CN101912359A - Enrofloxacin injection - Google Patents
Enrofloxacin injection Download PDFInfo
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- CN101912359A CN101912359A CN 201010189976 CN201010189976A CN101912359A CN 101912359 A CN101912359 A CN 101912359A CN 201010189976 CN201010189976 CN 201010189976 CN 201010189976 A CN201010189976 A CN 201010189976A CN 101912359 A CN101912359 A CN 101912359A
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- enrofloxacin
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- polyvinylpyrrolidone
- benzyl alcohol
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Abstract
The invention relates to an enrofloxacin injection and a preparation method thereof. The enrofloxacin injection comprises 4%-6% of enrofloxacin, 18%-20% of benzyl alcohol, 3%-6% of polyvinylpyrrolidone, 1%-2% of anhydrous sodium sulfite and the balance of water for injection. The preparation method of the enrofloxacin injection comprises the following steps of: taking a proper amount of water for injection, polyvinylpyrrolidone and benzyl alcohol, introducing air and heating to 80 DEG C; stirring and adding the anhydrous sodium sulfite dissolved in the water for injection to the mixed solution; stirring and dissolving the enrofloxacin in the solution, filtering the solution, adding the water for injection to the whole weight, and regulating the PH value. The enrofloxacin injection has the advantages of wide antibacterial spectrum, slow-release antibacterial action and is effective to bacteria in stationary periods and growth periods and is an effective antibacterial medicament for livestock and poultry.
Description
Technical field
The present invention relates to a kind of poultry antimicrobial drug, relate in particular to a kind of fluoroquinolones of poultry special use, the invention still further relates to the preparation method of this medicine.
Background technology
Enrofloxacin, have another name called the fluoroquinolone that ethyl cyclopropyl (norfloxacin) is first poultry special use (Flu roqu ino lones) class medicine, English name is Enrofloxacin, ethyl compound for ciprofloxacin, it is third generation fluoroquinolones, broad-spectrum bactericidal action is arranged, all effective to the antibacterial of resting stage and trophophase.
Enrofloxacin is at first succeeded in developing by Bayer A.G in the 80's, has entered most of country in the world and market at present.China succeeded in developing in 1993, now had been widely used in veterinary clinic.Enrofloxacin has that has a broad antifungal spectrum, bactericidal activity are strong, widely distributed in the body, do not have characteristics such as cross resistance with other antibacterials.Prove through clinical trial, be better than other antibacterials commonly used at present.After the administration, enrofloxacin can reach quite high concentration at tissues such as liver, lung, kidneys, for several times of blood drug level, is obtaining good effect aspect prevention and treatment fowl bacterial and the Mycoplasma disease.Enrofloxacin is at the existing many reports of the research of healthy poultry interior medicine dynamics.
At present, at home and abroad in the poultry antimicrobial drug, the sales volume maximum of enrofloxacin, drug effect are better, and price is lower.But the sterile water solution that basic composition is enrofloxacin of present enrofloxacin medicament, its shortcoming is to fill a prescription single, and the injection post-absorption is slow, eliminates the half-life weak point, and bioavailability is lower; Its manufacturing process adds water to 100ml for getting enrofloxacin 5 grams, after the heating for dissolving, regulates pH value to 9.5 ~ 10.5 with sodium hydroxide, and packing gets final product, and with the enrofloxacin less stable that this method produces, alkalescence is bigger, and pain is stronger during injection.
Summary of the invention
The purpose of this invention is to provide a kind of enrofloxacin injection, it is a kind of antimicrobial agent by inflammation such as domestic animal respiratory tract obstruction syndrome, the disease of breathing, pneumonia, lung plague, rhinitis, pleuritis, atrophic rhinitis, mastitis, metritis, vaginitis, ophthalmia, encephalitis, myocarditis due to antibacterial, mycoplasma and other pathogenic infection, the injection post-absorption is fast, eliminate long half time, bioavailability is higher, stability better can reduce pain during injection.
The present invention also provides the preparation method of enrofloxacin injection.
Purpose of the present invention is achieved through the following technical solutions.
A kind of enrofloxacin injection is calculated formulated by following raw materials by weight:
Enrofloxacin 4% ~ 6%;
Benzyl alcohol 18% ~ 20%;
Polyvinylpyrrolidone 3% ~ 6%;
Anhydrous sodium sulfite 1% ~ 2%;
Water for injection adds to full dose.
