CN101933935A - Tulathromycin composition and use thereof in preparation of drugs for treating or preventing bacterial diseases of poultry - Google Patents
Tulathromycin composition and use thereof in preparation of drugs for treating or preventing bacterial diseases of poultry Download PDFInfo
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Abstract
The invention discloses an application of a tulathromycin composition in treatment or prevention of bacterial diseases of poultry. The invention further discloses a pharmaceutical composition containing tulathromycin and a preparation method thereof, and the composition has wide distribution in a poultry body, large apparent distribution volume, long half-life period and slow elimination, has the characteristics of small dosage and good efficacy when being used for treating the bacterial diseases of the poultry, and further has broad market prospects and value when being applied in the preparation of the drugs which are widely clinically used in veterinary.
Description
Technical field
The present invention relates to a kind of Thailand and draw the purposes of mould promotor composition in treatment or prevention fowl bacterial disease, belong to field of veterinary.
Background technology
Bacterial disease is the main disease of all animals of harm China.Birds bacterial disease serious harm aquaculture can cause that the animal feed remuneration reduces, and arrest of development even death cause serious economy loss to aquaculture.Antibiotic is the most frequently used medicine that tackles bacterial infection.Domestic because antibiotic abuse, Resistant strain increases gradually, and many antibacterials curative effects descend, and add the standardization gradually of domestic veterinary drug industry, therefore domestic good antibacterials are less, the appearance of the antibacterials of the animal specific that presses for of vast clinical veterinary work person.
Mycin (Tulathromycin) draws in Thailand to be a kind of listing recently and to be the Macrolide semisynthetic antibiotics of animal specific.China Ministry of Agriculture allows Thailand to draw mycin to use in animal produces in 2008 No. 957 bulletin first, has that antibacterial, bactericidal action, consumption are few, numerous advantages such as single administration, low-residual and animal specific.In China, the existing use of Macrocyclolactone lactone kind medicine is tylosin and tilmicosin comparatively widely, though these two kinds of medicines have all been obtained good effect aborning, but prolongation along with service time, drug resistance has in various degree appearred in a lot of areas of China, cause consumption constantly to increase, but therapeutic effect progressively reducing, and Thailand draw the mycin drug effect all to be better than the widely used Macrocyclolactone lactone kind medicines in market such as tylosin and tilmicosin.Thailand draws mycin not have carcinogenic, teratogenesis and genetoxic, most ofly after the administration excretes with original shape Excreta form, and degrades by effects such as deoxidation, oxidation, hydrolysis, can not produce big influence to environment.Thailand draws mycin oral, and acute very low with subacute toxicity, the fatal dose of dog and Mus is respectively greater than 1000 mg/kg body weight and 2000 mg/kg body weight.During 1000 mg/kg body weight, the breathing rate of dog and Mus, heart rate, body temperature, blood pressure etc. all with normally are as good as.The HAS of Mus is 300 mg/kg body weight; During intravenous injection, it is 10 mg/kg body weight that the maximum of dog and Mus does not have lethal dose.Aspect specific toxicity, tertogenicity test of rat and rat reproduction test confirm no teratogenesis or fetal toxicity.At present, do not see that Thailand draws the application of mycin aspect the poultry disease treatment.Patent ZL 01808630.6 has announced the application of azacyclo-macrolide antibiotic compositions in treatment or prevention mammal antibacterial or protozoal infections, does not use in birds but relate to azacyclo-macrolide antibiotic compositions.
Summary of the invention
In view of this, main purpose of the present invention is to provide a kind of Thailand to draw mould promotor composition, it is characterized in that, described Thailand draws mould promotor composition to comprise:
The mixture of the chemical compound of the chemical compound of a formula I or its pharmaceutically acceptable salt, formula II or any one or two kinds in its pharmaceutically acceptable salt;
With the pharmaceutically acceptable carrier of b.
Preferably, Thailand of the present invention draws in the mould promotor composition, and the chemical compound of formula I or the ratio of its pharmaceutically acceptable salt are greater than the ratio of chemical compound or its pharmaceutically acceptable salt of formula II.
Preferably, it is peroral dosage form that the dosage form of mould promotor composition is drawn by Thailand of the present invention, comprises soluble powder or granule or oral liquid or pre-mixing agent.
Preferably, soluble powder of the present invention comprises: drawing mycin content in Thailand is the chemical compound of the chemical compound of 1%-20%W/W formula I or its pharmaceutically acceptable salt, formula II or any one or two kinds of mixture in its pharmaceutically acceptable salt, and 0-0.5mmol/g cosolvent and pharmaceutically acceptable carrier are to full dose.
More preferably, the cosolvent in the above-mentioned soluble powder comprise in tartaric acid, citric acid, lauryl sulfate, gluconic acid, malic acid, glutamic acid, the tryptophan any one or multiple.
More preferably, acceptable carrier comprises any one or its multiple mixture in sucrose, glucose, lactose, Matrii Sulfas Exsiccatus, the soluble starch on the said medicine.
Preferably, oral liquid of the present invention comprises: draw the chemical compound of the chemical compound of mycin content 1%-20%W/V formula I or its pharmaceutically acceptable salt, formula II or any one or two kinds of mixture in its pharmaceutically acceptable salt in Thailand, 0-0.5mmol/ml cosolvent, the 20%-70%V/V organic solvent, the 0.01-0.3%W/V antiseptic, purified water is to full dose.
More preferably, the cosolvent in the above-mentioned oral liquid comprise in phosphoric acid, tartaric acid, citric acid, lauryl sulfate, gluconic acid, malic acid, acetic acid, glutamic acid, tryptophan, the hydrochloric acid any one or multiple.
More preferably, the organic solvent in the above-mentioned oral liquid be can with the organic solvent of water mixing, comprise ethanol, propylene glycol, glycerol, Polyethylene Glycol, alpha-pyrrolidone or glycerin methylal.
More preferably, the antiseptic in the above-mentioned oral liquid comprises merthiolate, sodium benzoate, potassium sorbate, benzoic acid or sorbic acid.
