CN102106857A - Compound ceftiofur sodium freeze-dried power injection used for injection - Google Patents
Compound ceftiofur sodium freeze-dried power injection used for injection Download PDFInfo
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- CN102106857A CN102106857A CN2009102561141A CN200910256114A CN102106857A CN 102106857 A CN102106857 A CN 102106857A CN 2009102561141 A CN2009102561141 A CN 2009102561141A CN 200910256114 A CN200910256114 A CN 200910256114A CN 102106857 A CN102106857 A CN 102106857A
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Abstract
The invention is a compound ceftiofur sodium freeze-dried power injection used for injection, and the compound ceftiofur sodium freeze-dried power injection provided by the invention is mainly composed of the following effective components in parts by weight: 2-4 parts of ceftiofur sodium, 1 parts of sulbactam sodium and 1 parts of flunixin meglumine; a vacuum freeze drying method is adopted to prepare the effective components into the compound ceftiofur sodium freeze-dried power injection used for injection. The compound ceftiofur sodium freeze-dried power injection has the advantages that the preparation cost can be lowered, and the drug resistance of bacteria on the ceftiofur sodium is relieved; and the broad antimicrobial spectrum is wide, the activity is strong, the drug administration times is less, and low stress and slight side effect are endured; and the negative effect of endotoxin can be effectively blocked.
Description
Technical field:
The invention belongs to the animal drug field, specifically a kind of injection use compound ceftiofur sodium freeze-dried preparation.
Background technology:
Ceftiofur sodium (Ceftiofur Sodium) is U.S.'s Pharmacia ﹠ Upjohn (Pharmacia ﹠amp; Upjohn) the third generation cephalosporin class antibiotic of first poultry special use of company's initiative.This medicine acts on the synthetic of transpeptidase blocking-up bacteria cell wall and presents bactericidal action.Gram positive bacteria, gram negative bacteria and some anaerobe there are very strong antibacterial activity, more excellent to the antibacterial effect of common livestock pathogen such as actinomyces bacillus pleuropneumoniae, pasteurella multocida property pneumonia clinically.Since being used for the treatment of the respiratory system infection of cattle by FDA approval in 1988, because of its good antibacterial activity and body internal dynamics process, the application in the veterinary clinic treatment both at home and abroad is extensive day by day now.Compare with other antibiotic, the unique distinction of this product is that the content of medicine in infected tissue is higher 2～4 times than non-infected tissue, is the concentrated distribution performance drug effect that target is arranged, and has the characteristics of lasting medicine.Up to the present, ceftiofur sodium has been used for the treatment of the bacterial disease of animals such as cattle, sheep, pig, fowl.
Yet along with the extensive use of this medicine, antibacterial also is on the rise to its drug resistance.In colibacillary research, many reports about the ceftiofur fastbacteria are arranged; Report ceftiofurs such as Fu Xiuling are up to 640 μ g/ml to the colibacillary minimal inhibitory concentration of clinical isolating 30 strains, and resistant rate is up to 72%; Report escherichia coli such as White reach 69% to the general resistant rate of ceftiofur; Report escherichia coli such as Sarah C.Donaldson reach 88.5% to the resistant rate of ceftiofur.It is reported that it is to produce beta-lactamase that antibacterial produces chemical sproof mechanism to cephalosporins, therefore, the research and development of new drug and drug resistance enzyme inhibitor are the effective ways that reduces bacterial resistance, minimizing drug residue, improves drug effect.
Sulbactam (sulbactam) is the irreversible wide spectrum beta-lactamase inhibitor of a kind of competitiveness, can suppress the common clinically plasmid and the beta-lactamase of chromosome mediation, existing studies show that sulbactam and the compound use of cephalosporins medicine can be brought into play but the enzyme potentiation, reduce antibacterial cephalosporins is produced drug resistance, the cephalo antibiotics is had obvious synergistic effect.
At present, more to the research of cefoperazone and sulbactam complex preparation aspect medical, its usage ratio is 1～2: 1; But aspect veterinary drug, a kind of compound ceftiofur oil suspension injection is only disclosed, but because complex process, the cost height has limited application clinically; Particularly long-term a large amount of antibiotics that uses, be easy to generate negative effect to body, cost an arm and a leg owing to ceftiofur sodium again, medical expense is increased substantially, and the popularization of animal specific medicine, price advantage is primary, therefore, research and development are applicable to the novel compound preparation of cephalo-type of animal specific, are to solve antibacterial to the antibiotic drug resistance effective way of cephalo-type.