Each raw materials by weight of described enrofloxacin injection is calculated and specifically can is:
Enrofloxacin 5.5%;
Benzyl alcohol 19%;
Polyvinylpyrrolidone 5.5%;
Anhydrous sodium sulfite 1.8%;
Water for injection adds to full dose.
Each raw materials by weight of described enrofloxacin injection is calculated and specifically can also is:
Enrofloxacin 4%;
Benzyl alcohol 18%;
Polyvinylpyrrolidone 3%;
Anhydrous sodium sulfite 1%;
Water for injection adds to full dose.
Each raw materials by weight of described enrofloxacin injection is calculated and specifically also can is:
Enrofloxacin 4.5%;
Benzyl alcohol 18.5%;
Polyvinylpyrrolidone 3.5%;
Anhydrous sodium sulfite 1.2%;
Water for injection adds to full dose.
Each raw materials by weight of described enrofloxacin injection is calculated and is specially:
Enrofloxacin 5%;
Benzyl alcohol 19%;
Polyvinylpyrrolidone 4.5%;
Anhydrous sodium sulfite 1.5%;
Water for injection adds to full dose.
The preparation method of above-mentioned any enrofloxacin injection is:
A, get polyvinylpyrrolidone, benzyl alcohol and an amount of water for injection adds dense joining in the cylinder by aforementioned percentage by weight, logical vapour is heated to 80 ℃;
B, with an amount of water for injection dissolving anhydrous sodium sulfite, under agitation add dense joining in the cylinder;
The enrofloxacin of c, the aforementioned percentage by weight of adding stirs and makes dissolving, is filtered to rare cylinder of joining, and adds to the full amount of water for injection.
Above-mentioned enrofloxacin injection, after finishing above-mentioned steps c, use inorganic base aqueous solution, transfer pH value to 7.5～8.5, that intermediate detects is qualified, fine straining, fill the nitrogen embedding, 110 ℃ of vapor sterilization 30 minutes, is cooled to room temperature then, after packing, to be checked, the product inspection of warehouse-in were qualified, warehouse-in was treated pin.
Inorganic base aqueous solution in the above-mentioned enrofloxacin injection is a sodium hydrate aqueous solution.
Compared with prior art, the invention has the advantages that: be to adopt advanced production technology, third generation fluoroquinolones medicine becomes the macromole complex with synergist with prolongation of effect agent complexation, after this product is expelled in the animal body, the elimination half-life reaches 7-32 hour, reaching 3-5 days thereby can keep effective antibiotic concentration, is a kind of long-acting veterinary fluoroquinolone injection; Broad-spectrum bactericidal action is arranged, all effective to the antibacterial of resting stage and trophophase; Its bactericidal activity depends on concentration, and is dead in 20～30min after sensitive organism contact this product.
This product has good antibacterial action to multiple gram negative bacilli and coccus, comprise bacillus pyocyaneus, klebsiella, escherichia coli, Enterobacter, campylobacter, Shigella, Salmonella, Aeromonas, haemophilus, yersinia's genus, Serratia, vibrio, Proteus etc.Also effective to Brucella, pasteurella, Erysipelothrix, Bordetella, staphylococcus (comprise and produce penicillium sp enzyme and methicillin resistance bacterial strain), Mycoplasma and chlamydia.In addition, compound sulfamethoxazole fastbacteria, gentamycin drug-resistant pseudomonas aeruginosa, penicillin drug resistance staphylococcus aureus and tylosin or taimulin drug resistance mycoplasma all there is good effect.
Be below will band packing enrofloxacin injection sample of the present invention carried out the investigation that keeps sample of exposure experiments to light investigation, accelerated test and room temperature respectively, outward appearance, changes of contents investigation have been carried out, test the stability of enrofloxacin injection of the present invention, result of the test is as follows: wherein detecting prescription is
1) enrofloxacin 5.5%; Benzyl alcohol 19%; Polyvinylpyrrolidone 5.5%; Anhydrous sodium sulfite 1.8%; Water for injection adds to full dose.(lot number 090601)
2) enrofloxacin 4%; Benzyl alcohol 18%; Polyvinylpyrrolidone 3%; Anhydrous sodium sulfite 1%; Water for injection adds to full dose.(lot number 090602)
3) enrofloxacin 4.5%; Benzyl alcohol 18.5%; Polyvinylpyrrolidone 3.5%; Anhydrous sodium sulfite 1.2%; Water for injection adds to full dose.(lot number 090603)
One, exposure experiments to light: above-mentioned sample is placed under the injection clarity detector, and temperature is at 25 ℃ of illumination 4500 ± 500LX, and light application time 10 days the results are shown in Table 1.
