CN103768056A - Amoxicillin and clavulanate potassium dispersible tablet - Google Patents
Amoxicillin and clavulanate potassium dispersible tablet Download PDFInfo
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- CN103768056A CN103768056A CN201410028419.8A CN201410028419A CN103768056A CN 103768056 A CN103768056 A CN 103768056A CN 201410028419 A CN201410028419 A CN 201410028419A CN 103768056 A CN103768056 A CN 103768056A
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- clavulanate potassium
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Abstract
The invention discloses an amoxicillin and clavulanate potassium dispersible tablet applied to the field of a preparation of the amoxicillin and clavulanate potassium dispersible tablet. The dispersible tablet is prepared from the following components: amoxicillin trihydrate, clavulanate potassium, microcrystalline cellulose, a disintegrant, diatomite, a sweetener and an aromatic, wherein the disintegrant is selected from one of croscarmellose sodium, carboxymethyl starch sodium and polyvinylpolypyrrolidone; the disintegrant is preferably selected from croscarmellose sodium; the sweetener is selected from one of aspartame and sucralose; the aromatic is selected from one of a blueberry flavor and a lemon essence; the sweetener is preferably selected from sucralose; the aromatic is preferably selected from the blueberry flavor; the weight ratio of amoxicillin trihydrate to clavulanate potassium in the dispersible tablet is 4:1 based on amoxicillin and clavulanate; the dispersible tablet is prepared from powder by a direct compression method. The amoxicillin and clavulanate potassium dispersible tablet is rapid to disintegrate, still can be rapidly disintegrated at low water temperature, and is good in stability, good in mouthfeel, simple in prescription, good in mobility of mixed powder in the prescription, and not sticking in the tabletting process.
Description
Technical field
The present invention relates to a kind of amoxicillin and clavulanate potassium dispersible tablet in amoxicillin and clavulanate potassium compound preparation field.
Background technology
Amoxicillin and clavulanate potassium dispersible tablet is made up of Utimox and clavulanate potassium.Amoxicillin and clavulanate potassium compound preparation is the compound preparation that Britain forms at beta-lactam inhibitor and the semisynthetic penicillin of the release eighties in last century than Qie Mu company.The molecular formula of Utimox is C
16h
19n
3o
5s3H
2o, molecular weight is 419.46, the molecular formula of amoxicillin is C
16h
19n
3o
5s, molecular weight 365.4042.The molecular formula of clavulanate potassium is C
8h
8kNO
5, molecular weight is 237.25, the molecular formula of clavulanic acid is C
8h
9nO
5, molecular weight is 199.16.The ratio of amoxicillin and clavulanate potassium has 2:1,4:1,5:1,7:1,10:1,14:1 and 16:1 etc., and its ratio is in amoxicillin and clavulanic acid.Amoxicillin and clavulanate potassium dispersible tablet is applicable to the various infection such as responsive microbial peritonitis, skin and soft tissue infection, otitis media, osteomyelitis, cystitis, pelvic inflammatory disease.The antimicrobial spectrum of this product is identical with amoxicillin, and expands to some extent.To producing enzyme staphylococcus aureus, staphylococcus epidermidis, coagulase negative staphylococcus and the equal tool good action of enterococcus, intestinal liver Cordycepps antibacterial, hemophilus influenza, moraxelle catarrhalis, bacteroides fragilis etc. that some is produced to beta-lactamase also have better antibacterial activity.This product is produced the enterobacteriaceae lactobacteriaceae of Chromosome-encoded I type enzyme and Rhodopseudomonas without effect to methicillin-resistant Staphylococcus and Enterobacter etc.The Chinese market sales volume of amoxicillin and clavulanate potassium compound preparation in 2002 reaches 11.82 hundred million yuans.
Amoxicillin and clavulanate potassium (4:1) dispersible tablet is current clinical conventional a kind of amoxicillin and clavulanate potassium dispersible tablet specification.But it is long to there is disintegration, prescription mixed powder poor fluidity, easy sticking, write out a prescription more complicated, the problems such as taste bad will, poor stability.Therefore the new recipe of, developing a kind of amoxicillin and clavulanate potassium dispersible tablet is new problem urgently to be resolved hurrily always.
