CN101987105A - Compound preparation for treating diseases caused by poultry sensitive bacteria and preparation method thereof - Google Patents
Compound preparation for treating diseases caused by poultry sensitive bacteria and preparation method thereof Download PDFInfo
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- CN101987105A CN101987105A CN2009100699392A CN200910069939A CN101987105A CN 101987105 A CN101987105 A CN 101987105A CN 2009100699392 A CN2009100699392 A CN 2009100699392A CN 200910069939 A CN200910069939 A CN 200910069939A CN 101987105 A CN101987105 A CN 101987105A
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
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Abstract
The invention relates to a compound preparation for treating diseases caused by poultry sensitive bacteria and a preparation method thereof. The compound preparation is a long-acting injectable suspension prepared from florfenicol and occrycetin as main medicines and comprises 2.0-20.0% (W/V) of florfenicol, 5.0-30.0% (W/V) of occrycetin, 0.05-0.40% (W/V) of antioxidant, 1-10% (W/V) of antiallergic factor synergist, 0.01-0.04% (W/V) of complexing agent, 0.01-15% (W/V) of suspending agent, 1.0-10.0% (W/V) of flocculating agent, 0.01-0.5% (W/V) of preservative and 60-100% (W/V) of water for injection. The liquid medicine of the invention has stable performance and can effectively overcome the defects of instable performance, easy color change, precipitation and failure and the like of injections. The compound preparation has small irritativeness, low cost and simple process and can prolong the residence time of medicine in body and increase the bioavailability of the medicine. The compound preparation can be used for preventing and treating infectious diseases caused by poultry sensitive bacteria, such as pasteurellosis, colibacillosis, salmonellosis, contagious pleuropneumonia, mycoplasmlpneumonia of swine, acute respiratory infection and the like.
Description
Technical field
The invention belongs to the veterinary drug technical field, be particularly related to a kind of compound recipe suspensoid and preparation method that is used for the treatment of the long-acting injectable of livestock and poultry caused by sensitive bacteria associated diseases, this compound preparation is used to prevent and treats infection due to the poultry sensitive bacterial, as Bacillus pasteurii disease, colibacillosis and salmonellosis, contagious pleuropneumonia, mycoplasma pneumoniae of swine, acute respiratory infection etc.
Background technology
At present along with the life-time service of antibiotic medicine, poultry are faced with chemical sproof grave danger, and the pathogen Drug resistance strengthens year by year, cause curative effect to descend, and dosage improves.Often show state of an illness complexity clinically, multiple mixed infection.Therefore development safety, efficient, an urgent demand that medicine that antimicrobial spectrum is wider becomes China's modern farming, the exploitation of compound preparation simultaneously also is an important directions that enlarges antimicrobial spectrum.
Tetramycin hydrochloride has another name called terramycin hydrochloride, has a broad antifungal spectrum, and the pharmacokinetics feature is good, and toxic and side effects is little, and is residual low, is long-acting effect, can keep antibiotic effective blood drug concentration 2～3 days.Most of Gram-positives and negative bacterium all there are depression effect, and spirillum, mycoplasma, rickettsia, actinomycetes etc. are also had depression effect, the secondary mixed infectious disease that is caused by virus is had good effect.This medicine is particularly remarkable to intestinal infection, is used for the treatment of escherichia coli or salmonellal white scour, lamb dysentery, yellow scour of piglet and Hakuri etc.; The cattle hemorrhagic septicemia that pasteurella multocida causes, pig lung plague, fowl cholera etc.; The pleuropneumonia that mycoplasma causes, swine enzootic pneumonia etc.After the long-acting tetramycin hydrochloride intramuscular injection, be absorbed into blood rapidly, and keep 8 hours peak concentration (＞3 μ g/ml), 48 hours blood drug level Mlc (＞1 μ g/ml) of still remaining valid was reduced to 0.5 μ g/ml in 76 hours.Tetramycin hydrochloride is distributed widely in body tissue after absorbing, and is the highest with concentration in kidney,liver,spleen, the lung especially, and can enter in thoracic cavity, abdominal cavity, fetus and the cerebrospinal fluid through barrier, and content is also high in the milk, is about half amount of haemoconcentration.This drug main will enter biliary medicine through renal excretion, still can partially absorb after entering enteral, and carry out the liver sausage circulation.
