CN107550881A - A kind of felodipine sustained-release tablets and its preparation technology - Google Patents
A kind of felodipine sustained-release tablets and its preparation technology Download PDFInfo
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- felodipine
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- release tablets
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Abstract
The invention discloses a kind of felodipine sustained-release tablets and preparation method thereof, in terms of belonging to chemicals medicine, comprising felodipine solid dispersions, filler, disintegrant, lubricant, described felodipine solid dispersions are by felodipine, carbomer resin, sodium alginate, it is suspended in absolute ethyl alcohol, dries and remove ethanol and obtain, then be well mixed with filler, disintegrant, 60% ethanol is as binder, granulation, 45 DEG C of dryings, obtains medicine-containing particle；This medicine-containing particle is crossed into 18 mesh sieves, then uniform with the mix lubricant of recipe quantity, tabletting forms, present invention successfully solves felodipine sustained-release problem, medicine can discharge completely, can maintain effective blood drug concentration for a long time, bioavilability is high, and preparation technology is simple, is adapted to industrialized production.
Description
Technical field
The invention belongs to technical field of medicine, contains in particular to a kind of pharmaceutical preparation, more particularly to one kind
The sustained release tablets and its preparation technology of felodipine.
Background technology
Felodipine chemistry entitled (±) -2,6- dimethyl -4- (2,3- dichlorophenyls) -1,4- dihydro -3,5- pyridines two
Methyl formate ethyl ester.White is to pale yellow crystals or crystalline powder；It is odorless, it is tasteless；Meet photo-labile.This product is in acetone, first
It is readily soluble in alcohol or ethanol, it is almost insoluble in water.Molecular formula is C18H19Cl2NO4, molecular weight 384.25400, density is
1.277g/cm3, boiling point are 471.5 DEG C of at 760mmHg, and flash-point is 239 DEG C.
This product is selective cerebrocrast, and the main interior stream for suppressing the outer calcium of petty action smooth muscle cells, selectivity expands
Parteriole is opened, vein is acted on without this, does not cause postural hypotension；To cardiac muscle also without obvious inhibiting effect.This product is reducing
While renal vascular resistance, glomerular filtration rate(GFR and creatinine clearance rate are not influenceed, renal blood flow is unchanged or even has increased slightly, and has
Promote natruresis and diuresis.This product can increase output quantity and cardiac index, significantly reduce afterload, and to heart contraction work(
Energy, preload and heart rate have no significant effect.This product is used for the light, treatment of Moderate Essential Hypertension.Sustained release is made in felodipine
After preparation, medicine can be made slowly to discharge, reduce blood concentration fluctuation amplitude, blood pressure is maintained more stable state, reduced
The generation of adverse reaction.
CN101953837A discloses a kind of felodipine sustained-release tablets and preparation method thereof, employs cyclodextrin encapsulated side
Active component felodipine is dissolved in the macromolecular gap of cyclodextrin by method, and because cyclodextrin hydrophilic is good, thus preparation discharges
Steadily, longer time is needed when but preparing felodipine cyclodextrin system's inclusion compound using this method, technique is cumbersome and not easily-controllable
System.
CN102552200A discloses a kind of felodipine sustained-release tablets, and the sustained release tablets contain felodipine, high viscosity hydroxypropyl
Methylcellulose, low-viscosity hydroxypropyl methylcellulose and water-soluble filler, also containing other pharmaceutic adjuvants, due to hydroxypropyl methylcellulose
Compressibility and poor fluidity, preparations shaping are difficult.
CN102462663A discloses a kind of depressor felodipine Pharmaceutical composition and preparation method thereof, and said composition includes
Felodipine, dispersant, filler, disintegrant, solubilizer, lubricant and adhesive, method are first by felodipine with disperseing
After agent is micronized together, then using dry granulation preparation felodipine pharmaceutical preparation, the use of water and organic solvent is avoided, is subtracted
Damp and hot process and energy consumption, the quality control being easy in production process are lacked.
CN103006568A discloses a kind of felodipine medicine solid dispersion thing and preparation method thereof, and it is with slightly solubility medicine
Thing felodipine is active component, after active medicine is well mixed according to a certain percentage with macromolecule carrier, is squeezed by heating
Go out the solid dispersion thing that felodipine is prepared in method, wherein, felodipine medicine accounts for the 10 of whole solid dispersion thing gross mass
~40%.
