CN102846564B - A cefprozil tablet and its preparation method - Google Patents
A cefprozil tablet and its preparation method Download PDFInfo
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- CN102846564B CN102846564B CN 201110176199 CN201110176199A CN102846564B CN 102846564 B CN102846564 B CN 102846564B CN 201110176199 CN201110176199 CN 201110176199 CN 201110176199 A CN201110176199 A CN 201110176199A CN 102846564 B CN102846564 B CN 102846564B
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Abstract
The invention discloses a cefprozil tablet and its preparation method. The invention aims at the disadvantages of heat- and moisture-instability of cefprozil, and can provide a cefprozil tablet by enhancing the stability of cefprozil through micropellet package and increasing the compacting property. The invention also discloses a pelletization by cold-process dry pelletization, in which the pressing roller is cooled in the pressing process through water circulation (the interior of the pressing roller will not contact the materials) so that the materials will not contact moisture or high temperature during the whole production process so as to ensure the stability and curative effect of cefprozil drug.
Description
One, technical field
The present invention relates to cefprozil sheet and preparation method thereof.
Two, background technology:
Cefprozil (Cefprozil) is the oral cephalosporin of drugs approved by FDA listing in the end of the year 1991, executes your treasured by the U.S. and produces listing in 1992.Cefprozil is roughly similar to inhibitory action and the first generation cephalosporin of gram positive bacteria, and the inhibitory action of most gram negative bacterias is obviously strengthened, and is efficient and stable to multiple beta-lactamase to anaerobe.
Cefprozil is as cephalosporins of new generation, because it has has a broad antifungal spectrum, antibacterial activity is strong, to the mould characteristics with good stable of β one lactams, become clinically that treatment is light, one of moderate respiratory tract infection choice drug, and be one of choice drug of the treatment community acquired pneumonia of generally acknowledging both at home and abroad.
The cefprozil oral absorption is good, there is 95% dosage to be absorbed approximately, because of its plasma half-life longer relatively, make cefprozil be administered once in one day or secondary also can provide lasting antibacterial action, therapeutic regimen is easy, improve patient's compliance and compliance, saved patient's treatment cost simultaneously.
Cefprozil has good safety, the more traditional cephalosporin incidence rate of untoward reaction is low, and nephrotoxicity has bigger alleviating than former generation, cefprozil become drugs approved by FDA first can be used for treating the cephalosporins of child's otitis media and sinusitis.
The transportation of cefprozil sheet is stored and is carried, and uses more conveniently, and the character of product is stable, and dosage is accurate, and cost and price reduce, and according to the characteristics of tablet, my company adopts special adjuvant to improve production technology, and dissolution rate and bioavailability are better.Adopt PVC aluminum-plastic packaged, moisture resistance is better, and stability is more done, and has reduced the difficulty that stores.To execute the market share that cefprozil sheet that expensive precious pharmaceutical Co. Ltd produces captures bigger in view of present Shanghai, I will utilize good prescription and fabricating technology by the cefprozil sheet of company's independent research, for vast doctors and patients colony provides determined curative effect, safe, the medicine of reasonable price.
Summary of the invention
The present invention is just at the shortcoming of cefprozil to heat and moist lability method, thereby it is carried out the micropill parcel increases its stability, improves compressibility, the abnormal flavour that hides cefprozil itself cooperates the adding of sweeting agent and essence well to improve mouthfeel, and a kind of cefprozil sheet that provides.
Technical scheme of the present invention is as follows:
A kind of cefprozil sheet uses polyvinylpyrrolidone, ethyl cellulose, hydroxypropyl methylcellulose or Polyethylene Glycol that cefprozil is carried out the micropill parcel, mainly is made up of cefprozil micropill and citric acid.Their quality proportioning is: cefprozil A gram, polyvinylpyrrolidone, ethyl cellulose, hydroxypropyl methylcellulose or Polyethylene Glycol (0.03～0.2) A gram, citric acid, tartaric acid or adipic acid (1～3) A gram.
Citric acid, tartaric acid or adipic acid help and improve stability.
Cefprozil sheet at mentioned component, the present invention also relates to the preparation method of cefprozil sheet simultaneously: above-mentioned cefprozil sheet uses dry granulation method granule processed, use the cold working granulating process, in extrusion process, by water cycle pinch roller is lowered the temperature simultaneously, make material in whole process of production, not touch moisture content and high temperature, guaranteed stability and the curative effect of cefprozil medicine.
