CN102240285A - Amoxicillin and potassium clavulanate tablet for dogs and cats, and its preparation method and application - Google Patents
Amoxicillin and potassium clavulanate tablet for dogs and cats, and its preparation method and application Download PDFInfo
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- CN102240285A CN102240285A CN2011101126840A CN201110112684A CN102240285A CN 102240285 A CN102240285 A CN 102240285A CN 2011101126840 A CN2011101126840 A CN 2011101126840A CN 201110112684 A CN201110112684 A CN 201110112684A CN 102240285 A CN102240285 A CN 102240285A
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- ABVRVIZBZKUTMK-JSYANWSFSA-M potassium clavulanate Chemical compound [K+].[O-]C(=O)[C@H]1C(=C/CO)/O[C@@H]2CC(=O)N21 ABVRVIZBZKUTMK-JSYANWSFSA-M 0.000 title claims abstract description 94
- LSQZJLSUYDQPKJ-NJBDSQKTSA-N amoxicillin Chemical compound C1([C@@H](N)C(=O)N[C@H]2[C@H]3SC([C@@H](N3C2=O)C(O)=O)(C)C)=CC=C(O)C=C1 LSQZJLSUYDQPKJ-NJBDSQKTSA-N 0.000 title claims abstract description 93
- 229960003022 amoxicillin Drugs 0.000 title claims abstract description 93
- LSQZJLSUYDQPKJ-UHFFFAOYSA-N p-Hydroxyampicillin Natural products O=C1N2C(C(O)=O)C(C)(C)SC2C1NC(=O)C(N)C1=CC=C(O)C=C1 LSQZJLSUYDQPKJ-UHFFFAOYSA-N 0.000 title claims abstract description 93
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- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 17
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- 238000001035 drying Methods 0.000 claims abstract description 11
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- 229940038649 clavulanate potassium Drugs 0.000 claims description 87
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 23
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- HZZVJAQRINQKSD-UHFFFAOYSA-N Clavulanic acid Natural products OC(=O)C1C(=CCO)OC2CC(=O)N21 HZZVJAQRINQKSD-UHFFFAOYSA-N 0.000 description 4
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Abstract
The invention relates to an amoxicillin and potassium clavulanate tablet for dogs and cats, and its preparation method and application; the tablet is mainly used for treating and preventing infectious diseases of dogs and cats. According to the invention, the problem of control scope for environmental temperature and humidity in production of the tablet is solved, accessories that guarantee the stability of the tablet are obtained through screening, and a package form that ensures stabilization of the tablet is employed. The tablet is prepared by granulating amoxicillin in advance and then mixing amoxicillin granules with potassium clavulanate for tabletting, which guarantees the quality of tabletting on one hand and reduces the possibility of decomposition of potassium clavulanate on the other hand. The amoxicillin and potassium clavulanate tablet for dogs and cats comprises, by weight, 5 to 45% of amoxicillin, 1 to 20% of potassium clavulanate, 50 to 90% of a diluent, 1 to 10% of a disintegrating agent, 1 to 5% of an adhesive, 0.1 to 3% of a sweetener, 0.2 to 2% of an aromatic and 0.5 to 3% of a lubricant, wherein the carrier for potassium clavulanate is microcrystalline cellulose. The preparation method mainly comprises the steps of pulverizing, granulating, drying, size grading, granule mixing, tabletting and packaging.
Description
Technical field
The present invention relates to the amoxicillin and clavulanate potassium sheet, relate in particular to be fit to be applied to veterinary clinic the dog cat with amoxicillin and clavulanate potassium sheet and preparation method thereof, use.
