CN100411621C - Cefixime oral disintegration tablet and its preparation method - Google Patents
Cefixime oral disintegration tablet and its preparation method Download PDFInfo
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- CN100411621C CN100411621C CNB2006100329353A CN200610032935A CN100411621C CN 100411621 C CN100411621 C CN 100411621C CN B2006100329353 A CNB2006100329353 A CN B2006100329353A CN 200610032935 A CN200610032935 A CN 200610032935A CN 100411621 C CN100411621 C CN 100411621C
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Abstract
The present invention discloses a cefixime oral disintegration tablet and a preparation method thereof. The present invention solves technical problems to realize that a cefixime oral preparation has short disintegration time and production cost is reduced. The cefixime oral disintegration tablet of the present invention comprises the components of 10.0 wt% to 35.0 wt% of cefixime, 0 wt% to 10.0 wt% of microcrystalline cellulose, 0 wt% to 35.0 wt% of lactose starch, 35.0 wt% to 59.0 wt% of mannitol, 4.0 wt% to 15.0 wt% of croscarmellose sodium, 1.0 wt% to 5.0 wt% of kollidon, 0.01 wt% to 1.0 wt% of sodium dodecyl sulfate and 0.01 wt% to 0.5 wt% of superfine silica gel powder. The preparation method comprises the steps of uniformly mixing medical materials, adding water and ethanol or a mixture of water and ethanol to carry out granulation, drying, uniformly mixing with superfine silica gel powder and tabletting. Compared with the prior art, the cefixime oral disintegration tablet of the present invention can be rapidly disintegrated and dissolved in the oral cavity, is prepared by ordinary preparation equipment and a conventional granulation tabletting technique and has the advantage of low cost.
Description
Technical field
The present invention relates to a kind of medicine and preparation method thereof, but the preparation method of particularly a kind of cefixime oral disintegration tablet and industrial applications thereof.
Background technology
In recent years, along with the drug-supplying system theoretical research deeply carry out development with polymer material science, the research of drug delivery system is all constantly increasing from the kind to the dosage form.Oral cavity disintegration tablet be a kind of can be in the oral cavity disintegrate or dissolved tablet rapidly.Usually collapsing the molten time is extremely tens of seconds of several seconds, generally is no more than 1 minute.Water and form suspension or solution in addition not in the oral cavity.Oral cavity disintegration tablet is fit to infant, old man and swallows the personage that has any problem and take very much, improves the compliance of patient's medication; Can solve its problem of taking medicine preferably to disease such as laryngopharyngeal diseases, Parkinson's disease, acquired immune deficiency syndrome (AIDS), thyroid operation, incidence radiotherapy, migraine, abalienation, cerebral palsy, renal failure and long-term bed patient, reduce the burden of nursery work; In addition, also can be convenient for people to medication under the environment of anhydrous supply.
Cefixime belongs to semisynthetic first oral third generation cephalosporin, gram positive bacteria and negative bacterium there is broad-spectrum antibacterial action, particularly to the Streptococcus in the gram positive bacteria, streptococcus pneumoniae, gonococcus in the gram negative bacteria, branhamella catarrhalis, escherichia coli, Klebsiella, Serratia, Proteus, influenza Pseudomonas etc. demonstrate the antibacterial action stronger than other oral cephalosporins, and the beta-lactamase that various bacterium produce is stablized.Mechanism of action is for stoping the synthetic of bacteria cell wall, and its application point is different because of strain, with 1 in the penicillin-binding protein (PBP) (1a, 1b, 1c) and 3 have than high-affinity.Be applicable to the responsive microbial bronchitis of cefixime, bronchiectasis (during infection) clinically, the secondary infection that chronic respiratory system catches, pneumonia; Pyelonephritis, cystitis, gonococcal urethritis; Cholecystitis, cholangitis; Scarlet fever; The treatment of otitis media, nasal sinusitis etc.