Concrete preparation method is as follows:
(1) former, adjuvant are all placed under 50 ℃ of conditions dry 4 hours in advance, it is standby to cross 80 mesh sieves;
(2) use polyvinylpyrrolidone, ethyl cellulose, hydroxypropyl methylcellulose or Polyethylene Glycol are to cephalo
Propylene carries out the micropill parcel, makes micropill;
(3) get cefprozil micropill and citric acid, tartaric acid or adipic acid must mix powder;
(4) get mixed powder and carry out the cold working dry granulation, in granule extrusion process, by water cycle pinch roller is lowered the temperature, make granule avoid contacting moisture content and high temperature;
(5) pack after getting dried granule compress tablet coating, namely get cefprozil sheet of the present invention.
In sum, medicine of the present invention has following characteristics:
1, the cephalo propylene feedstocks is adopted polyvinylpyrrolidone, ethyl cellulose, hydroxypropyl methylcellulose or Polyethylene Glycol wrap up, and ratio accounts for 3%～20% of cefprozil, can effectively hide the abnormal flavour of cefprozil, and all increase significantly for stability of drug.
2, the present invention adds citric acid after this has fully studied the character of cefprozil, and tartaric acid or adipic acid not only have raising preferably and after brewing, make cefprozil under acid condition for stability of drug products, improve its dissolubility.
3, the preparation technology of dried granule adopts cold working dry granulation technology to granulate, in extrusion process, by water cycle (pinch roller inside does not contact with material) pinch roller is lowered the temperature simultaneously, make material in whole process of production, not touch moisture content and high temperature, guaranteed stability and the curative effect of cefprozil medicine.
Three, the specific embodiment
Embodiment 1 (by 1000 calculating of preparation)
Prescription
At first, former, adjuvant are all placed under 50 ℃ of conditions dry 4 hours in advance, standby: as to get cefprozil then, use polyvinylpyrrolidone that cefprozil is carried out the micropill coating, get microcrystalline Cellulose, citric acid again by equivalent incremental method mix homogeneously, cross 60 mesh sieves; Cross 18 mesh sieve granulate behind the cold working dry granulation, with the magnesium stearate mixing.Compress tablet coating, every contains cefprozil 250mg.
Embodiment 2 (by 1000 calculating of preparation)
At first, former, adjuvant are all placed under 50 ℃ of conditions dry 4 hours in advance, standby: as to get cefprozil then, use ethyl cellulose that cefprozil is carried out the micropill coating, get lactose, tartaric acid again by equivalent incremental method mix homogeneously, cross 60 mesh sieves; Cross 18 mesh sieve granulate behind the cold working dry granulation, with the magnesium stearate mixing.Compress tablet coating, every contains cefprozil 250mg.
Embodiment 3 (by 1000 calculating of preparation)
At first, former, adjuvant are all placed under 50 ℃ of conditions dry 4 hours in advance, standby: as to get cefprozil then, use hydroxypropyl methylcellulose that cefprozil is carried out the micropill coating, get crospolyvinylpyrrolidone, lactose, adipic acid again by equivalent incremental method mix homogeneously, cross 60 mesh sieves; Cross 18 mesh sieve granulate behind the cold working dry granulation, with the magnesium stearate mixing.Compress tablet coating, every contains cefprozil 250mg.
Embodiment 4 (by 1000 calculating of preparation)
At first, former, adjuvant are all placed under 50 ℃ of conditions dry 4 hours in advance, standby: as to get cefprozil 100g then, use polyvinylpyrrolidone that cefprozil is carried out the micropill coating, get sucrose, adipic acid again by equivalent incremental method mix homogeneously, cross 60 mesh sieves; Cross 18 mesh sieve granulate behind the cold working dry granulation, with the magnesium stearate mixing.Compress tablet coating, every contains cefprozil 250mg.
Embodiment 5 (by 1000 calculating of preparation)
At first, former, adjuvant are all placed under 60 ℃ of conditions dry 4 hours in advance, standby: as to get cefprozil then, use Polyethylene Glycol that cefprozil is carried out the micropill coating, get glucose, tartaric acid again by equivalent incremental method mix homogeneously, cross 60 mesh sieves; Cross 18 mesh sieve granulate behind the cold working dry granulation, with the magnesium stearate mixing.Compress tablet coating, every contains cefprozil 2500mg.
Embodiment 6 (by 1000 calculating of preparation)
At first, former, adjuvant are all placed under 50 ℃ of conditions dry 4 hours in advance, standby: as to get cefprozil then, use the 30g hydroxypropyl methyl fiber that cefprozil is carried out the micropill coating, get Icing Sugar, citric acid again, by equivalent incremental method mix homogeneously, cross 60 mesh sieves; Cross 18 mesh sieve granulate behind the cold working dry granulation, with the magnesium stearate mixing.Compress tablet coating, every contains cefprozil 250mg.
Five. the stability test data are relatively
Getting the cefprozil sheet of example 1 of the present invention, embodiment 3 and embodiment 5 preparations and cefprozil sheet that expensive precious pharmaceutical Co. Ltd is executed in Shanghai is 40 ℃ ± 2 ℃ in temperature, and relative humidity is to place 6 months under 75% ± 5% the condition.
