CN101554381A - Candesartan cilexetil hydrochlorothiazide double-layer tablets and preparation mehtod thereof - Google Patents
Candesartan cilexetil hydrochlorothiazide double-layer tablets and preparation mehtod thereof Download PDFInfo
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- CN101554381A CN101554381A CNA2009100154155A CN200910015415A CN101554381A CN 101554381 A CN101554381 A CN 101554381A CN A2009100154155 A CNA2009100154155 A CN A2009100154155A CN 200910015415 A CN200910015415 A CN 200910015415A CN 101554381 A CN101554381 A CN 101554381A
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Abstract
The invention discloses candesartan cilexetil hydrochlorothiazide double-layer tablets, belonging to the technical field of western medicines. The candesartan cilexetil hydrochlorothiazide double-layer tablets comprise slowly-releasing parts and fast-releasing parts. In each tablet, the slowly-releasing part comprises 16 or 32 mg of candesartan cilexetil, 30-100 mg of slowly-releasing framework material, 50-200 mg of loading agent, 30-70 mg of binder, 1-10 mg of lubricant and 1-10 mg of glidant, and the fast-releasing part comprises 12.5 mg of hydrochlorothiazide, 30-150 mg of loading agent, 30-60 mg of binder, 1-10 mg of disintegrant 1-10 mg of lubricant and 1-10 mg of glidant. The slowly-releasing parts are prepared first and the fast-releasing parts are prepared; and the grains of the two types undergo secondary tabletting so as to form the double-layer tablets. The double-layer tablets both speed up and prong the pharmaceutical effect, cause the depressurization effect to be more stable and effective and meanwhile reduce the side effect of the medicine.
Description
Technical field
The present invention relates to a kind of double-layer tablet that comprises candesartan Cilexetil and hydrochlorothiazide, particularly a kind of double-layer tablet that comprises candesartan Cilexetil slow-released part and hydrochlorothiazide immediate release section and preparation method thereof belongs to technical field of western medicines.
Background technology
Candesartan Cilexetil is a kind of orally active antihypertensive drug.It is by blocking the vasoconstrictive and the aldosterone secretory action of Angiotensin II mediation specifically, and makes blood pressure drops.Hydrochlorothiazide is a thiazide diuretic.It directly increases the secretion of sodium ion and chloride ion by influencing renal tubules to electrolytical heavy absorption, and the urine amount is increased, and blood volume reduces.Simultaneously, hydrochlorothiazide reduces plasma volume by its diuresis, and plasma renin activity is increased, and the aldosterone secretion increases, and urine potassium is discharged and increased, and blood potassium is reduced.The effect of feritin-aldosterone system is by Angiotensin II mediation, and therefore, hydrochlorothiazide share the angiotensin ii receptor antagonist candesartan Cilexetil, can strengthen drug effect and reverse mistake potassium effect due to the hydrochlorothiazide.
The tablet of common candesartan cilexetil/hydrochlorothiazide (16mg/12.5mg) compound recipe of developing of military field of Japan and AstraZeneca company, commodity are called AtacandHCT, obtain the approval of FDA in JIUYUE in 2000 on the 5th, can be used as the hypertensive two wires of treatment medicine.AtacandHCT is with the specification listing of two kinds of fixed dosage compatibilities; 32mg candesartan Cilexetil and 12.5mg hydrochlorothiazide and 16mg candesartan Cilexetil and 12.5mg hydrochlorothiazide.This compound preparation has also obtained European Union's approval and has been used for hypertensive treatment.Multinomial clinical trial shows that candesartan Cilexetil-hydrochlorothiazide compound preparation side effect is little, and safety and better tolerance are the hypertensive desirable line medications of treatment.
The candesartan Cilexetil that uses clinically and the compound preparation of hydrochlorothiazide are tablet and capsule at present, aspect drug release, belong to ordinary preparation, therefore we are according to the needs of hypertension clinical treatment, and the research antihypertensive effect is more steadily effective, the lower medicine of side effect, helps clinical use.
