CN104706618A - Amoxicillin capsules and preparation method thereof - Google Patents
Amoxicillin capsules and preparation method thereof Download PDFInfo
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- CN104706618A CN104706618A CN201510070123.7A CN201510070123A CN104706618A CN 104706618 A CN104706618 A CN 104706618A CN 201510070123 A CN201510070123 A CN 201510070123A CN 104706618 A CN104706618 A CN 104706618A
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- amoxicillin
- amoxicillin capsules
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Abstract
The invention relates to amoxicillin capsules and a preparation method thereof, through preferable selection of a filling agent, a disintegrating agent and a lubricant, and through dry-process preparation, the method is simple and easy to operate, effectively controls the generation of high-molecular impurities in a production process, and reduces toxic and side effects; and the drug dissolution degree is high, and an ideal drug effect is achieved.
Description
Technical field
The invention belongs to field of medicaments, in particular to being specially a kind of Amoxicillin Capsules and preparation method thereof.
Background technology
Amoxicillin, be a kind of the most frequently used semi-synthetic penicillins wide spectrum beta-lactam antibiotic, stablize in acid condition, gastrointestinal absorption rate reaches 90%.Amoxicillin bactericidal action is strong, and the ability of permeates cell membranes is also strong, is one of current widely used oral semisynthetic penicillin.Lactam group in drug after oral administration molecule is hydrolyzed generation peptide bond immediately, rapid and endobacillary transpeptidase combines and makes it inactivation, having cut off thalline relies on transpeptidase synthesis glycopeptide to be used for building the unique channel of cell wall, bacterial cell is made to become spheroplast rapidly and dissolving of breaking, thalline is finally because of cell wall loss, and moisture content constantly permeates and spalling is dead.The G+ bacterium of cause a disease to great majority and G-bacterium (comprising coccus and bacillus) all have powerful antibacterial and bactericidal action.Wherein to the Streptococcus such as streptococcus pneumoniae, Hemolytic streptococcus, do not produce the aerobic gram positive coccus such as penicillinase staphylococcus, enterococcus faecalis, the aerobic gram-negative bacteria such as escherichia coli, proteus mirabilis, Salmonella, hemophilus influenza, Diplococcus gonorrhoeae do not produce beta lactamase bacterial strain and helicobacter pylori has good antibacterial activity.
Due to the unstability of the beta-lactam structure in Penicillin antibiotics, very easily there is intermolecular polyreaction in amoxicillin, forms the macromolecule impurity with sensitization, make the anaphylaxis of its preparation become a problem that can not be ignored clinically.Macromolecule impurity in general oral amoxicillin preparation can not produce penicillin allergy when being less than 0.2%, therefore controls the macromolecule impurity content in Wymox, is reduce the anaphylactoid fundamental way of this type of antibiotic.
Summary of the invention
The object of this invention is to provide a kind of Amoxicillin Capsules and preparation method thereof, improve production security, reduce macromolecule impurity, improve drug solubility and stability.
The object of the invention is to be achieved through the following technical solutions:
A kind of Amoxicillin Capsules, comprises following raw material components (by weight percentage):
Described filler is one or more in lactose, microcrystalline Cellulose, mannitol, starch, sucrose, oligochitosan.
Described disintegrating agent be in low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, alginate, hydroxypropyl cellulose, hydroxypropyl starch sodium, carboxymethyl starch sodium, sodium lauryl sulphate one or more.
Described lubricant: in Pulvis Talci, zinc stearate, magnesium stearate, silicon dioxide one or more.
Preferred version is described filler is starch and oligochitosan, and disintegrating agent is carboxymethyl starch sodium, and lubricant is silicon dioxide.
According to a kind of Amoxicillin Capsules described above, be prepared as follows and form:
(1) by amoxicillin and filler mix homogeneously;
(2) hybrid medicine of step (1) and dry nitrogen are injected jointly super micron mill to carry out pulverizing for 0.5 ~ 1.5 hour under the operating temperature of the operating pressure of 1.0 ~ 1.8MPa and 35 DEG C ~ 60 DEG C, reaching particle diameter is 800 ~ 1000 object fine powders;
(3) above-mentioned fine powder and disintegrating agent, mix lubricant is even, drop into dry granulating machine, squeeze pressure is 8KPa ~ 16KPa, obtains flake drug;
(4) flake drug of step (3) is broken for granule through concussion, after crossing 60 eye mesh screens, enters capsulae vacuus according to medicament contg fill and namely obtain Amoxicillin Capsules.
Positive beneficial effect of the present invention:
A kind of Amoxicillin Capsules of the present invention, preparation method is simply easy to operation, and the macromolecule impurity effectively controlled in production process produces, and reduce toxic and side effects, drug dissolution is high, reaches desirable drug effect.
