CN108057027A - Glimepiride oral disnitegration tablet and preparation method thereof - Google Patents
Glimepiride oral disnitegration tablet and preparation method thereof Download PDFInfo
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- CN108057027A CN108057027A CN201810060332.7A CN201810060332A CN108057027A CN 108057027 A CN108057027 A CN 108057027A CN 201810060332 A CN201810060332 A CN 201810060332A CN 108057027 A CN108057027 A CN 108057027A
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- glimepiride
- recipe quantity
- oral disnitegration
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- disnitegration tablet
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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
- A61K9/2063—Proteins, e.g. gelatin
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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
- A61K31/64—Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
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- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
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Abstract
The invention discloses a kind of Glimepiride oral disnitegration tablet and preparation method thereof, contain in the Glimepiride oral disnitegration tablet described in every 1000：1 4g of Glimepiride, 50 70g of microcrystalline cellulose, 8 15g of polylactic acid, 5 10g of starch, 5 10g of gelatin, 3 7g of chitosan, 15 20g of crospovidone, 0.08 0.12g of Aspartame, 3% HPMC E50 solution, 60 100mL, 0.8 1.2g of magnesium stearate；Its preparation method is simple and practicable, and Glimepiride Orally disintegrating tablet stability obtained is good, bioavilability is high, and tablet is contained in oral cavity when taking to be disintegrated rapidly, is not required to or only needs a small amount of water, without chewing, after medicine disintegration, enters alimentary canal by means of swallowing act and works.
Description
Technical field
The present invention relates to pharmaceutical technology field, more specifically more particularly to a kind of Glimepiride oral disnitegration tablet and its
Preparation method.
Background technology
Glimepiride (glimepiride) is sulfonylurea hypoglycemic agent of new generation, is developed by German HMR companies, nineteen ninety-five 9
The moon is listed for the first time in Sweden with trade name Amaryl, 1996 through FDA approvals into American market, keep a diet for treating and
Be engaged in movement and fail control type-2 diabetes mellitus, Glimepiride have it is efficient, long-acting, dosage is few (2-4mg/d), side effect
The advantages that small is the good sulfonylurea hypoglycemic agent of current clinical evaluation.
The invention of Application No. CN200510200565.5 provides a kind of dispersive glimepiride tablet and preparation method thereof；It
Pancreas beta cell is acted on, ATP sensitive potassium channels is blocked, stimulates insulin secretion；It can be individually used for keeping on a diet, temper nothing
The patient of effect can also use with other antidiabetic drugs or insulin 5, have the characteristics that efficient, safety, low dosage, hypotoxicity, this hair
The dispersible tablet formulation of bright offer solves the problems, such as that poorly water-soluble, the dissolution rate of existing Glimepiride conventional tablet are low, has
It works the characteristics of rapid, evident in efficacy.
The disclosure of the invention of Application No. CN200910023340.5 a kind of dispersive glimepiride tablet and its preparation method and detection
Method, by Glimepiride, pregelatinized starch, microcrystalline cellulose, crospovidone, silica, magnesium stearate, 50% ethanol water
Solution etc. is prepared, and has Clinical practice convenience, definite curative effect, can preferably improve clinical symptoms, few side effects, price just
The characteristics of suitable, is clinically used for treatment type-2 diabetes mellitus.
The invention of Application No. CN200810041997.X is related to a kind of preparation method of Glimepiride oral disnitegration tablet, bag
It includes：1) method of micronization is taken to be co-mulled and made into glimepiride raw material and superfine silica gel powder, crosses 80-100 mesh sieves, obtain the lattice of micronizing
The U.S. urea of row and superfine silica gel powder mixed-powder, wherein, the weight ratio of Glimepiride and superfine silica gel powder is 1: 1；2) prepared by step 1)
Mixed-powder and filler, disintegrant, lubricant, adhesive and volumetric concentration be the ethanol solution of 30%-40% normal
Temperature lower mixing 15-20 minutes, crosses the granulation of 18-24 mesh sieves, and particle increases slightly solubility main ingredient in by selecting micronization technology
Surface area is conducive to the crushing of Glimepiride, improves the wet performance of powder particle surface, improves the dissolution of bulk pharmaceutical chemicals in tablet
Quality stability in degree and product storage period.
