CN106727333A - A kind of Enrofloxacin water solube powder and preparation method thereof - Google Patents
A kind of Enrofloxacin water solube powder and preparation method thereof Download PDFInfo
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- CN106727333A CN106727333A CN201611043090.8A CN201611043090A CN106727333A CN 106727333 A CN106727333 A CN 106727333A CN 201611043090 A CN201611043090 A CN 201611043090A CN 106727333 A CN106727333 A CN 106727333A
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- enrofloxacin
- water
- soluble
- solube powder
- cyclodextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene
Abstract
The present invention relates to a kind of Enrofloxacin water solube powder and preparation method thereof.The water solube powder, including following weight portion raw material components：5 20 parts of Enrofloxacin, 80 95 parts of water-soluble cyclodextrin.The present invention is compounded using water-soluble cyclodextrin and Enrofloxacin, and obtained pulvis can reach completely water-soluble, and substantially reduce bitter taste, be conducive to domestic animal to search for food.Completely water-soluble characteristic enables Enrofloxacin farthest to be absorbed by animal, reaches optimum utilization effect.What the present invention was used is nontoxic, capable of being fast degraded cyclodextrin derivative, it is to avoid using the solubilized cosolvent of other toxic side effects, substantially reduce the residual of animal systematic toxicity material.
Description
Technical field
The present invention relates to a kind of Enrofloxacin water solube powder and preparation method thereof, belong to technical field of veterinary.
Background technology
Enrofloxacin, also known as grace fluorine quinoline carboxylic acid, belong to the chemical synthesis bacteriostatic agent of Fluoroquinolones, are slightly yellow or light
Yellow crystalline powder, bitter is water insoluble.
Enrofloxacin has that has a broad antifungal spectrum, bactericidal activity are strong, distribution in vivo is wide, antibacterial action is unique, bioavilability is high,
Toxic and side effect is small, without cross resistance the features such as, be widely used in the prevention and treatment of various animal infectious diseases, be most
One of conventional antibacterials.But its poorly water-soluble, there is bitter taste, limit the development and application of its formulation.
In order to increase the dissolubility of Enrofloxacin and cover bitter taste, at present research focus mostly in by Enrofloxacin with it is various
Auxiliary agent is compounded, and realizes the effect that solubilising is de-tasted.
The A of Chinese patent document CN 105412111 disclose a kind of Enrofloxacin meglumine preparation and preparation method thereof, by
Enrofloxacin, meglumine, acetamide, water, flavouring, carrier composition, help by using meglumine, acetamide as Enrofloxacin
Solvent, increases dissolubility of the Enrofloxacin in water when Enrofloxacin meglumine preparation drinking-water is used.
The A of Chinese patent document CN 105434359 disclose a kind of Enrofloxacin preparation and preparation method thereof, by En Nuosha
Star, taurine, citric acid, glycerine, carrier composition, by using glycerine and taurine as the cosolvent of Enrofloxacin, increasing grace
Dissolubility of the Enrofloxacin in water when promise sand star preparation drinking-water is used.
The A of Chinese patent document CN 105534916 disclose a kind of Enrofloxacin soluble preparation and preparation method thereof, by
Enrofloxacin, sodium bicarbonate, acetamide, water, carrier composition, by using sodium bicarbonate, acetamide as the cosolvent of Enrofloxacin, increasing
Plus the Enrofloxacin preparation drinking-water dissolubility of Enrofloxacin in water when using.
The above-mentioned Enrofloxacin water solubility for preparing in the prior art is not good enough, and bitter taste can not be covered well, and domestic animal is deposited
In feeding conflict, and a large amount of emulsifying agents or solubilizer are added, it is relatively costly.
The content of the invention
In view of the shortcomings of the prior art, the present invention provides a kind of Enrofloxacin water solube powder, and the pulvis can reach
It is complete water-soluble, and bitter taste can be substantially reduced.
The present invention also provides a kind of preparation method of Enrofloxacin water solube powder.
