CN106963725A - A kind of dexamethasone nanogel and preparation method thereof - Google Patents
A kind of dexamethasone nanogel and preparation method thereof Download PDFInfo
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- CN106963725A CN106963725A CN201710256563.0A CN201710256563A CN106963725A CN 106963725 A CN106963725 A CN 106963725A CN 201710256563 A CN201710256563 A CN 201710256563A CN 106963725 A CN106963725 A CN 106963725A
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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
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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Abstract
The present invention relates to a kind of dexamethasone nanogel and preparation method thereof, it is added water and dexamethasone nanogel 1000g is made by the 1.5g of dexamethasone bulk drug 0.9, the 25ml of castor oil 20, Emulsifier EL-60 mixed with propylene glycol surfactant 20g, the 12g of carbomer 10, the 55g of glycerine 50, the 16g of triethanolamine 14, the 50g of ethanol 40, the 1.5g of nipalgin 1.The present invention, as microcarrier, can be improved its solubility, using the characteristic of nanoemulsion transdermal, can improve its transdermal efficiency using gel-type vehicle；2nd, gel has the characteristic slowly discharged, makes it have long-acting effect；3rd, liver first-pass effect can be avoided, while decreasing because the infringement directly contributed to intestines and stomach is administered orally.
Description
Technical field
The present invention relates to field of medicaments, especially a kind of dexamethasone nanogel and preparation method thereof.
Background technology
Dexamethasone is cortex hormone of aadrenaline, with anti-inflammatory, antiallergy and suppresses the multiple pharmacological effect such as immune, is being faced
Its external preparation is mainly used in treatment neurodermatitis, contact dermatitis, seborrhea and chronic eczema etc. on bed.It is long-term big
Amount using can secondary bacterial, fungal infection, can locally occur acne, schlempe sample dermatitis, atrophoderma and telangiectasis, and
There can be the reaction such as itch, pigmentation, face erythema, wound healing disorders.
Percutaneous dosing has turned into the third-largest administering mode outside oral, injection, traditional promotion Drug Percutaneous Absorption
Method include chemistry and promote saturating method, such as apply azone, surfactant, the various transdermal enhancers of cutin NMF；Physics promotees saturating method,
Such as electro-ionic osmosis, electroporation, ultrasound promote saturating.
But at present, the research for the basic theory and key technology of percutaneous dosing is also more delayed, particularly percutaneously give
The research of medicine new support and skin pharmacokinetics, it has also become " bottleneck " of restriction percutaneous dosing development.
The content of the invention
For described above, it is an object of the invention to provide a kind of dexamethasone nanogel and preparation method thereof, have
Solve above mentioned problem to effect.
The invention provides a kind of dexamethasone nanogel, it is by dexamethasone bulk drug 0.9-1.5g, castor oil
20-25ml, Emulsifier EL-60-mixed with propylene glycol surfactant 20g, carbomer 10-12g, glycerine 50-55g, three ethanol
Amine 14-16g, ethanol 40-50g, nipalgin 1-1.5g, which add water, is made dexamethasone nanogel 1000g.
Further, Emulsifier EL-60 and the third two in the Emulsifier EL-60-mixed with propylene glycol surfactant
The mass ratio of alcohol is 14: 6.
A kind of dexamethasone nanogel preparation method, is carried out according to the following steps：
A, according to recipe ratio, pass through dexamethasone bulk drug, castor oil, Emulsifier EL-60-mixed with propylene glycol surface
Dexamethasone nano-emulsion is made in activating agent.
B, according to recipe ratio, by Acritamer 940, gel-type vehicle is made in glycerine, triethanolamine；
C, according to recipe ratio, dexamethasone nanometer is made by dexamethasone nano-emulsion, ethanol, nipalgin, gel-type vehicle
Gel.
Further, step A includes：
A1：According to recipe ratio, dexamethasone bulk drug is added in tool plug test tube, castor oil is added in 37 DEG C of water-baths
Shaking 1 hour, is allowed to be completely dissolved.