Preferably, pre-mixing agent described in the present invention comprises: draw the chemical compound of the chemical compound of mycin 1%-20%W/W formula I or its pharmaceutically acceptable salt, formula II or any one or two kinds of mixture in its pharmaceutically acceptable salt, the pharmaceutically acceptable carrier of 80%-99%W/W in Thailand.
More preferably, the pharmaceutically acceptable carrier described in the above-mentioned pre-mixing agent comprises any one or more than one the mixture in starch, dextrin, stone powder, maize cob meal, soybean cake powder, bean cake powder, wheat bran, Testa oryzae or the Semen Maydis powder.
Preferably, granule described in the present invention comprises: draw the chemical compound of the chemical compound of formula I of mycin 1%-20%W/W or its pharmaceutically acceptable salt, formula II or any one or two kinds of mixture in its pharmaceutically acceptable salt in Thailand, 0-0.5mmol/g cosolvent and pharmaceutically acceptable carrier are to full dose.
More preferably, the described pharmaceutically acceptable carrier in the above-mentioned granule is dextrin and sucrose, glucose or lactose any one or two kinds of mixture that mixture is formed.
More preferably, the ratio 5%-45%W/W in granule of the described dextrin in the above-mentioned granule.
More preferably, the described cosolvent in the above-mentioned granule comprise in tartaric acid, citric acid, lauryl sulfate, gluconic acid, malic acid, glutamic acid, the tryptophan any one or multiple.
Another aspect of the invention is above-mentioned Thailand and draw the purposes of mould promotor composition in the pharmaceutical composition of preparation treatment or prevention fowl bacterial disease.
Preferably, in the purposes of the present invention, described fowl bacterial disease comprises avian colibacillosis, pullorum disease, fowl cholera, fowl enteritis, avian typhoid, avian paratyphoid.
More preferably, in the purposes of the present invention, described fowl bacterial disease comprises: chicken colibacillosis, Pullorum Disease, chicken cholera, chicken paratyphoid fever, infectious serositis in duck, duck e. coli septicemia.
Preferably, in the purposes of the present invention, described amount of drug is drawn the every 1L water of mycin 10-100mg in Thailand, every 1kg feedstuff 10-100mg; Logotype 2-3 days.
Technique effect
The present invention is used for the treatment of or prevents the Thailand that contains of fowl bacterial disease to draw mould promotor composition to have in the fowl body widely distributed, and apparent volume of distribution is big, and long half time is eliminated slowly; When being used for the treatment of bacterial disease in poultry, have little, the eutherapeutic characteristics of consumption.
Description of drawings
Fig. 1 is for to draw mycin 5%W/W Thailand to draw the mycin soluble powder at chicken interior medicine dynamics curve in Thailand.
The specific embodiment
The Thailand of embodiment of the invention preparation draws in the mycin composition medicine, and the chemical compound of formula I or the ratio of its pharmaceutically acceptable salt are greater than the ratio of chemical compound or its pharmaceutically acceptable salt of formula II.But be to be understood that, the chemical compound of the chemical compound of formula I or the ratio of its pharmaceutically acceptable salt and formula II or the ratio of its pharmaceutically acceptable salt, only for using the actual ratio that mould promotor composition draws in Thailand for preparing of embodiment of the invention preparation method, mould promotor composition draws in the Thailand that the chemical compound of the chemical compound of the formula I of the arbitrary proportion that any other preparation method or purification process obtain or the ratio of its pharmaceutically acceptable salt and formula II or its pharmaceutically acceptable salt are formed, and its content of effective does not change.Therefore use the Thailand of the arbitrary proportion that other any preparation methoies or purification process obtain to draw the medicine of mould promotor composition, in its medicine generation, is identical with the drug effect and the embodiment of the invention, all can be used for preparing in the purposes of medicine of the present invention.
Safe in the embodiment of the invention to draw the dosage form of mould promotor composition be peroral dosage form, comprises soluble powder or granule or oral liquid or pre-mixing agent.
Preferably, soluble powder of the present invention comprises: drawing mycin content in Thailand is the chemical compound of the chemical compound of 1%-20%W/W formula I or its pharmaceutically acceptable salt, formula II or any one or two kinds of mixture in its pharmaceutically acceptable salt, and 0-0.5mmol/g cosolvent and pharmaceutically acceptable carrier are to full dose.
More preferably, the cosolvent in the above-mentioned soluble powder comprise in tartaric acid, citric acid, lauryl sulfate, gluconic acid, malic acid, glutamic acid, the tryptophan any one or multiple.
More preferably, acceptable carrier comprises any one or its multiple mixture in sucrose, glucose, lactose, Matrii Sulfas Exsiccatus, the soluble starch on the said medicine.
Preferably, oral liquid of the present invention comprises: draw the chemical compound of the chemical compound of mycin content 1%-20%W/V formula I or its pharmaceutically acceptable salt, formula II or any one or two kinds of mixture in its pharmaceutically acceptable salt in Thailand, 0-0.5mmol/ml cosolvent, the 20%-70%V/V organic solvent, the 0.01-0.3%W/V antiseptic, purified water is to full dose.
More preferably, the cosolvent in the above-mentioned oral liquid comprise in phosphoric acid, tartaric acid, citric acid, lauryl sulfate, gluconic acid, malic acid, acetic acid, glutamic acid, tryptophan, the hydrochloric acid any one or multiple.
More preferably, the organic solvent in the above-mentioned oral liquid be can with the organic solvent of water mixing, comprise ethanol, propylene glycol, glycerol, Polyethylene Glycol, alpha-pyrrolidone or glycerin methylal.
More preferably, the antiseptic in the above-mentioned oral liquid comprises merthiolate, sodium benzoate, potassium sorbate, benzoic acid or sorbic acid.
Preferably, pre-mixing agent described in the present invention comprises: draw the chemical compound of the chemical compound of mycin 1%-20%W/W formula I or its pharmaceutically acceptable salt, formula II or any one or two kinds of mixture in its pharmaceutically acceptable salt, the pharmaceutically acceptable carrier of 80%-99%W/W in Thailand.
