CN102973504A - Adprin nano-emulsion anticoccidial drug and preparation process thereof - Google Patents
Adprin nano-emulsion anticoccidial drug and preparation process thereof Download PDFInfo
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- CN102973504A CN102973504A CN2012104232507A CN201210423250A CN102973504A CN 102973504 A CN102973504 A CN 102973504A CN 2012104232507 A CN2012104232507 A CN 2012104232507A CN 201210423250 A CN201210423250 A CN 201210423250A CN 102973504 A CN102973504 A CN 102973504A
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Abstract
The invention relates to an adprin nano-emulsion anticoccidial drug which has a particle size of 1 to 100 nm and comprises, by mass, 0.1 to 6.0% of adprin, 20.0 to 35.0% of a surfactant, 0 to 22.0% of a cosurfactant, 1.0 to 8.0% of a cosolvent and 1.5 to 12.0% of oil, with the balance being distilled water. The drug is colorless or light-yellow clear transparent liquid, has the characteristics of good stability, low viscosity, strong dispersibility, rapid absorption and the like, can improve bioavailability of adprin, allows adprin to have a prolonged half life in vivo and an enhanced curative effect and has the effects of slow release and targeting; and a preparation process for the drug has the advantages of easiness, low energy consumption, small toxicity, high security and no need for special equipment for mass production.
Description
Technical field
The invention belongs to field of veterinary, relate to a kind of novel form of drug for treating animal coccidiosis, particularly a kind of Adprin nanoemulsion coccidium-resisting drug and preparation method thereof.
Background technology
Adprin (adprin) is a kind of novel chemosynthesis ucleosides poultry anticoccidial drug, and it is mainly by bringing into play the anticoccidial effect by the purine metabolism that disturbs coccidiosis.Coccidiostat activity mainly concentrates on the agamocytogeny of coccidiosis, and the Sporulated of egg capsule is also had certain inhibitory action.Adprin in animal body in the liver under the effect of drug metabolizing enzyme, oxidable one-tenth Adprin-nitrogen-oxide, the coccidiostat activity of its oxide is stronger than former medicine, is a kind of novel wide spectrum coccidiostat.Adprin (adprin) is off-white color or pale yellow powder.This product is water insoluble, is slightly soluble in ethanol, is dissolved in glacial acetic acid, DMF.
Adprin is coccidiostat unique in the present ucleosides, and it brings into play the anticoccidial effect by the purine metabolism that disturbs coccidiosis.Its anticoccidial Peak of action is the agamocytogeny of coccidiosis, and namely effect in 1～3 day is the strongest behind coccidium infection.It is also effective to the coccidian oocyst formation stages simultaneously, and the virulence of egg capsule is reduced, and reduces appeal.Therefore, be applicable to treatment and prevent various chicken coccidiosis, Adprin belongs to the wide spectrum anticoccidial drug, and is all effective to Eimeria tenella, heap type Eimeria, Eimeria maxima and Eimeria Necatrix.But Adprin is water insoluble, so utilization rate is lower, uses waste.And studies show that Adprin is along with its particle diameter reduces, its anticoccidial effect is stronger, but most of particle diameters of China's pre existing mixture do not reach requirement, can't give full play to the anticoccidial effect of Adprin.Therefore thereby seek water solublity that a kind of suitable dosage form improves Adprin, reduce zest, improve palatability, heightening the effect of a treatment becomes current urgent problem.
Summary of the invention
For above-mentioned prior art defective, the object of the invention is to provide a kind of good stability, drug effect is high, zest is little and the nanoscale Adprin coccidiostat of good palatability, the invention also discloses the preparation method of this medicine.
For achieving the above object, the present invention adopts following technical scheme:
A kind of Adprin nanoemulsion coccidium-resisting drug, this nanoemulsion coccidium-resisting drug particle diameter is between 1～100nm, its one-tenth by following mass percent is grouped into: Adprin 0.1～6.0%, surfactant 20.0～35.0%, cosurfactant 0～22.0%, cosolvent 1.0～8.0%, oil 1.5～12.0%, surplus is distilled water.The mass percent sum of above-mentioned each composition is 100%.
Concrete, described Adprin nanoemulsion coccidium-resisting drug can be grouped into by the one-tenth of following mass percent: Adprin 0.1～5.3%, surfactant 20.5～32.3%, cosurfactant 0～20.0%, cosolvent 1.2～7.0%, oil 2.0～10.0%, surplus is distilled water.