A2：According to recipe ratio, Emulsifier EL-60-mixed with propylene glycol surfactant is added into A1, in 1300r/
Under min constant speed stirring 30min, distilled water is slowly added dropwise using self-emulsification approach, until solution is presented transparent or semitransparent, formed
Dexamethasone nano-emulsion.
Further, step B includes：According to recipe ratio, Acritamer 940 is weighed, is stood overnight in water, makes it fully molten
It is swollen, glycerine is added afterwards, and triethanolamine is added dropwise, gel-type vehicle is stirred into.
Further, step C includes：According to recipe ratio, dexamethasone nano-emulsion prepared by step A is dissolved in ethanol, plus
Enter in nipalgin dissolving, the gel-type vehicle for being slowly poured into step B preparations, 4 DEG C of refrigerators are put into after sealing stand overnight and be swelled, produce
Dexamethasone nanogel.
Further, Emulsifier EL-60 and the third two in the Emulsifier EL-60-mixed with propylene glycol surfactant
The mass ratio of alcohol is 14: 6.
The present invention has some following benefit：
1st, using gel-type vehicle as microcarrier, its solubility can be improved, the characteristic of nanoemulsion transdermal, Ke Yiti is utilized
Its high transdermal efficiency；
2nd, gel has the characteristic slowly discharged, makes it have long-acting effect；
3rd, liver first-pass effect can be avoided, while decreasing because the infringement directly contributed to intestines and stomach is administered orally.
Embodiment
With reference to embodiment, the invention will be further described.
Embodiment 1
Take dexamethasone bulk drug 0.9g, castor oil 20ml, Emulsifier EL-60-mixed with propylene glycol surfactant
20g, Acritamer 940 10g, glycerine 50g, triethanolamine 14g, ethanol 40g, nipalgin 1g, water completion to 1000g.
Carry out in following manner：0.9g dexamethasone bulk drugs are added in tool plug test tube, add 20ml castor oil in
Shaken 1 hour in 37 DEG C of water-baths, be allowed to be completely dissolved, add 20g Emulsifier EL-60s-mixed with propylene glycol surface-active
Agent, under 1300r/min constant speed stirring 30min, water is slowly added dropwise using self-emulsification approach, until solution is presented transparent or semi-transparent
It is bright, form dexamethasone nano-emulsion；10g Acritamer 940s then are weighed, is stood overnight in water, it is fully swelled, added
50g glycerine, is added dropwise triethanolamine 14g, stirs into gel-type vehicle；Finally dexamethasone nano-emulsion is dissolved in 40g ethanol, added
1g nipalgins dissolve, and are slowly poured into gel-type vehicle, 4 DEG C of refrigerators are put into after sealing stand overnight and be swelled, and produce dexamethasone
Nanogel.
In the present embodiment, using transmission electron microscope observing form, dexamethasone nano-emulsion exists in the homogeneous spheroid of rounding, size
30nm or so, dexamethasone nanogel is the transparent gel of uniform and smooth.
PH value is checked：1g of the present invention is taken, is dissolved with 10ml distilled water, pH value is measured for 6.0-7.0.
Centrifugal test：Take 10g of the present invention to be loaded in centrifuge tube, 30min, no lamination are centrifuged with 3000r/min rotating speeds.
Heat-resisting low temperature resistant test：Take 20g of the present invention to be loaded on closed in ground conical flask, put 50 DEG C of water bath with thermostatic control 24h, 0~5 DEG C
30 days in refrigerator, without lamination.
Reserved sample observing：Keep sample preservation 6 months under normal temperature, respectively with 0, and sampling in 1,3,6 month carries out quality investigation, as a result originally
Invention character, pH value, the uniformity, color and luster, go mouldy it is without exception.
Percutaneous penetration is carried out below for the present invention
The preparation of isolated skin：The SD rats that body weight is 200 ± 20g are taken, belly, about 5 minutes are smeared with appropriate depilatory cream
Scrubbed afterwards with warm water wetting gauze, be careful not to injure skin, rest 1d to eliminate the influence of residual depilatory cream, at the neck that breaks
Extremely, skin of abdomen is carefully peeled off with scissors and tweezers, is cleaned with avoiding damage to rat skin physiological saline, immerse physiological saline
Put after solution refrigerated in 4 DEG C of refrigerators it is standby.