Summary of the invention
The purpose of this invention is to provide the candesartan Cilexetil hydrochlorothiazide double-layer tablets, this kind double-layer tablet had both been accelerated the onset speed of medicine, had prolonged the action effect of medicine again, made antihypertensive effect more steadily, effectively, reduced side effects of pharmaceutical drugs simultaneously.
Another object of the present invention provides the preparation method of candesartan Cilexetil hydrochlorothiazide double-layer tablets.
The technical scheme that the present invention takes is:
The candesartan Cilexetil hydrochlorothiazide double-layer tablets, it is characterized in that comprising slow-released part and immediate release section, in every, the composition of slow-released part is candesartan Cilexetil 16 or 32mg, sustained-release matrix material 30～100mg, filler 50～200mg, binding agent 30～70mg, lubricant 1～10mg, fluidizer 1～10mg, and the composition of immediate release section is hydrochlorothiazide 12.5mg, filler 30～150mg, binding agent 30～60mg, disintegrating agent 1～10mg, lubricant 1～10mg, fluidizer 1～10mg.
Described candesartan Cilexetil hydrochlorothiazide double-layer tablets, wherein said sustained-release matrix material is a hydroxypropyl methylcellulose; Described disintegrating agent be in cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, the carboxymethyl starch sodium any one or multiple; Filler in described slow-released part and the immediate release section be in lactose, mannitol, microcrystalline Cellulose, hydroxypropyl cellulose, the starch any one or multiple; Binding agent in described slow-released part and the immediate release section is any one the solution in polyvinylpyrrolidone, starch, hydroxypropyl emthylcellulose, the methylcellulose; Lubricant in described slow-released part and the immediate release section be in micropowder silica gel, magnesium stearate, the Pulvis Talci any one or multiple; Fluidizer in described slow-released part and the immediate release section be in micropowder silica gel, magnesium stearate, the Pulvis Talci any one or multiple.
Described candesartan Cilexetil hydrochlorothiazide double-layer tablets, in preferred every, the composition of slow-released part is candesartan Cilexetil 16 or 32mg, hydroxypropyl methylcellulose 30～100mg, lactose 90～150mg, microcrystalline Cellulose 30～50mg, magnesium stearate 0.7mg, mass concentration is alcoholic solution 50～70mg of 10% polyvinylpyrrolidone K30, and the composition of immediate release section is hydrochlorothiazide 12.5mg, lactose 10～30mg, microcrystalline Cellulose 40～60mg, hydroxypropyl cellulose 30～50mg, cross-linking sodium carboxymethyl cellulose 1～3mg, magnesium stearate 0.5mg, mass concentration is the alcoholic solution 40～60mg of 10% polyvinylpyrrolidone.
The preparation method of described candesartan Cilexetil hydrochlorothiazide double-layer tablets may further comprise the steps:
(a) preparation of slow-released part: take by weighing candesartan Cilexetil, sustained-release matrix material and filler, mix homogeneously adds binding agent and makes soft material in right amount, 18～24 mesh sieves are granulated, in 40～60 ℃ of dryings, 16～24 mesh sieve granulate add lubricant and fluidizer mix homogeneously behind the granulate with the wet granular that makes;
(b) preparation of immediate release section: take by weighing hydrochlorothiazide, filler, mix homogeneously adds binding agent and makes soft material in right amount, 18～24 mesh sieves are granulated, in 40～60 ℃ of dryings, 16～24 mesh sieve granulate add disintegrating agent, lubricant and fluidizer and mix homogeneously behind the granulate with the wet granular that makes;
(c) by bi-layer tablet press two kinds of granules that (a) and (b) make are prepared into double-layer tablet through the secondary tabletting.
Candesartan Cilexetil hydrochlorothiazide double-layer tablets of the present invention is compared with existing ordinary tablet has following benefit:
1. candesartan Cilexetil slow-released part of the present invention has the effect that delays drug release, makes antihypertensive effect more steady, and drug effect is more lasting, compares with capsule with common candesartan cilexetil, reduces side effects of pharmaceutical drugs.
2. hydrochlorothiazide immediate release section of the present invention has disperses soon, and stripping is fast, in vivo the characteristics of quick acting.
