CN101874774A - Suspension composition containing lysozyme and florfenicol and preparation method thereof - Google Patents
Suspension composition containing lysozyme and florfenicol and preparation method thereof Download PDFInfo
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- CN101874774A CN101874774A CN200910068698XA CN200910068698A CN101874774A CN 101874774 A CN101874774 A CN 101874774A CN 200910068698X A CN200910068698X A CN 200910068698XA CN 200910068698 A CN200910068698 A CN 200910068698A CN 101874774 A CN101874774 A CN 101874774A
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Abstract
The invention relates to a suspension composition containing lysozyme and florfenicol, which is a microemulsion solution prepared from the lysozyme, the florfenicol, tween-80, sodium citrate, methylparaben, propylene glycol and water for injection. The composition adopts compatibility of the lysozyme and the florfenicol, not only enlarges the antimicrobial spectrum, but also has high efficiency, low toxicity, less residues and drug resistance prevention; and the prepared suspension not only can solve the problem that the florfenicol is hardly soluble in water, improves the biological utilization of the florfenicol, but also protects the activity of the lysozyme in gastrointestinal fluid, and plays a slow release effect on the lysozyme and the florfenicol to ensure that the medicament maintains long-term effective blood concentration in vivo, is integrated with instant effect, high efficiency and long action, and can be used for treating mycoplasma gallisepticum infections of livestock and poultry.
Description
Technical field
The invention belongs to technical field of pharmaceuticals, particularly a kind of suspension composition that contains lysozyme and florfenicol and preparation method thereof.
Background technology
Lysozyme is the general name with class of enzymes of dissolution of bacteria cell wall, its antibacterial action is by-acetylmuramic acid in the destruction cell wall and the β-1 between the N-n acetylglucosamine n, 4 glycosidic bonds, make the insoluble mucopolysaccharide of cell wall resolve into the solubility glycopeptide, cause the effusion of cell wall rupture content and make bacterolysis.Lysozyme can also combine with the various acidic materials that bring out inflammation, makes its inactivation.Lysozyme is used for various antibacterials and the viral infection that causes, the treatment and the prevention of inflammation clinically, and prevents and treats chronic respiratory, chronic bronchitis, also can be used to comprise nonspecific defence infection immunity reaction.The lysozyme antivirus action is by directly combining with electronegative virus protein, form double salt with DNA, RNA, apoprotein, making virally inactivated.Discover that lysozyme not only has stronger killing action to gram positive bacteria, and have good antiviral activity.Lysozyme has good safety and anti-drug resistance as a kind of natural protein, especially at present because the drug resistance problem that the antibiotic abuse grows in intensity makes lysozyme that very big advantage be arranged in clinical practice.But lysozyme is as a kind of protein medicaments, and same the existence is subjected to degrade the easily problem of inactivation of gastric acid, makes oral medication produce little effect, and therefore is badly in need of the new oral formulations of exploitation.
Florfenicol has advantages such as has a broad antifungal spectrum, antibacterial activity is strong, absorption is good, and relatively safe.The florfenicol preparation that existing market is sold is mainly powder, pre-mixing agent, solution and injection.Solution and injection are having its unique distinction aspect the serious bacterial infection of treatment, but because florfenicol is insoluble in water, to add a large amount of organic solvents in the preparation and make its dissolving, therefore the expense on preparation is higher, produce complicated, online production employee's health is had problems such as its hazardness, and the medication animal is had distress reaction and zest.Though and administration inconvenience when powder and pre-mixing agent prophylactic, be difficult for molten water, by problem such as mixed feeding drug treatment effect is relatively poor.Therefore the suspension composition of developing florfenicol has practical significance, and the antibacterial range of said composition is wide, applied range, and production technology is simple, and cost is low, characteristics such as drug safety.
Summary of the invention
The purpose of this invention is to provide a kind of suspensoid that contains lysozyme and florfenicol.
A kind of suspensoid that contains the suspensoid of lysozyme and florfenicol is characterized in that: main component is made up of florfenicol and lysozyme.
