CN105997989B - 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 - Google Patents
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 Download PDFInfo
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- CN105997989B CN105997989B CN201610324490.XA CN201610324490A CN105997989B CN 105997989 B CN105997989 B CN 105997989B CN 201610324490 A CN201610324490 A CN 201610324490A CN 105997989 B CN105997989 B CN 105997989B
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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
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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
- A61K31/16—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
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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
- A61K31/33—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
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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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Abstract
Causing the urea and vitamin E cream of chap for treating rhagadia manus et pedis and Keratotic tinea hand or pedis the present invention relates to a kind of, including urea, 7 stearate of vitamin E, catechin and polyethylene glycol.Exquisiteness, granularity fine uniform, the good emulsifiable paste of coating performance can be prepared in present invention stirring at low speed in preparation process；This emulsifiable paste has better heat-resistant stable, is not likely to produce grease layering.It is of the present invention a kind of for treating rhagadia manus et pedis and Keratotic tinea hand or pedis causes the urea and vitamin E cream of chap, be conducive to industrialized production, simplify production technology, energy saving, stability is more preferable.
Description
Technical field
The invention belongs to pharmaceutical technology fields, and in particular to one kind is used to treat rhagadia manus et pedis and Keratotic tinea hand or pedis causes
The urea and vitamin E cream of chap.
Background technology
Urea and vitamin E cream is the common product for treating rhagadia manus et pedis, is disclosed according to Shanghai General Pharmaceutical Co., ltd.
Urea and vitamin E cream product, emulsifiable paste prescription is：Every gram contains 150 milligrams of urea, 10 milligrams of vitamin E；Auxiliary material is：Bai Fanshi
Woods, hexadeca-octadecyl alcohol, glycerin monostearate, liquid paraffin, cera alba, Triton X-100（OP）, glycerine, second
Edetate disodium, lauryl sodium sulfate, preservative（Ethyl hydroxy benzoate）, three extraits, purified water.The formula still needs to improve
Place be：Using Triton X-100（OP）When preparing urea and vitamin E cream as emulsifier, made in the emulsifiable paste
It is susceptible to the non-uniform problem of grain size during standby, oil phase is mixed with water conjunction emulsification in preparation process, and when emulsification uses height
Fast homogeneous, it is difficult to obtain the emulsifiable paste of particle diameter distribution uniformly, fine and smooth.Patent application 201110330517.3 also discloses that a kind of dimension E
Urea frost by saualane, caprylic capric glyceryl ester, white oil, dimethicone, monoglyceride, octadecyl alcolol, stearic acid, Arlacel-60,
Albolene, vitamin E, methyl hydroxybenzoate, propylben, glycerine, Tween-60, urea, essence and purified water composition；Match
Process processed is：Oil phase, water phase are heated respectively, then mixed, then high speed homogenization again.The preparation deficiency of this emulsifiable paste is,
It needs to be stirred in preparing process and be produced with the complicated technologies such as high speed homogenization, the equipment of stirring and homogeneous needed for preparation
High cost and energy consumption.
Invention content
Causing the urea and vitamin E cream of chap for treating rhagadia manus et pedis and Keratotic tinea hand or pedis the present invention provides a kind of,
Including urea, vitamin E and pegoxol 7 stearate, simple production process, the requirement to mixing speed and high speed homogenization
It is relatively low, it can be not necessarily to homogeneous, the breast that milk particle is fine and smooth uniformly, meets States Pharmacopoeia specifications can be prepared using lower mixing speed
Cream is more advantageous to the industrial production of emulsifiable paste, reduces the cost of equipment and energy consumption；There is good stabilization in 40 DEG C or more high temperature
Property, it is not easy to that water-oil separating occurs in 60 DEG C or more high temperature.
Causing the urea and vitamin E cream of chap for treating rhagadia manus et pedis and Keratotic tinea hand or pedis the present invention provides a kind of,
The emulsifiable paste is made of urea, dimension E and emulsifiable paste matrix, and the parts by weight containing 2-20 is poly- in the emulsifiable paste of every 100 parts by weight
The catechin of ethylene glycol -7- stearates and 1 ~ 500 ppm, the catechin grain size are no more than 100 μm, and the emulsifiable paste glues
Degree control is in 1000 ~ 6000cp.