Florfenicol is a chloromycetin of new generation synthetic antibacterial agents for animals, is the broad spectrum antibiotic for animals of U.S. elder generation spirit-Schering-Plough's development.This medicine from the nineties in 20th century successively since listings such as Japan, America and Europe and China, be mainly used in the bacterial infection of control cattle, pig and aquatic product animal.Florfenicol on chemical constitution with CH
3SO
2Replaced NO
2, the untoward reaction that does not produce aplastic anemia after the medication.Therefore, in the diseases prevention and treatment of animal, food animal especially, florfenicol has broad application prospects.
Florfenicol and tetramycin hydrochloride have share synergism, antimicrobial spectrum can enlarge, and the two is having complementary action aspect the antibiotic mechanism, effective in cure enhanced effect when compatibility uses, this drug regimen is with the two combination, both having guaranteed has powerful inhibitory or killing effect to sensitive organism, has saved cost again, will prove the fungistatic effect that the two share with drug sensitive test below.Infectious disease that this combination causes the gram positive bacteria of sensitivity and negative bacterium, rickettsia, mycoplasma etc. and pasteurella haemolytica, pasteurella multocida, actinobacillus pleuropneumoniae are extremely sensitive to this product, and be all responsive to the dysentery bacterium of escherichia coli, streptococcus, Salmonella, anti-thiamphenicol, the hemophilus influenza of anti-ampicillin etc.
Mostly the tetramycin hydrochloride and the florfenicol of existing market sale are the folk prescription injection in addition, and there is not long lasting suspensoid product, and YANSUAN TUMEISU ZHUSHEYE unstable properties, easy to change, precipitation, lost efficacy, be made into behind the suspensoid its character generation significant change, and there is great risk in injection on preparation uses, be placed with the volume organic solvent in the preparation, can bigger stimulation and pain be arranged to animal body, and suspensoid can the prolong drug holdup time in vivo, improved bioavailability of medicament, and the preparation method of preparation is simple, cost is low.Injectable suspensoid also is better than the injection product on ease of use simultaneously.
Summary of the invention
Purpose one of the present invention provides a kind of compound preparation that is used for the treatment of the livestock and poultry caused by sensitive bacteria associated diseases.
Purpose two of the present invention provides the preparation method of this compound preparation.
Tetramycin hydrochloride of the present invention, florfenicol suspension formulations are made by following composition proportion:
Florfenicol 2.0%～20.0% (W/V)
Tetramycin hydrochloride 5.0%～30.0% (W/V)
Antioxidant 0.05%～0.60% (W/V)
Antiallergic factor synergist 1～10% (W/V)
Chelating agent 0.02～0.04% (W/V)
Suspending agent 0.01%～15% (W/V)
Flocculating agent 1.0%～10.0% (W/V)
Antiseptic 0.01%～1% (W/V)
Water for injection is added into 100% (V/V)
The percentage ratio of above composition is based on the cumulative volume meter of suspensoid.
Above-mentioned antioxidant includes but not limited to wherein one or more the combination of sodium metabisulfite, sodium formaldehyde sulfoxylate, sodium sulfite, anhydrous sodium sulfite.
Above-mentioned antiallergic factor synergist includes but not limited to wherein one or more the combination into chlorphenamine maleate, Indomethacin sodium, diclofenac sodium.
Above-mentioned suspending agent includes but not limited to wherein one or more the combination of sodium alginate, polyvinylpyrrolidone, carboxymethyl cellulose, methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl fiber, tween 80 etc.
Above-mentioned flocculating agent includes but not limited to wherein one or more the combination of citrate, acetate, phosphate, tartrate, biatrate etc.
Above-mentioned antiseptic includes but not limited to wherein one or more the combination of benzoic acid, sorbic acid, methyl hydroxybenzoate, ethyl hydroxybenzoate, propylparaben etc.
Above-mentioned chelating agent is selected from disodiumedetate, and consumption is 0.01%～0.06%, and optimum amount is 0.02～0.04%.
The present invention realizes by following step:
(1) earlier chelating agent, flocculating agent and antiseptic are dissolved in a small amount of water for injection successively, with 0.45 μ m microporous filter membrane filter solution A.