The major technique that is used at present to prepare oral cavity disintegration tablet abroad has lyophilization and pressed disc method.Wherein, 1. lyophilization comprises R.P.Scherer company
Technology, Farmalyoc company
Technology and Janssen company
Technology; 2. pressed disc method comprises Yamanouchi company
Technology, Cima company
Technology, Elan company
Technology, Fuisz company
Technology, Prographarm company
Technology and KV Pharmaceutical company
Technology etc.These technology all need special equipment and technology, and production cost is higher.
The present domestic application for a patent for invention prospectus that also has many pieces about oral cavity disintegration tablet and preparation method thereof.Wherein, 1. Whitta Science Co., Ltd (publication number: CN 1568838A) oral cavity disintegration tablet of disclosed direct compression method preparation contains at least 59.5% mannitol, be lower than 10% active component, 10%～18% microcrystalline Cellulose, 1%～4% cross-linking sodium carboxymethyl cellulose and 0.5%～2% lubricant.Because direct compression method is had relatively high expectations to material and equipment, is difficult to realize industrialization under the current at home pharmaceutical production condition.2. (publication number: CN 1568941A) oral cavity disintegration tablet of disclosed fluidized bed coating preparation contains 1%～15% disintegrating agent to Fan Minhua, 30%～90% solubility diluent, 0.001%～1% binding agent and 0.05%～2% lubricant.Because the powder coating technology difficulty of medicine material is big, causes production cost higher.3. the Beijing Zhongxi Jinwei Drug Release Technology Co., Ltd (publication number: CN 1476826A) disclosed respectively separately the oral cavity disintegration tablet of granulation preparation contain active constituents of medicine and adjuvant, adjuvant comprises diluent and disintegrating agent, diluent is mannitol, lactose; Disintegrating agent is microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone.Independent respectively granulation has increased manufacturing process, thereby causes the increase of production cost.
Summary of the invention
The purpose of this invention is to provide a kind of cefixime oral disintegration tablet and preparation method thereof, the technical problem that solves is to make the cefixime oral administration preparation have the short time of loosing and the good mouthfeel of collapsing, and reduces the production cost of cefixime oral disintegration tablet simultaneously.
The present invention is by the following technical solutions: a kind of cefixime oral disintegration tablet, form by the component of following weight ratio: cefixime 10.0%～20.0%, microcrystalline Cellulose 5.0%～10.0%, lactose starch 15.0%～35.0%, mannitol 35.0%～59.0%, cross-linking sodium carboxymethyl cellulose 4.5%～12.0%, copolyvidone 1.5%～4.0%, sodium lauryl sulphate 0.05%～0.5%, micropowder silica gel 0.05%～0.5%, correctives and coloring agent 0%～3.0%.
Correctives of the present invention select for use menthol, aspartame, saccharin sodium, Fructus Fragariae Ananssae powdered flavor, Rhizoma et radix valerianae powdered flavor, fragrant citrus powdered flavor, described in two or more mixture arbitrarily; Coloring agent is selected the mixture of Sunset yellow aluminum lake, tartrazine aluminum lake or two kinds for use.
A kind of preparation method of cefixime oral disintegration tablet, may further comprise the steps: one, take by weighing cefixime micropowder 10.0%～20.0%, microcrystalline Cellulose 5.0%～10.0%, lactose starch 15.0%～35.0%, mannitol 35.0%～59.0%, cross-linking sodium carboxymethyl cellulose 4.5%～12.0%, copolyvidone 1.5%～4.0%, sodium lauryl sulphate 0.05%～0.5%, correctives and coloring agent 0%～3.0% by weight, mix homogeneously; Two, add entry, ethanol or both mixture in the spice of mix homogeneously, wet method is sieved and is granulated or the high-speed stirred granulation, and the particulate granularity of gained is 16 orders～100 orders; Three, with medicine grain in 30 ℃～60 ℃ temperature dry 1 hour～6 hours, or dry 10 minutes～60 minutes of fluid boiling; Four, get dried granule, add the micropowder silica gel of weight ratio 0.05%～0.5%, mix homogeneously; Five, tabletting.
