CN105997989A - Urea and vitamin E cream for treating hand and foot rahagades and rahagades caused by keratotic tinea hand or pedis - Google Patents
Urea and vitamin E cream for treating hand and foot rahagades and rahagades caused by keratotic tinea hand or pedis Download PDFInfo
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- CN105997989A CN105997989A CN201610324490.XA CN201610324490A CN105997989A CN 105997989 A CN105997989 A CN 105997989A CN 201610324490 A CN201610324490 A CN 201610324490A CN 105997989 A CN105997989 A CN 105997989A
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- cream
- vitamin
- urea
- emulsifiable paste
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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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/17—Amides, e.g. hydroxamic acids having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine
-
- 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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
- A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
- A61K31/355—Tocopherols, e.g. vitamin E
-
- 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
Abstract
The invention relates to urea and vitamin E cream for treating hand and foot rahagades and rahagades caused by keratotic tinea hand or pedis. The cream contains urea, vitamin E, catechinic acid and polyoxyethylene-7-stearate. The fine cream with small and uniform particle size and good coating property can be prepared through low-speed stirring. The cream has higher high temperature stability, and oil-water layering does not occur easily. The cream is suitable for industrial production, production processes are simplified, energy is saved, and stability is higher.
Description
Technical field
The invention belongs to pharmaceutical technology field, be specifically related to one and cause for treating rhagadia manus et pedis and Keratotic tinea hand or pedis
The urea and vitamin E cream chapped.
Background technology
Urea and vitamin E cream is the conventional product for the treatment of rhagadia manus et pedis, open according to Shanghai General Pharmaceutical Co., ltd.
Urea and vitamin E cream product, emulsifiable paste prescription is: every gram contain 150 milligrams of carbamide, vitamin E 10 milligrams；Adjuvant is: Bai Fanshi
Woods, hexadeca-octadecyl alcohol, glyceryl monostearate, liquid Paraffin, cera alba, Triton X-100 (OP), glycerol, second
Edetate disodium, sodium lauryl sulphate, preservative (ethyl hydroxybenzoate), three extraits, purified water.This formula still needs to improve
Place be: use Triton X-100 (OP) as emulsifying agent preparation urea and vitamin E cream time, this emulsifiable paste system
Easily occurring the problem that particle diameter is uneven during Bei, in preparation process, oil phase and aqueous phase mixing and emulsifying, have employed height during emulsifying
Speed homogenizing, it is difficult to obtain even particle size distribution, fine and smooth emulsifiable paste.Patent application 201110330517.3 also discloses that a kind of dimension E
Urea frost by squalane, caprylic capric triglyceride, white oil, dimethicone, monoglyceride, octadecanol, stearic acid, Arlacel-60,
White vaseline, vitamin E, methyl hydroxybenzoate, propylparaben, glycerol, Tween-60, carbamide, essence and purified water composition；Join
Process processed is: oil phase, aqueous phase is heated respectively, then mixes, the most again high speed homogenization.The preparation deficiency of this emulsifiable paste is,
Needing the complicated technologies such as stirring mixing and high speed homogenization in preparing process, stirring required in preparation and the equipment of homogenizing created
High cost and energy consumption.
Summary of the invention
The invention provides and a kind of cause the urea and vitamin E cream chapped for treating rhagadia manus et pedis and Keratotic tinea hand or pedis,
Including carbamide, vitamin E and pegoxol 7 stearate, production technology is simple, to mixing speed and the requirement of high speed homogenization
Relatively low, can be without homogenizing, utilize relatively low mixing speed to prepare breast grain is fine and smooth uniformly, meet States Pharmacopoeia specifications breast
Cream, is more beneficial for the commercial production of emulsifiable paste, reduces equipment and the cost of energy consumption；When 40 DEG C of high temperature above, there is good stablizing
Property, it is not easy to oil-water separation 60 DEG C of high temperature above.
