CN102697725A - Veterinary ciprofloxacin lactate injection and preparation method thereof - Google Patents
Veterinary ciprofloxacin lactate injection and preparation method thereof Download PDFInfo
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- CN102697725A CN102697725A CN2012101860985A CN201210186098A CN102697725A CN 102697725 A CN102697725 A CN 102697725A CN 2012101860985 A CN2012101860985 A CN 2012101860985A CN 201210186098 A CN201210186098 A CN 201210186098A CN 102697725 A CN102697725 A CN 102697725A
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Abstract
The invention relates to the technical field of veterinary administration, in particular to a veterinary ciprofloxacin lactate injection. The veterinary ciprofloxacin lactate injection consists of the following components in percentage by weight: 4-10 percent of ciprofloxacin lactate counted by ciprofloxacin, 10-15 percent of polyoxyethylene 40 hydrogenated castor oil, 0.5-1.0 percent of carbomer, 0.1 percent of sodium bisulfite, 0.01 percent of ethylene diamine tetraacetic acid, and the balance of water for injection. The injection is convenient to use; compared with the conventional injection, the veterinary ciprofloxacin lactate injection has the advantages: the injection times are reduced from twice a day to once a day, treatment cost is saved, stress caused by repeated injection for animals is reduced, and medicament tolerance of bacteria is avoided; the veterinary ciprofloxacin lactate injection has low toxicity and a reliable curative effect, acts for a long time, and can be used for effectively treating white scour of piglets and white diarrhea; and the swine muscle injection half-life period is 22.96 hours, which is equivalent to five times that of an ordinary injection (4.6 hours).
Description
Technical field
The present invention relates to beasts practical technique field, particularly a kind of ciprofloxacin lactate injection for animals also relates to the method for preparing of said ciprofloxacin lactate injection for animals.
Background technology
Along with China's aquaculture to the intensification, large-scale development; The sickness rate of livestock and poultry also rises year by year; New disease constantly increases, and especially fowl bacterial disease, viral disease etc. have the trend of rapid spread, becomes the important diseases of puzzlement China aquaculture.Bacterial disease accounts for 40% of poultry morbidity sum, and mixed infection accounts for about 60% of poultry morbidity sum, and bacterial disease is the main infectious disease of current livestock and poultry.The fast development of modern animal husbandry has proposed safe, inexpensive, requirement efficiently to veterinary drug.For adapting to these requirements, slow releasing preparation must be researched and developed and become focus.Ciprofloxacin lactate is a third generation fluoroquinolone antibacterial agent, is higher a kind of of FQNS antibacterial activity, has been widely used in the various infectious disease due to poultry sensitive bacterial and the mycoplasma.Conventional ciprofloxacin lactate injection for animals on the market, exist in the use access times many, produce stress and make greatly, easily that poultry develop immunity to drugs, heavy livestock is difficult for injection, be not suitable for problem such as large-scale cultivation.Therefore, study a kind of clinical easy to use, curative effect lasting, reduce the poultry stress, practice thrift treatment cost, improve the veterinary drug slow release long-acting ciprofloxacin lactate injection of cure rate, be the current technical issues that need to address.
Application number is 20061010048419.X; The Chinese invention patent that name is called " a kind of preparation technology of novel lactic ciprofloxacin injection " discloses a kind of use polymer substance such as ciprofloxacin lactate colloid solution that Polyethylene Glycol/carboxymethyl cellulose/propylene glycol/polyvidone (PVP)+sodium sulfite+EDTA-2Na etc. processes, also is a kind of durative action preparation.Polyethylene Glycol/carboxymethyl cellulose/propylene glycol/polyvidone, is explained that binding agent is used in can play in the ciprofloxacin lactate injection drug releasing rate is acted on more stably mainly as binding agent at pharmaceutical field.But the material except binding agent does not still have relevant record can make ciprofloxacin lactate injection drug release speed more steady now.