Preferably, the dimension E and 2-20 parts by weight containing the urea of 15 parts by weight, 1 parts by weight in the emulsifiable paste of every 100 parts by weight
Pegoxol 7 stearate.
Preferably, the content of pegoxol 7 stearate should be 4-12 weights in the urea and vitamin E cream of every 100 parts by weight
Measure part.
Preferably, the content of pegoxol 7 stearate should be and be no more than in the urea and vitamin E cream of every 100 parts by weight
4-8 parts by weight.
Causing the urea and vitamin E cream of chap for treating rhagadia manus et pedis and Keratotic tinea hand or pedis the present invention provides a kind of,
The emulsifiable paste also contain pharmaceutically acceptable emulsifiable paste matrix, the emulsifiable paste matrix be albolene, light liquid petrolatum,
Carbomer, or combinations thereof content of the emulsifiable paste matrix in the emulsifiable paste of every 100 parts by weight be 0.01-20 parts by weight.
Causing the urea and vitamin E cream of chap for treating rhagadia manus et pedis and Keratotic tinea hand or pedis the present invention provides a kind of,
The emulsifiable paste also contains pharmaceutically acceptable preservative, and the preservative is Phenoxyethanol, benzoic acid, fourth hydroxyl fennel
Ether, or combinations thereof, content of the preservative in every 100 parts by weight emulsifiable paste is 0.05-2 parts by weight.
Causing the urea and vitamin E cream of chap for treating rhagadia manus et pedis and Keratotic tinea hand or pedis the present invention provides a kind of,
The emulsifiable paste also contain pharmaceutically acceptable surfactant, the surfactant be Labrasol,
LabrafilM1944 CS, or combinations thereof, content of the surfactant in the emulsifiable paste of every 100 parts by weight is 0.05-
20 parts by weight.
Preferably, the emulsifiable paste of every 100 parts by weight includes the urea of 15 parts by weight, the dimension E and 20 parts by weight of 1 parts by weight
Pegoxol 7 stearate.
Preferably, further include the LabrafilM1944 CS of 10 parts by weight in the emulsifiable paste of every 100 parts by weight, 10 parts by weight
Light liquid paraffin, the Phenoxyethanol of 0.5 parts by weight.
Preferably, further include the LabrafilM1944 CS of 2 parts by weight, 0.02 parts by weight in the emulsifiable paste of every 100 parts by weight
Carbomer, the Phenoxyethanol of the sodium hydroxide of 0.01 parts by weight and 0.5 parts by weight.
Emulsifiable paste provided by the invention is compared with traditional emulsifiable paste, in preparation process stirring at low speed can be prepared it is fine and smooth,
The good emulsifiable paste of granularity fine uniform, coating performance；This emulsifiable paste has better heat-resistant stable, is not likely to produce grease layering,
Be conducive to industrialized production, simplify production technology, energy saving.
Specific implementation mode
" range " disclosed herein is in the form of lower and upper limit.Can be respectively one or more lower limits and one
Or multiple upper limits.Given range is defined by selecting a lower limit and a upper limit.Selected lower and upper limit limit
The boundary of special range is determined.All ranges that can be defined in this way comprising and can combine, i.e., any lower limit
It can combine to form a range with any upper limit.For example, the range of 60-120 and 80-110 are listed for special parameter, reason
Solution is that the range of 60-110 and 80-120 is also to expect.In addition, if the minimum zone value 1 and 2 listed, and if list
Maximum magnitude value 3,4 and 5, then below range can all expect：1-3,1-4,1-5,2-3,2-4 and 2-5.
In the present invention, unless otherwise indicated, between the content range of each component of composition and its preferred scope
It can be combined with each other to form new technical solution.
In the present invention, unless otherwise indicated, " a combination thereof " indicates the multicomponent mixture of each element, such as two
Kind, three kinds, four kinds and until maximum possible multicomponent mixture.
In the present invention, unless otherwise indicated, owns " part " and percentage（%）All refer to weight percent.
In the present invention, unless otherwise indicated, the sum of percentage of each component is 100% in all compositions.
In the present invention, unless otherwise indicated, numberical range " a-b " indicates the contracting of the arbitrary real combinings between a to b
Sketch form shows that wherein a and b are real numbers.Such as numberical range " 0-5 " indicates all to have listed herein between " 0-5 "
Whole real numbers, " 0-5 " are that the breviary of these combinations of values indicates.
