone, superfine silica gel powder, talcum powder are uniformly mixed wet granulation and obtain felodipine immediate release section particle, by the different mountain of nitric acid
Pear ester, chitosan, starch, microcrystalline cellulose, fatty acid sorbitan, magnesium stearate are uniformly mixed wet granulation and obtain nitric acid
Soquad slow-released part particle；
3) particle obtained by step 2 is crossed 40 mesh sieves by whole grain respectively；
4) tabletting, by particle obtained by step 3) by the tabletting of high speed bi-layer tablet press, specification is every and contains felodipine
5mg, Isosorbide Nitrate 10mg.
Usage and dosage: it takes orally 2 times a day, 1 ~ 2 every time.
Embodiment 4
Compound slow-release tablet friability inspection of the invention
According to " Chinese Pharmacopoeia " 2015 editions (four) 0923 tablet friability inspection technique inspections.
Instrument: friability tester.
Method: if slice weight is that 0.65g or following person take dry plate, making its gross weight is about 6.5 g；Slice weight is greater than 0.65g person and takes
10 are blown away the powder to fall off with hair dryer, and precise weighing is set in cylinder, are rotated 100 times.It takes out, removes powder with method, it is accurate
Weighing, less loss weight must not cross 1%, and must not detect the piece of fracture, cracking and crushing.This test is general only to be made 1 time.Such as less loss
When weight is more than 1%, it should recheck 2 times, 3 average less loss weight must not cross 1 %, and must not detect fracture, cracking and crushing
Piece.
As a result: sample obtained by the embodiment of the present invention 1-3 meets regulation through friability test inspection.
Embodiment 5
Release inspection of the invention
According to 2015 editions (four) 0931 dissolution rates of Chinese Pharmacopoeia and the second method of drug release determination method, with 0.3% hexadecane
Base trimethyl amine bromide phosphate buffer (pH6.5) 500ml is medium, and revolving speed is 100 revs/min, is operated according to methods.Respectively
Measure the release of sample obtained by embodiment 1-3.Each sample is sampled in 1h, 2h, 4h, 8h, is detected by HPLC, nitric acid is different
Sorb ester release (%) the result is shown in Figure 1.
Conclusion: the compound sustained-released film vitro release of felodipine Isosorbide Nitrate of the invention is the result shows that the sustained release
Piece has slow release drug, and drug concentration is steady, fluctuates small feature.
Embodiment 6
Toxicity Analysis of the invention:
Hypotensive activity to Hypertensive Rats, using spontaneous hypertensive rat (SHR) male of 20 ~ 26 week old
Rat is equally divided into four groups, and every group 10, single dose is administered orally respectively with compound dose, detects its antihypertensive effect.Pass through I
The big rat-tail pressure heart rate measurement instrument of type measures big rat-tail pressure, and it is different that felodipine 0.2mg/kg/d, nitric acid is administered in folk prescription single oral dose
Sorb ester 0.5mg/kg/d；Felodipine 0.2mg/kg/d, Isosorbide Nitrate 0.5mg/kg/ is administered in compound single oral dose
D, Isosorbide Nitrate are quick releasing formulation；Felodipine 0.2mg/kg/d, Isosorbide Nitrate is administered in compound single oral dose
0.5mg/kg/d, wherein slow release layer is made in Isosorbide Nitrate.Folk prescription single dose Isosorbide Nitrate needs multiple dosing, right
Vein pressure effect is relatively 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, and it is only good to angiosthenia 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 decompression
It is low lasting to act on, and 4 ~ 5h, systolic pressure can reduce by 34.26 ~ 39.48mmHg, diastole pressure drop after administration for maximum reducing appearance
Low 32.46 ~ 37.32mmHg, year survival rate be 86.9%, antihypertensive effect is good, and substantially increases the existence of medication mouse
Rate.
The above is a preferred embodiment of the present invention, and its object is to allow person skilled in the art to understand the present invention
Content is simultaneously implemented, it is noted that for those skilled in the art, is not departing from the principle of the invention
Under the premise of, several improvements and modifications can also be made, these modifications and embellishments are also considered to be within the scope of the present invention.