Summary of the invention
In order to make the ciprofloxacin lactate injection drug release speed deficient problem of auxiliary agent kind more stably more than solving, the invention provides a kind of use solubilizing agent and thickening agent and make ciprofloxacin lactate injection drug release speed ciprofloxacin lactate injection for animals more stably.
The present invention also provides a kind of method for preparing of said ciprofloxacin lactate injection for animals.
The present invention realizes through following measure:
A kind of ciprofloxacin lactate injection for animals, form by following components in weight percentage:
In the ciprofloxacin lactate 4～10% of ciprofloxacin,
Polyoxyl 40 hydrogenated castor oil 10～15%,
Carbomer 0.1%～0.5%,
Sodium sulfite 0.1%,
Disodiumedetate 0.01%,
Water for injection adds to 100%,
Carbomer viscosity is 30000～40000 mPas.
Described ciprofloxacin lactate injection for animals, form by following components in weight percentage:
In the ciprofloxacin lactate 8% of ciprofloxacin,
Polyoxyl 40 hydrogenated castor oil is 12%,
Carbomer 0.25%,
Sodium sulfite 0.1%,
Disodiumedetate 0.01%,
Water for injection adds to 100%.
The method for preparing of described ciprofloxacin lactate injection for animals may further comprise the steps:
1. ciprofloxacin lactate adds a certain amount of water for injection, and dissolving adds carbomer, is uniformly dispersed, and regulates pH value to 3.8～4.2, adds polyoxyl 40 hydrogenated castor oil, and mixing gets liquid a;
2. sodium sulfite, disodiumedetate respectively with a certain amount of water for injection dissolve liquid b, liquid c,
3. liquid a, liquid b, liquid c are mixed, add to the full amount of water for injection, add the injection stage active carbon, stirring and adsorbing 10～15min; 4. 0.45 μ m titanium rod filters, and promptly gets.
The injection water yield of dissolving ciprofloxacin lactate is the 30-40% of total injection water yield in the step (1).
The injection water yield of dissolving sodium sulfite, disodiumedetate is respectively the 5-10% of total injection water yield in the step (2).
Ciprofloxacin lactate adds a certain amount of water for injection in the step (1), is heated to 40～50 ℃, stirring and dissolving.
Step is regulated pH value with sodium hydroxide in (1).
Polyoxyl 40 hydrogenated castor oil is used as ingredient not soluble in water solubilizing agent in injection usually in injection; But ciprofloxacin lactate of the present invention is soluble in water; Therefore, its effect in injection of the present invention is different with its effect commonly used.This relevant teachings also useless in the prior art.
Method for using: intramuscular injection or subcutaneous injection, in ciprofloxacin, once measure every 1kg body weight, domestic animal 5mg, fowl 10mg, 1 time on the one, logotype 2-3 day.
Beneficial effect of the present invention:
1, injection of the present invention is easy to use, compares with conventional injection, and frequency injection is reduced to 1 time/day by 2 times/day, has both practiced thrift medical expense, has reduced the stress that animal causes because of multiple injection again, and antibacterial is not easy to produce drug resistance;
2, injection of the present invention is fit to the poultry use, low toxicity, and curative effect is reliable, and persistent can effectively be treated piglet pujos blancos, Pullorum Disease;
3, injection of the present invention is a durative action preparation, and the pig muscle injection half-life is 22.96h, is equivalent to 5 times of normal injection (4.6h).
The specific embodiment
For a better understanding of the present invention, further specify below in conjunction with specific embodiment.If no special instructions, used percentage ratio below is all percentage by weight.
Embodiment 1
Ciprofloxacin lactate injection for animals, composed of the following components:
In the ciprofloxacin lactate 4% of ciprofloxacin,
Polyoxyl 40 hydrogenated castor oil 10%,
Carbomer 0.5%,
Sodium sulfite 0.1%,
Disodiumedetate 0.01%,
Water for injection adds to 100%,
Carbomer viscosity is 30000～40000 mPas.