More preferably, the pharmaceutically acceptable carrier described in the above-mentioned pre-mixing agent comprises any one or more than one the mixture in starch, dextrin, stone powder, maize cob meal, soybean cake powder, bean cake powder, wheat bran, Testa oryzae or the Semen Maydis powder.
Preferably, granule described in the present invention comprises: draw the chemical compound of the chemical compound of formula I of mycin 1%-20%W/W or its pharmaceutically acceptable salt, formula II or any one or two kinds of mixture in its pharmaceutically acceptable salt in Thailand, 0-0.5mmol/g cosolvent and pharmaceutically acceptable carrier are to full dose.
More preferably, the described pharmaceutically acceptable carrier in the above-mentioned granule is dextrin and sucrose, glucose or lactose any one or two kinds of mixture that mixture is formed.
More preferably, the ratio 5%-45%W/W in granule of the described dextrin in the above-mentioned granule.
More preferably, the described cosolvent in the above-mentioned granule comprise in tartaric acid, citric acid, lauryl sulfate, gluconic acid, malic acid, glutamic acid, the tryptophan any one or multiple.
In the embodiment of the invention, it is peroral dosage form that the dosage form of mould promotor composition is drawn by Thailand, and other dosage forms that this area medicine is commonly used as injection, spray etc., also can be used for Thailand of the present invention and draw mycin preparation of compositions and application.In the embodiment of the invention, the peroral dosage form of mould promotor composition draws in Thailand, comprising: soluble powder or granule or oral liquid or pre-mixing agent, other peroral dosage forms that this area medicine is commonly used, its action principle is identical with the present invention, also can be used for Thailand of the present invention and draw mycin preparation of compositions and application.
Tested the safe therapeutic effect of the medicine of mould promotor composition that draw in the invention process to chicken colibacillosis and Pullorum Disease, draw among mycin broad-spectrum bactericidal action and the embodiment 1 certificate of inspection to understand that Thailand draws the bacteriostasis of mycin to common fowl bacterial disease pathogen bacterium based on Thailand, Thailand draws the medicine of mould promotor composition to can be used for fowl bacterial disease such as chicken colibacillosis, Pullorum Disease, chicken cholera, chicken paratyphoid fever, infectious serositis in duck, duck e. coli septicemia.It is same or analogous at the intravital drug metabolism of chicken and effect of drugs and other birdss that mycin draws in Thailand, and therefore, Thailand of the present invention draws the medicine of mould promotor composition also can be applied to comprise avian colibacillosis, pullorum disease, fowl cholera, fowl enteritis.
Tested different amount of drug in the embodiment of the invention to fowl bacterial treatment of diseases or preventive effect, test is found to draw the every 1L water of mycin 10-100mg, every 1kg feedstuff 10-100mg in Thailand, though its consumption is compared less with similar antibiotic, but can treat or prevent the fowl bacterial disease effectively, reduce mortality rate, do not influence the weightening finish of birds.
Preferably, the embodiment of the invention 2 usefulness 5% Thailand draws the mycin soluble powder to be used for the treatment of chicken artificial challenge Salmonella, and its drug dose is every 1L water 10-100mg.
Preferably, the embodiment of the invention 3 usefulness 2%W/W Thailands draw mould crude granule to be used for the treatment of chicken manually to feel Salmonella, and drug dose is every 1L water 10-100mg.
For making the present invention easier to understand,, further set forth the present invention below in conjunction with specific embodiment.Should be understood that these embodiment only to be used to the present invention is described and be not used in to limit the scope of the invention that NM concrete experimental technique in the following example carries out according to the normal experiment method usually.
The sensitivity testing of mycin is drawn in embodiment 1 clinical isolates strain to Thailand
The detection of resistant strains: this operation is according in the U.S. NCCLS antimicrobial agents sensitivity tests operative norm, the inhibition zone diameter of enterobacteriaceae and minimum inhibitory concentration (MIC) break value, the sensitivity standard of drawing mould promotor composition for Thailand.
Experimental condition: culture medium: Mueller-Hinton inoculum: provoke single bacterium colony, in the inoculation meat soup, be equivalent to 0.5 Maxwell standard; Hatch: 35 ℃ ± 2 ℃; Air: 16～18h;
Bacterial strain: separate obtaining in the clinical disease fowl internal organs;
Standard scraps of paper preparation: 1. select No. 1 middling speed qualitative filter paper of Xinhua; Break into the scraps of paper that diameter is 6mm with card punch, 160 ℃ of dry heat sterilization 2h; 2. pastille scraps of paper preparation: prepare according to the scraps of paper content of dispersion under the U.S. NCCLS antimicrobial agents sensitivity tests operative norm item, adopt Thailand to draw the mycin feedstock production pastille scraps of paper; 3. the Quality Control of the standard scraps of paper: carry out according to the Quality Control bacterial strain and the standard of recommending; Quality Control bacterium: escherichia coli ATCC25922, staphylococcus aureus ATCC25923;
Operation: 1. dip in and get bacterium liquid with aseptic cotton rod, and cotton is excellent when tube wall pushes not water outlet, coating; 2. place the pastille scraps of paper: 4 kinds of scraps of paper of every ware (diameter 90mm), place 35 ℃ ± 2 ℃, hatch 16～18h; 3. the inhibition zone analyzer is measured the size of inhibition zone; 4. antimicrobial antibacterial circle diameter criteria for interpretation is seen U.S. NCCLS antimicrobial agents sensitivity tests operative norm; Clinical isolates strain sensitivity testing the results are shown in Table 1-4.
