CN102784159B - Compound synergistic tartaric acid tylosin for injection of livestock - Google Patents

Compound synergistic tartaric acid tylosin for injection of livestock Download PDF

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Publication number
CN102784159B
CN102784159B CN 201210277167 CN201210277167A CN102784159B CN 102784159 B CN102784159 B CN 102784159B CN 201210277167 CN201210277167 CN 201210277167 CN 201210277167 A CN201210277167 A CN 201210277167A CN 102784159 B CN102784159 B CN 102784159B
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Prior art keywords
tylosin
injection
tartaric acid
trimethoprim
livestock
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CN 201210277167
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CN102784159A (en
Inventor
陈益德
胡学全
周可刚
何丽花
刘亚
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SICHUAN DERUNTONG BIOTECHNOLOGY Co Ltd
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SICHUAN DERUNTONG BIOTECHNOLOGY Co Ltd
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Abstract

The invention relates to a compound synergistic tartaric acid tylosin for injection of livestock and aims at providing a compound synergistic tartaric acid tylosin, which can be used for achieving a rapid and definite curative effect on the breathing system infection and complications of livestock, for injection of livestock. The medicine comprises the following components in parts by weight: 1 part of tartaric acid tylosin, 1 part of kanamycin sulfate, 0.2 parts of trimethoprim, 0.2 parts of cosolvent and 0.05-0.1 parts of pain alleviator, wherein the cosolvent is citric acid or succinic acid or a combination of the citric acid and the succinic acid; and the pain alleviator is procaine hydrochloride or lidocaine hydrochloride or a combination of procaine hydrochloride and the lidocaine hydrochloride. The compound synergistic tartaric acid tylosin for injection of livestock contains medicine components of three types, namely tartaric acid tylosin, kanamycin sulfate and trimethoprim, can be used for solving the problems that tartaric acid tylosin is narrow in antimicrobial spectrum and cannot well control secondary infection during the treatment of mycoplasma infection and the problem that trimethoprim is insoluble in water, and achieving a synergy effect on tartaric acid tylosin and kanamycin sulfate, and is accurate in dosage and convenient in use.