Claims (10)
1. a kind of felodipine Isosorbide Nitrate compound slow-release tablet, which is characterized in that the compound slow-release tablet includes felodipine
Immediate release section and Isosorbide Nitrate slow-released part, wherein the component and part of felodipine immediate release section includes: 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, lubricant 0.5~1
Part, the component and part of Isosorbide Nitrate slow-released part includes: 3~8 parts of Isosorbide Nitrate, slow-release material 20~30
Part, 10~15 parts of diluent, 0.1~0.5 part of surfactant, 0.3~0.8 part of lubricant.
2. a kind of felodipine Isosorbide Nitrate compound slow-release tablet according to claim 1, which is characterized in that non-Lip river
The component and part of flat immediate release section includes: 8 parts of felodipine, 18 parts of diluent, 0.3 part of surfactant, disintegrating agent
12 parts, 0.7 part of lubricant, the component and part of Isosorbide Nitrate slow-released part include: 5 parts of Isosorbide Nitrate, delay
Release 24 parts of material, 13 parts of diluent, 0.4 part of surfactant, 0.6 part of lubricant.
3. a kind of felodipine Isosorbide Nitrate compound slow-release tablet according to claim 1, which is characterized in that diluent
For at least one of starch, microcrystalline cellulose, mannitol.
4. a kind of felodipine Isosorbide Nitrate compound slow-release tablet according to claim 1, which is characterized in that surface is living
Property agent be at least one of sucrose ester, fatty acid sorbitan, polysorbate.
5. a kind of felodipine Isosorbide Nitrate compound slow-release tablet according to claim 1, which is characterized in that disintegrating agent
For at least one of sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, crosslinked polyvinylpyrrolidone.
6. a kind of felodipine Isosorbide Nitrate compound slow-release tablet according to claim 1, which is characterized in that lubricant
For at least one of magnesium stearate, superfine silica gel powder, talcum powder.
7. a kind of felodipine Isosorbide Nitrate compound slow-release tablet according to claim 1, which is characterized in that sustained release material
Material is at least one of alginate, chitosan.
8. the preparation side of described in any item a kind of felodipine Isosorbide Nitrate compound slow-release tablets according to claim 1~7
Method, which comprises the steps of:
1) it stocks up, according to a kind of described in any item groups of felodipine Isosorbide Nitrate compound slow-release tablet of claim 1~7
Point and parts by weight stock, wherein felodipine crushing sieves with 100 mesh sieve, and Isosorbide Nitrate crushed 120 meshes, diluent,
Surfactant, disintegrating agent, lubricant, slow-release material crushed 80 meshes respectively；
2) it pelletizes, by felodipine, diluent, surfactant, disintegrating agent, mix lubricant uniform wet granulation get Fei Luo
Isosorbide Nitrate, diluent, surfactant, lubricant, slow-release material are uniformly mixed wet process system by flat immediate release section particle
Grain obtains Isosorbide Nitrate slow-released part particle；
3) particle obtained by step 2) is crossed 20~40 mesh sieves by whole grain respectively；
4) tabletting, by particle obtained by step 3) by the tabletting of high speed bi-layer tablet press, specification be every containing 2~5mg of felodipine,
5~10mg of Isosorbide Nitrate.
9. a kind of preparation method of felodipine Isosorbide Nitrate compound slow-release tablet according to claim 8, feature
It is, drying equipment used in the step 2) granulation step is fluidized bed, felodipine immediate release section technological parameter are as follows: air inlet temperature
Degree is 55~60 DEG C, and temperature of charge is 45~50 DEG C, and leaving air temp is 35~40 DEG C；Isosorbide Nitrate slow-released part technique ginseng
Number are as follows: inlet air 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. the purposes of described in any item a kind of felodipine Isosorbide Nitrate compound slow-release tablets according to claim 1~7,
It is characterized in that, application of the sustained release tablets in the drug of preparation treatment hypertension.
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20070098791A1 (en) * | 2005-10-31 | 2007-05-03 | Rekhi Gurvinder S | Controlled release compositions comprising a combination of isosorbide dinitrate and hydralazine hydrochloride |
| US20100068267A1 (en) * | 1999-10-29 | 2010-03-18 | Nitromed, Inc. | Compositions for treating vascular diseases characterized by nitric oxide insufficiency |
| 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 |
-
2016
- 2016-08-31 CN CN201610787959.3A patent/CN106389430B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
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