Method for preparing:
1. ciprofloxacin lactate adds a certain amount of water for injection, and dissolving adds carbomer, is uniformly dispersed, and regulates pH value to 3.8～4.2, adds polyoxyl 40 hydrogenated castor oil, and mixing gets liquid a;
2. sodium sulfite, disodiumedetate respectively with a certain amount of water for injection dissolve liquid b, liquid c,
3. liquid a, liquid b, liquid c are mixed, add to the full amount of water for injection, add the injection stage active carbon, stirring and adsorbing 10～15min; 4. 0.45 μ m titanium rod filters, and promptly gets.
Injection water yield those of ordinary skill in the art of the 1. middle dissolving ciprofloxacin lactate of step can select according to general knowledge voluntarily, is generally the 30-40% into total injection water yield.
The injection water yield of the 2. middle dissolving sodium sulfite of step, disodiumedetate also is that those skilled in the art can select voluntarily, is generally the 5-10% of total injection water yield.
The 1. middle ciprofloxacin lactate of step adds a certain amount of water for injection, can adopt during dissolving to be heated to 40～50 ℃, and the mode of stirring and dissolving, but be not limited only to this dissolution mechanism.
Can use sodium hydroxide when step is regulated pH value in 1., also can use the alkali of other adjusting pH value commonly used.
Embodiment 2
Ciprofloxacin lactate injection for animals, composed of the following components:
In the ciprofloxacin lactate 10% of ciprofloxacin,
Polyoxyl 40 hydrogenated castor oil 15%,
Carbomer 0.1%,
Sodium sulfite 0.1%,
Disodiumedetate 0.01%,
Water for injection adds to 100%,
Carbomer viscosity is 30000～40000 mPas.
Method for preparing:
1. ciprofloxacin lactate adds a certain amount of water for injection, and dissolving adds carbomer, is uniformly dispersed, and regulates pH value to 3.8～4.2, adds polyoxyl 40 hydrogenated castor oil, and mixing gets liquid a;
2. sodium sulfite, disodiumedetate respectively with a certain amount of water for injection dissolve liquid b, liquid c,
3. liquid a, liquid b, liquid c are mixed, add to the full amount of water for injection, add the injection stage active carbon, stirring and adsorbing 10～15min; 4. 0.45 μ m titanium rod filters, and promptly gets.
Embodiment 3
Ciprofloxacin lactate injection for animals, composed of the following components:
In the ciprofloxacin lactate 8% of ciprofloxacin,
Polyoxyl 40 hydrogenated castor oil 12%,
Carbomer 0.25%,
Sodium sulfite 0.1%,
Disodiumedetate 0.01%,
Water for injection adds to 100%,
Carbomer viscosity is 30000～40000 mPas.
Method for preparing:
1. ciprofloxacin lactate adds a certain amount of water for injection, and dissolving adds carbomer, is uniformly dispersed, and regulates pH value to 3.8～4.2, adds polyoxyl 40 hydrogenated castor oil, and mixing gets liquid a;
2. sodium sulfite, disodiumedetate respectively with a certain amount of water for injection dissolve liquid b, liquid c,
3. liquid a, liquid b, liquid c are mixed, add to the full amount of water for injection, add the injection stage active carbon, stirring and adsorbing 10～15min; 4. 0.45 μ m titanium rod filters, and promptly gets.
The comparative example 1
Ciprofloxacin lactate injection for animals, composed of the following components:
In the ciprofloxacin lactate 8% of ciprofloxacin,
Polyethylene Glycol 12%,
Sodium carboxymethyl cellulose 0.25%,
Sodium sulfite 0.1%,
Disodiumedetate 0.01%,
Water for injection adds to 100%.
Method for preparing:
1. ciprofloxacin lactate adds a certain amount of water for injection, and dissolving adds carbomer, is uniformly dispersed, and regulates pH value to 3.8～4.2, adds polyoxyl 40 hydrogenated castor oil, and mixing gets liquid a;
2. sodium sulfite, disodiumedetate respectively with a certain amount of water for injection dissolve liquid b, liquid c,
3. liquid a, liquid b, liquid c are mixed, add to the full amount of water for injection, add the injection stage active carbon, stirring and adsorbing 10～15min; 4. 0.45 μ m titanium rod filters, and promptly gets.