The invention provides and a kind of cause the urea and vitamin E cream chapped for treating rhagadia manus et pedis and Keratotic tinea hand or pedis,
Described emulsifiable paste is made up of carbamide, dimension E and emulsifiable paste matrix, gathering containing 2-20 weight portion in the described emulsifiable paste of every 100 weight portions
Ethylene glycol-7-stearate and the catechin of 1 ~ 500 ppm, described catechin particle diameter is less than 100 μm, gluing of described emulsifiable paste
Degree controls at 1000 ~ 6000cp.
It is preferably, the emulsifiable paste of every 100 weight portions contains dimension E and the 2-20 weight portion of the carbamide of 15 weight portions, 1 weight portion
Pegoxol 7 stearate.
Being preferably, in the urea and vitamin E cream of every 100 weight portions, the content of pegoxol 7 stearate should be 4-12 weight
Amount part.
Being preferably, in the urea and vitamin E cream of every 100 weight portions, the content of pegoxol 7 stearate should be and is less than
4-8 weight portion.
The invention provides and a kind of cause the urea and vitamin E cream chapped for treating rhagadia manus et pedis and Keratotic tinea hand or pedis,
Described emulsifiable paste possibly together with pharmaceutically acceptable emulsifiable paste matrix, described emulsifiable paste matrix be white vaseline, light liquid petrolatum,
Carbomer or a combination thereof emulsifiable paste matrix content in the emulsifiable paste of every 100 weight portions are 0.01-20 weight portion.
The invention provides and a kind of cause the urea and vitamin E cream chapped for treating rhagadia manus et pedis and Keratotic tinea hand or pedis,
Described emulsifiable paste is possibly together with pharmaceutically acceptable preservative, and described preservative is phenoxyethanol, benzoic acid, fourth hydroxyl Fructus Foeniculi
Ether or a combination thereof, described preservative content in every 100 weight portion emulsifiable pastes is 0.05-2 weight portion.
The invention provides and a kind of cause the urea and vitamin E cream chapped for treating rhagadia manus et pedis and Keratotic tinea hand or pedis,
Described emulsifiable paste possibly together with pharmaceutically acceptable surfactant, described surfactant be Labrasol,
LabrafilM1944 CS or a combination thereof, described surfactant content in the emulsifiable paste of every 100 weight portions is 0.05-
20 weight portions.
Being preferably, the emulsifiable paste of every 100 weight portions includes the carbamide of 15 weight portions, dimension E of 1 weight portion, and 20 weight portions
Pegoxol 7 stearate.
It is preferably, the emulsifiable paste of every 100 weight portions also includes the LabrafilM1944 CS of 10 weight portions, 10 weight portions
Liquid paraffin,light, the phenoxyethanol of 0.5 weight portion.
It is preferably, the emulsifiable paste of every 100 weight portions also includes the LabrafilM1944 CS of 2 weight portions, 0.02 weight portion
Carbomer, the sodium hydroxide of 0.01 weight portion, and the phenoxyethanol of 0.5 weight portion.
Emulsifiable paste and traditional emulsifiable paste that the present invention provides are compared, in preparation process stirring at low speed can prepare exquisiteness,
The emulsifiable paste that granularity fine uniform, coating performance are good；This emulsifiable paste has more preferable heat-resistant stable, is not likely to produce profit layering,
Be conducive to industrialized production, simplify production technology, save the energy.
Detailed description of the invention
" scope " disclosed herein is with lower limit and the form of the upper limit.One or more lower limit, and one can be respectively
Or the multiple upper limit.Given range is defined by a selected lower limit and a upper limit.Selected lower limit and upper limit limit
Determine the border of special scope.All scopes that can be defined by this way comprise and can be combined, the most any lower limit
A scope can be formed with the combination of any upper limit.Such as, list the scope of 60-120 and 80-110 for special parameter, reason
The scope for 60-110 and 80-120 that solves also expects.If additionally, the minimum zone value 1 and 2 listed, and if listed
Maximum magnitude value 3,4 and 5, then scope below can all expect: 1-3,1-4,1-5,2-3,2-4 and 2-5.
In the present invention, unless otherwise indicated, between content range and its preferred scope of each component of compositions
Can be mutually combined and form new technical scheme.
In the present invention, unless otherwise indicated, " a combination thereof " represents the multicomponent mixture of described each element, such as two
Kind, three kinds, four kinds and until the multicomponent mixture of maximum possible.