Summary of the invention
The object of the present invention is to provide a kind of amoxicillin and clavulanate potassium dispersible tablet, this product disintegrate is quick, still disintegrate fast under lower water temperature, and good stability, mouthfeel is good, and the prescription of dispersible tablet is simple, mixed powder good fluidity, not sticking of tabletting process.
The object of the present invention is achieved like this: a kind of amoxicillin and clavulanate potassium dispersible tablet, described dispersible tablet is made up of the component of following percentage by weight: Utimox 18.95%-25.26%, clavulanate potassium 4.92%-6.55%, microcrystalline Cellulose 62.35%-68.79%, disintegrating agent 2.2%-2.75%, kieselguhr 1.29%-6.13%, sweeting agent 0.11%-0.50%, aromatic 0.22%-0.28%; Described disintegrating agent is selected from the one in cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, polyvinylpolypyrrolidone; Described disintegrating agent is self-crosslinking sodium carboxymethyl cellulose most preferably; Described sweeting agent is selected from the one in aspartame, sucralose, and described aromatic is selected from the one in blue berry essence, Fructus Citri Limoniae essence; Described sweeting agent is most preferably from sucralose, and described aromatic is most preferably from blue berry essence; In described dispersible tablet, Utimox and clavulanate potassium are respectively take the weight ratio of amoxicillin and clavulanic acid as 4:1; Described dispersible tablet adopts direct powder compression to be prepared; Described dispersible tablet is made up of the component of following percentage by weight: Utimox 21.66%, clavulanate potassium 5.62%, microcrystalline Cellulose 66.03%, cross-linking sodium carboxymethyl cellulose 2.51%, kieselguhr 3.77%, blue berry essence 0.25%, sucralose 0.16%.
Main points of the present invention are a kind of amoxicillin and clavulanate potassium dispersible tablet.Its principle is: (1), in the situation that adopting cross-linking sodium carboxymethyl cellulose to be disintegrating agent, by adding kieselguhr can shorten greatly the disintegration of dispersible tablet in prescription, especially still can make shorten fast disintegration under the low temperature of 5 ℃.(2) by add kieselguhr in prescription, not adding other antiplastering aid or lubricant, in the situation of micropowder silica gel or magnesium stearate, the good fluidity of mixed powder that still can make to write out a prescription, sticking not.(3) carry out taste masking by the combination that uses blue berry essence and sucralose in prescription, can make the good mouthfeel after dispersible tablet dissolves, without bilgy odour.(4) by add kieselguhr in prescription, can make the stability of dispersible tablet better.
A kind of amoxicillin and clavulanate potassium dispersible tablet compared with prior art, have disintegrate fast, still disintegrate fast under lower water temperature, good stability, mouthfeel is good, prescription is simple, prescription mixed powder good fluidity, tabletting process be the advantage such as sticking not, will be widely used in the formulation art of amoxicillin and clavulanate potassium dispersible tablet.
Below in conjunction with embodiment, the present invention is described in detail.
The specific embodiment
Following examples are used for illustrating the present invention, but are not used for limiting the scope of the invention.
Embodiment mono-
When table 1 adopts cross-linking sodium carboxymethyl cellulose to be disintegrating agent, the prescription of the different additions of kieselguhr
Employing direct powder compression is prepared, and concrete grammar is as follows:
Take various active component and adjuvant by prescription, cross respectively 100 mesh sieves, wherein dry 2 hours of 60 ℃ of microcrystalline Cellulose, various adjuvants add to according to equivalent incremental method in the mixed powder of Utimox and clavulanate potassium, in mixer after mix homogeneously, discharging, carries out tabletting with oval special-shaped punch die, obtains amoxicillin and clavulanate potassium (4:1) dispersible tablet.
