CN101890006A - Amoxicillin sustained-release preparation composition and preparation method thereof - Google Patents
Amoxicillin sustained-release preparation composition and preparation method thereof Download PDFInfo
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- CN101890006A CN101890006A CN2009100846349A CN200910084634A CN101890006A CN 101890006 A CN101890006 A CN 101890006A CN 2009100846349 A CN2009100846349 A CN 2009100846349A CN 200910084634 A CN200910084634 A CN 200910084634A CN 101890006 A CN101890006 A CN 101890006A
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- amoxicillin
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Abstract
The invention discloses an amoxicillin sustained-release preparation composition and a preparation method thereof, and the amoxicillin sustained-release preparation composition is mainly prepared by amoxicillin bulk drug, sustained-release material and other proper auxiliary materials. The provided amoxicillin sustained-release preparation can slow down the release rate of main drug, reduces the medicine taking times and improves the compliance of patients. The invention provides the amoxicillin sustained-release preparation composition, and the preparation technique of the composition has good quality controllability and stability.
Description
Technical field
The invention belongs to medical technical field, relate to a kind of amoxicillin slow release preparation compositions and preparation method thereof.
Background technology
The amoxicillin, its chemistry is by name: (2S, 5R, 6R)-3, the 3-dimethyl-6-[(R)-(-)-2-amino-2-(4-hydroxy phenyl) acetylamino]-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-formic acid trihydrate, be penbritin class beta-lactam semisynthetic antibiotics, mechanism of action is suppress bacteria cell wall synthetic, have bactericidal action fast, effective to most of grams and positive bacteria and negative bacterium.To producing enzyme staphylococcus aureus, staphylococcus epidermidis, coagulase negative staphylococcus and the equal tool good action of enterococcus, some intestinal liver Cordycepps antibacterial, hemophilus influenza, moraxelle catarrhalis, bacteroides fragilis etc. that produce beta-lactamase also there is better antibacterial activity.
According to reports, the amoxicillin oral absorption is good, and food does not have obvious influence to its absorption.The oral amoxicillin 250mg of empty stomach, the amoxicillin reached blood peak concentration of drug (Cmax) in 1.5 hours, be about 5.6mg/L, and blood elimination half-life (t1/2b) is about 1 hour, and the urine discharge rate was 50%～78% in 8 hours, and oral bioavailability is 97%.
The amoxicillin is applicable to lower respiratory infection, otitis media, the sinusitis due to hemophilus influenza and the moraxelle catarrhalis; Respiratory tract, urinary tract and skin soft-tissue infection etc. due to product enzyme staphylococcus aureus and product enzyme enterobacteriaceae lactobacteriaceae such as escherichia coli, the Klebsiella; Also can be used for the light grade and moderate infection due to the enterococcus, it also can be used for the above-mentioned various infection due to the responsive not zymogenic bacteria.
The amoxicillin is the severe infection one line infection medication of clinical common broad-spectrum high efficacy.
At present, except that the aseptic powder injection, still there are peroral dosage forms such as dry syrup, tablet (ordinary tablet, chewable tablet, dispersible tablet, oral cavity disintegration tablet), granule, capsule, dry suspension the amoxicillin of approved listing both at home and abroad.
But prior art is prepared into common stomach dissolution type oral formulations with the amoxicillin, because the metabolic half life of amoxicillin is short, this just needs repeatedly medication patient's every day (3～5 times on the one), can cause relatively poor patient's compliance like this and is difficult to guarantee therapeutic effect.Therefore, searching out the suitable preparation of energy head it off, is goal task of the present invention.We are through exploring repeatedly, developed the amoxicillin slow release preparation, the advantage of these slow release formulations is: both onset was very fast relatively, can delay the rate of release of medicine again, reduce the number of times of taking of medicine, improve compliance of patients, the blood drug level of remaining valid, improve curative effect, reduce side effect.
For this reason, we are through exploring repeatedly, developed one group of amoxicillin slow release preparation compositions, the advantage of this slow release formulation is: the rate of release that can delay medicine, reduce the number of times of taking of medicine, improve compliance of patients, the blood drug level of remaining valid, improve curative effect, reduce side effect, reduce medical expense.
Show through relevant patent and prior art literature search result, there is no the relevant report of amoxicillin slow release preparation compositions.
