CN105748472A - Ampicillin and clavulanate potassium dispersible tablet and preparation method thereof - Google Patents
Ampicillin and clavulanate potassium dispersible tablet and preparation method thereof Download PDFInfo
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- CN105748472A CN105748472A CN201410774085.9A CN201410774085A CN105748472A CN 105748472 A CN105748472 A CN 105748472A CN 201410774085 A CN201410774085 A CN 201410774085A CN 105748472 A CN105748472 A CN 105748472A
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- ampicillin
- clavulanate potassium
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- dispersible tablets
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Abstract
The invention discloses an ampicillin and clavulanate potassium dispersible tablet and a preparation method thereof. The ampicillin and clavulanate potassium dispersible tablet is characterized by comprising, by weight, 420 parts of ampicillin, 60 parts of clavulanate potassium, 360 to 420 parts of a filler, 95 to 130 parts of a disintegrating agent and 5 to 8 parts of a lubricant. The ampicillin and clavulanate potassium dispersible tablet is scientific in formula, simple in preparation process, rapid in disintegration and good in dissolution rate; and since all the accessory materials are cheap and easily available, the dispersible tablet is low in cost, and the dispersible tablet can be produced in large scale, so drug cost for patients can be reduced.
Description
Technical field
The invention belongs to field of medicine preparations, be specifically related to a kind of ampicillin clavulanate potassium dispersible tablets and preparation method thereof.
Background technology
The compound preparation that ampicillin clavulanate potassium is made up of with 7:1 proportioning ampicillin and clavulanate potassium, acts predominantly on the reproductive stage of microorganism, works by suppressing the biosynthesis of the viscous polypeptide of cell wall.Clavulanate potassium has beta-lactam structure like penicillins, can by blocking the active site of beta-lactamase, make major part antibacterial these enzyme deactivations produced, especially to clinically important, better by plasmid-mediated beta-lactamase (these enzymes are generally relevant with the Drug resistance change of penicillin and cephalosporin) effect.In vitro tests and result in clinical application all show, this compound recipe is effective to following most microorganisms;Gram-positive aerobic microorganism: staphylococcus aureus (produces beta-lactamase and do not produce the bacterial strain of beta-lactamase) has drug-fast staphylococcus that this product has Drug resistance equally methicillin/oxazacillin.Gram-negative aerobe: escherichia coli (produce beta-lactamase and do not produce the bacterial strain of beta-lactamase) hemophilus influenza (produce beta-lactamase and do not produce the bacterial strain of beta-lactamase) Klebsiella (all known bacterial strains are beta-lactamase-producing strain) mucositis Morakot Salmonella (produce beta-lactamase and do not produce the bacterial strain of beta-lactamase) the existing results of in vitro studies of most microorganisms below, but its clinical meaning is still not clear: major part streptococcus pneumoniae, Neisseria gonorrheae, most of staphylococcus and anaerobe etc..
Ampicillin antimicrobial spectrum is similar to penicillin, and the antibacterial effect of penicillin-susceptible is relatively low, and antibacterial action and penicillin to Streptococcus viridans are similar or slightly strong.Its usefulness of diphtheria corynebacterium, clostridium tetani and actinomycetes is basic identical with penicillin.Enterococcus and listerial effect are then better than benzylpcnicillin.To resistant Staphylococcus species and other can produce the antibacterial of penicillinase all without antibacterial action.Gram-negative bacteria is effective, but it is easily generated drug resistance.Clavulanate potassium only has faint antibacterial activity, but can with most beta-lactamase strong bonded, generate irreversible conjugate, it there is brute force and the effect suppressing beta-lactamase of wide spectrum, not only staphylococcic enzyme there is effect, and enzyme produced by multiple gram-negative bacteria is also had effect, therefore it is an effective β-lactamase inhibitor.Both are combined and can produce cooperative effect, make the drug resistance of ampicillin reduce.
Summary of the invention
It is desirable to provide a kind of dispersing uniformity, disintegrate is rapid, and dissolution is good, ampicillin clavulanate potassium dispersible tablets of cost savings and preparation method thereof.
For achieving the above object, one ampicillin of the present invention clavulanate potassium dispersible tablets and preparation method thereof, specific embodiments is:
A kind of ampicillin of the present invention clavulanate potassium dispersible tablets and preparation method thereof, it is characterised in that this ampicillin clavulanate potassium dispersible tablets is made up of ampicillin, clavulanate potassium, filler, disintegrating agent and lubricant.
