CN1965834A - Enrofolxacn solution containing clustered water used for animal - Google Patents
Enrofolxacn solution containing clustered water used for animal Download PDFInfo
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- CN1965834A CN1965834A CN 200510016147 CN200510016147A CN1965834A CN 1965834 A CN1965834 A CN 1965834A CN 200510016147 CN200510016147 CN 200510016147 CN 200510016147 A CN200510016147 A CN 200510016147A CN 1965834 A CN1965834 A CN 1965834A
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- enrofloxacin
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Abstract
The invention relates to a method for using Nenosulfonic to prepare wide-spectrum antibiosis solution, wherein it uses hexacyclic ring water as carrier that adds frozen hexacyclic ring water into Nenosulfonic solution, to reduce the volume of hydrone group, the viscosity and surface tension, to reduce the expand resistance and accelerate the drug release. The hexacyclic ring water has strong affinity with cell, to improve the treatment effect on animal bacterial and mycoplasma affection.
Description
Technical field
The invention belongs to the technical field of veterinary drug, relating to the enrofloxacin is a kind of broad spectrum antibiotic of feedstock production, is used for the animal medicament and the method for making thereof of poultry antibacterial and mycoplasma infection.
Background technology
Water is most important composition in all biologies, and the general water content of organism is all more than 60%; Except that dry products, water content is all between 65%-90% in the food; We can say that water plays important effect in our life.Water has many special nature, causes people's attention in recent years.For example: introduced the water with six water clusters structures in magazine " Jiangxi chemical industry " fourth phase in 1997 the 34th page " water of the water mystery of life ", promptly so-called " clustered water " has sanatory function.
University Of Tianjin's journal the 33rd the 1st phase of volume of January in 2000 " six ring structures of water and to the influence of lysozyme thermal denaturation " that record is by theory analysis and experimental results show that six ring structures and the biological function thereof of water.Studies show that, water through low temperature is ultrasonic decide frequency spectrum and shake after, great majority are six rings and the existence of six cage type water clusters, this water plays an important role in bioprotein, nucleic acid, cell and organization activity; When the DSC method experiment showed, with clustered water hydration lysozyme, improved its hot antitypy ability.
" change of water clusters clustering architecture and biological effect thereof " that the chemistry circular fourth phase in 2004 is recorded summarized over nearly 30 years from the rock-steady structure that is found to water cluster of water clusters clustering architecture and the progress of correlation theory calculating; Four kinds of methods that change the water clusters clustering architecture have been summed up, comprise externally-applied magnetic field, extra electric field, laser emission and snead process, the mechanism of action of these four kinds of methods has been discussed respectively, after having introduced the water clusters clustering architecture and diminishing, act on organism, can produce multiple biological effect, aspect much, can improve the physiological function of organism.
Scientific research shows that water clusters is more little, and activity is big more, and this water drinks good more drinking, and vice versa.Many when experiment showed, the structure that changes water the physiological reaction to biology very big influence is arranged; Water with subset structure of five hydrones or six hydrones, promptly five rings water and clustered water have good facilitation to health.In the preparation technology of veterinary oral liquid, pure water is the most frequently used solvent at present, after soon tap water carries out certain water treatment, is used as the solvent of medicine.Yet scientific research shows, uses light water in the process that medicine is made, because the structure of hydrone can not be brought into play bioavailability of medicament to greatest extent.Yet clustered water can keep the stability of long period, for cell very strong affinity is arranged, and can significantly improve the curative effect of medicine, for the recovery of disease facilitation is faster arranged.
Water is a kind of special material, and it has a lot of functions.At first it is a kind of good solvent, and it contains O
2, CO
2Deng material, has different pH values.Therefore, can dissolve a lot of mineral, for human body is carried nutrition; Water body is again one " chemical fields ", wherein can carry out chemical reaction such as acid-base reaction, the redox reaction etc. of various complexity, simultaneously, can also dissolve, chemical action such as precipitation, decomposition, chemical combination, peptization, in the preparation technology of veterinary oral liquid, pure water is the most frequently used solvent.After soon tap water will carry out certain water treatment, as the solvent of medicine.In the process that medicine is made, use light water,, bioavailability of medicament can not be brought into play to greatest extent owing to reasons such as the structure of hydrone and arrangements thereof.