In the present invention, unless otherwise indicated, all " part " and percent (%) all refers to percetage by weight.
In the present invention, unless otherwise indicated, in all compositionss, the percent sum of each component is 100%.
In the present invention, unless otherwise indicated, numerical range " a-b " represents the contracting of any real combinings between a to b
Sketch form shows, wherein a and b is real number.Such as numerical range " 0-5 " expression the most all lists between " 0-5 "
All real numbers, " 0-5 " is that the breviary of these combinations of values represents.
In the present invention, unless otherwise indicated, integer numerical range " a-b " represents the arbitrary integer combination between a to b
Breviary represent, wherein a and b is integer.Such as integer numerical range " 1-N " represents 1,2 ... N, wherein N is integer.
Without particularly pointing out, the term " a kind of " used by this specification refers to " at least one ".
Without particularly pointing out, the benchmark of percent of the present invention (including percetage by weight) is all described combination
The gross weight of thing.
The invention provides and a kind of cause the urea and vitamin E cream chapped for treating rhagadia manus et pedis and Keratotic tinea hand or pedis,
In the described emulsifiable paste of every 100 weight portions containing the carbamide of 15 weight portions, dimension E of 1 weight portion, 5 ~ 30 weight portions Polyethylene Glycol-
7-stearate and the catechin of 1 ~ 500 ppm, described catechin particle diameter raw material is less than 100 μm.In the combination of the present invention, poly-
It is semi-solid state that the content of ethylene glycol-7-stearate should be the emulsifiable paste that can make to be joined, and emulsifiable paste viscosity controls 1000 ~
6000cp(viscosimetric analysis uses rotary viscosimeter in 25 DEG C of mensuration), emulsifiable paste is fine and smooth uniformly, and can preferably tolerate high temperature not
Easily there is oil-water separation.In the urea and vitamin E cream of the most every 100 weight portions the content of pegoxol 7 stearate should be 4 ~
32 weight portions, preferably 10 ~ 28 weight portions.
In the present invention, described pegoxol 7 stearate is by Liquid Macrogol, polyethylene glycol 1500 and second
Alcohol and 50% stearic acid obtained by esterification, in end product, the average degree of polymerization of ethylene glycol is about 7.Polyethylene Glycol-7-
Stearate records in U.S. FDA adjuvant guide (English name: Pegoxol 7 Stearate), be a kind of pharmaceutically allow auxiliary
Material.
In the urea and vitamin E cream of the present invention, may also include other the most acceptable additives.
The type of described additive is not had any restriction, additive conventional in the art can be made, specifically select
From pharmaceutically acceptable consistency modifiers, pharmaceutically acceptable surfactant, pharmaceutically acceptable preservative, pharmacy
One or more in upper acceptable pH adjusting agent；In the present invention, the consumption for described additive is the most any
Limit.
In a preferred embodiment of the present invention, in the emulsifiable paste of every 100 weight portions, the content containing described additive is
0.05 ~ 30 weight portion, preferably 1 ~ 10 weight portion.
In the present invention, the type for pharmaceutically acceptable emulsifiable paste matrix does not has any restriction, and it can be this
Viscosity modifier conventional in field；Can be consistency modifiers miscible with water selected from carbomer, sodium carboxymethyl cellulose or
A combination thereof；Can also be that the most water-miscible viscosity modifier is selected from liquid paraffin, vaseline, octadecanol or a combination thereof.
In a preferred embodiment of the present invention, described emulsifiable paste matrix is selected from carbomer, white vaseline, light liquid stone
Wax or a combination thereof.In the present invention, the consumption of described emulsifiable paste matrix is not had any restriction, can be the routine in this area
Consumption.
In a preferred embodiment of the present invention, the content of emulsifiable paste matrix described in the emulsifiable paste of every 100 weight portions is 0.1 ~
20 weight portions, preferably 1 ~ 15 weight portion.By add emulsifiable paste matrix, by the viscosity adjustment of described urea and vitamin E cream to 1000 ~
2000cp preferably, again with viscosity be 1200 ~ 1500cp more preferably.
