CN101297960A - Preparation of chicken interferon novel dosage form - Google Patents
Preparation of chicken interferon novel dosage form Download PDFInfo
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- CN101297960A CN101297960A CNA2008100533602A CN200810053360A CN101297960A CN 101297960 A CN101297960 A CN 101297960A CN A2008100533602 A CNA2008100533602 A CN A2008100533602A CN 200810053360 A CN200810053360 A CN 200810053360A CN 101297960 A CN101297960 A CN 101297960A
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Abstract
The invention relates to a preparation method of a new formulation chicken interferon, which has the steps as follows: (1) the chicken interferon is dissolved in an aqueous phase buffer solution to form a solution (A), the pH value of which ranges from 2.5 to 7.0 and the content of the chicken interferon is 0.5-5.0 mg/ml; (2) the acid solution (A) containing the chicken interferon is added into a liquid nonionic type surfactant solution, the hydrophile-lyophile balance value of which is HLB being more than or equal to 9 and less than or equal to 15, or into amphipathic grease, or into the intermixture of the nonionic type surfactant solution and the amphipathic grease to be mixed as a solution (B); (3) the solution (B) is added into liquid oil phase with the hydrophile-lyophile balance value of HLB being more than or equal to 0 and less than or equal to 9, or into a lipophilic emulsifier, or into the intermixture of the oil phase and the lipophilic emulsifier. The ratio of the solution (B) and the intermixture ranges from 1:1 to 1:9 and the two solutions are stirred and mixed at the temperature of 5 DEG C to 30 DEG C to form an oil phase formulation (C); (4) a stabilizing agent is added. The preparation method of the invention has simple preparation, simple and convenient application and easy absorption, and can better realize the effect of treating chicken viral diseases.
Description
Technical field
The invention belongs to the preparing technical field of bio-pharmaceutical, particularly a kind of preparation method of chicken interferon novel dosage form.
Background technology
At present, chicken interferon all is with the administration of injecting better therapeutic effect to be arranged, and many persons need inject 1-2 time every day, brings a lot of inconvenience for the use of culturing the owner, and therefore being made into drinking-water, oral formulations just becomes the target that people pursue.If have breakthrough in this regard, will produce huge social and economic benefit.But directly with these bio-pharmaceutical drinking-water, oral, because the degraded digestion of gastrointestinal tract endoenzyme and the absorption barrier of intestinal make its availability very low, therapeutic effect is relatively poor.
Therefore, providing a kind of preparation method of chicken interferon novel dosage form, effectively prevent and prevent and treat various chicken viral diseases, is one of this technical field scientific research personnel new problem of being badly in need of developing.
Summary of the invention
The objective of the invention is for overcoming the weak point of prior art, provide a kind of and prepare simply, use preparation method convenient, the obvious results chicken interferon novel dosage form.
A kind of preparation method of chicken interferon novel dosage form is characterized in that comprising the steps:
(1) a certain amount of chicken interferon is dissolved in the water buffer solution, the pH value of this solution (A) is 2.5-7.0, and the content of chicken interferon is the 0.5-5.0 mg/ml;
(2) the above-mentioned acid solution (A) that contains chicken interferon is joined in the nonionic surfactant solution of liquid state that hydrophile-lipophile balance value (HLB) is 9≤HLB≤15, or in the amphiphilic grease, or in their mixed liquor; Described solution (A) and these surfactants, or amphiphilic grease, or the ratio of their mixed liquor is 1: 4 to 1: 40; These two kinds of solution stir under temperature 5-30 ℃, and it is mixed uniformly, become a kind of transparent solution (B);
(3) solution (B) is added in the oil phase of liquid state that hydrophile-lipophile balance value is 0≤HLB≤9, or in the lipophilic emulsifier, or in the mixed liquor of oil phase and lipophilic emulsifier, solution (B) is 1: 1 to 1: 9 with its ratio, these two kinds of solution are mixed under temperature 5-30 ℃, finally become a kind of transparent oil phase formulation (C), preserve down at 4-10 ℃;
(4) in order to keep the stable of solution, add certain amount of stabilizer; Stabilizing agent directly joins in described preparation process (1) solution, in the solution in the perhaps described step (3).
Surfactant in the described step (2), or amphiphilic grease, or their mixed liquor adopts following one or more mixing: ten Monooctamoins, Polyethylene Glycol-8-glycerol are sad/decanoin, Tween 80.