The content of the invention
It is an object of the present invention to provide a kind of Glimepiride oral disnitegration tablets, and tablet is contained in oral cavity when taking can be fast
Speed disintegration, is not required to or only needs a small amount of water, without chewing, after medicine disintegration, enters alimentary canal by means of swallowing act and works, rapid-action, treatment
It imitates.
To achieve the above object, the technical solution adopted by the present invention is：
A kind of Glimepiride oral disnitegration tablet, the Glimepiride oral disnitegration tablet described in every 1000, formula composition are：
Another object of the present invention is to provide the preparation method of above-mentioned Glimepiride oral disnitegration tablet, the preparation methods
It is simple and practicable, specifically include following steps：
1) ball milling：The Glimepiride of recipe quantity and portions microcrystalline cellulose are packed into ball mill tank and carry out ball milling, ball milling
Machine rotating speed 200rpm, ball milling 4-5h, collection material are spare；
2) adhesive is prepared：The aqueous solution that HPMC E50 are configured to 3% concentration is spare；
3) capsule material processed：The poly lactose of recipe quantity, starch, gelatin and chitosan are dissolved in 100mL purified waters, stirred
30-40min makes it fully dissolve；
4) softwood processed：The microcrystalline cellulose of the crospovidone of recipe quantity, Aspartame and remaining recipe quantity is placed in system
After stirring 3-5min in grain machine, the adhesive of preparation, is stirred for 3-5min and softwood is made in adding in 2)；
5) pelletize：4) softwood obtained in is pelletized with oscillating granulator, 20 mesh of mesh number of pelletizing；
6) it is dry：5) wet granular obtained in is placed in 70-80 DEG C of cyclic drying case drying 2-3h, is less than moisture
3.0%；
7) micro-capsule processed：1) the middle material collected is placed in fast boiling drying machine, by recipe quantity from 3) spray gun sprays into
The solution of preparation, 80-90 DEG C of drying temperature；
8) mix：By dried particle in 6) and 7) magnesium stearate of dried micro-capsule and recipe quantity is placed in mixed in
15-20min is mixed in conjunction machine, makes to be uniformly mixed；
9) tabletting：By mixed material in 8) be placed in tablet press machine tabletting to get.
Compared with prior art, the invention has the advantages that：
1st, it is water-soluble to solve existing Glimepiride conventional tablet for Glimepiride oral disnitegration tablet provided by the present invention
Difference, the problem of dissolution rate is low.
2nd, Glimepiride oral disnitegration tablet provided by the present invention, through industrialized production and study on the stability, it was demonstrated that production
Quality is stablized, and therapeutic effect is apparent, and toxic side effect is small.
3rd, the preparation method of Glimepiride oral disnitegration tablet provided by the present invention, this method is simple and practicable, prepared
Glimepiride oral disnitegration tablet is in good taste, bioavilability is high.
Specific embodiment
With reference to embodiment, the present invention is described in further detail, but does not form any limit to the present invention
System.
Embodiment 1
A kind of Glimepiride oral disnitegration tablet, the Glimepiride oral disnitegration tablet described in every 1000, formula composition are：
Its preparation method comprises the following steps：
1) ball milling：The Glimepiride of recipe quantity and portions microcrystalline cellulose are packed into ball mill tank and carry out ball milling, ball milling
Machine rotating speed 200rpm, ball milling 4h, collection material are spare；
2) adhesive is prepared：The aqueous solution that HPMC E50 are configured to 3% concentration is spare；
3) capsule material processed：The poly lactose of recipe quantity, starch, gelatin and chitosan are dissolved in 100mL purified waters, stirred
30min makes it fully dissolve；
4) softwood processed：The microcrystalline cellulose of the crospovidone of recipe quantity, Aspartame and remaining recipe quantity is placed in system
After stirring 3min in grain machine, the adhesive of preparation, is stirred for 3min and softwood is made in adding in 2)；
5) pelletize：4) softwood obtained in is pelletized with oscillating granulator, 20 mesh of mesh number of pelletizing；
6) it is dry：5) wet granular obtained in is placed in 70 DEG C of cyclic drying casees drying 2h, moisture is made to be less than 3.0%；
7) micro-capsule processed：1) the middle material collected is placed in fast boiling drying machine, by recipe quantity from 3) spray gun sprays into
The solution of preparation, 80 DEG C of drying temperature；
8) mix：By dried particle in 6) and 7) magnesium stearate of dried micro-capsule and recipe quantity is placed in mixed in
15min is mixed in conjunction machine, makes to be uniformly mixed；
9) tabletting：By mixed material in 8) be placed in tablet press machine tabletting to get.
