CN103405466B - Compound synergistic tylosin tartrate - Google Patents
Compound synergistic tylosin tartrate Download PDFInfo
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- CN103405466B CN103405466B CN201310364326.8A CN201310364326A CN103405466B CN 103405466 B CN103405466 B CN 103405466B CN 201310364326 A CN201310364326 A CN 201310364326A CN 103405466 B CN103405466 B CN 103405466B
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- tylosin tartrate
- tylosin
- injection
- trimethoprim
- livestock
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Abstract
The invention relates to a compound synergistic tylosin tartrate. The invention aims to provide an compound synergistic tylosin tartrate for injection for livestock, which has quick and definite curative effect on livestock and fowl respiratory system infections and complications. The medicine is composed of the following components in parts by weight: 1 part of tylosin tartrate, 1 part of kanamycin sulfate, 0.2 part of trimethoprim, 0.2 part of cosolvent and 0.05-0.1 part of pain relieving agent. The cosolvent is citric acid or succinic acid or compound of both, and the pain relieving agent is procaine hydrochloride or lidocaine hydrochloride or compound of both. The compound synergistic tylosin tartrate for injection for livestock contains the three pharmaceutical components, including tylosin tartrate, kanamycin sulfate and trimethoprim. The invention solves the problem of incapability of well controlling the secondary infection due to the narrow antimicrobial spectrum of the tylosin tartrate in treating mycoplasma infection, solves the problem of insolubility of trimethoprim in water, has a synergistic effect on tylosin tartrate and kanamycin sulfate, and is accurate in dosage and convenient to use.
Description
The application is application number: 201210277167.3, and patent name is: the divisional application of the patent of invention of " compound synergistic tartaric acid tylosin for injection of livestock ", the original bill applying date: on 08 06th, 2012.
Technical field
The present invention relates to compound synergistic tartaric acid tylosin for injection of livestock.
Background technology
From the state of development of current China animal husbandry, current poultry respiratory system infection is occurred frequently, complication is seriously large to poultry harm.Now commercially also there is no the medicine of ideal treating both the principal and secondary aspects of a disease.By finding the investigation of domestic, international market, market is in the urgent need to a kind of efficacy stability, good effect, stability, complication serious specific medicine occurred frequently to poultry respiratory system infection high, easy to use.
In prior art, tylosin tartrate belongs to vinegar class animal specific antibacterials in macro ring, mainly has good action to most gram-positive bacteria, Gram-negative coccus, anaerobe level legionella, mycoplasma, chlamydia.Belong to the quick-acting antibacterial of trophophase.In higher concentrations, there is bactericidal action, be macrolide apoplexy due to endogenous wind to one of the strongest medicine of mycoplasma effect, be mainly used in control pig, avian mycoplasmas is sick, as chronic respiratory disease of fowl (CRD) with infectiousness hole chamber is scorching and the mycoplasma pneumonia of pig.
The antimicrobial spectrum of kanamycin sulfate is similar to streptomycin, but effect is slightly strong.To most of gram negative bacteria as escherichia coli, Bacillus proteus, Salmonella and pasteurella multocida etc. have powerful antibacterial action, to gold-coloured staphylococci and tubercule bacillus also more responsive.Intramuscular injection is used for the various severe infections caused by sensitive organism, as septicemia, urogenital infection, respiratory tract infection, Skin and soft tissue infection etc.
Trimethoprim is broad-spectrum antiseptic synergist, can increase substantially (can potentiation several times to tens times), and can reduce the appearance of drug resistance strain to the antibacterial action of multiple antibiotics.
Injection means sterile solution confession being injected in vivo, emulsion or suspension that medicine is made, and supplies the sterilized powder concentrated solution of wiring solution-forming or suspension before use.The feature of injection, be mainly manifested in route of administration and directly inject tissue or blood vessel without digestive system and defence tissue (liver), therefore drug effect is rapid, is applicable to first aid.But also the curative effect of some injection is extended, to adapt to needs medically.The dosage of injection is accurate, and reliable effect, may suffer the impact such as Digestive system, food, and make the dosage taken completely curative effect can not occur unlike endo-medicine.In addition, some drugs can be made again to play positioning action.
Injectable sterile powder is also known as powder pin, and injection after dissolving with sterilized water for injection is before use a kind of comparatively conventional injection type.Be applicable to medicine unstable in water, particularly to wet heat sensitive antibiotic and biological product.