Table 1 exposure experiments to light
As shown in Table 1, the enrofloxacin injection of band packing to the light property instability, is answered shading, airtight preservation.
Two, accelerated test: the enrofloxacin injection of band packing, 40 ± 2 ℃ of temperature, placed six months under the condition of relative humidity 75 ± 5%, detected once every 1 month, the results are shown in Table 2
Table 2 accelerated tests
As shown in Table 2, the enrofloxacin injection of band packing, stability better can be declared production.
Three, long term test: the enrofloxacin injection of band packing was placed 0 ~ 18 month under relative humidity 60 ± 5% conditions at 25 ± 2 ℃, the results are shown in Table 3,4.
Table 3 long-term experiment
By table 3 as seen, 090601,090602,090603 batch of this product at 25 ± 2 ℃, was placed 18 months under relative humidity 60 ± 5% conditions, carried out statistical analysis, and effect duration was respectively 26.3 months, 28.7 months, 28.0 months.To sum up three batches, it is 2 years that the effect duration of this product can fix tentatively.
Table 4 long-term experiment
By table 4 as seen, 090601,090602,090603 batch of this product at 25 ± 2 ℃, was placed 18 months under relative humidity 60 ± 5% conditions, carried out statistical analysis, and effect duration was respectively 28.9 months, 27.0 months, 26.5 months.To sum up three batches, it is 2 years that the effect duration of this product can fix tentatively.
In sum, enrofloxacin injection stability in phototesting, accelerated test and long term test is all better, and keeping life is all more than 24 months, and can fix tentatively its effect duration is 2 years.
The present invention is evident in efficacy by clinical trial:
300 the growing and fattening pigs generations in Zhong Shan pig farm, Guangdong eqpidemic disease, its clinical manifestation is incessant chronic diarrhea, be off one's feed, manic uneasiness, dyspnea, shake shiver, furious swelling and ache, through clinical diagnosis is the respiratory tract obstruction syndrome, this veterinary uses " enrofloxacin injection " immediately, obviously alleviate by symptom after the operation instruction injection once, the food of can standing after 1 hour, transference cure after three days.
280 the nursery pig generations in pig farm, Nanning eqpidemic disease, its clinical manifestation are that incessant chronic diarrhea, happiness are crouched, do not eaten, erubescence, fervescence to 42 is spent, and is the respiratory tract obstruction syndrome through clinical diagnosis.This veterinary uses " enrofloxacin injection " immediately, obviously alleviates by symptom after the operation instruction injection once, and body temperature obviously reduces, the food of can standing after 1.5 hours, and body temperature reaches normal value, transference cure after three days.
The Guangzhou city flower is 200 the nursery pig generations in certain pig farm eqpidemic disease all, this pig farm boss in time gets in touch I technician of the company work up of showing up, be diagnosed as respiratory system obstacle syndrome from its clinical symptoms, the technician uses " enrofloxacin injection " to treat immediately, because find in time, so eqpidemic disease has obtained timely control, transference cure two days later.
Disease takes place in pig farm, Yantai City, Shandong Province, and its clinical symptoms shows as: rapid breathing, stream nose liquid, anorexia, fervescence to 41 ℃, the acute pneumonia that causes for mycoplasma pneumoniae after diagnosing.This veterinary is with conventional florfenicol injection poor effect, after use " enrofloxacin injection " instead, just controlled disease in one day, remission many, after three days again injection once, disease got control fully, transference cure.