Background technology
The amoxicillin and clavulanate potassium sheet has a wide range of applications in clinical medicine, is the compound preparation of amoxicillin and clavulanate potassium, belongs to beta-lactam antibiotic.Beta-lactam antibiotic is present most important veterinary clinic anti-infectives, the amoxicillin be the ampicillin to hydroxyl homologue, its antimicrobial spectrum and antibacterial action and ampicillin are basic identical, by suppressing its antibacterial action of synthetic performance of sensitive organism mucopeptide cell wall.Continually develop and be widely used in clinical along with antibiotic, caused drug-resistance of bacteria, its main mechanism is because antibacterial produces beta-lactamase.And clavulanic acid is exactly a kind of beta-lactamase inhibitor that is most widely used.Clavulanic acid is bacteriogenic natural beta-lactamase inhibitor, contains beta-lactam nucleus in the structure, and antibacterial action is very weak, but has the strong effect wide-spectrum bacteriostasis.Clavulanic acid and the coupling of beta-lactam antibiotic amoxicillin are made enzyme and are suppressed combination formulations, can effectively suppress the hydrolysis to the amoxicillin of these 5 kinds of wide spectrums of TEN-1, SHV-1, PSE-4, KI and K-CAZ and super wide spectrum enzyme.Experimental results show that clavulanate potassium below 10mg/ml concentration, is 83-98% to the inhibition efficient of amoxicillin.Clavulanic acid makes the amoxicillin avoid the destruction of beta-lactamase, can protect the amoxicillin not by the beta-lactam enzyme-deactivating in varying degrees, thereby improves the latter's the drug-fast effect of anti-product enzyme, improves clinical efficacy.Studies have shown that beta-lactam antibiotic and its inhibitor have good antibacterial action to producing ESBLs (extended spectrum) bacterium such as escherichia coli, Klebsiella Pneumoniae external.Amoxicillin and clavulanate potassium can be killed multiple Gram-positive and gram negative bacteria clinically, particularly the fastbacteria that produces beta-lactamase is had special efficacy.
In the prior art, the scope of application of amoxicillin and clavulanate potassium on house pet is narrower, and the restriction of dog cat dispensing in addition also just has certain restriction to the dosage form selection of amoxicillin and clavulanate potassium.In addition, amoxicillin and clavulanate potassium has very strong hygroscopicity, and meet water capacity changeableness and decompose, so that its solution prepares difficulty is bigger, and the solution unstable product quality, degeneration easily.The amoxicillin and clavulanate potassium sheet has that dosage is accurate, and content is even, and chemical property is stable, carries, transports, takes characteristics such as all more convenient, especially is beneficial to the dog cat and takes.The amoxicillin and clavulanate potassium sheet of how mankind being used is used for treatment of diseases such as dog cat, lacks the amoxicillin and clavulanate potassium tablets product that is used for the dog cat but present dog cat clinically.Because human consumption and dog cat consumption are very different, its content specification is unsuitable for the dog cat and uses, so often can not treat the disease of dog cat effectively.
Summary of the invention
The present invention proposes in view of the above problems, at the dog cat amoxicillin and clavulanate potassium is absorbed characteristics, make the dosage that makes things convenient for the dog cat to use, more help the clinical use of dog cat, the object of the present invention is to provide the dog cat to use amoxicillin and clavulanate potassium sheet and preparation method thereof, use.
The present invention relates to a kind of dog cat and use the amoxicillin and clavulanate potassium sheet, this dog cat is made of following component with the amoxicillin and clavulanate potassium sheet, the mass percent of each component is respectively: amoxicillin 5-45%, clavulanate potassium 1-20%, disintegrating agent 1-10%, diluent 50-90%, sweeting agent 0.1-3%, aromatic 0.2-2%, binding agent 1-5%, lubricant 0.5-3%, wherein the carrier of above-mentioned clavulanate potassium is a microcrystalline Cellulose.
Above-mentioned dog cat is with in the amoxicillin and clavulanate potassium sheet, preferred lactose and the microcrystalline Cellulose of adopting is as above-mentioned diluent, adopt cross-linked pvp as above-mentioned disintegrating agent, the ethanol solution that adopts polyvinylpyrrolidone is as above-mentioned binding agent, adopt aspartame as above-mentioned sweeting agent, adopt beef flavor as above-mentioned aromatic, adopt magnesium stearate as above-mentioned lubricant.
According to foregoing invention, by the stability of adjuvant screening raising tablet medicine itself.
The invention still further relates to the preparation method of above-mentioned dog cat, comprise the steps: the powder process step, the amoxicillin is mixed in mixer with diluent, disintegrating agent, obtain mixed powder with the amoxicillin and clavulanate potassium sheet; Granulation step adds binding agent in above-mentioned mixed powder, adopt and wave the granulator granulation, makes wet granular; Drying steps places in the baking oven 50 ℃ to be dried to moisture and to be lower than 5% above-mentioned wet granular; The granulate step after the drying, is crossed 20 mesh sieve granulate; Mix the grain step, pour mix homogeneously in the mixer into sweeting agent, aromatic and clavulanate potassium and by the granule that above-mentioned granulate step obtains, add mix lubricant, wherein the mass ratio of amoxicillin and clavulanate potassium is 4: 1; The tabletting step is poured the material that obtains in the above-mentioned mixed grain step in the hopper of tablet machine into, carries out tabletting; Packaging step adopts two In Aluminium Foil Packings, is sealed in the aluminium foil bag that desiccant is housed.
