CN104490922B - A kind of oral tablet containing gliclazide and colesevelam hydrocholoride and preparation method thereof - Google Patents
A kind of oral tablet containing gliclazide and colesevelam hydrocholoride and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a kind of oral tablet containing gliclazide and colesevelam hydrocholoride and preparation method thereof, it includes release layer and slow release layer, and slow release layer is externally provided with one layer of coating；In parts by weight, the composition of release layer is：Colesevelam hydrocholoride, release layer filler, disintegrant, the composition of slow release layer is：Gliclazide, slow release layer filler, magnesium stearate, hydroxypropyl cellulose, PVP；The preparation method of the oral tablet is：A, preparation release layer, each composition of release layer is sieved, is well mixed, using direct powder compression, precompressed or first compression shaping；B, prepare slow release layer；C, tablet shaping, outside slow release layer wrap up one layer coating, then with release layer compression forming；Compared with prior art, the present invention can play the synergy of medicine, reach 1+1>2 effect, the metabolic syndrome for correcting diabetic, the high fat of blood for advantageously reducing diabetic is at a specified future date dangerous.
Description
Technical field
The present invention relates to field of medicaments, more particularly to a kind of oral tablet containing gliclazide and colesevelam hydrocholoride and its
Preparation method.
Background technology
Gliclazide biguanides can be by stimulating pancreatic β cell to increase the concentration of insulin, so as to reach hypoglycemic
Purpose.Colesevelam hydrocholoride is as a kind of non-absorbent polymer class fat-reducing medicament, and it can be combined simultaneously with the cholic acid in enteron aisle
The re-absorption of the latter is substantially reduced, and because the exhaustion of cholic acid can improve the balance that cholesterol is converted into cholic acid, therefore hydrochloric acid is examined
It can be used for reducing cholesterol concentration to tie up logical sequence, it can reduce the concentration 15%-18% of low density cholesterol (LDL-C), carry
The concentration 3% of high HDL (HDL-C).
Current medical field does not use still colesevelam hydrocholoride to be combined with gliclazide and prepares medicine, and drug regimen
Purpose be allow its play synergy, reach 1+1>2 effect, is the direction of pharmaceutical preparation development, is also being total to for the world of medicine
Same purpose.The medicine containing gliclazide and colesevelam hydrocholoride is taken respectively, although can respectively reach hypoglycemic and reducing blood lipid
Purpose, but do not play the synergy of two kinds of medicines, do not reach 1+1>2 effect.
The content of the invention
The purpose of the present invention be intended to overcome it is above-mentioned it is of the prior art it is not enough there is provided one kind it is convenient to take, can more preferably send out
Wave oral tablet containing gliclazide and colesevelam hydrocholoride of synergy of medicine and preparation method thereof.
To solve above-mentioned technical problem, the present invention uses following technical scheme：
A kind of oral tablet containing gliclazide and colesevelam hydrocholoride, it includes release layer and slow release layer, the sustained release
Layer is externally provided with one layer of coating；
In parts by weight, the constituent of described release layer is：
500-1000 parts of colesevelam hydrocholoride,
100-150 parts of release layer filler,
20-40 parts of disintegrant；
The constituent of described slow release layer is：
As a kind of preferred embodiment of the present invention, described release layer filler is selected from lactose, crystallite to be one or more
Cellulose, processing agar, mannitol, superfine silica gel powder, the pharmaceutic adjuvant of magnesium stearate；
As another preferred embodiment of the present invention, described disintegrant is that Ac-Di-Sol or carboxymethyl form sediment
Powder sodium and their compositions；
As another preferred embodiment of the present invention, described slow release layer filler for it is one or more selected from lactose, it is micro-
Crystalline cellulose, processing agar, mannitol, the pharmaceutic adjuvant of superfine silica gel powder；
As another preferred embodiment of the present invention, described hydroxypropyl cellulose is the serial hydroxypropyl methyl celluloses of K；
A kind of preparation method of oral tablet as described above, it the step of it is as follows：
A, preparation release layer
First colesevelam hydrocholoride, release layer filler and disintegrant are sieved respectively, obtained powder is then mixed equal
It is even, then using direct powder compression, precompressed or first compression shaping, that is, obtain release layer；
B, prepare slow release layer
PVP is first configured to the PVP aqueous solution, then respectively by gliclazide, slow release layer filler and hydroxypropyl
Cellulose is sieved, and obtained powder is well mixed, and is added the PVP aqueous solution as adhesive, is mixed equal to dry and wet
It is even, then pelletize, dry, then additional magnesium stearate is well mixed, then precompressed obtains slow release layer；
C, tablet shaping
Wrap up one layer outside the slow release layer that step B is obtained to be coated, the release layer compression forming then obtained with step A,
Obtain described oral tablet.