Summary of the invention
Repeatedly take medicine every day in order to overcome the amoxicillin, cause relatively poor shortcomings such as patient's compliance, the invention provides the amoxicillin slow release preparation.It can delay the rate of release of medicine, reduces the number of times of taking of medicine, improves compliance of patients, and the blood drug level of remaining valid improves curative effect, reduces side effect, reduces medical expense.
The object of the present invention is to provide a kind of amoxicillin slow release preparation compositions and preparation method thereof.
Technical scheme of the present invention is: a kind of amoxicillin slow release preparation compositions and preparation method thereof is characterized in that: said composition is made up of amoxicillin, slow-release material and one or more pharmaceutically acceptable pharmaceutical carriers and/or adjuvant; Amoxicillin slow release preparation compositions specification is designated as 100～3000mg with the amoxicillin.
Described amoxicillin is characterized in that it is amoxicillin hydrate and anhydrous amoxicillin, wherein preferred amoxicillin trihydrate.
Described pharmaceutical carrier and adjuvant are characterised in that it is filler, disintegrating agent, porogen, binding agent, lubricant, solubilizing agent, emulsifying agent, plasticizer, foaming agent, bleach activator, solvent etc.
Described slow-release material is characterized in that being selected from the following material one or more: the solubility/insoluble salt of hydroxypropyl emthylcellulose, Cellulose ethyl hydroxypropyl ether, methylcellulose, ethyl cellulose, hydroxyethyl-cellulose, cellulose acetate, polyvinylpyrrolidone, polycarboxy ethene, sodium carboxymethyl cellulose, polyvinyl alcohol, Rikemal B 200, alginic acid etc.
Described binding agent is characterised in that it is selected from the following material one or more: starch, gelatin, sugar (as sucrose, glucose, dextrose, lactose etc.), rubber polymer, sodium alginate, hydroxy methocel, methylcellulose, polyvinylpyrrolidone, Polyethylene Glycol, ethyl cellulose, water, wax, alcohol etc.
Described solubilizing agent is characterised in that it can select tartaric acid, citric acid, Polyethylene Glycol etc. one or more for use.
Described lubricant is characterised in that it can be selected from the following material one or more: Pulvis Talci, magnesium stearate, calcium stearate, stearic acid, hydrogenated vegetable oil, Polyethylene Glycol etc.
Described plasticizer is characterised in that it can be selected from medium at least a of propylene glycol, glycerol, Polyethylene Glycol, triacetin, acetyl list monoglyceride, phthalic acid ester, Oleum Ricini.
Described porogen is characterised in that it can select saccharide, mannitol, starch, Pulvis Talci, silicon dioxide, water soluble salt etc. one or more for use.
Amoxicillin slow release preparation compositions preparation method: necessary relevant auxiliary materials is made the plain sheet or the crude granule of molding by corresponding technology with amoxicillin and corresponding preparations molding the time, wraps slow-release material again and makes slow releasing tablet and sustained-release granular formulation; Perhaps slow-release material is incorporated in other required adjuvants of molding by existing granulating process preparation as the skeleton of slow release, granulation after drying, granulate become granule or further tabletting, promptly get sustained-release granular formulation and slow releasing tablet.Slow releasing capsule can be made compositions the suitable hybrid particles that contains slow-release material and be filled in the hard capsule; Or mixture such as amoxicillin, binding agent are made the pastille micropill by corresponding preparation technology, and again the pastille micropill is made sustained-release microparticle with the slow-release material coating, be filled into and promptly get the sustained-release micro-pill capsules agent in the hard capsule.The granulation of related preparations can be passed through the moulding process of corresponding preparations, the oral sustained release solubility preparation that gets final product correspondingly then by existing granulating process preparation such as dry method, wet method, spray drying, centrifugal granulating.
Amoxicillin slow release novel form provided by the invention can delay the rate of release of principal agent, reduces the number of times of taking of medicine, improves compliance of patients.
Amoxicillin slow release novel form preparation technology's quality controllability provided by the invention and good stability.