Laboratory apparatus：Using transdermal diffusion apparatus, effective transmission area A be 0.85cm2, reception liquid for have to dexamethasone compared with
The PBS (containing 30% absolute ethyl alcohol, pH=7.4) of good solution ability, reception tank volume V is equal to 5mL.
Percutaneous penetration：Each preparation of dexamethasone is taken to be placed on the rat skin of reception tank respectively, reception tank, which is put into, to be stirred
Mix son, under 300r/min rotating speeds, Transdermal absorption experiment carried out at a temperature of (36.5 ± 0.5) DEG C, following time point (0.5h,
1h, 2h, 4h, 6h, 8h, 10h and 12h) take 1.0mL reception liquids respectively with syringe, while supplement equivalent contain 30% anhydrous second
The PBS of alcohol, reception liquid crosses 0.22 μm of filtering with microporous membrane, abandons primary filtrate, takes subsequent filtrate feed liquor matter combined instrument to be analyzed；Meter
Calculate unit area accumulation transdermal penetration amount Qn.
The unit area accumulation transdermal penetration amount of transdermal penetration experiment is calculated as follows formula：
Qn=(CnVn+ ∑ Ci Vi)/A
Cn is the corrected concentrations of n-th of sample point medicine in formula, and Ci is the drug concentration that i-th of sample point is measured, Vi
It is the volume (5mL) of sample volume (1mL) and reception tank respectively with Vn.A is the diffusion area (A=0.85cm2) of diffusion cell.
Time t is mapped using Qn, and to the straight line portion linear regression in curve, calculates its straight slope dQn/dt,
That is steady-state permeation speed Js (ngcm-2h-1).
The comparison (n=6) of each system Transdermal Absorption of table 1
| System | Qn/ng·cm-2 | Js/ng·cm-2·h-1 |
| Saturated aqueous solution | ND | ND |
| Ordinary gel | ND | ND |
| Nano-emulsion | 498.8±46.40 | 43.65 |
| Nanogel | 249.0±19.67 | 19.58 |
From upper result, four kinds of drug delivery systems of dexamethasone, 12h accumulation infiltration capacity and infiltration rate compare,
Dexamethasone nano-emulsion gel ＜ dexamethasone nano-emulsions, dexamethasone saturated aqueous solution and dexamethasone ordinary gel are difficult
To pass through rat skin, dexamethasone is made to the administration by percutaneous absorption for being conducive to medicine after nanogel, nano-emulsion.
Embodiment 2
Take dexamethasone bulk drug 1.5g, castor oil 25ml, Emulsifier EL-60-mixed with propylene glycol surfactant
20g, Acritamer 940 12g, glycerine 55g, triethanolamine 16g, ethanol 50g, nipalgin 1.5g, water completion to 1000g.
Carry out in following manner：1.5g dexamethasone bulk drugs are added in tool plug test tube, add 20ml castor oil in
Shaken 1 hour in 37 DEG C of water-baths, be allowed to be completely dissolved, add 20g Emulsifier EL-60s-mixed with propylene glycol surface-active
Agent, under 1300r/min constant speed stirring 30min, water is slowly added dropwise using self-emulsification approach, until solution is presented transparent or semi-transparent
It is bright, form dexamethasone nano-emulsion；12g Acritamer 940s then are weighed, is stood overnight in water, it is fully swelled, added
55g glycerine, is added dropwise triethanolamine 16g, stirs .5 and mix gel-type vehicle；Finally dexamethasone nano-emulsion is dissolved in 50g ethanol, plus
Enter the dissolving of 1.5g nipalgins, and be slowly poured into gel-type vehicle, 4 DEG C of refrigerators are put into after sealing stand overnight and be swelled, fill in producing
The loose nanogel of rice.
In the present embodiment, using transmission electron microscope observing form, dexamethasone nano-emulsion exists in the homogeneous spheroid of rounding, size
35nm or so, dexamethasone nanogel is the transparent gel of uniform and smooth.
