CN104856951A - Follicle stimulating hormone transdermal nanometer emulsion and preparation method thereof - Google Patents
Follicle stimulating hormone transdermal nanometer emulsion and preparation method thereof Download PDFInfo
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- CN104856951A CN104856951A CN201510226660.6A CN201510226660A CN104856951A CN 104856951 A CN104856951 A CN 104856951A CN 201510226660 A CN201510226660 A CN 201510226660A CN 104856951 A CN104856951 A CN 104856951A
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Abstract
The invention discloses a type of follicle stimulating hormone transdermal nanometer emulsion. The follicle stimulating hormone transdermal nanometer emulsion comprises, by weight, 20% to 75% of aqueous phase, 0.001% to 0.1% of FSH, 10% to 50% of protein structure stabilizer, 5% to 25% of surfactant, 1% to 5% of cosurfactant, and 0.01% to 2% of oil phase. The emulsion droplet grain size of the FSH transdermal nanometer emulsion ranges from 50 nm to 500 nm, the follicle stimulating hormone transdermal nanometer emulsion has the advantages of being stable, good in transdermal permeation performance and the like, in addition, the preparation process is simple, operation is convenient, energy consumption is low, the prices of needed raw materials are moderate, and the follicle stimulating hormone transdermal nanometer emulsion is applicable to large-scale industrial production.
Description
Technical field
The invention belongs to veterinary drug field of pharmaceutical preparations, relate to the medicine of the multiple follicular development of a kind of stimulating animal, superovulation, be specifically related to a kind of follicule-stimulating hormone (FSH) (FSH) transdermal nano-emulsion and preparation method thereof.
Background technology
Follicule-stimulating hormone (FSH) (FSH) is a kind of heterodimer glycoprotein promoting sexual gland hormone of the synthesis of animal anterior pituitary basophil cell and secretion, be made up of α and the β subunit of Non-covalent binding, molecular weight is about 30kDa, can promote the growth of jenny follicle and normal generation that is ripe, buck sperm.Under natural physiological condition, FSH window is very narrow, monotocous animal only has a follicular development ripe to ovulation in a normal onset of ovulation, even if multiparous animal also only has artially follicular to reach maturity, other follicles are successively degenerated in different developmental phases, and the FSH of visible normal pituitary secretion can only ensure that one or artially follicular are reached maturity.If inject a large amount of FSH at proestrum to animal, just can make the follicular development maturation that will degenerate, its ovulation amount can exceed the several times of normal number of eggs ovulated.Therefore, in clinical practice, FSH is by the critical medication as the multiple follicular development of auxiliary procreation technology moderate stimulation, superovulation.But the FSH half-life is in vivo short, is only about 3h, internal metabolism and elimination are rapidly.The follicule-stimulating hormone (FSH) preparation of current Clinical practice is freeze-dried powder or injection, and administration animal needs every day 1 time or 2 subcutaneous or intramuscular injection, and will inject continuously in 10 ~ 12 of reproductive cycle day, and the compliance of animal is poor.If FSH is prepared into Percutaneously administrable preparation to replace traditional injection type, while raising animals administer compliance, can be continuously and effectively delivered to body circulation, be overcome half-life short shortcoming.But FSH belongs to macromolecular drug, the feature that water solublity is strong, molecular weight is large and bear is electric makes it be difficult to through keratodermatitis.
Summary of the invention
The object of this invention is to provide a kind of follicule-stimulating hormone (FSH) transdermal nano-emulsion and preparation method thereof, the follicule-stimulating hormone (FSH) transdermal nano-emulsion prepared by the inventive method has good Cutaneous permeation performance.
Concrete technical scheme of the present invention is as follows:
A kind of follicule-stimulating hormone (FSH) transdermal nano-emulsion, be prepared from primarily of aqueous phase, follicule-stimulating hormone (FSH), protein structure stabilizing agent, surfactant, cosurfactant and oil phase, count by weight percentage, composition and the content of its raw material are as follows:
The gross weight of above-mentioned raw materials is 100%.
Described aqueous phase is distilled water, deionized water or purified water.
Described follicule-stimulating hormone (FSH) is restructuring pig follicle stimulin (Porcine FSH).
Described protein structure stabilizing agent is sucrose or glycerol.
Described surfactant is selected from sorbitan fatty acid ester (span, Span), polyoxyethylene sorbitan fatty acid ester (tween, Tween), polyoxyethylene aliphatic alcohol ether class (Brij, Brij), polyoxyethylene fatty acid ester class (Myrij, Myrj) one or more, in POLOXAMER (poloxamer, Poloxamer), emulsifing wax, castor oil hydrogenated, pyrrolidone sodium carboxylate, lecithin, fabaceous lecithin.
Described cosurfactant is selected from one or more in propylene glycol, glycerol, Polyethylene Glycol, medium chain monoglyceride, sorbitan fatty acid ester (span, Span), polyoxyethylene fatty acid ester class (Myrij, Myrj).