A kind of Enrofloxacin water solube powder, including raw material components are as follows, by weight：
Enrofloxacin 5-20 parts
Water-soluble cyclodextrin 80-95 parts.
According to currently preferred, the Enrofloxacin water solube powder, including raw material components are as follows, by weight：
Enrofloxacin 10-20 parts
Water-soluble cyclodextrin 80-90 parts.
According to currently preferred, the water-soluble cyclodextrin is that soluble epoxide chloropropane is crosslinked alpha-cyclodextrin
Polymer, soluble epoxide chloropropane crosslinking beta cyclo dextrin polymer or the crosslinking gamma-cyclodextrin polymerization of soluble epoxide chloropropane
One or more mixture in thing.
According to currently preferred, the Enrofloxacin water solube powder, contain in every 100g water solube powders：En Nuosha
Star 5-20g, water-soluble cyclodextrin 80-95g.
Preferably, contain in every 100g Enrofloxacin water solube powders：Enrofloxacin 10-20g, water soluble Beta-cyclodextrin polymerization
Thing 80-90g.
A kind of preparation method of Enrofloxacin water solube powder, including step is as follows：
(1) water-soluble cyclodextrin is dissolved in deionized water, obtains polymer solution；
(2) Enrofloxacin is dissolved in glacial acetic acid aqueous solution, obtains the Enrofloxacin aqueous solution；
(3) the Enrofloxacin aqueous solution for obtaining step (2) is added in the polymer solution that step (1) is obtained, and mixing is equal
It is even, stirring at normal temperature 1-5h；It is spray-dried to obtain final product Enrofloxacin water solube powder.
According to currently preferred, the mass ratio of water-soluble cyclodextrin and deionized water is in the step (1)
1:10-20。
According to currently preferred, the mass concentration of glacial acetic acid aqueous solution is 1%-2% in the step (2).
According to currently preferred, water-soluble cyclodextrin in Enrofloxacin and step (1) in the step (2)
Mass ratio is 1:4-9.
According to currently preferred, mixing time is 2-3h in the step (3).
According to currently preferred, spray drying condition is in the step (3)：160-200 DEG C of EAT, goes out wind-warm syndrome
70-110 DEG C of degree.
Preferably, the spray drying condition is：185-195 DEG C of EAT, 85-100 DEG C of leaving air temp.
Beneficial effects of the present invention are as follows：
(1) Enrofloxacin water solube powder prepared by the present invention, is to be with Enrofloxacin with water-soluble cyclodextrin
Raw material, is stirred at room temperature prepared, simple production process, environmental protection, safety, low cost in water.
(2) Enrofloxacin water solube powder prepared by the present invention, only with a kind of cyclodextrine derivatives auxiliary agent, while ring
The supermolecule package action of dextrin is favorably improved the stability of Enrofloxacin, so as to improve bioavilability.With cyclodextrin phase
Than, water-soluble cyclodextrin because with end group long-chain, when inclusion compound is formed, guest molecule and cyclodextrin cavity bag
While wrapping up in, end group long-chain can also form network structure, clathration of the enhancing to guest molecule.
(3) present invention is main is compounded using water-soluble cyclodextrin with Enrofloxacin, and obtained pulvis can reach
To completely water-soluble, and bitter taste is substantially reduced, be conducive to domestic animal to search for food.Completely water-soluble characteristic enables Enrofloxacin at utmost
Absorbed by animal, reach optimum utilization effect.What the present invention was used is that nontoxic, capable of being fast degraded cyclodextrin spreads out
It is biological, it is to avoid using the solubilized cosolvent of other toxic side effects, to substantially reduce the residual of animal systematic toxicity material.
Specific embodiment
With reference to specific embodiment, the present invention is described further, but not limited to this.
Experimental technique described in following embodiments, unless otherwise specified, is conventional method simultaneously；The reagent and material
Material, unless otherwise specified, commercially obtains.