In the present invention, the type for pharmaceutically acceptable surfactant does not has any restriction, and it can be this
Surfactant conventional in field.
In a preferred embodiment of the present invention, described surfactant is, Miglyol 812 (Labrasol,
Purchased from Jia Fasai (Gattefosse) company of France).In the present invention, the consumption of Surfactant does not has any restriction, it
It can be the conventional amount used in this area.
In a preferred embodiment of the present invention, the content of surfactant described in the emulsifiable paste of every 100 weight portions is 0.5 ~
10 weight portions, preferably 0.5 ~ 5 weight portion.
In the present invention, the type for pharmaceutically acceptable preservative does not has any restriction, and it can be ability
Preservative conventional in territory.
In one embodiment of the invention, described preservative is selected from phenoxyethanol, Butylated hydroxyanisole or its group
Close.
In a preferred embodiment of the present invention, in the emulsifiable paste of every 100 weight portions, the amount of contained preservative is 0.05 ~ 5 weight
Amount part, preferably 0.1 ~ 2 weight portion.
In the present invention, the type for pharmaceutically acceptable pH adjusting agent does not has any restriction, and it can be this
PH adjusting agent conventional in field.
In a preferred embodiment of the present invention, described pH adjusting agent selects sodium hydroxide, triethylamine, hydrochloric acid or its group
Close.By pH adjusting agent, the pH value of described urea and vitamin E cream is regulated to 4.0 ~ 8.0, preferably 6.0 ~ 8.0.
The invention provides a kind of method preparing urea and vitamin E cream, it includes step:
A pegoxol 7 stearate is heated to 60 ~ 90 DEG C of fusings by ()；
B purified water is heated to the temperature identical with (a) by ()；
C the material that step (a) obtains with step (b) under continuous stirring, is mixed by (), temperature controls at 60 ~ 90 DEG C；
D the mixture of step (c) gained at 30 ~ 50 DEG C of low rate mixings, is added carbamide and dimension E is uniformly mixed by ()；
E () subpackage obtains urea and vitamin E cream.
Described step (a) can also add 0.01 ~ 20 weight portion pharmaceutically acceptable viscosity modifier and
The pharmaceutically acceptable surfactant of 0.05 ~ 15 weight portion；
Pharmaceutically acceptable viscosity modifier and 0.05 ~ 5 weight of 0.01 ~ 2 weight portion can also be added in above-mentioned steps (b)
The pharmaceutically acceptable antibacterial of amount part；
Pharmaceutically acceptable pH adjusting agent can also be added in described step (d).
Further describe the present invention below by specific embodiment, but do not limit the scope of the invention.
Raw material:
Pegoxol 7 stearate Tefose63: purchased from Jia Fasai company of France；
Miglyol 812 Labrasol: purchased from Jia Fasai company of France；
LabrafilM1944 CS: be medical auxiliary materials Technology Co., Ltd. purchased from upper Hydron；
Other raw material is commercially available prod.
The preparation of embodiment 1 urea and vitamin E cream 1
The formula of emulsifiable paste 1 is as follows:
Prepared by emulsifiable paste 1, carry out in accordance with the following methods:
A pegoxol 7 stearate (tefose63), Miglyol 812 (Labrasol) and liquid Paraffin are added by ()
Heat is to 60 DEG C of fusings；
B () mixing is all by the catechin (catechin raw material need to be crushed to particle diameter less than 100 μm) of purified water, carbamide and 5 ppm
Even, it is heated to 60 DEG C；
C step (a), under continuous slow stirring (30rpm), is mixed, stirring and emulsifying by () with step (b), temperature controls 60
℃；
D step (c) is obtained mixture stirring and is cooled to 25 ~ 50 DEG C by (), add dimension E and stir, obtain urea and vitamin E cream.
The preparation of embodiment 2 urea and vitamin E cream 2
The formula of emulsifiable paste 2 is as follows:
Preparation process:
A pegoxol 7 stearate (tefose63), hexadecanol are heated to 75 DEG C of fusings by (), add light liquid stone
Wax mix homogeneously, keeps temperature 75 DEG C；
B () mixing is all by the catechin (catechin raw material need to be crushed to particle diameter less than 100 μm) of purified water, carbamide and 4 ppm
Even, it is heated to 75 DEG C；
C step (a), under continuous slow stirring (40rpm), is mixed, stirring and emulsifying by () with step (b), temperature controls 75
℃；
D step (c) is obtained mixture stirring and is cooled to 25 ~ 50 DEG C by (), add dimension E and stir, obtain urea and vitamin E cream.