The correctives of preparation method of the present invention select for use menthol, aspartame, saccharin sodium, Fructus Fragariae Ananssae powdered flavor, Rhizoma et radix valerianae powdered flavor, fragrant citrus powdered flavor, described in two or more mixture arbitrarily; Coloring agent is selected the mixture of Sunset yellow aluminum lake, tartrazine aluminum lake or two kinds for use.
The granularity of preparation method cefixime micropowder of the present invention is 120 orders, can be all by No. seven sieves of Chinese Pharmacopoeia.
The wet method of preparation method of the present invention is sieved to granulate and is adopted mixer to make soft material earlier, granulates with granulator then; High-speed stirred is granulated and is adopted High Speed Stirring Machine directly to carry out mixed at high speed stirring granulation.
The drying of preparation method of the present invention is carried out in electric drying oven with forced convection, and the fluid boiling drying is carried out airpillow-dry with fluid bed.
The KM800 type vertical mixer that the mixer of preparation method of the present invention adopts Britain KENWOOD company to make; the YK-160 type oscillating granulator that granulator adopts Baoji Pharmaceutical Machinery Factory to make; High Speed Stirring Machine adopts and goes up KJZ-10 type High Speed Stirring Machine or the Belgian GRAL-150 type High Speed Stirring Machine that friendship pharmaceutical equipment company of Hisense makes; air dry oven adopts Chongqing four to reach the CS101-2E type electric drying oven with forced convection that company makes; the GCCP1.1 type fluid bed that fluid bed adopts German GLATT company to make; dried granule mixes the KM800 type vertical mixer of employing Britain KENWOOD company manufacturing or the multidirectional movement mixer of HD-600 type that pharmaceutical equipment factory in Wenzhou makes, DP-30 type tablet machine or GZPL-32A type tablet machine that tabletting adopts Beijing Gylongli Sci.﹠Tech. Co., Ltd. to make with micropowder silica gel.
The present invention compared with prior art, cefixime oral disintegration tablet is than traditional conventional tablet, capsule, granule etc., have the shorter time of loosing and the better mouthfeel of collapsing, need not taking of water, can in the oral cavity, collapse fast and loose and stripping, quick acting, improve infant, old man and swallow the effectiveness of the personage's medication of having any problem, safety and compliance, and cefixime oral disintegration tablet has enough hardness and lower friability, can satisfy production, packing, the requirement of accumulating adopts ordinary preparation equipment and conventional pelletizing press sheet technology to prepare cefixime oral disintegration tablet, and preparation method is simple, be fit to suitability for industrialized production, and cost is low.
The specific embodiment
Below in conjunction with embodiment the present invention is described in further detail.Cefixime oral disintegration tablet of the present invention has components in part by weight: cefixime 10.0%～20.0%, microcrystalline Cellulose 5.0%～10.0%, lactose starch 15.0%～35.0%, mannitol 35.0%～59.0%, cross-linking sodium carboxymethyl cellulose 4.5%～12.0%, copolyvidone 1.5%～4.0%, sodium lauryl sulphate 0.05%～0.5%, micropowder silica gel 0.05%～0.5%, correctives and coloring agent 0%～3.0%.
Correctives select for use menthol, aspartame, saccharin sodium, Fructus Fragariae Ananssae powdered flavor, Rhizoma et radix valerianae powdered flavor, fragrant citrus powdered flavor, described in two or more mixture arbitrarily; Coloring agent is selected the mixture of Sunset yellow aluminum lake, tartrazine aluminum lake or two kinds for use.
Cefixime oral disintegration tablet of the present invention is as traditional general formulation, for example: replenishing of tablet, capsule or granule, can reduce the misery of patient's medication process as much as possible.Some patient is because of handicapped or dysphagia in clinical, taking traditional tablet, capsule, granule etc. has difficulties, cefixime oral disintegration tablet need not taking of water, just can in the oral cavity, collapse diffusing stripping rapidly with 20 to 60 seconds time, mouthfeel is good, can solve some patient's medication inconvenient problem of mismatching, swallow, take medicine effectively.