As a kind of preferred embodiment of the present invention, in step, colesevelam hydrocholoride is crossed into 100 mesh sieves, release layer is filled out
Fill agent and disintegrant crosses 80 mesh sieves.
As another preferred embodiment of the present invention, in stepb, by PVP be configured to mass fraction for 5% it is poly-
The ketone aqueous solution is tieed up, gliclazide is crossed into 100 mesh sieves, slow release layer filler and hydroxypropyl cellulose are crossed into 80 mesh sieves.
As another preferred embodiment of the present invention, in stepb, pelletized with 16-24 mesh sieves.
As another preferred embodiment of the present invention, in stepb, dry to moisture and be less than 5%, the percentage
For mass fraction.
The quality of gliclazide meets in the present invention《Chinese Pharmacopoeia》Version two in 2010, colesevelam hydrocholoride meets content
>=99.0%.
The release layer of oral tablet is disintegrated in 10 minutes in the present invention, and the stripping quantity of 30 minutes colesevelam hydrocholorides is no less than
90%；Slow release layer 1 hour, 3 hours with the gliclazide burst size of 10 hours mutually should be respectively labelled amount 20%-40%,
40%-65% and more than 75%.
Oral tablet in the present invention is divided into release layer and slow release layer, and wherein release layer uses direct powder compression, sustained release
Layer is first pelletized tabletting again, and in one layer of coating of slow release layer peripheral hardware, not only technique is prepared simple, it is easy to industrialized production,
And the oral tablet prepared can preferably control the insoluble drug release of release layer and slow release layer, the hydrochloric acid for first discharging release layer is examined
To tie up logical sequence, the low density cholesterol and triglycerides in reduction diabetic's body are played, and improve blood middle-high density lipoprotein
The effect of level, wait colesevelam hydrocholoride patient is worked after slow release slow release layer again gliclazide, so as to play this
The synergy of two kinds of medicines, preferably plays hypoglycemic effect, reaches 1+1>2 effect.
Disintegrant selected in the present invention has water insoluble (can be incompletely dissolved in water) and bibulous feature, water
Molecule is penetrated among tablet by capillarity or expansion, and powder expands and do not dissolved after water suction, does not form glue
Liquid solution, is unlikely to hinder the continuation of hydrone to penetrate into and influence the further disintegration of tablet.
Compared with prior art, the beneficial effects of the invention are as follows：
Oral tablet prepared by the present invention can preferably control the insoluble drug release of release layer and slow release layer, at utmost send out
The synergy of both medicines of colesevelam hydrocholoride Yu gliclazide is waved, 1+1 is reached>2 effect, is conducive to correcting diabetes
The metabolic syndrome of patient, the high fat of blood for advantageously reducing diabetic is at a specified future date dangerous.
Embodiment
In order to be able to preferably understand technical scheme, carried out in detail below by specific embodiment
Explanation：
Embodiment one
A kind of oral tablet containing gliclazide and colesevelam hydrocholoride, it includes release layer and slow release layer, the sustained release
Layer is externally provided with one layer of coating；
In parts by weight, the constituent of described release layer is：
500 parts of colesevelam hydrocholoride,
150 parts of release layer filler,
20 parts of disintegrant；
The constituent of described slow release layer is：
Wherein, release layer filler is the composition of 100 parts of microcrystalline celluloses, 30 parts of processing agar, 20 portions of mannitol；
Disintegrant is sodium carboxymethyl starch；
Slow release layer filler is the composition of 70 parts of microcrystalline celluloses, 30 portions of mannitol, 10 parts of superfine silica gel powders.
A kind of preparation method of oral tablet as described above, it the step of it is as follows：
A, preparation release layer
Colesevelam hydrocholoride is first crossed into 100 mesh sieves respectively, release layer filler and disintegrant are crossed into 80 mesh sieves, is then incited somebody to action
The powder arrived is well mixed, then using direct powder compression, precompressed or first compression shaping, that is, obtains release layer；
B, prepare slow release layer
PVP is first configured to the PVP aqueous solution that mass fraction is 5%, gliclazide is crossed into 100 mesh sieves, will be slow
Release layer filler and hydroxypropyl cellulose crosses 80 mesh sieves, and obtained powder is well mixed, add as the poly- of adhesive
The ketone aqueous solution is tieed up, mixes uniform to dry and wet, is then pelletized with 16 mesh sieves, dry to moisture and be less than 5% (mass fraction), then
Additional magnesium stearate is well mixed, and then precompressed obtains slow release layer；
C, tablet shaping
Wrap up one layer outside the slow release layer that step B is obtained to be coated, the release layer compression forming then obtained with step A,
Obtain described oral tablet.