The preparation of embodiment 3 urea and vitamin E cream 3
The formula of emulsifiable paste 3 is as follows:
Preparation process:
A pegoxol 7 stearate, liquid paraffin,light, cera alba and LabrafilM1944 CS are heated to 70 DEG C by ()
Fusing；
B () (catechin raw material need to be crushed to particle diameter less than 100 by the catechin of purified water, phenoxyethanol, carbamide and 3 ppm
μm) mix homogeneously, it is heated to 70 DEG C；
C step (a), under continuous slow stirring (35rpm), is mixed, stirring and emulsifying by () with step (b), temperature controls 70
℃；
D step (c) is obtained mixture stirring and is cooled to 25 ~ 50 DEG C by (), add dimension E and stir, obtain urea and vitamin E cream.
The preparation of embodiment 4 urea and vitamin E cream 4
The formula of emulsifiable paste 4 is as follows:
Preparation process:
A () is by pegoxol 7 stearate (tefose63), white vaseline, light liquid petrolatum, octadecanol and the sad last of the ten Heavenly stems
After acid glyceride (Labrasol) is heated to 75 DEG C of fusings, add Butylated hydroxyanisole, after mix homogeneously, keep temperature 75 DEG C；
B carbomer is initially charged appropriate purified water by () swelling overnight, and adding sodium hydroxide regulation next day is gel to carbomer
Shape, adds mix homogeneously in the catechin (catechin raw material need to be crushed to particle diameter less than 100 μm) of carbamide and 2 ppm, heating
To 75 DEG C；
C step (a), under continuous slow stirring (300rpm), is mixed, stirring and emulsifying by () with step (b), temperature controls 75
℃；
D step (c) is obtained mixture stirring and is cooled to 25 ~ 50 DEG C by (), add dimension E and stir, obtain urea and vitamin E cream.
The preparation of embodiment 5 urea and vitamin E cream 5
The formula of emulsifiable paste 5 is as follows:
Preparation process:
A pegoxol 7 stearate (tefose63), octadecanol and LabrafilM1944 CS are heated to 70 DEG C and melt by ()
Change, after adding Butylated hydroxyanisole mix homogeneously, keep temperature 70 C；
B () mixing is all by the catechin (catechin raw material need to be crushed to particle diameter less than 100 μm) of purified water, carbamide and 1ppm
Even, add vaseline mix homogeneously, be heated to 70 DEG C；
C step (a), under continuous slow stirring (32rpm), is mixed, stirring and emulsifying by () with step (b), temperature controls 70
℃；
D step (c) is obtained mixture stirring and is cooled to 25 ~ 50 DEG C by (), add dimension E and stir, obtain urea and vitamin E cream.
The preparation of embodiment 6 urea and vitamin E cream 6
The formula of emulsifiable paste 6 is as follows:
Preparation process:
(a) by pegoxol 7 stearate, liquid paraffin,light, Miglyol 812 (Labrasol) and
LabrafilM1944 CS is heated to 70 DEG C of fusings；
(b) by purified water, phenoxyethanol, carbamide and and the catechin of 5 ppm (catechin raw material need to be crushed to particle diameter and be less than
100 μm) mix homogeneously, it is heated to 70 DEG C；
C step (a), under continuous slow stirring (33rpm), is mixed, stirring and emulsifying by () with step (b), temperature controls 70
℃；
D step (c) is obtained mixture stirring and is cooled to 25 ~ 50 DEG C by (), add dimension E and stir, obtain urea and vitamin E cream.