CN104758266A discloses a kind of felodipine sustained-release tablets and its preparation technology, and said preparation is disperseed by fast release solid
Body, sustained release pellet and tabletting after pharmaceutically acceptable auxiliary materials and mixing form；In described fast release solid dispersion by non-Lip river
Flat, copolyvidone and polacrilin potassium composition；Described sustained release pellet is to wrap up containing in described fast release solid dispersion
The ethyl cellulose of pore-foaming agent and obtain.
Dissolving of the above-mentioned art methods to a certain extent to felodipine medicine serves the effect of solubilising, but makes
Standby complex process, the requirement to production equipment and operation are higher.
Direct tablet compressing or dry granulation are employed to the problem of wet, hot, photostability is poor, someone in order to tackle felodipine
Method：
Patent CN102920677A provides a kind of felodipine sustained-release preparation and preparation method thereof.The felodipine sustained-release
Piece includes following component：Active component felodipine, hydroxypropyl methyl cellulose, superfine silica gel powder, filler, antioxidant, solubilising
Agent and lubricant, felodipine sustained-release tablets are made using tabletting after dry granulation, the invention not fundamentally solution Lip river by no means
Flat stability problem, because all auxiliary materials are respectively provided with larger hygroscopicity, can still result in catabolite in storage process substantially increases
It is long.Meanwhile direct tablet compressing requires higher to the mobility of auxiliary material, it is adapted to the auxiliary material price general charged of direct tablet compressing expensive；Directly press
The defects of piece is most obvious is exactly that content uniformity is poor.And dry granulation particle heterogeneity, tablet weight variation can be caused larger and hard
Spend the problems such as uneven, dissolution is too fast.
In summary, fail to provide a kind of good stability, steady dissolution, Small side effects, preparation technology in the prior art
Simple felodipine sustained-release tablets.
The content of the invention
In view of the deficiencies in the prior art, the present inventor to supplementary product kind and technique by optimizing, there is provided one kind is stable
Good, the steady dissolution of property, Small side effects, the simple felodipine sustained-release tablets of preparation technology.
In order to realize the purpose of the present invention, inventor is analyzed prior art, is contained using direct compression method preparation
It is poor to measure the uniformity, release is too fast；Inventor has been attempted using SMA copolymer, carbomer resin, alginic acid
Sodium, poloxamer188, polyvinylpyrrolidone PVP K30, be prepared into felodipine solid dispersions, find carbomer resin,
Sodium alginate mixture can significantly change the stability in preparation process, and long-time stability are had clear improvement, and find to use
A certain proportion of carbomer resin, sodium alginate can both ensure stability, and and can makes release too fast.
Filler and disintegrant calcium phosphate dibasic anhydrous, D-mannital, pregelatinized starch, mannitol, second are investigated simultaneously
Alkyd sodium starch and sodium alginate, find calcium phosphate dibasic anhydrous and D-mannital, Sodium Carboxymethyl Starch and sodium alginate combination
Effect is preferable.
Specifically, the purpose of the present invention is achieved by the following technical solution：
A kind of felodipine sustained-release tablets, it is described comprising felodipine solid dispersions, filler, disintegrant, lubricant
Felodipine solid dispersions are by felodipine, carbomer resin, sodium alginate, are suspended in absolute ethyl alcohol, dry and remove
Ethanol and obtain.
The felodipine sustained-release tablets, felodipine, carbomer resin and sodium alginate in felodipine solid dispersions
Weight consumption ratio be 1：(1-3)：(3-5).
The felodipine sustained-release tablets, felodipine, carbomer resin and sodium alginate in felodipine solid dispersions
Weight consumption ratio be 1：(1.5-2.5)：(3.5-4.5).
The felodipine sustained-release tablets, felodipine, carbomer resin and sodium alginate in felodipine solid dispersions
Weight consumption ratio be 1：2：4.
The weight proportion of the felodipine sustained-release tablets, wherein each component is 1 part of felodipine solid dispersions, filling
0.1 part of 4 parts of agent, 2 parts of disintegrant and lubricant.