Eqpidemic disease takes place in pig farm, Zhengzhou City, Henan Province, its boar, ablactational baby pig, nursery pig are fallen ill simultaneously, clinical symptoms shows as: most of pig spirit is depressed, feed intake descends or does not have appetite, serious ventral breathing occurs, asthma is rapid, dyspnea, cough, discharge of eye increase, and the conjunctivitis symptom occurs.The temperature of pig body of acute onset raises, and sudden death takes place.Most of pig becomes chronic or to form endemicity at the child care house popular by acute, and sick pig poor growth or stagnation are become thin, mortality rate, the rising of cad pig ratio.Suckling pig is based on dyspnea and nervous symptoms, and mortality rate is higher.Be respiratory disease syndrome after diagnosing, technology department of back company advises that this pig farm does feeding and management well, notes the humiture of pig house, uses " enrofloxacin " pig that all falls ill to inject simultaneously, the very fast alleviation of symptom, after three days again injection once, transference cure.
The specific embodiment
Enrofloxacin injection of the present invention is calculated formulated by following raw materials by weight:
Enrofloxacin 4% ~ 6%;
Benzyl alcohol 18% ~ 20%;
Polyvinylpyrrolidone 3% ~ 6%;
Anhydrous sodium sulfite 1% ~ 2%;
Water for injection (being distilled water or the deionization water through the distillation gained, the distilled water of weighing again) adds to full dose.
Embodiment one
Enrofloxacin injection is made by following raw material of counting by weight percentage:
Enrofloxacin 5.5%;
Benzyl alcohol 19%;
Polyvinylpyrrolidone 5.5%;
Anhydrous sodium sulfite 1.8%;
Water for injection adds to full dose.
Embodiment two
Enrofloxacin injection is made by following raw material of counting by weight percentage:
Enrofloxacin 4%;
Benzyl alcohol 18%;
Polyvinylpyrrolidone 3%;
Anhydrous sodium sulfite 1%;
Water for injection adds to full dose.
Embodiment three
Enrofloxacin injection is made by following raw material of counting by weight percentage:
Enrofloxacin 4.5%;
Benzyl alcohol 18.5%;
Polyvinylpyrrolidone 3.5%;
Anhydrous sodium sulfite 1.2%;
Water for injection adds to full dose.
Embodiment four
Enrofloxacin injection is made by following raw material of counting by weight percentage:
Enrofloxacin 5%;
Benzyl alcohol 19%;
Polyvinylpyrrolidone 4.5%;
Anhydrous sodium sulfite 1.5%;
Water for injection adds to full dose.
The preparation method of enrofloxacin injection of the present invention is:
A, get polyvinylpyrrolidone, benzyl alcohol and an amount of water for injection adds dense joining in the cylinder by aforementioned percentage by weight, logical vapour is heated to 80 ℃;
B, with an amount of water for injection dissolving anhydrous sodium sulfite, under agitation add dense joining in the cylinder;
The enrofloxacin of c, the aforementioned percentage by weight of adding stirs and makes dissolving, is filtered to rare cylinder of joining, and adds to the full amount of water for injection;
D, transfer pH value to 7.5～8.5 with inorganic base or organic base (sodium hydroxide is diluted to 40% solution with water for injection);
It is qualified that e, intermediate detect, and fine straining fills the nitrogen embedding;
F, 110 ℃ of vapor sterilization 30 minutes are cooled to room temperature;
G, packing, warehouse-in are to be checked, product inspection qualified after, warehouse-in is treated pin.
Claims (8)
1. enrofloxacin injection is characterized in that described enrofloxacin injection calculates formulated by following raw materials by weight:
Enrofloxacin 4% ~ 6%;
Benzyl alcohol 18% ~ 20%;
Polyvinylpyrrolidone 3% ~ 6%;
Anhydrous sodium sulfite 1% ~ 2%;
Water for injection adds to full dose.
2. enrofloxacin injection according to claim 1 is characterized in that: described
Enrofloxacin 5.5%;
Benzyl alcohol 19%;
Polyvinylpyrrolidone 5.5%;
Anhydrous sodium sulfite 1.8%;
Water for injection adds to full dose.
3. enrofloxacin injection according to claim 1 is characterized in that described
Enrofloxacin 4%;
Benzyl alcohol 18%;
Polyvinylpyrrolidone 3%;
Anhydrous sodium sulfite 1%;
Water for injection adds to full dose.