Embodiment bis-
When table 2 adopts carboxymethyl starch sodium to be disintegrating agent, the prescription of the different additions of kieselguhr
Employing direct powder compression is prepared, and concrete grammar is as follows:
Take various active component and adjuvant by prescription, cross respectively 100 mesh sieves, wherein dry 2 hours of 60 ℃ of microcrystalline Cellulose, various adjuvants add to according to equivalent incremental method in the mixed powder of Utimox and clavulanate potassium, in mixer after mix homogeneously, discharging, carries out tabletting with oval special-shaped punch die, obtains amoxicillin and clavulanate potassium (4:1) dispersible tablet.
Embodiment tri-
When table 3 adopts polyvinylpolypyrrolidone to be disintegrating agent, the prescription of the different additions of kieselguhr
Employing direct powder compression is prepared, and concrete grammar is as follows:
Take various active component and adjuvant by prescription, cross respectively 100 mesh sieves, wherein dry 2 hours of 60 ℃ of microcrystalline Cellulose, various adjuvants add to according to equivalent incremental method in the mixed powder of Utimox and clavulanate potassium, in mixer after mix homogeneously, discharging, carries out tabletting with oval special-shaped punch die, obtains amoxicillin and clavulanate potassium (4:1) dispersible tablet.
Embodiment tetra-
When table 4 adopts cross-linking sodium carboxymethyl cellulose to be disintegrating agent, the prescription of the different additions of adjuvant
Employing direct powder compression is prepared, and concrete grammar is as follows:
Take various active component and adjuvant by prescription, cross respectively 100 mesh sieves, wherein dry 2 hours of 60 ℃ of microcrystalline Cellulose, various adjuvants add to according to equivalent incremental method in the mixed powder of Utimox and clavulanate potassium, in mixer after mix homogeneously, discharging, carries out tabletting with oval special-shaped punch die, obtains amoxicillin and clavulanate potassium (4:1) dispersible tablet.
Embodiment five
When table 5 adopts cross-linking sodium carboxymethyl cellulose to be disintegrating agent, the prescription of different correctivess
Employing direct powder compression is prepared, and concrete grammar is as follows:
Take various active component and adjuvant by prescription, cross respectively 100 mesh sieves, wherein dry 2 hours of 60 ℃ of microcrystalline Cellulose, various adjuvants add to according to equivalent incremental method in the mixed powder of Utimox and clavulanate potassium, in mixer after mix homogeneously, discharging, carries out tabletting with oval special-shaped punch die, obtains amoxicillin and clavulanate potassium (4:1) dispersible tablet.
Embodiment six
Table 6 adopts the prescription of different lubricants
Employing direct powder compression is prepared, and concrete grammar is as follows:
Take various active component and adjuvant by prescription, cross respectively 100 mesh sieves, wherein dry 2 hours of 60 ℃ of microcrystalline Cellulose, various adjuvants add to according to equivalent incremental method in the mixed powder of Utimox and clavulanate potassium, in mixer after mix homogeneously, discharging, carries out tabletting with oval special-shaped punch die, obtains amoxicillin and clavulanate potassium (4:1) dispersible tablet.
Testing result for above prescription is as follows:
1, dispersing uniformity
Method according to " dispersing uniformity " item in 2010 editions second appendix IA of Chinese Pharmacopoeia is carried out.
Get 6 of test samples, put in 250ml beaker, add the water 100ml of 15-25 ℃, jolting 3 minutes, all disintegrate is also by No. two sieves.In this test, specifically select 5 ℃ of 15 ℃, 25 ℃ and lower temperature to test.
When table 7 adopts cross-linking sodium carboxymethyl cellulose to be disintegrating agent, diatomaceous different additions are on the prescription impact of disintegration
Illustrate: the LVFS in table refers to and shorten percentage rate the disintegration of writing out a prescription compared with writing out a prescription with contrast under same temperature.
Can find out, prescription 1 to prescription 5 and contrast prescription 1 relatively, all significantly shorten than the disintegration of the contrast prescription 1 under same temperature its disintegration, wherein writes out a prescription 3 the highest at LVFS at each temperature.
When table 8 adopts carboxymethyl starch sodium to be disintegrating agent, diatomaceous different additions are on the prescription impact of disintegration
Illustrate: the LVFS in table refers to and shorten percentage rate the disintegration of writing out a prescription compared with writing out a prescription with contrast under same temperature.