The felodipine sustained-release tablets, the filler be selected from calcium phosphate dibasic anhydrous, D-mannital, pregelatinized starch and
One or more in mannitol；Disintegrant is Sodium Carboxymethyl Starch and sodium alginate, and the lubricant is selected from superfine silica gel powder, hard
One or more in fatty acid magnesium, calcium stearate and sodium stearyl fumarate.
The felodipine sustained-release tablets, the filler are selected from calcium phosphate dibasic anhydrous and D-mannital, weight consumption ratio
For 2-4:1；Disintegrant is Sodium Carboxymethyl Starch and sodium alginate weight consumption ratio is 3-6:1, lubricant is superfine silica gel powder.
The felodipine sustained-release tablets, the filler are selected from calcium phosphate dibasic anhydrous and D-mannital, weight consumption ratio
For 3:1；Disintegrant is Sodium Carboxymethyl Starch and sodium alginate weight consumption ratio is 4:1.
The felodipine sustained-release tablets, preparation technology comprise the following steps：
(1) felodipine, carbomer resin and sodium alginate mixing are taken, is suspended in absolute ethyl alcohol, is dried and remove ethanol
And obtain felodipine solid dispersions；
(2) felodipine solid dispersions obtained by step (1) are well mixed with filler, disintegrant, 60% ethanol is made
For adhesive, granulation, 45 DEG C of dryings, medicine-containing particle is obtained；This medicine-containing particle is crossed into 18 mesh sieves, then with the lubricant of recipe quantity
Well mixed, tabletting forms.
Compared with prior art, felodipine sustained-release tablets of the present invention and its preparation technology have the following advantages that and shown
Write progressive：
(1) present invention successfully solves felodipine to discharge stability, and release can be made steady；
(2) preparation technology is simple, it is not necessary to complicated preparation equipment, is easy to industrialized production.
Embodiment
Now the preparation process of the present invention and implementation result, but the protection of the present invention are further described by following examples
Scope is not limited to following examples.
Embodiment 1
Preparation technology：Take felodipine 5g, carbomer resin 5g and sodium alginate 25g to mix, be suspended in absolute ethyl alcohol,
Dry and remove ethanol and obtain felodipine solid dispersions；By gained felodipine solid dispersions and calcium phosphate dibasic anhydrous 90g,
D-mannital 50g, Sodium Carboxymethyl Starch 60g, sodium alginate 10g are well mixed, and 60% ethanol is as adhesive, granulation, and 45
DEG C drying, obtains medicine-containing particle；This medicine-containing particle is crossed into 18 mesh sieves, then with place superfine silica gel powder 3.5g be well mixed, tabletting and
Into.
Embodiment 2
Preparation technology：Take felodipine 5g, carbomer resin 15g and sodium alginate 15g to mix, be suspended in absolute ethyl alcohol
In, dry and remove ethanol and obtain felodipine solid dispersions；By gained felodipine solid dispersions and calcium phosphate dibasic anhydrous
112g, D-mannital 28g, Sodium Carboxymethyl Starch 52.5g, sodium alginate 17.5g are well mixed, and 60% ethanol is as bonding
Agent, granulation, 45 DEG C of dryings, obtains medicine-containing particle；This medicine-containing particle is crossed into 18 mesh sieves, then mixed with place superfine silica gel powder 3.5g
Even, tabletting forms.
Embodiment 3
Preparation technology：Take felodipine 5g, carbomer resin 10g and sodium alginate 20g to mix, be suspended in absolute ethyl alcohol
In, dry and remove ethanol and obtain felodipine solid dispersions；By gained felodipine solid dispersions and calcium phosphate dibasic anhydrous
105g, D-mannital 35g, Sodium Carboxymethyl Starch 56g, sodium alginate 14g are well mixed, and 60% ethanol is as adhesive, system
Grain, 45 DEG C of dryings, obtains medicine-containing particle；This medicine-containing particle is crossed into 18 mesh sieves, is then well mixed, presses with place superfine silica gel powder 3.5g
Piece forms.
