CN102614129A - Enrofloxacin dry suspension - Google Patents
Enrofloxacin dry suspension Download PDFInfo
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- CN102614129A CN102614129A CN2012101099369A CN201210109936A CN102614129A CN 102614129 A CN102614129 A CN 102614129A CN 2012101099369 A CN2012101099369 A CN 2012101099369A CN 201210109936 A CN201210109936 A CN 201210109936A CN 102614129 A CN102614129 A CN 102614129A
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Abstract
The invention belongs to the technical field of antibiotic preparations for livestock and in particular discloses a dry suspension component containing enrofloxacin. The enrofloxacin dry suspension is prepared by the following steps: performing solid dispersion to the water-insoluble enrofloxacin; and mixing the enrofloxacin and auxiliary materials comprising suspending aid, wetting agent, diluent, sweetener, adsorbent and flow aid uniformly to prepare the enrofloxacin dry suspension which can be dispersed into water uniformly and is used for performing oral administration to livestock. The enrofloxacin dry suspension has the advantages of simple method, low cost, stable quality, good suspension effect in water, excellent palatability and the like. In addition, the enrofloxacin dry suspension has the advantages of convenience in use, long acting time of medicines, high bioavailability and the like.
Description
Technical field
The invention belongs to antibiotic formulations technical field for animals, be specifically related to a kind of dry suspension prescription, relate in particular to a kind of can be in water homodisperse, can supply the clinical oral administration administration, the enrofloxacin dry suspension that mouthfeel is good.
Background technology
Enrofloxacin is the fluoroquinolone antibacterial agent of animal specific, is broad spectrum antibiotic, have that has a broad antifungal spectrum, sterilizing power are strong, effect rapidly, distribute extensively in the body and with other antibiotics between characteristics such as no cross resistance, enjoy veterinary's circle attention.Be widely used in control animal bacteria property disease and mycoplasma at present both at home and abroad, yellow and white dysentery of piglet, bowel oedema disease, mycoplasma pneumoniae of swine, mycoplasma gallinarum disease, avian colibacillosis, Pullorum Disease etc. are all had significant curative effect.
In home poultry raising, poultry-farm or specialist often adopt the mode of oral administration to carry out fowl diseases prevention and treatment, because oral administration is easy, time saving and energy saving, can reduce or avoid the poultry stress simultaneously.Because it is poorly soluble that enrofloxacin itself has in water, bitter in the mouth, the shortcoming of palatability difference; Clinical practice both at home and abroad at present is used for the insensible chicken of bitterness in oral enrofloxacin solution more, is not used in the responsive animals such as pig of the sense of taste, for example; The enrofloxacin soluble powder is in mixing the drink use; Usually drinking refusal causes the waste of medicine and the delay of the state of an illness to pig because its palatability is bad, thereby has influenced the convenience and the economy of its use.
Dry suspension is that slightly solubility solid drugs and proper auxiliary materials are processed powder or shot-like particle, faces the time spent to add the water jolting and can be dispersed into suspensoid and supply to orally use.Compare with pre-mixing agent or powder, it adds water when using can become solution, and is uniformly dispersed.Because of incomplete mixing, or search for food to descend after the poultry morbidity and cause drug effect undesirable when having overcome pre-mixing agent or powder spice and using, also avoided taking the high feedstuff of local drug concentration and caused the phenomenon of poisoning; Dry suspension is big than the specific surface area of pre-mixing agent simultaneously, absorbs rapidly, and bioavailability is high, and cure rate is higher.With the solution ratio, because it is in dry anhydrous state all the time, stability more is prone to realize.In addition, dry suspension is easy to use, has saved lot of manpower and material resources.
Yet the enrofloxacin crude drug is very bitter, must be very bitter if process dry suspension according to routine techniques, be difficult to swallow, and cause the poultry refusing to eat.Therefore, how can overcome and cover bitterness effectively, also guarantee that adding water can form homodisperse suspension, be the key issue of preparation enrofloxacin dry suspension.
Summary of the invention
To the deficiency that exists in the prior art, the object of the present invention is to provide a kind of facing with preceding filler clothes, dispersibility and good palatability, strong drug action, the enrofloxacin dry suspension of long action time.
Technical conceive of the present invention is through adding solid dispersion carrier, suspending agent, wetting agent, guaranteeing that preparation suspendible when adding water is even; Cover the bitterness of enrofloxacin through adding a certain proportion of sweeting agent and a certain proportion of adsorbent again, increase the compliance of the responsive animal of the sense of taste; Add the flowability of powder in the fluidizer assurance preparation process again, reach the purpose of mix homogeneously, add diluent at last and obtain product.