4. enrofloxacin injection according to claim 1 is characterized in that described
Enrofloxacin 4.5%;
Benzyl alcohol 18.5%;
Polyvinylpyrrolidone 3.5%;
Anhydrous sodium sulfite 1.2%;
Water for injection adds to full dose.
5. enrofloxacin injection according to claim 1 is characterized in that described
Enrofloxacin 5%;
Benzyl alcohol 19%;
Polyvinylpyrrolidone 4.5%;
Anhydrous sodium sulfite 1.5%;
Water for injection adds to full dose.
6. the preparation method according to the described any enrofloxacin injection of claim 1 ~ 5 is:
A, get polyvinylpyrrolidone, benzyl alcohol and an amount of water for injection by aforementioned percentage by weight and add
Go into dense joining in the cylinder, logical vapour is heated to 80 ℃;
B, with an amount of water for injection dissolving anhydrous sodium sulfite, under agitation add dense joining in the cylinder;
The enrofloxacin of c, the aforementioned percentage by weight of adding stirs and makes dissolving, is filtered to rare cylinder of joining, and adds to the full amount of water for injection.
7. enrofloxacin injection according to claim 6 is characterized in that finishing the described step
After among the rapid c, use inorganic base aqueous solution, transfer pH value to 7.5～8.5, that intermediate detects is qualified, fine straining, fill the nitrogen embedding, 110 ℃ of vapor sterilization 30 minutes, is cooled to room temperature then, packing, warehouse-in are to be checked, product inspection qualified after, put in storage and treat pin.
8. enrofloxacin injection according to claim 7 is characterized in that: described inorganic base aqueous solution is a sodium hydrate aqueous solution.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN 201010189976 CN101912359A (en) | 2010-06-02 | 2010-06-02 | Enrofloxacin injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201010189976 CN101912359A (en) | 2010-06-02 | 2010-06-02 | Enrofloxacin injection |
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| CN101912359A true CN101912359A (en) | 2010-12-15 |
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Family Applications (1)
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102772359A (en) * | 2012-08-02 | 2012-11-14 | 挑战（天津）动物药业有限公司 | Enrofloxacin injection and preparation method thereof |
| CN103977006A (en) * | 2014-05-30 | 2014-08-13 | 成都乾坤动物药业有限公司 | Medicinal composition for treating cow mastitis and preparation method and application thereof |
| CN112138165A (en) * | 2020-09-25 | 2020-12-29 | 河南牧翔动物药业有限公司 | Valnemulin hydrochloride diluent and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101301291A (en) * | 2008-04-11 | 2008-11-12 | 天津生机集团股份有限公司 | Compound enrofloxacin injection for animals and preparation thereof |
| CN101361709A (en) * | 2008-09-28 | 2009-02-11 | 河南亚卫动物药业有限公司 | 0Long-acting enrofloxacin injection and preparation method thereof |
| CN101703776A (en) * | 2009-09-28 | 2010-05-12 | 洛阳惠中兽药有限公司 | Method for preparing anti-infective agent long-acting injection |
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2010
- 2010-06-02 CN CN 201010189976 patent/CN101912359A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101301291A (en) * | 2008-04-11 | 2008-11-12 | 天津生机集团股份有限公司 | Compound enrofloxacin injection for animals and preparation thereof |
| CN101361709A (en) * | 2008-09-28 | 2009-02-11 | 河南亚卫动物药业有限公司 | 0Long-acting enrofloxacin injection and preparation method thereof |
| CN101703776A (en) * | 2009-09-28 | 2010-05-12 | 洛阳惠中兽药有限公司 | Method for preparing anti-infective agent long-acting injection |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102772359A (en) * | 2012-08-02 | 2012-11-14 | 挑战（天津）动物药业有限公司 | Enrofloxacin injection and preparation method thereof |
| CN103977006A (en) * | 2014-05-30 | 2014-08-13 | 成都乾坤动物药业有限公司 | Medicinal composition for treating cow mastitis and preparation method and application thereof |
| CN103977006B (en) * | 2014-05-30 | 2016-06-08 | 成都乾坤动物药业有限公司 | A kind of pharmaceutical composition treating mammitis of cow and its production and use |
| CN112138165A (en) * | 2020-09-25 | 2020-12-29 | 河南牧翔动物药业有限公司 | Valnemulin hydrochloride diluent and preparation method thereof |
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Open date: 20101215 |