3. two kinds of medicines are made compound preparation, in the blood pressure lowering treatment, have synergism, increase curative effect.
The specific embodiment
By following concrete embodiment, can further understand the present invention, but following example not a limitation of the invention.
Embodiment 1
The slow-released part prescription:
Candesartan Cilexetil 16g
Hydroxypropyl methylcellulose 30g
Lactose 90g
Microcrystalline Cellulose 30g
The alcoholic solution 50mg of 10% (w/w) polyvinylpyrrolidone K30
Magnesium stearate 0.7g
The immediate release section prescription:
Hydrochlorothiazide 12.5g
Microcrystalline Cellulose 40g
Hydroxypropyl cellulose 30g
Lactose 10g
The alcoholic solution 40mg of 10% (w/w) polyvinylpyrrolidone K30
Cross-linking sodium carboxymethyl cellulose 3g
Magnesium stearate 0.5g
Preparation method:
(a) preparation of slow-released part: take by weighing candesartan Cilexetil, hydroxypropyl methylcellulose, lactose, microcrystalline Cellulose, mix homogeneously, the alcoholic solution that adds mass concentration and be 10% polyvinylpyrrolidone K30 is made soft material in right amount, 18～24 mesh sieves are granulated, the wet granular that obtains is dry down in 60 ℃, 16～24 mesh sieve granulate add the magnesium stearate mix homogeneously behind the granulate;
(b) preparation of immediate release section; Take by weighing hydrochlorothiazide, microcrystalline Cellulose, hydroxypropyl cellulose, lactose, mix homogeneously, the alcoholic solution that adds mass concentration and be 10% polyvinylpyrrolidone K30 is made soft material in right amount, 18～24 mesh sieves are granulated, the wet granular that obtains is dry down in 60 ℃, 16～24 mesh sieve granulate add cross-linking sodium carboxymethyl cellulose, magnesium stearate, mix homogeneously behind the granulate;
(c) by bi-layer tablet press two kinds of granules that (a) and (b) make are prepared into double-layer tablet through the secondary tabletting.
Embodiment 2
The slow-released part prescription:
Candesartan Cilexetil 16g
Hydroxypropyl methylcellulose 40g
Lactose 120g
Microcrystalline Cellulose 40g
The alcoholic solution 60mg of 10% (w/w) polyvinylpyrrolidone K30
Magnesium stearate 0.7g
The immediate release section prescription:
Hydrochlorothiazide 12.5g
Microcrystalline Cellulose 50g
Hydroxypropyl cellulose 40g
Lactose 20g
The alcoholic solution 50mg of 10% (w/w) polyvinylpyrrolidone K30
Cross-linking sodium carboxymethyl cellulose 3g
Magnesium stearate 0.5g
Preparation method is with embodiment 1.
Embodiment 3
The slow-released part prescription:
Candesartan Cilexetil 16g
Hydroxypropyl methylcellulose 50g
Lactose 150g
Microcrystalline Cellulose 50g
The alcoholic solution 70mg of 10% (w/w) polyvinylpyrrolidone K30
Magnesium stearate 0.7g
The immediate release section prescription:
Hydrochlorothiazide 12.5g
Microcrystalline Cellulose 60g
Hydroxypropyl cellulose 50g
Lactose 30g
The alcoholic solution 60mg of 10% (w/w) polyvinylpyrrolidone K30
Cross-linking sodium carboxymethyl cellulose 3g
Magnesium stearate 0.5g
Preparation method is with embodiment 1.
Embodiment 4
The slow-released part prescription:
Candesartan Cilexetil 32g
Hydroxypropyl methylcellulose 30g
Lactose 90g
Microcrystalline Cellulose 30g
The alcoholic solution 50mg of 10% (w/w) polyvinylpyrrolidone K30
Magnesium stearate 0.7g
The immediate release section prescription:
Hydrochlorothiazide 12.5g
Microcrystalline Cellulose 40g
Hydroxypropyl cellulose 30g
Lactose 10g
The alcoholic solution 40mg of 10% (w/w) polyvinylpyrrolidone K30
Cross-linking sodium carboxymethyl cellulose 3g
Magnesium stearate 0.5g
Preparation method is with embodiment 1.