In the present invention, unless otherwise indicated, integer numberical range " a-b " indicates the arbitrary integer combination between a to b
Breviary indicate, wherein a and b are integers.Such as integer numberical range " 1-N " indicates 1,2 ... N, wherein N is integer.
If be not specifically stated, the term "an" used in this specification refers to "at least one".
If be not specifically stated, percentage of the present invention（Including weight percent）Benchmark be all the combination
The total weight of object.
Causing the urea and vitamin E cream of chap for treating rhagadia manus et pedis and Keratotic tinea hand or pedis the present invention provides a kind of,
The polyethylene glycol-containing the urea of 15 parts by weight, the dimension E of 1 parts by weight, 5 ~ 30 parts by weight in the emulsifiable paste of every 100 parts by weight
The catechin of 7- stearates and 1 ~ 500 ppm, the catechin grain size raw material are no more than 100 μm.In the combination of the present invention, gather
It is in semi-solid state that the content of ethylene glycol -7- stearates, which should be the emulsifiable paste that can make to match, the control of emulsifiable paste viscosity 1000 ~
6000cp（Viscosimetric analysis is using rotary viscosimeter in 25 DEG C of measurement）, emulsifiable paste is fine and smooth uniformly, and can preferably be resistant to high temperature not
Water-oil separating easily occurs.Therefore in the urea and vitamin E cream of every 100 parts by weight the content of pegoxol 7 stearate should be 4 ~
32 parts by weight, preferably 10 ~ 28 parts by weight.
In the present invention, the pegoxol 7 stearate is by Liquid Macrogol, polyethylene glycol 1500 and second
Alcohol is obtained with 50% stearic acid by esterification, and the average degree of polymerization of ethylene glycol is about 7 in final product.Polyethylene glycol -7-
Stearate is recorded in U.S. FDA auxiliary material guide（English name：Pegoxol 7 Stearate）, be it is a kind of pharmaceutically allow it is auxiliary
Material.
In the urea and vitamin E cream of the present invention, it may also include other pharmaceutically acceptable additives.
To the type of the additive, there is no any restrictions, can make additive conventional in the art, specifically select
From pharmaceutically acceptable consistency modifiers, pharmaceutically acceptable surfactant, pharmaceutically acceptable preservative, pharmacy
One or more of upper acceptable pH adjusting agent；In the present invention, for the dosage of the additive, there is no any
Limitation.
In the preferred embodiment of the present invention, the content containing the additive is in the emulsifiable paste of every 100 parts by weight
0.05 ~ 30 parts by weight, preferably 1 ~ 10 parts by weight.
In the present invention, for the type of pharmaceutically acceptable emulsifiable paste matrix, there is no any restrictions, it can be this
Common viscosity modifier in field；Can be consistency modifiers miscible with water be selected from carbomer, sodium carboxymethylcellulose or
A combination thereof；Can also be not water-miscible viscosity modifier be selected from atoleine, vaseline, octadecyl alcolol, or combinations thereof.
In the preferred embodiment of the present invention, the emulsifiable paste matrix is selected from carbomer, albolene, light liquid stone
Wax, or combinations thereof.In the present invention, there is no any restrictions to the dosage of the emulsifiable paste matrix, can be the routine in this field
Dosage.
The present invention a preferred embodiment in, the content of emulsifiable paste matrix described in the emulsifiable paste of every 100 parts by weight be 0.1 ~
20 parts by weight, preferably 1 ~ 15 parts by weight.By be added emulsifiable paste matrix, by the viscosity-adjusting agent of the urea and vitamin E cream to 1000 ~
2000cp preferably, and with viscosity be 1200 ~ 1500cp more preferably.
In the present invention, for pharmaceutically acceptable surfactant type there is no any restrictions, it can be this
Common surfactant in field.
In the preferred embodiment of the present invention, the surfactant is, Miglyol 812（Labrasol,
Purchased from French Jia Fasai（Gattefosse）Company）.In the present invention, the dosage of Surfactant does not have any restrictions, it
It can be the conventional amount used in this field.
The present invention a preferred embodiment in, the content of surfactant described in the emulsifiable paste of every 100 parts by weight be 0.5 ~
10 parts by weight, preferably 0.5 ~ 5 parts by weight.
In the present invention, for the type of pharmaceutically acceptable preservative, there is no any restrictions, it can be ability
Common preservative in domain.