Preferably the one-tenth by following mass percent is grouped into: Adprin 0.1～5.0%, surfactant 22.1～30.0%, cosurfactant 0.01～18.3%, cosolvent 1.5～2.7%, oil 2.2～8.3%, surplus is distilled water.
Preferably the one-tenth by following mass percent is grouped into: Adprin 0.5～5.0%, surfactant 23.5～29.0%, cosurfactant 0.01～17.3%, cosolvent 1.6～2.5%, oil 2.5～8.0%, surplus is distilled water.
The mass ratio of described surfactant and cosurfactant is advisable with 2～4:1; The mass ratio of described surfactant and cosurfactant sum and oil is for to be advisable with 9～4:1.
Described surfactant is preferably castor oil polyoxyethylene ether (EL-40), polyoxyethylene ether-40 castor oil hydrogenated (RH-40) or triton x-100; Described cosurfactant is preferably ethylene glycol, isopropyl alcohol or dehydrated alcohol; Described cosolvent is preferably formic acid or glacial acetic acid; Described oil is isopropyl myristate (IPM) or Jojoba oil.
The preparation method of described nanoemulsion coccidium-resisting drug, the method is specially: get at first in proportion each material composition, then with surfactant, cosurfactant and cosolvent mixing, then add successively Adprin and oil, dripping distilled water behind the mixing constantly stirs simultaneously, until form the system of homogeneous transparent, be the Adprin nanoemulsion coccidium-resisting drug.
According to the formation mechanism of nano-emulsion, when the required HLB value of hydrophile-lipophile balance (HLB) value and the oil of surfactant equates or be close, form easily the highly stable nano-emulsion of character.The present invention selects the toxicity less according to the method, is not subject to the impact of electrolyte, inorganic salts and soda acid and the polyoxyethylene ether good with the compatibility of other surfactants-40 castor oil hydrogenated, tween 80 as surfactant.
Spent glycol, isopropyl alcohol, dehydrated alcohol are as cosurfactant, the nano-emulsion emulsifying capacity that forms is strong, can also regulate the HLB value with it, make the easier formation nano-emulsion of surfactant and oil, formic acid or glacial acetic acid are as the content of cosolvent for further raising carrier Chinese medicine.
Form mechanism according to nano-emulsion, oil is that the matching surface activating agent participates in forming the stabilized nanoscale breast, the oily isopropyl myristate (IPM) that the present invention selects, the HLB value of Jojoba oil all and the HLB value of RH-40 approaching, easily form stable nano-emulsion.Their molecular weight is little in addition, and effect and the cosurfactant of micromolecule oil phase are similar, easily is embedded in the surfactant, jointly forms with it interfacial film, and solubilising power is greater than the macromole oil phase.The shared percentage ratio of water is higher in the nano-emulsion system, and the probability that forms nano-emulsion is larger.
The present invention adopts pseudo-ternary phase diagram to filter out best proportioning to prepare the Adprin nano-emulsion.When surfactant and cosurfactant mass ratio are 2:1～4:1, the nano-emulsion district that the mass ratio of surfactant and cosurfactant sum and oil forms when being 9:1～8:2 is maximum, the most stable, and drug loading is the highest simultaneously.
The speed that the present invention is spread in Adprin nano-emulsion of the present invention by oil-soluble dyes tonyred and water-soluble dye methylene blue is judged the type of this microemulsion.Result of the test shows: methylene blue solution has diffusion in microemulsion, and the not diffusion in microemulsion of tonyred solution shows that prepared microemulsion is oil-in-water type (O/W).
Adprin nanoemulsion coccidium-resisting drug of the present invention is colourless or faint yellow clear liquid, does not have crystallization low temperature-4 ℃ long-term placement the to 60 ℃ of hot conditionss, also without research of chaotic phenomenon, as seen is a kind of highly stable pharmaceutical dosage form; And preparation method is simple, energy consumption is low, toxicity is little, safe, do not need special installation to can be used for producing in enormous quantities, thereby be used for the clinical treatment livestock and poultry, as can be used for the chicken coccidiosis that prevention and treatment are caused by various coccidiosiss (displacement, tender, huge, heap type, murder by poisoning and Bu Shi etc.).During use, be advisable to add the Adprin nano-emulsion of the present invention that contains the 40mg Adprin at per kilogram water, freely drink water, 3 days is a course for the treatment of.Adprin nano-emulsion of the present invention is soluble in water, directly mixes getting final product during use with water, and is easy to use, effective.
