CN106420642A - Cefixime chewable tablet and preparation method thereof - Google Patents
Cefixime chewable tablet and preparation method thereof Download PDFInfo
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- CN106420642A CN106420642A CN201610898082.5A CN201610898082A CN106420642A CN 106420642 A CN106420642 A CN 106420642A CN 201610898082 A CN201610898082 A CN 201610898082A CN 106420642 A CN106420642 A CN 106420642A
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- cefixime
- chewable tablet
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
- A61K31/542—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
- A61K31/545—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine
- A61K31/546—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine containing further heterocyclic rings, e.g. cephalothin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F27/00—Mixers with rotary stirring devices in fixed receptacles; Kneaders
- B01F27/05—Stirrers
- B01F27/11—Stirrers characterised by the configuration of the stirrers
- B01F27/119—Stirrers with rigid wires or flexible rods
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F27/00—Mixers with rotary stirring devices in fixed receptacles; Kneaders
- B01F27/80—Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis
- B01F27/90—Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis with paddles or arms
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
- B01F35/50—Mixing receptacles
- B01F35/53—Mixing receptacles characterised by the configuration of the interior, e.g. baffles for facilitating the mixing of components
- B01F35/531—Mixing receptacles characterised by the configuration of the interior, e.g. baffles for facilitating the mixing of components with baffles, plates or bars on the wall or the bottom
- B01F35/5311—Mixing receptacles characterised by the configuration of the interior, e.g. baffles for facilitating the mixing of components with baffles, plates or bars on the wall or the bottom with horizontal baffles mounted on the walls
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
- B01F35/71—Feed mechanisms
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
- B01F2101/22—Mixing of ingredients for pharmaceutical or medical compositions
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Zoology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention relates to a cefixime chewable tablet, and belongs to the technical field of western medicine preparations. The cefixime chewable tablet is prepared from the following components: 5-15 parts of cefixime, 150-300 parts of sucrose, 60-120 parts of microcrystalline cellulose and the like. The components are mixed by adopting a special particle mixer to be prepared into the chewable tablet. The tablet is smooth in sustained release.
Description
Technical field
The invention belongs to Western medicine preparation technical field, more particularly to a kind of Cefixime chewable tablet.
Background technology
Cefixime chewable tablet, indication is applied to the Streptococcus to cefixime sensitivity for this product, and (enterococcus remove
Outward), streptococcus pneumoniae, gonococcuss, branhamella catarrhalises, escherichia coli, Klebsiella, Serratia, Proteus
And the following bacterial infection disease that hemophilus influenza etc. causes：1. bronchitis, bronchiectasiss (during infection), chronic respiratory
The secondary infection of system infections disease, pneumonia；2. pyelonephritis, cystitis, gonococcal urethritises；3. cholecystitis, cholangitis；
4. scarlet fever；5. otitis media, nasal sinusitis.Existing Cefixime chewable tablet is all using compressing dry granulation technique or using the side such as inclusion
Method increases the stability of preparation, and dissolution is unstable, usually produces some side effect when clinically patient takes.
Content of the invention
In order to overcome the deficiencies in the prior art, the present invention is changed to adjuvant screening, process optimization and equipment by lot of experiments
Enter, there is provided a kind of Cefixime chewable tablet piece.The tablet slow release, gastrointestinal side-effect are little, preparation process is simple.
The object of the present invention is achieved like this：
A kind of Cefixime chewable tablet, by total weight of tablet percentages, consists of the following composition:Cefixime 5-15
Part, sucrose 150-300 part；Microcrystalline Cellulose 60-120 part；Citric acid 8-25 part；Micropowder silica gel 40-80 part；Magnesium stearate 5-15
Part.
The Cefixime chewable tablet, the formula of Cefixime chewable tablet is as follows：10 parts of cefixime, 200 parts of sucrose；Micro-
80 parts of crystalline cellulose；18 parts of citric acid；60 parts of micropowder silica gel；10 parts of magnesium stearate.
The Cefixime chewable tablet, preparation method comprises the following steps:Cefixime chewable tablet crude drug is taken, by head
Spore gram oxime chewable tablet crude drug is placed in disintegrating apparatus and crushes；According to quantity by the Cefixime chewable tablet crude drug after crushing with above-mentioned
Adjuvant mix homogeneously in Particle mixer, is pelletized according to a conventional method, tabletting, packs to obtain finished product.
