CN104490803A - Improved production process of cefixime tablets - Google Patents
Improved production process of cefixime tablets Download PDFInfo
- Publication number
- CN104490803A CN104490803A CN201410727299.0A CN201410727299A CN104490803A CN 104490803 A CN104490803 A CN 104490803A CN 201410727299 A CN201410727299 A CN 201410727299A CN 104490803 A CN104490803 A CN 104490803A
- Authority
- CN
- China
- Prior art keywords
- cefixime
- tablets
- lactose
- sticking
- cefixime tablets
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- OKBVVJOGVLARMR-QSWIMTSFSA-N cefixime Chemical compound S1C(N)=NC(C(=N\OCC(O)=O)\C(=O)N[C@@H]2C(N3C(=C(C=C)CS[C@@H]32)C(O)=O)=O)=C1 OKBVVJOGVLARMR-QSWIMTSFSA-N 0.000 title claims abstract description 45
- 229960002129 cefixime Drugs 0.000 title claims abstract description 44
- 238000004519 manufacturing process Methods 0.000 title abstract description 8
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims abstract description 20
- 239000008101 lactose Substances 0.000 claims abstract description 20
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 12
- 239000008187 granular material Substances 0.000 claims description 11
- 238000005507 spraying Methods 0.000 claims description 11
- 238000000034 method Methods 0.000 claims description 7
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 6
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 6
- 239000002671 adjuvant Substances 0.000 claims description 6
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 6
- 238000004132 cross linking Methods 0.000 claims description 6
- 235000019359 magnesium stearate Nutrition 0.000 claims description 6
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 6
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 6
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 6
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 6
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 6
- 239000003795 chemical substances by application Substances 0.000 claims description 3
- 238000007908 dry granulation Methods 0.000 claims description 3
- 229940085199 cefixime 100 mg Drugs 0.000 claims description 2
- 229960001375 lactose Drugs 0.000 abstract description 17
- 239000003814 drug Substances 0.000 abstract description 4
- 230000007547 defect Effects 0.000 abstract description 3
- 230000000694 effects Effects 0.000 abstract description 3
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical group O.O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 abstract description 2
- 229940079593 drug Drugs 0.000 abstract description 2
- 229960001021 lactose monohydrate Drugs 0.000 abstract description 2
- 239000002245 particle Substances 0.000 abstract 3
- 239000007921 spray Substances 0.000 abstract 3
- 238000003825 pressing Methods 0.000 abstract 1
- 238000001694 spray drying Methods 0.000 abstract 1
- 239000011812 mixed powder Substances 0.000 description 7
- 238000005516 engineering process Methods 0.000 description 4
- 239000000843 powder Substances 0.000 description 4
- 238000009702 powder compression Methods 0.000 description 2
- 238000001228 spectrum Methods 0.000 description 2
- 241000193830 Bacillus <bacterium> Species 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 229930186147 Cephalosporin Natural products 0.000 description 1
- 108090000204 Dipeptidase 1 Proteins 0.000 description 1
- 206010059866 Drug resistance Diseases 0.000 description 1
- 241000305071 Enterobacterales Species 0.000 description 1
- 241000192125 Firmicutes Species 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 206010034133 Pathogen resistance Diseases 0.000 description 1
- 241000588769 Proteus <enterobacteria> Species 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 230000000843 anti-fungal effect Effects 0.000 description 1
- 229940121375 antifungal agent Drugs 0.000 description 1
- 102000006635 beta-lactamase Human genes 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 229940124587 cephalosporin Drugs 0.000 description 1
- 150000001780 cephalosporins Chemical class 0.000 description 1
- 230000001186 cumulative effect Effects 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 238000011981 development test Methods 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 210000004877 mucosa Anatomy 0.000 description 1
- 238000005453 pelletization Methods 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 229940041007 third-generation cephalosporins Drugs 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention provides an improved production process of cefixime tablets. The problem on sticking of cefixime tablets can be solved effectively by replacing the frequently-used lactose with spray particle lactose with excellent flowability and compressibility, wherein the spray particle lactose is lactose monohydrate which is prepared by spray drying. Multiple research tests show that a significant effect of resisting the sticking of cefixime tablets can be achieved by replacing the 200-mesh lactose in a formula with the spray particle lactose. The cefixime tablets formed by pressing are smooth and attractive in surface and can release medicines rapidly, and the sticking defect rate of the cefixime tablets is reduced to 0.0% from 25.9%. The improved production process of the cefixime tables is simple and convenient. By adopting the improved production process of the cefixime tables, the problems on sticking of cefixime tablets can be solved effectively, and the time and labor utilization rate can be increased.