According to the invention of above-mentioned preparation method, adopt and granulated in advance in the amoxicillin, with the method for clavulanate potassium mixed pressuring plate, not only guaranteed the tabletting quality but also reduced the possibility that clavulanate potassium decomposes again.Select two aluminum to be packed by screening test, improved the stability of amoxicillin and clavulanate potassium tablet quality.
In the preparation method of above-mentioned dog cat with the amoxicillin and clavulanate potassium sheet, the humidity of preferred production environment is below 35%, and temperature is below 28 ℃.
According to the invention of above-mentioned preparation method, because the present invention is the adjuvant intensive drying, the humidity of control production environment has guaranteed the moisture in the absorbing environmental minimum in the process of producing product, by moisture Control, has improved the stability of tablet medicine itself.
In the preparation method of above-mentioned dog cat with the amoxicillin and clavulanate potassium sheet, preferred lactose and the microcrystalline Cellulose of adopting is as above-mentioned diluent, adopt cross-linked pvp as above-mentioned disintegrating agent, the ethanol solution that adopts polyvinylpyrrolidone is as above-mentioned binding agent, adopt aspartame as above-mentioned sweeting agent, adopt beef flavor as above-mentioned aromatic, adopt magnesium stearate as above-mentioned lubricant.
Invention according to above-mentioned preparation method, adopt the ethanol solution of polyvinylpyrrolidone to carry out wet granulation, guarantee the moisture in the absorbing environmental minimum in the process of producing product, reduced the possibility that clavulanate potassium absorbs moisture, improved the stability of tablet medicine itself.
The invention still further relates to the application of above-mentioned dog cat with the amoxicillin and clavulanate potassium sheet, it is specifically designed to the dog cat, the respiratory tract infection of treatment dog cat, urinary tract infection, digestive tract infection and skin infection.
According to foregoing invention, at the absorb characteristics of dog cat to amoxicillin and clavulanate potassium, the dosage of making that makes things convenient for the dog cat to use more helps the clinical use of dog cat.Be used for the treatment of the respiratory tract infection of dog cat, urinary tract infection, digestive tract infection and skin infection and have good therapeutic effect, cure rate reaches more than 95%, helps the application on house pet markets such as dog cat and widelys popularize.
Description of drawings
Fig. 1 is the step sketch map of the dog cat that the present invention relates to of expression with the preparation method of amoxicillin and clavulanate potassium sheet.
The specific embodiment
The invention provides a kind of dog cat and use the amoxicillin and clavulanate potassium sheet, it is clinical that it is mainly used in the dog cat.This dog cat mainly is made of following component with the amoxicillin and clavulanate potassium sheet, the mass percent of each component is respectively: amoxicillin 5-45%, clavulanate potassium (carrier is a microcrystalline Cellulose) 1-20%, disintegrating agent 1-10%, diluent 50-90%, sweeting agent 0.1-3%, aromatic 0.2-2%, binding agent 1-5%, lubricant 0.5-3%.
Amoxicillin and clavulanate potassium sheet of the present invention adopts amoxicillin and clavulanate potassium (carrier is a microcrystalline Cellulose) as principal agent, adopt lactose and microcrystalline Cellulose as diluent, adopt cross-linked pvp as disintegrating agent, the ethanol solution that adopts polyvinylpyrrolidone is as binding agent, adopt aspartame as sweeting agent, adopt beef flavor as aromatic, adopt magnesium stearate as lubricant.
Can exemplify out the following configuration example of each component, as preparation example of the present invention.In addition, the contained amoxicillin of every tablet of tablet, the content of clavulanate potassium are example in following each preparation example, should not be construed as concrete qualification to drug content in the tablet, difference according to the body weight of the dog that is suitable for, cat etc., type etc., can suitably regulate the specification of tablet, to regulate the content of every middle amoxicillin, clavulanate potassium.
Preparation example one
Take amoxicillin 90g, clavulanate potassium (carrier is a microcrystalline Cellulose) 40g, lactose 410g, microcrystalline Cellulose 350g, cross-linked pvp 62g, polyvinylpyrrolidone 38g (ethanol solution of polyvinylpyrrolidone), aspartame 5g, beef flavor 6g, magnesium stearate 9g respectively, make tablet according to the described method in back.This tablet can be every and comprise amoxicillin 50mg, the tablet of clavulanate potassium 12.5mg.