The clinical separating Escherichia coli sensitivity testing of table 1 result
| Bacterium numbering | Mycin 5 μ g/ sheets draw in Thailand |
| Escherichia coli GXD0074 | S? |
| Escherichia coli GXD0085 | S? |
| Escherichia coli GXD0092 | S? |
| Escherichia coli GXD0097 | I? |
| Escherichia coli GXD0129 | S? |
| Escherichia coli GXD0150 | S? |
| Escherichia coli GXD0191 | S? |
| Escherichia coli GXD0193 | S? |
The clinical SEPARATION OF GOLD Staphylococcus aureus of table 2 sensitivity testing result
| Bacterium numbering | Mycin 5 μ g/ sheets draw in Thailand |
| Staphylococcus aureus GXP013 | S? |
| Staphylococcus aureus GXP015 | S? |
| Staphylococcus aureus GXP016 | S? |
| Staphylococcus aureus GXP024 | S? |
| Staphylococcus aureus GXP027 | S? |
| Staphylococcus aureus GXP035 | S? |
| Staphylococcus aureus GXP048 | S? |
| Staphylococcus aureus GXP051 | I? |
The clinical separation Salmonella of table 3 sensitivity testing result
| Bacterium numbering | Mycin 5 μ g/ sheets draw in Thailand |
| Salmonella GXS0004 | S? |
| Salmonella GXS0005 | S? |
| Salmonella GXS0008 | S? |
| Salmonella GXS0010 | S? |
| Salmonella GXS0014 | S? |
| Salmonella GXS0015 | S? |
| Salmonella GXS0017 | S? |
| Salmonella GXS0018 | S? |
The clinical separation yersinia of table 4 sensitivity testing result
| Bacterium numbering | Mycin 5 μ g/ sheets draw in Thailand |
| Yersinia GXX004 | S? |
| Yersinia GXX005 | S? |
| Yersinia GXX007 | S? |
| Yersinia GXX009 | S? |
| Yersinia GXX014 | S? |
| Yersinia GXX017 | S? |
| Yersinia GXX018 | S? |
| Yersinia GXX023 | S? |
Notes show: S: expression is responsive; I: quick in the expression; R: expression drug resistance;
From table 1-4 as can be seen, clinical isolating fowl Escherichia coli, staphylococcus aureus, Salmonella, yersinia draw the sensitivity of mycin stronger to Thailand, illustrates that Thailand draws mycin that fowl pathogenic bacterial strains is clinically had stronger inhibitory action.
The application of mould promotor composition in the pharmaceutical composition of preparation treatment fowl bacterial disease drawn by embodiment 2 5%W/W Thailands
1. draw mycin (down together) 5%W/W Thailand to draw the soluble powder preparation of drug combination of mould promotor composition in Thailand
A. draw mycin 5%W/W Thailand to draw mycin phosphate (phosphate of the chemical compound of the phosphate of the chemical compound of 90% formula I and 10% formula II) in Thailand
B. carrier: glucose powder is to 1000g
Preparation process: get Thailand and draw mycin phosphate 68.36g, glucose powder mix homogeneously, pulverize, cross 80 mesh sieves, the i.e. pharmaceutical composition of the mould promotor composition of De Taila.
The pharmacokinetics research of mycin soluble powder to chicken is drawn by 2.5%W/W Thailand
Thailand gavages for chicken 10mg/kg body weight per os after drawing the mycin soluble powder with the purified water dissolving.After the administration 5,10,15,30min and 1,2,4,8,12h, and 1,2,4,6,8,10,12,15d heart blood sampling 1.5mL, place the heparin sodium anticoagulant tube, the centrifugal 10min of 4000rpm, separated plasma ,-20 ℃ of refrigerators are preserved, and are to be measured.Accurately draw the 0.5mL plasma sample in 10mL tool plug plastic centrifuge tube, add the 1.5mL acetonitrile, vortex mixed 1min, the centrifugal 10min of 5000rpm, separation of supernatant is in 5mL band scale glass tubing, water is settled to 5mL, and vortex 2min draws 1mL and carries out the LC-MS/MS detection with 0.22 μ m membrane filtration.The chromatograph working condition: (mobile phase is 0.1% formic acid-acetonitrile solution (A) and 0.1% formic acid-2mmol ammonium acetate solution to Agilent Eclipse XDB-C18, gradient elution for 5 μ m, 4.6 * 150mm) rustless steel chromatograph posts.Flow velocity is 1.0mL/min, 30 ℃ of column temperatures.Mass spectrum working condition: electric spray ion source (ESI), spray voltage (ionspray voltage, IS) 5500V, cation scanning, many reaction detection (MRM), atomization gas pressure (GSI) 40psi, secondary air speed (GS2) 60L/min, gas curtain atmospheric pressure (CUR) 20psi, 500 ℃ of ion source temperatures (TEM), collision cell pressure (CAD) Medium.Blood drug level compartment model match, calculation of parameter the results are shown in Table 5.
The oral back of table 5 chicken pharmacokinetic parameter result of calculation
K
a: absorption rate constant, AUC: area under the drug-time curve, AUMC: first moment, MRT: average residence time, K
e: elimination rate constant, C
Max: plasma drug level peak concentration, T
Max: peak time
The oral Thailand of chicken draws behind the mycin soluble powder widely distributedly as can be seen from Table 5, and apparent volume of distribution is big, and long half time is eliminated slowly.
3. the therapeutic effect of mycin soluble powder to chicken colibacillosis draws in oral various dose 5% Thailand
Model preparation method: get drug resistance escherichia coli GXD0129 (clinical separation) and be inoculated on the MH agar plate 37 ℃ and cultivated 24 hours, the single colony inoculation of picking is in the MH nutrient broth, 37 ℃ of shaken cultivation 24h, adopting viable bacteria counting method to calculate e. coli concentration, is 7.6 * 10 with the nutrient broth dilution
9CFU/mL, 10 of chest muscle injection Luo Man chickens in 3 age in week, 0.2mL/ plumage.Model group began to have chicken appearance spirit depressed after 4 hours, and two wings are sagging, and it is slow-witted upright, drowsiness to peel off, row's yellow-white loose stool, and chicken appearance spirit was depressed in 10 hours 100%, and two wings are sagging, and it is slow-witted upright, drowsiness to peel off, row's yellow-white loose stool, appearance is dead.The chicken that will fall ill is cutd open the visible airbag wall of inspection and thickens muddiness.The modeling success is described.