The preparation method of cefixime oral disintegration tablet of the present invention may further comprise the steps: one, with active component cefixime micronization, and whole No. seven sieves (120 mesh sieve) by Chinese Pharmacopoeia regulation; Two, by weight taking by weighing micronized cefixime 10.0%～20.0%, microcrystalline Cellulose 5.0%～10.0%, lactose starch 15.0%～35.0%, mannitol 35.0%～59.0%, cross-linking sodium carboxymethyl cellulose 4.5%～12.0%, copolyvidone 1.5%～4.0%, sodium lauryl sulphate 0.05%～0.5%, correctives and coloring agent 0%～3.0%, mix homogeneously earlier; Three, it is an amount of to add entry, ethanol or both mixture in the spice of mix homogeneously, the KM800 type vertical mixer made from Britain KENWOOD company makes soft material, the gained soft material is held agglomerating, the light pressure promptly loose, the YK-160 type oscillating granulator made from Baoji Pharmaceutical Machinery Factory is granulated then, and the particulate granularity of gained is 16 orders～100 orders; Or it is an amount of to add entry, ethanol or both mixture in the spice of mix homogeneously, use the KJZ-10 type High Speed Stirring Machine or the Belgian GRAL-150 type High Speed Stirring Machine of the manufacturing of friendship pharmaceutical equipment company of Hisense and directly carry out mixed at high speed stirring granulation, the particulate granularity of gained is 16 orders～100 orders; Four, the medicine grain is placed Chongqing four reach in the CS101-2E type electric drying oven with forced convection of company's manufacturing, in 30 ℃～60 ℃ temperature, carried out hot air drying 1 hour～6 hours; Or the GCCP1.1 type fluid bed that places German GLATT company to make the medicine grain carried out airpillow-dry 10 minutes～60 minutes, 30 ℃～60 ℃ of inlet temperature; Five, get dried granule, add the micropowder silica gel of weight ratio 0.05%～0.5%, with the KM800 type vertical mixer of Britain KENWOOD company manufacturing or the multidirectional movement mixer mix homogeneously of HD-600 type of Wenzhou pharmaceutical equipment factory manufacturing; Six, DP-30 type tablet machine or the GZPL-32A type tablet machine tabletting made from Beijing Gylongli Sci.﹠Tech. Co., Ltd., the gained cefixime oral disintegration tablet meets the pertinent regulations under the Chinese Pharmacopoeia tablet item; Seven, the DPPS-170 type aluminum aluminum packer packing that adopts the two crane drugs manufacture equipment company limiteies in Beijing to make.
The sheet of the cefixime oral disintegration tablet of the inventive method preparation heavily is 200mg～650mg, and hardness is 3kg～6kg, and figure of tablet is circle, ellipse or capsule shape.The active component of this product is a cefixime, can be used for bronchitis, bronchiectasis (during infection) due to the sensitive organism, the secondary infection that chronic respiratory system catches, pneumonia; Pyelonephritis, cystitis, gonococcal urethritis; Cholecystitis, cholangitis; Scarlet fever; The treatment of otitis media, nasal sinusitis etc.This product is pressed 1.5～3.0mg/kg of body weight for oral, and 2 times on the one, in addition, suitably increase and decrease according to symptom, for severe cases, by 6mg/kg of body weight, 2 times on the one.This product need not taking of water, just can be in the oral cavity time with tens seconds collapse diffusing stripping rapidly, good mouthfeel can solve some patient's medication inconvenient problem of mismatching, swallow, take medicine effectively.
