CN107019679A - A kind of eplerenone tablet and preparation method thereof - Google Patents
A kind of eplerenone tablet and preparation method thereof Download PDFInfo
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- CN107019679A CN107019679A CN201710186546.4A CN201710186546A CN107019679A CN 107019679 A CN107019679 A CN 107019679A CN 201710186546 A CN201710186546 A CN 201710186546A CN 107019679 A CN107019679 A CN 107019679A
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- Prior art keywords
- eplerenone
- filler
- disintegrant
- tablet
- sodium
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
- A61K31/585—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin containing lactone rings, e.g. oxandrolone, bufalin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Preparation (AREA)
Abstract
Present disclose provides a kind of eplerenone tablet and preparation method thereof, belong to field of pharmaceutical preparations.The eplerenone tablet includes label and coating, and label includes following component according to percentage by weight：Eplerenone 10% 30%, filler 15% 80%, disintegrant 1% 20%, surfactant 0.1% 5%, lubricant 0.1% 8%, appropriate adhesive.The eplerenone tablet while surfactant, which is used in combination, makes insoluble drug eplerenone dissolution, and then increases the solubility of eplerenone, improves its bioavilability by using potent disintegrant in rational proportion.And the eplerenone tablet quality is controllable, has good stability, preparation technology is simple, it is not necessary to special installation, it is adapted to industrialized production.
Description
Technical field
The present invention relates to a kind of pharmaceutical dosage form, specifically a kind of eplerenone tablet belongs to field of pharmaceutical preparations.
Background technology
Eplerenone（Eplerenone,I）It is short of money by the selective aldosterone of a new generation of Pfizer/Pharmacia Corp's exploitation
Anti-agent, the hyperpietic for treating 1 phase and 2 phases, efficient and reduction systolic pressure and the amplitude and enalapril of diastolic pressure
It is similar.The original of not good low renin level is acted on angiotensin converting enzyme inhibitor and angiotensin-ii-receptor depressant
Essential hypertension patient, eplerenone also has good antihypertensive effect.
The content of the invention
The eplerenone tablet of the disclosure, including label and coating, are using eplerenone as active drug composition, with pharmacy
Acceptable auxiliary element is collectively constituted, it is characterised in that the label is according to weight, and specific composition is such as
Under：
Eplerenone 10%-30%
Filler 15%-80%
Disintegrant 1%-20%
Surfactant 0.1%-5%
Lubricant 0.1%-8%
Appropriate adhesive.
The filler in mannitol, lactose, microcrystalline cellulose, pregelatinized starch or dextrin it is a kind of, two kinds or
More than two kinds of composition.
The disintegrant is selected from sodium carboxymethylcellulose, Ac-Di-Sol, carboxyrnethyl starch sodium, crosslinking carboxylic first and formed sediment
One kind, two or more composition in powder sodium, PVPP or low-substituted hydroxypropyl cellulose.
One or more of compositions of the surfactant in lauryl sodium sulfate, tween or sapn.
The lubricant is one or more of in superfine silica gel powder, talcum powder, magnesium stearate or sodium stearyl fumarate
Composition.
Described adhesive is a kind of in water, ethanol, hydroxypropyl methyl cellulose, ethyl cellulose, PVP or starch
Or several compositions.
Described be coated includes following component according to weight percentage：
Water-soluble coating material 5%-20%
Coating solvent 80%-95%.
In the coating：
The water-soluble coating material is polyvinylpyrrolidone or Opadry；
The coating solvent is one kind in water, ethanol, acetone or chloroform, two or more composition.
Described eplerenone tablet, comprises the following steps：
1. eplerenone, surfactant and partially filled agent are well mixed, carry out ultramicro grinding, control its average grain diameter to exist
Less than 50 μm；
2. mixture after crushing is well mixed with remaining filler, partial disintegration agent, adds adhesive softwood, pelletized, do
It is dry；
3. lubricant and remaining disintegrant after above-mentioned dried particle whole grain, will be added, is well mixed, tabletting produces label；
4. label is put in coating pan, be coated, eplerenone tablet is produced after drying.