Embodiment 1
A kind of Enrofloxacin water solube powder, including raw material components are as follows, by weight：
15 parts of Enrofloxacin
Soluble epoxide chloropropane is crosslinked 85 parts of beta cyclo dextrin polymer.
Preparation process is as follows：
(1) 85g soluble epoxides chloropropane is crosslinked into beta cyclo dextrin polymer (β-CDP) to be dissolved in 1275g deionized waters,
Obtain polymer solution；
(2) 15g Enrofloxacins are dissolved in the glacial acetic acid aqueous solution of 75ml 1.5%, obtain the Enrofloxacin aqueous solution；
(3) the Enrofloxacin aqueous solution for obtaining step (2) is added in the polymer solution that step (1) is obtained, and mixing is equal
It is even, stirring at normal temperature 3h；It is spray-dried to obtain final product Enrofloxacin water solube powder.
Embodiment 2
A kind of Enrofloxacin water solube powder, including raw material components are as follows, by weight：
20 parts of Enrofloxacin
80 parts of soluble epoxide chloropropane crosslinking gamma-cyclodextrin polymer.
Preparation process is as follows：
(1) 80g soluble epoxides chloropropane is crosslinked gamma-cyclodextrin polymer (γ-CDP) and is dissolved in 800g deionized waters
In, obtain polymer solution；
(2) 20g Enrofloxacins are dissolved in the glacial acetic acid aqueous solution of 100ml 1.5%, obtain the Enrofloxacin aqueous solution；
(3) the Enrofloxacin aqueous solution for obtaining step (2) is added in the polymer solution that step (1) is obtained, and mixing is equal
It is even, stirring at normal temperature 2h；It is spray-dried to obtain final product Enrofloxacin water solube powder.
Embodiment 3
A kind of Enrofloxacin water solube powder, including raw material components are as follows, by weight：
10 parts of Enrofloxacin
90 parts of soluble epoxide chloropropane crosslinking alpha-cyclodextrin polymer.
Preparation process is as follows：
(1) 90g soluble epoxides chloropropane is crosslinked into alpha-cyclodextrin polymer (CDP) to be dissolved in 900g deionized waters, is obtained
Polymer solution；
(2) 10g Enrofloxacins are dissolved in the glacial acetic acid aqueous solution of 50ml 1.5%, obtain the Enrofloxacin aqueous solution；
(3) the Enrofloxacin aqueous solution for obtaining step (2) is added in the polymer solution that step (1) is obtained, and mixing is equal
It is even, stirring at normal temperature 5h；It is spray-dried to obtain final product Enrofloxacin water solube powder.
Embodiment 4
A kind of Enrofloxacin water solube powder, including raw material components are as follows, by weight：
5 parts of Enrofloxacin
95 parts of soluble epoxide chloropropane crosslinking alpha-cyclodextrin polymer.
Preparation process is as follows：
(1) 95g soluble epoxides chloropropane is crosslinked into alpha-cyclodextrin polymer (CDP) to be dissolved in 1900g deionized waters, is obtained
Polymer solution；
(2) 5g Enrofloxacins are dissolved in the glacial acetic acid aqueous solution of 50ml 1.5%, obtain the Enrofloxacin aqueous solution；
(3) the Enrofloxacin aqueous solution for obtaining step (2) is added in the polymer solution that step (1) is obtained, and mixing is equal
It is even, stirring at normal temperature 5h；It is spray-dried to obtain final product Enrofloxacin water solube powder.
Comparative example 1
A kind of Enrofloxacin pulvis, including raw material components are as follows, by weight：
15 parts of Enrofloxacin
85 parts of beta-schardinger dextrin.
Preparation process is as follows：
(1) 85g beta-schardinger dextrins are dissolved in 1275g deionized waters, obtain beta-schardinger dextrin solution；
(2) 15g Enrofloxacins are dissolved in the glacial acetic acid aqueous solution of 75ml 1.5%, obtain the Enrofloxacin aqueous solution；
(3) the Enrofloxacin aqueous solution for obtaining step (2) is added in the beta-schardinger dextrin that step (1) is obtained, and is well mixed,
Stirring at normal temperature 3h；It is spray-dried to obtain final product Enrofloxacin water solube powder.