Description

Injection use compound potentiation tylosin tartrate for animals
Technical field
The present invention relates to injection use compound potentiation tylosin tartrate for animals.
Background technology
From present China Developing of Animal Industry situation, current poultry respiratory system infection is occurred frequently, complication is seriously big to poultry harm.The medicine that does not also have comparatively desirable treating both the principal and secondary aspects of a disease now on the market.By investigation domestic, the international market is found that market presses for a kind of efficacy stability, good effect, stable high, easy to use, complication serious specific medicine occurred frequently to the poultry respiratory system infection.
In the prior art, tylosin tartrate belongs to vinegar class animal specific antibacterials in the macro ring, mainly most gram-positive bacterias, Gram-negative coccus, anaerobe level legionella, mycoplasma, chlamydia is had good action.Belong to the quick-acting antibacterial of trophophase.Under high concentration, have bactericidal action, be the macrolide apoplexy due to endogenous wind to one of the strongest medicine of mycoplasma effect, be mainly used in preventing and treating pig, fowl mycoplasma, as the mycoplasma pneumonia of chronic respiratory disease of fowl (CRD) and infectiousness hole chamber inflammation and pig.
The antimicrobial spectrum of kanamycin sulfate is similar to streptomycin, but effect is strong slightly.Most of gram negative bacterias such as escherichia coli, Bacillus proteus, Salmonella and pasteurella multocida etc. there are powerful antibacterial action, also responsive to gold-coloured staphylococci and tubercule bacillus.Intramuscular injection is used for the various severe infections due to the sensitive organism, as septicemia, urogenital infection, respiratory tract infection, skin and soft tissue infection etc.
Trimethoprim is the broad-spectrum antiseptic synergist, can the antibacterial action of multiple antibiotics be increased substantially (but potentiation several times to tens times), and can reduce the appearance of drug resistance strain.
Injection means interior sterile solution, emulsion or the suspension of confession injection body that medicine is made, and for the sterilized powder concentrated solution of facing with preceding wiring solution-forming or suspension.The characteristics of injection mainly show route of administration without digestive system and defend tissue (liver) and direct injection tissue or blood vessel, so drug effect are rapid, is applicable to first aid.But also the curative effect of some injection is extended, to adapt to the needs in the medical treatment.The dosage of injection is accurate, and reliable effect may suffer influences such as Digestive system, food, and make the dosage of taking that curative effect can not take place fully unlike endo-medicine.In addition, can make some drugs performance positioning action again.
Injectable sterile powder claims the powder pin again, faces with preceding and injects with sterilized water for injection dissolving back, and be a kind of injection type commonly used.Be applicable to unsettled medicine in water, particularly to damp and hot sensitive antibiotics and biological product.
Summary of the invention
The purpose of this invention is to provide a kind of injection use compound potentiation tylosin tartrate for animals, it has quick, definite curative effect to poultry respiratory system infection and complication.
For achieving the above object, the technical solution adopted in the present invention is: a kind of injection use compound potentiation tylosin tartrate for animals, it is characterized in that, and formed by following components in part by weight:
Figure BDA00001979453000021
Amounts of components is strict in the described prescription, and other component does not almost have the leeway of adjustment except pain relief agents.Only can do following replacement in material choice:
Described cosolvent is that citric acid or succinic acid or the two are composite.
Described pain relief agents is that procaine hydrochloride or lidocaine hydrochloride or the two are composite.
The preparation method of injection of the present invention:
Take by weighing trimethoprim, the cosolvent of recipe quantity, mix by fluid energy mill and pulverize, cross 120 orders or thinner sieve;
Again with tylosin tartrate, kanamycin sulfate, pain relief agents by the equivalent method mix homogeneously that progressively increases;
Inspection of semifinished product content, dissolubility, qualified back packing, packing, namely.
Further, described pulverizing is to pulverize through fluid energy mill.
Further, described sieving to crossing 120 mesh sieves.
The usage of product of the present invention and consumption: earlier product of the present invention is used analog dissolvings such as solvent for injection such as water for injection or ethylene glycol, ethanol, muscle or subcutaneous injection then.In tylosin tartrate: amount once, every 1kg body weight, pig, fowl 5~13mg, once a day.
The injection use compound potentiation tylosin tartrate for animals of the present invention's development includes tylosin tartrate, kanamycin sulfate, three kinds of pharmaceutical compositions of trimethoprim.Three kinds of ingredients composite not only at indication more extensive, and enhancing evident in efficacy.And have a following effect of having a mind to:
1, develops for veterinary clinic a kind of injection use compound potentiation tylosin tartrate for animals and preparation method thereof is provided;
2, solved because the tylosin tartrate narrow antimicrobial spectrum, can not fine control secondary infection during the treatment mycoplasma infection;