Embodiment 2
A kind of Glimepiride oral disnitegration tablet, the Glimepiride oral disnitegration tablet described in every 1000, formula composition are：
Its preparation method comprises the following steps：
1) ball milling：The Glimepiride of recipe quantity and portions microcrystalline cellulose are packed into ball mill tank and carry out ball milling, ball milling
Machine rotating speed 200rpm, ball milling 4.5h, collection material are spare；
2) adhesive is prepared：The aqueous solution that HPMC E50 are configured to 3% concentration is spare；
3) capsule material processed：The poly lactose of recipe quantity, starch, gelatin and chitosan are dissolved in 100mL purified waters, stirred
35min makes it fully dissolve；
4) softwood processed：The microcrystalline cellulose of the crospovidone of recipe quantity, Aspartame and remaining recipe quantity is placed in system
After stirring 4min in grain machine, the adhesive of preparation, is stirred for 4min and softwood is made in adding in 2)；
5) pelletize：4) softwood obtained in is pelletized with oscillating granulator, 20 mesh of mesh number of pelletizing；
6) it is dry：5) wet granular obtained in is placed in 75 DEG C of cyclic drying casees drying 2.5h, moisture is made to be less than 3.0%；
7) micro-capsule processed：1) the middle material collected is placed in fast boiling drying machine, by recipe quantity from 3) spray gun sprays into
The solution of preparation, 85 DEG C of drying temperature；
8) mix：By dried particle in 6) and 7) magnesium stearate of dried micro-capsule and recipe quantity is placed in mixed in
18min is mixed in conjunction machine, makes to be uniformly mixed；
9) tabletting：By mixed material in 8) be placed in tablet press machine tabletting to get.
Embodiment 3
A kind of Glimepiride oral disnitegration tablet, the Glimepiride oral disnitegration tablet described in every 1000, formula composition are：
Its preparation method comprises the following steps：
1) ball milling：The Glimepiride of recipe quantity and portions microcrystalline cellulose are packed into ball mill tank and carry out ball milling, ball milling
Machine rotating speed 200rpm, ball milling 5h, collection material are spare；
2) adhesive is prepared：The aqueous solution that HPMC E50 are configured to 3% concentration is spare；
3) capsule material processed：The poly lactose of recipe quantity, starch, gelatin and chitosan are dissolved in 100mL purified waters, stirred
40min makes it fully dissolve；
4) softwood processed：The microcrystalline cellulose of the crospovidone of recipe quantity, Aspartame and remaining recipe quantity is placed in system
After stirring 5min in grain machine, the adhesive of preparation, is stirred for 5min and softwood is made in adding in 2)；
5) pelletize：4) softwood obtained in is pelletized with oscillating granulator, 20 mesh of mesh number of pelletizing；
6) it is dry：5) wet granular obtained in is placed in 80 DEG C of cyclic drying casees drying 2h, moisture is made to be less than 3.0%；
7) micro-capsule processed：1) the middle material collected is placed in fast boiling drying machine, by recipe quantity from 3) spray gun sprays into
The solution of preparation, 90 DEG C of drying temperature；
8) mix：By dried particle in 6) and 7) magnesium stearate of dried micro-capsule and recipe quantity is placed in mixed in
20min is mixed in conjunction machine, makes to be uniformly mixed；
9) tabletting：By mixed material in 8) be placed in tablet press machine tabletting to get.
Claims (3)
1. a kind of Glimepiride oral disnitegration tablet, which is characterized in that the Glimepiride oral disnitegration tablet described in every 1000 is matched somebody with somebody
Fang Zucheng is：
Glimepiride 1-4 g
Microcrystalline cellulose 50-70 g
Polylactic acid 8-15 g
Starch 5-10 g
Gelatin 5-10 g
Chitosan 3-7 g
Crospovidone 15-20 g
Aspartame 0.08-0.12 g
3% HPMC E50 solution 60-100 mL
Magnesium stearate 0.8-1.2 g.