Can find out, prescription 6 to prescription 10 and contrast prescription 2 relatively, its disintegration is than slightly shortening the disintegration of the contrast prescription 2 under same temperature, wherein writes out a prescription 9 the highest at LVFS at each temperature.
When table 9 adopts polyvinylpolypyrrolidone to be disintegrating agent, diatomaceous different additions are on the prescription impact of disintegration
Illustrate: the LVFS in table refers to and shorten percentage rate the disintegration of writing out a prescription compared with writing out a prescription with contrast under same temperature.
Can find out, prescription 11 to prescription 15 and contrast prescription 3 relatively, its disintegration is than slightly shortening the disintegration of the contrast prescription 3 under same temperature, wherein writes out a prescription 12 the highest at LVFS at each temperature.
When table 10 adopts cross-linking sodium carboxymethyl cellulose to be disintegrating agent, different ratio of adjuvant is on the prescription impact of disintegration
Illustrate: the LVFS in table refers to and shorten percentage rate the disintegration of writing out a prescription compared with writing out a prescription with contrast under same temperature.
Can find out, prescription 16 writes out a prescription 1 relatively to prescription 19 and contrast, and its disintegration is than significantly shortening the disintegration of the contrast prescription 1 under same temperature.
When table 11 adopts cross-linking sodium carboxymethyl cellulose to be disintegrating agent, different correctivess is on the prescription impact of disintegration
Illustrate: the LVFS in table refers to and shorten percentage rate the disintegration of writing out a prescription compared with writing out a prescription with contrast under same temperature.
Can find out, prescription 20 writes out a prescription 1 relatively to prescription 22 and contrast, and its disintegration is than significantly shortening the disintegration of the contrast prescription 1 under same temperature.
It is disintegrating agent and while not adding kieselguhr, different lubricants is on the prescription impact of disintegration that table 12 adopts cross-linking sodium carboxymethyl cellulose
Illustrate: the LVFS in table refers to and shorten percentage rate the disintegration of writing out a prescription compared with writing out a prescription with contrast under same temperature.
Can find out, contrast prescription 4 writes out a prescription 1 relatively with contrast, its disintegration is than slightly extending or maintain an equal level the disintegration of the contrast prescription 1 under same temperature, relatively, its disintegration is than slightly shortening the disintegration of the contrast prescription 1 under same temperature for contrast prescription 5, contrast prescription 6 and contrast prescription 1.
2, mobility and sticking
Mobility is to embody angle of repose, and the assay method of angle of repose is as follows:
Adopt the comprehensive analyzer of powder to measure in conjunction with fixing conical bottom method: to get a certain amount of powder to be measured, under certain frequency of vibration (about 100nz), making powder pass through funnel evenly flows out, until obtain the highest cone, measure the angle of cone inclined-plane and plane and get final product, each measurement repeated 3 times, gets its meansigma methods.Mixed powder after each prescription active component and adjuvant mix homogeneously in embodiment is carried out to the test of angle of repose and sticking, the results are shown in Table 13.