A kind of ampicillin of the present invention clavulanate potassium dispersible tablets and preparation method thereof, it is characterized in that these ampicillin clavulanate potassium dispersible tablets prescription parts by weight are calculated as: 420 parts, ampicillin, clavulanate potassium 60 parts, filler 360-420 part, disintegrating agent 95-130 part, lubricant 5-8 part.
A kind of ampicillin of the present invention clavulanate potassium dispersible tablets and preparation method thereof, it is characterized in that these ampicillin clavulanate potassium dispersible tablets prescription parts by weight are calculated as: 420 parts, ampicillin, clavulanate potassium 60 parts, filler 400 parts, disintegrating agent 115 parts, lubricant 6 parts.
A kind of ampicillin of the present invention clavulanate potassium dispersible tablets and preparation method thereof, it is characterised in that filler is one or more in Icing Sugar, starch, microcrystalline Cellulose.
A kind of ampicillin of the present invention clavulanate potassium dispersible tablets and preparation method thereof, it is characterised in that disintegrating agent is one or more in sugar low-substituted hydroxypropyl cellulose, colloidal silica, sodium carboxymethyl cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone.
A kind of ampicillin of the present invention clavulanate potassium dispersible tablets and preparation method thereof, it is characterised in that lubricant is one or more in magnesium stearate, micropowder silica gel, Pulvis Talci.
A kind of ampicillin of the present invention clavulanate potassium dispersible tablets and preparation method thereof, it is characterised in that this ampicillin clavulanate potassium dispersible tablets preparation method is:
1) weighing supplementary material by prescription to be dried, wherein ampicillin and magnesium stearate temperature are set in 40 ± 5 DEG C dry 5 hours；All the other adjuvant temperature are set in 80 ± 5 DEG C dry 5 hours；
2) by dried ampicillin, clavulanate potassium, filler, disintegrating agent mixing, just mixed 0.5-2 hour, mixed material is carried out dry granulation, cross 16 mesh sieves；
3) by the granule after sieving and mix lubricant, tabletting, to obtain final product.
A kind of ampicillin of the present invention clavulanate potassium dispersible tablets and preparation method thereof, it is characterised in that step 2) just mixed preferably 1 hour time.
The method have the benefit that
1. scientific formula, formulation disperses uniformity, disintegrate is rapid, and dissolution is good；
2. supplementary material is cheap and easy to get, and technique is simple, and the slice, thin piece hardness pressed is at 7 ~ 9kg/cm2, ordinary packing, greatly reduce production cost.
Detailed description of the invention
Example below, only for further illustrating the present invention, does not limit the scope of the invention in any form.
Example 1
Prescription (4000):
420 parts, ampicillin
Clavulanate potassium 60 parts
Icing Sugar 210 parts
Starch 200 parts
Low-substituted hydroxypropyl cellulose 90 parts
Colloidal silica 15 parts
Magnesium stearate 5 parts
Example 2
Prescription (4000):
420 parts, ampicillin
Clavulanate potassium 60 parts
Icing Sugar 250 parts
Microcrystalline Cellulose 150 parts
Low-substituted hydroxypropyl cellulose 95 parts
Colloidal silica 20 parts
Magnesium stearate 5 parts
Example 3
Prescription (4000):
420 parts, ampicillin
Clavulanate potassium 60 parts
Icing Sugar 150 parts
Starch 250 parts
Low-substituted hydroxypropyl cellulose 100 parts
Colloidal silica 15 parts
Magnesium stearate 5 parts
Embodiment 1-3 ampicillin clavulanate potassium dispersible tablets preparation method:
Weighing supplementary material by prescription, the supplementary material outside ampicillin clavulanate potassium mixed powder and colloidal silica is dried, and wherein ampicillin and magnesium stearate temperature are set in 40 ± 5 DEG C dry 5 hours；All the other adjuvant temperature are set in 80 ± 5 DEG C dry 5 hours.Dried ampicillin, clavulanate potassium, filler, low-substituted hydroxypropyl cellulose mixing are just mixed 1 hour, mixed material is carried out dry granulation, crosses 16 mesh sieves；To the granulation after sieving.
The dispersible tablet of this product embodiment 1-3 is carried out dispersing uniformity inspection and dissolution test.