Description
Technical field
The present invention relates to a kind of Cefixime tablets and production technology, belong to medical art.
Background technology
Cefixime (cefixime) is oral third generation cephalosporins, is developed by Japanese Teng Ze company, and is first gone on the market in Japan in 1987 by Japanese Fujisawa Pharmaceutical Co., Ltd, and commodity are called Cefspan.Cefixime has following several feature: has a broad antifungal spectrum, all has spectrum antibacterial effect to gram positive bacteria and negative bacterium; Long half time, daily 1 ~ 2 time, easy to use; Cross resistance is less, extremely stable to various bacteriogenic beta-lactamase, can effectively suppress or kill clinically to the Serratieae, enterobacteria, Bacillus proteus etc. of other cephalosporins drug resistances; Dosage is few, and distribution in vivo is wide, and curative effect is high, and use cost is low, and the market competitiveness is strong; Good penetrability, penetration into tissue is strong, all exists, therefore can treat inflammation in multiple body fluid, mucosa and system.
Because cefixime is to damp and hot instability, if use conventional wet lay pelletizing press sheet, all can cause the content of cefixime and the decline of tiring that degradation problem under variable color, content easily occurs.For this reason, adopt direct powder compression technology, cefixime can be avoided to be subject to damp and hot impact, so not only ensure that the stability of cefixime, and simplify technique, shorten the production cycle, reduce cost.But the selection of adjuvant is vital in direct powder compression, to the requirement of adjuvant except possessing the performance of general additive of tablet, wherein most importantly adjuvant will have good mobility and compressibility.Because this product drug powder does not have good mobility, compressibility and lubricity, therefore easy sticking, easily block, had a strong impact on manufacturing schedule.
Summary of the invention
For Cefixime tablets sticking problem, in order to solve the problem, the invention provides a kind of improving technique producing Cefixime tablets.The technical scheme that the present invention can realize is as described below:
A kind of Cefixime tablets, is characterized in that, containing cefixime 50 ~ 100mg in unit dose Cefixime tablets, and spraying granule lactose 30 ~ 90mg, microcrystalline Cellulose 50 ~ 100mg, cross-linking sodium carboxymethyl cellulose 15 ~ 20mg, magnesium stearate 1 ~ 2mg.
In the present invention Cefixime tablets production technology, it is characterized in that,
The first step takes the cefixime of recipe quantity, spraying granule lactose, microcrystalline Cellulose, crosses 100 mesh sieves;
Second step takes the cross-linking sodium carboxymethyl cellulose of recipe quantity, magnesium stearate, crosses 60 mesh sieves;
Above principal agent and adjuvant are placed in dry granulating machine by the 3rd step, dry granulation, tabletting.
Advantage of the present invention is: because spraying granule lactose is a kind of through spray-dired lactose monohydrate, there is remarkable mobility and excellent compressibility, spraying granule lactose is adopted to replace conventional lactose, effectively solve Cefixime tablets sticking problem, and through repeatedly development test, 200 order lactose in prescription are replaced with spraying granule lactose, effect clearly, the tablet surface be pressed into is bright and clean, attractive in appearance, release medicine is fast, sticking ratio of defects drops to 0.0% from 25.9%, improves the rate of utilization of work hour.
Detailed description of the invention
Following Application Example is described further it, and the simple replacement or improvement etc. done the present invention those skilled in the art all belong within the technical scheme that the present invention protects.
