CN109692175A - A kind of amlodipine besylate medicinal preparation - Google Patents
A kind of amlodipine besylate medicinal preparation Download PDFInfo
- Publication number
- CN109692175A CN109692175A CN201710999393.5A CN201710999393A CN109692175A CN 109692175 A CN109692175 A CN 109692175A CN 201710999393 A CN201710999393 A CN 201710999393A CN 109692175 A CN109692175 A CN 109692175A
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- CN
- China
- Prior art keywords
- amlodipine besylate
- medicinal preparation
- dry
- variety
- preparation according
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Classifications
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
-
- 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
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Abstract
The present invention provides a kind of amlodipine besylate medicinal preparations, which is characterized in that the pharmaceutical preparation prescription weight percent is calculated as: Amlodipine Besylate Tablet 1-3%, stabilizer 20-50%, filler 30-70%, glidant 0.5-3%, adhesive 2-10%.By high-quality supplementary material rational proportion, addition adhesive appropriate, remove auxiliary material unreasonable in pharmaceutical composition and advanced production technology.Not only product quality and drug safety are improved, but also is suitble to production.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, and in particular to a kind of amlodipine besylate medicinal preparation.
Background technique
Amlodipine Besylate Tablet is dihydropyridine type calcium antagonists (calcium ion antagonist or slow channel blocking agent).Cardiac muscle and
The contraction of smooth muscle enters cell by specific ion channel dependent on extracellular calcium.This product selective depression calcium ion
Cross-film enters smooth muscle cell and cardiac muscle cell, is greater than cardiac muscle to the effect of smooth muscle.The interaction of itself and calcium channel determines
Gradual rate in it and acceptor site association and dissociation, therefore pharmacological action gradually generates.This product is peripheral arterial expansion
Agent directly acts on vascular smooth muscle, peripheral vascular resistance is reduced, to reduce blood pressure.
The amlodipine besylate tablets produced on the market at present are generally existing to have the users such as hardness is inadequate, and disintegration is too fast to throw
It tells.The present invention is based on this statuses, by high-quality supplementary material rational proportion, addition adhesive appropriate, remove in pharmaceutical composition not
Reasonable auxiliary material and advanced production technology, prove through repetition test, have obtained the conjunction for meeting Chinese Pharmacopoeia (2015 editions)
Lattice product solves the problems, such as the complaint of user in use, is mentioned to patient medication safety and Compliance
Height meets enterprise scale production requirement at this stage.
Summary of the invention
The present invention is intended to provide the pharmaceutical composition convenient for a kind of life containing amlodipine besylate tablets taken that quality is stable
Object and preparation method.
For achieving the above object, a kind of amlodipine besylate medicinal preparation of the present invention, the specific scheme is that
A kind of amlodipine besylate medicinal preparation of the present invention, the pharmaceutical preparation prescription weight percent are calculated as:
Amlodipine Besylate Tablet 1-3%
Stabilizer 20-50%
Filler 30-70%
Glidant 0.5-3%
Adhesive 2-10%.
A kind of amlodipine besylate medicinal preparation of the present invention, the stabilizer are calcium phosphate dibasic anhydrous, hydroxide
One of sodium, calcium phosphate dibasic dihydrate are a variety of.
A kind of amlodipine besylate medicinal preparation of the present invention, the filler are starch, lactose, microcrystalline cellulose
One of element, dextrin, carboxyrnethyl starch sodium are a variety of.
A kind of amlodipine besylate medicinal preparation of the present invention, the glidant are magnesium stearate, talcum powder.
A kind of amlodipine besylate medicinal preparation of the present invention, described adhesive be purified water, ethyl alcohol, povidone,
One of croscarmellose sodium, sodium carboxymethylcellulose, hydroxypropyl methylcellulose are one of a variety of or a variety of.