The preparation of embodiment 7 urea and vitamin E cream 7
The formula of emulsifiable paste 7 is as follows:
Preparation process:
A pegoxol 7 stearate (tefose63), white vaseline, cera alba and LabrafilM1944 CS are heated by ()
To 65 DEG C of fusings；
B carbomer is initially charged appropriate purified water by () swelling overnight, and adding sodium hydroxide regulation next day is gel to carbomer
Shape, adds catechin (catechin raw material need to be crushed to particle diameter less than the 100 μm) mixing of phenoxyethanol, carbamide and 500 ppm
Uniformly, 65 DEG C it are heated to；
C step (a), under continuous slow stirring (35rpm), is mixed, stirring and emulsifying by () with step (b), temperature controls 65
℃；
D step (c) is obtained mixture stirring and is cooled to 25 ~ 50 DEG C by (), add dimension E and stir, obtain urea and vitamin E cream.
The preparation of embodiment 8 urea and vitamin E cream 8
The formula of emulsifiable paste 8 is as follows:
Preparation process:
(a) by pegoxol 7 stearate (tefose63), glyceryl monostearate, white vaseline, hexadecanol and
LabrafilM1944 CS is heated to 80 DEG C of fusings；
B carbomer is initially charged appropriate purified water by () swelling overnight, and adding sodium hydroxide regulation next day is gel to carbomer
Shape, adds catechin (catechin raw material need to be crushed to particle diameter less than the 100 μm) mixing of phenoxyethanol, carbamide and 200 ppm
Uniformly, 80 DEG C it are heated to；
C step (a), under continuous slow stirring (210rpm), is mixed, stirring and emulsifying by () with step (b), temperature controls 80
℃；
D step (c) is obtained mixture stirring and is cooled to 25 ~ 50 DEG C by (), add dimension E and stir, adjust PH to 6.0, continue to stir
Mix mixing, obtain urea and vitamin E cream.
The preparation of embodiment 9 urea and vitamin E cream 9
The formula of emulsifiable paste 9 is as follows:
Preparation process:
A () is by pegoxol 7 stearate (tefose63), lanoline, liquid Paraffin, vaseline and LabrafilM1944
CS is heated to 90 DEG C of fusings；
B carbomer is initially charged appropriate purified water by () swelling overnight, and adding sodium hydroxide regulation next day is gel to carbomer
Shape, adds catechin (catechin raw material need to be crushed to particle diameter less than the 100 μm) mixing of phenoxyethanol, carbamide and 100 ppm
Uniformly, 90 DEG C it are heated to；
C step (a), under continuous slow stirring (260rpm), is mixed, stirring and emulsifying by () with step (b), temperature controls 90
℃；
D step (c) is obtained mixture stirring and is cooled to 25 ~ 50 DEG C by (), add dimension E and stir, obtain urea and vitamin E cream.
In above embodiment 1 ~ 9, the viscosity of the emulsifiable paste of final preparation all controls within 1000 ~ 6000cp scope.
The preparation of embodiment 10 urea and vitamin E cream 10
The formula of emulsifiable paste 10 is as follows:
Preparation process:
A LabrafilM1944 CS, white vaseline, light liquid petrolatum, Cera Flava are heated to 90 DEG C of fusings by ()；
B carbomer is initially charged appropriate purified water by () swelling overnight, and adding sodium hydroxide regulation next day is gel to carbomer
Shape, adds phenoxyethanol and carbamide mix homogeneously, is heated to 90 DEG C；
C step (a), under continuous slow stirring (270rpm), is mixed with step (b), adds sodium lauryl sulphate and stir by ()
Mixing emulsifying, temperature controls at 90 DEG C；
D step (c) is obtained mixture stirring and is cooled to 25 ~ 50 DEG C by (), add dimension E and stir, obtain urea and vitamin E cream.
The preparation of embodiment 11 urea and vitamin E cream 11
The formula of emulsifiable paste 11 is as follows:
Preparation process:
A white vaseline, light liquid petrolatum, hexadeca-octadecyl alcohol are heated to 60 DEG C of fusings by ()；
B (), by purified water and carbamide mix homogeneously, is heated to 60 DEG C；
C step (a), under continuous slow stirring (35rpm), is mixed by () with step (b), add sodium lauryl sulphate stirring
Emulsifying, temperature controls at 60 DEG C；
D step (c) is obtained mixture stirring and is cooled to 25 ~ 50 DEG C by (), add dimension E and stir, obtain urea and vitamin E cream.