The specific embodiment
Embodiment 1
Slow releasing tablet
Prescription:
Amoxicillin trihydrate 344.38g (in amoxicillin 300.00g)
Hydroxypropyl emthylcellulose 70.00g
Starch 70.00g
Microcrystalline Cellulose 60.00g
Magnesium stearate 5.50g
4% polyvinylpyrrolidone, 75% alcoholic solution is an amount of
Make 1000
Preparation technology:
With amoxicillin trihydrate; hydroxypropyl emthylcellulose; starch; microcrystalline Cellulose; magnesium stearate is crossed behind 80 mesh sieves standby respectively; take by weighing hydroxypropyl emthylcellulose by recipe quantity; starch; microcrystalline Cellulose is put in the mixer behind the mixing; press equivalent incremental method mixing with amoxicillin trihydrate again; it is an amount of to add 4% polyvinylpyrrolidone, 75% alcoholic solution; granulate; granulate; 60 ℃ of dryings; dried granule adds the magnesium stearate mixing of recipe quantity; cross 16 eye mesh screen granulate with oscillating granulator; granule is carried out assay, and the heavy scope of definite sheet, tabletting; drying is packed after the passed examination.
Embodiment 2
Slow releasing tablet
Prescription: plain sheet
Amoxicillin 450.00g
Starch 23.00g
Lactose 22.00g
Magnesium stearate 5.00g
4% polyvinylpyrrolidone, 75% alcoholic solution is an amount of
Make 1000
Prescription: sustained release coating liquid
25 parts of hydroxypropyl emthylcelluloses
10 parts of ethyl celluloses
5 parts of propylene glycol
6 parts of titanium dioxide
4 parts of Pulvis Talci
2% ethyl cellulose ethanol liquid is an amount of
Preparation technology:
Amoxicillin, starch, lactose, magnesium stearate are crossed 100 mesh sieves respectively; take by weighing amoxicillin, starch, lactose by recipe quantity; put mixing in the mixer; it is an amount of to add 4% polyvinylpyrrolidone, 75% alcoholic solution; granulate; 65 ℃ of dry 30min; dried granule adds the magnesium stearate mixing of recipe quantity; cross 16 eye mesh screen granulate with oscillating granulator, granule is carried out assay, and the heavy scope of definite sheet; tabletting gets plain sheet; be equipped with coating solution by sustained release coating liquid prescription plain sheet is carried out coating, after the passed examination, packing.
Embodiment 3
Slow releasing capsule
Prescription:
Amoxicillin 300.00g
Hydroxypropyl emthylcellulose 60.00g
Ethyl cellulose 20.00g
Lactose 32.00g
Magnesium stearate 4.00g
4% polyvinylpyrrolidone, 85% alcoholic solution is an amount of
Make 1000
Preparation technology:
Amoxicillin, hydroxypropyl emthylcellulose, ethyl cellulose, lactose, magnesium stearate are crossed 80 mesh sieves respectively; take by weighing hydroxypropyl emthylcellulose, ethyl cellulose, lactose, magnesium stearate by recipe quantity; put in the mixer behind the mix homogeneously; press equivalent incremental method mixing with the amoxicillin again; 4% polyvinylpyrrolidone, 85% alcoholic solution is made soft material in right amount, granulates in granulation machine.With the above-mentioned granule that makes in 60 ℃ of dryings.Again by oscillating granulator, with 20 eye mesh screen granulate.Hybrid particles is carried out assay, and determine common hard capsule case range of capacity filling, pack after the passed examination.
Embodiment 4
Sustained-release micro-pill capsules
Prescription: crude granule
Amoxicillin trihydrate 344.38g (in amoxicillin 300.00g)
Microcrystalline Cellulose 35.00g
Cane sugar powder 16.00g
Magnesium stearate 4.00g
4% polyvinylpyrrolidone, 85% alcoholic solution is an amount of
Make 1000
Prescription: sustained release coating liquid
15 parts of hydroxypropyl emthylcelluloses
3 parts of propylene glycol
2 parts of titanium dioxide
1 part of sodium lauryl sulphate
2 parts of Pulvis Talci
Water is an amount of
Preparation technology:
Amoxicillin trihydrate, microcrystalline Cellulose, cane sugar powder, magnesium stearate are crossed 100 mesh sieves respectively; claim microcrystalline Cellulose, cane sugar powder, magnesium stearate by recipe quantity; put in the mixer behind the mix homogeneously; press equivalent incremental method mix homogeneously with amoxicillin trihydrate again; place the centrifugal granulator machine; spray into 4% polyvinylpyrrolidone, 85% alcoholic solution system crude granule; be equipped with coating solution by sustained release coating liquid prescription crude granule is carried out coating; coated granule is carried out assay, determine common hard capsule case range of capacity filling.After the passed examination, packing.