Embodiment 4
Preparation technology：Take felodipine 5g, carbomer resin 10g and sodium alginate 20g to mix, be suspended in absolute ethyl alcohol
In, dry and remove ethanol and obtain felodipine solid dispersions；By gained felodipine solid dispersions and calcium phosphate dibasic anhydrous
105g, D-mannital 35g, Sodium Carboxymethyl Starch 60g, sodium alginate 10g are well mixed, and 60% ethanol is as adhesive, system
Grain, 45 DEG C of dryings, obtains medicine-containing particle；This medicine-containing particle is crossed into 18 mesh sieves, is then well mixed, presses with place superfine silica gel powder 3.5g
Piece forms.
Comparative example 1
Preparation technology：Take felodipine raw material fine powder 5g, carbomer resin 10g and sodium alginate 34g, calcium phosphate dibasic anhydrous
105g, D-mannital 35g, Sodium Carboxymethyl Starch 56g, sodium alginate 14g are well mixed, and 60% ethanol is as adhesive, system
Grain, 45 DEG C of dryings, obtains medicine-containing particle；This medicine-containing particle is crossed into 18 mesh sieves, is then well mixed, presses with place superfine silica gel powder 3.5g
Piece forms.
Comparative example 2
Preparation technology：Take felodipine 5g, carbomer resin 30g to mix, be suspended in absolute ethyl alcohol, dry and remove ethanol
And obtain felodipine solid dispersions；By gained felodipine solid dispersions and calcium phosphate dibasic anhydrous 105g, D-mannital
35g, Sodium Carboxymethyl Starch 56g, sodium alginate 14g are well mixed, and 60% ethanol granulation, 45 DEG C of dryings, obtains as adhesive
Medicine-containing particle；This medicine-containing particle is crossed into 18 mesh sieves, is then well mixed with place superfine silica gel powder 3.5g, tabletting forms.
Comparative example 3
Preparation technology：Take felodipine 5g and sodium alginate 30g to mix, be suspended in absolute ethyl alcohol, dry and remove ethanol
And obtain felodipine solid dispersions；By gained felodipine solid dispersions and calcium phosphate dibasic anhydrous 105g, D-mannital
35g, Sodium Carboxymethyl Starch 56g, sodium alginate 14g are well mixed, and 60% ethanol granulation, 45 DEG C of dryings, obtains as adhesive
Medicine-containing particle；This medicine-containing particle is crossed into 18 mesh sieves, is then well mixed with place superfine silica gel powder 3.5g, tabletting forms.
Comparative example 4
Preparation technology：Take felodipine 5g, carbomer resin 10g and sodium alginate 20g to mix, be suspended in absolute ethyl alcohol
In, dry and remove ethanol and obtain felodipine solid dispersions；By gained felodipine solid dispersions and calcium phosphate dibasic anhydrous
140g, Sodium Carboxymethyl Starch 70g are well mixed, and 60% ethanol granulation, 45 DEG C of dryings, obtains medicine-containing particle as adhesive；Will
This medicine-containing particle crosses 18 mesh sieves, is then well mixed with place superfine silica gel powder 3.5g, tabletting forms.
Comparative example 5
Preparation technology：Take felodipine 5g, carbomer resin 10g and sodium alginate 20g to mix, be suspended in absolute ethyl alcohol
In, dry and remove ethanol and obtain felodipine solid dispersions；By gained felodipine solid dispersions and D-mannital
140g, sodium alginate 70g are well mixed, and 60% ethanol granulation, 45 DEG C of dryings, obtains medicine-containing particle as adhesive；This is contained
Medicine particle crosses 18 mesh sieves, is then well mixed with place superfine silica gel powder 3.5g, tabletting forms..
Comparative example 6
Preparation technology：Take felodipine 5g, carbomer resin 10g and sodium alginate 20g to mix, be suspended in absolute ethyl alcohol
In, dry and remove ethanol and obtain felodipine solid dispersions；By gained felodipine solid dispersions and D-mannital
140g, Sodium Carboxymethyl Starch 70g are well mixed, and 60% ethanol granulation, 45 DEG C of dryings, obtains medicine-containing particle as adhesive；Will
This medicine-containing particle crosses 18 mesh sieves, is then well mixed with place superfine silica gel powder 3.5g, tabletting forms.