Described oil phase is aromatic hydrocarbon, paraffin, Oleum Arachidis hypogaeae semen or soybean oil.
A preparation method for follicule-stimulating hormone (FSH) transdermal nano-emulsion, specifically comprises the steps:
(1) follicule-stimulating hormone (FSH), protein structure stabilizing agent, surfactant, cosurfactant, oil phase and aqueous phase is taken respectively by formula proportion, for subsequent use;
(2) by follicule-stimulating hormone (FSH) with after suitable quantity of water phased soln, add the protein structure stabilizing agent of recipe quantity, prepare stable follicule-stimulating hormone (FSH) solution;
(3) oil phase of recipe quantity, surfactant, cosurfactant and remaining aqueous phase are mixed, magnetic stirring apparatus stirs with the rotating speed of 200 ~ 400rpm, after being heated to 40 ~ 65 DEG C, stop heating, and add the follicule-stimulating hormone (FSH) solution obtained in step (2), continue stirring 10 ~ 30min and make homogeneous mixed liquor, i.e. primary emulsion;
(4) by primary emulsion homogenizer with the rotating speed of 10000 ~ 14000rpm, circulate under room temperature homogenizing 10 ~ 30min, finally obtains the follicule-stimulating hormone (FSH) transdermal nano-emulsion of particle diameter at 50 ~ 500nm of dispersed phase particles.
A kind of follicule-stimulating hormone (FSH) transdermal nano-emulsion that the present invention prepares, its emulsion droplet size, between 50 ~ 500nm, therefore has the features such as stable, transdermal penetration performance is good, and preparation process simple, easy to operate, consume energy low, needed raw material is moderate, is applicable to large-scale industrial production.
Detailed description of the invention
Set forth medicine of the present invention and preparation method thereof further below by specific embodiment, but do not limit the present invention.
Embodiment 1
Precision takes FSH 0.010g, after dissolving, adds 3.4g glycerol, makes FSH glycerite with 3.4g distilled water.0.09g soybean oil, 0.8g pyrrolidone sodium carboxylate, 0.5g emulsifing wax, 0.2g Span60 and 1.6g distilled water are mixed, magnetic stirring apparatus to stir with the rotating speed of 200rpm and after being heated to 40 DEG C, stop heating, and add FSH glycerite, continue to stir 30min and make homogeneous mixed liquor.Then use homogenizer with the rotating speed of 10000rpm, circulate under room temperature homogenizing 20min, namely obtains the FSH transdermal nano-emulsion of particle diameter at 50 ~ 500nm.
Embodiment 2
Precision takes FSH 0.007g, after dissolving, adds 3.2g glycerol, makes FSH glycerite with 3.2g distilled water.0.013g soybean oil, 0.68g pyrrolidone sodium carboxylate, 0.4g emulsifing wax, 0.5g propylene glycol and 2g distilled water are mixed, magnetic stirring apparatus to stir with the rotating speed of 300rpm and after being heated to 65 DEG C, stop heating, and add FSH glycerite, continue to stir 30min and make homogeneous mixed liquor.Then use homogenizer with the rotating speed of 12000rpm, circulate under room temperature homogenizing 20min, namely obtains the FSH transdermal nano-emulsion of particle diameter at 50 ~ 500nm.
Embodiment 3
Precision takes FSH 0.005g, after dissolving, adds 3g glycerol, makes FSH glycerite with 2.8g distilled water.0.01g Oleum Arachidis hypogaeae semen, 0.5g pyrrolidone sodium carboxylate, 0.9g emulsifing wax, 0.385g Span60 and 2.4g distilled water are mixed, magnetic stirring apparatus to stir with the rotating speed of 400rpm and after being heated to 40 DEG C, stop heating, and add FSH glycerite, continue to stir 10min and make homogeneous mixed liquor.Then use homogenizer with the rotating speed of 14000rpm, circulate under room temperature homogenizing 10min, namely obtains the FSH transdermal nano-emulsion of particle diameter at 50 ~ 500nm.
Embodiment 4
Precision takes FSH 0.010g, after dissolving, adds 3.4g sucrose, makes FSH sucrose solution with 3.4g distilled water.0.09g soybean oil, 0.8g pyrrolidone sodium carboxylate, 0.5g emulsifing wax, 0.2g Span60 and 1.6g distilled water are mixed, magnetic stirring apparatus to stir with the rotating speed of 200rpm and after being heated to 40 DEG C, stop heating, and add FSH sucrose solution, continue to stir 30min and make homogeneous mixed liquor.Then use homogenizer with the rotating speed of 10000rpm, circulate under room temperature homogenizing 20min, namely obtains the FSH transdermal nano-emulsion of particle diameter at 50 ~ 500nm.