(2) get an amount of water for injection, add antioxidant and antiallergic factor synergist, heating in case of necessity is placed to room temperature after making its dissolving again, adds suspending agent again, after stirring, with the microporous filter membrane of 0.45 μ m filter solution B.
(3) solution B is poured in the solution A, behind the stirring and evenly mixing, added florfenicol and tetramycin hydrochloride, be settled to 100% (V/V), get mixture C with water for injection.
(4) mixture C is homogenized under 30-100Mpa pressure by high pressure homogenizer.
(5) by behind 2～4 circulation homogenizing, fill obtains tetramycin hydrochloride, florfenicol suspension through autoclaving.
The invention has the beneficial effects as follows:
1, zest of the present invention is little;
2, injectable suspensoid of the present invention is of a specified duration action time;
3, this preparation process simply is easy to promote, and medicinal liquid is stable, safety.
The specific embodiment
Embodiment 1:
Component
Tetramycin hydrochloride 20g
Florfenicol 5g
Anhydrous sodium sulfite 0.4g
Disodiumedetate 0.03g
Polyvinylpyrrolidone 0.50g
Sodium carboxymethyl cellulose 0.3g
Indomethacin sodium 2g
Tween 80 0.35g
Sodium citrate 5.0g
Methyl hydroxybenzoate 0.05g
Water for injection adds to 100ml
Preparation technology is:
(1) earlier disodiumedetate, sodium citrate and anhydrous sodium sulfite are dissolved in the 20ml water for injection successively, with 0.45 μ m microporous filter membrane filter solution A.
(2) get 10ml water for injection, add methyl hydroxybenzoate, heating makes its dissolving back and is cooled to room temperature, add 50ml water for injection again, add polyvinylpyrrolidone and tween 80 after dissolving in sodium carboxymethyl cellulose and Indomethacin sodium, after stirring, with the microporous filter membrane of 0.45 μ m filter solution B.
(3) solution B is poured in the solution A, behind the stirring and evenly mixing, added florfenicol and tetramycin hydrochloride, be settled to 100% (V/V), get mixture C with water for injection.
(4) mixture C is homogenized under 30～100Mpa pressure by high pressure homogenizer.
(5) by behind 2～4 circulation homogenizing, obtain tetramycin hydrochloride, florfenicol suspension through 121 degrees centigrade of autoclavings.
Embodiment 2:
Component
Tetramycin hydrochloride 30g
Florfenicol 10g
Anhydrous sodium sulfite 0.5g
Sodium formaldehyde sulfoxylate 0.35g
Disodiumedetate 0.04g
Sodium citrate 4.0g
Polyvinylpyrrolidone 0.55g
Sodium carboxymethyl cellulose 0.5g
Indomethacin sodium 3g
Potassium dihydrogen phosphate 2.2g
Methyl hydroxybenzoate 0.03g
Ethyl hydroxybenzoate 0.03g
Water for injection adds to 100ml
Preparation technology is:
(1) earlier disodiumedetate, sodium citrate, potassium dihydrogen phosphate, sodium formaldehyde sulfoxylate and anhydrous sodium sulfite are dissolved in the 20ml water for injection successively, with 0.45 μ m microporous filter membrane filter solution A.
(2) get 10ml water for injection, add methyl hydroxybenzoate, ethyl hydroxybenzoate, heating makes its dissolving back and is cooled to room temperature, add 50ml water for injection again, add polyvinylpyrrolidone after dissolving in sodium carboxymethyl cellulose and Indomethacin sodium, after stirring, with the microporous filter membrane of 0.45 μ m filter solution B.
(3) solution B is poured in the solution A, behind the stirring and evenly mixing, added florfenicol and tetramycin hydrochloride, be settled to 100% (V/V), get mixture C with water for injection.
(4) mixture C is homogenized under 30～100Mpa pressure by high pressure homogenizer.
(5) by behind 2～4 circulation homogenizing, obtain tetramycin hydrochloride, florfenicol suspension through 121 degrees centigrade of autoclavings.
Embodiment 3: the fungistatic effect of using susceptibility evidence tetramycin hydrochloride and florfenicol use in conjunction:
The drug sensitive test report
Annotate: 0 is insensitive; Hypoallergenic≤10mm; In quick 10-14mm; High quick 15-20mm; Extremely quick 〉=20mm.* * is for extremely clear; * for extremely unintelligible
Therefore show that by above test data compositions of the present invention has good accumulative action and fungistatic effect, prove both synergism that combined.