The comparative example 2
Ciprofloxacin lactate injection for animals, composed of the following components:
In the ciprofloxacin lactate 8% of ciprofloxacin,
Glycerol 12%,
Polyvidone 10%
Sodium sulfite 0.1%,
Disodiumedetate 0.01%,
Water for injection adds to 100%.
Method for preparing:
1. ciprofloxacin lactate adds a certain amount of water for injection, and dissolving adds carbomer, is uniformly dispersed, and regulates pH value to 3.8～4.2, adds polyoxyl 40 hydrogenated castor oil, and mixing gets liquid a;
2. sodium sulfite, disodiumedetate respectively with a certain amount of water for injection dissolve liquid b, liquid c,
3. liquid a, liquid b, liquid c are mixed, add to the full amount of water for injection, add the injection stage active carbon, stirring and adsorbing 10～15min; 4. 0.45 μ m titanium rod filters, and promptly gets.
The half-life determination test:
Test unit: academy of agricultural sciences, Shandong Province animal and veterinary institute:
Experimental animal: 15 healthy long white * big York * Du Luoke hybridized pigs, in 8 ages in week, public mother has (boar is castration) concurrently:
Test drug: the injection that the foregoing description 1-3 and comparative example 1-3 prepare:
Test method: carry out the pharmacokinetics test by Latin square design at random, by the dosage intramuscular injection amount of every 1kg body weight 5mg ciprofloxacin lactate.Respectively at 6min, 15min, 30min, 45min and 1h, 2h, 4h, 6h, 9h, 12h, 16h, 24h, 36h, 48h blood sampling, each blood sampling volume 3ml places the centrifuge tube that contains heparin, mixing, the centrifugal 10min of 4000r/min, separated plasma.After adding methanol, high speed centrifugation processing in the blood plasma,, adopt PK Solver pharmacokinetic parameter calculation procedure, handle actual measurement blood plasma ciprofloxacin concentration-time data with rp-hplc determination ciprofloxacin content.
Result of the test: the half-life (t of embodiment 1-3
1/2 β) be respectively 16.69h, 17.59h, 22.96h, be equivalent to 3.6 times, 3.8 times and 5 times of normal injection half-life (4.6h) respectively; Comparative example 1,2 half-life is respectively 11.80h, 11.52h, less than embodiment 1-3.
Table 1 intramuscular injection slow release long-acting ciprofloxacin lactate injection time-the blood drug level value
Acute toxicity test in mice
Test unit: the strong Bioceuticals Inc. of herding in Shandong Province.
Experimental animal: the healthy Kunming of SPF level kind white mice, 18～22g.
Test drug: the injection of the embodiment of the invention 2 preparations.
Test method: on the basis of trial test, 100 of picked at random white mice, male and female half and half are divided 10 groups, and preceding 5 groups of subcutaneous injections, the 5 groups of administered intramuscular in back are carried out formal test.1200.00,1020.00,867.00,736.95,626.41mg/kg 4800.00,3408.00,2419.68,1717.97,1219.76mg/kg subcutaneous injection dosage is respectively:, intramuscular injection dosage is respectively:.Observe mouse toxicity reaction and dead distribution situation after the administration, carry out record every day, put to death whole mices after 7 days.
Result of the test: main toxic reaction for alarm hair, flock together, drowsiness, hypopnea, mouse diing time concentrates on 4～12h after the medication, twitches before dead; The death toll of 1-10 group mice is respectively 10,7,5,2,0,10,8,6,3,0; Calculate intramuscular injection of the present invention and hypodermic LD by the improvement karber's method
50Be respectively 839.27mg/kg, 2504.38mg/kg (in ciprofloxacin); 95% fiducial limit is respectively 750.76mg/kg～938.21mg/kg, 1976.97mg/kg～3172.49mg/kg; Meet the low toxicity standard, explain that clinical subcutaneous injection of this medicine and intramuscular injection are safe in utilization.