A kind of amlodipine besylate medicinal preparation of the present invention, the pharmaceutical preparation the preparation method comprises the following steps: 1) supplementary material
Processing: supplementary material is sieved with 100 mesh screens；
2) filler of the weight such as Amlodipine Besylate Tablet addition is claimed to mix secondary, addition residue by equal increments method by recipe quantity
Auxiliary material, be sufficiently mixed, water-soluble bonding agent is appropriate, and softwood is made；
3) it makes wet grain: above-mentioned softwood being taken to pelletize by 16 mesh nylon mesh；
4) dry: wet granular is dry, and dry particl water content is made to reach prescribed limit.50-70 DEG C of temperature of charge or so；
5) whole grain: by 16 mesh screen whole grains of dry particle；
6) whole grain particle: being added the glidant of recipe quantity by total mix, is mixed；
7) φ 6.5mm shallow concave punch tabletting is used after intermediate is examined;
8) it is aluminum-plastic packaged that brown is carried out after qualification is tested in packet product examine.
The invention has the advantages that: pass through high-quality supplementary material rational proportion, addition adhesive appropriate, remove in pharmaceutical composition
Unreasonable auxiliary material and advanced production technology.Not only product quality and drug safety are improved, but also is suitble to production.
Specific embodiment
Following example is only to further illustrate the present invention, range that the invention is not limited in any way.
Embodiment 1:
Amlodipine Besylate Tablet 50g (presses amlodipine)
Anhydrous calcium phosphate 346.7g
Microcrystalline cellulose 688.4g
Povidone 16.5g
0.8% carboxymethyl cellulose sodium water solution is appropriate
Magnesium stearate 11.4g
10000 are made altogether
Embodiment 2:
Amlodipine Besylate Tablet 50g (presses amlodipine)
Anhydrous calcium phosphate 346.7g
Microcrystalline cellulose 693.9g
Carboxyrnethyl starch sodium 11g
0.8% carboxymethyl cellulose sodium water solution is appropriate
Magnesium stearate 11.4g
10000 are made altogether
Embodiment 3:
Amlodipine Besylate Tablet 50g(presses amlodipine)
Calcium phosphate dibasic anhydrous 300g
Microcrystalline cellulose 715.8g
Hydroxypropyl methyl cellulose 36.5g
0.5% carboxymethyl cellulose sodium water solution is appropriate
Magnesium stearate 1.14g
10000 are made altogether
Embodiment 4:
Amlodipine Besylate Tablet 50g(presses amlodipine)
Calcium phosphate dibasic anhydrous 346.7g
Microcrystalline cellulose 682.88g
Carboxyrnethyl starch sodium 22g
0.5% carboxymethyl cellulose sodium water solution is appropriate
Magnesium stearate 11.4g
10000 are made altogether
The preparation method of embodiment 1-4:
1, supplementary material is handled: supplementary material is sieved with 100 mesh screens.
2, the filler of the weight such as Amlodipine Besylate Tablet addition is claimed to mix secondary, addition by equal increments method by recipe quantity
Remaining auxiliary material, is sufficiently mixed, and water-soluble bonding agent is appropriate, and softwood is made.
3, it makes wet grain: above-mentioned softwood being taken to pelletize by 16 mesh nylon mesh.
4, dry: wet granular is dry, and dry particl water content is made to reach prescribed limit.50-70 DEG C of temperature of charge or so.
5, whole grain: by 16 mesh screen whole grains of dry particle.
6, whole grain particle: being added the glidant of recipe quantity by total mix, is mixed.
7, φ 6.5mm shallow concave punch tabletting is used after intermediate is examined.
8, it is aluminum-plastic packaged that brown is carried out after qualification is tested in packet product examine.Embodiment 3, which is stablized, investigates data: (acceleration)
Embodiment 3 is obtained most by study on the stability can solve that hardness is inadequate, be disintegrated too fast problem.
