CN101401810A - Dispersible tablet containing Cefixime and preparation method thereof - Google Patents
Dispersible tablet containing Cefixime and preparation method thereof Download PDFInfo
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- CN101401810A CN101401810A CNA2008102265995A CN200810226599A CN101401810A CN 101401810 A CN101401810 A CN 101401810A CN A2008102265995 A CNA2008102265995 A CN A2008102265995A CN 200810226599 A CN200810226599 A CN 200810226599A CN 101401810 A CN101401810 A CN 101401810A
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- cefixime
- dispersible tablet
- cellulose
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Abstract
The invention belongs to the technical field of pharmaceutical preparation, and in particular relates to a cefixime dispersible tablet and a method for preparing the same. The method comprises the following steps: firstly, weighing cefixime, starch, microcrystalline cellulose, partially cross-linked polyvinylpyrrolidone, partially cross-linked sodium carboxymethyl cellulose, and partially low substituted-hydroxypropyl cellulose, and mixing the components evenly; secondly, dripping 5 percent polyvinylpyrrolidone K30 ethanol solution into the mixture prepare a soft material, and performing granulating through a sieve of between 18 and 24 meshes; thirdly, drying wet particles at a temperature of between 50 and 80 DEG C, palletizing the particles through the sieve of between 18 and 24 meshes, adding the remaining cross-linked polyvinylpyrrolidone, the remaining cross-linked sodium carboxymethyl cellulose, and the remaining low substituted-hydroxypropyl cellulose, magnesium stearate and superfine silica gel powder into the mixture to be mixed evenly, and tabletting the mixture to obtain the required cefixime dispersible tablet. The cefixime dispersible tablet has the characteristics of rapid disintegration with water, even dispersion, high dissolution, and convenient taking and carrying around.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition that contains cefixime, more particularly, the present invention relates to a kind of cefixime dispersible tablet.The invention still further relates to the preparation method of described cefixime dispersible tablet.
Background technology
Cefixime (Cefixime) is to the stable oral semi-synthetic cephalosporins of beta-lactamase, is first oral third generation cephalosporin of Japanese rattan pool company research and development, at first goes on the market in Japan in 1987.The characteristics of cefixime are has a broad antifungal spectrum, anti-enzyme, long-acting, convenient oral, and the fastbacteria that can not resist other oral cephalos comprises that escherichia coli, pneumobacillus, gonococcus all show good antibacterial action.
Cefixime antibacterial action mechanism is similar to other third generation cephalosporin, and by combining with one or more penicillin-binding protein, the cell wall that suppresses the antibacterial somatoblast is synthetic.Penicillin-binding protein is positioned on the bacterial cell plasma membrane, may be the bacteria cell wall catalyzing enzyme in synthetic latter stage, and the exercising result of this product is that antibacterial is formed the unsettled deficient cells wall of osmotic pressure, thereby plays antibacterial action.The affinity of different penicillin-binding proteins is not both influences the active principal element of cefixime antimicrobial spectrum, and 1 (1a, 1b, 1c) and 3 has than high-affinity in its main and penicillin-binding protein.
Because cefixime poorly soluble in water, it is relatively poor that conventional tablet exists disintegrating property, and the deficiency that onset is slower limits and weakened cefixime to the gastrointestinal protective effect.The cefixime dosage is bigger, and the exploitation cefixime dispersible tablet also helps always, the patient young and difficulty of swallowing takes.
Summary of the invention
The objective of the invention is at the deficiencies in the prior art, overcome the limitation of cefixime ordinary tablet, the methods and applications of preparation cefixime dispersible tablet are provided.This dosage form can significantly be carried the disintegration rate and the dissolving out capability of medicine.
Purpose of the present invention is achieved by following technical proposals.Except as otherwise noted, percent of the present invention is percetage by weight.