The clinical trial of treatment Pullorum Disease
Test unit: the strong Bioceuticals Inc. of herding in Shandong Province.
Experimental animal: 7 age in days healthy AA chickling.
Trial drug: the injection of the embodiment of the invention 3 preparations.
Control drug: ENNUOSHAXING ZHUSHEYE.
Test method: test divides 7 groups, every group of 50 chickens, and first group is high dose group, 20mg/kg body weight subcutaneous injection; Second group is middle dose groups, 10mg/kg body weight subcutaneous injection; The 3rd group is low dose group, 5mg/kg body weight subcutaneous injection, and the 4th group is the ENNUOSHAXING ZHUSHEYE matched group, 10mg/kg body weight subcutaneous injection; The 5th group is the blank group, counteracting toxic substances not, not medication; The 6th group is the counteracting toxic substances matched group, a counteracting toxic substances, not medication; The 7th group is the safe dose group, 100mg/kg body weight subcutaneous injection.
Give chicken counteracting toxic substances Hakuri Salmonella, and be diagnosed as Pullorum Disease, by test grouping medication 3 days.
Result of the test: first to fourth group, symptom obviously alleviates after 4 hours, stops death on the 2nd day, recovery from illness after 3 days.Safe dose test chicken well-grown, no abnormal.The cure rate 80% of the 4th group of ENNUOSHAXING ZHUSHEYE matched group, effective percentage 86%; 92%, the first group of the 3rd group of low dose group cure rate of the present invention 82%, effective percentage and second group high, middle dose groups cure rate are 96%, effective percentage is 100%, and survival rate improves 12%.
The treatment piglet pujos blancos
200 of big York meat piglets are cultured on pig farm, Zhangqiu, Jinan, 14 ages in days, and wherein 51 appetite decline occurs, and the symptom of drawing the canescence loose stool is diagnosed as the piglet pujos blancos that escherichia coli cause.
Test drug: the injection of the embodiment of the invention 3 preparations.
Contrast medicine: chloramphenicol inj.
Therapeutic Method: pig is only divided three groups, 17 every group, presses the intramuscular injection of 10mg/kg body weight with the present invention for first group and uses 1 time on the one; Press the intramuscular injection of 5mg/kg body weight with the present invention for second group and use 1 time on the one; Second group with the intramuscular injection of contrast medicine 20mg/kg body weight, 2 times on the one.
As a result, first group and second group begin to improve in feces on the secondth, all cure in 3rd; The 3rd group of feces on the 2nd improves, and all cures in 3rd.The present invention and control drug therapeutic effect no significant difference, but these article access times reduce half, have practiced thrift the treatment cost, have alleviated the stress that multiple injection causes simultaneously.
Claims (7)
1. ciprofloxacin lactate injection for animals is characterized in that being made up of following components in weight percentage:
In the ciprofloxacin lactate 4%～10% of ciprofloxacin,
Polyoxyl 40 hydrogenated castor oil 10%～15%,
Carbomer 0.1%～0.5%,
Sodium sulfite 0.1%,
Disodiumedetate 0.01%,
Water for injection adds to 100%,
Carbomer viscosity is 30000～40000 mPas.
2. ciprofloxacin lactate injection for animals according to claim 1 is characterized in that being made up of following components in weight percentage:
In the ciprofloxacin lactate 8% of ciprofloxacin,
Polyoxyl 40 hydrogenated castor oil is 12%,
Carbomer 0.25%,
Sodium sulfite 0.1%,
Disodiumedetate 0.01%,
Water for injection adds to 100%.
3. the method for preparing of claim 1 or 2 described ciprofloxacin lactate injections for animals is characterized in that may further comprise the steps:
1. ciprofloxacin lactate adds a certain amount of water for injection, and dissolving adds carbomer, is uniformly dispersed, and regulates pH value to 3.8～4.2, adds polyoxyl 40 hydrogenated castor oil, and mixing gets liquid a;
2. sodium sulfite, disodiumedetate respectively with a certain amount of water for injection dissolve liquid b, liquid c,
3. liquid a, liquid b, liquid c are mixed, add to the full amount of water for injection, add the injection stage active carbon, stirring and adsorbing 10～15min; 4. 0.45 μ m titanium rod filters, and promptly gets.