Detailed description of the invention
The embodiment below provided, will contribute to the present invention is described, but invention is not limited to embodiment.
Embodiment 1
A kind of Amoxicillin Capsules, comprises following raw material components (by weight percentage):
Filler is sucrose, and disintegrating agent is low-substituted hydroxypropyl cellulose, and lubricant is magnesium stearate.
According to a kind of Amoxicillin Capsules described above, be prepared as follows and form:
(1) by amoxicillin and filler mix homogeneously;
(2) hybrid medicine of step (1) and dry nitrogen are injected jointly super micron mill to carry out pulverizing for 1 hour under the operating temperature of the operating pressure of 1.4MPa and 40 DEG C, reaching particle diameter is 800 ~ 1000 object fine powders;
(3) above-mentioned fine powder and disintegrating agent, mix lubricant is even, drop into dry granulating machine, squeeze pressure is 10KPa, obtains flake drug;
(4) flake drug of step (3) is broken for granule through concussion, after crossing 60 eye mesh screens, enters capsulae vacuus according to medicament contg fill and namely obtain Amoxicillin Capsules.
By the Amoxicillin Capsules disintegrate that obtains 5 minutes, dissolution was 95.3%; Hplc determination macromolecule impurity content is adopted to be 0.08%.
Embodiment 2
A kind of Amoxicillin Capsules, comprises following raw material components (by weight percentage):
Filler is starch and oligochitosan, and disintegrating agent is carboxymethyl starch sodium, and lubricant is silicon dioxide.
According to a kind of Amoxicillin Capsules described above, be prepared as follows and form:
(1) by amoxicillin and filler mix homogeneously;
(2) hybrid medicine of step (1) and dry nitrogen are injected jointly super micron mill to carry out pulverizing for 1.2 hours under the operating temperature of the operating pressure of 1.5MPa and 40 DEG C, reaching particle diameter is 800 ~ 1000 object fine powders;
(3) above-mentioned fine powder and disintegrating agent, mix lubricant is even, drop into dry granulating machine, squeeze pressure is 9KPa, obtains flake drug;
(4) flake drug of step (3) is broken for granule through concussion, after crossing 60 eye mesh screens, enters capsulae vacuus according to medicament contg fill and namely obtain Amoxicillin Capsules.
By the Amoxicillin Capsules disintegrate that obtains 5 minutes, dissolution was 96.4%; Hplc determination macromolecule impurity content is adopted to be 0.07%.
Embodiment 3
A kind of Amoxicillin Capsules, comprises following raw material components (by weight percentage):
Filler is microcrystalline Cellulose, and disintegrating agent is hydroxypropyl cellulose, and lubricant is zinc stearate.
According to a kind of Amoxicillin Capsules described above, be prepared as follows and form:
(1) by amoxicillin and filler mix homogeneously;
(2) hybrid medicine of step (1) and dry nitrogen are injected jointly super micron mill to carry out pulverizing for 1.5 hours under the operating temperature of the operating pressure of 1.6MPa and 45 DEG C, reaching particle diameter is 800 ~ 1000 object fine powders;
(3) above-mentioned fine powder and disintegrating agent, mix lubricant is even, drop into dry granulating machine, squeeze pressure is 10KPa, obtains flake drug;
(4) flake drug of step (3) is broken for granule through concussion, after crossing 60 eye mesh screens, enters capsulae vacuus according to medicament contg fill and namely obtain Amoxicillin Capsules.
By the Amoxicillin Capsules disintegrate that obtains 5 minutes, dissolution was 94.9%; Hplc determination macromolecule impurity content is adopted to be 0.09%.
The above; be only the present invention's preferably detailed description of the invention; but protection scope of the present invention is not limited thereto; anyly be familiar with those skilled in the art in the technical scope that the present invention discloses; be equal to according to technical scheme of the present invention and inventive concept thereof and replaced or conversion, all should be encompassed within protection scope of the present invention.
Claims (5)
1. an Amoxicillin Capsules, is characterized in that, raw material components (by weight percentage):
A kind of Amoxicillin Capsules according to claim 1, is characterized in that, described filler is one or more in lactose, microcrystalline Cellulose, mannitol, starch, sucrose, oligochitosan.
2. a kind of Amoxicillin Capsules according to claim 1, it is characterized in that, described disintegrating agent be in low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, alginate, hydroxypropyl cellulose, hydroxypropyl starch sodium, carboxymethyl starch sodium, sodium lauryl sulphate one or more.
3. a kind of Amoxicillin Capsules according to claim 1, is characterized in that, described lubricant: in Pulvis Talci, zinc stearate, magnesium stearate, silicon dioxide one or more.
4. a kind of Amoxicillin Capsules according to claim 1, is characterized in that, described filler is starch and oligochitosan, and disintegrating agent is carboxymethyl starch sodium, and lubricant is silicon dioxide.