A kind of compositions that contains the suspensoid of lysozyme and florfenicol is characterized in that main component is made up of following proportioning: lysozyme 1-15; Florfenicol 1-30 part.
Wherein be preferable over: 7.5 parts of lysozyme, 15 parts of florfenicols
Another object of the present invention provides a kind of preparation method that contains the suspensoid of lysozyme and florfenicol, comprises the steps:
Lysozyme 1-15; Florfenicol 1-30 part; Tween 80 2-10 part; Sodium citrate 1-8 part; Methyl hydroxybenzoate 0.1-1.0 part; Propylene glycol 5-20 part; Water for injection 90-100 part, and the mass ratio of lysozyme and florfenicol is 1: 5-5: 10.
1. take by weighing lysozyme 1-15 and florfenicol 1-30 part is put into an amount of water for injection, add tween 80 2-10 part, stir.
2. add sodium citrate 1-8 part, stir.
3. add methyl hydroxybenzoate 0.1-1.0 part, stir.
4. add propylene glycol 5-20 part, stir.
5. last, be settled to 100 parts with water for injection, be stirred well to evenly, under 30-100Mpa pressure, carry out homogenizing promptly for twice.
During stirring, the stirrer rotating speed is 1000-2000rpm, and the time is 30-80 minute, and temperature is a room temperature, can form the suspensoid product that contains lysozyme and florfenicol of outward appearance homogeneous.
A kind of preparation method that contains the suspensoid of lysozyme and florfenicol wherein is preferable over:
7.5 parts of lysozyme, florfenicol 1-30 part; Tween 80,8 parts; Sodium citrate, 1.6 parts; Methyl hydroxybenzoate, 0.3 part; 15 parts of propylene glycol; Use water for injection standardize solution to 100 part at last
1. take by weighing 7.5 parts of lysozyme and florfenicol and put into an amount of water for injection for 15 parts, add 8 parts of tween 80s, stir.
2. add 1.6 parts of sodium citrate, stir.
3. add 0.3 part of methyl hydroxybenzoate, stir.
4. add 15 parts of propylene glycol, stir.
5. last, be settled to 100 parts with water for injection, be stirred well to evenly, under 30-100Mpa pressure, carry out homogenizing promptly for twice.
During stirring, the stirrer rotating speed is 1500rpm, and the time is 50 minutes, and temperature is a room temperature, can form the suspensoid product that contains lysozyme and florfenicol of outward appearance homogeneous.
The therapeutic effect of medicine of the present invention is described with clinical trial below:
Use this drug regimen treatment chronic respiratory disease, chronic respiratory disease claims Mycoplasma gallisepticum (Mycoplasma) to infect again, it is a kind of respiratory tract disease that causes by mycoplasma, it is characterized in that the course of disease is long, the pathological change development is slow, mainly shows as clinically to breathe toot sound, cough, rhinorrhea and airsacculitis etc.This disease is a frequently-occurring disease common in the poultry husbandry.
The specific embodiment
Come below by embodiment that the present invention will be further described, but institute's content of describing foundation of conduct qualification protection domain of the present invention not.
Embodiment one:
A kind of suspension composition and preparation method that contains lysozyme and florfenicol:
(1) take by weighing 5 parts of lysozyme, florfenicol is put into an amount of water for injection for 10 parts, adds 6 parts of tween 80s, stirs;
(2) add 1 part of sodium citrate, stir;
(3) add 0.3 part of methyl hydroxybenzoate, stir;
(4) add 10 parts of propylene glycol, stir;
(5) be settled to 100 parts with water for injection at last, be stirred well to evenly, under 30-100Mpa pressure, carry out homogenizing promptly for twice.
Rotating speed is 1500rpm, and the time is 45 minutes, and temperature is a room temperature.
Embodiment two:
A kind of suspension composition and preparation method that contains lysozyme and florfenicol:
(1) take by weighing 7.5 parts of lysozyme, florfenicol is put into an amount of water for injection for 15 parts, adds 8 parts of tween 80s, stirs;
(2) add 1.6 parts of sodium citrate, stir;
(3). add 0.3 part of methyl hydroxybenzoate, stir;
(4) add 15 parts of propylene glycol, stir;
(5) be settled to 100 parts with water for injection at last, be stirred well to evenly, under 30-100Mpa pressure, carry out homogenizing promptly for twice.