Result of the test：Release layer disintegration time<10 minutes, 30 minutes colesevelam hydrocholoride stripping quantities were 94.6%；Sustained release
Layer gliclazide release 1 hour, 3 hours and 10 hours is respectively 29.8%, 49.7% and 80.4%.
Embodiment two
A kind of oral tablet containing gliclazide and colesevelam hydrocholoride, it includes release layer and slow release layer, the sustained release
Layer is externally provided with one layer of coating；
In parts by weight, the constituent of described release layer is：
1000 parts of colesevelam hydrocholoride,
100 parts of release layer filler,
40 parts of disintegrant；
The constituent of described slow release layer is：
Wherein, release layer filler is 40 parts of microcrystalline celluloses, 30 parts of processing agar, 15 parts of mannitol, 5 parts of micro mist silicon
Glue, 10 parts of magnesium stearates；
Disintegrant is the composition of 20 parts of Ac-Di-Sols and 20 parts of sodium carboxymethyl starches；
Slow release layer filler is 30 parts of microcrystalline celluloses.
A kind of preparation method of oral tablet as described above, it the step of it is as follows：
A, preparation release layer
Colesevelam hydrocholoride is first crossed into 100 mesh sieves respectively, release layer filler and disintegrant are crossed into 80 mesh sieves, is then incited somebody to action
The powder arrived is well mixed, then using direct powder compression, precompressed or first compression shaping, that is, obtains release layer；
B, prepare slow release layer
PVP is first configured to the PVP aqueous solution that mass fraction is 5%, gliclazide is crossed into 100 mesh sieves, will be slow
Release layer filler and hydroxypropyl cellulose crosses 80 mesh sieves, and obtained powder is well mixed, add as the poly- of adhesive
The ketone aqueous solution is tieed up, mixes uniform to dry and wet, is then pelletized with 20 mesh sieves, dry to moisture and be less than 5% (mass fraction), then
Additional magnesium stearate is well mixed, and then precompressed obtains slow release layer；
C, tablet shaping
Wrap up one layer outside the slow release layer that step B is obtained to be coated, the release layer compression forming then obtained with step A,
Obtain described oral tablet.
Result of the test：Release layer disintegration time<10 minutes, 30 minutes colesevelam hydrocholoride stripping quantities 92.1%；Slow release layer
Gliclazide release 1 hour, 3 hours and 10 hours is respectively 25.9%, 44.6% and 79.3%.
Embodiment three
A kind of oral tablet containing gliclazide and colesevelam hydrocholoride, it includes release layer and slow release layer, the sustained release
Layer is externally provided with one layer of coating；
In parts by weight, the constituent of described release layer is：
750 parts of colesevelam hydrocholoride,
125 parts of release layer filler,
30 parts of disintegrant；
The constituent of described slow release layer is：
Wherein, release layer filler is the composition of 70 parts of lactose, 30 parts of microcrystalline celluloses, 25 portions of mannitol；
Disintegrant is the composition of 10 parts of Ac-Di-Sols and 20 parts of sodium carboxymethyl starches；
Slow release layer filler is the composition of 20 parts of microcrystalline celluloses, 20 parts of processing agar, 15 portions of mannitol.
A kind of preparation method of oral tablet as described above, it the step of it is as follows：
A, preparation release layer
Colesevelam hydrocholoride is first crossed into 100 mesh sieves respectively, release layer filler and disintegrant are crossed into 80 mesh sieves, is then incited somebody to action
The powder arrived is well mixed, then using direct powder compression, precompressed or first compression shaping, that is, obtains release layer；
B, prepare slow release layer
PVP is first configured to the PVP aqueous solution that mass fraction is 5%, gliclazide is crossed into 100 mesh sieves, will be slow
Release layer filler and hydroxypropyl cellulose crosses 80 mesh sieves, and obtained powder is well mixed, add as the poly- of adhesive
The ketone aqueous solution is tieed up, mixes uniform to dry and wet, is then pelletized with 24 mesh sieves, dry to moisture and be less than 5% (mass fraction), then
Additional magnesium stearate is well mixed, and then precompressed obtains slow release layer；
C, tablet shaping
Wrap up one layer outside the slow release layer that step B is obtained to be coated, the release layer compression forming then obtained with step A,
Obtain described oral tablet.