Described preparation method, it is characterised in that：
The filler is divided into two kinds, including the first filler and the second filler；First filler refers to and bulk drug
And surfactant carries out the filler of ultramicro grinding, it accounts for the 30%-40% of the filler gross weight；
The disintegrant is two kinds, including interior plus disintegrant and additional disintegrant；Disintegrant is added to account for the disintegrant in described total
The 50%-70% of weight；
Described preparation method, it is characterised in that：
First filler is one kind in lactose or pregelatinized starch, preferably lactose；
Second filler is one kind in microcrystalline cellulose, mannitol or dextrin, preferably microcrystalline cellulose；
It is carboxyrnethyl starch sodium, sodium carboxymethylcellulose, Ac-Di-Sol, crosslinking carboxymethylstarch to add disintegrant in described
One kind in sodium, preferably Ac-Di-Sol；
The additional disintegrant is one kind in PVPP or low-substituted hydroxypropyl cellulose, preferably low-substituted hydroxypropyl fiber
Element.
Embodiment
The following is the specific embodiment of the present invention, technical scheme is described further, but the present invention
Protection domain is not limited to these embodiments.Every change or equivalent substitute without departing substantially from present inventive concept is included in the present invention
Protection domain within.
Embodiment 1
Core formulation：
Eplerenone 45g 30%
Lactose 27g 18%
Lauryl sodium sulfate 1.80g 1.2%
Ac-Di-Sol 7.5g 5.0%
Microcrystalline cellulose 60g 40%
Low-substituted hydroxypropyl cellulose 7.5g 5.0%
Talcum powder 1.20g 0.8%, is made 1000.
Adhesive：
Starch 8.0g
Water 100ml, is made 8% starch slurry.
Coating fluid prescription：
Opadry 15g
Purified water 100ml, is made about 100ml.
Preparation technology：
1. crushed after the eplerenone, lactose and lauryl sodium sulfate of recipe quantity are well mixed with micronizer,
Average grain diameter is controlled below 50 μm；
2. after the mixture after crushing and recipe quantity microcrystalline cellulose, Ac-Di-Sol are well mixed, add viscous
The starch slurry softwood of mixture 8%, crosses 24 mesh sieves, wet granular is made；
3. wet granular is placed in drying box, 50-60 DEG C of forced air drying drying；
4. dry particl is crossed into 16 mesh sieve whole grains, recipe quantity lubricant and low-substituted hydroxypropyl cellulose are added, after being well mixed, tabletting
Produce label；
5. being coated with the Opadry aqueous solution, coating weight gain is about 3%, is drying to obtain after coating.
6. gained tablet is carried out into dissolution rate investigation, experimental result is shown in Table 1.
The dissolution test result of the embodiment one of table 1
。
Embodiment 2
Core formulation：
Eplerenone 30g 20%
Pregelatinized starch 34.5g 23%
Lauryl sodium sulfate 1.80g 1.2%
Carboxyrnethyl starch sodium 7.5g 5.0%
Mannitol 67.5g 45%
Low-substituted hydroxypropyl cellulose 7.5g 5.0%
Superfine silica gel powder 1.20g 0.8%, is made 1000.
Adhesive：
Starch 8.0g
Water 100ml, is made 8% starch slurry.
Coating fluid prescription：
Opadry 15g
Purified water 100ml, is made about 100ml.
Preparation technology：
1. carried out after the eplerenone, pregelatinized starch and lauryl sodium sulfate of recipe quantity are well mixed with micronizer
Crush, control average grain diameter is below 50 μm；
2. after the mixture after crushing and recipe quantity mannitol, carboxyrnethyl starch sodium are well mixed, add the starch slurry of adhesive 8%
Softwood processed, crosses 24 mesh sieves, wet granular is made；
3. wet granular is placed in drying box, 50-60 DEG C of forced air drying drying；
4. dry particl is crossed into 16 mesh sieve whole grains, recipe quantity lubricant and low-substituted hydroxypropyl cellulose are added, after being well mixed, tabletting
Produce label；
5. being coated with the Opadry aqueous solution, coating weight gain is about 3%, is drying to obtain after coating；
6. gained tablet is carried out into dissolution rate investigation, experimental result is shown in Table 2.