Claims (6)
1. a kind of amlodipine besylate medicinal preparation, which is characterized in that the pharmaceutical preparation prescription weight percent is calculated as:
Amlodipine Besylate Tablet 1-3%
Stabilizer 20-50%
Filler 30-70%
Glidant 0.5-3%
Adhesive 2-10%.
2. a kind of amlodipine besylate medicinal preparation according to claim 1, which is characterized in that the stabilizer is anhydrous
One of calcium monohydrogen phosphate, sodium hydroxide, calcium phosphate dibasic dihydrate are a variety of.
3. a kind of amlodipine besylate medicinal preparation according to claim 1, which is characterized in that the filler is to form sediment
One of powder, lactose, microcrystalline cellulose, dextrin, carboxyrnethyl starch sodium are a variety of.
4. a kind of amlodipine besylate medicinal preparation according to claim 1, which is characterized in that the glidant is tristearin
One of sour magnesium, talcum powder are a variety of.
5. a kind of amlodipine besylate medicinal preparation according to claim 1, which is characterized in that described adhesive is purifying
One of water, ethyl alcohol, povidone, croscarmellose sodium, sodium carboxymethylcellulose, hydroxypropyl methylcellulose are a variety of.
6. a kind of amlodipine besylate medicinal preparation according to claim 1, which is characterized in that the preparation of the pharmaceutical preparation
Method are as follows: 1) supplementary material is handled: supplementary material is sieved with 100 mesh screens；
2) filler of the weight such as Amlodipine Besylate Tablet addition is claimed to mix secondary, addition residue by equal increments method by recipe quantity
Auxiliary material, be sufficiently mixed, water-soluble bonding agent is appropriate, and softwood is made；
3) it makes wet grain: above-mentioned softwood being taken to pelletize by 16 mesh nylon mesh；
4) dry: wet granular is dry, and dry particl water content is made to reach prescribed limit；
50-70 DEG C of temperature of charge or so；
5) whole grain: by 16 mesh screen whole grains of dry particle；
6) whole grain particle: being added the glidant of recipe quantity by total mix, is mixed；
7) φ 6.5mm shallow concave punch tabletting is used after intermediate is examined;
8) it is aluminum-plastic packaged that brown is carried out after qualification is tested in packet product examine.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710999393.5A CN109692175A (en) | 2017-10-24 | 2017-10-24 | A kind of amlodipine besylate medicinal preparation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710999393.5A CN109692175A (en) | 2017-10-24 | 2017-10-24 | A kind of amlodipine besylate medicinal preparation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN109692175A true CN109692175A (en) | 2019-04-30 |
Family
ID=66227607
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710999393.5A Pending CN109692175A (en) | 2017-10-24 | 2017-10-24 | A kind of amlodipine besylate medicinal preparation |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN109692175A (en) |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102988317A (en) * | 2012-11-28 | 2013-03-27 | 康普药业股份有限公司 | Amlodipine besylate medicinal preparation and preparation method thereof |
| CN104415036A (en) * | 2013-08-27 | 2015-03-18 | 长春海悦药业有限公司 | Amlodipine besylate-containing pharmaceutical composition |
| CN104721159A (en) * | 2015-03-24 | 2015-06-24 | 浙江康乐药业股份有限公司 | Amlodipine benzenesulfonate tablet and preparation method thereof |
-
2017
- 2017-10-24 CN CN201710999393.5A patent/CN109692175A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102988317A (en) * | 2012-11-28 | 2013-03-27 | 康普药业股份有限公司 | Amlodipine besylate medicinal preparation and preparation method thereof |
| CN104415036A (en) * | 2013-08-27 | 2015-03-18 | 长春海悦药业有限公司 | Amlodipine besylate-containing pharmaceutical composition |
| CN104721159A (en) * | 2015-03-24 | 2015-06-24 | 浙江康乐药业股份有限公司 | Amlodipine benzenesulfonate tablet and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 徐玉萍: "苯磺酸氨氯地平分散片的制备及质量考察" * |
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