Result of the test：Release layer disintegration time<10 minutes, 30 minutes colesevelam hydrocholoride stripping quantities were 95.3%；Sustained release
Layer gliclazide release 1 hour, 3 hours and 10 hours is respectively 30.1%, 52.7% and 95.8%.
Example IV
A kind of oral tablet containing gliclazide and colesevelam hydrocholoride, it includes release layer and slow release layer, the sustained release
Layer is externally provided with one layer of coating；
In parts by weight, the constituent of described release layer is：
625 parts of colesevelam hydrocholoride,
105 parts of release layer filler,
30 parts of disintegrant；
The constituent of described slow release layer is：
Wherein, release layer filler is the composition of 100 parts of lactose, 5 parts of magnesium stearates, and lactose can use vertical compression lactose
Or lactose monohydrate；
Disintegrant is the composition of 20 parts of Ac-Di-Sols, 10 parts of sodium carboxymethyl starches；
Slow release layer filler is lactose；
Hydroxypropyl cellulose is preferably the serial hydroxypropyl methyl celluloses of K.
A kind of preparation method of oral tablet as described above, it the step of it is as follows：
A, preparation release layer
Colesevelam hydrocholoride is first crossed into 100 mesh sieves respectively, release layer filler and disintegrant are crossed into 80 mesh sieves, is then incited somebody to action
The powder arrived is well mixed, then using direct powder compression, precompressed or first compression shaping, that is, obtains release layer；
B, prepare slow release layer
PVP is first configured to the PVP aqueous solution that mass fraction is 5%, gliclazide is crossed into 100 mesh sieves, will be slow
Release layer filler and hydroxypropyl cellulose crosses 80 mesh sieves, and obtained powder is well mixed, add as the poly- of adhesive
The ketone aqueous solution is tieed up, mixes uniform to dry and wet, is then pelletized with 16 mesh sieves, dry to moisture and be less than 5% (mass fraction), then
Additional magnesium stearate is well mixed, and then precompressed obtains slow release layer；
C, tablet shaping
Wrap up one layer outside the slow release layer that step B is obtained to be coated, the release layer compression forming then obtained with step A,
Obtain described oral tablet.
Result of the test：Release layer disintegration time<5 minutes, 30 minutes colesevelam hydrocholoride stripping quantities were 97.7%；Slow release layer
Gliclazide release 1 hour, 3 hours and 10 hours is respectively 31.3%, 58.6%, 88.7%.
Embodiment five
A kind of oral tablet containing gliclazide and colesevelam hydrocholoride, it includes release layer and slow release layer, the sustained release
Layer is externally provided with one layer of coating；
In parts by weight, the constituent of described release layer is：
625 parts of colesevelam hydrocholoride,
125 parts of release layer filler,
20 parts of disintegrant；
The constituent of described slow release layer is：
Wherein, release layer filler is the composition of 100 parts of vertical compression lactose, 20 parts of processing agar, 5 parts of magnesium stearates；
Disintegrant is 20 parts of cross-linked carboxymethyl celluloses；
Hydroxypropyl cellulose is preferably the serial hydroxypropyl methyl celluloses of K.
A kind of preparation method of oral tablet as described above, it the step of it is as follows：
A, preparation release layer
Colesevelam hydrocholoride is first crossed into 100 mesh sieves respectively, release layer filler and disintegrant are crossed into 80 mesh sieves, is then incited somebody to action
The powder arrived is well mixed, then using direct powder compression, precompressed or first compression shaping, that is, obtains release layer；
B, prepare slow release layer
PVP is first configured to the PVP aqueous solution that mass fraction is 5%, gliclazide is crossed into 100 mesh sieves, will be slow
Release layer filler and hydroxypropyl cellulose crosses 80 mesh sieves, and obtained powder is well mixed, add as the poly- of adhesive
The ketone aqueous solution is tieed up, mixes uniform to dry and wet, is then pelletized with 24 mesh sieves, dry to moisture and be less than 5% (mass fraction), then
Additional magnesium stearate is well mixed, and then precompressed obtains slow release layer；
C, tablet shaping
Wrap up one layer outside the slow release layer that step B is obtained to be coated, the release layer compression forming then obtained with step A,
Obtain described oral tablet.
Result of the test：Release layer disintegration time<5 minutes, 30 minutes colesevelam hydrocholoride stripping quantities 96.2%；Slow release layer lattice
Lie Qite releases 1 hour, 3 hours and 10 hours are respectively 31.2%, 59.1%, 98.6%.
Although reference be made herein to invention has been described for explanatory embodiment of the invention, and above-described embodiment is only this hair
Bright preferably embodiment, embodiments of the present invention are simultaneously not restricted to the described embodiments, it should be appreciated that people in the art
Member can be designed that a lot of other modification and embodiment, and that is made within the spirit and principles of the invention any repaiies
Change, equivalent substitution and improvement etc., should be included in the scope of the protection.