Investigation project: character, related substance, dissolution and content.The investigation result is as follows:
Result of the test shows, the product quality of example 1 of the present invention, embodiment 3 and embodiment 5 preparations is more stable, content, and the variation of stripping and related substance is less, and illustrate by the cefprozil sheet of the technology of the present invention preparation has superiority in raising aspect stable.
Claims (4)
1. cefprozil tablet, it is characterized in that: by 1000, it is by cefprozil 250g, polyvinylpyrrolidone 10g, microcrystalline Cellulose 160g, citric acid 10g, magnesium stearate 10g forms, the preparation method of described tablet is: at first, former, adjuvant are all placed under 50 ℃ of conditions dry 4 hours in advance, standby: as to get cefprozil then, use polyvinylpyrrolidone that cefprozil is carried out the micropill coating, get microcrystalline Cellulose, citric acid again by equivalent incremental method mix homogeneously, cross 60 mesh sieves; Cross 18 mesh sieve granulate behind the cold working dry granulation, with the magnesium stearate mixing; Compress tablet coating, every contains cefprozil 250mg.
2. cefprozil tablet, it is characterized in that: by 1000, it is by cefprozil 250g, ethyl cellulose 20g, lactose 130g, tartaric acid 15g, magnesium stearate 10g forms, the preparation method of described tablet is: at first, former, adjuvant are all placed under 50 ℃ of conditions dry 4 hours in advance, standby: as to get cefprozil then, use ethyl cellulose that cefprozil is carried out the micropill coating, get lactose, tartaric acid again by equivalent incremental method mix homogeneously, cross 60 mesh sieves; Cross 18 mesh sieve granulate behind the cold working dry granulation, with the magnesium stearate mixing; Compress tablet coating, every contains cefprozil 250mg.
3. cefprozil tablet, it is characterized in that: by 1000, it is by cefprozil 250g, hydroxypropyl methylcellulose 35g, crospolyvinylpyrrolidone 30g, lactose 80g, adipic acid 10g, magnesium stearate 15g forms, and the preparation method of described tablet is: at first, former, adjuvant were all placed under 50 ℃ of conditions dry 4 hours in advance, standby: as to get cefprozil then, use hydroxypropyl methylcellulose that cefprozil is carried out the micropill coating, get crospolyvinylpyrrolidone, lactose, adipic acid again by equivalent incremental method mix homogeneously, cross 60 mesh sieves; Cross 18 mesh sieve granulate behind the cold working dry granulation, with the magnesium stearate mixing; Compress tablet coating, every contains cefprozil 250mg.
4. cefprozil tablet, it is characterized in that: by 1000, it is by cefprozil 250g, Polyethylene Glycol 60g, glucose 130g, tartaric acid 18g, magnesium stearate 10g forms, the preparation method of described tablet is: at first, former, adjuvant are all placed under 60 ℃ of conditions dry 4 hours in advance, standby: as to get cefprozil then, use Polyethylene Glycol that cefprozil is carried out the micropill coating, get glucose, tartaric acid again by equivalent incremental method mix homogeneously, cross 60 mesh sieves; Cross 18 mesh sieve granulate behind the cold working dry granulation, with the magnesium stearate mixing; Compress tablet coating, every contains cefprozil 250mg.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201110176199 CN102846564B (en) | 2011-06-28 | 2011-06-28 | A cefprozil tablet and its preparation method |
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| CN 201110176199 CN102846564B (en) | 2011-06-28 | 2011-06-28 | A cefprozil tablet and its preparation method |
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| CN102846564A CN102846564A (en) | 2013-01-02 |
| CN102846564B true CN102846564B (en) | 2013-10-09 |
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| CN 201110176199 Expired - Fee Related CN102846564B (en) | 2011-06-28 | 2011-06-28 | A cefprozil tablet and its preparation method |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1317309A (en) * | 2000-04-12 | 2001-10-17 | 布里斯托尔-迈尔斯斯奎布公司 | Instant oral medincinal preparation |
| CN1634014A (en) * | 2004-12-01 | 2005-07-06 | 北京科信必成医药科技发展有限公司 | Sodium ferulate oral disintegrating tablet and its preparation process |
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2011
- 2011-06-28 CN CN 201110176199 patent/CN102846564B/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1317309A (en) * | 2000-04-12 | 2001-10-17 | 布里斯托尔-迈尔斯斯奎布公司 | Instant oral medincinal preparation |
| CN1634014A (en) * | 2004-12-01 | 2005-07-06 | 北京科信必成医药科技发展有限公司 | Sodium ferulate oral disintegrating tablet and its preparation process |
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| CN102846564A (en) | 2013-01-02 |
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Granted publication date: 20131009 Termination date: 20160628 |