Embodiment 5
Sustained-release granular formulation
Prescription:
Amoxicillin 1000.00g
Cellulose ethyl hydroxypropyl ether 100.00g
Ethyl cellulose 23.00g
Starch 71.00g
Magnesium stearate 6.00g
30% polyvinylpyrrolidone, 90% alcoholic solution is an amount of
Make 1000 bags
Preparation technology:
Amoxicillin, Cellulose ethyl hydroxypropyl ether, ethyl cellulose, starch, magnesium stearate are crossed 80 mesh sieves respectively; taking by weighing Cellulose ethyl hydroxypropyl ether, ethyl cellulose, starch, magnesium stearate by recipe quantity puts in the mixer behind the mix homogeneously; press equivalent incremental method mixing with the amoxicillin again; 30% polyvinylpyrrolidone, 90% alcoholic solution is made soft material in right amount, granulates in granulation machine.With the above-mentioned granule that makes in 60 ℃ of dryings.Again by oscillating granulator, with 20 eye mesh screen granulate.Granule is carried out assay, pack after the passed examination.
Embodiment 6
Sustained-release granular formulation
Prescription: crude granule
Amoxicillin trihydrate 860.96g (in amoxicillin 750.00g)
Polyvinylpyrrolidone 60.00g
Starch 165.00g
Lactose 102.00g
Magnesium stearate 12.00g
80% ethanol is an amount of
Make 1000 bags
Prescription: sustained release coating liquid
30 parts of hydroxypropyl emthylcelluloses
5 parts of propylene glycol
6 parts of titanium dioxide
4 parts of Pulvis Talci
2% ethyl cellulose ethanol liquid is an amount of
Preparation technology:
Amoxicillin trihydrate, polyvinylpyrrolidone, starch, lactose, magnesium stearate are crossed 100 mesh sieves respectively; take by weighing polyvinylpyrrolidone, starch, lactose, magnesium stearate by recipe quantity; put in the mixer behind the mix homogeneously; press equivalent incremental method mixing with amoxicillin trihydrate again; place the centrifugal granulator machine; spray into 80% ethanol system crude granule; be equipped with coating solution by sustained release coating liquid prescription crude granule is carried out coating; coated granule is carried out assay; after the passed examination, packing.
Claims (10)
1. amoxicillin slow release preparation compositions and preparation method thereof, it is characterized in that: said composition is made up of amoxicillin, slow-release material and one or more pharmaceutically acceptable pharmaceutical carriers and/or adjuvant; Amoxicillin slow release preparation compositions specification is designated as 100～3000mg with the amoxicillin.
Amoxicillin slow release preparation compositions preparation method: necessary relevant auxiliary materials is made the plain sheet or the crude granule of molding by corresponding technology with amoxicillin and corresponding preparations molding the time, wraps slow-release material again and makes slow releasing tablet and sustained-release granular formulation; Perhaps slow-release material is incorporated in other required adjuvants of molding by existing granulating process preparation as the skeleton of slow release, granulation after drying, granulate become granule or further tabletting, promptly get sustained-release granular formulation and slow releasing tablet.Slow releasing capsule can be made compositions the suitable hybrid particles that contains slow-release material and be filled in the hard capsule; Or mixture such as amoxicillin, binding agent are made the pastille micropill by corresponding preparation technology, and again the pastille micropill is made sustained-release microparticle with the slow-release material coating, be filled into and promptly get the sustained-release micro-pill capsules agent in the hard capsule.
2. according to the described amoxicillin of claim 1, it is characterized in that it is amoxicillin hydrate and anhydrous amoxicillin, wherein preferred amoxicillin trihydrate.
3. according to described pharmaceutical carrier of claim 1 and adjuvant, be characterised in that it is filler, disintegrating agent, porogen, binding agent, lubricant, solubilizing agent, emulsifying agent, plasticizer, foaming agent, bleach activator, solvent etc.
4. according to the described slow-release material of claim 1, it is characterized in that being selected from the following material one or more: the solubility/insoluble salt of hydroxypropyl emthylcellulose, Cellulose ethyl hydroxypropyl ether, methylcellulose, ethyl cellulose, hydroxyethyl-cellulose, cellulose acetate, polyvinylpyrrolidone, polycarboxy ethene, sodium carboxymethyl cellulose, polyvinyl alcohol, Rikemal B 200, alginic acid etc.