Preparation example two
Take amoxicillin 180g, clavulanate potassium (carrier is a microcrystalline Cellulose) 80g, lactose 400g, microcrystalline Cellulose 260g, cross-linked pvp 40g, polyvinylpyrrolidone 32g (ethanol solution of polyvinylpyrrolidone), aspartame 5g, beef flavor 5g, magnesium stearate 10g respectively, make tablet according to the described method in back.This tablet can be every and comprise amoxicillin 100mg, the tablet of clavulanate potassium 25mg.
Preparation example three
Take amoxicillin 360g, clavulanate potassium (carrier is a microcrystalline Cellulose) 160g, lactose 280g, microcrystalline Cellulose 120g, cross-linked pvp 40g, polyvinylpyrrolidone 28g (ethanol solution of polyvinylpyrrolidone), aspartame 4g, beef flavor 6g, magnesium stearate 12g respectively, make tablet according to the described method in back.This tablet can be every and comprise amoxicillin 200mg, the tablet of clavulanate potassium 50mg.
The preparation method example
Below, be example with the process for preparing above-mentioned preparation example two, the preparation method of dog cat with amoxicillin and clavulanate potassium (4: 1) sheet is described.
At first, in mixer, mix amoxicillin 180g and lactose 400g, microcrystalline Cellulose 260g, cross-linked pvp 40g, obtain mixed powder A.Add the ethanol solution of polyvinylpyrrolidone in mixed powder A, employing is waved granulator and is granulated, and obtains wet granular.This wet granular is poured out back stand dish, place in the baking oven 50 ℃ to be dried to moisture and to be lower than 5%.After the drying, cross 20 mesh sieve granulate, obtain dried granule B.Aspartame 5g, beef flavor 5g and clavulanate potassium 80g and dried granule B are poured in the mixer behind the mix homogeneously, add magnesium stearate 10g, continue mix homogeneously.Then, mixed material is poured in the hopper of tablet machine, carried out tabletting.Behind the tabletting, the plates that tabletting is made carry out two In Aluminium Foil Packings, are sealed in the aluminium foil bag that desiccant is housed, and obtain packaged dog cat and use amoxycillin with clavulanate potassium (4: 1) sheet.Preferably above-mentioned production environment is controlled to be humidity below 35%, temperature is more preferably above-mentioned production environment is controlled to be humidity below 30% below 28 ℃, and temperature is below 25 ℃.
With reference to foregoing and Fig. 1, prepare the dog cat as can be known and mainly may further comprise the steps with the method for amoxicillin and clavulanate potassium sheet:
A) powder process step is mixed with diluent, disintegrating agent the amoxicillin in mixer, obtain mixed powder;
B) granulation step adds binding agent in above-mentioned mixed powder, adopt and wave the granulator granulation, makes wet granular;
C) drying steps places in the baking oven 50 ℃ to be dried to moisture and to be lower than 5% above-mentioned wet granular;
D) granulate step after the drying, is crossed 20 mesh sieve granulate, obtains dried granule;
E) mix the grain step, with sweeting agent, aromatic and clavulanate potassium (amoxicillin: clavulanate potassium=4: 1) pour mix homogeneously in the mixer into, add mix lubricant with above-mentioned dried granule;
F) tabletting step is poured mixed material in the hopper of tablet machine, carries out tabletting.
G) packaging step adopts two In Aluminium Foil Packings, is sealed in the aluminium foil bag that desiccant is housed.
In the said method, utilize the ethanol solution of polyvinylpyrrolidone to carry out wet granulation, granulated in amoxicillin and corresponding adjuvant, reduce the density of supplementary material, improved drug loading.Because granulation solution has adopted dehydrated alcohol, so can reduce the influence of water to amoxicillin and clavulanate potassium to greatest extent.The humidity of whole production environment is controlled at below 35%, preferably below 30%, can reduces ambient humidity when high, water is to the influence of amoxicillin and clavulanate potassium.In baking oven, wet granular is carried out 50 ℃ of dryings, can the intensive drying adjuvant.These technological means have all reduced the influence to amoxicillin and clavulanate potassium of moisture that production technology brings to greatest extent, overcome amoxicillin and clavulanate potassium and had very strong hygroscopicity, meet the difficult problem that water capacity changeableness decomposes, so can guarantee product quality, solve the problem of the moisture Control scope in the supplementary material in the production technology.