Test example 1
1. water solubility determination test
First, for trial product：The respectively product of embodiment 1, embodiment 2, embodiment 3, embodiment 4 and comparative example 1.
2nd, test method
Weigh and supply trial product, be placed in 25 ± 2 DEG C of distilled water of certain capacity, every strength shaking in 5 minutes 30 seconds, see
The dissolving situation in 30 minutes is examined, such as without visual visible particles of solute or drop, that is, is considered as and is completely dissolved.
3rd, result of the test
Result of the test is shown in Table 1.
The water solubility test result of table 1
| For trial product | Water solubility (g/100g) | Solution appearance |
| Embodiment 1 | ＞ 100 | It is completely dissolved, solution clarification, without precipitation, without floating object |
| Embodiment 2 | ＞ 120 | It is completely dissolved, solution clarification, without precipitation, without floating object |
| Embodiment 3 | ＞ 105 | It is completely dissolved, solution clarification, without precipitation, without floating object |
| Embodiment 4 | ＞ 105 | It is completely dissolved, solution clarification, without precipitation, without floating object |
| Comparative example 1 | ＜ 1.5 | It is partly dissolved, there is sediment |
From result of the test, Enrofloxacin water solube powder of the invention can be completely dissolved in water, and the aqueous solution is complete
Full clarification, water-soluble cyclodextrin (CDP) is significantly improved to Enrofloxacin water solubility.
2. stability test
Product obtained in 1.5g embodiments 1,2,3,4 is dissolved in 100g water respectively, by the closed standing of 24h room temperatures, all
It is not in deposited phenomenon.And product obtained in 1.5g comparative examples 1 is dissolved in 100g water, by the closed standing of 24h room temperatures, go out
Now precipitation increases phenomenon.Illustrate that stability is preferable in aqueous for the Enrofloxacin water solube powder for preparing of the invention.
3. palatability testing
First, for trial product：The respectively product of embodiment 1, embodiment 2, embodiment 3, embodiment 4 and comparative example 1.
2nd, experimental animal
60 health pigs, average weight is randomly divided into six groups in 35kg or so, every group 10, sets control group, embodiment
1 group, 2 groups of embodiment, 3 groups of embodiment, 1 group of 4 groups of embodiment and comparative example.
3rd, test method
Control group fed is not added with the daily feed 10kg of the Enrofloxacin water solube powder of present invention preparation.
1 group of feeding of embodiment adds the daily feed 10kg of the Enrofloxacin water solube powder of the preparation of embodiment 1.
2 groups of feedings of embodiment add the daily feed 10kg of the Enrofloxacin water solube powder of the preparation of embodiment 2.
3 groups of feedings of embodiment add the daily feed 10kg of the Enrofloxacin water solube powder of the preparation of embodiment 3.
4 groups of feedings of embodiment add the daily feed 10kg of the Enrofloxacin water solube powder of the preparation of embodiment 4.
1 group of feeding of comparative example adds the daily feed 10kg of the Enrofloxacin pulvis of the preparation of comparative example 1.
The same time starts feeding, and observation each group feeding situation weighs the remaining feed relative of each group, calculates feed intake.
4th, result of the test
Experimental animal feeding situation is as shown in the table：
The experimental animal of table 2 feeding situation
| Experiment packet | Feeding situation | Feed intake |
| Control group | Normally | 8kg |
| 1 group of embodiment | Normally | 9kg |
| 2 groups of embodiment | Normally | 8.5kg |
| 3 groups of embodiment | Normally | 8.5kg |
| 4 groups of embodiment | Normally | 9.5kg |
| 1 group of comparative example | It is reluctant feeding | 4kg |
From result of the test, the Enrofloxacin water solube powder prepared by the present invention effectively masks Enrofloxacin
Bitter taste, does not influence animal normally to search for food, and feed intake is increased slightly, and palatability is preferable.