2. Glimepiride oral disnitegration tablet according to claim 1, which is characterized in that the Glimepiride described in every 1000
Oral disnitegration tablet, formula composition are：
2 g of Glimepiride
60 g of microcrystalline cellulose
10 g of polylactic acid
8 g of starch
7 g of gelatin
5 g of chitosan
18 g of crospovidone
0.1 g of Aspartame
3% HPMC E50 solution, 80 mL
1 g of magnesium stearate.
3. the preparation method of Glimepiride oral disnitegration tablet according to claim 1 or 2, which is characterized in that including following
Step：
Ball milling：The Glimepiride of recipe quantity and portions microcrystalline cellulose are packed into ball mill tank and carry out ball milling, drum's speed of rotation
200rpm, ball milling 4-5h, collection material are spare；
Prepare adhesive：The aqueous solution that HPMC E50 are configured to 3% concentration is spare；
Capsule material processed：The poly lactose of recipe quantity, starch, gelatin and chitosan are dissolved in 100 mL purified waters, stir 30-
40min makes it fully dissolve；
Softwood processed：The microcrystalline cellulose of the crospovidone of recipe quantity, Aspartame and remaining recipe quantity is placed in granulator
After stirring 3-5min, 2 are added in）The adhesive of middle preparation is stirred for 3-5min and softwood is made；
Granulation：By 4）In softwood obtained pelletized with oscillating granulator, pelletize 20 mesh of mesh number；
It is dry：By 5）In wet granular obtained be placed in 70-80 DEG C of cyclic drying case drying 2-3h, moisture is made to be less than 3.0%；
Micro-capsule processed：By 1）The material of middle collection is placed in fast boiling drying machine, and 3 are sprayed into from spray gun by recipe quantity）Middle preparation
Solution, 80-90 DEG C of drying temperature；
Mixing：By 6）In dried particle and 7）In the magnesium stearate of dried micro-capsule and recipe quantity be placed in mixer
15-20min is mixed, makes to be uniformly mixed；
Tabletting：By 8）In mixed material be placed in tablet press machine tabletting to get.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810060332.7A CN108057027A (en) | 2018-01-22 | 2018-01-22 | Glimepiride oral disnitegration tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810060332.7A CN108057027A (en) | 2018-01-22 | 2018-01-22 | Glimepiride oral disnitegration tablet and preparation method thereof |
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| Publication Number | Publication Date |
|---|---|
| CN108057027A true CN108057027A (en) | 2018-05-22 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810060332.7A Pending CN108057027A (en) | 2018-01-22 | 2018-01-22 | Glimepiride oral disnitegration tablet and preparation method thereof |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1555843A (en) * | 2003-12-31 | 2004-12-22 | 北京科信必成医药科技发展有限公司 | Ginkgoleaf oral cavity disintegrating tablet and its preparation method |
| CN1568981A (en) * | 2004-04-23 | 2005-01-26 | 北京科信必成医药科技发展有限公司 | Orally disintegrating tablet of phentolamine mesylate and its preparation method |
| CN102512388A (en) * | 2011-12-26 | 2012-06-27 | 天津市嵩锐医药科技有限公司 | Glimepiride orally disintegrating medicine composition |
-
2018
- 2018-01-22 CN CN201810060332.7A patent/CN108057027A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1555843A (en) * | 2003-12-31 | 2004-12-22 | 北京科信必成医药科技发展有限公司 | Ginkgoleaf oral cavity disintegrating tablet and its preparation method |
| CN1568981A (en) * | 2004-04-23 | 2005-01-26 | 北京科信必成医药科技发展有限公司 | Orally disintegrating tablet of phentolamine mesylate and its preparation method |
| CN102512388A (en) * | 2011-12-26 | 2012-06-27 | 天津市嵩锐医药科技有限公司 | Glimepiride orally disintegrating medicine composition |
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| PB01 | Publication | ||
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Application publication date: 20180522 |