Claims (9)
1. a kind of oral tablet containing gliclazide and colesevelam hydrocholoride, it is characterised in that it includes release layer and slow release layer,
The slow release layer is externally provided with one layer of coating；
In parts by weight, the constituent of described release layer is：
500-1000 parts of colesevelam hydrocholoride,
100-150 parts of release layer filler,
20-40 parts of disintegrant；
The constituent of described slow release layer is：
2. oral tablet according to claim 1, it is characterised in that described release layer filler selects to be one or more
From lactose, microcrystalline cellulose, the pharmaceutic adjuvant for handling agar, mannitol, superfine silica gel powder, magnesium stearate.
3. oral tablet according to claim 1, it is characterised in that described disintegrant is Ac-Di-Sol
Or sodium carboxymethyl starch and their compositions.
4. oral tablet according to claim 1, it is characterised in that described slow release layer filler selects to be one or more
From lactose, microcrystalline cellulose, the pharmaceutic adjuvant for handling agar, mannitol, superfine silica gel powder.
5. a kind of preparation method of oral tablet as any one of claim 1-4, it is characterised in that it the step of such as
Under：
A, preparation release layer
First colesevelam hydrocholoride, release layer filler and disintegrant are sieved respectively, then obtained powder is well mixed, then
Using direct powder compression, precompressed or first compression shaping obtain release layer；
B, prepare slow release layer
PVP is first configured to the PVP aqueous solution, then respectively by the serial hydroxypropyl of gliclazide, slow release layer filler and K
Methylcellulose is sieved, and obtained powder is well mixed, and adds the PVP aqueous solution as adhesive, is mixed to dry
It is wet uniform, then pelletize, dry, then additional magnesium stearate is well mixed, then precompressed obtains slow release layer；
C, tablet shaping
One layer of coating is wrapped up outside the slow release layer that step B is obtained, the release layer compression forming then obtained with step A is produced
To described oral tablet.
6. preparation method according to claim 5, it is characterised in that in step, 100 mesh are crossed by colesevelam hydrocholoride
Sieve, 80 mesh sieves are crossed by release layer filler and disintegrant.
7. preparation method according to claim 5, it is characterised in that in stepb, mass fraction is configured to by PVP
For the 5% PVP aqueous solution, gliclazide is crossed into 100 mesh sieves, by slow release layer filler and the serial hydroxypropyl methyl celluloses of K
Cross 80 mesh sieves.
8. preparation method according to claim 5, it is characterised in that in stepb, is pelletized with 16-24 mesh sieves.
9. preparation method according to claim 5, it is characterised in that in stepb, dries to moisture and is less than 5%,
The percentage is mass fraction.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410848512.3A CN104490922B (en) | 2014-12-29 | 2014-12-29 | A kind of oral tablet containing gliclazide and colesevelam hydrocholoride and preparation method thereof |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1729005A (en) * | 2002-11-15 | 2006-02-01 | 兰贝克赛实验室有限公司 | Pharmaceutical dosage forms of biguanide-sulfonylurea combinations |
| CN103285398A (en) * | 2013-06-28 | 2013-09-11 | 青岛黄海制药有限责任公司 | Compound preparation containing DPP-IV (dipeptidyl peptidase-IV) inhibitor and type-II diabetes medicine and preparation method thereof |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20070025953A1 (en) * | 2005-07-27 | 2007-02-01 | Jones Michael R | Co-therapy for diabetic conditions |
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2014
- 2014-12-29 CN CN201410848512.3A patent/CN104490922B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1729005A (en) * | 2002-11-15 | 2006-02-01 | 兰贝克赛实验室有限公司 | Pharmaceutical dosage forms of biguanide-sulfonylurea combinations |
| CN103285398A (en) * | 2013-06-28 | 2013-09-11 | 青岛黄海制药有限责任公司 | Compound preparation containing DPP-IV (dipeptidyl peptidase-IV) inhibitor and type-II diabetes medicine and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| BAS作为降糖药——降糖机制、临床疗效及应用前景;洪珊珊等;《中国糖尿病杂志》;20120331;第20卷(第3期);第235-238页 * |
| Colesevelam HCl Improves Glycemic Control and Reduces LDL Cholesterol in Patients With Inadequately Controlled Type 2 Diabetes on Sulfonylurea-Based Therapy;VIVIAN A. FONSECA等;《DIABETES CARE》;20080831;第31卷(第8期);第1479-1484页 * |
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