PH value is checked：1g of the present invention is taken, is dissolved with 10ml distilled water, pH value is measured for 6.5-7.8.
Centrifugal test：Take 10g of the present invention to be loaded in centrifuge tube, 30min, no lamination are centrifuged with 3000r/min rotating speeds.
Heat-resisting low temperature resistant test：Take 20g of the present invention to be loaded on closed in ground conical flask, put 50 DEG C of water bath with thermostatic control 24h, 0~5 DEG C
30 days in refrigerator, without lamination.
Reserved sample observing：Keep sample preservation 6 months under normal temperature, respectively with 0, and sampling in 1,3,6 month carries out quality investigation, as a result originally
Invention character, pH value, the uniformity, color and luster, go mouldy it is without exception.
Percutaneous penetration is carried out below for the present invention
The preparation of isolated skin：The SD rats that body weight is 200 ± 20g are taken, belly, about 5 minutes are smeared with appropriate depilatory cream
Scrubbed afterwards with warm water wetting gauze, be careful not to injure skin, rest 1d to eliminate the influence of residual depilatory cream, at the neck that breaks
Extremely, skin of abdomen is carefully peeled off with scissors and tweezers, is cleaned with avoiding damage to rat skin physiological saline, immerse physiological saline
Put after solution refrigerated in 4 DEG C of refrigerators it is standby.
Laboratory apparatus：Using transdermal diffusion apparatus, effective transmission area A be 0.85cm2, reception liquid for have to dexamethasone compared with
The PBS (containing 30% absolute ethyl alcohol, pH=7.4) of good solution ability, reception tank volume V is equal to 5mL.
Percutaneous penetration：Each preparation of dexamethasone is taken to be placed on the rat skin of reception tank respectively, reception tank, which is put into, to be stirred
Mix son, under 300r/min rotating speeds, Transdermal absorption experiment carried out at a temperature of (36.5 ± 0.5) DEG C, following time point (0.5h,
1h, 2h, 4h, 6h, 8h, 10h and 12h) take 1.0mL reception liquids respectively with syringe, while supplement equivalent contain 30% anhydrous second
The PBS of alcohol, reception liquid crosses 0.22 μm of filtering with microporous membrane, abandons primary filtrate, takes subsequent filtrate feed liquor matter combined instrument to be analyzed；Meter
Calculate unit area accumulation transdermal penetration amount Qn.
The unit area accumulation transdermal penetration amount of transdermal penetration experiment is calculated as follows formula：
Qn=(CnVn+ ∑ Ci Vi)/A
Cn is the corrected concentrations of n-th of sample point medicine in formula, and Ci is the drug concentration that i-th of sample point is measured, Vi
It is the volume (5mL) of sample volume (1mL) and reception tank respectively with Vn.A is the diffusion area (A=0.85cm2) of diffusion cell.
Time t is mapped using Qn, and to the straight line portion linear regression in curve, calculates its straight slope dQn/dt,
That is steady-state permeation speed Js (ngcm-2h-1).
The comparison (n=6) of each system Transdermal Absorption of table 2
| System | Qn/ng·cm-2 | Js/ng·cm-2·h-1 |
| Saturated aqueous solution | ND | ND |
| Ordinary gel | ND | ND |
| Nano-emulsion | 510.8±37.40 | 49.55 |
| Nanogel | 260.0±20.67 | 21.22 |
From upper result, four kinds of drug delivery systems of dexamethasone, 12h accumulation infiltration capacity and infiltration rate compare,
Dexamethasone nano-emulsion gel ＜ dexamethasone nano-emulsions, dexamethasone saturated aqueous solution and dexamethasone ordinary gel are difficult
To pass through rat skin, dexamethasone is made to the administration by percutaneous absorption for being conducive to medicine after nanogel, nano-emulsion.
Some embodiments of the present invention are these are only, to those skilled in the art, this hair are not being departed from
On the premise of bright creation design, several modifications and improvements can be also carried out, these belong to the scope of the present invention.