The Cefixime chewable tablet, Particle mixer in preparation method, including base, it is arranged on stirring on the base
Cylinder is mixed, and stirring motor, the main shaft of the stirring motor and the bottom wall central phase for stirring cylinder is provided with the base
Connection, is provided with stirring mast on the diapire in the mixing drum body, is vertically uniformly provided with the side wall of the stirring cylinder
At least two cavitys, are provided with L-type material casting plate in the cavity, and the corner of the L-type material casting plate is connected to by rotary shaft
In cavity and the outboard end of the L-type material casting plate is stretched in the mixing drum body, in the cavity, material casting motor is provided with,
It is provided with the main shaft of the material casting motor and eccentric is compressed, the medial extremity of the L-type material casting plate and the side of the cavity
Stress spring is provided between wall, and the wheel side for compressing eccentric is pressed between L-type material casting plate medial extremity and cavity side walls,
Support rod being additionally provided with the base, regulation vertical slot is provided with the support rod, is provided with elevator in the regulation vertical slot,
Lift cylinder being provided between the elevator and the regulation vertical slot, electric rotating machine is provided with the elevator, described
The main shaft of electric rotating machine is provided with column spinner, and the column spinner stretches in the mixing drum and described when the elevator declines
Column spinner is staggered setting with stirring mast.
Sealing gasket is provided with the opening of the cavity, the rotary shaft is wrapped in the sealing gasket.
The column spinner is provided with stirring palpus, is provided with charging aperture and feeding detection mouth on the roof of the stirring cylinder.
Compared with prior art, Cefixime chewable tablet piece according to the present invention has technique effect beneficial as follows：
(1) discharge steady.(2) preparation process is simple, simple structure, be provided with L-type material casting plate, its using when by compressing
Eccentric coordinates stress spring that L-type material casting plate can be made to rotate centered on rotary shaft, so as to throw mixing drum interior part medicine
To the center of mixing drum, and column spinner is additionally provided with, by column spinner and the reverse rotation of mixing drum, will can throw in L-type
The bottom medicine agitation of flitch, the medicine decline such that it is able to make L-type material casting back is stirred by column spinner, so as to greatly improve
Stirring efficiency, and it is not easy stirring dead angle occur, solving the stirring of conventional art medicine agitating device has dead angle and stirring
The low technical deficiency of efficiency, the good and strong applicability of stability in use.
Description of the drawings
Fig. 1 is the structural representation of Particle mixer
Specific embodiment
Form is described in further detail again to the above of the present invention by the following examples, but should not be managed this
Solve the scope for the above-mentioned theme of the present invention and Examples below is only limitted to, all technology that is realized based on the above of the present invention are all belonged to
In the scope of the present invention.
Embodiment 1
Weigh cefixime 5,300 parts of sucrose；60 parts of Microcrystalline Cellulose；25 parts of citric acid；40 parts of micropowder silica gel；Stearic acid
15 parts of magnesium.
Preparation technology：Cefixime chewable tablet crude drug is placed in disintegrating apparatus and is crushed；According to quantity by the cephalo after crushing
Gram oxime chewable tablet crude drug is mixed homogeneously in Particle mixer with above-mentioned adjuvant, pelletizes according to a conventional method, and tabletting is packed
Product.
Above-mentioned Particle mixer, is shown in Fig. 1, including including base 1, the stirring cylinder 2 being arranged on the base 1, in institute
State and stirring motor 3 in base 1, is provided with, the main shaft of the stirring motor 3 is connected with the bottom wall central of the stirring cylinder 2,
Diapire in the stirring cylinder 2 is provided with stirring mast 4, is vertically uniformly provided with least in the side wall of the stirring cylinder 2
Two cavitys 5, are provided with L-type material casting plate 6 in the cavity 5, and the corner of the L-type material casting plate 6 is connected to by rotary shaft 7
In cavity 5 and the outboard end of the L-type material casting plate 6 is stretched in the stirring cylinder 2, material casting driving is provided with the cavity 5
Motor 8, is provided with the main shaft of the material casting motor 8 and compresses eccentric 9, the medial extremity of the L-type material casting plate 6 with described
Be provided with stress spring 10 between the side wall of cavity 5, the wheel side for compressing eccentric 9 be pressed on 6 medial extremity of L-type material casting plate with recessed
Between 5 side wall of chamber, when using, the wheel side activity for compressing eccentric is pressed on the end of L-type material casting plate, so that L-type material casting
The end of plate is rotated centered on rotary shaft and stretching stress spring makes which store power, when the concave edge for compressing eccentric is rotated to, L
The end of type material casting plate is resetted under the pulling of stress spring, so that medical material is thrown to and stirred by the plate body movement in mixing drum
The center of cylinder being mixed, support rod 11 is additionally provided with the base 1, is provided with regulation vertical slot 12, described in the support rod 11
Adjust in vertical slot 12 and elevator 13 is provided with, between the elevator 13 and the regulation vertical slot 12, lift cylinder 14 is provided with,
Electric rotating machine 15 is provided with the elevator 13, column spinner 16, the column spinner is provided with the main shaft of the electric rotating machine 15
16 stretch into when the elevator 13 declines in the mixing drum 2 and the column spinner 16 and stirring mast 4 stagger setting.In order to
Facilitate column spinner that mixing drum is entered, the top cover of mixing drum can be opened after loading column spinner, then top cover is covered.