Described mixing speed is 100-1800 rev/min, and mixing time is 0.4-4 hour.
Lipophile solution or emulsifying agent in the described step (3) are: glyceryl oleate, polyglycereol-3-oleate, Polyethylene Glycol-6-glycerin mono-fatty acid ester.
Whipping temp in the described step (3) is 5-30 ℃, and mixing speed is 100-1800 rev/min, and mixing time is 0.4-4.0 hour.
Described stabilizing agent is selected from one or more of trehalose, bovine serum albumin, egg white powder and Polyethylene Glycol.
The addition of described stabilizing agent is the 0.1%-10% of final solution.
Described chicken interferon is reorganization chicken genetic engineering interferon IFN-α, IFN-β and the natural LeIF of chicken.
The beneficial effect of the inventive method is: it is simple to have preparation technology, realize easily, it is convenient to use, characteristics such as required cost is low, this method adopts toxicity little, materials such as oral safe dispersant and oil phase make the uniform dispersing and dissolving of chicken interferon in oil phase, finally become a kind of transparent chicken interferon oil phase formulation.The oil phase formulation experiment in vitro that adopts this method to make shows that it in different pH (2-11) solution emulsification can both take place, and chicken interferon still is wrapped in basically in the oil and does not enter water.Therefore at drinking-water, when oral, Degradation that can reasonable opposing gastrointestinal enzyme, and absorbing is easily better brought into play the antiviral drug effect.
The specific embodiment
Below in conjunction with embodiment, to details are as follows according to the specific embodiment provided by the invention:
Embodiment 1
A kind of preparation method of chicken interferon novel dosage form is characterized in that concrete implementation step is as follows:
(1) is to add 32.0mg chicken genetic engineering interferon IFN-α in 4.5 the solution at 8ml pH, makes its dissolving (A solution);
(2) taking polyethylene glycol-8-glycerol sad/decanoin 40.0ml, A solution added mix into 48ml.Mixing speed: 500 rev/mins; Time: 3.0 hours; Temperature: 20 ℃ (B solution);
(3) get polyglycereol-3-oleate 152ml, the adding of B solution is mixed into 200ml, mixing speed: 500 rev/mins, the time: 3.0 hours, temperature: 20 ℃ (C solution);
(4) add 500mg trehalose and 500mg egg white powder at C solution; And mix homogeneously, deposit in refrigerator and cooled and hide.
Embodiment 2
A kind of preparation method of chicken interferon novel dosage form is characterized in that concrete implementation step is as follows:
(1) in the solution of 10ml pH=3.5, adds the natural LeIF 16.0mg of chicken, make its dissolving (solution A);
(2) get Tween 80 14ml, ten Monooctamoin 26ml, mix homogeneously adds solution A then and mixes, and stirs; Mixing speed: 1000 rev/mins; Time: 2.5 hours; Temperature: 18 ℃ (solution B);
(3) get glyceryl oleate 150ml, above-mentioned B solution adding is mixed into 200ml; Mixing speed: 1000 rev/mins; Time: 2.5 hours; Temperature: 18 ℃ (C solution);
(4) add 100mg trehalose and 200mg bovine serum albumin in C solution, mix homogeneously is deposited in refrigerator and cooled and is hidden.
Embodiment 3
A kind of preparation method of chicken interferon novel dosage form is characterized in that concrete implementation step is as follows:
(1) add 50.0mg chicken genetic engineering interferon IFN-β in the solution of 10ml pH=4,200mg Polyethylene Glycol 5000 makes its dissolving (A solution);
(2) taking polyethylene glycol-8-glycerol sad/decanoin 80ml; A solution is added, be mixed into 90ml; Mixing speed: 1500 rev/mins; Time: 2 hours; Temperature: 25 ℃ (B solution);
(3) get polyglycereol 3 oleate 55ml and Polyethylene Glycol-6-glycerol list olein 55ml, be mixed into 110ml solution, then B solution is mixed mixing speed with this mixed liquor under following condition: 1500 rev/mins; Time: 2 hours; Temperature: 25 ℃ (C solution), deposit in refrigerator and cooled and hide, preserve down at 4-10 ℃.