The dissolution test result of the embodiment two of table 2
。
Embodiment 3
Core formulation：
Eplerenone 24g 16%
Lactose 34.5g 23.0%
Tween 3.00g 2.0%
Sodium carboxymethylcellulose 7.8g 5.2%
Microcrystalline cellulose 72.0g 48.0%
PVPP 7.5g 5.0%
Sodium stearyl fumarate 1.20g 0.8%, is made 1000.
Adhesive：
Starch 8.0g
Water 100ml, is made 8% starch slurry.
Coating fluid prescription：
Opadry 15g
Purified water 100ml, is made about 100ml.
Preparation technology：
1. crushed after the eplerenone, lactose and tween of recipe quantity are well mixed with micronizer, the average grain of control
Footpath is below 50 μm；
2. after the mixture after crushing and recipe quantity microcrystalline cellulose, sodium carboxymethylcellulose are well mixed, add adhesive
8% starch slurry softwood, crosses 24 mesh sieves, wet granular is made；
3. wet granular is placed in drying box, 50-60 DEG C of forced air drying drying；
4. dry particl is crossed into 16 mesh sieve whole grains, recipe quantity lubricant and PVPP are added, after being well mixed, tabletting produces piece
Core；
5. being coated with the Opadry aqueous solution, coating weight gain is about 3%, is drying to obtain after coating；
6. gained tablet is carried out into dissolution rate investigation, experimental result is shown in Table 3.
The dissolution test result of the embodiment three of table 3
。
Embodiment 4
Core formulation：
Eplerenone 15.0g 10%
Lactose 34.5g 23.0%
Lauryl sodium sulfate 3.00g 2.0%
Carboxyrnethyl starch sodium 12.0g 8.0%
Microcrystalline cellulose 72.0g 48.0%
Low-substituted hydroxypropyl cellulose 10.5g 7.0%
Magnesium stearate 3.00g 2.0%, is made 1000.
Adhesive：
Starch 8.0g
Water 100ml, be made 8% starch slurry,
Coating fluid prescription：
Opadry 15g
Purified water 100ml, is made about 100ml.
Preparation technology：
1. crushed after the eplerenone, lactose and lauryl sodium sulfate of recipe quantity are well mixed with micronizer,
Average grain diameter is controlled below 50 μm；
2. after the mixture after crushing and recipe quantity microcrystalline cellulose, carboxyrnethyl starch sodium are well mixed, add adhesive 8% and form sediment
Slurry softwood, crosses 24 mesh sieves, wet granular is made；
3. wet granular is placed in drying box, 50-60 DEG C of forced air drying drying；
4. dry particl is crossed into 16 mesh sieve whole grains, recipe quantity lubricant and low-substituted hydroxypropyl cellulose are added, after being well mixed, tabletting
Produce label；
5. being coated with the Opadry aqueous solution, coating weight gain is about 3%, is drying to obtain after coating；
6. gained tablet is carried out into dissolution rate investigation, experimental result is shown in Table 4.
The dissolution test result of the example IV of table 4
。
Embodiment 5
Core formulation：
Eplerenone 30.0g 20%
Lactose 34.5g 23%
Lauryl sodium sulfate 1.80g 1.2%
Ac-Di-Sol 7.5g 5.0%
Microcrystalline cellulose 67.5g 45%
PVPP 7.5g 5.0%
Superfine silica gel powder 1.20g 0.8%, is made 1000.
Adhesive：
Starch 8.0g
Water 100ml, is made 8% starch slurry.
Coating fluid prescription：
Opadry 15g
Purified water 100ml, is made about 100ml.
Preparation technology：
1. crushed after the eplerenone, lactose and lauryl sodium sulfate of recipe quantity are well mixed with micronizer,
Average grain diameter is controlled below 50 μm；
2. after the mixture after crushing and recipe quantity microcrystalline cellulose, Ac-Di-Sol are well mixed, add viscous
The starch slurry softwood of mixture 8%, crosses 24 mesh sieves, wet granular is made；
3. wet granular is placed in drying box, 50-60 DEG C of forced air drying drying；
4. dry particl is crossed into 16 mesh sieve whole grains, recipe quantity lubricant and PVPP are added, after being well mixed, tabletting produces piece
Core；
5. being coated with the Opadry aqueous solution, coating weight gain is about 3%, is drying to obtain after coating；
6. gained tablet is carried out into dissolution rate investigation, experimental result is shown in Table 5.