Cefixime dispersible tablet of the present invention, every contains cefixime 25～500mg and pharmaceutic adjuvant, described pharmaceutic adjuvant comprise filler 0～200mg, binding agent 0～200mg. disintegrating agent or swellability adjuvant 2～300mg, lubricant 0.1～20mg, fluidizer 0.1～15mg, antitack agent 0～15mg, aromatic and sweeting agent 0～15mg.Described filler is selected from a kind of in starch, dextrin, Icing Sugar, lactose, mannitol or the microcrystalline Cellulose or their mixture: described wetting agent is selected from water or ethanol or their mixture; Described binding agent is selected from a kind of of starch slurry, hydroxypropyl starch, modified starch, pregelatinized Starch, dextrin, Icing Sugar, syrup, microcrystalline Cellulose, cellulose derivative (comprising hydroxypropyl emthylcellulose, methylcellulose, sodium carboxymethyl cellulose, ethyl cellulose), polyvinylpyrrolidone rubber cement, gelatine size or their mixture; Described disintegrating agent or swellability adjuvant are selected from hydroxypropyl starch, modified starch, starch, carboxymethyl starch sodium, microcrystalline Cellulose, cellulose derivative (comprises hydroxypropyl emthylcellulose, methylcellulose, sodium carboxymethyl cellulose, the low hyprolose that replaces, cross-linking sodium carboxymethyl cellulose, carboxy-propyl cellulose, carboxymethylcellulose calcium), crospolyvinylpyrrolidone, tween 80, sodium lauryl sulphate, guar gum, Herba Xanthii glue, a kind of in the xanthan gum or their mixture; Described lubricant, fluidizer, antitack agent are selected from a kind of in modified starch, microcrystalline Cellulose, aluminium hydroxide, boric acid, hydrogenated vegetable oil, Polyethylene Glycol, magnesium stearate, Pulvis Talci, Stepanol MG, sodium lauryl sulphate or the micropowder silica gel or their mixture; Described aromatic and sweeting agent are selected from a kind of in stevioside, essence or the aspartame or their mixture.
The preferential composition of cefixime dispersible tablet of the present invention is:
Every comprises cefixime 25～500mg, starch 0～200mg, microcrystalline Cellulose 0～200mg, crospolyvinylpyrrolidone 2～200mg, cross-linking sodium carboxymethyl cellulose 0～200mg, a low hyprolose 0～200mg that replaces, micropowder silica gel 0～15mg, magnesium stearate 0.1～20mg, sodium lauryl sulphate 0～15mg, stevioside 0～15mg.
Preparation method of the present invention comprises the step of following order:
1. take by weighing cefixime, starch, microcrystalline Cellulose, partial cross-linked polyvinylpyrrolidone, partial cross-linked sodium carboxymethyl cellulose, a low hyprolose, the mix homogeneously of replacing of part;
2. Dropwise 5 % polyvinylpyrrolidone K30 ethanol liquid system soft material: cross 18～24 mesh sieves and granulate;
3. wet granular carries out drying under 50～80 ℃ of conditions;
4. with 18～24 mesh sieve granulate, add the residue crospolyvinylpyrrolidone, residue cross-linking sodium carboxymethyl cellulose, the low hyprolose that replaces of residue, magnesium stearate and micropowder silica gel mixing, tabletting promptly gets required cefixime dispersible tablet.
The specific embodiment
By specific embodiment given below, can further be well understood to the present invention, but they not limitation of the invention.
Embodiment 1
Take by weighing cefixime 100g, pregelatinized Starch 20g, microcrystalline Cellulose 40g, crospolyvinylpyrrolidone 20g, mix homogeneously; Dropwise 5 %PVP K30 ethanol liquid system soft material is crossed 18～30 mesh sieves and is granulated, and wet grain carries out drying under 50～80 ℃ of conditions, with 18～30 mesh sieve granulate, adds magnesium stearate 3g and micropowder silica gel 1g mixing, and tabletting is made 1000 flake products.
Embodiment 2
Take by weighing cefixime 50g, microcrystalline Cellulose 20g, crospolyvinylpyrrolidone 10g, low-substituted hydroxypropyl cellulose 10g, mix homogeneously; Dropwise 5 %PVP K30 ethanol liquid system soft material is crossed 18～30 mesh sieves and is granulated, and wet grain carries out drying under 50～80 ℃ of conditions, with 18～30 mesh sieve granulate, add crospolyvinylpyrrolidone 10g, the low hyprolose 10g that replaces, magnesium stearate 5g mixing, tabletting is made 1000 flake products.