Comparative example 7
Preparation technology：Take felodipine 5g, carbomer resin 10g and sodium alginate 20g to mix, be suspended in absolute ethyl alcohol
In, dry and remove ethanol and obtain felodipine solid dispersions；By gained felodipine solid dispersions and calcium phosphate dibasic anhydrous
140g, sodium alginate 70g are well mixed, and 60% ethanol granulation, 45 DEG C of dryings, obtains medicine-containing particle as adhesive；This is contained
Medicine particle crosses 18 mesh sieves, is then well mixed with place superfine silica gel powder 3.5g, tabletting forms.
The release of the felodipine sustained-release tablets of embodiment 8 is investigated
Chromatographic condition：Chromatographic condition：It is filler with octadecylsilane chemically bonded silica, is delayed with methanol-second eyeball-phosphate
Fliud flushing (1：2：2) it is mobile phase：Detection wavelength is 254nm, 25 DEG C of column temperature.
According to drug release determination method (Chinese Pharmacopoeia the second methods of version annex XD in 2010), filled using the method for dissolution method second
(Chinese Pharmacopoeia version annex XC in 2010) is put, using 0.02% Tween-80 solution 900ml as solvent, rotating speed is 50 turns per minute, according to
Method operates, and during through 0.25,2,4,6,8,12h, takes solution 5m1 respectively, filters, and supplements phase equality of temperature in process container immediately
Degree, the dissolution medium of same volume；Subsequent filtrate is taken as need testing solution；Separately take felodipine reference substance appropriate, be dissolved in water
And dilute and be made, being dissolved in water and quantifying dilution is made containing about 10 μ g solution in every lml, as reference substance solution.Precision amount
Need testing solution and each 20 μ l injections liquid chromatograph of reference substance solution are taken, chromatogram is recorded, is distinguished by external standard method with peak area
The every burst size in different time is calculated, each group takes the average value of all samples release.Drug release determination the results are shown in Table 1.
Dissolution of sustained-release tablets measurement result prepared by 1 each embodiment of table
| Sample source | 0.25h (%) | 2h (%) | 4h (%) | 6h (%) | 8h (%) | 12h (%) |
| Embodiment 1 | 27.5 | 40.5 | 67.8 | 82.3 | 92.4 | 98.5 |
| Embodiment 2 | 24.5 | 38.7 | 61.3 | 79.6 | 91.1 | 98.7 |
| Embodiment 3 | 26.6 | 46.5 | 71.6 | 85.4 | 94.4 | 99.9 |
| Embodiment 4 | 23.5 | 41.6 | 60.9 | 80.3 | 93.1 | 98.3 |
| Comparative example 1 | 17.2 | 26.3 | 37.3 | 40.5 | 57.4 | 74.3 |
| Comparative example 2 | 21.4 | 35.1 | 42.5 | 50.4 | 69.1 | 89.4 |
| Comparative example 3 | 18.2 | 29.5 | 39.6 | 54.1 | 60.5 | 79.9 |
| Comparative example 4 | 16.4 | 35.7 | 43.8 | 57.8 | 65.3 | 86.4 |
| Comparative example 5 | 26.5 | 36.4 | 45.6 | 54.8 | 47.8 | 87.3 |
| Comparative example 6 | 19.3 | 37.7 | 49.2 | 50.3 | 69.5 | 79.6 |
| Comparative example 7 | 17.5 | 35.6 | 43.5 | 52.6 | 68.5 | 76.4 |
It is steady according to the release of the results showed that embodiment of the present invention 1-4 of table 1 felodipine sustained-release tablets；Contrast is real
Apply a 1-2 and carbomer resin, sodium alginate is respectively adopted in felodipine solid dispersions are prepared, comparative example 3 uses
Felodipine fine powder prepares felodipine sustained-release tablets, and release is incomplete, illustrates to be prepared into the important of felodipine solid dispersions
Property, the filler in comparative example 4-6 and disintegrant are respectively calcium phosphate dibasic anhydrous, Sodium Carboxymethyl Starch, D- sweet dews in addition
One kind in sugar alcohol, sodium alginate, it is complete that medicine is difficult to release.Experimental result can be drawn, felodipine solid dispersions, be filled out
The particular combination of agent and disintegrant is filled, has the influence of highly significant for the sustained release of medicine, especially inside and outside sodium alginate use
Addition, filler calcium phosphate dibasic anhydrous and D-mannital weight consumption ratio are 3:1；Disintegrant Sodium Carboxymethyl Starch and alginic acid
Sodium weight consumption ratio is 4:When 1, dissolution is the most steady.