The technical scheme that the present invention taked is following:
A kind of enrofloxacin dry suspension is prepared from following raw materials by weight percent:
Enrofloxacin 2.5-10%,
Solid dispersion carrier 10-35%,
Suspending agent 15-30%,
Wetting agent 4-10%,
Sweeting agent 2-10%,
Adsorbent 2.5-5%,
Fluidizer 0.05-0.15%,
Diluent 10-63.45%.
More excellent, a kind of enrofloxacin dry suspension is prepared from following raw materials by weight percent:
Enrofloxacin 2.5-7.5%,
Solid dispersion carrier 10-30%,
Suspending agent 15-30%,
Wetting agent 4-10%,
Sweeting agent 2.5-8%,
Adsorbent 2.5-5%,
Fluidizer 0.05-0.15%,
Diluent 15-63.45%.
More excellent, a kind of enrofloxacin dry suspension is prepared from following raw materials by weight percent:
Enrofloxacin 3-6%,
Solid dispersion carrier 10-20%,
Suspending agent 15-25%,
Wetting agent 8-10%,
Sweeting agent 3-6%,
Adsorbent 3-5%,
Fluidizer 0.05-0.1%,
Diluent 30-50%.
Best, a kind of enrofloxacin dry suspension is prepared from following raw materials by weight percent:
Enrofloxacin 5%,
Solid dispersion carrier 15%,
Suspending agent 20%,
Wetting agent 10%,
Sweeting agent 5%,
Adsorbent 5%,
Fluidizer 0.075%,
Diluent 39.925%.
Wherein, the solid dispersion carrier is selected from one or more in Macrogol 4000, beta-schardinger dextrin-, the carbamide.
Suspending agent is selected from one or more in sodium carboxymethyl cellulose, xanthan gum, hydroxypropyl emthylcellulose, the arabic gum.
Wetting agent is selected from one or more in sodium lauryl sulphate, poloxamer 188, polyoxyethylene stearate (40) ester.
Sweeting agent is selected from one or more in saccharin sodium, stevioside, aspartame, cyclamate, the acesulfame-K, requires its granularity >=100 orders.
Adsorbent is alkaline earth oxide or alkaline earth metal hydroxide, preferred magnesium oxide.
Fluidizer is selected from one or more in micropowder silica gel, Pulvis Talci, the magnesium stearate, preferred micropowder silica gel.
Diluent is selected from one or more in anhydrous glucose, lactose, Matrii Sulfas Exsiccatus, the sucrose.
The method for preparing of enrofloxacin dry suspension of the present invention is with behind enrofloxacin crude drug, solid dispersion carrier, suspending agent, the abundant mix homogeneously of wetting agent, is crushed to all to cross 200 mesh sieves; Mixture after will sieving then and sweeting agent, adsorbent, fluidizer, the abundant mix homogeneously of diluent, packing promptly gets.
Compared with prior art, advantage of the present invention and beneficial effect are:
1, the present invention is through adding sweeting agent and adsorbent, faces the time spent to add water, and mouthfeel is better, can cover the bitterness of enrofloxacin itself well; Improved enrofloxacin on the disease of treatment pig since bitter in the mouth can not be oral limitation, and do not influence pig and search for food.
2, the present invention has significantly improved the dispersibility of enrofloxacin in water through solid dispersion technology, and it can be dispersed in the water for a long time, makes things convenient for oral administration.
3, product of the present invention has long-acting, can reduce administration number of times, saves the labour; And preparation technology is simple, and production cost is low, is fit to industrialized great production.
The specific embodiment
Following applicant will combine concrete embodiment that product of the present invention is specified, so that those skilled in the art has understanding further to the present invention, but following examples are interpreted as the restriction to protection domain of the present invention never in any form.
Embodiment 1:
A kind of enrofloxacin dry suspension is formed by the feedstock production of following prescription:
| Raw material | Consumption |
| The enrofloxacin crude drug | 2.5g |
| Macrogol 4000 | 10g |
| Sodium carboxymethyl cellulose | 15g |
| Sodium lauryl sulphate | 4g |
| Cyclamate (granularity >;=100 orders) | 2.5g |
| Magnesium oxide | 2.5g |
| Micropowder silica gel | 0.05g |
| Matrii Sulfas Exsiccatus | 63.45g |
The total amount of above-mentioned raw materials is 100g.