Embodiment 3
Take by weighing cefixime 50g, lactose 20g, guar gum 10g, crospolyvinylpyrrolidone 20g, sodium lauryl sulphate 1g, stevioside 2g, mix homogeneously; Dropwise 5 %PVP K30 ethanol liquid system soft material is crossed 18～30 mesh sieves and is granulated, and wet grain carries out drying under 50～80 ℃ of conditions, with 18～30 mesh sieve granulate, adds Pulvis Talci 2g and micropowder silica gel 1g mixing, and tabletting is made 1000 flake products.
Embodiment 4
Take by weighing cefixime 100g, pregelatinized Starch 5g, microcrystalline Cellulose 20g, cross-linking sodium carboxymethyl cellulose 20g, mix homogeneously; Dropwise 5 %PVP K30 ethanol liquid system soft material is crossed 18～30 mesh sieves and is granulated, and wet grain carries out drying under 50～80 ℃ of conditions, with 18～30 mesh sieve granulate, adds cross-linking sodium carboxymethyl cellulose 20g, magnesium stearate 5g mixing, and tabletting is made 1000 flake products.
Embodiment 5
Take by weighing cefixime 100g, microcrystalline Cellulose 20g, crospolyvinylpyrrolidone 25g, low-substituted hydroxypropyl cellulose 20g, essence (Fructus Citri tangerinae) 5g, mix homogeneously; Dropwise 5 %PVP K30 ethanol liquid system soft material is crossed 18～30 mesh sieves and is granulated, and wet grain carries out drying under 50～80 ℃ of conditions, with 18～30 mesh sieve granulate, adds magnesium stearate 3g and micropowder silica gel 1.5g, mixing, and tabletting is made 1000 flake products.
Embodiment 6
Take by weighing cefixime 100g, lactose 20g, mannitol 10g, microcrystalline Cellulose 20g, crospolyvinylpyrrolidone 30g, mix homogeneously; Dropwise 5 %PVP K30 ethanol liquid system soft material is crossed 18～30 mesh sieves and is granulated, and wet grain carries out drying under 50～80 ℃ of conditions, with 18～30 mesh sieve granulate, adds crospolyvinylpyrrolidone 20g, magnesium stearate 5g mixing, and tabletting is made 1000 flake products.
Embodiment 7
Take by weighing cefixime 200g, microcrystalline Cellulose 20g, crospolyvinylpyrrolidone 30g, mix homogeneously; Dropwise 5 %PVP K30 ethanol liquid system soft material is crossed 18～30 mesh sieves and is granulated, and wet grain carries out drying under 50～80 ℃ of conditions, with 18～30 mesh sieve granulate, add crospolyvinylpyrrolidone 20g, magnesium stearate 3g and micropowder silica gel 2g, mixing, tabletting is made 1000 flake products.
Embodiment 8
Take by weighing cefixime 200g, crospolyvinylpyrrolidone 40g, mix homogeneously; Dropwise 5 %PVP K30 ethanol liquid system soft material is crossed 18～30 mesh sieves and is granulated, and wet grain carries out drying under 50～80 ℃ of conditions, with 18～30 mesh sieve granulate, adds crospolyvinylpyrrolidone 40g, magnesium stearate 5g mixing, and tabletting is made 1000 flake products.
Embodiment 9
Take by weighing cefixime 200g, starch 10g, microcrystalline Cellulose 40g, crospolyvinylpyrrolidone 20g, Stepanol MG 3g, stevioside 3g, mix homogeneously; Dropwise 5 %PVP K30 ethanol liquid system soft material is crossed 18～30 mesh sieves and is granulated, and wet grain carries out drying under 50～80 ℃ of conditions, with 18～30 mesh sieve granulate, adds magnesium stearate 5g and micropowder silica gel 1.5g, mixing, and tabletting is made 1000 flake products.