Claims (9)
1. a kind of felodipine sustained-release tablets, it is characterised in that include felodipine solid dispersions, filler, disintegrant, lubrication
Agent, described felodipine solid dispersions are by felodipine, carbomer resin, sodium alginate, are suspended in absolute ethyl alcohol,
Dry and remove ethanol and obtain.
2. felodipine sustained-release tablets according to claim 1, it is characterised in that non-Lip river in felodipine solid dispersions
The weight consumption ratio of flat, carbomer resin and sodium alginate is 1：(1-3)：(3-5).
3. felodipine sustained-release tablets according to claim 2, it is characterised in that non-Lip river in felodipine solid dispersions
The weight consumption ratio of flat, carbomer resin and sodium alginate is 1：(1.5-2.5)：(3.5-4.5).
4. felodipine sustained-release tablets according to claim 3, it is characterised in that non-Lip river in felodipine solid dispersions
The weight consumption ratio of flat, carbomer resin and sodium alginate is 1：2：4.
5. felodipine sustained-release tablets according to claim 1, it is characterised in that the weight proportion of wherein each component is non-Lip river
0.1 part of 1 part of Horizon solid dispersions, 3 parts of filler, 2 parts of disintegrant and lubricant.
6. felodipine sustained-release tablets according to claim 5, it is characterised in that the filler be selected from calcium phosphate dibasic anhydrous,
One or more in D-mannital, pregelatinized starch and mannitol；Disintegrant is Sodium Carboxymethyl Starch and sodium alginate, institute
State one or more of the lubricant in superfine silica gel powder, magnesium stearate, calcium stearate and sodium stearyl fumarate.
7. felodipine sustained-release tablets according to claim 6, it is characterised in that the filler be selected from calcium phosphate dibasic anhydrous and
D-mannital, weight consumption ratio are 2-4:1；Disintegrant is Sodium Carboxymethyl Starch and sodium alginate weight consumption ratio is 3-6:1,
Lubricant is superfine silica gel powder.
8. felodipine sustained-release tablets according to claim 7, it is characterised in that the filler be selected from calcium phosphate dibasic anhydrous and
D-mannital, weight consumption ratio are 3:1；Disintegrant is Sodium Carboxymethyl Starch and sodium alginate weight consumption ratio is 4:1.
9. according to any one of the claim 1-4 felodipine sustained-release tablets, it is characterised in that preparation technology includes following step
Suddenly：
(1) felodipine, carbomer resin and sodium alginate mixing are taken, is suspended in absolute ethyl alcohol, is dried and remove ethanol and obtain
Felodipine solid dispersions；
(2) felodipine solid dispersions obtained by step (1) are well mixed with filler, disintegrant, 60% ethanol is as glutinous
Mixture, granulation, 45 DEG C of dryings, obtains medicine-containing particle；This medicine-containing particle is crossed into 18 mesh sieves, then with the mix lubricant of recipe quantity
Uniformly, tabletting forms.
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| CN201710893684.6A CN107550881B (en) | 2017-09-28 | 2017-09-28 | Felodipine sustained-release tablet and preparation process thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112263567A (en) * | 2020-10-19 | 2021-01-26 | 南京易亨制药有限公司 | Ibuprofen sustained-release capsule and preparation method thereof |
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| KR20090107954A (en) * | 2008-04-10 | 2009-10-14 | 한올제약주식회사 | Pharmaceutical formulation |
| CN102316856A (en) * | 2009-02-27 | 2012-01-11 | 韩兀生物制药株式会社 | Pharmaceutical preparation |
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2017
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|---|---|---|---|---|
| KR20090107954A (en) * | 2008-04-10 | 2009-10-14 | 한올제약주식회사 | Pharmaceutical formulation |
| CN102316856A (en) * | 2009-02-27 | 2012-01-11 | 韩兀生物制药株式会社 | Pharmaceutical preparation |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112263567A (en) * | 2020-10-19 | 2021-01-26 | 南京易亨制药有限公司 | Ibuprofen sustained-release capsule and preparation method thereof |
| CN112263567B (en) * | 2020-10-19 | 2022-05-03 | 南京易亨制药有限公司 | Ibuprofen sustained-release capsule and preparation method thereof |
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