The dissolution test result of the embodiment five of table 5
。
Embodiment 6
Core formulation：
Eplerenone 45g 30%
Pregelatinized starch 27g 18%
Tween 1.80g 1.2%
CCMS-Na 7.5g 5.0%
Microcrystalline cellulose 60g 40%
Low-substituted hydroxypropyl cellulose 7.5g 5.0%
Talcum powder 1.20g 0.8%, is made 1000.
Adhesive：
Starch 8.0g
Water 100ml, is made 8% starch slurry.
Coating fluid prescription：
Opadry 15g
Purified water 100ml, is made about 100ml.
Preparation technology：
1. being crushed after the eplerenone, pregelatinized starch and tween of recipe quantity are well mixed with micronizer, control
Average grain diameter is below 50 μm；
2. after the mixture after crushing and recipe quantity microcrystalline cellulose, CCMS-Na are well mixed, add adhesive
8% starch slurry softwood, crosses 24 mesh sieves, wet granular is made；
3. wet granular is placed in drying box, 50-60 DEG C of forced air drying drying；
4. dry particl is crossed into 16 mesh sieve whole grains, recipe quantity lubricant and low-substituted hydroxypropyl cellulose are added, after being well mixed, tabletting
Produce label；
5. being coated with the Opadry aqueous solution, coating weight gain is about 3%, is drying to obtain after coating；
6. gained tablet is carried out into dissolution rate investigation, experimental result is shown in Table 6.
The dissolution test result of the embodiment six of table 6
。
The eplerenone tablet provided in data result, embodiment of the present disclosure 1-6 is tested in above-mentioned table 1- tables 6
With extraordinary dissolution rate.
, below will be further to the disclosure in order to further prove the stability for the eplerenone tablet that the disclosure is provided
The eplerenone tablet provided carries out medicine stability test.
The eplerenone tablet that embodiment of the present disclosure 1-6 is provided is respectively provided with preferable stability, in order to save space, with
Under only list the stability data of eplerenone tablet prepared by embodiment 1, specific test method is as follows：
Medicine stability is tested：
Take sample, respectively at 40 DEG C of high temperature, 60 DEG C of high temperature, high humidity RH75%, high humidity RH92.5% and intensity of illumination 5000Lx ±
Placed 10 days under the conditions of 500Lx, sampling detection, and compared with 0 day, result of the test is shown in Table 7.
The eplerenone tablet influence factor result of the test of table 7
。
From the above-mentioned test data result of table 7, its is relevant after influence factor setting-out in 10 days is carried out for the tablet of the disclosure
Material, appearance character, dissolution rate, content had no significant changes compared with 0 day.So as to illustrate the eplerenone piece of disclosure offer
Eplerenone tablet obtained by agent and preparation method thereof has certain superiority in terms of stability.
Conclusion, the eplerenone tablet that the disclosure is provided by rational proportion use potent disintegrant,
Surfactant is used in combination simultaneously makes insoluble drug eplerenone dissolution, and then increases the solubility of eplerenone, improves
Its bioavilability.Meanwhile, the eplerenone method for preparing tablet thereof that the disclosure is provided has technique simple, quality controllable, steady
It is qualitative good, it is adaptable to the advantages of industrialized production.
The preferred embodiments of the present invention are the foregoing is only, are not intended to limit the invention.
Claims (10)
1. a kind of eplerenone tablet, including label and coating, be using eplerenone as active drug composition, it is and pharmaceutically acceptable
Auxiliary element collectively constitute, it is characterised in that the label is according to weight, and specific composition is as follows：
Eplerenone 10%-30%
Filler 15%-80%
Disintegrant 1%-20%
Surfactant 0.1%-5%
Lubricant 0.1%-8%
Appropriate adhesive.
2. eplerenone tablet according to claim 1, it is characterised in that the filler is selected from mannitol, lactose, micro-
One kind, two or more composition in crystalline cellulose, pregelatinized starch or dextrin.
3. eplerenone tablet according to claim 1, it is characterised in that the disintegrant is selected from carboxymethyl cellulose
Sodium, Ac-Di-Sol, carboxyrnethyl starch sodium, CCMS-Na, PVPP or low-substituted hydroxypropyl cellulose
In one kind, two or more composition.