Summary of the invention:
In order to overcome problems such as existing existing bacterial drug resistance of animal specific cephalosporins ceftiofur sodium and cost be higher, the inventor provides a kind of injection use compound ceftiofur sodium freeze-dried powder injection, both can solve the drug resistance of antibacterial to ceftiofur sodium, help again reducing cost, simultaneously, also can alleviate infringement and the endotoxin heat source response of existing medicament to animal kidney.
The main effective ingredient of the injection use compound ceftiofur sodium freeze-dried powder injection that the inventor provided is made up of ceftiofur sodium, sulbactam sodium and three kinds of medicines of flunixin meglumine.
Flunixin meglumine (Flunixin meglumine) is a U.S. Schering Plough company in one of minority non-steroidal drug for animals of the approved of the exploitation nineties in 20th century, mainly brings into play analgesic, antiinflammatory and analgesic activity by the generation that suppresses Cycloxygenase, reduces inflammatory mediators such as prostaglandin.
Add flunixin meglumine in the compound ceftiofur sodium freeze-dried powder injection of the present invention as the third effective ingredient, Synergistic function by the composite generation of three, can strengthen the antibacterial activity of ceftiofur sodium significantly, alleviate the drug resistance of antibacterial to ceftiofur sodium, simultaneously, owing to added flunixin meglumine, compound ceftiofur preparation of sodium of the present invention has been strengthened stop escherichia coli endotoxin to cause that the interior exudate of bronchus in the respiratory tract disease increases, neutrophil cell in the exudate, the accumulative function of albumin, can obviously suppress to inoculate the body temperature that endotoxin causes and the rising of PGF-A concentration, effectively alleviate organism fever, inflammation and pain.
The weight consumption of the main effective ingredient of the injection use compound ceftiofur sodium freeze-dried powder injection that the inventor provided is preferably as follows:
Ceftiofur sodium 2～4 weight portions
Sulbactam sodium 1 weight portion
Flunixin meglumine 1 weight portion
Choose active ingredient raw materials by above-mentioned weight proportion, in case of necessity, add conventional pharmaceutic adjuvant, be mixed with mixed solution, adopt vacuum freeze-drying method, can make injection use compound ceftiofur sodium freeze-dried powder injection of the present invention with sterilized water.
Injection use compound ceftiofur sodium freeze-dried powder injection has a broad antifungal spectrum of the present invention, antibacterial activity is strong, administration number of times is few, stress be little, ill effect is slight; Thereby and can suppress the body generation and discharge inflammatory mediator effectively to block endotoxic negative interaction.
The present invention adopts vacuum freeze-drying method to prepare injection use compound ceftiofur sodium freeze dry, and technology is simple, and products obtained therefrom stability is high, safe in utilization, convenient.
The specific embodiment:
Embodiment 1.
Temperature control is at 10 ± 5 ℃, 1 weight portion sulbactam sodium and 1 weight portion flunixin meglumine are joined in the sterile chamber, add to the full amount of water for injection 85%, open vacuum (making slightly negative pressure of system), stir and make dissolving, then 2 weight portion ceftiofur sodiums are joined above-mentioned solution, open vacuum, stir and make dissolving, adjusting pH value is 4.5～6.5, add water for injection to full dose, stir.
The content of sampling and measuring pH value and ceftiofur sodium, sulbactam sodium, flunixin meglumine after index to be detected is qualified, filters with 0.45 μ m cellulose filter membrane earlier, and reuse 0.22 μ m cellulose filter membrane filters, and removes impurity.
Filtrate filtered is sub-packed in the pipe-produced glass bottle, presses half plug, vacuum lyophilization makes compound ceftiofur sodium freeze-dried powder injection of the present invention.
Embodiment 2.
Temperature control is at 10 ± 5 ℃, 4 weight portion ceftiofur sodiums are joined in the sterile chamber, add to the full amount of water for injection 85%, open vacuum, stir and make dissolving, then 1 weight portion sulbactam sodium and 1 weight portion flunixin meglumine are joined above-mentioned solution, open vacuum, stir and make dissolving, adjusting pH value is 4.5～6.5, add water for injection to full dose, stir.
The content of sampling and measuring pH value and ceftiofur sodium, sulbactam sodium, flunixin meglumine after index to be detected is qualified, filters with 0.45 μ m cellulose filter membrane earlier, and reuse 0.22 μ m cellulose filter membrane filters, and removes impurity.