1. prepare Cefixime tablets, take the cefixime 100mg of recipe quantity, spraying granule lactose 60mg, microcrystalline Cellulose 50mg, cross 100 mesh sieves; Take the cross-linking sodium carboxymethyl cellulose 15mg of recipe quantity again, magnesium stearate 2mg, cross 60 mesh sieves; Above principal agent and adjuvant are placed in dry granulating machine, dry granulation, tabletting, obtained Cefixime tablets A1.The same method simultaneously adopted and dosage, change prescription 200 order lactose into by spraying granule lactose, the Cefixime tablets A2 that the obtained test contrasted is used.
1. first apply Cefixime tablets A2, carried out Cefixime tablets trial test, find to occur sticking phenomenon in tableting processes in process of the test, and carried out relative recording, above result of the test shows, Cefixime tablets sticking cumulative percent is 25.9%.Result is as follows:
Table one Cefixime tablets sticking is tested
2, in order to find out Cefixime tablets sticking reason, getting the mixed powder of three batch samples, measuring mixed powder moisture and the results are shown in following table.Result of the test moisture content is all less than inner quality standard, shows that mixed powder moisture content is not the main cause causing sticking.
Table two Cefixime tablets mixes powder moisture result
3, get three crowdes of mixed powder 200g, measure angle of repose respectively, result of the test is mixed powder and is all greater than 30 ° angle of repose, shows that mobility is defective, show mixed powder mobility bad be the main cause causing sticking.Data are as following table.
Table three mixes the mensuration of powder angle of repose
4,200 order lactose in prescription are replaced with spraying granule lactose, obtained Cefixime tablets A1 result of the test is mixed powder and is all less than 30 ° angle of repose, and the tablet surface be pressed into is bright and clean, attractive in appearance, and release medicine is fast, and sticking ratio of defects drops to 0.0% from 25.9%.The results are shown in following table.
Table four mixes the mensuration of powder angle of repose
Claims (3)
1. a Cefixime tablets, is characterized in that, containing cefixime 50 ~ 100mg in unit dose Cefixime tablets, and spraying granule lactose 30 ~ 90mg, microcrystalline Cellulose 50 ~ 100mg, cross-linking sodium carboxymethyl cellulose 15 ~ 20mg, magnesium stearate 1 ~ 2mg.
2. a kind of Cefixime tablets according to claim 1, is characterized in that, containing cefixime 100mg in unit dose Cefixime tablets, and spraying granule lactose 60mg, microcrystalline Cellulose 50mg, cross-linking sodium carboxymethyl cellulose 15mg, magnesium stearate 2mg.
3. produce an improving technique for Cefixime tablets, it is characterized in that, its concrete step is as described below:
The first step takes the cefixime of recipe quantity, spraying granule lactose, microcrystalline Cellulose, crosses 100 mesh sieves;
Second step takes the cross-linking sodium carboxymethyl cellulose of recipe quantity, magnesium stearate, crosses 60 mesh sieves;
Above principal agent and adjuvant are placed in dry granulating machine by the 3rd step, dry granulation, and tabletting, obtains Cefixime tablets.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201410727299.0A CN104490803A (en) | 2014-12-03 | 2014-12-03 | Improved production process of cefixime tablets |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201410727299.0A CN104490803A (en) | 2014-12-03 | 2014-12-03 | Improved production process of cefixime tablets |
Publications (1)
Publication Number | Publication Date |
---|---|
CN104490803A true CN104490803A (en) | 2015-04-08 |
Family
ID=52932321
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201410727299.0A Pending CN104490803A (en) | 2014-12-03 | 2014-12-03 | Improved production process of cefixime tablets |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN104490803A (en) |
-
2014
- 2014-12-03 CN CN201410727299.0A patent/CN104490803A/en active Pending
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C06 | Publication | ||
PB01 | Publication | ||
WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20150408 |
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WD01 | Invention patent application deemed withdrawn after publication |