Embodiment 10
Take by weighing cefixime 200g, lactose 10g, microcrystalline Cellulose 100g, essence (Fructus Citri tangerinae) 5g, stevioside 3g, mix homogeneously; Dropwise 5 %PVP K30 ethanol liquid system soft material is crossed 18～30 mesh sieves and is granulated, and wet grain carries out drying under 50～80 ℃ of conditions, add cross-linking sodium carboxymethyl cellulose 40g with 18～30 mesh sieve granulate, magnesium stearate 5g, and mixing, tabletting is made 1000 flake products.
Embodiment 11
Take by weighing cefixime 200g, starch 10g, microcrystalline Cellulose 40g, low-substituted hydroxypropyl cellulose 40g, sodium lauryl sulphate 3g, mix homogeneously; Dropwise 5 %PVP K30 ethanol liquid system soft material is crossed 18～30 mesh sieves and is granulated, and wet grain carries out drying under 50～80 ℃ of conditions, with 18～30 mesh sieve granulate, adds Pulvis Talci 2g and micropowder silica gel 2g, mixing, and tabletting is made 1000 flake products.
Embodiment 12
Take by weighing cefixime 250g, mannitol 10g, microcrystalline Cellulose 30g, crospolyvinylpyrrolidone 50g, sodium lauryl sulphate 6g, mix homogeneously; Dropwise 5 %PVP K30 ethanol liquid system soft material is crossed 18～30 mesh sieves and is granulated, and wet grain carries out drying under 50～80 ℃ of conditions, with 18～30 mesh sieve granulate, adds magnesium stearate 8g, mixing, and tabletting is made 1000 flake products.
Embodiment 13
Take by weighing cefixime 250g, crospolyvinylpyrrolidone 40g, low-substituted hydroxypropyl cellulose 40g, sodium lauryl sulphate 6g, stevioside 5g, mix homogeneously; Dropwise 5 %PVP K30 ethanol liquid system soft material is crossed 18～30 mesh sieves and is granulated, and wet grain carries out drying under 50～80 ℃ of conditions, with 18～30 mesh sieve granulate, adds magnesium stearate 5g and micropowder silica gel 2g, mixing, and tabletting is made 1000 flake products.
Embodiment 14
Take by weighing cefixime 500g, starch 10g, crospolyvinylpyrrolidone 200g, Herba Xanthii glue 20g, Stepanol MG 3g, stevioside 3g, mix homogeneously; Dropwise 5 %PVP K30 ethanol liquid system soft material is crossed 18～30 mesh sieves and is granulated, and wet grain carries out drying under 50～80 ℃ of conditions, with 18～30 mesh sieve granulate, add crospolyvinylpyrrolidone 50g, magnesium stearate 5g and micropowder silica gel 1.5g, mixing, tabletting is made 1000 flake products.
Claims (3)
1, a kind of cefixime dispersible tablet, wherein every contains cefixime 25～250mg, starch 0～200mg, microcrystalline Cellulose 0～200mg, low-substituted hydroxypropyl cellulose 0～200mg, crospolyvinylpyrrolidone 2～200mg, cross-linking sodium carboxymethyl cellulose 0～200mg, micropowder silica gel 0～15mg, magnesium stearate 0.1～20mg, sodium lauryl sulphate 0～15mg, stevioside 0～15mg.
2, the preparation method of cefixime dispersible tablet according to claim 1, its concrete steps are as follows:
2.1 take by weighing cefixime, starch, microcrystalline Cellulose, sodium lauryl sulphate, stevioside, partial cross-linked polyvinylpyrrolidone, partial cross-linked sodium carboxymethyl cellulose, part low-substituted hydroxypropyl cellulose, mix homogeneously;
2.2 Dropwise 5 % polyvinylpyrrolidone K30 ethanol liquid system soft material is crossed 18～24 mesh sieves and is granulated;
2.3 wet granular carries out drying under 50～80 ℃ of conditions;
2.4 with 18～24 mesh sieve granulate, add the residue crospolyvinylpyrrolidone, residue cross-linking sodium carboxymethyl cellulose, residue low-substituted hydroxypropyl cellulose, magnesium stearate and micropowder silica gel mixing, tabletting promptly gets required cefixime dispersible tablet.