Embodiment 4:
The present invention will be further described below by the clinical practice example.
Pig farm, Ninghe County, Tianjin, the piglet of 30-35 age in days, average weight is about 20 jin, and poor growth clinically mainly shows as dry cough, low grade fever, dyspnea, breathes, and is diagnosed as the piglet disease of breathing.
The experiment grouping, choose 5 normally do not fall ill pig and 15 sick pigs, sick pig is divided into a at random, b, three groups of c, be respectively florfenicol injection (challenge Bioisystech Co., Ltd in Tianjin produces) contrast treatment group a, the plain injection of tetramycin hydrochloride (production of Rui Pu Bioceuticals Inc.) contrast treatment group b, a, two groups of equal administered intramuscular of b, 2 administrations every day, sooner or later respectively once, treatment group c of the present invention (making) by embodiment two, drinking-water administration (annotate: injection of this suspensoid or drinking-water administration all can), logotype 3 days, 2 administrations every day, sooner or later respectively once, and the clinical symptoms of observing every group of sick pig, the disease pig food amount and the mental status write down.All experiment pig continue to observe to 14d, observe the weightening finish situation.The result is as follows:
| Test group | Cure rate % | Mortality rate % | 14d average daily gain g/d |
| Control drug a group | 60 | 1 | 369 |
| Control drug b group | 60 | 1 | 347 |
| Test c group | 100 | 0 | 526 |
| The normal healthy controls group | 0 | 0 | 563 |
Conclusion: the result shows, a kind of compound preparation that is used for the treatment of the livestock and poultry caused by sensitive bacteria associated diseases of the present invention has good cure rate to the disease of breathing of pig, all be better than a, b group, wherein average daily gain also is higher than the control drug group, the c group was observed and clinical unusual performance do not occur after the 14th day, the mental status of piglet is good, search for food normal, the speed of growth is fast than before, there not breathe the cough phenomenon, therefore illustrate that this drug regimen is safely and effectively, the disease of breathing for the treatment of piglet is had certain curative effect.
Claims (9)
1. compound preparation that is used for the treatment of the livestock and poultry caused by sensitive bacteria associated diseases is characterized in that said composition is is the suspensoid that principal agent is equipped with the formulated long-acting injectable of pharmaceutic adjuvant with florfenicol, tetramycin hydrochloride; Described pharmaceutic adjuvant comprises antioxidant, antiallergic factor synergist, chelating agent, suspending agent, flocculating agent, antiseptic.
2. a kind of compound preparation that is used for the treatment of the livestock and poultry caused by sensitive bacteria associated diseases according to claim 1 is characterized in that containing in the prescription: florfenicol: 2.0%～20.0% (W/V), tetramycin hydrochloride: 5.0%～30.0% (W/V), antioxidant: 0.05%～0.40% (W/V), antiallergic factor synergist: 1～10%, chelating agent: 1%～10% (W/V), suspending agent: 0.01%～15% (W/V), flocculating agent: 1.0%～10.0% (W/V), antiseptic: 0.01%～0.5% (W/V), water for injection add to 100% (V/V).
3. a kind of compound preparation that is used for the treatment of the livestock and poultry caused by sensitive bacteria associated diseases according to claim 1, it comprises the steps:
(1) earlier chelating agent, flocculating agent and antiseptic are dissolved in a small amount of water for injection successively, with 0.45 μ m microporous filter membrane filter solution A.
(2) get an amount of water for injection, add antioxidant, antiallergic factor synergist, heating in case of necessity is placed to room temperature after making its dissolving again, adds suspending agent again, after stirring, with the microporous filter membrane of 0.45 μ m filter solution B.
(3) solution B is poured in the solution A, behind the stirring and evenly mixing, added florfenicol and tetramycin hydrochloride, be settled to 100% (V/V), get mixture C with water for injection.
(4) mixture C is homogenized under 30-100Mpa pressure by high pressure homogenizer.
(5) by behind 2～4 circulation homogenizing, obtain tetramycin hydrochloride, florfenicol suspension through autoclaving.