Sealing gasket 17 is provided with the opening of the cavity 5, and the rotary shaft is wrapped in the sealing gasket.
The column spinner is provided with stirring palpus 18, is provided with charging aperture 19 and feeding detection on the roof of the stirring cylinder
Mouth 20.Using stirring palpus, as which is flexible material, so do not interfere with the normal material casting operation of L-type material casting plate.
Embodiment 2
Weigh 15 parts of cefixime, 150 parts of sucrose；120 parts of Microcrystalline Cellulose；8 parts of citric acid；80 parts of micropowder silica gel；Firmly
5 parts of fatty acid magnesium.
Preparation technology is ibid.
Embodiment 3
Weigh 10 parts of cefixime, sucrose 150-300 part；Microcrystalline Cellulose 60-120 part；Citric acid 8-25 part；Micropowder silicon
Glue 40-80 part；Magnesium stearate 5-15 part.
Preparation technology is ibid.
Comparative example 4
Weigh 10 parts of cefixime, 200 parts of sucrose；80 parts of Microcrystalline Cellulose；18 parts of citric acid；60 parts of micropowder silica gel；Firmly
10 parts of fatty acid magnesium.
Plain particles blender is adopted in preparation technology, other steps are ibid.
The release research of 5 Cefixime chewable tablet of embodiment
Embodiment of the present invention 1-3, the tablet of comparative example 4 preparation are taken respectively, according to drug release determination method [version 5 in 2005
Chinese Pharmacopoeia (two) the first method of annex XD], with 0.5% sodium dodecyl sulfate solution 1000mL as solvent, rotating speed is 50r/
Min, is operated in accordance with the law, takes solution 10mL respectively at 2,4,6,8,10,12,14,16,18,20,22,24h, filtration, and is supplemented in time
Above-mentioned solvent 10mL；Subsequent filtrate is taken, according to spectrophotography (5 Chinese Pharmacopoeia of version (two) annex IVA in 2005) in 274nm wavelength
Place determines trap；Another precision is weighed through 105 degree of cefixime reference substances for drying 2h in right amount, plus 0.5% lauryl sulphate acid
Sodium solution heating supersound process dissolving the quantitative solution being diluted to containing 10ug medicine in every 1mL, are measured in the same method trap, and divide
Burst size in different time is not calculated.Dissolution determination result such as table 1
Dissolution of sustained-release tablets measurement result prepared by each embodiment of table 1
| Sample source | 1h (%) | 3h (%) | 6h (%) | 9h (%) | 12h (%) | 24h (%) |
| Embodiment 1 | 28.3 | 52.5 | 73.9 | 84.9 | 93.4 | 102.1 |
| Comparative example 2 | 29.8 | 41.6 | 65.4 | 82.5 | 94.9 | 97.3 |
| Comparative example 3 | 24.7 | 31.5 | 48.8 | 61.9 | 93.8 | 98.2 |
| Comparative example 4 | 56.4 | 93.8 | 95.9 | 102.7 | 98.6 | 98.3 |
According to the result of the test of table 1, Cefixime chewable tablet piece release prepared by embodiment of the present invention 1-3 is steady；
Cefixime chewable tablet is mixed by comparative example 4 using plain particles blender, due to cefixime nozzle in the granule of preparation
Chew piece fully not wrapped up by adjuvant, therefore discharge too fast.
Claims (6)
1. a kind of Cefixime chewable tablet, it is characterised in that by total weight of tablet percentages, consist of the following composition:Cephalo gram
Oxime 5-15 part, sucrose 150-300 part；Microcrystalline Cellulose 60-120 part；Citric acid 8-25 part；Micropowder silica gel 40-80 part；Stearic acid
Magnesium 5-15 part.
