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 realizing the foregoing invention purpose, the technical scheme that the present invention adopted is: a kind of injection use compound potentiation tylosin tartrate for animals, it is characterized in that, and form by following components in part by weight:
Amounts of components is strict in the described prescription, and other component does not almost have the leeway of adjustment except that pain relief agents.Only can on material choice, do following replacement:
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 method for preparing of injection of the present invention:
Take by weighing trimethoprim, the cosolvent of recipe quantity, mix, cross 120 orders or thinner sieve after fluid energy mill is pulverized;
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 promptly gets.
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 dissolved with analog such as solvent for injection such as water for injection or ethylene glycol, ethanol, then muscle or subcutaneous injection.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 composite indications that not only are directed against of ingredient are 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, and bioavailability is high;
6, safe in utilization, 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.
Method for preparing:
Take by weighing trimethoprim, the citric acid of recipe quantity respectively, mix, cross 120 mesh sieves after fluid energy mill is pulverized; 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 promptly gets.
Embodiment two
Tylosin tartrate 1g, kanamycin sulfate 1g, trimethoprim 0.2g, succinic acid 0.2g, procaine hydrochloride 0.05g.
Method for preparing:
Take by weighing trimethoprim, the succinic acid of recipe quantity respectively, mix, cross 120 mesh sieves after fluid energy mill is pulverized, 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 promptly gets.
Embodiment three
Tylosin tartrate 1g, kanamycin sulfate 1g, trimethoprim 0.2g, citric acid 0.2g, lidocaine hydrochloride 0.05g.
Method for preparing:
Take by weighing trimethoprim, the citric acid of recipe quantity respectively, mix, cross 150 mesh sieves after fluid energy mill is pulverized, 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 promptly gets.
Embodiment four
Tylosin tartrate 1g, kanamycin sulfate 1g, trimethoprim 0.2g, succinic acid 0.2g, lidocaine hydrochloride 0.05g.
Method for preparing:
Take by weighing trimethoprim, the succinic acid of recipe quantity respectively, mix, cross 120 mesh sieves after fluid energy mill is pulverized, 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 promptly gets.
Embodiment five
Tylosin tartrate 0.5g, kanamycin sulfate 0.5g, trimethoprim 0.1g, citric acid 0.1g, procaine hydrochloride 0.05g.
Method for preparing:
Take by weighing trimethoprim, the citric acid of recipe quantity respectively, mix, cross 120 mesh sieves after fluid energy mill is pulverized, 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 promptly gets.
Embodiment six
Tylosin tartrate 0.5g, kanamycin sulfate 0.5g, trimethoprim 0.1g, succinic acid 0.1g, procaine hydrochloride 0.05g.
Method for preparing:
Take by weighing trimethoprim, the succinic acid of recipe quantity respectively, mix, sieve after fluid energy mill is pulverized, 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 promptly gets.
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.
Method for preparing:
Take by weighing trimethoprim, the cosolvent of recipe quantity respectively, mix, cross 120 mesh sieves after fluid energy mill is pulverized, 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 promptly gets.
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.
Method for preparing:
Take by weighing trimethoprim, the cosolvent of recipe quantity respectively, mix, sieve after fluid energy mill is pulverized, 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 promptly gets.
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 with 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 these article, and staphylococcus aureus has part crossing drug resistant phenomenon to these article and erythromycin; The antimicrobial spectrum of kanamycin sulfate is similar with 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, like 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, can solve the pain that produces when tylosin tartrate is injected; 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; System is according to " veterinary drug stability test technical specification (trying) " way of the Ministry of Agriculture's promulgation; Adopt temperature, humidity accelerated test and acceleration by light test, three lot sample article 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 at 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 confirmed 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
Name of product: injection use compound potentiation tylosin tartrate for animals, product batch number: 110702
Name of product: injection use compound potentiation tylosin tartrate for animals, product batch number: 110703
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: in the proof box of test medicament strong illumination, 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, in the condition held of illumination 4500LX ± 500LX ten days, sampling when walking in the 5th, ten day detected by stable high spot reviews project.
2.2.4 investigation project: character, pH value, clarity, content, investigation project are confirmed 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
Name of product: injection use compound potentiation tylosin tartrate for animals, product batch number: 110702
Name of product: injection use compound potentiation tylosin tartrate for animals, product batch number: 110703
2.3 result of study: product three lot sample article of the present invention are investigated through temperature, humidity accelerated test and first accelerated test; The result shows that product character, pH value, clarity, content etc. detect in each investigation time all up to specification, compares each item 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) the kanamycin sulfate matched group is used in 2 intramuscular injections of medicine 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,, write down infected animal health situation of change every day, treat and add up therapeutic outcome after 2 days with identical administering mode and corresponding disease.
The result shows that the matched group 1,2 of injection use compound potentiation tylosin tartrate for animals and folk prescription medicine is relatively treated disease effects and obviously is superior to matched group.The compound of 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