Summary of the invention
The object of this invention is to provide a kind of compound synergistic tartaric acid tylosin for injection of livestock, 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 compound synergistic tartaric acid tylosin for injection of livestock, is characterized in that, is made up of the component of following weight ratio:
In described formula, amounts of components requires strict, the leeway that other component does not almost adjust except pain relief agents.Only can do following replacement in material choice:
Described cosolvent is citric acid or succinic acid or the two is composite.
Described pain relief agents is procaine hydrochloride or lidocaine hydrochloride or the two is composite.
The preparation method of injection of the present invention:
Take the trimethoprim of recipe quantity, cosolvent, pulverize through fluid energy mill after mixing, cross 120 orders or thinner sieve;
Mix homogeneously by the equivalent method of progressively increasing with tylosin tartrate, kanamycin sulfate, pain relief agents again;
Inspection of semifinished product content, dissolubility, qualified rear subpackage, packaging, to obtain final product.
Further, described pulverizing is pulverize through fluid energy mill.
Further, describedly to sieve as crossing 120 mesh sieves.
The usage of product of the present invention and consumption: first by product solvent for injection of the present invention as water for injection or the analog such as ethylene glycol, ethanol dissolve, then muscle or subcutaneous injection.In tylosin tartrate: a secondary amounts, every 1kg body weight, pig, fowl 5 ~ 13mg, once a day.
The compound synergistic tartaric acid tylosin for injection of livestock of the present invention's development, includes tylosin tartrate, kanamycin sulfate, trimethoprim three kinds of pharmaceutical compositions.Three kinds of ingredients composite not only for indication more extensive, and enhancing evident in efficacy.And there is following beneficial aspects:
1, develop for veterinary clinic a kind of compound synergistic tartaric acid tylosin for injection of livestock and preparation method thereof is provided;
2, solve due to tylosin tartrate narrow antimicrobial spectrum, during treatment mycoplasma infection, secondary infection can not be controlled very well;
3, solve trimethoprim and be insoluble in water problem, 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, use safety, determined curative effect, quality controllable;
7, dosage is accurate, easy to use;
8, excitatory little, reduce to poultry stress.
Detailed description of the invention
Embodiment one
Tylosin tartrate 1g, kanamycin sulfate 1g, trimethoprim 0.2g, citric acid 0.2g, procaine hydrochloride 0.05g.
Preparation method:
Take the trimethoprim of recipe quantity, citric acid respectively, pulverize through fluid energy mill after mixing, cross 120 mesh sieves, mix homogeneously by the equivalent method of progressively increasing with tylosin tartrate, kanamycin sulfate, procaine hydrochloride again, the inspection of semifinished product, subpackage, packaging, product inspection, to obtain final product.
Embodiment two
Tylosin tartrate 1g, kanamycin sulfate 1g, trimethoprim 0.2g, succinic acid 0.2g, procaine hydrochloride 0.05g.
Preparation method:
Take the trimethoprim of recipe quantity, succinic acid respectively, pulverize through fluid energy mill after mixing, cross 120 mesh sieves, then mix homogeneously by the equivalent method of progressively increasing with tylosin tartrate, kanamycin sulfate, pain relief agents, the inspection of semifinished product, subpackage, packaging, product inspection, warehouse-in, to obtain final product.
Embodiment three
Tylosin tartrate 1g, kanamycin sulfate 1g, trimethoprim 0.2g, citric acid 0.2g, lidocaine hydrochloride 0.05g.
Preparation method:
Take the trimethoprim of recipe quantity, citric acid respectively, pulverize through fluid energy mill after mixing, cross 150 mesh sieves, then mix homogeneously by the equivalent method of progressively increasing with tylosin tartrate, kanamycin sulfate, pain relief agents, the inspection of semifinished product, subpackage, packaging, product inspection, warehouse-in, to obtain final product.
Embodiment four
Tylosin tartrate 1g, kanamycin sulfate 1g, trimethoprim 0.2g, succinic acid 0.2g, lidocaine hydrochloride 0.05g.
Preparation method:
Take the trimethoprim of recipe quantity, succinic acid respectively, pulverize through fluid energy mill after mixing, cross 120 mesh sieves, then mix homogeneously by the equivalent method of progressively increasing with tylosin tartrate, kanamycin sulfate, pain relief agents, the inspection of semifinished product, subpackage, packaging, product inspection, warehouse-in, to obtain final product.