Modeling: according to above-mentioned model preparation method;
Grouping: 3 age in week 300 of Luo Man laying hens, be divided into 6 groups at random, 50/group, mould extract for treating group is drawn by Thailand, and (application process is that mould promotor composition draws in the 5%W/W Thailand that every 1L water is got 0.5g, 1g, 2g, draw mycin to be respectively 25mg, 50mg, 100mg in Thailand), blank group, model control group, medicine matched group;
Medicine: the mycin soluble powder draws in Thailand, white or off-white powder, and specification: 100g: 5g mixes the drink administration, logotype 3 days.The medicine matched group gives Norfloxacin Lactate soluble powder (Fuzhou Shi big magnificent animal pharmaceutcal corporation, Ltd), specification: 100g: 2g, and dosage 1L water this product 5g mixes drink, logotype 3 days.Model control group, blank group give tap water;
Administration and observation: when treating that tangible disease symptom appears in 80% above chicken, logotype 3 days, administration finishes the back and continues to observe to the 17th day, observe the chicken symptom every day and score, after experiment finishes, calculate each batch total branch result, the result is added up and estimates, the results are shown in Table 6 with mortality rate, cure rate, effective percentage, the relative weight gain rate judgement index.
Each dosage group Thailand of table 6 draws mould crude granule to artificial infection chicken's drug resistance colibacillosis curative effect
| Group | Mortality rate (%) | Cure rate (%) | Effective percentage (%) | The relative weight gain rate (%) |
| The blank group | -? | -? | -? | 100? |
| Model control group | 74? | -? | -? | 52.1? |
| The mycin low dose group is drawn by Thailand | 16? | 70? | 84? | 77.9? |
| Dosage group in the mycin is drawn by Thailand | 12? | 80? | 88? | 86.7? |
| The mycin high dose group is drawn by Thailand | 6 * | 86? | 94 * | 93.5? |
| The medicine matched group | 20? | 78? | 80? | 75.4? |
*: P＜0.05, significant difference
The mortality rate of each administration group chicken is compared obvious reduction with negative control group as can be seen from Table 6, illustrates safe to draw the mycin soluble powder can reduce the mortality rate of artificial challenge escherichia coli chicken; Thailand draws each dosage group of mycin and medicine matched group can obviously improve cure rate and the effective percentage of ill chicken, and Thailand draws mycin high dose group mortality rate and effective percentage group and medicine matched group that notable difference (P＜0.05) is arranged; Each administration group the relative weight gain rate is higher than negative control group.Illustrate and safe draw the mycin soluble powder to have the effect of treatment chicken colibacillosis preferably.
The application of mould promotor composition in the particle medicinal composition of preparation treatment fowl bacterial disease drawn by embodiment 3 2%W/W Thailands
1. draw mycin (down together) 2%W/W Thailand to draw the preparation of drug combination of mould promotor composition in Thailand
A. draw mycin 2%W/W Thailand to draw mycin tartrate (tartrate of the chemical compound of the tartrate of the chemical compound of 90% formula I and 10% formula II) in Thailand;
B. carrier: dextrin 200g, sucrose are to 1000g.
Preparation process: get sucrose, pulverize, draw mycin tartrate 31.17g, dextrin mix homogeneously, granulate drying, the i.e. pharmaceutical composition of the mould promotor composition of De Taila with Thailand.
2. the therapeutic effect of mould promotor composition to Pullorum Disease draws in oral various dose 2%W/W Thailand
Model preparation method: get drug resistance Salmonella GXS0014 (clinical separation) and be inoculated on the MH agar plate 37 ℃ and cultivated 24 hours, the single colony inoculation of picking is in the MH nutrient broth, 37 ℃ of shaken cultivation 24h, adopting viable bacteria counting method to calculate Salmonella concentration, is 2.1 * 10 with the nutrient broth dilution
8CFU/mL, 10 of chest muscle injection Luo Man laying hens in 2 age in week, 0.2mL/ plumage.Model group chicken cardinal symptom after beginning to have chicken counteracting toxic substances to occur after 6 hours is a lassitude, and appetite, drinking-water reduce, and the wing that hangs down, is afraid of cold, flocks together, arranges white pasty state loose stool; Be stained with dry and hard one-tenth Calx sample feces around the anus that has, the defecation difficulty, it is unable to walk; Feces is isolated salmonella.Pathology cuts open the visible liver enlargement of inspection, and downright bad point of the big canescence of needle point or lesser tubercle are arranged on cardiac muscle or the liver.The modeling success is described.
Modeling: according to above-mentioned model preparation method;
Grouping: 2 age in week 300 of Luo Man laying hens, be divided into 6 groups at random, 50/group, mould extract for treating group is drawn by Thailand, (application process is that mould promotor composition draws in the 2%W/W Thailand that every 1L water is got 0.5g, 1g, 2g, draw mycin to be respectively 10mg, 20mg, 40mg in Thailand), blank group, model control group, medicine matched group;
Medicine: mould promotor composition draws in Thailand, white or off-white color granule, and specification: 100g: 2g mixes the drink administration, logotype 3 days.The medicine matched group gives ciprofloxacin lactate soluble powder (Fuzhou Shi big magnificent animal pharmaceutcal corporation, Ltd), specification: 100g: 2g, and dosage 1L water this product 5g mixes drink, logotype 3 days.Model control group, blank group give drinking water;
Administration and observation: when treating that tangible disease symptom appears in 80% above chicken, logotype 3 days, administration finishes the back and continues to observe to the 17th day, observe the chicken symptom every day and score, after experiment finishes, calculate each batch total branch result, the result is added up and estimates, the results are shown in Table 7 with mortality rate, cure rate, effective percentage, the relative weight gain rate judgement index.
Each dosage group Thailand of table 7 draws mould promotor composition to artificial infection chicken's drug resistance Salmonella curative effect
| Group | Mortality rate (%) | Cure rate (%) | Effective percentage (%) | The relative weight gain rate (%) |
| The blank group | -? | -? | -? | 100? |
| Model control group | 70? | -? | -? | 46.2? |
| The mycin low dose group is drawn by Thailand | 20? | 66? | 80? | 73.3? |
| Dosage group in the mycin is drawn by Thailand | 14? | 78? | 86? | 85.2? |
| The mycin high dose group is drawn by Thailand | 8? | 84? | 92? | 89.2? |
| The medicine matched group | 12? | 72? | 88? | 87.1? |
The mortality rate of each administration group chicken is compared obvious reduction with negative control group as can be seen from Table 7, illustrates safe to draw mould crude granule can reduce the mortality rate of artificial challenge's Salmonella chicken; Thailand draws each dosage group of mycin and medicine matched group can obviously improve cure rate and the effective percentage of ill chicken, and mould promotor composition group and medicine matched group no significant difference (P＞0.05) draw in Thailand; Each administration group the relative weight gain rate is higher than negative control group.Illustrate and safe draw mould promotor composition to have the effect of treatment Pullorum Disease preferably.