Compared with prior art, Adprin nano-emulsion of the present invention has the following advantages:
1) has the characteristics such as viscosity is low, good stability, dispersibility is strong, absorption is rapid, medicine is wrapped in the kernel oil phase, also have slow release and targeting, and in vivo half-life of the bioavailability, prolong drug that can improve medicine, heighten the effect of a treatment, reduce toxic and side effects.
2) it also has the characteristics that surface tension is low, wellability is good, so medicine well is attached on the antibacterial, penetrates into its metabolism of coccidiosis internal interference and brings into play the anticoccidial effect.
The specific embodiment
Below by preferred embodiment the present invention is described in further details, but protection scope of the present invention is not limited to this.
Embodiment 1A kind of Adprin nanoemulsion coccidium-resisting drug, its each proportioning raw materials is as follows:
Adprin 0.03g
EL-40 9.0g
Isopropyl alcohol 3.0g
Formic acid 1.0g
IPM 1.0g
Distilled water 15.0g
The drug level of above-mentioned Adprin nano-emulsion is 0.1%; It prepares as follows and gets: get at first in proportion each material composition, then with surfactant EL-40, cosurfactant isopropyl alcohol and cosolvent triethanolamine mixing, then add successively Adprin and oily IPM, dripping distilled water behind the mixing constantly stirs simultaneously, until form the system of homogeneous transparent, namely getting particle diameter is the Adprin nanoemulsion coccidium-resisting drug of 1～100 nm, appearance transparent.
Embodiment 2A kind of Adprin nanoemulsion coccidium-resisting drug, its each proportioning raw materials is as follows:
Adprin 0.5g
Triton x-100 8.0g
Dehydrated alcohol 3.5g
Glacial acetic acid 0.8g
Jojoba oil 0.95g
Distilled water 16.0g
The drug level of above-mentioned Adprin nano-emulsion is 1.7%; Its preparation method prepares gained Adprin nanoemulsion coccidium-resisting drug outward appearance homogeneous transparent with reference to embodiment 1, and particle size range is 1～100 nm.
Embodiment 3A kind of Adprin nanoemulsion coccidium-resisting drug, its each proportioning raw materials is as follows:
Adprin 1.0g
RH40 7.5g
Ethylene glycol 3.0g
Formic acid 2.0g
IPM 1.4g
Distilled water 15.0g
The drug level of above-mentioned Adprin nano-emulsion is 3.3%; Its preparation method prepares gained Adprin nanoemulsion coccidium-resisting drug outward appearance homogeneous transparent with reference to embodiment 1, and particle size range is 1～100 nm.
Embodiment 4A kind of Adprin nanoemulsion coccidium-resisting drug, its each proportioning raw materials is as follows:
Adprin 1.3g
EL40 6.0g
Isopropyl alcohol 2.5g
Formic acid 1.5g
Jojoba oil 1.1g
Distilled water 9.4g
The drug level of above-mentioned Adprin nano-emulsion is 6.0%; Its preparation method prepares gained Adprin nanoemulsion coccidium-resisting drug outward appearance homogeneous transparent with reference to embodiment 1, and particle size range is 1～100 nm.
Adprin nano-emulsion anticoccidial drug of the present invention is carried out high speed centrifugation and carry out reserved sample observing under-4 ℃, room temperature, 60 ℃ of conditions, according to whether having layering and crystallization phenomenon to judge its stability.
1. the high speed centrifugation test is on the impact of nano-emulsion stability
Get the Adprin nanoemulsion coccidium-resisting drug liquid of an amount of preparation in centrifuge tube, sealing orifice sets high in the fast centrifuge, carries out centrifugal with the rotating speed of 12000r/min, still keep clear through the centrifugal nanoemulsions of 20 min, have no that Adprin is separated out and the profit lamination.