In one embodiment of the invention, the preservative is selected from Phenoxyethanol, butylated hydroxy anisole or its group
It closes.
In the preferred embodiment of the present invention, the amount of contained preservative is 0.05 ~ 5 weight in the emulsifiable paste of every 100 parts by weight
Measure part, preferably 0.1 ~ 2 parts by weight.
In the present invention, for the type of pharmaceutically acceptable pH adjusting agent, there is no any restrictions, it can be this
Common pH adjusting agent in field.
In the preferred embodiment of the present invention, the pH adjusting agent selection sodium hydroxide, triethylamine, hydrochloric acid or its group
It closes.The pH value of the urea and vitamin E cream is adjusted to 4.0 ~ 8.0, preferably 6.0 ~ 8.0 by pH adjusting agent.
The present invention provides a kind of methods preparing urea and vitamin E cream, it includes step：
（a）Pegoxol 7 stearate is heated to 60 ~ 90 DEG C of fusings；
（b）By purified water be heated to（a）Identical temperature；
（c）Under continuous stirring, by step（a）With step（b）Obtained material mixing, temperature are controlled at 60 ~ 90 DEG C；
（d）By step（c）The mixture of gained is mixed slowly at 30 ~ 50 DEG C, and urea is added and dimension E is uniformly mixed；
（e）Packing obtains urea and vitamin E cream.
In the step（a）In can also be added 0.01 ~ 20 parts by weight pharmaceutically acceptable viscosity modifier and
The pharmaceutically acceptable surfactant of 0.05 ~ 15 parts by weight；
In above-mentioned steps（b）In the pharmaceutically acceptable viscosity modifiers and 0.05 of 0.01 ~ 2 parts by weight can also be added
The pharmaceutically acceptable bacteriostatic agent of ~ 5 parts by weight；
In the step（d）In pharmaceutically acceptable pH adjusting agent can also be added.
The present invention is further described below by specific embodiment, but is not limited the scope of the invention.
Raw material：
Pegoxol 7 stearate Tefose63：Purchased from French Jia Fasai companies；
Miglyol 812 Labrasol：Purchased from French Jia Fasai companies；
LabrafilM1944 CS：It is medical auxiliary materials Technology Co., Ltd. purchased from upper Hydron；
Other raw materials are commercial product.
The preparation of 1 urea and vitamin E cream 1 of embodiment
The formula of emulsifiable paste 1 is as follows：
Prepared by emulsifiable paste 1, carry out in accordance with the following methods：
（a）By pegoxol 7 stearate（tefose63）, Miglyol 812（Labrasol）With liquid stone
Wax is heated to 60 DEG C of fusings；
（b）By purified water, the catechin of urea and 5 ppm（Catechin raw material need to be crushed to grain size and be no more than 100 μm）It is mixed
It closes uniformly, is heated to 60 DEG C；
（c）It is stirred in continuous slow（30rpm）Under, by step（a）With step（b）Mixing, stirring and emulsifying, temperature control
At 60 DEG C；
（d）By step（c）It obtains mixture stirring and is cooled to 25 ~ 50 DEG C, dimension E is added and stirs evenly, obtain urea dimension E
Emulsifiable paste.
The preparation of 2 urea and vitamin E cream 2 of embodiment
The formula of emulsifiable paste 2 is as follows：
Preparation process：
（a）By pegoxol 7 stearate（tefose63）, hexadecanol be heated to 75 DEG C fusing, add lightweight liquid
Shape paraffin is uniformly mixed, and keeps 75 DEG C of temperature；
（b）By purified water, the catechin of urea and 4 ppm（Catechin raw material need to be crushed to grain size and be no more than 100 μm）It is mixed
It closes uniformly, is heated to 75 DEG C；
（c）It is stirred in continuous slow（40rpm）Under, by step（a）With step（b）Mixing, stirring and emulsifying, temperature control
At 75 DEG C；
（d）By step（c）It obtains mixture stirring and is cooled to 25 ~ 50 DEG C, dimension E is added and stirs evenly, obtain urea dimension E
Emulsifiable paste.