Embodiment 4 draws mycin (down together) 10%W/W Thailand to draw the particle medicinal composition of mould promotor composition in Thailand
A. draw the 10%W/W Thailand of mycin to draw mycin tartrate (tartaric acid of the chemical compound of the tartrate of the chemical compound of 99.9% formula I and 0.1% formula II) in Thailand;
B. carrier: dextrin 200g, sucrose are to 1000g.
Preparation process: get Thailand and draw mycin tartrate 155.83g and dextrin, sucrose mix homogeneously, granulate drying, the i.e. pharmaceutical composition of the mould promotor composition of De Taila.
Embodiment 5 draws mycin (down together) 20%W/W Thailand to draw the pharmaceutical composition of mould promotor composition in Thailand
A. draw mycin 20%W/W Thailand to draw mycin phosphate (phosphate of the chemical compound of the phosphate of the chemical compound of 95% formula I and 5% formula II) in Thailand
B. carrier: starch 200g, bean cake powder 526.56g
Preparation process: get Thailand and draw mycin phosphate 273.44g, starch, bean cake powder mix homogeneously, the i.e. pharmaceutical composition of the mould promotor composition of De Taila.
Embodiment 6 draws mycin (down together) 5%W/V Thailand to draw the pharmaceutical composition of mould promotor composition in Thailand
A. draw mycin 5%W/V Thailand to draw mycin phosphate (phosphate of the phosphoric acid hydrochlorate of the chemical compound of 90% formula I and the chemical compound of 10% formula II) in Thailand
B. carrier: merthiolate 0.1g, ethanol 300ml, purified water is to 1000ml
Preparation process:
1) gets ethanol 300ml, add purified water to 900ml, mix homogeneously;
2) get Thailand and draw mycin phosphate 68.36g, merthiolate 0.1g adds in the above-mentioned alcoholic solution, adds purified water to 1000ml, and mix homogeneously filters, i.e. the pharmaceutical composition of the mould promotor composition of De Taila.
The pharmaceutical composition of mould promotor composition draws in embodiment 71%W/W Thailand
A. mycin (chemical compound of the chemical compound of 80% formula I and 20% formula II) draws in Thailand
B. cosolvent: tartaric acid 5.65g
C. carrier: glucose powder is to 1000g
Preparation process: get Thailand and draw mycin 10g, tartaric acid, glucose powder mix homogeneously, grind, cross 80 mesh sieves, the i.e. pharmaceutical composition of the mould promotor composition of De Taila.
Embodiment 8 draws mycin (down together) 20%W/W Thailand to draw the pharmaceutical composition of mould promotor composition in Thailand
A. draw mycin 20%W/W Thailand to draw mycin phosphate (the chemical compound phosphate of 100% formula I) in Thailand
B. carrier: glucose powder is to 1000g
Preparation process: mycin phosphate 273.45g, glucose powder mix homogeneously draw in Thailand, grind, and cross 80 mesh sieves, the i.e. pharmaceutical composition of the mould promotor composition of De Taila.
Embodiment 9 draws mycin (down together) 20%W/W Thailand to draw the granules medicine compositions of mould promotor composition in Thailand
A. draw mycin 20%W/W Thailand to draw mycin phosphate (the chemical compound phosphate of 95% formula I and the chemical compound phosphate of 5% formula II) in Thailand
B. carrier: dextrin 250g, glucose are to 1000g
Preparation process: get Thailand and draw mycin phosphate 273.45g and dextrin, glucose mix homogeneously, granulate drying, the i.e. pharmaceutical composition of the mould promotor composition of De Taila.
The pharmaceutical composition of mould promotor composition draws in embodiment 101%W/W Thailand
A.1%W/W mycin (chemical compound of 100% formula II) 10g draws in Thailand
B. carrier: stone powder 300g, maize cob meal 690g
Preparation process: get Thailand and draw mycin 10g, starch, bean cake powder mix homogeneously, the i.e. pharmaceutical composition of the mould promotor composition of De Taila.
The pharmaceutical composition of mould promotor composition draws in embodiment 1110%W/W Thailand
A.10%W/W mycin (chemical compound of the chemical compound of 97% formula I and 3% formula II) draws in Thailand
B. carrier: starch 200g, bean cake powder 600g
Preparation process: get Thailand and draw mycin 100g, starch, bean cake powder mix homogeneously, the i.e. pharmaceutical composition of the mould promotor composition of De Taila.
Embodiment 12 draws mycin 1%W/W Thailand to draw the pharmaceutical composition of mould promotor composition in Thailand
A. draw mycin 1%W/W Thailand to draw mycin tartrate (tartrate of the chemical compound of the tartrate of the chemical compound of 90% formula I and 10% formula II) in Thailand
B. carrier: potassium sorbate 1g, propylene glycol 200ml, purified water is to 1000ml
Preparation process:
1) gets propylene glycol 200ml, add purified water to 900ml, mix homogeneously;
2) get Thailand and draw mycin tartrate 15.58g, potassium sorbate 1g adds in the above-mentioned propylene glycol solution, adds purified water to 1000ml, and mix homogeneously filters, i.e. the pharmaceutical composition of the mould promotor composition of De Taila.
Embodiment 13 draws mycin 20%W/V Thailand to draw the pharmaceutical composition of mould promotor composition in Thailand
A. draw mycin 20%W/V Thailand to draw mycin phosphate (phosphate of the chemical compound of the phosphate of the chemical compound of 90% formula I and 10% formula II) in Thailand
B. carrier: merthiolate 0.1g, ethanol 700ml, purified water is to 1000ml
Preparation process:
1) gets ethanol 700ml, add purified water to 900ml, mix homogeneously;
2) get Thailand and draw mycin phosphate 273.44g, merthiolate 0.1g adds in the above-mentioned alcoholic solution, adds purified water to 1000ml, and mix homogeneously filters, i.e. the pharmaceutical composition of the mould promotor composition of De Taila.