Known enrofloxacin chemical name is 1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-7-(4-ethyl-1-piperazinyl)-3-quinoline carboxylic acid, and molecular formula is C
19H
22FN
3O
3, molecular weight is 359.4, chemical constitution is seen figure.This medicine is little yellow or off-white color crystalline powder, odorless, and mildly bitter flavor is soluble in the alkaline solution, and slightly soluble in water, methanol is insoluble in ethanol; Meeting light fades to orange red.Structural formula is:
The mechanism of action of enrofloxacin has been for to have introduced fluorine atom on 6 of quinolinones structure, thereby strengthened the affinity of medicine and antibacterial target position, and enlarged antimicrobial spectrum, and the cyclopropyl on 1 can promote the tissue permeability of medicine.Enrofloxacin metabolism in animal body is that ciprofloxacin is brought into play antibacterial activity, identical with the antibiotic mechanism of other Du-6859as, enrofloxacin is that the distrand DNA distortion of target bacteria becomes loop shape or helical form (being called superhelix) with DNA (deoxyribonucleic acid) (DNA) enzyme of antibacterial, makes DNA form supercoiled enzyme and is called the DNA gyrase.Medicine suppresses the cutting and the linkage function of this enzyme by combining with DNA of bacteria gyrase subunit A, and chromosome is caused irreversible lesion, stops bacterial cell division and brings into play antibacterial action.Simultaneously, it has the penetration of height and destroys the after birth of antibacterial bacteria cell wall.Therefore, enrofloxacin is to reach bacteriolyze, germ-resistant purpose by dual antibacterial action.The curative effect of disease that a large amount of experiment confirm enrofloxacins cause antibacterial, mycoplasma etc. generally is better than ciprofloxacin, norfloxacin and other similar antibiotics.Enrofloxacin has fine solubility in water, it is a broad spectrum antibiotic, and anti-mycoplasma effectiveness is stronger than tylosin, colistin sulfate.Be mainly used in calf escherichia coli, Salmonella typhimurium infection, pig Hakuri, yellow scour of piglet, bowel oedema disease and the various mycoplasma infections of poultry.Usage and dosage: for oral administration, once measure every 1kg body weight, dog, cat 2.5-5mg, fowl 5-7.5mg, 2 times on the one, logotype 3-5 days.
The product of at present relevant enrofloxacin mainly contains enrofloxacin solution, is with enrofloxacin and the formulated solution of suitable solvent, contains enrofloxacin (C
19H
22FN
3O
3) be 90.0%～110.0% of labelled amount, character is odorless, little yellow clear liquid.
The discrimination method of this medicine is:
(1) it is an amount of to get this product, adds rare nitric acid acidify, adjusts solution pH value to 6.5～9.0, and promptly the adularescent precipitation is separated out.
(2) it is an amount of to get this product, adds bismuth potassium iodide test solution number droplet, promptly generates the salmon pink precipitation.
(3) get need testing solution under the assay item, according to spectrophotography (17 pages of appendix of " People's Republic of China's veterinary drug allusion quotation " version in 2000), 271 ± 2,322 ± 2, there is absorption maximum at 334 ± 2nm place.
PH value should be 10.5～12.0 (40 pages of appendix of " People's Republic of China's veterinary drug allusion quotation " version in 2000)
Content assaying method is as follows: be taken at 105 ℃ of enrofloxacin reference substance 25mg that are dried to constant weight, the accurate title, decide, put in the 500ml measuring bottle, and hydro-oxidation sodium solution (0.1mol/l) 10ml, jolting makes dissolving, is diluted with water to scale, shakes up; Precision is measured 10ml, puts in the 100ml measuring bottle, is diluted with water to scale, shakes up, promptly.
The preparation of need testing solution: precision is measured this product an amount of (being equivalent to enrofloxacin 25mg approximately), adds water and makes the solution that contains enrofloxacin 5ug among every 1ml approximately, shakes up, promptly.
Algoscopy: draw above-mentioned two kinds of solution,, measure trap respectively,, calculate, promptly according to the two absorbance ratio at the wavelength place of 271nm according to spectrophotography (17 pages of appendix of " People's Republic of China's veterinary drug allusion quotation " version in 2000).
Enrofloxacin solution manufacturing method: wash bottle: at first the 12-15ml cillin bottle is slightly washed, fine purifiation, 100 ℃ of oven dry 30 minutes are cooled off stand-by.
1, enrofloxacin 25g being added an amount of purified water makes it abundant dilution, stirs.