The preparation of 3 urea and vitamin E cream 3 of embodiment
The formula of emulsifiable paste 3 is as follows：
Preparation process：
（a）Pegoxol 7 stearate, light liquid paraffin, cera alba and LabrafilM1944 CS are heated to
70 DEG C of fusings；
（b）By purified water, the catechin of Phenoxyethanol, urea and 3 ppm（Catechin raw material need to be crushed to grain size and not surpass
Cross 100 μm）It is uniformly mixed, is heated to 70 DEG C；
（c）It is stirred in continuous slow（35rpm）Under, by step（a）With step（b）Mixing, stirring and emulsifying, temperature control
At 70 DEG C；
（d）By step（c）It obtains mixture stirring and is cooled to 25 ~ 50 DEG C, dimension E is added and stirs evenly, obtain urea dimension E
Emulsifiable paste.
The preparation of 4 urea and vitamin E cream 4 of embodiment
The formula of emulsifiable paste 4 is as follows：
Preparation process：
（a）By pegoxol 7 stearate（tefose63）, albolene, light liquid petrolatum, octadecyl alcolol and pungent
Sour glycerol decanoate（Labrasol）After being heated to 75 DEG C of fusings, butylated hydroxy anisole is added, keeps temperature after mixing
75℃；
（b）It is water-swellable overnight that carbomer is first added to suitable purifying, next day addition sodium hydroxide is adjusted to carbomer and is in
The catechin of urea and 2 ppm is added in gel（Catechin raw material need to be crushed to grain size and be no more than 100 μm）In be uniformly mixed,
It is heated to 75 DEG C；
（c）It is stirred in continuous slow（300rpm）Under, by step（a）With step（b）Mixing, stirring and emulsifying, temperature control
At 75 DEG C；
（d）By step（c）It obtains mixture stirring and is cooled to 25 ~ 50 DEG C, dimension E is added and stirs evenly, obtain urea dimension E
Emulsifiable paste.
The preparation of 5 urea and vitamin E cream 5 of embodiment
The formula of emulsifiable paste 5 is as follows：
Preparation process：
（a）By pegoxol 7 stearate（tefose63）, octadecyl alcolol and LabrafilM1944 CS be heated to 70
DEG C fusing, add butylated hydroxy anisole and keep temperature 70 C after mixing；
（b）By the catechin of purified water, urea and 1ppm（Catechin raw material need to be crushed to grain size and be no more than 100 μm）It is mixed
It closes uniformly, adds vaseline and be uniformly mixed, be heated to 70 DEG C；
（c）It is stirred in continuous slow（32rpm）Under, by step（a）With step（b）Mixing, stirring and emulsifying, temperature control
At 70 DEG C；
（d）By step（c）It obtains mixture stirring and is cooled to 25 ~ 50 DEG C, dimension E is added and stirs evenly, obtain urea dimension E
Emulsifiable paste.
The preparation of 6 urea and vitamin E cream 6 of embodiment
The formula of emulsifiable paste 6 is as follows：
Preparation process：
（a）By pegoxol 7 stearate, light liquid paraffin, Miglyol 812（Labrasol）With
LabrafilM1944 CS are heated to 70 DEG C of fusings；
（b）By purified water, Phenoxyethanol, urea and catechin with 5 ppm（Catechin raw material need to be crushed to grain size not
More than 100 μm）It is uniformly mixed, is heated to 70 DEG C；
（c）It is stirred in continuous slow（33rpm）Under, by step（a）With step（b）Mixing, stirring and emulsifying, temperature control
At 70 DEG C；
（d）By step（c）It obtains mixture stirring and is cooled to 25 ~ 50 DEG C, dimension E is added and stirs evenly, obtain urea dimension E
Emulsifiable paste.
The preparation of 7 urea and vitamin E cream 7 of embodiment
The formula of emulsifiable paste 7 is as follows：
Preparation process：
（a）By pegoxol 7 stearate（tefose63）, albolene, cera alba and LabrafilM1944 CS
It is heated to 65 DEG C of fusings；
（b）It is water-swellable overnight that carbomer is first added to suitable purifying, next day addition sodium hydroxide is adjusted to carbomer and is in
The catechin of Phenoxyethanol, urea and 500 ppm is added in gel（Catechin raw material need to be crushed to grain size and be no more than 100 μm）
It is uniformly mixed, is heated to 65 DEG C；
（c）It is stirred in continuous slow（35rpm）Under, by step（a）With step（b）Mixing, stirring and emulsifying, temperature control
At 65 DEG C；
（d）By step（c）It obtains mixture stirring and is cooled to 25 ~ 50 DEG C, dimension E is added and stirs evenly, obtain urea dimension E
Emulsifiable paste.