Rotating speed is 1500rpm, and the time is 60 minutes, and temperature is a room temperature.
Embodiment three:
A kind of suspension composition and preparation method that contains lysozyme and florfenicol:
(1) take by weighing 10 parts of lysozyme, florfenicol is put into an amount of water for injection for 20 parts, adds 9 parts of tween 80s, stirs;
(2) add 2 parts of sodium citrate, stir;
(3) add 0.3 part of methyl hydroxybenzoate, stir;
(4) add 18 parts of propylene glycol, stir;
(5) be settled to 100 parts with water for injection at last, be stirred well to evenly, under 30-100Mpa pressure, carry out homogenizing promptly for twice.
Rotating speed is 1500rpm, and the time is 45 minutes, and temperature is a room temperature.
Clinical experiment:
Manual-induced broiler chronic respiratory case is carried out the clinical trial of lysozyme suspension composition to chronic respiratory tract disease, and duration of test is added up mortality rate, cure rate, effective percentage and weightening finish respectively.The test concrete condition is as follows:
1. material and method
1.1 test material
1.1.1 a kind of suspension composition (embodiment two) that contains lysozyme and florfenicol of trial drug, recommended dose is to add this product 0.66g in every 1L water, freely drink, once a day, logotype 3 days; Control drug: A: lysozyme, production unit Dalian Sanyi Animal Medicine Co., Ltd., using dosage is raised for mixing drink or won ton, and recommended dose is to add this product 1g in every 1L water, once a day, logotype three days; Control drug B: florfenicol solution, herd the veterinary drug company limited in the production unit Shandong, recommended dose is to add this product 1g in every 1L water, freely drinks every day twice, logotype 3 days.
1.1.2 test strain Mycoplasma gallisepticum MG BG44T strain is available from China Veterinary Drugs Supervisory Inst..
1.1.3 300 of experimental animal 10 age in days broiler, from chicken farm, Jinghai County, Tianjin, program is carried out feeding and management routinely, feed before the test and do not contain the complete feed of antibacterials, freely drink water, it is divided into six groups at random, first group is compound recipe lysozyme suspension composition experimental group; Second group is medicine A matched group; The 3rd group is medicine B matched group; The 4th group for infecting matched group; The 5th group is normal healthy controls (not infecting) group; The 6th group is the safe dose group.
1.2 test method
1.2.1 manual-induced Mycoplasma gallisepticum Mycoplasma gallisepticum MG BG44T strain lyophilizing pipe goes down to posterity through 4 times, the growth turbidity reaches 10
9CCU/ml inoculation mycoplasma liquid.Except that normal healthy controls group and safe dose group, every left and right torso bag of chicken inoculated mycoplasma liquid 1ml, in addition with 0.5ml mycoplasma drop nose.
1.2.2 the clinical symptoms of observing every chicken respectively before and after administration and the characteristics record inoculation, as situations of change such as the mental status, appetite, breathings, the record body weight.After the test chicken inoculation mycoplasma, respectively organize clinical symptoms, the mental status of chicken, record morbidity number, cut open the dead chicken of inspection, behind the test chicken inoculation mycoplasma 7d, each group chicken mixed drink drug treatment, successive administration 3d by the sky record.Observe clinical symptoms after each medication.Write down death toll and dead chicken is carried out necropsy, observe the air bag pathological changes, to determine the cause of the death.All experimental chickens continue to observe to inoculation back 14d.
1.2.3 therapeutic evaluation standard
Mortality rate: duration of test is all Mycoplasma gallisepticum classical symptom and dead to occur, and what the necropsy air bag had a typical cytopathic feature then is judged as death.Calculate mortality rate according to death toll.
Cure rate: all at duration of test, the mental status, appetite, breathing recover normal after the chicken medication, cough, hello sound, mouth breathing no longer occur, and clinical symptoms persons such as stream nose liquid all belong to and curing.The ratio that accounts for the whole test group according to healing chicken number is calculated cure rate.