5. a kind of Amoxicillin Capsules according to claim 1, is characterized in that, described a kind of Amoxicillin Capsules, is prepared as follows and forms:
(1) by amoxicillin and filler mix homogeneously;
(2) hybrid medicine of step (1) and dry nitrogen are injected jointly super micron mill to carry out pulverizing for 0.5 ~ 1.5 hour under the operating temperature of the operating pressure of 1.0 ~ 1.8MPa and 35 DEG C ~ 60 DEG C, reaching particle diameter is 800 ~ 1000 object fine powders;
(3) above-mentioned fine powder and disintegrating agent, mix lubricant is even, drop into dry granulating machine, squeeze pressure is 8KPa ~ 16KPa, obtains flake drug;
(4) flake drug of step (3) is broken for granule through concussion, after crossing 60 eye mesh screens, enters capsulae vacuus according to medicament contg fill and namely obtain Amoxicillin Capsules.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510070123.7A CN104706618A (en) | 2015-02-04 | 2015-02-04 | Amoxicillin capsules and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510070123.7A CN104706618A (en) | 2015-02-04 | 2015-02-04 | Amoxicillin capsules and preparation method thereof |
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| CN104706618A true CN104706618A (en) | 2015-06-17 |
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| CN201510070123.7A Pending CN104706618A (en) | 2015-02-04 | 2015-02-04 | Amoxicillin capsules and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105796528A (en) * | 2016-05-31 | 2016-07-27 | 海南通用三洋药业有限公司 | Amoxicillin and dicloxacillin sodium compound medicine composition |
| CN107095857A (en) * | 2017-04-26 | 2017-08-29 | 四川制药制剂有限公司 | The production technology of Biomox |
| CN107875136A (en) * | 2017-12-27 | 2018-04-06 | 广州白云山医药集团股份有限公司白云山制药总厂 | A kind of Amoxicillin pharmaceutical preparation and preparation method thereof |
| CN112156082A (en) * | 2020-11-16 | 2021-01-01 | 海南海力制药有限公司 | Amoxicillin capsule preparation method and amoxicillin capsule |
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| WO2006066930A1 (en) * | 2004-12-24 | 2006-06-29 | Lek Pharmaceuticals D.D. | Stable pharmaceutical composition comprising amoxicillin and clavulanic acid |
| CN101390837A (en) * | 2008-11-10 | 2009-03-25 | 海南美大制药有限公司 | Amoxicillin granule and production method thereof |
| CN101390846A (en) * | 2008-11-10 | 2009-03-25 | 海南美大制药有限公司 | Amoxicillin capsule and production method thereof |
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| EP2601947A1 (en) * | 2011-12-05 | 2013-06-12 | Abo Bakr Mohammed Ali Al-Mehdar | Fixed-dose combination for treatment of helicobacter pylori associated diseases |
| CN103735529A (en) * | 2014-01-22 | 2014-04-23 | 华北制药股份有限公司 | Preparation method of amoxil dry-method granulated capsules |
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2015
- 2015-02-04 CN CN201510070123.7A patent/CN104706618A/en active Pending
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| WO2006066930A1 (en) * | 2004-12-24 | 2006-06-29 | Lek Pharmaceuticals D.D. | Stable pharmaceutical composition comprising amoxicillin and clavulanic acid |
| CN101390837A (en) * | 2008-11-10 | 2009-03-25 | 海南美大制药有限公司 | Amoxicillin granule and production method thereof |
| CN101390846A (en) * | 2008-11-10 | 2009-03-25 | 海南美大制药有限公司 | Amoxicillin capsule and production method thereof |
| KR20110098565A (en) * | 2010-02-26 | 2011-09-01 | 일양약품주식회사 | Oral pharmaceutical composition for preventing or treating a gastroenteric disease comprising ilaprazole, antibiotics and/or lactic acid bacteria |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105796528A (en) * | 2016-05-31 | 2016-07-27 | 海南通用三洋药业有限公司 | Amoxicillin and dicloxacillin sodium compound medicine composition |
| CN107095857A (en) * | 2017-04-26 | 2017-08-29 | 四川制药制剂有限公司 | The production technology of Biomox |
| CN107875136A (en) * | 2017-12-27 | 2018-04-06 | 广州白云山医药集团股份有限公司白云山制药总厂 | A kind of Amoxicillin pharmaceutical preparation and preparation method thereof |
| CN107875136B (en) * | 2017-12-27 | 2021-03-05 | 广州白云山医药集团股份有限公司白云山制药总厂 | Amoxicillin medicinal preparation and preparation method thereof |
| CN112156082A (en) * | 2020-11-16 | 2021-01-01 | 海南海力制药有限公司 | Amoxicillin capsule preparation method and amoxicillin capsule |
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Application publication date: 20150617 |