Compound method: behind the abundant mix homogeneously of enrofloxacin crude drug, Macrogol 4000, sodium carboxymethyl cellulose, sodium lauryl sulphate with above-mentioned formula ratio; Be crushed to and all cross 200 mesh sieves, the mixture after will sieving then and cyclamate, magnesium oxide, micropowder silica gel, the Matrii Sulfas Exsiccatus mix homogeneously of above-mentioned formula ratio promptly get.
Face with before adding water, oral getting final product, following examples 2-5 with.
Embodiment 2:
A kind of enrofloxacin dry suspension is formed by the feedstock production of following prescription:
| Raw material | Consumption |
| The enrofloxacin crude drug | 5g |
| Beta-schardinger dextrin- | 10g |
| Carbamide | 5g |
| Sodium carboxymethyl cellulose | 20g |
| Polyoxyethylene stearate (40) ester | 10g |
| Aspartame (granularity >;=100 orders) | 5g |
| Magnesium oxide | 5g |
| Micropowder silica gel | 0.075g |
| Anhydrous glucose | 39.925g |
The total amount of above-mentioned raw materials is 100g.
Compound method: behind the enrofloxacin crude drug of above-mentioned formula ratio, beta-schardinger dextrin-, carbamide, sodium carboxymethyl cellulose, the abundant mix homogeneously of polyoxyethylene stearate (40) ester; Be crushed to and all cross 200 mesh sieves, the mixture after will sieving then and aspartame, magnesium oxide, micropowder silica gel, the anhydrous glucose mix homogeneously of above-mentioned formula ratio promptly get.
Embodiment 3:
A kind of enrofloxacin dry suspension is formed by the feedstock production of following prescription:
| Raw material | Consumption |
| The enrofloxacin crude drug | 5g |
| Beta-schardinger dextrin- | 15g |
| Xanthan gum | 20g |
| Sodium lauryl sulphate | 10g |
| Stevioside (granularity >;=100 orders) | 6g |
| Magnesium oxide | 5g |
| Micropowder silica gel | 0.075g |
| Matrii Sulfas Exsiccatus | 38.925g |
The total amount of above-mentioned raw materials is 100g.
Compound method: behind the abundant mix homogeneously of enrofloxacin crude drug, beta-schardinger dextrin-, xanthan gum, sodium lauryl sulphate with above-mentioned formula ratio; Be crushed to and all cross 200 mesh sieves, the mixture after will sieving then and stevioside, magnesium oxide, micropowder silica gel, the Matrii Sulfas Exsiccatus mix homogeneously of above-mentioned formula ratio promptly get.
Embodiment 4:
A kind of enrofloxacin dry suspension is formed by the feedstock production of following prescription:
| Raw material | Consumption |
| The enrofloxacin crude drug | 7.5g |
| Beta-schardinger dextrin- | 15g |
| Carbamide | 15g |
| Arabic gum | 15g |
| Sodium carboxymethyl cellulose | 15g |
| Polyoxyethylene stearate (40) ester | 6g |
| Acesulfame-K (granularity >;=100 orders) | 7g |
| Magnesium oxide | 5g |
| Micropowder silica gel | 0.1g |
| Lactose | 14.4g |
The total amount of above-mentioned raw materials is 100g.
Compound method: behind the enrofloxacin crude drug of above-mentioned formula ratio, beta-schardinger dextrin-, carbamide, arabic gum, sodium carboxymethyl cellulose, the abundant mix homogeneously of polyoxyethylene stearate (40) ester; Be crushed to and all cross 200 mesh sieves, the mixture after will sieving then and acesulfame-K, magnesium oxide, micropowder silica gel, the lactose mix homogeneously of above-mentioned formula ratio promptly get.
Embodiment 5:
A kind of enrofloxacin dry suspension is formed by the feedstock production of following prescription:
| Raw material | Consumption |
| The enrofloxacin crude drug | 10g |
| Beta-schardinger dextrin- | 15g |
| Carbamide | 20g |
| Xanthan gum | 5g |
| Hydroxypropyl emthylcellulose | 20g |
| Poloxamer 188 | 5g |
| Saccharin sodium (granularity >;=100 orders) | 8g |
| Magnesium oxide | 5g |
| Micropowder silica gel | 0.15g |
| Anhydrous glucose | 11.85g |
The total amount of above-mentioned raw materials is 100g.
Compound method: behind enrofloxacin crude drug, beta-schardinger dextrin-, carbamide, xanthan gum, hydroxypropyl emthylcellulose, poloxamer 188 abundant mix homogeneously; Be crushed to and all cross 200 mesh sieves, mixture and saccharin sodium, magnesium oxide, micropowder silica gel, anhydrous glucose mix homogeneously after will sieving then promptly get.