2, add 40% sodium hydroxide solution 10-40ml, make it dissolving.
3, the filling purified water is reconciled PH to 9.5-10.5 to full dose 1000ml.
4, add EDTA-2Na 0.5-1.5g again, stir.
5, with 120 ℃ of autoclave cabinet sterilizations, 30 minutes, intermediate is filling-in and closing bottle by applying cap after the assay was approved.
Above-described enrofloxacin solution existing preparation technology and the detection method of being exists problems such as rate of release is slow, blood medicine peak concentration life period weak point, bioavailability difference but have enrofloxacin solution now.
Summary of the invention
The object of the present invention is to provide a kind of enrofloxacin solution veterinary formulations that rate of release is fast, blood medicine peak concentration time is long, bioavailability is high that has with the clustered water preparation.
In order to achieve the above object, the invention provides a kind of poultry antibacterials, comprise: clustered water is characterized in that with the clustered water be carrier with slightly soluble or the antibacterials that are dissolved in clustered water being active component, preparation poultry antibacterials.
Described poultry antibacterials comprise: clustered water, enrofloxacin (chemical name is 1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-7-(4-ethyl-1-piperazinyl)-3-quinoline carboxylic acid, and molecular formula is C
19H
22FN
3O
3, molecular weight is 359.4.)
Chemical structural formula is:
It is characterized in that with the clustered water being preparing carriers enrofloxacin solution.
Described enrofloxacin solution is characterized in that:
A, select for use the water (being pure water) of purification as former water, general commercially available qualified pure water, electrical conductivity gets final product less than 20 μ s/cm, leaves standstill after a few hours slowly freezingly, and rate of temperature fall is 2-5 ℃/h, freezing minimum temperature reaches-30～-50 ℃, make the water sufficient crystallising, then thaw again, its course of defrosting is carried out being lower than under 10 ℃, the water that dissolves is in time collected in the temperature environment that is stored in 4-10 ℃, promptly obtains clustered water;
B, enrofloxacin 25g is added an amount of clustered water make it abundant dilution, stir;
C, adding 40% sodium hydroxide solution 10-40ml make it dissolving.
D, filling clustered water are reconciled PH to 9.5-10.5 to full dose 1000ml;
E, add people EDTA-2Na 0.5-1.5g again, stir;
F, with 120 ℃ of autoclave cabinet sterilizations, 30 minutes, intermediate is filling-in and closing bottle by applying cap after the assay was approved, promptly obtained containing the enrofloxacin solution of clustered water.
G, lamp inspection, chemical examination, labeling, the packing warehouse-in.After one month low temperature (4 ℃) storage, the analytical test result shows that the structure of solution do not have significant change.
Below with description of test therapeutic effect of the present invention:
1 materials and methods
Test drug: the experiment medicine is the enrofloxacin solution with the clustered water preparation, and control drug is the enrofloxacin solution of light water preparation
Experimental animal: 140 of parts in Beijing opera spoken in Beijing dialect chickling (anti-mycoplasma gallisepticum negative antibody), available from the big fowl industry in Tianjin side Development Co., Ltd.Test chicken is equally divided into 4 groups at random, raises routinely before the test, feed complete feed, do not contain any antibacterials, free choice feeding and drinking-water, and carry out clinical observation, when 35 ages in days, be used for test.
Manual-induced chronic respiratory disease
Mycoplasma strain: the strong toadstool kind of mycoplasma gallisepticum PG
31, provide by China Veterinary Drugs Supervisory Inst..During use bacterial classification inoculation is digested in the soup, in 50mL/L CO in Cor Bovis seu Bubali
2Condition is cultivated 7d for following 37 ℃, with common bacteria counting method counting bacterium number, is diluted to the suspension that every 1mL contains viable bacteria 2.0 hundred million.Inoculum concentration and route of inoculation: through toxicity test, determine that to the chicken inoculation amount be 0.5mL/, contain 1.0 hundred million of viable bacterias, route of inoculation is a collunarium, oral.
The clinicing symptom observation of chicken before and after the inoculation: the mental status of main viewing test chicken, food are drunk desire, feces character, are breathed performance etc.Dead chicken is carried out necropsy, get nose, tracheal secretion and tissues such as lung, air bag and carry out the mycoplasma gallisepticum separation and Culture.Adopt not dead Sanguis Gallus domesticus separation of serum, detect anti-mycoplasma gallisepticum antibody with plate agglutination test.