2. reserved sample observing experiment
Get part Adprin nano-emulsion, be sub-packed in several vials, placing respectively after the sealing keeps sample under refrigerator-4 ℃, 25 ℃ of room temperatures, 60 ℃ of conditions of high temperature investigates 60d, observes every the 5d sampling.The result shows that this nano-emulsion all keeps the outward appearance of clear under three kinds of temperature conditions, breakdown of emulsion, layering and crystallization are not arranged.Observe under the transmission electron microscope, the drop of Adprin nano-emulsion is spherical in shape, and its size is 1～100nm, and is evenly distributed, favorable dispersibility.
Adopt international anticoccidial index (ACI) that Adprin nano-emulsion anticoccidial effect of the present invention is assessed.
1 test material
1.1 experimental animal
1 age in days Luo Man egg cock broods under the non-ball worm environment to 11 ages in days, weighs, divides into groups behind the pretest inspection non-ball worm egg capsule.
1.2 trial drug
Ball smooth (effective ingredient is: sulfaclozine sodium, Henan are herded Xiang animal pharmaceutical estate company and produced, as treatment matched group medicine); Embodiment 4 described Adprin nano-emulsions (as the treatment group medicine).
2 test methods
2.1 test grouping
According to the body weight dispersion, experimental chicken is divided into 4 groups at random, 10 every group, record is starting weight just.The 1st～2 group for infecting the medication group, and the 3rd group for infecting not medication group (infection matched group), and the 4th group for not infecting not medication group (normal healthy controls group).
2.2 infect and administration
Except the 4th group, other respectively organizes chicken (the 1st～3 group) all in 11 age in days oral vaccination coccidiosis (Anhui strain) egg capsules 4.0 * 10
5Individual/only.1～3 group after infecting 72h anticoccidial drug to the experiment of throwing something and feeding finish.See table 1 for details.
Duration of test observed and recorded every day is respectively organized mental status, appetite, drinking-water and the feces situation of chicken.Morbidity and the death condition of chicken respectively organized in record, and inspection and the record cause of death are weighed, cutd open to dead chicken at any time.Calculate behind the counteracting toxic substances the 6th day gram feces egg capsule output (OPG), behind the counteracting toxic substances the 8th day, test chicken all weighed, cuts open on an empty stomach kill, carry out lesion score, measure corresponding test index.
Results and analysis
3.1 the curative effect of anticoccidial drug
Carry out Comprehensive Assessment by the relative weight gain rate, survival rate, pathological changes value, egg capsule output (OPG) and 5 indexs of anticoccidial index (ACI).See table 2 for details.
3.1.1 the relative weight gain rate
The the 1st to 3 group all is not higher than the 4th group (normal healthy controls group), and wherein the 2nd group (test group) is significantly higher than the 3rd group (infection matched group), but still is starkly lower than the 4th group; The 1st group (treatment matched group) with the 3rd group without significant difference.
3.1.2 survival rate
Death concentrates on the 6th day, wherein the 3rd group in the 6th day dead 2, other the group chicken without the phenomena of mortality.
3.1.3 pathological changes value: damage and the anti-damage criterion of reflection body have important reference significance to drug screening.
The 1st group and the 3rd group has the petechia that is dispersed in that duodenum goes out, and all the other groups all do not have pathological changes.
3.1.4 egg capsule output: the important inherent index that is reflection coccidiostat curative effect.
Each organize the result by good to poor being followed successively by: the 4th group=the 2nd group〉the 1st group the 3rd group
3.1.5 anticoccidial index (ACI)
ACI is followed successively by from high to low: the 4th group〉the 2nd group〉the 1st group〉the 3rd group
4 conclusions
Can be found out obviously that by the above results Adprin nano-emulsion anticoccidial of the present invention is evident in efficacy to be higher than the smooth group of ball and to infect matched group, is a kind of coccidiostat of works very well.
Claims (7)
1. Adprin nanoemulsion coccidium-resisting drug, it is characterized in that, this nanoemulsion coccidium-resisting drug particle diameter is 1～100nm, its one-tenth by following mass percent is grouped into: Adprin 0.1～6.0%, surfactant 20.0～35.0%, cosurfactant 0～22.0%, cosolvent 1. 0～8.0%, oil 1.5～12.0%, surplus is distilled water.
2. nanoemulsion coccidium-resisting drug according to claim 1, it is characterized in that, one-tenth by following mass percent is grouped into: Adprin 0.1～5.3%, surfactant 20.5～32.3%, cosurfactant 0～20.0%, cosolvent 1.2～7.0%, oil 2.0～10.0%, surplus is distilled water.