Filtrate filtered is sub-packed in the pipe-produced glass bottle, presses half plug, vacuum lyophilization obtains compound ceftiofur sodium of the present invention/sulbactam sodium freeze-dried powder.
Above-mentioned concrete freeze-dry process can be with reference to related art.
The vitro inhibition coli test shows, ceftiofur sodium in the foregoing description 2: sulbactam sodium: ceftiofur sodium among flunixin meglumine=4: 1: 1 and the embodiment 1: sulbactam sodium: the bacteriostasis of two kinds of prescriptions of flunixin meglumine=2: 1: 1 is basic identical, all than spore ceftiofur sodium: the bacteriostasis of sulbactam sodium=2: 1 is enhanced about more than once, wherein, the consumption of ceftiofur sodium is higher than 4 parts or be lower than 2 parts, bacteriostasis all can descend, the prescription of embodiment 2, cost is lower, the prescription of embodiment 1, it is better to block endotoxic effect.
Contrast test to the escherichia coli antibacterial activity
Annotate: this is tested selected strain and all is selected from the clinical isolating fastbacteria of large-scale cultivation factory.
Prove that through experiment in vitro compound preparation of the present invention is stronger than the antibacterial activity of ceftiofur sodium/sulbactam sodium composition.
The clinical trial result of compound ceftiofur sodium/sulbactam sodium/flunixin meglumine:
(1) piglet is 300, is used for the treatment of the piglet diarrhea that escherichia coli cause, presses the intramuscular injection of 3mg/kg body weight every day, and logotype 3-5 days, cure rate reached 97.3%.
(2) pig is 560, is used for the treatment of the pig pleuropneumonia that Actinobacillus causes, presses the intramuscular injection of 3mg/kg body weight every day, and logotype 3-5 days, cure rate reached 94.5%.
(3) sheep is 300, is used for the treatment of the Pulmonis caprae seu ovis inflammation that pasteurella haemolytica and pasteurella multocida cause, presses the intramuscular injection of 2-3mg/kg body weight every day, and logotype 3-5 day, cure rate reaches 97%.
Claims (6)
1. injection use compound ceftiofur sodium freeze-dried powder injection is characterized in that main effective ingredient is made up of ceftiofur sodium, sulbactam sodium and flunixin meglumine.
2. injection use compound ceftiofur sodium freeze-dried powder injection as claimed in claim 1 is characterized in that the weight consumption of main effective ingredient is as follows:
Ceftiofur sodium 2～4 weight portions
Sulbactam sodium 1 weight portion
Flunixin meglumine 1 weight portion.
3. injection use compound ceftiofur sodium freeze-dried powder injection as claimed in claim 1 or 2 is characterized in that the weight consumption of main effective ingredient is as follows:
Ceftiofur sodium 2 weight portions
Sulbactam sodium 1 weight portion
Flunixin meglumine 1 weight portion.
4. injection use compound ceftiofur sodium freeze-dried powder injection as claimed in claim 1 or 2 is characterized in that the weight consumption of main effective ingredient is as follows:
Ceftiofur sodium 4 weight portions
Sulbactam sodium 1 weight portion
Flunixin meglumine 1 weight portion.
5. as claim 1 or 3 described injection use compound ceftiofur sodium freeze-dried powder injections, it is characterized in that concrete preparation method is as follows:
Temperature control is at 10 ± 5 ℃, 1 weight portion sulbactam sodium and 1 weight portion flunixin meglumine are joined in the sterile chamber, add to the full amount of water for injection 85%, open vacuum stirring and make dissolving, then 2 weight portion ceftiofur sodiums are joined above-mentioned solution, open vacuum, stirring makes dissolving, adjusting pH value is 4.5～6.5, adds water for injection to full dose, stirs;
The content of sampling and measuring pH value and ceftiofur sodium, sulbactam sodium, flunixin meglumine after index to be detected is qualified, filters with 0.45 μ m cellulose filter membrane earlier, and reuse 0.22 μ m cellulose filter membrane filters, and removes impurity;
Filtrate filtered is sub-packed in the pipe-produced glass bottle, presses half plug, vacuum lyophilization makes the compound ceftiofur sodium freeze-dried powder injection.