Embodiment five
Tylosin tartrate 0.5g, kanamycin sulfate 0.5g, trimethoprim 0.1g, citric acid 0.1g, procaine hydrochloride 0.05g.
Preparation method:
Take the trimethoprim of recipe quantity, citric acid respectively, pulverize through fluid energy mill after mixing, cross 120 mesh sieves, then mix homogeneously by the equivalent method of progressively increasing with tylosin tartrate, kanamycin sulfate, pain relief agents, the inspection of semifinished product, subpackage, packaging, product inspection, warehouse-in, to obtain final product.
Embodiment six
Tylosin tartrate 0.5g, kanamycin sulfate 0.5g, trimethoprim 0.1g, succinic acid 0.1g, procaine hydrochloride 0.05g.
Preparation method:
Take the trimethoprim of recipe quantity, succinic acid respectively, pulverize through fluid energy mill after mixing, sieve, then mix homogeneously by the equivalent method of progressively increasing with tylosin tartrate, kanamycin sulfate, pain relief agents, the inspection of semifinished product, subpackage, packaging, product inspection, warehouse-in, to obtain final product.
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 the trimethoprim of recipe quantity, cosolvent respectively, pulverize through fluid energy mill after mixing, cross 120 mesh sieves, then mix homogeneously by the equivalent method of progressively increasing with tylosin tartrate, kanamycin sulfate, pain relief agents, the inspection of semifinished product, subpackage, packaging, product inspection, warehouse-in, to obtain final product.
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 the trimethoprim of recipe quantity, cosolvent respectively, pulverize through fluid energy mill after mixing, sieve, then mix homogeneously by the equivalent method of progressively increasing with tylosin tartrate, kanamycin sulfate, pain relief agents, the inspection of semifinished product, subpackage, packaging, product inspection, warehouse-in, to obtain final product.
Result of study
1, formulation study
Prescription crude drug tylosin tartrate of the present invention, kanamycin sulfate, trimethoprim, record " Chinese veterinary pharmacopoeia " version in 2010." Chinese veterinary pharmacopoeia " is recorded, similar to erythromycin antimicrobial spectrum.More weak to the effect of antibacterial, strong to Mycoplasma effect, be macrolide apoplexy due to endogenous wind to one of the strongest medicine of mycoplasma effect.Sensitive organism produces drug resistance to this product, and staphylococcus aureus has partial intersection drug resistance phenomenon to this product and erythromycin; The antimicrobial spectrum of kanamycin sulfate is similar to streptomycin, but effect is slightly strong.To most of gram negative bacteria as escherichia coli, Bacillus proteus, Salmonella and pasteurella multocida etc. have powerful antibacterial action, to gold-coloured staphylococci and tubercule bacillus also more responsive.Intramuscular injection is used for the various severe infections caused by sensitive organism, as septicemia, urogenital infection, respiratory tract infection, Skin and soft tissue infection etc.; Trimethoprim is broad-spectrum antiseptic synergist, can increase substantially, and can reduce the appearance of drug resistance strain to the antibacterial action of multiple antibiotics.
Prescription of the present invention is by tylosin tartrate, kanamycin sulfate drug combination, through trimethoprim potentiation, clinical trial shows, on the effect recorded at " Chinese veterinary pharmacopoeia " and purposes basis, the pain produced when can solve tylosin tartrate injection, control livestock and poultry respiratory and digestive tract disease effect are more remarkable, and reduce the generation of drug resistance.
2, stability study
Compound synergistic tartaric acid tylosin for injection of livestock product stability research 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, stability study is carried out to three batch samples.
2.1 temperature, humidity accelerated test
2.1.1 test material
Product of the present invention: compound synergistic tartaric acid tylosin for injection of livestock
Batch number: 110701,110702,110703
Product requirement: commercially available back
2.1.2 experimental condition: adopt medicine stability test case, temperature is adjusted to 40 ± 2 DEG C, and relative humidity controls 75 ± 5%.
2.1.3 observing time: product of the present invention places 6 months, at duration of test, each moon sampling secondary, detects product by stability high spot reviews project.
2.1.4 investigate project: character, content, investigating project definition base is " veterinary drug stability test technical specification (trying) " way that the Ministry of Agriculture promulgates.