Embodiment 6: settling volume is than measuring
In order to measure the dispersibility of preparation of the present invention in water; According to the requirement of " People's Republic of China's veterinary drug allusion quotation ", the product of embodiment 1, embodiment 2, embodiment 3, embodiment 4, embodiment 5 is carried out settling volume than measuring, get these article 0.25g respectively to put in the tool plug graduated cylinder; Add water to 50mL; Airtight, firmly jolting 1min writes down the height H that suspended matter begins
0, leave standstill 3 hours after, write down the final height H of suspended matter, be calculated as follows; Settling volume ratio=H/H
0, the settling volume ratio should be not less than 0.90.
Mensuration result shows, the sample of embodiment 1-embodiment 5 is even after placing 24 hours by above-mentioned requirements, settling volume explains that than all still greater than 0.98 the present invention has good suspendible effect.
Experimental example 7: stability test
Accelerated test
In order to measure stability of formulation; According to the requirement of " veterinary drug stability test technical specification ", the accelerated test under the ad hoc fixed following condition, the dry suspension that embodiment 1, embodiment 2, embodiment 4, embodiment 5 are made is 40 ± 2 ℃ of temperature; The condition held of relative humidity 75 ± 5% 6 months; Sampling in 0,1,2,3,6 month once, investigate by stable high spot reviews project respectively, investigate character, settling volume ratio, content.The result sees table 1-table 4.
The dry suspension accelerated stability test result of table 1 embodiment 1
| Time | Content (%/w) | Appearance character | The settling volume ratio |
| 0 month | 2.53 | Off-white powder | 1.00 |
| January | 2.51 | Off-white powder | 0.99 |
| February | 2.52 | Off-white powder | 0.99 |
| March | 2.51 | Off-white powder | 0.98 |
| June | 2.49 | Off-white powder | 0.96 |
The dry suspension accelerated stability test result of table 2 embodiment 2
| Time | Content (%/w) | Appearance character | The settling volume ratio |
| 0 month | 5.06 | Off-white powder | 1.00 |
| January | 5.04 | Off-white powder | 0.98 |
| February | 5.05 | Off-white powder | 0.96 |
| March | 5.02 | Off-white powder | 0.95 |
| June | 4.98 | Off-white powder | 0.94 |
The dry suspension accelerated stability test result of table 3 embodiment 4
| Time | Content (%/w) | Appearance character | The settling volume ratio |
| 0 month | 7.59 | Off-white powder | 1.00 |
| January | 7.56 | Off-white powder | 0.97 |
| February | 7.55 | Off-white powder | 0.96 |
| March | 7.52 | Off-white powder | 0.95 |
| June | 7.48 | Off-white powder | 0.94 |
The dry suspension accelerated stability test result of table 4 embodiment 5
| Time | Content (%/w) | Appearance character | The settling volume ratio |
| 0 month | 10.10 | Off-white powder | 1.00 |
| January | 10.08 | Off-white powder | 0.96 |
| February | 10.04 | Off-white powder | 0.95 |
| March | 9.99 | Off-white powder | 0.94 |
| June | 9.89 | Off-white powder | 0.92 |
See that from testing result in the phase, character does not all change the enrofloxacin dry suspension of embodiment 1, embodiment 2, embodiment 4, embodiment 5 at accelerated stability test; Settling ratio is all greater than 0.9; Content does not have significant change, and each item index meets the requirements, and these article good stability is described.
Experimental example 8: enrofloxacin dry suspension of the present invention is tested the yellow and white dysentery of piglet clinical efficacy
Control drug: commercially available 2.5% enrofloxacin solution, the animal health article company limited production of Guangzhou favour China.
Trial drug: the enrofloxacin dry suspension of present embodiment 2 preparation, face the time spent to be dissolved in water into suspension solution.
Test method: choose 120 of the piglets that HUANGBAI(sic) dysentery symptom is arranged, body weight 10 ± 2kg is divided into 3 groups at random, is respectively test I group, contrast II group, blank III group, 40 every group.Test I group is by 5mg/kg (enrofloxacin) oral test drug group, every day 1 time, logotype 5 days; Contrast II group is by the oral control drug of 2.5mg/kg (enrofloxacin), every day 2 times, logotype 5 days; Blank III group, not administration.
Result of the test: see table 5 according to the enrofloxacin dry suspension of embodiment 2 preparations and the clinical efficacy result of the test of control drug:
In the process of the test, test I group piglet recovers the fastest, and feed intake, the mental status are clearly better, and do not have bad side reaction, and the average daily ingestion amount of curing piglet is close with the normal piglets of not falling ill; Contrast II group effect in the piglet that sb.'s illness took a favorable turn, occurs part piglet refusing to eat phenomenon inferior to test I group, and the average daily ingestion amount of curing piglet is starkly lower than the healing piglet of test I group; No matter blank III group still be that the mental status obviously is worse than test I group, contrast II organizes in feed intake.