The preparation of embodiment 12 urea and vitamin E cream 12
The formula of emulsifiable paste 12 is as follows:
Preparation process:
A white vaseline, liquid paraffin,light and LabrafilM1944 CS are heated to 70 DEG C of fusings by ()；
B (), by purified water, phenoxyethanol and carbamide mix homogeneously, is heated to 70 DEG C；
C step (a), under continuous slow stirring (30rpm), is mixed, stirring and emulsifying by () with step (b), temperature controls 70
℃；
D step (c) is obtained mixture stirring and is cooled to 25 ~ 50 DEG C by (), add dimension E and stir, obtain urea and vitamin E cream.
Embodiment 13: oil-water separation condition monitoring
Emulsifiable paste in Example 1 ~ 12, at 60 DEG C of water-bath 24h, takes out emulsifiable paste sample, observes oil-water separation, experimental result such as following table
Shown in:
By experimental result, it can be seen that in emulsifiable paste 1 ~ 9 prepared by the present invention, do not observe oil-water separation at 60 DEG C of water-bath 24h
Phenomenon, the emulsifiable paste prepared by the present invention is more stable.
Embodiment 14
Emulsifiable paste in Example 1 ~ 12, respectively after (or not existing) 60 DEG C of water-bath 24h, according to national drug standards WS-10001-
(HD-0528)-2002 have carried out the content of carbamide the most respectively and have tieed up E two analyses of discriminating emulsifiable paste, and result is as follows:
By experimental result, it can be seen that emulsifiable paste component and the content of preparing gained are compared with the emulsifiable paste of non-water-bath, all do not occur substantially
Change.Take cream products of the present invention to observe under scanning electron microscope, it can be seen that granularity fine uniform, fine and smooth, less than traditional method system
Standby cream products.
The foregoing is only presently preferred embodiments of the present invention, be not limited to the substantial technological content model of the present invention
Enclosing, the substantial technological content of the present invention is broadly to be defined in the right of application, any technology that other people complete
Entity or method, if with the right of application defined in identical, also or the change of a kind of equivalence, all by
It is considered to be covered by among this right.
The all documents mentioned in the present invention are incorporated as reference the most in this application, just as each document by individually
It is incorporated as with reference to like that.In addition, it is to be understood that after the foregoing having read the present invention, those skilled in the art can be right
The present invention makes various changes or modifications, and these equivalent form of values fall within the application appended claims limited range equally.
Claims (7)
1. one kind for the urea and vitamin E cream treating rhagadia manus et pedis and Keratotic tinea hand or pedis causes to chap, it is characterised in that described
Emulsifiable paste be made up of carbamide, dimension E and emulsifiable paste matrix, containing the poly-second two of 2-20 weight portion in the described emulsifiable paste of every 100 weight portions
Alcohol-7-stearate and the catechin of 1 ~ 500 ppm, described catechin particle diameter is less than 100 μm, the viscosity control of described emulsifiable paste
System is at 1000 ~ 6000cp.
Urea and vitamin E cream the most according to claim 1, it is characterised in that containing 15 weight portions in the emulsifiable paste of every 100 weight portions
Carbamide, the pegoxol 7 stearate of dimension E and 2-20 weight portion of 1 weight portion.
Urea and vitamin E cream the most according to claim 1, it is characterised in that poly-in the urea and vitamin E cream of every 100 weight portions
The content of ethylene glycol-7-stearate should be 4-12 weight portion.
Urea and vitamin E cream the most according to claim 1, it is characterised in that poly-in the urea and vitamin E cream of every 100 weight portions
The content of ethylene glycol-7-stearate should be 4-8 weight portion.
Urea and vitamin E cream the most according to claim 1, it is characterised in that possibly together with pharmaceutically acceptable emulsifiable paste matrix,
Described emulsifiable paste matrix is that white vaseline, light liquid petrolatum, carbomer or a combination thereof emulsifiable paste matrix are at every 100 weight portions
Content in emulsifiable paste is 0.01-20 weight portion.