The pharmaceutical composition of mould promotor composition draws in embodiment 1410%W/W Thailand
A.1% mycin (chemical compound of the chemical compound of 93.5% formula I and 6.5% formula II) draws in Thailand
B. cosolvent: malic acid 56.5g
C. carrier: the lactose powder is to 1000g
Preparation process: get Thailand and draw mycin 100g, malic acid, lactose powder mix homogeneously, grind, cross 80 mesh sieves, the i.e. pharmaceutical composition of the mould promotor composition of De Taila.
Embodiment 15 draws mycin (down together) 10%W/W Thailand to draw the granules medicine compositions of mould promotor composition in Thailand
A. draw mycin 10%W/W Thailand to draw mycin phosphate (the chemical compound phosphate of 93% formula I and the chemical compound phosphate of 7% formula II) in Thailand
B. carrier: dextrin 250g, sucrose are to 1000g
Preparation process: get Thailand and draw mycin phosphate 136.72g and dextrin, sucrose mix homogeneously, granulate drying, the i.e. pharmaceutical composition of the mould promotor composition of De Taila.
Embodiment 16 draws mycin 10%W/V Thailand to draw the pharmaceutical composition of mould promotor composition in Thailand
A. draw mycin 10%W/V Thailand to draw mycin phosphate (phosphate of the chemical compound of the phosphate of the chemical compound of 90% formula I and 10% formula II) in Thailand
B. carrier: potassium sorbate 1g, ethanol 700ml, purified water is to 1000ml
Preparation process:
1) gets ethanol 700ml, add purified water to 900ml, mix homogeneously;
2) get Thailand and draw mycin phosphate 136.72g, potassium sorbate 1g adds in the above-mentioned alcoholic solution, adds purified water to 1000ml, and mix homogeneously filters, i.e. the pharmaceutical composition of the mould promotor composition of De Taila.
The embodiment of the invention 1 selects for use clinical separation fowl pathogenic strain to measure it draws mycin to Thailand sensitivity, the clinical Thailand of result draws mycin to draw the sensitivity of mycin all stronger to isolating fowl Escherichia coli, staphylococcus aureus, Salmonella, yersinia to Thailand, illustrates that the safe mycin that draws has stronger inhibitory action to fowl pathogenic bacterial strains clinically.
The embodiment of the invention 2 selects for use 5%W/W Thailand to draw the mycin soluble powder to having carried out pharmacokinetic study in the chicken body, and the result shows that Thailand draws the mycin soluble powder widely distributed in the chicken body, and apparent volume of distribution is big, and long half time is eliminated slowly.The pharmacokinetics curve is seen Fig. 1.
The embodiment of the invention 2 usefulness 5% Thailand draws the mycin soluble powder to be used for the treatment of chicken colibacillosis, can obviously reduce the mortality rate of chicken; Thailand draws each dosage group of mycin and medicine matched group can obviously improve cure rate and the effective percentage of ill chicken; Each administration group the relative weight gain rate is higher than negative control group.Illustrate and safe draw the mycin soluble powder to have the effect of treatment chicken colibacillosis preferably.
The embodiment of the invention 3 usefulness 2%W/W Thailands draw mould crude granule to be used for the treatment of Pullorum Disease, can obviously reduce the mortality rate of chicken; Thailand draws each dosage group of mycin and medicine matched group can obviously improve cure rate and the effective percentage of ill chicken; Each administration group the relative weight gain rate is higher than negative control group.Illustrate and safe draw mould crude granule to have the effect of treatment Pullorum Disease preferably.
Embodiment 4-16, having prepared Thailand draws the Thailand of mycin different dosage form different content to draw the mycin composition medicine, the medicine of mould promotor composition draws in the common formulations of other this area birds medicine and the Thailand of other content, because of being Thailand, its effective ingredient draws mycin, all can treat or prevent the fowl bacterial disease effectively, reduce mortality rate, do not influence the weightening finish of birds.
The above only is preferred embodiment of the present invention, and is in order to restriction the present invention, within the spirit and principles in the present invention not all, any modification of being done, is equal to replacement, improvement etc., all should be included within protection scope of the present invention.
Claims (20)
1. mould promotor composition draws in a Thailand, it is characterized in that, described Thailand draws mould promotor composition to comprise:
The mixture of the chemical compound of the chemical compound of a formula I or its pharmaceutically acceptable salt, formula II or any one or two kinds in its pharmaceutically acceptable salt;
With the pharmaceutically acceptable carrier of b.
2. compositions according to claim 1 is characterized in that, the chemical compound of formula I or the ratio of its pharmaceutically acceptable salt are greater than the ratio of chemical compound or its pharmaceutically acceptable salt of formula II.
3. compositions according to claim 1 is characterized in that, it is peroral dosage form that the dosage form of mould promotor composition is drawn by Thailand, comprises soluble powder or granule or oral liquid or pre-mixing agent.
4. compositions according to claim 3, it is characterized in that, described soluble powder comprises: content is for drawing the chemical compound of the chemical compound of mycin 1%-20%W/W formula I or its pharmaceutically acceptable salt, formula II or any one or two kinds of mixture in its pharmaceutically acceptable salt in Thailand, 0-0.5mmol/g cosolvent and pharmaceutically acceptable carrier are to full dose.
5. compositions according to claim 4 is characterized in that, described cosolvent comprise in tartaric acid, citric acid, lauryl sulfate, gluconic acid, malic acid, glutamic acid, the tryptophan any one or multiple.
6. compositions according to claim 4 is characterized in that, described pharmaceutically acceptable carrier comprises any one or its multiple mixture in sucrose, glucose, lactose, Matrii Sulfas Exsiccatus, the soluble starch.