6. as claim 1 or 4 described injection use compound ceftiofur sodium freeze-dried powder injections, it is characterized in that concrete preparation method is as follows:
Temperature control is at 10 ± 5 ℃, 4 weight portion ceftiofur sodiums are joined in the sterile chamber, add to the full amount of water for injection 85%, open vacuum, stir and make dissolving, then 1 weight portion sulbactam sodium and 1 weight portion flunixin meglumine are joined above-mentioned solution, open vacuum, stir and make dissolving, adjusting pH value is 4.5～6.5, add water for injection to full dose, stir;
The content of sampling and measuring pH value and ceftiofur sodium, sulbactam sodium, flunixin meglumine after index to be detected is qualified, filters with 0.45 μ m cellulose filter membrane earlier, and reuse 0.22 μ m cellulose filter membrane filters, and removes impurity;
Filtrate filtered is sub-packed in the pipe-produced glass bottle, presses half plug, vacuum lyophilization obtains compound ceftiofur sodium of the present invention/sulbactam sodium freeze-dried powder.
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200910256114 CN102106857B (en) | 2009-12-29 | 2009-12-29 | Compound ceftiofur sodium freeze-dried power injection used for injection |
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| CN 200910256114 CN102106857B (en) | 2009-12-29 | 2009-12-29 | Compound ceftiofur sodium freeze-dried power injection used for injection |
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| CN102106857A true CN102106857A (en) | 2011-06-29 |
| CN102106857B CN102106857B (en) | 2012-07-18 |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102319219A (en) * | 2011-09-30 | 2012-01-18 | 四川金瑞克动物药业有限公司 | Chitosan nanoparticle preparation of ceftiofur sodium, and preparation method thereof |
| US20140094447A1 (en) * | 2011-07-26 | 2014-04-03 | Sachin Subhash Bhagwat | Pharmaceutical compositions comprising sulbactam and beta-lactamase inhibitor |
| CN104352501A (en) * | 2014-11-10 | 2015-02-18 | 重庆泰通动物药业有限公司 | Compound ceftiofur sodium injection |
| CN104586777A (en) * | 2014-12-22 | 2015-05-06 | 广东省天宝生物制药有限公司 | Ceftiofur hydrochloride powder injection as well as preparation method and application thereof |
| CN106491537A (en) * | 2016-12-02 | 2017-03-15 | 瑞阳制药有限公司 | Injectable sterile powder comprising Ceftaroline Fosamil and preparation method thereof |
| CN108815168A (en) * | 2018-04-12 | 2018-11-16 | 浙江大学 | Nano-emulsion preparation of bacterial-infection resisting and its preparation method and application |
-
2009
- 2009-12-29 CN CN 200910256114 patent/CN102106857B/en active Active
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20140094447A1 (en) * | 2011-07-26 | 2014-04-03 | Sachin Subhash Bhagwat | Pharmaceutical compositions comprising sulbactam and beta-lactamase inhibitor |
| US9744160B2 (en) * | 2011-07-26 | 2017-08-29 | Wockhardt Limited | Pharmaceutical compositions comprising sulbactam and beta-lactamase inhibitor |
| CN102319219A (en) * | 2011-09-30 | 2012-01-18 | 四川金瑞克动物药业有限公司 | Chitosan nanoparticle preparation of ceftiofur sodium, and preparation method thereof |
| CN104352501A (en) * | 2014-11-10 | 2015-02-18 | 重庆泰通动物药业有限公司 | Compound ceftiofur sodium injection |
| CN104586777A (en) * | 2014-12-22 | 2015-05-06 | 广东省天宝生物制药有限公司 | Ceftiofur hydrochloride powder injection as well as preparation method and application thereof |
| CN104586777B (en) * | 2014-12-22 | 2017-07-21 | 广东省天宝生物制药有限公司 | Ceftiofur Hydrochloride powder-injection and preparation method and application |
| CN106491537A (en) * | 2016-12-02 | 2017-03-15 | 瑞阳制药有限公司 | Injectable sterile powder comprising Ceftaroline Fosamil and preparation method thereof |
| CN108815168A (en) * | 2018-04-12 | 2018-11-16 | 浙江大学 | Nano-emulsion preparation of bacterial-infection resisting and its preparation method and application |
| CN108815168B (en) * | 2018-04-12 | 2021-02-12 | 浙江大学 | Nano-emulsion preparation for resisting bacterial infection and preparation method and application thereof |
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| CN102106857B (en) | 2012-07-18 |
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