The preparation method of cefixime oral disintegration tablet of the present invention, adopt ordinary preparation equipment and conventional pelletizing press sheet technology, the oral cavity disintegration tablet active component that makes reaches 10.0%～35.0%, strengthen the effect of taking medicine of oral cavity disintegration tablet, reduce the consumption of adjuvant, diluents microcrystalline cellulose contains 0%～10.0%, mannitol contains 35.0%～59.0%, all be lower than the consumption of the oral cavity disintegration tablet that prior art for preparing goes out, in addition, diluent can adopt lactose starch, and cost is lower, and preparation method of the present invention has no special requirements to crude drug, operation is few, preparation method is simple, production cost is low, is fit to suitability for industrialized production.
Embodiment 1, prepares 1000 cefixime oral disintegration tablet (specifications: 25mg)
Embodiment 2, prepare 1000 cefixime oral disintegration tablet (specifications: 50mg)
Embodiment 3, prepare 1000 cefixime oral disintegration tablet (specifications: 50mg)
Embodiment 4, prepare 1000 cefixime oral disintegration tablet (specifications: 75mg)
Embodiment 5, prepare 1000 cefixime oral disintegration tablet (specifications: 100mg)
Embodiment 6, prepare 1000 cefixime oral disintegration tablet (specifications: 125mg)
Embodiment 7, prepare 1000 cefixime oral disintegration tablet (specifications: 150mg)
Embodiment 8, prepare 1000 cefixime oral disintegration tablet (specifications: 175mg)
Embodiment 9, prepare 1000 cefixime oral disintegration tablet (specifications: 200mg)
Claims (8)
1. cefixime oral disintegration tablet, it is characterized in that: the component by following weight ratio is formed: cefixime 10.0%～20.0%, microcrystalline Cellulose 5.0%～10.0%, lactose starch 15.0%～35.0%, mannitol 35.0%～59.0%, cross-linking sodium carboxymethyl cellulose 4.5%～12.0%, copolyvidone 1.5%～4.0%, sodium lauryl sulphate 0.05%～0.5%, micropowder silica gel 0.05%～0.5%, correctives and coloring agent 0%～3.0%.
2. cefixime oral disintegration tablet according to claim 1 is characterized in that: described correctives select for use menthol, aspartame, saccharin sodium, Fructus Fragariae Ananssae powdered flavor, Rhizoma et radix valerianae powdered flavor, fragrant citrus powdered flavor, described in two or more mixture arbitrarily; Coloring agent is selected the mixture of Sunset yellow aluminum lake, tartrazine aluminum lake or two kinds for use.
3. the preparation method of a cefixime oral disintegration tablet, may further comprise the steps: one, take by weighing cefixime micropowder 10.0%～20.0%, microcrystalline Cellulose 5.0%～10.0%, lactose starch 15.0%～35.0%, mannitol 35.0%～59.0%, cross-linking sodium carboxymethyl cellulose 4.5%～12.0%, copolyvidone 1.5%～4.0%, sodium lauryl sulphate 0.05%～0.5%, correctives and coloring agent 0%～3.0% by weight, mix homogeneously; Two, add entry, ethanol or both mixture in the spice of mix homogeneously, wet method is sieved and is granulated or the high-speed stirred granulation, and the particulate granularity of gained is 16 orders～100 orders; Three, with medicine grain in 30 ℃～60 ℃ temperature dry 1 hour～6 hours, or dry 10 minutes～60 minutes of fluid boiling; Four, get dried granule, add the micropowder silica gel of weight ratio 0.05%～0.5%, mix homogeneously; Five, tabletting.
4. the preparation method of cefixime oral disintegration tablet according to claim 3 is characterized in that: described correctives select for use menthol, aspartame, saccharin sodium, Fructus Fragariae Ananssae powdered flavor, Rhizoma et radix valerianae powdered flavor, fragrant citrus powdered flavor, described in two or more mixture arbitrarily; Coloring agent is selected the mixture of Sunset yellow aluminum lake, tartrazine aluminum lake or two kinds for use.
5. the preparation method of cefixime oral disintegration tablet according to claim 4, it is characterized in that: the granularity of described cefixime micropowder is 120 orders, can be all by No. seven sieves of Chinese Pharmacopoeia.