3, solve the problem that trimethoprim is insoluble in water, and paratartaric acid tylosin and kanamycin sulfate potentiation;
4, be injectable sterile powder, preparation stabilization, storage period is long;
5, rapid-action, duration of efficacy is long, the bioavailability height;
6, use safety, determined curative effect, quality controllable;
7, dosage is accurate, and is easy to use;
8, irritating property is little, reduce to poultry stress.
The specific embodiment
Embodiment one
Tylosin tartrate 1g, kanamycin sulfate 1g, trimethoprim 0.2g, citric acid 0.2g, procaine hydrochloride 0.05g.
Preparation method:
Take by weighing trimethoprim, the citric acid of recipe quantity respectively, mix by fluid energy mill and pulverize, cross 120 mesh sieves, again with tylosin tartrate, kanamycin sulfate, procaine hydrochloride by the equivalent method mix homogeneously that progressively increases, the inspection of semifinished product, packing, packing, product inspection, namely.
Embodiment two
Tylosin tartrate 1g, kanamycin sulfate 1g, trimethoprim 0.2g, succinic acid 0.2g, procaine hydrochloride 0.05g.
Preparation method:
Take by weighing trimethoprim, the succinic acid of recipe quantity respectively, mix by fluid energy mill and pulverize, cross 120 mesh sieves, again with tylosin tartrate, kanamycin sulfate, pain relief agents by the equivalent method mix homogeneously that progressively increases, the inspection of semifinished product, packing, packing, product inspection, warehouse-in, namely.
Embodiment three
Tylosin tartrate 1g, kanamycin sulfate 1g, trimethoprim 0.2g, citric acid 0.2g, lidocaine hydrochloride 0.05g.
Preparation method:
Take by weighing trimethoprim, the citric acid of recipe quantity respectively, mix by fluid energy mill and pulverize, cross 150 mesh sieves, again with tylosin tartrate, kanamycin sulfate, pain relief agents by the equivalent method mix homogeneously that progressively increases, the inspection of semifinished product, packing, packing, product inspection, warehouse-in, namely.
Embodiment four
Tylosin tartrate 1g, kanamycin sulfate 1g, trimethoprim 0.2g, succinic acid 0.2g, lidocaine hydrochloride 0.05g.
Preparation method:
Take by weighing trimethoprim, the succinic acid of recipe quantity respectively, mix by fluid energy mill and pulverize, cross 120 mesh sieves, again with tylosin tartrate, kanamycin sulfate, pain relief agents by the equivalent method mix homogeneously that progressively increases, the inspection of semifinished product, packing, packing, product inspection, warehouse-in, namely.
Embodiment five
Tylosin tartrate 0.5g, kanamycin sulfate 0.5g, trimethoprim 0.1g, citric acid 0.1g, procaine hydrochloride 0.05g.
Preparation method:
Take by weighing trimethoprim, the citric acid of recipe quantity respectively, mix by fluid energy mill and pulverize, cross 120 mesh sieves, again with tylosin tartrate, kanamycin sulfate, pain relief agents by the equivalent method mix homogeneously that progressively increases, the inspection of semifinished product, packing, packing, product inspection, warehouse-in, namely.
Embodiment six
Tylosin tartrate 0.5g, kanamycin sulfate 0.5g, trimethoprim 0.1g, succinic acid 0.1g, procaine hydrochloride 0.05g.
Preparation method:
Take by weighing trimethoprim, the succinic acid of recipe quantity respectively, mix by fluid energy mill and pulverize, sieve, again with tylosin tartrate, kanamycin sulfate, pain relief agents by the equivalent method mix homogeneously that progressively increases, the inspection of semifinished product, packing, packing, product inspection, warehouse-in, namely.
Embodiment seven
Tylosin tartrate 0.5g, kanamycin sulfate 0.5g, trimethoprim 0.1g, citric acid 0.1g, procaine hydrochloride 0.03g, lidocaine hydrochloride 0.02g.
Preparation method:
Take by weighing trimethoprim, the cosolvent of recipe quantity respectively, mix by fluid energy mill and pulverize, cross 120 mesh sieves, again with tylosin tartrate, kanamycin sulfate, pain relief agents by the equivalent method mix homogeneously that progressively increases, the inspection of semifinished product, packing, packing, product inspection, warehouse-in, namely.
Embodiment eight
Tylosin tartrate 0.5g, kanamycin sulfate 0.5g, trimethoprim 0.1g, citric acid 0.05g, succinic acid 0.05g, lidocaine hydrochloride 0.05g.
Preparation method:
Take by weighing trimethoprim, the cosolvent of recipe quantity respectively, mix by fluid energy mill and pulverize, sieve, again with tylosin tartrate, kanamycin sulfate, pain relief agents by the equivalent method mix homogeneously that progressively increases, the inspection of semifinished product, packing, packing, product inspection, warehouse-in, namely.
Result of study
1, prescription research
The present invention writes out a prescription with crude drug tylosin tartrate, kanamycin sulfate, trimethoprim, records one one of " Chinese veterinary drug allusion quotation " version in 2010." Chinese veterinary drug allusion quotation " record, similar to the erythromycin antimicrobial spectrum.A little less than the effect to antibacterial, strong to the Mycoplasma effect, be that the macrolide apoplexy due to endogenous wind is to one of the strongest medicine of mycoplasma effect.Sensitive organism produces drug resistance to this product, and staphylococcus aureus has part crossing drug resistant phenomenon to this product and erythromycin; The antimicrobial spectrum of kanamycin sulfate is similar to streptomycin, but effect is strong slightly.Most of gram negative bacterias such as escherichia coli, Bacillus proteus, Salmonella and pasteurella multocida etc. there are powerful antibacterial action, also responsive to gold-coloured staphylococci and tubercule bacillus.Intramuscular injection is used for the various severe infections due to the sensitive organism, as septicemia, urogenital infection, respiratory tract infection, skin and soft tissue infection etc.; Trimethoprim is the broad-spectrum antiseptic synergist, can the antibacterial action of multiple antibiotics be increased substantially, and can reduce the appearance of drug resistance strain.