4. eplerenone tablet according to claim 1, it is characterised in that the surfactant is selected from dodecyl sulphur
One or more of compositions in sour sodium, tween or sapn.
5. eplerenone tablet according to claim 1, it is characterised in that the lubricant is selected from superfine silica gel powder, talcum
One or more of compositions in powder, magnesium stearate or sodium stearyl fumarate.
6. eplerenone tablet according to claim 1, it is characterised in that described adhesive is water, ethanol, hydroxypropyl first
One or more of composition in base cellulose, ethyl cellulose, PVP or starch.
7. eplerenone tablet according to claim 1, it is characterised in that the coating includes according to weight percentage
Following component：
Water-soluble coating material 5%-20%
Coating solvent 80%-95%
Wherein, water-soluble coating material is polyvinylpyrrolidone or Opadry, and coating solvent is water, ethanol, acetone or chloroform
In one kind, two or more composition.
8. eplerenone tablet according to claim 1, it is characterised in that comprise the following steps：
1. eplerenone, surfactant and partially filled agent are well mixed, carry out ultramicro grinding, control its average grain diameter to exist
Less than 50 μm；
2. mixture after crushing is well mixed with remaining filler, partial disintegration agent, adds adhesive softwood, pelletized, do
It is dry；
3. lubricant and remaining disintegrant after above-mentioned dried particle whole grain, will be added, is well mixed, tabletting produces label；
4. label is put in coating pan, be coated, eplerenone tablet is produced after drying.
9. preparation method according to claim 8, it is characterised in that：
The filler is divided into two kinds, including the first filler and the second filler；First filler refers to and bulk drug
And surfactant carries out the filler of ultramicro grinding, it accounts for the 30%-40% of the filler gross weight；
The disintegrant is two kinds, including interior plus disintegrant and additional disintegrant；Disintegrant is added to account for the disintegrant in described total
The 50%-70% of weight.
10. preparation method according to claim 8, it is characterised in that：
First filler is one kind in lactose or pregelatinized starch, preferably lactose；
Second filler is one kind in microcrystalline cellulose, mannitol or dextrin, preferably microcrystalline cellulose；
It is carboxyrnethyl starch sodium, sodium carboxymethylcellulose, Ac-Di-Sol, crosslinking carboxymethylstarch to add disintegrant in described
One kind in sodium, preferably Ac-Di-Sol；
The additional disintegrant is one kind in PVPP or low-substituted hydroxypropyl cellulose, preferably low-substituted hydroxypropyl fiber
Element.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710186546.4A CN107019679A (en) | 2017-03-27 | 2017-03-27 | A kind of eplerenone tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710186546.4A CN107019679A (en) | 2017-03-27 | 2017-03-27 | A kind of eplerenone tablet and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109925293A (en) * | 2019-03-15 | 2019-06-25 | 南京卡文迪许生物工程技术有限公司 | Eplerenone oral solid formulation and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20100087412A1 (en) * | 2004-04-02 | 2010-04-08 | Pfizer Inc | Micronized Eplerenone Compositions |
| CN102488665A (en) * | 2011-12-15 | 2012-06-13 | 宁夏康亚药业有限公司 | Febuxostat tablet and preparation method thereof |
| CN105362242A (en) * | 2015-12-10 | 2016-03-02 | 合肥久诺医药科技有限公司 | Eplerenone dispersible tablet |
-
2017
- 2017-03-27 CN CN201710186546.4A patent/CN107019679A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20100087412A1 (en) * | 2004-04-02 | 2010-04-08 | Pfizer Inc | Micronized Eplerenone Compositions |
| CN102488665A (en) * | 2011-12-15 | 2012-06-13 | 宁夏康亚药业有限公司 | Febuxostat tablet and preparation method thereof |
| CN105362242A (en) * | 2015-12-10 | 2016-03-02 | 合肥久诺医药科技有限公司 | Eplerenone dispersible tablet |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109925293A (en) * | 2019-03-15 | 2019-06-25 | 南京卡文迪许生物工程技术有限公司 | Eplerenone oral solid formulation and preparation method thereof |
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