3, the purposes of cefixime dispersible tablet according to claim 1 in the medicine of preparation bacterial-infection resisting.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008102265995A CN101401810A (en) | 2008-11-17 | 2008-11-17 | Dispersible tablet containing Cefixime and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CNA2008102265995A CN101401810A (en) | 2008-11-17 | 2008-11-17 | Dispersible tablet containing Cefixime and preparation method thereof |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102670536A (en) * | 2012-06-08 | 2012-09-19 | 上海新亚药业有限公司 | Method for preparing cefixime dispersible tablets |
| CN101606913B (en) * | 2009-07-16 | 2012-12-19 | 广州白云山制药股份有限公司广州白云山制药总厂 | Cefixime dispersing tablet and preparation methods thereof |
| CN103040782A (en) * | 2013-01-24 | 2013-04-17 | 南京正宽医药科技有限公司 | Cefixime tablets and preparation method thereof |
| CN101889987B (en) * | 2009-11-16 | 2013-12-04 | 江苏亚邦强生药业有限公司 | Method for preparing novel cefixime tablets and cefixime capsules |
| CN103479587A (en) * | 2013-09-06 | 2014-01-01 | 海南葫芦娃制药有限公司 | Cefixime dispersible tablets and preparation method thereof |
| CN106137990A (en) * | 2016-07-29 | 2016-11-23 | 花园药业股份有限公司 | Azithromycin dispersible tablet and preparation technology thereof |
| CN111544412A (en) * | 2020-04-17 | 2020-08-18 | 广州白云山医药集团股份有限公司白云山制药总厂 | Cefixime composition and preparation method thereof |
| CN113081988A (en) * | 2021-05-10 | 2021-07-09 | 河北医科大学 | Cefradine dispersible tablet and preparation method thereof |
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2008
- 2008-11-17 CN CNA2008102265995A patent/CN101401810A/en active Pending
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101606913B (en) * | 2009-07-16 | 2012-12-19 | 广州白云山制药股份有限公司广州白云山制药总厂 | Cefixime dispersing tablet and preparation methods thereof |
| CN101889987B (en) * | 2009-11-16 | 2013-12-04 | 江苏亚邦强生药业有限公司 | Method for preparing novel cefixime tablets and cefixime capsules |
| CN102670536A (en) * | 2012-06-08 | 2012-09-19 | 上海新亚药业有限公司 | Method for preparing cefixime dispersible tablets |
| CN103040782A (en) * | 2013-01-24 | 2013-04-17 | 南京正宽医药科技有限公司 | Cefixime tablets and preparation method thereof |
| CN103479587A (en) * | 2013-09-06 | 2014-01-01 | 海南葫芦娃制药有限公司 | Cefixime dispersible tablets and preparation method thereof |
| CN103479587B (en) * | 2013-09-06 | 2015-10-21 | 海南葫芦娃制药有限公司 | Cefixime dispersible tablet and preparation method thereof |
| CN106137990A (en) * | 2016-07-29 | 2016-11-23 | 花园药业股份有限公司 | Azithromycin dispersible tablet and preparation technology thereof |
| CN111544412A (en) * | 2020-04-17 | 2020-08-18 | 广州白云山医药集团股份有限公司白云山制药总厂 | Cefixime composition and preparation method thereof |
| CN111544412B (en) * | 2020-04-17 | 2022-06-24 | 广州白云山医药集团股份有限公司白云山制药总厂 | Cefixime composition and preparation method thereof |
| CN113081988A (en) * | 2021-05-10 | 2021-07-09 | 河北医科大学 | Cefradine dispersible tablet and preparation method thereof |
| CN113081988B (en) * | 2021-05-10 | 2022-07-12 | 河北医科大学 | Cefradine dispersible tablet and preparation method thereof |
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Open date: 20090408 |