The preparation of 8 urea and vitamin E cream 8 of embodiment
The formula of emulsifiable paste 8 is as follows：
Preparation process：
（a）By pegoxol 7 stearate（tefose63）, glycerin monostearate, albolene, hexadecanol and
LabrafilM1944 CS are heated to 80 DEG C of fusings；
（b）It is water-swellable overnight that carbomer is first added to suitable purifying, next day addition sodium hydroxide is adjusted to carbomer and is in
The catechin of Phenoxyethanol, urea and 200 ppm is added in gel（Catechin raw material need to be crushed to grain size and be no more than 100 μm）
It is uniformly mixed, is heated to 80 DEG C；
（c）It is stirred in continuous slow（210rpm）Under, by step（a）With step（b）Mixing, stirring and emulsifying, temperature control
At 80 DEG C；
（d）By step（c）It obtains mixture stirring and is cooled to 25 ~ 50 DEG C, dimension E is added and stirs evenly, adjusts PH to 6.0, after
It is continuous to stir and evenly mix, obtain urea and vitamin E cream.
The preparation of 9 urea and vitamin E cream 9 of embodiment
The formula of emulsifiable paste 9 is as follows：
Preparation process：
（a）By pegoxol 7 stearate（tefose63）, lanolin, liquid paraffin, vaseline and
LabrafilM1944 CS are heated to 90 DEG C of fusings；
（b）It is water-swellable overnight that carbomer is first added to suitable purifying, next day addition sodium hydroxide is adjusted to carbomer and is in
The catechin of Phenoxyethanol, urea and 100 ppm is added in gel（Catechin raw material need to be crushed to grain size and be no more than 100 μm）
It is uniformly mixed, is heated to 90 DEG C；
（c）It is stirred in continuous slow（260rpm）Under, by step（a）With step（b）Mixing, stirring and emulsifying, temperature control
At 90 DEG C；
（d）By step（c）It obtains mixture stirring and is cooled to 25 ~ 50 DEG C, dimension E is added and stirs evenly, obtain urea dimension E
Emulsifiable paste.
In above embodiment 1 ~ 9, the viscosity of the emulsifiable paste finally prepared controls within 1000 ~ 6000cp ranges.
The preparation of 10 urea and vitamin E cream 10 of embodiment
The formula of emulsifiable paste 10 is as follows：
Preparation process：
（a）LabrafilM1944 CS, albolene, light liquid petrolatum, beeswax are heated to 90 DEG C of fusings；
（b）It is water-swellable overnight that carbomer is first added to suitable purifying, next day addition sodium hydroxide is adjusted to carbomer and is in
Gel, is added Phenoxyethanol and urea is uniformly mixed, and is heated to 90 DEG C；
（c）It is stirred in continuous slow（270rpm）Under, by step（a）With step（b）Mixing, adds dodecyl sulphur
Sour sodium stirring and emulsifying, temperature are controlled at 90 DEG C；
（d）By step（c）It obtains mixture stirring and is cooled to 25 ~ 50 DEG C, dimension E is added and stirs evenly, obtain urea dimension E
Emulsifiable paste.
The preparation of 11 urea and vitamin E cream 11 of embodiment
The formula of emulsifiable paste 11 is as follows：
Preparation process：
（a）Albolene, light liquid petrolatum, hexadeca-octadecyl alcohol are heated to 60 DEG C of fusings；
（b）Purified water and urea are uniformly mixed, are heated to 60 DEG C；
（c）It is stirred in continuous slow（35rpm）Under, by step（a）With step（b）Lauryl sodium sulfate is added in mixing
Stirring and emulsifying, temperature are controlled at 60 DEG C；
（d）By step（c）It obtains mixture stirring and is cooled to 25 ~ 50 DEG C, dimension E is added and stirs evenly, obtain urea dimension E
Emulsifiable paste.
The preparation of 12 urea and vitamin E cream 12 of embodiment
The formula of emulsifiable paste 12 is as follows：
Preparation process：
（a）Albolene, light liquid paraffin and LabrafilM1944 CS are heated to 70 DEG C of fusings；
（b）Purified water, Phenoxyethanol and urea are uniformly mixed, are heated to 70 DEG C；
（c）It is stirred in continuous slow（30rpm）Under, by step（a）With step（b）Mixing, stirring and emulsifying, temperature control
At 70 DEG C；
（d）By step（c）It obtains mixture stirring and is cooled to 25 ~ 50 DEG C, dimension E is added and stirs evenly, obtain urea dimension E
Emulsifiable paste.