Embodiment 5
The slow-released part prescription:
Candesartan Cilexetil 32g
Hydroxypropyl methylcellulose 40g
Lactose 120g
Microcrystalline Cellulose 40g
The alcoholic solution 60mg of 10% (w/w) polyvinylpyrrolidone K30
Magnesium stearate 0.7g
The immediate release section prescription:
Hydrochlorothiazide 12.5g
Microcrystalline Cellulose 50g
Hydroxypropyl cellulose 40g
Lactose 20g
The alcoholic solution 50mg of 10% (w/w) polyvinylpyrrolidone K30
Cross-linking sodium carboxymethyl cellulose 3g
Magnesium stearate 0.5g
Preparation method is with embodiment 1.
Embodiment 6
The slow-released part prescription:
Candesartan Cilexetil 32g
Hydroxypropyl methylcellulose 50g
Lactose 150g
Microcrystalline Cellulose 50g
The alcoholic solution 70mg of 10% (w/w) polyvinylpyrrolidone K30
Magnesium stearate 0.7g
The immediate release section prescription:
Hydrochlorothiazide 12.5g
Microcrystalline Cellulose 60g
Hydroxypropyl cellulose 50g
Lactose 30g
The alcoholic solution 60mg of 10% (w/w) polyvinylpyrrolidone K30
Cross-linking sodium carboxymethyl cellulose 3g
Magnesium stearate 0.5g
Preparation method is with embodiment 1.
Embodiment 7
The slow-released part prescription:
Candesartan Cilexetil 16g
Hydroxypropyl methylcellulose 30g
Lactose 90g
The alcoholic solution 50mg of 10% (w/w) polyvinylpyrrolidone K30
Pulvis Talci 1g
The immediate release section prescription:
Hydrochlorothiazide 12.5g
Microcrystalline Cellulose 40g
Hydroxypropyl cellulose 30g
Lactose 10g
The alcoholic solution 40mg of 10% (w/w) polyvinylpyrrolidone K30
Crospolyvinylpyrrolidone 3g
Magnesium stearate 1g
Preparation method:
(a) preparation of slow-released part: take by weighing candesartan Cilexetil, hydroxypropyl methylcellulose, lactose, mix homogeneously, the alcoholic solution that adds mass concentration 10% polyvinylpyrrolidone K30 is made soft material in right amount, 18～24 mesh sieves are granulated, the wet granular that obtains is dry down in 40 ℃, 16～24 mesh sieve granulate add Talcum arogel mix homogeneously behind the granulate;
(b) preparation of immediate release section: take by weighing hydrochlorothiazide, microcrystalline Cellulose, hydroxypropyl cellulose, lactose, mix homogeneously, the alcoholic solution that adds mass concentration 10% polyvinylpyrrolidone K30 is made soft material in right amount, 18～24 mesh sieves are granulated, the wet granular that obtains is dry down in 40 ℃, 16～24 mesh sieve granulate add crospolyvinylpyrrolidone, magnesium stearate, mix homogeneously behind the granulate;
(c) by bi-layer tablet press two kinds of granules that (a) and (b) make are prepared into double-layer tablet through the secondary tabletting.