Therapeutic trial: inoculation is after clinical symptoms appears in chicken, and to the administration of the 1st～4 group of chicken drinking-water, 5d observes 30d continuously, and the clinical manifestation and morbidity, death condition of chicken respectively organized in record, and dead chicken is cooked the mycoplasma gallisepticum separation and Culture with definite cause of death.
Curative effect of medication evaluation index: in the inspection, transfer positive person to the anti-mycoplasma gallisepticum antibody of not dead chicken serum artificial challenge's success is described.Curative effect of medication is represented with protective rate; allly the clinical symptoms of chronic respiratory tract disease occurs and the part chicken death is arranged at duration of test; necropsy has the pathological changes of comparative feature, and the Mycoplasma that is judged to that is separated to mycoplasma gallisepticum PG31 from tissues such as nose, tracheal secretion and lung and air bag infects dead.
2 results
The clinical symptoms of test chicken and pathological changes: 4d begins to show spiritual depressed behind the test chicken inoculation mycoplasma gallisepticum, inappetence, tangible respiratory symptom appears in 5d, as cough, sneeze, stream nose liquid etc., the severe patient dyspnea, gets rid of head, breathes rale and increase the weight of at sick chicken mouth breathing.The sick clavus that has is moistening, shed tears, and later stage indivedual clavus eyelid swelling has mucus or purulent secretion.Dead chicken nasal sinuses myxedema, hyperemia, plumpness.The hole intracavity is filled with mucus or cheesy exudate, and mucus shape material is arranged in trachea and the larynx, and tunica mucosa tracheae thickens.Tangible catarrhal inflammation is arranged in lung and air bag, the bronchus, torso bag Lycoperdon polymorphum Vitt muddiness, plumpness, air bag contains muddy slightly thickness exudate or caseous substance, and the chicken saccus abdominalis that has also has same pathological changes.
Mycoplasma separation and Culture result in the dead fowl disease material: from each organizes the materials such as nasal discharge, air bag of dead chicken, all be separated to mycoplasma gallisepticum.
Anti-mycoplasma gallisepticum antibody test result in the not dead chicken serum: all do not detect anti-mycoplasma gallisepticum antibody the serum of dead chicken from each group.
Each protective rate of organizing chicken sees Table 1
Clustered water enrofloxacin solution is to the therapeutic effect of chronic respiratory disease
| Group and medicine | Inoculum concentration (hundred million/only) | Drug level (ml medicine/L water) | Test chicken (only) | Dead chicken (only) | Protective rate (%) |
| Enrofloxacin clustered water group | 1.0 | 45 | 35 | 5 | 85 |
| Enrofloxacin light water group | 1.0 | 45 | 35 | 10 | 66.7 |
| Positive control | 1.0 | 0 | 35 | 22 | 26.7 |
| Negative control | 0 | 0 | 35 | 0 | 100 |
As can be seen from the above table, under the identical situation of drug level, the enrofloxacin solution that the protective rate of the enrofloxacin solution made from clustered water is made apparently higher than light water has curative effect preferably to chronic respiratory disease.
Invention effect: under other condition same case, contain purified water enrofloxacin solution and compare with existing, in the clustered water filling enrofloxacin solution with cryopreparation, the smaller volume of water cluster, the viscosity of corresponding water, surface tension etc. descend to some extent, the enrofloxacin diffusional resistance is reduced, promote drug release, enrofloxacin solution drug release rate and burst size all increase.Clustered water has very strong affinity for cell, and bioavailability is good, is used for poultry antibacterial and mycoplasma infection, can significantly improve the curative effect of medicine, for the recovery of disease facilitation is faster arranged.
The specific embodiment
Embodiment 1:1, wash bottle: at first the 12-15ml cillin bottle is slightly washed, fine purifiation, 100 ℃ of oven dry 30 minutes are cooled off stand-by.
2, select for use the water (being pure water) of purification as former water, general commercially available qualified pure water (electrical conductivity is less than 20 μ s/cm) gets final product, leave standstill after a few hours slowly freezing, rate of temperature fall is 2-5 ℃/h, and freezing minimum temperature reaches-30～-50 ℃, makes the water sufficient crystallising, then thaw again, its course of defrosting is carried out being lower than under 10 ℃ the condition, and the water that dissolves is in time collected in the temperature environment that is stored in 4-10 ℃, promptly obtains clustered water.