2. Cefixime chewable tablet as claimed in claim 1, it is characterised in that the formula of Cefixime chewable tablet is as follows：Cephalo gram
10 parts of oxime, 200 parts of sucrose；80 parts of Microcrystalline Cellulose；18 parts of citric acid；60 parts of micropowder silica gel；10 parts of magnesium stearate.
3. Cefixime chewable tablet as claimed in claim 1, it is characterised in that preparation method comprises the following steps:Take cephalo gram
Oxime crude drug is placed in disintegrating apparatus and crushes；According to quantity by the cefixime crude drug after crushing with above-mentioned adjuvant in Particle mixer
Middle mix homogeneously, is pelletized according to a conventional method, tabletting, packs to obtain finished product.
4. Cefixime chewable tablet as claimed in claim 3, it is characterised in that Particle mixer in preparation method, including base,
The stirring cylinder being arranged on the base, is provided with stirring motor in the base, the main shaft of the stirring motor with described
The bottom wall central of stirring cylinder is connected, and is provided with stirring mast, in the stirring cylinder on the diapire in the mixing drum body
Side wall in be vertically uniformly provided with least two cavitys, be provided with L-type material casting plate in the cavity, the turning of the L-type material casting plate
It is connected in cavity by rotary shaft at angle and the outboard end of the L-type material casting plate is stretched in the mixing drum body, in the sky
Intracavity is provided with material casting motor, is provided with and compresses eccentric on the main shaft of the material casting motor, the L-type material casting plate
Stress spring is provided between the side wall of medial extremity and the cavity, and the wheel side for compressing eccentric is pressed in L-type material casting plate
Between side and cavity side walls, on the base, support rod being additionally provided with, regulation vertical slot is provided with the support rod, described
Adjusting in vertical slot and elevator is provided with, lift cylinder is provided between the elevator and the regulation vertical slot, in the elevator
Electric rotating machine is inside provided with, on the main shaft of the electric rotating machine, column spinner is provided with, the column spinner is when the elevator declines
Stretch in the mixing drum and the column spinner and stirring mast stagger setting.
5. Cefixime chewable tablet according to claim 4, it is characterised in that be provided with sealing gasket, institute at the opening of the cavity
State rotary shaft to be wrapped in the sealing gasket.
6. Cefixime chewable tablet according to claim 4, it is characterised in that the column spinner be provided with stirring must, described
The roof of stirring cylinder is provided with charging aperture and feeding detection mouth.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610898082.5A CN106420642A (en) | 2016-10-14 | 2016-10-14 | Cefixime chewable tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610898082.5A CN106420642A (en) | 2016-10-14 | 2016-10-14 | Cefixime chewable tablet and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106420642A true CN106420642A (en) | 2017-02-22 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610898082.5A Pending CN106420642A (en) | 2016-10-14 | 2016-10-14 | Cefixime chewable tablet and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107213860A (en) * | 2017-07-28 | 2017-09-29 | 德清县东来化学有限公司 | A kind of reactor for producing liquid barium zinc heat stabilizer |
| CN114210290A (en) * | 2022-01-29 | 2022-03-22 | 无锡恒诚硅业有限公司 | Recovery device for treating sulfur-containing tail gas of reaction kettle |
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| CN103735524A (en) * | 2013-12-30 | 2014-04-23 | 海南葫芦娃制药有限公司 | Cefixime chewable tablet and preparation method thereof |
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| CN105943514A (en) * | 2016-06-22 | 2016-09-21 | 南京华宽信息咨询中心 | Glipizide tablets for treating diabetes and preparation method thereof |
| CN106619707A (en) * | 2016-10-12 | 2017-05-10 | 南京康凯生物科技有限公司 | Compound reserpine tablet for treating hypertension and preparation method thereof |
| CN106619554A (en) * | 2016-10-12 | 2017-05-10 | 南京康凯生物科技有限公司 | Adenosine triphosphate disodium tablet and preparation method thereof |
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2016
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107213860A (en) * | 2017-07-28 | 2017-09-29 | 德清县东来化学有限公司 | A kind of reactor for producing liquid barium zinc heat stabilizer |
| CN114210290A (en) * | 2022-01-29 | 2022-03-22 | 无锡恒诚硅业有限公司 | Recovery device for treating sulfur-containing tail gas of reaction kettle |
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Application publication date: 20170222 |