4. method for preparing according to claim 3 is characterized in that the injection water yield of dissolving ciprofloxacin lactate during step 1. is the 30-40% of total injection water yield.
5. method for preparing according to claim 3 is characterized in that the injection water yield of dissolving sodium sulfite, disodiumedetate during step 2. is respectively the 5-10% of total injection water yield.
6. method for preparing according to claim 3 is characterized in that the 1. middle ciprofloxacin lactate of step adds a certain amount of water for injection, is heated to 40～50 ℃, stirring and dissolving.
7. method for preparing according to claim 3 is characterized in that regulating pH value with sodium hydroxide during step 1..
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105147598A (en) * | 2015-08-27 | 2015-12-16 | 浙江大飞龙动物保健品有限公司 | Veterinary ciprofloxacin injection and preparation method thereof |
| CN107308106A (en) * | 2017-07-01 | 2017-11-03 | 山东中牧兽药有限公司 | A kind of veterinary ciprofloxacin lactate injection and preparation method thereof |
| CN107362133A (en) * | 2017-06-27 | 2017-11-21 | 北京立时达药业有限公司 | A kind of ciprofloxacin lactate injection and its production method |
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| KR930001302B1 (en) * | 1990-12-07 | 1993-02-25 | 주식회사 중외제약 | Ciprofloxacin injectable composition |
| CN1095269A (en) * | 1993-05-19 | 1994-11-23 | 山东省农业科学院实验兽药厂 | Broad-spectrum antibiotic for animal |
| CN1907261A (en) * | 2006-05-22 | 2007-02-07 | 青岛康地恩实业有限公司 | Long-acting carbostyril family antibacterial drugs suspension injection |
| CN101108163A (en) * | 2006-07-18 | 2008-01-23 | 洛阳普莱柯生物工程有限公司 | Novel technique of preparing lactic acid ciprofloxacin injection |
| CN101690713A (en) * | 2009-09-28 | 2010-04-07 | 洛阳普莱柯生物工程有限公司 | Preparation method for carbostyril injection |
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Patent Citations (5)
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| KR930001302B1 (en) * | 1990-12-07 | 1993-02-25 | 주식회사 중외제약 | Ciprofloxacin injectable composition |
| CN1095269A (en) * | 1993-05-19 | 1994-11-23 | 山东省农业科学院实验兽药厂 | Broad-spectrum antibiotic for animal |
| CN1907261A (en) * | 2006-05-22 | 2007-02-07 | 青岛康地恩实业有限公司 | Long-acting carbostyril family antibacterial drugs suspension injection |
| CN101108163A (en) * | 2006-07-18 | 2008-01-23 | 洛阳普莱柯生物工程有限公司 | Novel technique of preparing lactic acid ciprofloxacin injection |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105147598A (en) * | 2015-08-27 | 2015-12-16 | 浙江大飞龙动物保健品有限公司 | Veterinary ciprofloxacin injection and preparation method thereof |
| CN105147598B (en) * | 2015-08-27 | 2018-08-28 | 浙江大飞龙动物保健品有限公司 | A kind of veterinary ciprofloxacin lactate injection and preparation method thereof |
| CN107362133A (en) * | 2017-06-27 | 2017-11-21 | 北京立时达药业有限公司 | A kind of ciprofloxacin lactate injection and its production method |
| CN107362133B (en) * | 2017-06-27 | 2020-06-30 | 北京立时达药业有限公司 | Ciprofloxacin lactate injection and production method thereof |
| CN107308106A (en) * | 2017-07-01 | 2017-11-03 | 山东中牧兽药有限公司 | A kind of veterinary ciprofloxacin lactate injection and preparation method thereof |
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