Embodiment 13：Water-oil separating condition monitoring
Emulsifiable paste in Example 1 ~ 12,60 DEG C of water-baths for 24 hours, take out emulsifiable paste sample, observe water-oil separating, experimental result is such as
Shown in following table：
By experimental result, it can be seen that in emulsifiable paste 1 ~ 9 prepared by the present invention, grease point is not observed for 24 hours in 60 DEG C of water-baths
From the phenomenon that, the present invention prepared by emulsifiable paste it is more stable.
Embodiment 14
Emulsifiable paste in Example 1 ~ 12, exists respectively（Or do not exist）After 60 DEG C of water-baths for 24 hours, according to national drug standards WS-
10001- (HD-0528) -2002 has P.6-94 carried out the content of urea to emulsifiable paste respectively and dimension E differentiates two analyses, as a result
It is as follows：
By experimental result, it can be seen that the emulsifiable paste component and content for preparing gained are compared with the emulsifiable paste of non-water-bath, are not occurred
Significant change.Cream products of the present invention are taken to be observed under scanning electron microscope, it can be seen that granularity fine uniform, it is fine and smooth, it is less than tradition side
Cream products prepared by method.
The foregoing is merely illustrative of the preferred embodiments of the present invention, is not limited to the substantial technological content model of the present invention
It encloses, substantial technological content of the invention is broadly to be defined in the right of application, any technology that other people complete
Entity or method also or a kind of equivalent change, will if identical with defined in the right of application
It is considered as being covered by among the right.
All references mentioned in the present invention is incorporated herein by reference, independent just as each document
It is incorporated as with reference to such.In addition, it should also be understood that, after the above for having read the present invention, those skilled in the art can be right
The present invention makes various changes or modifications, and these equivalent forms also fall within the scope of the appended claims of the present application.
Claims (4)
1. a kind of causing the urea and vitamin E cream of chap for treating rhagadia manus et pedis and Keratotic tinea hand or pedis, which is characterized in that described
Emulsifiable paste by urea, dimension E and emulsifiable paste matrix form, in the emulsifiable paste of every 100 parts by weight contain 15 parts by weight urea, 1 weight
Dimension E, the 0.01-20 parts by weight emulsifiable paste matrix for measuring part, the also poly- second of the parts by weight containing 2-20 in the emulsifiable paste of every 100 parts by weight
Glycol -7- stearates, the surfactant of 0.05-20 parts by weight and the catechin of 3ppm, the catechin grain size do not surpass
100 μm are crossed, in 1000~6000cp, the preparation method of the urea and vitamin E cream includes following step for the viscosity control of the emulsifiable paste
Suddenly：
(a) pegoxol 7 stearate, light liquid paraffin, cera alba and LabrafilM1944CS 70 DEG C are heated to melt
Change；
(b) catechin of purified water, Phenoxyethanol, urea and 3ppm are uniformly mixed, are heated to 70 DEG C；
(c) under 35rpm mixing speeds, step (a) is mixed with step (b), purified water adds to 100 parts by weight, stirring and emulsifying,
Temperature is controlled at 70 DEG C；
(d) step (c) is obtained into mixture stirring and is cooled to 25~50 DEG C, dimension E is added and stirs evenly, obtains urea and vitamin E cream.
2. urea and vitamin E cream according to claim 1, which is characterized in that gather in the urea and vitamin E cream of every 100 parts by weight
The content of ethylene glycol -7- stearates should be 4-12 parts by weight.
3. urea and vitamin E cream according to claim 1, which is characterized in that gather in the urea and vitamin E cream of every 100 parts by weight
The content of ethylene glycol -7- stearates should be 4-8 parts by weight.
4. urea and vitamin E cream according to claim 1, which is characterized in that also contain pharmaceutically acceptable preservative, institute
The preservative stated be Phenoxyethanol, benzoic acid, butyl anisole, or combinations thereof, the preservative every 100 parts by weight breast
Content in cream is 0.05-2 parts by weight.
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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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| 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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| 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 |
| 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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| CN105250333B (en) * | 2015-11-19 | 2017-03-15 | 李君佩 | A kind of pharmaceutical composition of antibacterial skin moistening and preparation method thereof |
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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. |