Effective percentage: after the medication, the spirit of test chicken, appetite, breathing take an evident turn for the better, body weight than medication before enhancer, be judged as effectively.Calculate effective percentage in view of the above.
Weightening finish: according to before the administration and the chicken body weight during off-test, calculate the gain in weight of every chicken, calculate the average weight gain amount of every group of test chicken then.
1.2.4 the analyzing and processing of data is carried out the significance test of data with biometrics, wherein mortality rate, cure rate and effective percentage are all used X 2 test, and the t check is adopted in difference between each group and weightening finish.
2 results
Each mortality rate, cure rate, effective percentage, average weight gain amount of organizing chicken sees Table.
Table clinical verification test efficacy result
2.1 each medication group of mortality rate is compared, compound recipe lysozyme suspension composition experimental group mortality rate is lower.Medicine A is relative higher with medicine B matched group and infection matched group mortality rate.Statistical analysis shows that the mortality rate of compound recipe lysozyme suspension composition experimental group significantly is lower than the mortality rate of matched group.
2.2 the cure rate of cure rate and effective percentage compound recipe lysozyme suspension composition experimental group is higher, all above 90%.
2.3 gain in weight is the highest with compound recipe lysozyme suspension composition experimental group.Statistical analysis, weightening finish of medication group and the poor heteropole of infection matched group remarkable (p＜0.01).
2.4 the safety testing healthy chicken is freely drunk the compound recipe lysozyme suspension composition of 11.25g/3L water concentration, logotype 3 days.During the medication, chicken essence is refreshing active, and it is normal, full-fledged to search for food, and cuts open inspection back internal organs and organizes no abnormality seen.
3 conclusions
Infect and to have excellent curative 3.1 compound recipe lysozyme suspension composition is used for the treatment of Mycoplasma gallisepticum, and cure rate, effective percentage significantly are better than matched group; Mortality rate significantly is lower than matched group.
3.2 show through safety testing (3 times of drinking-water of recommended dose were with 3 days) to healthy chicken, do not see clinical unusual performance between the operating period, healthy chicken there is not obvious influence, illustrate that this preparation is safe.
Beneficial effect of the present invention:
1, mixed suspension form has been adopted in this invention, because the particle of supensoid agent is ultra tiny, than common preparation convenient drug administration, cost is low, animal body and cells in vivo is had good permeability, the absorptivity height, low dosage just can be brought into play good drug effect, and can environmental contamination reduction. And improved the bioavilability of medicine and prolonged effective blood drug concentration holding time in vivo.
2, this invention can improve the bioavilability of medicine, farthest brings into play the antibacterial action of medicament composing prescription, and certain, permanent protection is provided. Can be used for prevention and treat the sick infection of various livestock and poultry Frustrate blood and mycoplasmas.
3. the equipment that needs in the process of producing is simple, has reduced production cost, has saved a large amount of manpower and materials, does not also produce environmental pollution, is suitable for applying in animal husbandry.
4. has good result for the treatment of to being used for the treatment of the diseases such as the sick infection of livestock and poultry Frustrate blood and mycoplasma.
Claims (5)
1. preparation that contains the suspensoid of lysozyme and florfenicol, it is characterized in that: main component is made up of florfenicol and lysozyme.
2. a kind of compositions that contains the suspensoid of lysozyme and florfenicol according to claim 1 is characterized in that main component is made up of following proportioning: lysozyme 1-15 part, florfenicol 1-30 part.
Wherein be preferable over: 7.5 parts of lysozyme, 15 parts of florfenicols.
3. a kind of preparation method that contains the suspensoid of lysozyme and florfenicol according to claim 1 and 2 comprises the steps:
Lysozyme 1-15 part, florfenicol 1-30 part; Tween 80 2-10 part; Sodium citrate 1-8 part; Methyl hydroxybenzoate 0.1-1.0 part; Propylene glycol 5-20 part; Water for injection 90-100 part.
(1) take by weighing lysozyme 1-15 part, florfenicol 1-30 part is put into an amount of water for injection, adds tween 80 2-10 part, stir.