7. compositions according to claim 3, it is characterized in that, described oral liquid comprises: content draws the chemical compound of the chemical compound of mycin 1%-20%W/V formula I or its pharmaceutically acceptable salt, formula II or any one or two kinds of mixture in its pharmaceutically acceptable salt in Thailand, 0-0.5mmol/ml cosolvent, the 20%-70%V/V organic solvent, the 0.01-0.3%W/V antiseptic, purified water is to full dose.
8. compositions according to claim 7 is characterized in that, described cosolvent comprise in phosphoric acid, tartaric acid, citric acid, lauryl sulfate, gluconic acid, malic acid, acetic acid, glutamic acid, tryptophan, the hydrochloric acid any one or multiple.
9. compositions according to claim 7 is characterized in that, described organic solvent be can with the organic solvent of water mixing, comprise ethanol, propylene glycol, glycerol, Polyethylene Glycol, alpha-pyrrolidone or glycerin methylal.
10. compositions according to claim 7 is characterized in that described antiseptic comprises merthiolate, sodium benzoate, potassium sorbate, benzoic acid or sorbic acid.
11. compositions according to claim 3, it is characterized in that, described pre-mixing agent comprises: draw the chemical compound of the chemical compound of mycin 1%-20%W/W formula I or its pharmaceutically acceptable salt, formula II or any one or two kinds of mixture in its pharmaceutically acceptable salt, the pharmaceutically acceptable carrier of 80%-99%W/W in Thailand.
12. compositions according to claim 11, it is characterized in that described pharmaceutically acceptable carrier comprises any one or more than one the mixture in starch, dextrin, stone powder, maize cob meal, soybean cake powder, bean cake powder, wheat bran, Testa oryzae or the Semen Maydis powder.
13. compositions according to claim 3, it is characterized in that, described granule comprises: draw the chemical compound of the chemical compound of formula I of mycin content 1%-20%W/W or its pharmaceutically acceptable salt, formula II or any one or two kinds of mixture in its pharmaceutically acceptable salt in Thailand, 0-0.5mmol/g cosolvent and pharmaceutically acceptable carrier are to full dose.
14. compositions according to claim 13 is characterized in that, described pharmaceutically acceptable carrier is dextrin and sucrose, glucose or lactose any one or two kinds of mixture that mixture is formed.
15. compositions according to claim 14 is characterized in that, described dextrin is ratio 5%-45%W/W in granule.
16. compositions according to claim 13 is characterized in that, described cosolvent comprise in tartaric acid, citric acid, lauryl sulfate, gluconic acid, malic acid, glutamic acid, the tryptophan any one or multiple.
17. the purposes of mould promotor composition in the pharmaceutical composition of preparation treatment or prevention fowl bacterial disease drawn by any described Thailand of claim 1-16.
18. purposes according to claim 17 is characterized in that, described fowl bacterial disease comprises avian colibacillosis, pullorum disease, fowl cholera, fowl enteritis, avian typhoid, avian paratyphoid.
19. purposes according to claim 17 is characterized in that, described fowl bacterial disease comprises: chicken colibacillosis, Pullorum Disease, chicken cholera, chicken paratyphoid fever, infectious serositis in duck, duck e. coli septicemia.
20. purposes according to claim 1 is characterized in that, described amount of drug is drawn the every 1L water of mycin 10-100mg in Thailand, every 1kg feedstuff 10-100mg, logotype 3-5 days.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104351219A (en) * | 2014-10-30 | 2015-02-18 | 安徽省黄淮兽药有限公司 | Compound abamectin preparation for aquaculture, as well as preparation method and application of compound abamectin preparation |
| CN106153740A (en) * | 2015-03-25 | 2016-11-23 | 上海医药工业研究院 | A kind of Tulathromycin have related substance, its be enriched with preparation method and application |
| CN109069474A (en) * | 2016-03-14 | 2018-12-21 | Septeos公司 | The Tulathromycin of synergy |
| CN111166719A (en) * | 2019-12-31 | 2020-05-19 | 郑州都灵兽药科技有限公司 | Preparation method of tulathromycin enteric-coated granules |
| CN114642641A (en) * | 2022-05-24 | 2022-06-21 | 山东国邦药业有限公司 | Tylosin tartrate water-soluble granules and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101647808A (en) * | 2008-08-14 | 2010-02-17 | 洛阳惠中兽药有限公司 | Pharmaceutical composition for treating respiratory diseases of livestock and poultry, preparation method thereof and application thereof |
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- 2010-06-30 CN CN 201010216881 patent/CN101933935A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101647808A (en) * | 2008-08-14 | 2010-02-17 | 洛阳惠中兽药有限公司 | Pharmaceutical composition for treating respiratory diseases of livestock and poultry, preparation method thereof and application thereof |
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104351219A (en) * | 2014-10-30 | 2015-02-18 | 安徽省黄淮兽药有限公司 | Compound abamectin preparation for aquaculture, as well as preparation method and application of compound abamectin preparation |
| CN104351219B (en) * | 2014-10-30 | 2016-07-06 | 安徽省黄淮兽药有限公司 | A kind of compound avilamycin preparation for aquaculture and its preparation method and application |
| CN106153740A (en) * | 2015-03-25 | 2016-11-23 | 上海医药工业研究院 | A kind of Tulathromycin have related substance, its be enriched with preparation method and application |
| CN106153740B (en) * | 2015-03-25 | 2019-01-01 | 上海医药工业研究院 | A kind of related substance of Tulathromycin, its be enriched with preparation method and application |
| CN109069474A (en) * | 2016-03-14 | 2018-12-21 | Septeos公司 | The Tulathromycin of synergy |
| CN109069474B (en) * | 2016-03-14 | 2021-08-31 | Septeos公司 | Synergistic tulathromycin |
| CN111166719A (en) * | 2019-12-31 | 2020-05-19 | 郑州都灵兽药科技有限公司 | Preparation method of tulathromycin enteric-coated granules |
| CN114642641A (en) * | 2022-05-24 | 2022-06-21 | 山东国邦药业有限公司 | Tylosin tartrate water-soluble granules and preparation method thereof |
| CN114642641B (en) * | 2022-05-24 | 2022-07-26 | 山东国邦药业有限公司 | Tylosin tartrate water-soluble granules and preparation method thereof |
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Application publication date: 20110105 |