Application example 1
Chicken interferon novel dosage form is to the therapeutical effect of newcastle disease
Therapeutic test makes chickling that newcastle disease take place with the method for artificial infection chicken's Avian pneumo-encephalitis virus the chicken of 36 10-20 ages in days in artificial Causative virus model, and the while is divided into 2 groups, 18 every group at random.The A group is " chicken interferon novel dosage form " treatment group, and chicken interferon novel dosage form is to adopt the preparation of embodiment 1 method; The B group is treated with normal saline for matched group.2 groups of chickens are contaminated with newcastle disease virus simultaneously, every chicken is with the strong malicious collunarium 0.2ml of newcastle disease virus, after waiting clinical symptoms to occur, only give " chicken interferon novel dosage form " 0.2ml/ to the A group with water way, once a day, B group chicken injecting normal saline 0.5ml/ only, once a day, logotype 2-3 days, observe morbidity death and the pathological change of chicken then, and itemized record.
The artificial therapeutic effect that causes a disease
Behind the contamination 24h, test chicken begins to occur clinical symptoms: lassitude, to stand transfixed to the ground, and feather is fluffy and disorderly, and row's yellow green loose stool, diet reduce or are useless exhausted.After the medication, A group chicken takes a turn for the better since the 2d state of an illness, and 3d, 4d have dead chicken to occur, the basic rehabilitation of the chicken that survives behind the 5d, sb.'s illness took a turn for the worse after the 2nd day symptom occurring for B group chicken, begins to occur dead, 3-5d reaches dead peak, spontaneous recovery behind the not dead chicken 6d.Chicken interferon novel dosage form treatment group and matched group difference is (P＜0.01) extremely significantly, illustrates that water way gives " chicken interferon novel dosage form " newcastle disease is had certain therapeutical effect.
Table 1 liang group therapeutic outcome comparison (example, %)
| Group | The example number | Cure | Take a turn for the better | Effectively | Dead |
| The A group | 18 | 4(22.2％) | 12(66.7％) | 16(88.9％) | 2(11.1％) |
| The B group | 18 | 0 | 0(0) | 4(22.2％) | 14(77.8％) |
Application example 2
Chicken interferon novel dosage form is to the therapeutical effect of infectious bronchitis of chicken
Typical infectious bronchitis of chicken morbidity chicken is selected in the clinical treatment test, and 54 chickens are divided into 3 groups at random, and the A group only gives chicken interferon novel dosage form 0.2ml/ with the spice oral way, and chicken interferon novel dosage form is to adopt the preparation of embodiment 2 methods; B group oral administration astragalus polysaccharide 5mg/ only.C organizes oral normal saline.
Experimental result
The avian infectious bronchopathy result of the test of table 2 " the oral novel form of chicken interferon " treatment
| Group | Quantity | The morbidity number | Death toll | Mortality rate % | Significant figure | Effective percentage % |
| The A group | 18 | 18 | 2 | 11.1 | 16 | 88.9 |
| The B group | 18 | 18 | 10 | 55.6 | 8 | 44.4 |
| The C group | 18 | 18 | 14 | 77.8 | 4 | 22.2 |
By table 2 as seen, " chicken interferon novel dosage form " test group effective percentage is 88.9%, and the effective percentage of oral normal saline group is 22.2%.As seen, give chicken interferon novel dosage form with the spice oral way avian infectious bronchopathy is had good therapeutic effect.
Application example 3
The example of " chicken interferon novel dosage form " treatment infectious bursal disease
March in 2008 Tianjin plant on the 10th laying hen, same symptoms appears successively: swollen eye socket, cough, snore, reductions of searching for food, laying rate decline, found later on that the chicken death rate rises on March 13, dead fast, feed intake descends fast, and per 1000 chicken dead 10-20 every day only.Through cuing open the inspection diagnosis: infectious bursal disease.At above-mentioned phenomenon, chicken interferon novel dosage form drinking-water is used in suggestion, logotype 2-3 days, cooperates multidimensional electrolyte etc. can control death rapidly in addition, the chicken group state that refreshes.Facts have proved, illustrate that water way gives the chicken interferon novel dosage form may command infectious bursal disease state of an illness, reduce mortality rate.