Experimental example one
Below, the application of this dog cat usefulness amoxicillin and clavulanate potassium tablets aspect the respiratory tract infection of treatment dog cat, urinary tract infection, digestive tract infection and skin infection is described.
(1) the dog cat is with the effect of amoxicillin and clavulanate potassium tablets to dog cat urinary tract infection
Experimental animal: each 36 of healthy adult beasle dog, common domestic cats, male and female half and half are divided into 6 groups respectively, 6 every group.Artificial induction's morbidity.First attack and do not pass through antibiotic therapy; Make a definite diagnosis by urine test, urine dyeing positive for bacteria and urine pH 〉=8.0, blood routine examination total white blood cells (WBC) raises simultaneously, and (WBC＞17.00 * 109/L) persons go into to elect as laboratory animal.And to the fast promise injection (production of Animal Health Care Products Corporation of Pfizer) of a certain infected group injection dosage form as positive controls (down with).
Test grouping: (1) blank (not infecting not administration) group;
(2) infect not administration group (negative control group);
(3) be subjected to reagent thing recommended dose to double group (250mg/10kg, high dose group);
(4) be subjected to reagent thing recommended dose group (125mg/10kg, middle dosage group);
(5) be subjected to the reagent thing recommended dose group (62.5mg/10kg, low dose group) that reduces by half;
(6) positive controls: infect and give fast promise injection, Animal Health Care Products Corporation of Pfizer produces.
Dosage regimen: be subjected to reagent thing oral administration; Every day 2 times; Logotype 5 days.
In the above-mentioned experiment grouping, what 250mg/10kg represented is, using the total amount that contains amoxicillin and clavulanate potassium for the dog of 10kg or cat is the dosage of 250mg, and wherein the mass ratio of amoxicillin and clavulanate potassium is 4: 1.In like manner, soluble 125mg/10kg and 62.5mg/10kg.
Therapeutic effect:
The same day and the 5th day before experiment begins to take medicine, gather the urine sample and the blood sample of every experimental animal, urine routine, the blood routine inspection of experimentize respectively dog and experiment cat.Observed 5 days after the experiment administration; Record clinical symptoms during on-test has or not toxicity after the administration, before the medication with medication after the mental status, the diet of dog desire, activeness, the situation etc. of urinating.Gather urine specimen during off-test, detect the index relevant with antibacterial effect.
Result of the test is as follows:
According to " house pet whole body antibacterials evaluating drug effect experiment instruction principle ", in the last result of the test, " healing " expression clinical symptom disappearance, vital sign, lab testing (routine blood test, routine urinalysis, bacteriology etc.) index recover normal, and antibacterial separates negative conversion rate 〉=90%." effectively " expression state of an illness takes an evident turn for the better, but laboratory checking index recovers normally antibacterial separation negative conversion rate 〉=60% fully.Engineering noise represent medication after 72 hours the state of an illness do not have being clearly better or increase the weight of, antibacterial separates negative conversion rate＜60%.
(2) the dog cat is with the effect of amoxicillin and clavulanate potassium tablets to the respiratory tract infection of dog cat
Experimental animal: each 36 of healthy adult beasle dog, common domestic cats, male and female half and half are divided into 6 groups respectively, 6 every group.Artificial induction's morbidity.First attack and do not pass through antibiotic therapy; Make a definite diagnosis by urine test, urine dyeing positive for bacteria and urine pH 〉=8.0, while blood routine examination total white blood cells (WBC) raise, and (WBC＞17.00 * 109/L) persons go into to elect as laboratory animal.
Test grouping: (1) blank (not infecting not administration) group;
(2) infect not administration group (negative control group);
(3) be subjected to reagent thing recommended dose to double group (250mg/10kg, high dose group);
(4) be subjected to reagent thing recommended dose group (125mg/10kg, middle dosage group);
(5) be subjected to the reagent thing recommended dose group (62.5mg/10kg, high dose group) that reduces by half;
(6) positive controls (give fast promise injection, Animal Health Care Products Corporation of Pfizer produces).
Dosage regimen: be subjected to reagent thing oral administration; Every day 2 times; Logotype 5 days.