Embodiment 5
Precision takes FSH 0.006g, after dissolving, adds 3.0g glycerol, makes FSH glycerite with 3.4g distilled water.By 0.144g soybean oil, 0.7g Span-80,0.8g Tween-80,0.35g propylene glycol and the mixing of 1.6g distilled water, magnetic stirring apparatus to stir with the rotating speed of 200rpm and after being heated to 40 DEG C, stop heating, and add FSH glycerite, continue to stir 30min and make homogeneous mixed liquor.Then use homogenizer with the rotating speed of 10000rpm, circulate under room temperature homogenizing 20min, namely obtains the FSH transdermal nano-emulsion of particle diameter at 50 ~ 500nm.
Claims (8)
1. a follicule-stimulating hormone (FSH) transdermal nano-emulsion, is characterized in that: be prepared from primarily of aqueous phase, follicule-stimulating hormone (FSH), protein structure stabilizing agent, surfactant, cosurfactant and oil phase, count by weight percentage, the content of each raw material is as follows:
The gross weight of each raw material is 100%.
2. follicule-stimulating hormone (FSH) transdermal nano-emulsion according to claim 1, is characterized in that: described aqueous phase is distilled water, deionized water or purified water.
3. follicule-stimulating hormone (FSH) transdermal nano-emulsion according to claim 1, is characterized in that: described follicule-stimulating hormone (FSH) is restructuring pig follicle stimulin.
4. follicule-stimulating hormone (FSH) transdermal nano-emulsion according to claim 1, is characterized in that: described protein structure stabilizing agent is sucrose or glycerol.
5. follicule-stimulating hormone (FSH) transdermal nano-emulsion according to claim 1, is characterized in that: described surfactant is selected from one or more in sorbitan fatty acid ester, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene aliphatic alcohol ether class, polyoxyethylene fatty acid ester class, POLOXAMER, emulsifing wax, castor oil hydrogenated, pyrrolidone sodium carboxylate, lecithin, fabaceous lecithin.
6. follicule-stimulating hormone (FSH) transdermal nano-emulsion according to claim 1, is characterized in that: described cosurfactant be selected from propylene glycol, glycerol, Polyethylene Glycol, medium chain monoglyceride, sorbitan fatty acid ester, polyoxyethylene fatty acid ester apoplexy due to endogenous wind one or more.
7. follicule-stimulating hormone (FSH) transdermal nano-emulsion according to claim 1, is characterized in that: described oil phase is aromatic hydrocarbon, paraffin, Oleum Arachidis hypogaeae semen or soybean oil.
8. prepare a kind of follicule-stimulating hormone (FSH) transdermal nano-emulsion as claimed in claim 1, it is characterized in that: comprise the following steps:
(1) follicule-stimulating hormone (FSH), protein structure stabilizing agent, surfactant, cosurfactant, oil phase and aqueous phase is taken respectively by formula proportion, for subsequent use;
(2) by follicule-stimulating hormone (FSH) with after suitable quantity of water phased soln, add the protein structure stabilizing agent of recipe quantity, prepare stable follicule-stimulating hormone (FSH) solution;
(3) oil phase of recipe quantity, surfactant, cosurfactant and remaining aqueous phase are mixed, magnetic stirring apparatus to stir with the rotating speed of 200 ~ 400rpm and after being heated to 40 ~ 65 DEG C, stop heating, and add the follicule-stimulating hormone (FSH) solution obtained in step (2), continue stirring 10 ~ 30min and make homogeneous mixed liquor, i.e. primary emulsion;
(4) by primary emulsion homogenizer with the rotating speed of 10000 ~ 14000rpm, circulate under room temperature homogenizing 10 ~ 30min, finally obtains the follicule-stimulating hormone (FSH) transdermal nano-emulsion of particle diameter at 50 ~ 500nm of dispersed phase particles.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105726468A (en) * | 2016-02-28 | 2016-07-06 | 中国农业科学院特产研究所 | Superovulation polyvinylpyrrolidone FSH composite slow-release injection for sika deer |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1568938A (en) * | 2003-07-22 | 2005-01-26 | 范敏华 | Nanometer emulsion and preparation method thereof |
| CN1795012A (en) * | 2003-04-02 | 2006-06-28 | 阿雷斯贸易股份有限公司 | Liquid pharmaceutical formulations of fsh and lh together with a non-ionic surfactant |
| CN102223876A (en) * | 2008-09-26 | 2011-10-19 | 纳米生物公司 | Nanoemulsion therapeutic compositions and methods of using the same |
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- 2015-05-06 CN CN201510226660.6A patent/CN104856951A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1795012A (en) * | 2003-04-02 | 2006-06-28 | 阿雷斯贸易股份有限公司 | Liquid pharmaceutical formulations of fsh and lh together with a non-ionic surfactant |
| CN1568938A (en) * | 2003-07-22 | 2005-01-26 | 范敏华 | Nanometer emulsion and preparation method thereof |
| CN102223876A (en) * | 2008-09-26 | 2011-10-19 | 纳米生物公司 | Nanoemulsion therapeutic compositions and methods of using the same |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105726468A (en) * | 2016-02-28 | 2016-07-06 | 中国农业科学院特产研究所 | Superovulation polyvinylpyrrolidone FSH composite slow-release injection for sika deer |
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