Embodiment 8
The slow-released part prescription:
Candesartan Cilexetil 32g
Hydroxypropyl methylcellulose 100g
Lactose 90g
Mass concentration is 10% starch slurry 50mg
Pulvis Talci 2g
The immediate release section prescription:
Hydrochlorothiazide 12.5g
Microcrystalline Cellulose 40g
Hydroxypropyl cellulose 30g
Lactose 10g
Mass concentration is 10% starch slurry 40mg
Crospolyvinylpyrrolidone 3g
Magnesium stearate 1g
Preparation method:
(a) preparation of slow-released part: take by weighing candesartan Cilexetil, hydroxypropyl methylcellulose, lactose, mix homogeneously adds mass concentration and is 10% starch slurry and makes soft material in right amount, and 18～24 mesh sieves are granulated; The wet granular that obtains is dry under 60 ℃, and 16～24 mesh sieve granulate add Talcum arogel mix homogeneously behind the granulate;
(b) preparation of immediate release section: take by weighing hydrochlorothiazide, microcrystalline Cellulose, hydroxypropyl cellulose, lactose, mix homogeneously, add mass concentration and be 10% starch slurry and make soft material in right amount, 18～24 mesh sieves are granulated, the wet granular that obtains is dry down in 60 ℃, 16～24 mesh sieve granulate add crospolyvinylpyrrolidone, magnesium stearate, mix homogeneously behind the granulate;
(c) by bi-layer tablet press two kinds of granules that (a) and (b) make are prepared into double-layer tablet through the secondary tabletting.
Embodiment 9
The slow-released part prescription:
Candesartan Cilexetil 32g
Hydroxypropyl methylcellulose 50g
Lactose 90g
Mannitol 10g
The aqueous solution 50mg of mass concentration 10% methylcellulose
Pulvis Talci 1g
Micropowder silica gel 1g
The immediate release section prescription:
Hydrochlorothiazide 12.5g
Hydroxypropyl cellulose 50g
Lactose 10g
The aqueous solution 40mg of mass concentration 10% methylcellulose
Carboxymethyl starch sodium 3g
Magnesium stearate 1g
Preparation method:
(a) preparation of slow-released part: take by weighing candesartan Cilexetil, hydroxypropyl methylcellulose, lactose, mannitol, mix homogeneously, the aqueous solution that adds mass concentration 10% methylcellulose is made soft material in right amount, 18～24 mesh sieves are granulated, the wet granular that obtains is dry down in 50 ℃, 16～24 mesh sieve granulate add Pulvis Talci, micropowder silica gel mix homogeneously behind the granulate;
(b) preparation of immediate release section: take by weighing hydrochlorothiazide, hydroxypropyl cellulose, lactose, mix homogeneously, the aqueous solution that adds mass concentration 10% methylcellulose is made soft material in right amount, 18～24 mesh sieves are granulated, wet granular is dry down in 50 ℃, 16～24 mesh sieve granulate add carboxymethyl starch sodium, magnesium stearate, mix homogeneously behind the granulate;
(c) by bi-layer tablet press two kinds of granules that (a) and (b) make are prepared into double-layer tablet through the secondary tabletting.
Claims (4)
1, candesartan Cilexetil hydrochlorothiazide double-layer tablets, it is characterized in that comprising slow-released part and immediate release section, in every, the composition of slow-released part is candesartan Cilexetil 16 or 32mg, sustained-release matrix material 30～100mg, filler 50～200mg, binding agent 30～70mg, lubricant 1～10mg, fluidizer 1～10mg, and the composition of immediate release section is hydrochlorothiazide 12.5mg, filler 30～150mg, binding agent 30～60mg, disintegrating agent 1～10mg, lubricant 1～10mg, fluidizer 1～10mg.
According to the described candesartan Cilexetil hydrochlorothiazide double-layer tablets of claim 1, it is characterized in that 2, described sustained-release matrix material is a hydroxypropyl methylcellulose; Described disintegrating agent be in cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, the carboxymethyl starch sodium any one or multiple; Filler in described slow-released part and the immediate release section be in lactose, mannitol, microcrystalline Cellulose, hydroxypropyl cellulose, the starch any one or multiple; Binding agent in described slow-released part and the immediate release section is any one the solution in polyvinylpyrrolidone, starch, hydroxypropyl emthylcellulose, the methylcellulose; Lubricant in described slow-released part and the immediate release section be in micropowder silica gel, magnesium stearate, the Pulvis Talci any one or multiple; Fluidizer in described slow-released part and the immediate release section be in micropowder silica gel, magnesium stearate, the Pulvis Talci any one or multiple.