In the above-mentioned experiment grouping, what 250mg/10kg represented is, using the total amount that contains amoxicillin and clavulanate potassium for the dog of 10kg or cat is the dosage of 250mg, and wherein the mass ratio of amoxicillin and clavulanate potassium is 4: 1.In like manner, soluble 125mg/10kg and 62.5mg/10kg.
Therapeutic effect is observed:
The same day and the 5th day before experiment begins to take medicine, gather the urine sample and the blood sample of every experimental animal, urine routine, the blood routine inspection of experimentize respectively dog and experiment cat.Observed 5 days after the experiment administration; Record clinical symptoms during on-test has or not toxicity after the administration, before the medication with medication after the mental status, the diet of dog desire, activeness, the situation etc. of urinating.Gather the respiratory tract sample during off-test, detect the index relevant with antibacterial effect.
Result of the test is as follows:
According to " house pet whole body antibacterials evaluating drug effect experiment instruction principle ", in the last result of the test, " healing " expression clinical symptom disappearance, vital sign, lab testing (routine blood test, routine urinalysis, bacteriology etc.) index recover normal, and antibacterial separates negative conversion rate 〉=90%." effectively " expression state of an illness takes an evident turn for the better, but laboratory checking index recovers normally antibacterial separation negative conversion rate 〉=60% fully.Engineering noise represent medication after 72 hours the state of an illness do not have being clearly better or increase the weight of, antibacterial separates negative conversion rate＜60%.
(3) the dog cat is with the effect of amoxicillin and clavulanate potassium tablets to dog cat digestive tract infection
Experimental animal: each 36 of healthy adult beasle dog, common domestic cats, male and female half and half are divided into 6 groups respectively, 6 every group.Artificial induction's morbidity.First attack and do not pass through antibiotic therapy; Make a definite diagnosis by urine test, urine dyeing positive for bacteria and urine pH 〉=8.0, while blood routine examination total white blood cells (WBC) raise, and (WBC＞17.00 * 109/L) persons go into to elect as laboratory animal.
Test grouping: (1) blank (not infecting not administration) group;
(2) infect not administration group (negative control group);
(3) be subjected to reagent thing recommended dose to double group (250mg/10kg, high dose group);
(4) be subjected to reagent thing recommended dose group (125mg/10kg, middle dosage group);
(5) be subjected to the reagent thing recommended dose group (62.5mg/10kg, high dose group) that reduces by half;
(6) positive controls (give fast promise injection, Animal Health Care Products Corporation of Pfizer produces).
Dosage regimen: be subjected to reagent thing oral administration; Every day 2 times; Logotype 5 days.
In the above-mentioned experiment grouping, what 250mg/10kg represented is, using the total amount that contains amoxicillin and clavulanate potassium for the dog of 10kg or cat is the dosage of 250mg, and wherein the mass ratio of amoxicillin and clavulanate potassium is 4: 1.In like manner, soluble 125mg/10kg and 62.5mg/10kg.
Therapeutic effect is observed:
The same day and the 5th day before experiment begins to take medicine, gather the urine sample and the blood sample of every experimental animal, urine routine, the blood routine inspection of experimentize respectively dog and experiment cat.Observed 5 days after the experiment administration; Record clinical symptoms during on-test has or not toxicity after the administration, before the medication with medication after the mental status, the diet of dog desire, activeness, the situation etc. of urinating.Gather fecal sample during off-test, detect the index relevant with antibacterial effect.
Result of the test is as follows:
According to " house pet whole body antibacterials evaluating drug effect experiment instruction principle ", in the last result of the test, " healing " expression clinical symptom disappearance, vital sign, lab testing (routine blood test, routine urinalysis, bacteriology etc.) index recover normal, and antibacterial separates negative conversion rate 〉=90%." effectively " expression state of an illness takes an evident turn for the better, but laboratory checking index recovers normally antibacterial separation negative conversion rate 〉=60% fully.Engineering noise represent medication after 72 hours the state of an illness do not have being clearly better or increase the weight of, antibacterial separates negative conversion rate＜60%.
(4) the dog cat is with the effect of amoxicillin and clavulanate potassium tablets to dog cat skin skin trauma infection contamination
Experimental animal: each 36 of healthy adult beasle dog, common domestic cats, male and female half and half are divided into 6 groups respectively, 6 every group.Artificial induction's morbidity.First attack and do not pass through antibiotic therapy; Make a definite diagnosis by urine test, urine dyeing positive for bacteria and urine pH 〉=8.0, while blood routine examination total white blood cells (WBC) raise, and (WBC＞17.00 * 109/L) persons go into to elect as laboratory animal.