2.1.5 test data
Name of product: compound synergistic tartaric acid tylosin for injection of livestock, product batch number: 110701
Name of product: compound synergistic tartaric acid tylosin for injection of livestock, product batch number: 110702
Name of product: compound synergistic tartaric acid tylosin for injection of livestock, product batch number: 110703
2.2 acceleration by light tests
2.2.1 test material
Product of the present invention: compound synergistic tartaric acid tylosin for injection of livestock
Batch number: 110701,110702,110703
Product requirement: commercially available back
2.2.2 experimental condition: in test with in the proof box of medicine strong illumination, illumination is 4500 native 500LX
2.2.3 observing time: get product of the present invention and load in water white transparency container, be positioned in light durability proof box, place ten days under the condition of illumination 4500LX ± 500LX, sample in time walking for the 5th, ten day, detect by stability high spot reviews project.
2.2.4 project is investigated: character, pH value, clarity, content, investigation project definition base are " veterinary drug stability test technical specification (trying) " way that the Ministry of Agriculture promulgates.
2.2.5 test data
Name of product: compound synergistic tartaric acid tylosin for injection of livestock, product batch number: 110701
Name of product: compound synergistic tartaric acid tylosin for injection of livestock, product batch number: 110702
Name of product: compound synergistic tartaric acid tylosin for injection of livestock, product batch number: 110703
2.3 results of study: product three batch sample of the present invention is investigated by temperature, humidity accelerated test and first accelerated test, result shows that product characteristics, pH value, clarity, content etc. detect within each investigation time and all conforms with the regulations, and every Testing index is without significant degree compared with 0 month.
3. the clinical trial of compound synergistic tartaric acid tylosin for injection of livestock
Method: choose ill dynamic, be divided into experimental group, matched group 1 and matched group 2 at random:
(1) drug test group intramuscular injection compound synergistic tartaric acid tylosin for injection of livestock of the present invention;
(2) drug control group 1 intramuscular injection injection tylosin tartrate matched group; Manufacturer: Chongqing Jinbang Animal Pharmaceutical Co., Ltd., effective ingredient: tylosin tartrate, trimethoprim.
(3) drug control group 2 intramuscular injection kanamycin sulfate matched group; Manufacturer: Jin Qingjinbang animal pharmaceutical estate company limited, effective ingredient: kanamycin sulfate, trimethoprim.
Therapeutic dose: test group in tylosin, 1kg body weight 5mg; Matched group 1 in tylosin, 1kg body weight 10mg; Matched group 2 in kanamycin sulfate, 1kg body weight 10mg.After treatment starts, with identical administering mode and corresponding disease, every day entry infected animal health situation of change, treats and adds up therapeutic outcome after 2 days.
Result shows, compound synergistic tartaric acid tylosin for injection of livestock compares with the matched group 1,2 of folk prescription medicine, and disease therapy successful 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.Disappear completely for curing with the disease of animal.
The clinical application effect statistics of compound synergistic tartaric acid tylosin for injection of livestock
Claims (1)
1. a compound synergistic tartaric acid tylosin for injection of livestock, is characterized in that, is made up of the component of following weight ratio:
Described cosolvent is citric acid or succinic acid or the two is composite;
Described pain relief agents is procaine hydrochloride or lidocaine hydrochloride or the two is composite.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310364326.8A CN103405466B (en) | 2012-08-06 | 2012-08-06 | Compound synergistic tylosin tartrate |
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| CN201310364326.8A CN103405466B (en) | 2012-08-06 | 2012-08-06 | Compound synergistic tylosin tartrate |
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|---|---|---|---|
| CN 201210277167 Division CN102784159B (en) | 2012-08-06 | 2012-08-06 | Compound synergistic tartaric acid tylosin for injection of livestock |
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| CN103405466A CN103405466A (en) | 2013-11-27 |
| CN103405466B true CN103405466B (en) | 2015-01-21 |
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| CN111821292A (en) * | 2020-06-15 | 2020-10-27 | 中南大学湘雅二医院 | Application method of nafamostat mesylate in treatment of chlamydia genital tract infection |
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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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Address after: 401519 Hechuan Industrial Park, Chongqing, Chongqing, Chongqing Patentee after: Jin He Xing (Chongqing) Biotechnology Co., Ltd. Address before: 401519 Hechuan Industrial Park, Chongqing, Chongqing, Chongqing Patentee before: Chongqing Jinbang Animal Pharmaceutical Co., Ltd. |
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