3, enrofloxacin 25g being added an amount of clustered water of people makes it abundant dilution, stirs.
4, add 40% sodium hydroxide solution 10-40ml, make it dissolving.
5, the filling clustered water is reconciled PH to 9.5-10.5 to full dose 1000ml.
6, add people EDTA-2Na0.5-1.5g again, stir.
7, with 120 ℃ of autoclave cabinet sterilizations, 30 minutes, intermediate is filling-in and closing bottle by applying cap after the assay was approved, promptly obtained containing the enrofloxacin solution of clustered water.
8, lamp inspection, chemical examination, labeling, the packing warehouse-in.After one month low temperature (4 ℃) storage, the analytical test result shows that the structure of solution do not have significant change.
This method technology is simple, is easy to realize.
Embodiment 2: medicine of the present invention can be used for treating calf escherichia coli, Salmonella typhimurium infection, pig Hakuri, yellow scour of piglet, bowel oedema disease and the various mycoplasma infections of poultry.Using method adds 1 milliliter of medicine of the present invention for mixing drink in every premium on currency, logotype 3-5 days is a course of treatment.
Claims (3)
1, a kind of poultry antibacterials comprise: clustered water is characterized in that with the clustered water be carrier with slightly soluble or the antibacterials that are dissolved in clustered water being that active component prepares the poultry antibacterials.
2, poultry antibacterials according to claim 1 comprise: clustered water, enrofloxacin (chemical name is 1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-7-(4-ethyl-1-piperazinyl)-3-quinoline carboxylic acid, and molecular formula is C
19H
22FN
3O
3, molecular weight is 359.4), chemical structural formula is:
It is characterized in that with the clustered water being preparing carriers enrofloxacin solution.
3, enrofloxacin solution according to claim 2 is characterized in that:
A, select the water of purification for use, be pure water as former water, general commercially available qualified pure water, electrical conductivity gets final product less than 20 μ s/cm, leave standstill after a few hours slowly freezing, rate of temperature fall is 2-5 ℃/h, and freezing minimum temperature reaches-30～-50 ℃, makes the water sufficient crystallising, then thaw again, its course of defrosting is carried out being lower than under 10 ℃ the condition, and the water that dissolves is in time collected in the temperature environment that is stored in 4-10 ℃, promptly obtains clustered water;
B, enrofloxacin 25g is added an amount of clustered water of people make it abundant dilution, stir;
C, adding 40% sodium hydroxide solution 10-40ml make it dissolving;
D, filling clustered water are reconciled PH to 9.5-10.5 to full dose 1000ml;
E, add people EDTA-2Na0.5-1.5g again, stir;
F, with autoclave cabinet sterilization 120 ℃, 30 minutes, intermediate is filling-in and closing bottle by applying cap after the assay was approved, promptly obtains containing the enrofloxacin solution of clustered water.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510016147 CN1965834B (en) | 2005-11-18 | 2005-11-18 | Enrofolxacn solution containing clustered water used for animal |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510016147 CN1965834B (en) | 2005-11-18 | 2005-11-18 | Enrofolxacn solution containing clustered water used for animal |
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| CN1965834A true CN1965834A (en) | 2007-05-23 |
| CN1965834B CN1965834B (en) | 2012-01-25 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101933928A (en) * | 2010-08-27 | 2011-01-05 | 济南百鸣生物制药有限公司 | Method for preparing medicament for treating chicken colibacillosis |
| CN113304507A (en) * | 2021-06-03 | 2021-08-27 | 黄铭 | The separation of the molecular clusters in the solution realizes the enrichment and separation of different substances |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1102536C (en) * | 1998-10-14 | 2003-03-05 | 天津大学 | Preparation method and equipment of liuhuan function water |
| CN1288725A (en) * | 2000-06-30 | 2001-03-28 | 程广亚 | Preparation of serial veterinary injecta products |
-
2005
- 2005-11-18 CN CN 200510016147 patent/CN1965834B/en active Active
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101933928A (en) * | 2010-08-27 | 2011-01-05 | 济南百鸣生物制药有限公司 | Method for preparing medicament for treating chicken colibacillosis |
| CN113304507A (en) * | 2021-06-03 | 2021-08-27 | 黄铭 | The separation of the molecular clusters in the solution realizes the enrichment and separation of different substances |
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| Publication number | Publication date |
|---|---|
| CN1965834B (en) | 2012-01-25 |
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