3, according to the described candesartan Cilexetil hydrochlorothiazide double-layer tablets of claim 1, it is characterized in that, in every, the composition of slow-released part is candesartan Cilexetil 16 or 32mg, hydroxypropyl methylcellulose 30～100mg, lactose 90～150mg, microcrystalline Cellulose 30～50mg, magnesium stearate 0.7mg, mass concentration is alcoholic solution 50～70mg of 10% polyvinylpyrrolidone K30, and the composition of immediate release section is hydrochlorothiazide 12.5mg, lactose 10～30mg, microcrystalline Cellulose 40～60mg, hydroxypropyl cellulose 30～50mg, cross-linking sodium carboxymethyl cellulose 1～3mg, magnesium stearate 0.5mg, mass concentration is the alcoholic solution 40～60mg of 10% polyvinylpyrrolidone.
4, according to the preparation method of the described candesartan Cilexetil hydrochlorothiazide double-layer tablets of claim 1, it is characterized in that, may further comprise the steps:
(a) preparation of slow-released part: take by weighing candesartan Cilexetil, sustained-release matrix material and filler, mix homogeneously adds binding agent and makes soft material in right amount, 18～24 mesh sieves are granulated, in 40～60 ℃ of dryings, 16～24 mesh sieve granulate add lubricant and fluidizer mix homogeneously behind the granulate with the wet granular that makes;
(b) preparation of immediate release section: take by weighing hydrochlorothiazide, filler, mix homogeneously adds binding agent and makes soft material in right amount, 18～24 mesh sieves are granulated, in 40～60 ℃ of dryings, 16～24 mesh sieve granulate add disintegrating agent, lubricant and fluidizer and mix homogeneously behind the granulate with the wet granular that makes;
(c) by bi-layer tablet press two kinds of granules that (a) and (b) make are prepared into double-layer tablet through the secondary tabletting.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2009100154155A CN101554381A (en) | 2009-05-18 | 2009-05-18 | Candesartan cilexetil hydrochlorothiazide double-layer tablets and preparation mehtod thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2009100154155A CN101554381A (en) | 2009-05-18 | 2009-05-18 | Candesartan cilexetil hydrochlorothiazide double-layer tablets and preparation mehtod thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102319250A (en) * | 2011-07-20 | 2012-01-18 | 南京正大天晴制药有限公司 | Irbesartan and hydrochlorothiazide medicinal composition and preparation method thereof |
| CN102743361A (en) * | 2012-07-31 | 2012-10-24 | 南京正科制药有限公司 | Irbesartan hydrochlorothiazide capsule |
| CN104306380A (en) * | 2014-09-18 | 2015-01-28 | 新疆特丰药业股份有限公司 | Conjugated estrogen and medroxyprogesterone dual-layer tablet and preparation method thereof |
| CN105142596A (en) * | 2013-03-14 | 2015-12-09 | 三合一牙科事务所 | Compositions for treatment of xerostomia and for tooth treatment |
-
2009
- 2009-05-18 CN CNA2009100154155A patent/CN101554381A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102319250A (en) * | 2011-07-20 | 2012-01-18 | 南京正大天晴制药有限公司 | Irbesartan and hydrochlorothiazide medicinal composition and preparation method thereof |
| CN102743361A (en) * | 2012-07-31 | 2012-10-24 | 南京正科制药有限公司 | Irbesartan hydrochlorothiazide capsule |
| CN105142596A (en) * | 2013-03-14 | 2015-12-09 | 三合一牙科事务所 | Compositions for treatment of xerostomia and for tooth treatment |
| US9968547B2 (en) | 2013-03-14 | 2018-05-15 | 3 In 1 Dental Pllc | Compositions for treatment of xerostomia and for tooth treatment |
| US10413503B2 (en) | 2013-03-14 | 2019-09-17 | 3 In 1 Dental Pllc | Compositions for treatment of xerostomia and for tooth treatment |
| CN105142596B (en) * | 2013-03-14 | 2020-12-18 | 三合一牙科事务所 | Composition for treating xerostomia and for dental treatment |
| CN104306380A (en) * | 2014-09-18 | 2015-01-28 | 新疆特丰药业股份有限公司 | Conjugated estrogen and medroxyprogesterone dual-layer tablet and preparation method thereof |
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