(2) add sodium citrate 1-8 part, stir.
(3) add methyl hydroxybenzoate 0.1-1.0 part, stir.
(4) add propylene glycol 5-20 part, stir.
(5) last, add injection water 90-100 part, stir, under 30-100Mpa pressure, homogenize promptly.
During stirring, the stirrer rotating speed is 1000-2000rpm, and the time is 30-80 minute, and temperature is a room temperature, can form the suspensoid product that contains lysozyme and florfenicol of outward appearance homogeneous.
4. according to claim 1 or 2 or 3 described a kind of preparation methoies that contain the suspensoid of lysozyme and florfenicol, comprise the steps:
7.5 parts of lysozyme, 15 parts of florfenicols; Tween 80,8 parts; Sodium citrate, 1.6 parts; Methyl hydroxybenzoate, 0.3 part; 15 parts of propylene glycol; Use water for injection standardize solution to 100 part at last
(1) takes by weighing 7.5 parts of lysozyme and florfenicol and put into an amount of water for injection for 15 parts, add 8 parts of tween 80s, stir.
(2) add 1.6 parts of sodium citrate, stir.
(3) add 0.3 part of methyl hydroxybenzoate, stir.
(4) add 15 parts of propylene glycol, stir.
(5) last, be settled to 100 parts with water for injection, be stirred well to evenly, under 30-100Mpa pressure, carry out homogenizing promptly for twice.
During stirring, the stirrer rotating speed is 1500rpm, and the time is 50 minutes, and temperature is a room temperature, can form the suspensoid product that contains lysozyme and florfenicol of outward appearance homogeneous.
5. a kind of suspension composition that contains lysozyme and florfenicol according to claim 1 is characterized in that said composition can be used for the treatment of diseases such as the sick infection of poultry Frustrate blood and mycoplasma.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910068698XA CN101874774A (en) | 2009-04-29 | 2009-04-29 | Suspension composition containing lysozyme and florfenicol and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN200910068698XA CN101874774A (en) | 2009-04-29 | 2009-04-29 | Suspension composition containing lysozyme and florfenicol and preparation method thereof |
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| CN101874774A true CN101874774A (en) | 2010-11-03 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103520111A (en) * | 2013-10-11 | 2014-01-22 | 成都乾坤动物药业有限公司 | Florfenicol dry suspension, and preparation method and application thereof |
| CN106581655A (en) * | 2017-01-02 | 2017-04-26 | 武汉新联大生物有限公司 | Compound levoflorfenicol solid dispersant and preparation method thereof |
| CN106620668A (en) * | 2017-01-02 | 2017-05-10 | 武汉新联大生物有限公司 | Compound tilmicosin solid dispersing agent and preparation method thereof |
| CN108904442A (en) * | 2018-08-09 | 2018-11-30 | 山西瑞象生物药业有限公司 | A kind of florfenicol solution agent and preparation method thereof |
-
2009
- 2009-04-29 CN CN200910068698XA patent/CN101874774A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103520111A (en) * | 2013-10-11 | 2014-01-22 | 成都乾坤动物药业有限公司 | Florfenicol dry suspension, and preparation method and application thereof |
| CN103520111B (en) * | 2013-10-11 | 2016-02-03 | 成都乾坤动物药业有限公司 | A kind of florfenicol dry suspension and its production and use |
| CN106581655A (en) * | 2017-01-02 | 2017-04-26 | 武汉新联大生物有限公司 | Compound levoflorfenicol solid dispersant and preparation method thereof |
| CN106620668A (en) * | 2017-01-02 | 2017-05-10 | 武汉新联大生物有限公司 | Compound tilmicosin solid dispersing agent and preparation method thereof |
| CN108904442A (en) * | 2018-08-09 | 2018-11-30 | 山西瑞象生物药业有限公司 | A kind of florfenicol solution agent and preparation method thereof |
| CN108904442B (en) * | 2018-08-09 | 2021-04-06 | 山西瑞象生物药业有限公司 | Florfenicol solution and preparation method thereof |
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Application publication date: 20101103 |