The present invention's prescription is with tylosin tartrate, kanamycin sulfate drug combination, through trimethoprim potentiation, clinical trial shows, in the effect and purposes basis of " Chinese veterinary drug allusion quotation " record, the pain that produces in the time of solving the tylosin tartrate injection, control livestock and poultry respiratory and digestive tract disease effect are more remarkable, and reduce chemical sproof generation.
2, stability study
Injection use compound potentiation tylosin tartrate product stability research for animals of the present invention, " veterinary drug stability test technical specification (trying) " way that system promulgates according to the Ministry of Agriculture, adopt temperature, humidity accelerated test and acceleration by light test, three batch samples are carried out stability study.
2.1 temperature, humidity accelerated test
2.1.1 test material
Product of the present invention: injection use compound potentiation tylosin tartrate for animals
Batch number: 110701,110702,110703
Product requirement: commercially available back
2.1.2 experimental condition: adopt the medicine stability test case, temperature transfers to 40 ± 2 ℃, and relative humidity is controlled 75 ± 5%.
2.1.3 observing time: product of the present invention was placed 6 months, and at duration of test, each month sampling secondary detects product by stable high spot reviews project.
2.1.4 investigation project: character, content, the investigation project is determined according to " veterinary drug stability test technical specification (the trying) " way for Ministry of Agriculture's promulgation.
2.1.5 test data
Name of product: injection use compound potentiation tylosin tartrate for animals, product batch number: 110701
Figure BDA00001979453000071
Name of product: injection use compound potentiation tylosin tartrate for animals, product batch number: 110702
Figure BDA00001979453000072
Name of product: injection use compound potentiation tylosin tartrate for animals, product batch number: 110703
Figure BDA00001979453000073
2.2 acceleration by light test
2.2.1 test material
Product of the present invention: injection use compound potentiation tylosin tartrate for animals
Batch number: 110701,110702,110703
Product requirement: commercially available back
2.2.2 experimental condition: use in the proof box of medicine strong illumination in test, illumination is 4500 native 500LX
2.2.3 observing time: get product of the present invention and pack in the water white transparency container, be positioned in the light durability proof box, placed ten days under the condition of illumination 4500LX ± 500LX, sampling when walking in the 5th, ten day detects by stable high spot reviews project.
2.2.4 investigation project: character, pH value, clarity, content, investigation project are determined according to " veterinary drug stability test technical specification (the trying) " way for Ministry of Agriculture's promulgation.
2.2.5 test data
Name of product: injection use compound potentiation tylosin tartrate for animals, product batch number: 110701
Figure BDA00001979453000081
Name of product: injection use compound potentiation tylosin tartrate for animals, product batch number: 110702
Figure BDA00001979453000082
Name of product: injection use compound potentiation tylosin tartrate for animals, product batch number: 110703
Figure BDA00001979453000083
2.3 result of study: product three batch samples of the present invention are investigated by temperature, humidity accelerated test and first accelerated test, the result shows that product characteristics, pH value, clarity, content etc. detect in each investigation time all up to specification, compares every detection index with the O month and do not have significant degreeization.
3. the clinical trial of injection use compound potentiation tylosin tartrate for animals
Method: choose ill moving, be divided into experimental group, matched group 1 and matched group 2 at random:
(1) drug test group intramuscular injection injection use compound potentiation tylosin tartrate for animals of the present invention;
(2) medicine matched group 1 intramuscular injection injection tylosin tartrate matched group; Manufacturer: animal pharmaceutcal corporation, Ltd of Chongqing gold nation, effective ingredient: tylosin tartrate, trimethoprim.
(3) medicine matched group 2 intramuscular injections kanamycin sulfate matched group; Manufacturer: animal pharmaceutcal corporation, Ltd of the golden nation of gold celebrating, effective ingredient: kanamycin sulfate, trimethoprim.
Therapeutic dose: test group is in tylosin, 1kg body weight 5mg; Matched group 1 is in tylosin, 1kg body weight 10mg; Matched group 2 is in kanamycin sulfate, 1kg body weight 10mg.After the treatment beginning, with identical administering mode and corresponding disease, record infected animal health situation of change every day, treat and add up therapeutic outcome after 2 days.
The result shows that the matched group 1 of injection use compound potentiation tylosin tartrate for animals and folk prescription medicine, 2 is relatively treated disease effects and obviously is better than matched group.The compound of the more existing tylosin tartrate of curative effect and trimethoprim or the compound of kanamycin sulfate and trimethoprim significantly strengthen.Disease complete obiteration with animal is healing.
The clinical application effect statistics of injection use compound potentiation tylosin tartrate for animals
Figure BDA00001979453000091