4. according to the described a kind of compound preparation that is used for the treatment of the livestock and poultry caused by sensitive bacteria associated diseases of claim 1-3, it is characterized in that described antioxidant includes but not limited to: one or more combinations of sodium thiosulfate, sodium metabisulfite, sodium formaldehyde sulfoxylate, sodium sulfite, anhydrous sodium sulfite etc.
5. according to the described a kind of compound preparation that is used for the treatment of the livestock and poultry caused by sensitive bacteria associated diseases of claim 1-3, it is characterized in that described suspending agent includes but not limited to: one or more combinations of sodium alginate, polyvinylpyrrolidone, carboxymethyl cellulose, methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl fiber, tween 80, glycerol etc.
6. according to the described a kind of compound preparation that is used for the treatment of the livestock and poultry caused by sensitive bacteria associated diseases of claim 1-3, it is characterized in that described flocculating agent includes but not limited to: the combination of one or more of phosphate, tartrate, biatrate etc.
7. according to the described a kind of compound preparation that is used for the treatment of the livestock and poultry caused by sensitive bacteria associated diseases of claim 1-3, it is characterized in that described antiseptic includes but not limited to: the combination of one or more of benzoic acid, sorbic acid, methyl hydroxybenzoate, ethyl hydroxybenzoate, propylparaben etc.
8. according to the described a kind of compound preparation that is used for the treatment of the livestock and poultry caused by sensitive bacteria associated diseases of claim 1-3, it is characterized in that described antiallergic factor synergist includes but not limited to: the combination of one or more of chlorphenamine maleate, Indomethacin sodium, diclofenac sodium etc.
9. according to the described a kind of compound preparation that is used for the treatment of the livestock and poultry caused by sensitive bacteria associated diseases of claim 1-3, described chelating agent is preferably disodiumedetate, and consumption is 0.01%～0.06%, and optimum amount is 0.02～0.04%.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2009100699392A CN101987105A (en) | 2009-07-30 | 2009-07-30 | Compound preparation for treating diseases caused by poultry sensitive bacteria and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN2009100699392A CN101987105A (en) | 2009-07-30 | 2009-07-30 | Compound preparation for treating diseases caused by poultry sensitive bacteria and preparation method thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103284944A (en) * | 2013-05-22 | 2013-09-11 | 安徽天安动物药业有限公司 | Method for preparing long-acting terramycin injection by utilizing carbamide and sodium bisulfite in combined way |
| CN104162144A (en) * | 2013-08-30 | 2014-11-26 | 郑州后羿制药有限公司 | Compound florfenicol suspension and preparation method thereof |
| WO2017098392A1 (en) * | 2015-12-07 | 2017-06-15 | Emcure Pharmaceuticals Limited | Sterile parenteral suspensions |
| CN108635393A (en) * | 2018-07-17 | 2018-10-12 | 安徽天安生物科技股份有限公司 | A kind of anti-oxidant occrycetin injection and preparation method thereof |
| CN111249232A (en) * | 2020-03-18 | 2020-06-09 | 潍坊富邦药业有限公司 | 30% florfenicol suspension and preparation method thereof |
-
2009
- 2009-07-30 CN CN2009100699392A patent/CN101987105A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103284944A (en) * | 2013-05-22 | 2013-09-11 | 安徽天安动物药业有限公司 | Method for preparing long-acting terramycin injection by utilizing carbamide and sodium bisulfite in combined way |
| CN104162144A (en) * | 2013-08-30 | 2014-11-26 | 郑州后羿制药有限公司 | Compound florfenicol suspension and preparation method thereof |
| CN104162144B (en) * | 2013-08-30 | 2016-04-20 | 郑州后羿制药有限公司 | A kind of compound florfenicol suspension and preparation method thereof |
| WO2017098392A1 (en) * | 2015-12-07 | 2017-06-15 | Emcure Pharmaceuticals Limited | Sterile parenteral suspensions |
| US20190269616A1 (en) * | 2015-12-07 | 2019-09-05 | Emcure Pharmaceuticals Limited | Sterile parenteral suspensions |
| CN108635393A (en) * | 2018-07-17 | 2018-10-12 | 安徽天安生物科技股份有限公司 | A kind of anti-oxidant occrycetin injection and preparation method thereof |
| CN111249232A (en) * | 2020-03-18 | 2020-06-09 | 潍坊富邦药业有限公司 | 30% florfenicol suspension and preparation method thereof |
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Application publication date: 20110323 |