Claims (8)
1. a kind of dexamethasone nanogel, it is by dexamethasone bulk drug 0.9-1.5g, castor oil 20-25ml, polyoxy second
Alkene castor oil-mixed with propylene glycol surfactant 20g, carbomer 10-12g, glycerine 50-55g, triethanolamine 14-16g, ethanol
40-50g, nipalgin 1-1.5g add water to 1000g and are made.
2. a kind of dexamethasone nanogel according to claim 1, it is characterised in that：The Emulsifier EL-60-
The mass ratio of Emulsifier EL-60 and propane diols is 14: 6 in mixed with propylene glycol surfactant.
3. a kind of dexamethasone nanogel according to claim 1, it is characterised in that：It is by Sai meter Song bulk drugs
1g, castor oil 20ml, Emulsifier EL-60-mixed with propylene glycol surfactant 20g, Acritamer 940 10g, glycerine 50g, three
Monoethanolamine 14g, ethanol 40g, nipalgin 1g, water completion are made to 1000g.
4. a kind of dexamethasone nanogel preparation method, is carried out according to the following steps：
A, according to recipe ratio, pass through dexamethasone bulk drug, castor oil, Emulsifier EL-60-mixed with propylene glycol surface-active
Dexamethasone nano-emulsion is made in agent.
B, according to recipe ratio, by Acritamer 940, gel-type vehicle is made in glycerine, triethanolamine；
C, according to recipe ratio, dexamethasone nanogel is made by dexamethasone nano-emulsion, ethanol, nipalgin, gel-type vehicle.
5. a kind of dexamethasone nanogel preparation method according to claim 4, it is characterised in that：
Step A includes：
A1：According to recipe ratio, dexamethasone bulk drug is added in tool plug test tube, castor oil is added and is shaken in 37 DEG C of water-baths
1 hour, it is allowed to be completely dissolved.
A2：According to recipe ratio, Emulsifier EL-60-mixed with propylene glycol surfactant is added into A1, it is permanent in 1300r/min
Under speed stirring 30min, distilled water is slowly added dropwise using self-emulsification approach, until solution is presented transparent or semitransparent, ground plug is formed
Meter Song Na rice milks.
6. a kind of dexamethasone nanogel preparation method according to claim 4, it is characterised in that：Step B includes：Press
According to recipe ratio, Acritamer 940 is weighed, is stood overnight in water, it is fully swelled, glycerine is added afterwards, triethanolamine is added dropwise, stirs
Mix gel-type vehicle.
7. a kind of dexamethasone nanogel preparation method according to claim 4, it is characterised in that：Step C includes：Press
According to recipe ratio, dexamethasone nano-emulsion prepared by step A is dissolved in ethanol, nipalgin dissolving is added, is slowly poured into step B systems
4 DEG C of refrigerators are put into standby gel-type vehicle, after sealing stand overnight and be swelled, produce dexamethasone nanogel.
8. a kind of dexamethasone nanogel preparation method according to claim 4, it is characterised in that：The polyoxyethylene
The mass ratio of Emulsifier EL-60 and propane diols is 14: 6 in castor oil-mixed with propylene glycol surfactant.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112263542A (en) * | 2020-10-19 | 2021-01-26 | 澳美制药厂有限公司 | Desonide nanoemulsion gel composition and preparation method thereof |
| CN112870155A (en) * | 2021-03-08 | 2021-06-01 | 上海昱聚科技有限公司 | Gel injection for slowly releasing dexamethasone medicament and preparation method and application thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112263542A (en) * | 2020-10-19 | 2021-01-26 | 澳美制药厂有限公司 | Desonide nanoemulsion gel composition and preparation method thereof |
| CN112263542B (en) * | 2020-10-19 | 2023-09-01 | 澳美制药厂有限公司 | Decne nano emulsion gel composition and its preparation method |
| CN112870155A (en) * | 2021-03-08 | 2021-06-01 | 上海昱聚科技有限公司 | Gel injection for slowly releasing dexamethasone medicament and preparation method and application thereof |
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