Mobility and the sticking of the each prescription of table 13
| Prescription sequence number | Mobility (angle of repose) | Sticking | Prescription sequence number | Mobility (angle of repose) | Sticking |
| Prescription 1 | 36° | No | Prescription 13 | 34° | No |
| Prescription 2 | 36° | No | Prescription 14 | 34° | No |
| Prescription 3 | 35° | No | Prescription 15 | 33° | No |
| Prescription 4 | 35° | No | Contrast prescription 3 | 45° | Be |
| Prescription 5 | 34° | No | Prescription 16 | 36° | No |
| Contrast prescription 1 | 46° | Be | Prescription 17 | 35° | No |
| Prescription 6 | 38° | No | Prescription 18 | 35° | No |
| Prescription 7 | 38° | No | Prescription 19 | 34° | No |
| Prescription 8 | 37° | No | Prescription 20 | 35° | No |
| Prescription 9 | 36° | No | Prescription 21 | 35° | No |
| Prescription 10 | 36° | No | Prescription 22 | 35° | No |
| Contrast prescription 2 | 50° | Be | Contrast prescription 4 | 37° | No |
| Prescription 11 | 35° | No | Contrast prescription 5 | 32° | No |
| Prescription 12 | 35° | No | Contrast prescription 6 | 35° | Slight sticking |
3, mouthfeel
Method of testing: 20 volunteers, men and women half and half, between age 25-30 year.Get the dispersible tablet of 1 prescription to be tested, every containing amoxicillin (in anhydride) 125mg, clavulanate potassium (in clavulanic acid) 31.25mg, insert in the water tumbler that fills 150ml water, water temperature is 20 ℃ of left and right, after dispersible tablet disperses completely, rock water tumbler, taste after making Dispersion of Solute Matter evenly, the test result of each prescription is in table 14:
The sensory test that table 14 is write out a prescription
| Prescription sequence number | Bad | Generally | Good | Feature |
| Prescription 3 | 0 | 4 | 16 | Micro-perfume (or spice) is micro-sweet in bilgy odour |
| Prescription 20 | 0 | 8 | 12 | Slightly bilgy odour |
| Prescription 21 | 2 | 8 | 10 | Slightly bilgy odour |
| Prescription 22 | 0 | 8 | 12 | Slightly bilgy odour |
4, the detection of content, dissolution, related substance, moisture
Method according to 2010 editions two text kind Part I of Chinese Pharmacopoeia " amoxicillin and clavulanate potassium dispersible tablet " is carried out accelerated test, and the dispersible tablet of each prescription adopts two In Aluminium Foil Packings, the results are shown in Table 15,16.
The accelerated test (character, content, moisture and related substance) that table 15 is write out a prescription
The accelerated test (dissolution) that table 16 is write out a prescription
Illustrate: the kieselguhr adopting in the present invention's prescription is white diatomite, and granularity is 200-300 order; The microcrystalline Cellulose adopting in the present invention's prescription is the microcrystalline Cellulose that the auspicious model of stepping on the production of Mel father and son company of Germany is PH102.
Claims (8)
1. an amoxicillin and clavulanate potassium dispersible tablet, it is characterized in that: described dispersible tablet is made up of the component of following percentage by weight: Utimox 18.95%-25.26%, clavulanate potassium 4.92%-6.55%, microcrystalline Cellulose 62.35%-68.79%, disintegrating agent 2.2%-2.75%, kieselguhr 1.29%-6.13%, sweeting agent 0.11%-0.50%, aromatic 0.22%-0.28%.
2. a kind of amoxicillin and clavulanate potassium dispersible tablet according to claim 1, is characterized in that: described disintegrating agent is selected from the one in cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, polyvinylpolypyrrolidone.
3. a kind of amoxicillin and clavulanate potassium dispersible tablet according to claim 1 and 2, is characterized in that: described disintegrating agent is self-crosslinking sodium carboxymethyl cellulose most preferably.
4. a kind of amoxicillin and clavulanate potassium dispersible tablet according to claim 1, is characterized in that: described sweeting agent is selected from the one in aspartame, sucralose, and described aromatic is selected from the one in blue berry essence, Fructus Citri Limoniae essence.
5. according to a kind of amoxicillin and clavulanate potassium dispersible tablet described in claim 1 or 4, it is characterized in that: described sweeting agent is most preferably from sucralose, and described aromatic is most preferably from blue berry essence.
6. a kind of amoxicillin and clavulanate potassium dispersible tablet according to claim 1, is characterized in that: in described dispersible tablet, Utimox and clavulanate potassium are respectively take the weight ratio of amoxicillin and clavulanic acid as 4:1.
7. a kind of amoxicillin and clavulanate potassium dispersible tablet according to claim 1, is characterized in that: described dispersible tablet adopts direct powder compression to be prepared.
8. a kind of amoxicillin and clavulanate potassium dispersible tablet according to claim 1, it is characterized in that: described dispersible tablet is made up of the component of following percentage by weight: Utimox 21.66%, clavulanate potassium 5.62%, microcrystalline Cellulose 66.03%, cross-linking sodium carboxymethyl cellulose 2.51%, kieselguhr 3.77%, blue berry essence 0.25%, sucralose 0.16%.
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