3. nanoemulsion coccidium-resisting drug according to claim 2, it is characterized in that, one-tenth by following mass percent is grouped into: Adprin 0.1～5.0%, surfactant 22.1～30.0%, cosurfactant 0.01～18.3%, cosolvent 1.5～2.7%, oil 2.2～8.3%, surplus is distilled water.
4. nanoemulsion coccidium-resisting drug according to claim 3, it is characterized in that, one-tenth by following mass percent is grouped into: Adprin 0.5～5.0%, surfactant 23.5～29.0%, cosurfactant 0.01～17.3%, cosolvent 1.6～2.5%, oil 2.5～8.0%, surplus is distilled water.
5. according to claim 1 to 4 arbitrary described nanoemulsion coccidium-resisting drugs, it is characterized in that the mass ratio of described surfactant and cosurfactant is 2～4:1; Described surfactant and cosurfactant sum are 9～4:1 with the mass ratio of oil.
6. nanoemulsion coccidium-resisting drug according to claim 5 is characterized in that, described surfactant is castor oil polyoxyethylene ether, polyoxyethylene ether-40 castor oil hydrogenated or triton x-100; Described cosurfactant is ethylene glycol, isopropyl alcohol or dehydrated alcohol; Described cosolvent is formic acid or glacial acetic acid; Described oil is isopropyl myristate or Jojoba oil.
7. the preparation method of the arbitrary described nanoemulsion coccidium-resisting drug of claim 1 to 4, it is characterized in that, get at first in proportion each material composition, then with surfactant, cosurfactant and cosolvent mixing, then add successively Adprin and oil, drip distilled water behind the mixing and constantly stir simultaneously, until form the system of homogeneous transparent, be the Adprin nanoemulsion coccidium-resisting drug.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103222958A (en) * | 2013-04-22 | 2013-07-31 | 安徽农业大学 | Anticoccidial adprin dry suspension and preparation method thereof |
| CN103417488A (en) * | 2013-09-11 | 2013-12-04 | 河南牧翔动物药业有限公司 | Adprin preparation for resisting coccidiosis and preparation method |
| CN104161725A (en) * | 2013-08-30 | 2014-11-26 | 郑州后羿制药有限公司 | Arprinocide nano-emulsion for coccidium resistance and preparation method thereof |
| CN104161727A (en) * | 2013-08-30 | 2014-11-26 | 郑州后羿制药有限公司 | Adprin liposome and preparation method thereof |
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| CN102274173A (en) * | 2011-09-09 | 2011-12-14 | 广州华农大实验兽药有限公司 | Novel anticoccidial agent adprin solution and preparation method thereof |
| CN102525919A (en) * | 2011-11-28 | 2012-07-04 | 河南牧翔动物药业有限公司 | Decoquinate nanoemulsion coccidium-resisting drug and preparation method thereof |
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2012
- 2012-10-30 CN CN2012104232507A patent/CN102973504A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102274173A (en) * | 2011-09-09 | 2011-12-14 | 广州华农大实验兽药有限公司 | Novel anticoccidial agent adprin solution and preparation method thereof |
| CN102525919A (en) * | 2011-11-28 | 2012-07-04 | 河南牧翔动物药业有限公司 | Decoquinate nanoemulsion coccidium-resisting drug and preparation method thereof |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103222958A (en) * | 2013-04-22 | 2013-07-31 | 安徽农业大学 | Anticoccidial adprin dry suspension and preparation method thereof |
| CN104161725A (en) * | 2013-08-30 | 2014-11-26 | 郑州后羿制药有限公司 | Arprinocide nano-emulsion for coccidium resistance and preparation method thereof |
| CN104161727A (en) * | 2013-08-30 | 2014-11-26 | 郑州后羿制药有限公司 | Adprin liposome and preparation method thereof |
| CN104161727B (en) * | 2013-08-30 | 2016-08-10 | 郑州后羿制药有限公司 | A kind of A De furan woods liposome and preparation method thereof |
| CN103417488A (en) * | 2013-09-11 | 2013-12-04 | 河南牧翔动物药业有限公司 | Adprin preparation for resisting coccidiosis and preparation method |
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Application publication date: 20130320 |