Test grouping: (1) blank (not infecting not administration) group;
(2) infect not administration group (negative control group);
(3) be subjected to reagent thing recommended dose to double group (250mg/10kg, high dose group);
(4) be subjected to reagent thing recommended dose group (125mg/10kg, middle dosage group);
(5) be subjected to the reagent thing recommended dose group (62.5mg/10kg, high dose group) that reduces by half;
(6) positive controls (give fast promise injection, Animal Health Care Products Corporation of Pfizer produces).
Dosage regimen: be subjected to reagent thing oral administration; Every day 2 times; Logotype 5 days.
In the above-mentioned experiment grouping, what 250mg/10kg represented is, using the total amount that contains amoxicillin and clavulanate potassium for the dog of 10kg or cat is the dosage of 250mg, and wherein the mass ratio of amoxicillin and clavulanate potassium is 4: 1.In like manner, soluble 125mg/10kg and 62.5mg/10kg.
Therapeutic effect is observed:
The same day and the 5th day before experiment begins to take medicine, gather the urine sample and the blood sample of every experimental animal, urine routine, the blood routine inspection of experimentize respectively dog and experiment cat.Observed 5 days after the experiment administration; Record clinical symptoms during on-test has or not toxicity after the administration, before the medication with medication after the mental status, the diet of dog desire, activeness, the situation etc. of urinating.Gather wound skin surface sample during off-test, detect the index relevant with antibacterial effect.
Result of the test is as follows:
According to " house pet whole body antibacterials evaluating drug effect experiment instruction principle ", in the result of the test, " healing " expression clinical symptom disappearance, vital sign, lab testing (routine blood test, routine urinalysis, bacteriology etc.) index recover normal, and antibacterial separates negative conversion rate 〉=90%." effectively " expression state of an illness takes an evident turn for the better, but laboratory checking index recovers normally antibacterial separation negative conversion rate 〉=60% fully.Engineering noise represent medication after 72 hours the state of an illness do not have being clearly better or increase the weight of, antibacterial separates negative conversion rate＜60%.
Above-mentioned experimental result is carried out statistical results show, the dog cat is with in the use of amoxicillin and clavulanate potassium tablets, basic, normal, high dosage group is significantly higher than positive controls (P＜0.01) to healing and the control rate that infects, and illustrates that dog cat of the present invention has curative effect preferably with amoxicillin and clavulanate potassium tablets to respiratory tract infection, urinary tract infection, digestive tract infection and the skin infection of dog cat.Basic, normal, high dosage group cure rate comparison shows that, best with middle and high dosage, consider the safety testing result, select for use middle dosage (promptly using the total amount that contains amoxicillin and clavulanate potassium for the dog of 10kg or cat is the dosage of 125mg, and the mass ratio of amoxicillin and clavulanate potassium is 4: 1) to be the final therapeutic dose of use.
Experimental example two
The dog cat of dosage in of the present invention is used for amoxicillin and clavulanate potassium tablets also drawn following clinical data in the case of dog cat of clinical natural occurrence, wherein at the data of dog:
Respiratory tract infection (28) example, recovery from illness (24), produce effects (3), effectively (1), invalid (0) worsens (0) cure rate (85.7%);
Urinary tract infection (21) example, recovery from illness (20), produce effects (1), effectively (0), invalid (0) worsens (0) cure rate (95.2%);
Digestive tract infection (30) example, recovery from illness (20), produce effects (4), effectively (1), invalid (5, be diagnosed as the mixing parvovirus infections, transfer the parvovirus treatment to), worsen (0) cure rate (66.7%);
Skin injury infects (25), recovery from illness (22), and produce effects (3), effectively (0), invalid (0) worsens (0) cure rate (88%).
Data at cat:
Respiratory tract infection (15) example, recovery from illness (12), produce effects (1), effectively (1), invalid (1) worsens (0) cure rate (80%);
Urinary tract infection (23) example, recovery from illness (19), produce effects (3), effectively (0), invalid (0) worsens (1, transfer chronic kidney hypofunction to) cure rate (82.6%);
Digestive tract infection (19) example, recovery from illness (19), produce effects (0), effectively (0), invalid (0) worsens (0) cure rate (100%);
Skin injury infects (12), recovery from illness (10), and produce effects (2), effectively (0), invalid (0) worsens (0) cure rate (83.3%).