Brief summary: enrofloxacin dry suspension of the present invention is used for the piglet oral administration, and good palatability influences the normal feed intake of piglet hardly; Evident in efficacy, help disease treatment, and preparation has certain long-acting, can reduce administration number of times, save the labour.
Claims (6)
1. enrofloxacin dry suspension is prepared from following raw materials by weight percent:
Enrofloxacin 2.5-10%,
Solid dispersion carrier 10-35%,
Suspending agent 15-30%,
Wetting agent 4-10%,
Sweeting agent 2-10%,
Adsorbent 2.5-5%,
Fluidizer 0.05-0.15%,
Diluent 10-63.45%;
Wherein, the solid dispersion carrier is selected from one or more in Macrogol 4000, beta-schardinger dextrin-, the carbamide;
Suspending agent is selected from one or more in sodium carboxymethyl cellulose, xanthan gum, hydroxypropyl emthylcellulose, the arabic gum;
Wetting agent is selected from one or more in sodium lauryl sulphate, poloxamer 188, polyoxyethylene stearate (40) ester;
Sweeting agent is selected from one or more in saccharin sodium, stevioside, aspartame, cyclamate, the acesulfame-K, granularity >=100 orders;
Adsorbent is alkaline earth oxide or alkaline earth metal hydroxide;
Fluidizer is selected from one or more in micropowder silica gel, Pulvis Talci, the magnesium stearate;
Diluent is selected from one or more in anhydrous glucose, lactose, Matrii Sulfas Exsiccatus, the sucrose.
2. enrofloxacin dry suspension according to claim 1 is characterized in that: said adsorbent is a magnesium oxide.
3. enrofloxacin dry suspension according to claim 1 is characterized in that: said fluidizer is micropowder silica gel.
4. according to arbitrary described enrofloxacin dry suspension among the claim 1-3, it is characterized in that: be prepared from following raw materials by weight percent:
Enrofloxacin 2.5-7.5%,
Solid dispersion carrier 10-30%,
Suspending agent 15-30%,
Wetting agent 4-10%,
Sweeting agent 2.5-8%,
Adsorbent 2.5-5%,
Fluidizer 0.05-0.15%,
Diluent 15-63.45%.
5. enrofloxacin dry suspension according to claim 4 is characterized in that: be prepared from following raw materials by weight percent:
Enrofloxacin 3-6%,
Solid dispersion carrier 10-20%,
Suspending agent 15-25%,
Wetting agent 8-10%,
Sweeting agent 3-6%,
Adsorbent 3-5%,
Fluidizer 0.05-0.1%,
Diluent 30-50%.
6. enrofloxacin dry suspension according to claim 5 is characterized in that: be prepared from following raw materials by weight percent:
Enrofloxacin 5%,
Solid dispersion carrier 15%,
Suspending agent 20%,
Wetting agent 10%,
Sweeting agent 5%,
Adsorbent 5%,
Fluidizer 0.075%,
Diluent 39.925%.
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| CN103800354A (en) * | 2013-12-24 | 2014-05-21 | 沈阳伟嘉牧业技术有限公司 | Compound albendazole dry suspension and preparation method thereof |
| CN104188919A (en) * | 2014-09-25 | 2014-12-10 | 河南亚卫动物药业有限公司 | Thiamphenicol powder dry suspension for livestock and preparation method of thiamphenicol powder dry suspension |
| CN106038482A (en) * | 2016-07-15 | 2016-10-26 | 华南农业大学 | Enrofloxacin uterus perfusion liquid as well as preparation method and application thereof |
| CN107349182A (en) * | 2017-05-31 | 2017-11-17 | 合肥中龙神力动物药业有限公司 | Animal enrofloxacin suspension and preparation method thereof |
| CN107823132A (en) * | 2017-11-23 | 2018-03-23 | 湖北龙翔药业科技股份有限公司 | A kind of Marbofloxacin suspension and preparation method thereof |
| CN117771175A (en) * | 2024-02-23 | 2024-03-29 | 中国农业科学院农业环境与可持续发展研究所 | Enrofloxacin nano suspension and preparation method and application thereof |
| CN117771175B (en) * | 2024-02-23 | 2024-06-07 | 中国农业科学院农业环境与可持续发展研究所 | Enrofloxacin nano suspension and preparation method and application thereof |
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