6. according to the preparation method of claim 3,4 or 5 described cefixime oral disintegration tablets, it is characterized in that: described wet method is sieved to granulate and is adopted mixer to make soft material earlier, granulates with granulator then; High-speed stirred is granulated and is adopted High Speed Stirring Machine directly to carry out mixed at high speed stirring granulation.
7. the preparation method of cefixime oral disintegration tablet according to claim 6, it is characterized in that: described drying is carried out in electric drying oven with forced convection, and the fluid boiling drying is carried out airpillow-dry with fluid bed.
8. the preparation method of cefixime oral disintegration tablet according to claim 7; it is characterized in that: the KM800 type vertical mixer that described mixer adopts Britain KENWOOD company to make; the YK-160 type oscillating granulator that granulator adopts Baoji Pharmaceutical Machinery Factory to make; High Speed Stirring Machine adopts and goes up KJZ-10 type High Speed Stirring Machine or the Belgian GRAL-150 type High Speed Stirring Machine that friendship pharmaceutical equipment company of Hisense makes; air dry oven adopts Chongqing four to reach the CS101-2E type electric drying oven with forced convection that company makes; the GCCP1.1 type fluid bed that fluid bed adopts German GLATT company to make; dried granule mixes the KM800 type vertical mixer of employing Britain KENWOOD company manufacturing or the multidirectional movement mixer of HD-600 type that pharmaceutical equipment factory in Wenzhou makes, DP-30 type tablet machine or GZPL-32A type tablet machine that tabletting adopts Beijing Gylongli Sci.﹠Tech. Co., Ltd. to make with micropowder silica gel.
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| CNB2006100329353A CN100411621C (en) | 2006-01-09 | 2006-01-09 | Cefixime oral disintegration tablet and its preparation method |
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| CNB2006100329353A CN100411621C (en) | 2006-01-09 | 2006-01-09 | Cefixime oral disintegration tablet and its preparation method |
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| CN100411621C true CN100411621C (en) | 2008-08-20 |
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101480397B (en) * | 2008-01-07 | 2012-09-19 | 上官清 | Cefixime orally disintegrating tablet and preparation method thereof |
| WO2013109228A1 (en) * | 2012-01-18 | 2013-07-25 | Mahmut Bilgic | Formulations comprising cefixime as active agent |
| CN102697736A (en) * | 2012-05-25 | 2012-10-03 | 深圳致君制药有限公司 | Cefixime granule and preparation method thereof |
| CN112089695A (en) * | 2020-10-30 | 2020-12-18 | 康普药业股份有限公司 | Cefixime granular preparation and preparation method thereof |
| CN113440530B (en) * | 2021-07-08 | 2023-08-08 | 广州白云山医药集团股份有限公司白云山制药总厂 | Cefixime medicine and preparation method thereof |
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| WO2004100857A2 (en) * | 2003-05-07 | 2004-11-25 | Akina, Inc. | Highly plastic granules for making fast melting tablets |
| CN1706372A (en) * | 2005-05-24 | 2005-12-14 | 中国人民解放军第二军医大学 | Orally disintegrated sodium ferulate tablet and its prepn process |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004100857A2 (en) * | 2003-05-07 | 2004-11-25 | Akina, Inc. | Highly plastic granules for making fast melting tablets |
| CN1706372A (en) * | 2005-05-24 | 2005-12-14 | 中国人民解放军第二军医大学 | Orally disintegrated sodium ferulate tablet and its prepn process |
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| 口腔崩解片及其制备技术进展. 柯学.中国药学杂志，第40卷第11期. 2005 |
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Address after: 518110, No. 16, Lan Qing Road, Guanlan new high tech Zone, Longhua New District, Guangdong, Shenzhen Patentee after: Sinopharm (Shenzhen) Pharmaceutical Co., Ltd. Address before: 518029, Bagualing Industrial Zone, Guangdong, Shenzhen, five Patentee before: Zhijun Pharmaceutical Co., Ltd., Shenzhen |