Chicken interferon novel dosage form mainly has significant advantage to the prevention and the treatment of treatment avian viral disease.Studies confirm that: chicken interferon novel dosage form also has remarkable therapeutical effect to the chicken model and the infectious bronchitis of chicken morbidity chicken of artificial challenge's newcastle disease virus.As seen, give the active drug that chicken interferon novel dosage form is the treatment avian viral disease with drinking-water, oral way.
Above-mentioned detailed description of the preparation method of this chicken interferon novel dosage form being carried out with reference to embodiment; be illustrative rather than determinate; can list several embodiment according to institute's limited range; therefore in the variation and the modification that do not break away under the general plotting of the present invention, should belong within protection scope of the present invention.
Claims (6)
1, a kind of preparation method of chicken interferon novel dosage form is characterized in that comprising the steps:
(1) a certain amount of chicken interferon is dissolved in the water buffer solution, the pH value of this solution (A) is 2.5-7.0, and the content of chicken interferon is the 0.5-5.0 mg/ml;
(2) the above-mentioned acid solution (A) that contains chicken interferon is joined in the nonionic surfactant solution of liquid state that hydrophile-lipophile balance value (HLB) is 9≤HLB≤15, or in the amphiphilic grease, or in their mixed liquor; Described solution (A) and these surfactants, or amphiphilic grease, or the ratio of their mixed liquor is 1: 4 to 1: 40; These two kinds of solution stir under temperature 5-30 ℃, and it is mixed uniformly, become a kind of transparent solution (B);
(3) solution (B) is added in the oil phase of liquid state that hydrophile-lipophile balance value is 0≤HLB≤9, or in the lipophilic emulsifier, or in the mixed liquor of oil phase and lipophilic emulsifier, solution (B) is 1: 1 to 1: 9 with its ratio, these two kinds of solution are mixed under temperature 5-30 ℃, finally become a kind of transparent oil phase formulation (C), preserve down at 4-10 ℃;
(4) in order to keep the stable of solution, add certain amount of stabilizer; Stabilizing agent directly joins in described preparation process (1) solution, in the solution in the perhaps described step (3).
2, the preparation method of chicken interferon novel dosage form according to claim 1, it is characterized in that the surfactant in the described step (2), or amphiphilic grease, or their mixed liquor adopts following one or more mixing: Polyethylene Glycol-8-glycerol is sad/and decanoin, Tween 80, ten Monooctamoins.
3, the preparation method of chicken interferon novel dosage form according to claim 1 is characterized in that lipophile solution or the emulsifying agent in the described step (3) is: glyceryl oleate, polyglycereol-3-oleate, Polyethylene Glycol-6-glycerin mono-fatty acid ester.
4, the preparation method of chicken interferon novel dosage form according to claim 1 is characterized in that described stabilizing agent is selected from one or more of trehalose, bovine serum albumin, egg white powder and Polyethylene Glycol.
5, the preparation method of chicken interferon novel dosage form according to claim 1, the addition that it is characterized in that described stabilizing agent is the 0.1%-10% of final solution.
6, the preparation method of chicken interferon novel dosage form according to claim 1 is characterized in that described chicken interferon is reorganization chicken genetic engineering interferon IFN-α, IFN-β and the natural LeIF of chicken.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008100533602A CN101297960A (en) | 2008-05-30 | 2008-05-30 | Preparation of chicken interferon novel dosage form |
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| Application Number | Priority Date | Filing Date | Title |
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| CNA2008100533602A CN101297960A (en) | 2008-05-30 | 2008-05-30 | Preparation of chicken interferon novel dosage form |
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| CN101297960A true CN101297960A (en) | 2008-11-05 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102961334A (en) * | 2012-12-11 | 2013-03-13 | 河南省康星药业股份有限公司 | Method for preparing stable chicken alpha interferon spray preparation |
| CN109125713A (en) * | 2017-06-19 | 2019-01-04 | 杭州俊丰生物工程有限公司 | A kind of chicken interferon-α Pharmaceutical composition |
-
2008
- 2008-05-30 CN CNA2008100533602A patent/CN101297960A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102961334A (en) * | 2012-12-11 | 2013-03-13 | 河南省康星药业股份有限公司 | Method for preparing stable chicken alpha interferon spray preparation |
| CN109125713A (en) * | 2017-06-19 | 2019-01-04 | 杭州俊丰生物工程有限公司 | A kind of chicken interferon-α Pharmaceutical composition |
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Open date: 20081105 |