Claims (10)
1. a kind of Enrofloxacin water solube powder, including raw material components is as follows, by weight：
Enrofloxacin 5-20 parts
Water-soluble cyclodextrin 80-95 parts.
2. Enrofloxacin water solube powder according to claim 1, it is characterised in that the Enrofloxacin water solube powder
It is as follows including raw material components, by weight：
Enrofloxacin 10-20 parts
Water-soluble cyclodextrin 80-90 parts.
3. Enrofloxacin water solube powder according to claim 1, it is characterised in that the water-soluble cyclodextrin
It is soluble epoxide chloropropane crosslinking alpha-cyclodextrin polymer, soluble epoxide chloropropane crosslinking beta cyclo dextrin polymer or water-soluble
Property epoxychloropropane crosslinking gamma-cyclodextrin polymer in one or more mixture.
4. Enrofloxacin water solube powder according to claim 1, it is characterised in that the Enrofloxacin water soluble powder
Agent, contains in every 100g water solube powders：Enrofloxacin 5-20g, water-soluble cyclodextrin 80-95g；
Preferably, contain in every 100g Enrofloxacin water solube powders：Enrofloxacin 10-20g, water-soluble cyclodextrin
80-90g。
5. a kind of preparation method of the Enrofloxacin water solube powder described in claim 1, including step is as follows：
(1) water-soluble cyclodextrin is dissolved in deionized water, obtains polymer solution；
(2) Enrofloxacin is dissolved in glacial acetic acid aqueous solution, obtains the Enrofloxacin aqueous solution；
(3) the Enrofloxacin aqueous solution for obtaining step (2) is added in the polymer solution that step (1) is obtained, and is well mixed, often
Temperature stirring 1-5h；It is spray-dried to obtain final product Enrofloxacin water solube powder.
6. the preparation method of Enrofloxacin water solube powder according to claim 5, it is characterised in that the step (1)
The mass ratio of middle water-soluble cyclodextrin and deionized water is 1:10-20.
7. the preparation method of Enrofloxacin water solube powder according to claim 5, it is characterised in that the step (2)
The mass concentration of middle glacial acetic acid aqueous solution is 1%-2%.
8. the preparation method of Enrofloxacin water solube powder according to claim 5, it is characterised in that the step (2)
The mass ratio of water-soluble cyclodextrin is 1 in middle Enrofloxacin and step (1):4-9.
9. the preparation method of Enrofloxacin water solube powder according to claim 5, it is characterised in that the step (3)
Middle mixing time is 2-3h.
10. the preparation method of Enrofloxacin water solube powder according to claim 5, it is characterised in that the step (3)
Middle spray drying condition is：160-200 DEG C of EAT, 70-110 DEG C of leaving air temp；
Preferably, the spray drying condition is：185-195 DEG C of EAT, 85-100 DEG C of leaving air temp.
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| CN108113966A (en) * | 2017-08-24 | 2018-06-05 | 北京中农华正兽药有限责任公司 | A kind of grace stone disperses the preparation method except bitter taste |
| CN112569370A (en) * | 2020-12-30 | 2021-03-30 | 广东三水正大康畜牧发展有限公司 | Water-soluble enrofloxacin clathrate compound, simple molecular coating method thereof and prepared solid preparation |
| CN114931553A (en) * | 2022-06-09 | 2022-08-23 | 山东百晟药业有限公司 | Coated enrofloxacin soluble powder and preparation method thereof |
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| CN114931553A (en) * | 2022-06-09 | 2022-08-23 | 山东百晟药业有限公司 | Coated enrofloxacin soluble powder and preparation method thereof |
| CN114931553B (en) * | 2022-06-09 | 2023-05-30 | 山东百晟药业有限公司 | Coated enrofloxacin soluble powder and preparation method thereof |
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Application publication date: 20170531 |
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