5. binding agent according to claim 3 is characterised in that it is selected from the following material one or more: starch, gelatin, sugar (as sucrose, glucose, dextrose, lactose etc.), rubber polymer, sodium alginate, hydroxy methocel, methylcellulose, polyvinylpyrrolidone, Polyethylene Glycol, ethyl cellulose, water, wax, alcohol etc.
6. solubilizing agent according to claim 3 is characterised in that it can select tartaric acid, citric acid, Polyethylene Glycol etc. one or more for use.
7. lubricant according to claim 3 is characterised in that it can be selected from the following material one or more: Pulvis Talci, magnesium stearate, calcium stearate, stearic acid, hydrogenated vegetable oil, Polyethylene Glycol etc.
8. plasticizer according to claim 3 is characterised in that it can be selected from medium at least a of propylene glycol, glycerol, Polyethylene Glycol, triacetin, acetyl list monoglyceride, phthalic acid ester, Oleum Ricini.
9. porogen according to claim 3 is characterised in that it can select saccharide, mannitol, starch, Pulvis Talci, silicon dioxide, water soluble salt etc. one or more for use.
10. according to the described preparation method of claim 1, the granulation that it is characterized in that related preparations can be by existing granulating process preparation such as dry method, wet method, spray drying, centrifugal granulating, pass through the moulding process of corresponding preparations then, the oral sustained release solubility preparation that gets final product correspondingly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009100846349A CN101890006A (en) | 2009-05-18 | 2009-05-18 | Amoxicillin sustained-release preparation composition and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009100846349A CN101890006A (en) | 2009-05-18 | 2009-05-18 | Amoxicillin sustained-release preparation composition and preparation method thereof |
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| CN101890006A true CN101890006A (en) | 2010-11-24 |
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| CN2009100846349A Pending CN101890006A (en) | 2009-05-18 | 2009-05-18 | Amoxicillin sustained-release preparation composition and preparation method thereof |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102727491A (en) * | 2012-06-28 | 2012-10-17 | 王纯金 | Acid type amoxicillin and production method thereof |
| CN104983692A (en) * | 2015-07-17 | 2015-10-21 | 江西博莱大药厂有限公司 | Amoxicillin slow release pellet and preparation method thereof |
| CN105832694A (en) * | 2016-03-25 | 2016-08-10 | 海南汤臣史克生物科技有限公司 | Penicillins medicine capsule and preparation method of same |
| CN108888603A (en) * | 2018-09-07 | 2018-11-27 | 石药集团中诺药业（石家庄）有限公司 | A kind of amoxicillin tablets of reliable in quality |
| CN112263569A (en) * | 2020-11-05 | 2021-01-26 | 南京致中生物科技有限公司 | Amoxicillin capsule and preparation method thereof |
| CN113116860A (en) * | 2021-04-22 | 2021-07-16 | 海南通用三洋药业有限公司 | Amoxicillin capsule and preparation method thereof |
-
2009
- 2009-05-18 CN CN2009100846349A patent/CN101890006A/en active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102727491A (en) * | 2012-06-28 | 2012-10-17 | 王纯金 | Acid type amoxicillin and production method thereof |
| CN104983692A (en) * | 2015-07-17 | 2015-10-21 | 江西博莱大药厂有限公司 | Amoxicillin slow release pellet and preparation method thereof |
| CN105832694A (en) * | 2016-03-25 | 2016-08-10 | 海南汤臣史克生物科技有限公司 | Penicillins medicine capsule and preparation method of same |
| CN108888603A (en) * | 2018-09-07 | 2018-11-27 | 石药集团中诺药业（石家庄）有限公司 | A kind of amoxicillin tablets of reliable in quality |
| CN108888603B (en) * | 2018-09-07 | 2020-11-24 | 石药集团中诺药业（石家庄）有限公司 | Amoxicillin tablet and preparation method thereof |
| CN112263569A (en) * | 2020-11-05 | 2021-01-26 | 南京致中生物科技有限公司 | Amoxicillin capsule and preparation method thereof |
| CN112263569B (en) * | 2020-11-05 | 2022-07-08 | 贝克诺顿(浙江)制药有限公司 | Amoxicillin capsule and preparation method thereof |
| CN113116860A (en) * | 2021-04-22 | 2021-07-16 | 海南通用三洋药业有限公司 | Amoxicillin capsule and preparation method thereof |
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Application publication date: 20101124 |