Dispersing uniformity inspection method: take 6, sample, put in 250ml beaker, adds the water 100ml of 15-25 DEG C, jolting 3 minutes, should all disintegrates by No. two sieves.
Adopt the dispersible tablet of dissolution method (Chinese Pharmacopoeia two annex XC the first methods of version in 2010) treating excess syndrome example 1-3 with the hydrochloric acid water of 0.1mol/L easily for dissolution medium, rotating speed is 50r/min, temperature is 37.5 ± 0.5 DEG C and operates in accordance with the law, 30 minutes sampling and measuring dissolutions, and result is shown in following table:
Claims (8)
1. ampicillin clavulanate potassium dispersible tablets and preparation method thereof, it is characterised in that this ampicillin clavulanate potassium dispersible tablets is made up of ampicillin, clavulanate potassium, filler, disintegrating agent and lubricant.
2. a kind of ampicillin clavulanate potassium dispersible tablets and preparation method thereof according to claim 1, it is characterized in that these ampicillin clavulanate potassium dispersible tablets prescription parts by weight are calculated as: 420 parts, ampicillin, clavulanate potassium 60 parts, filler 360-420 part, disintegrating agent 95-130 part, lubricant 5-8 part.
3. a kind of ampicillin clavulanate potassium dispersible tablets and preparation method thereof according to claim 1, it is characterized in that these ampicillin clavulanate potassium dispersible tablets prescription parts by weight are calculated as: 420 parts, ampicillin, clavulanate potassium 60 parts, filler 400 parts, disintegrating agent 115 parts, lubricant 6 parts.
4. a kind of ampicillin clavulanate potassium dispersible tablets and preparation method thereof according to claim 1, it is characterised in that filler is one or more in Icing Sugar, starch, microcrystalline Cellulose.
5. a kind of ampicillin clavulanate potassium dispersible tablets and preparation method thereof according to claim 1, it is characterised in that disintegrating agent is one or more in sugar low-substituted hydroxypropyl cellulose, colloidal silica, sodium carboxymethyl cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone.
6. a kind of ampicillin clavulanate potassium dispersible tablets and preparation method thereof according to claim 1, it is characterised in that lubricant is one or more in magnesium stearate, micropowder silica gel, Pulvis Talci.
7. a kind of ampicillin clavulanate potassium dispersible tablets and preparation method thereof according to claim 1-6, it is characterised in that this ampicillin clavulanate potassium dispersible tablets preparation method is:
1) weighing supplementary material by prescription to be dried, wherein ampicillin and magnesium stearate temperature are set in 40 ± 5 DEG C dry 5 hours；All the other adjuvant temperature are set in 80 ± 5 DEG C dry 5 hours；
2) by dried ampicillin, clavulanate potassium, filler, disintegrating agent mixing, just mixed 0.5-2 hour, mixed material is carried out dry granulation, cross 16 mesh sieves；
3) by the granule after sieving and mix lubricant, tabletting, to obtain final product.
8. a kind of ampicillin clavulanate potassium dispersible tablets and preparation method thereof according to claim 7, it is characterised in that step 2) just mixed preferably 1 hour time.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410774085.9A CN105748472A (en) | 2014-12-16 | 2014-12-16 | Ampicillin and clavulanate potassium dispersible tablet and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410774085.9A CN105748472A (en) | 2014-12-16 | 2014-12-16 | Ampicillin and clavulanate potassium dispersible tablet and preparation method thereof |
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| CN105748472A true CN105748472A (en) | 2016-07-13 |
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| CN201410774085.9A Pending CN105748472A (en) | 2014-12-16 | 2014-12-16 | Ampicillin and clavulanate potassium dispersible tablet and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114533727A (en) * | 2022-03-22 | 2022-05-27 | 青岛嘉智生物技术有限公司 | Composition for inhibiting multiple drug resistance of gram-negative bacteria of poultry and application thereof |
-
2014
- 2014-12-16 CN CN201410774085.9A patent/CN105748472A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114533727A (en) * | 2022-03-22 | 2022-05-27 | 青岛嘉智生物技术有限公司 | Composition for inhibiting multiple drug resistance of gram-negative bacteria of poultry and application thereof |
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| Date | Code | Title | Description |
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| C06 | Publication | ||
| PB01 | Publication | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20160713 |
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| WD01 | Invention patent application deemed withdrawn after publication |