Urea and vitamin E cream the most according to claim 1, it is characterised in that possibly together with pharmaceutically acceptable preservative, institute
The preservative stated is phenoxyethanol, benzoic acid, BHA or a combination thereof, and described preservative is at every 100 weight portion breasts
Content in cream is 0.05-2 weight portion.
Urea and vitamin E cream the most according to claim 1, it is characterised in that possibly together with pharmaceutically acceptable surface activity
Agent, described surfactant is Labrasol, LabrafilM1944 CS or a combination thereof, and described surfactant is often
Content in the emulsifiable paste of 100 weight portions is 0.05-20 weight portion.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610324490.XA CN105997989B (en) | 2016-05-17 | 2016-05-17 | It is a kind of to cause the urea and vitamin E cream of chap for treating rhagadia manus et pedis and Keratotic tinea hand or pedis |
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| CN201610324490.XA CN105997989B (en) | 2016-05-17 | 2016-05-17 | It is a kind of to cause the urea and vitamin E cream of chap for treating rhagadia manus et pedis and Keratotic tinea hand or pedis |
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| CN105997989A true CN105997989A (en) | 2016-10-12 |
| CN105997989B CN105997989B (en) | 2018-09-07 |
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| CN201610324490.XA Active CN105997989B (en) | 2016-05-17 | 2016-05-17 | It is a kind of to cause the urea and vitamin E cream of chap for treating rhagadia manus et pedis and Keratotic tinea hand or pedis |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN109758400A (en) * | 2019-03-25 | 2019-05-17 | 福州英荷日用化学品有限公司 | A kind of anti-chap bacteriostatic deodorizing foot liniment of moisturizing and preparation method thereof |
| CN111437246A (en) * | 2020-04-30 | 2020-07-24 | 福建太平洋制药有限公司 | Preparation method for improving stability of cream product |
| CN111920763A (en) * | 2020-09-18 | 2020-11-13 | 成都中医药大学 | Nutgrass galingale rhizome essential oil anti-allergy cream and preparation process thereof |
| CN116270606A (en) * | 2023-02-06 | 2023-06-23 | 上海旭东海普南通药业有限公司 | Urea vitamin E emulsifiable paste and preparation method thereof |
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| CN102210650A (en) * | 2010-04-06 | 2011-10-12 | 上海安瀚特生物医药技术有限公司 | Prednicarbate emulsifiable paste and preparation method thereof |
| CN105250333A (en) * | 2015-11-19 | 2016-01-20 | 李君佩 | Pharmaceutical composition for inhibiting bacteria and nourishing skin and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102210650A (en) * | 2010-04-06 | 2011-10-12 | 上海安瀚特生物医药技术有限公司 | Prednicarbate emulsifiable paste and preparation method thereof |
| CN105250333A (en) * | 2015-11-19 | 2016-01-20 | 李君佩 | Pharmaceutical composition for inhibiting bacteria and nourishing skin and preparation method thereof |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109758400A (en) * | 2019-03-25 | 2019-05-17 | 福州英荷日用化学品有限公司 | A kind of anti-chap bacteriostatic deodorizing foot liniment of moisturizing and preparation method thereof |
| CN111437246A (en) * | 2020-04-30 | 2020-07-24 | 福建太平洋制药有限公司 | Preparation method for improving stability of cream product |
| CN111437246B (en) * | 2020-04-30 | 2022-09-13 | 福建太平洋制药有限公司 | Preparation method for improving stability of cream product |
| CN111920763A (en) * | 2020-09-18 | 2020-11-13 | 成都中医药大学 | Nutgrass galingale rhizome essential oil anti-allergy cream and preparation process thereof |
| CN116270606A (en) * | 2023-02-06 | 2023-06-23 | 上海旭东海普南通药业有限公司 | Urea vitamin E emulsifiable paste and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| CN105997989B (en) | 2018-09-07 |
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Address after: 201108 No. 889, Shennan Road, Minhang District, Shanghai Patentee after: Shanghai Zhengda General Pharmaceutical Co.,Ltd. Address before: 201108 No. 889, Shennan Road, Minhang District, Shanghai Patentee before: SHANGHAI GENERAL PHARMACEUTICAL Co.,Ltd. |