As mentioned above, confirmed that dog cat of the present invention uses the amoxicillin and clavulanate potassium sheet, at the absorb characteristics of dog cat to amoxicillin and clavulanate potassium, the dosage of making that makes things convenient for the dog cat to use helps the clinical use of dog cat.Be used for the treatment of the respiratory tract infection of dog cat, urinary tract infection, digestive tract infection and skin infection and have good therapeutic effect, cure rate reaches more than 95%.
Because technological operation of the present invention is simple, by being granulated in the amoxicillin earlier, the humiture of control production environment, can reduce supplementary material aerial open-assembly time to greatest extent, effectively guaranteed the effectiveness of medicine, more help the performance of amoxicillin and clavulanate potassium drug action, economical and practical, help the application on house pets such as dog cat and widely popularize.
Claims (6)
1. a dog cat is used the amoxicillin and clavulanate potassium sheet, it is characterized in that, this dog cat is made of following component with the amoxicillin and clavulanate potassium sheet, the mass percent of various described components is respectively: amoxicillin 5-45%, clavulanate potassium 1-20%, diluent 50-90%, disintegrating agent 1-10%, binding agent 1-5%, sweeting agent 0.1-3%, aromatic 0.2-2% and lubricant 0.5-3%.
The carrier of wherein said clavulanate potassium is a microcrystalline Cellulose.
2. dog cat according to claim 1 is used the amoxicillin and clavulanate potassium sheet, it is characterized in that: adopt lactose and microcrystalline Cellulose as described diluent, adopt cross-linked pvp as described disintegrating agent, the ethanol solution that adopts polyvinylpyrrolidone is as described binding agent, adopt aspartame as described sweeting agent, adopt beef flavor as described aromatic, adopt magnesium stearate as described lubricant.
3. the preparation method of a dog cat usefulness amoxicillin and clavulanate potassium sheet is characterized in that comprising the steps:
The powder process step is mixed with diluent, disintegrating agent the amoxicillin in mixer, obtain mixed powder;
Granulation step adds binding agent in described mixed powder, adopt and wave the granulator granulation, makes wet granular;
Drying steps places in the baking oven 50 ℃ to be dried to moisture and to be lower than 5% described wet granular;
The granulate step after the drying, is crossed 20 mesh sieve granulate, obtains dried granule;
Mix the grain step, pour sweeting agent, aromatic and clavulanate potassium and described dried granule in mixer mix homogeneously, add mix lubricant, wherein the mass ratio of amoxicillin and clavulanate potassium is 4: 1;
The tabletting step is poured the material that obtains in the described mixed grain step in the hopper of tablet machine into, carries out tabletting;
Packaging step adopts two In Aluminium Foil Packings, is sealed in the aluminium foil bag that desiccant is housed.
4. dog cat according to claim 3 is used the preparation method of amoxicillin and clavulanate potassium sheet, and it is characterized in that: the humidity of production environment is below 35%, and temperature is below 28 ℃.
5. according to claim 3 or 4 described dog cats preparation method with the amoxicillin and clavulanate potassium sheets, it is characterized in that: adopt lactose and microcrystalline Cellulose as described diluent, adopt cross-linked pvp as described disintegrating agent, the ethanol solution that adopts polyvinylpyrrolidone is as described binding agent, adopt aspartame as described sweeting agent, adopt beef flavor as described aromatic, adopt magnesium stearate as described lubricant.
6. claim 1 or 2 described dog cats is characterized in that: be specifically designed to the dog cat, the respiratory tract infection of treatment dog cat, urinary tract infection, digestive tract infection and skin infection with the application of amoxicillin and clavulanate potassium sheet.
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| CN102512386A (en) * | 2011-12-16 | 2012-06-27 | 南京农业大学 | Amoxicillin or amoxicillin and clavulanate potassium instant chewable tablets for pet and preparation method for same |
| CN104337810A (en) * | 2013-07-30 | 2015-02-11 | 瑞普（天津）生物药业有限公司 | Amoxicillin and clavulanate potassium flavor tablet for pets |
| CN104473922A (en) * | 2013-07-16 | 2015-04-01 | 上海汉维生物医药科技有限公司 | Compound tablet and preparation method thereof |
| CN104546838A (en) * | 2013-07-16 | 2015-04-29 | 上海汉维生物医药科技有限公司 | Tablet and preparation method thereof |
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