Claims (2)

1. an injection use compound potentiation tylosin tartrate for animals is characterized in that, is made up of following components in part by weight:
1 part of tylosin tartrate;
1 part of kanamycin sulfate;
0.2 part of trimethoprim;
0.2 part of cosolvent;
0.05~0.1 part of pain relief agents;
Described cosolvent is that citric acid or succinic acid or the two are composite.
2. a kind of injection use compound potentiation tylosin tartrate for animals according to claim 1 is characterized in that: described pain relief agents is that procaine hydrochloride or lidocaine hydrochloride or the two are composite.
CN 201210277167 2012-08-06 2012-08-06 Compound synergistic tartaric acid tylosin for injection of livestock Expired - Fee Related CN102784159B (en)

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CN104926899A (en) * 2015-05-11 2015-09-23 成都中牧生物药业有限公司 Preparation process avoiding the reduction of tylosin tartrate original drug potency
CN104892705A (en) * 2015-05-11 2015-09-09 成都中牧生物药业有限公司 Preparation technology of tylosin tartrate for injection
CN107308176A (en) * 2017-07-05 2017-11-03 山东中牧兽药有限公司 A kind of injection Tylosin Tartrate and preparation method thereof
CN115068420A (en) * 2022-07-27 2022-09-20 石家庄石牧药业有限公司 Tylosin tartrate solution for livestock and poultry and preparation method thereof

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CN1843329A (en) * 2006-05-17 2006-10-11 天津生机集团有限公司 Compound amikacin sulfate injection for animal and its preparation method
CN101468032A (en) * 2007-12-26 2009-07-01 天津瑞普生物技术集团有限公司 Soluble powder for treating respiratory illness of livestock and poultry
CN101822688B (en) * 2010-05-19 2012-01-11 陈建波 Compound tylosin injection for animals and preparation method thereof

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