CN105832657B - A kind of compound lactic acid emulsifiable paste, preparation method and application - Google Patents
A kind of compound lactic acid emulsifiable paste, preparation method and application Download PDFInfo
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- CN105832657B CN105832657B CN201610364481.3A CN201610364481A CN105832657B CN 105832657 B CN105832657 B CN 105832657B CN 201610364481 A CN201610364481 A CN 201610364481A CN 105832657 B CN105832657 B CN 105832657B
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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
- A61K31/16—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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
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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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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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
Abstract
The present invention provides a kind of compound lactic acid emulsifiable pastes, the auxiliary material oleic acid that stability is influenced in prior art lactic acid ointment is removed in the compound lactic acid emulsifiable paste, simultaneously without further addition preservative, to solve the technical issues of poor lactic acid ointment thermal stability in the prior art, easy heat resolve.Compound lactic acid emulsifiable paste of the present invention has many advantages, such as that prescription is simple, stability is good, good effect and long shelf-life.Meanwhile the present invention also provides the preparation method of the compound lactic acid emulsifiable paste, in this method will dissolution of raw material of the present invention mix after compound lactic acid emulsifiable paste of the present invention is made, have many advantages, such as that preparation method is easy, good product quality.Similarly, the present invention also provides the applications of compound lactic acid emulsifiable paste of the present invention, it containing efficacy ingredients such as lactic acid, urea in compound lactic acid emulsifiable paste of the present invention, and added with other auxiliary materials and is used cooperatively, can be effectively relieved and treat ichthyosis and hand and foot chapping.
Description
Technical field
The present invention relates to compound medicinal formulation fields, in particular to a kind of compound lactic acid emulsifiable paste, preparation method and answer
With.
Background technique
Ichthyosis and hand and foot chapping are dermatology common diseases, are mainly shown as dry skin, angling, furfur, chap etc.,
It can be with pain and different degrees of itch.Ichthyosis is broadly divided into amphitypy, and a type is autosomal dominant inheritance ichthyosis vulgaris,
Familial inheritance, men and women can illness；Another type is that property interlocks hereditary ichthyosis vulgaris, and gene on X chromosome, only lose by this type
It is transmitted to male, women is gene carrier without sending out this disease.The disease incidence of the disease, which exists, to be shown to the epidemiological study of ichthyosis
23.3/ ten thousand.Ichthyosis will not self-healing, be existing heredity dyskeratosis disease throughout one's life, there is no radical treatment at present.Existing rank
Section mainly carries out immunotherapy targeted autoantibody according to the symptom of clinical manifestation for the treatment of ichthyosis, to alleviate symptom.And brothers' chap
Splitting disease is especially special thick in palm plantar etc. positions cuticula and cracking that occurs since cuticula is thicker, in winter temperature it is low and
When humidity is smaller, the skin for lacking sebum protection is just easy to happen cracking；Meanwhile the skin disorders such as ichthyosis will also result in skin
It is dry, and cuticula is more thickened, it is easier to cause hand and foot chapping.
Since ichthyosis and hand and foot chapping can bring ailing and many inconvenience in life to patient, it is used for
Treat the hot spot place that both dermopathic drugs are also people's research and development always.
Lactic acid belongs to a kind of 'alpha '-hydroxy acids, and 'alpha '-hydroxy acids are one group of organic acid, including glycolic, lactic acid, malic acid etc.,
Foreign countries have received the drying dermatoses that 'alpha '-hydroxy acids and its salt are used to treat ichthyosis and, for example, hand and foot chapping etc. very
Good curative effect.At this stage, it is believed that lactic acid main mechanism is that horny layer of epidermis cytoadherence is inhibited to increase, inhibit cutin shape
At process, epidermis is made to restore normal angling function.Meanwhile urea, as keratin-lytic agent, the hydration that can increase cuticula is made
With, make cutin swelling, reduces skin resistance, thus drug is increased to the penetrability of skin, it can also make skin moist, and have only
Itch effect.Lactic acid and urea with the use of curative effect can be increased, meanwhile, when treating ichthyosis and rhagadia manus et pedis, need it is long-term,
Multiple dosing, and lactic acid and urea are human endogenous compound, therefore safety in utilization is also relatively high associated with the two.
(CN1108940A, publication date: nineteen ninety-five September 27 days) discloses one kind and with lactic acid and urea is in the prior art
The lactic acid ointment of raw material, supplementary material have: lactic acid, urea, concentrated ammonia liquor, cholesterol, glycerin monostearate, glycerol, to hydroxyl
Ethyl benzoate, polyoxyethylene (40) monostearate, albolene, dibutyl hydroxy toluene, oleic acid, distilled water.
However, the auxiliary material oleic acid due to the emulsifiable paste is easy to oxidize, emulsifiable paste can gradually absorb oxygen, color in air
It is dimmed；Meanwhile the thermal stability of the auxiliary material oleic acid in this emulsifiable paste is poor, heats and is easy to decompose, also will affect the stability of emulsifiable paste.
In consideration of it, the present invention is specifically proposed.
Summary of the invention
The first object of the present invention is to provide a kind of compound lactic acid emulsifiable paste, by the prior art in the compound lactic acid emulsifiable paste
The auxiliary material oleic acid removal of stability is influenced in lactic acid ointment, while without further addition preservative, to solve existing
The technical issues of lactic acid ointment thermal stability is poor in technology, easy heat resolve.Compound lactic acid emulsifiable paste of the present invention have prescription it is simple,
Stability is good, good effect and the advantages that long shelf-life.
The second object of the present invention is to provide the preparation method of compound lactic acid emulsifiable paste described in one kind, incite somebody to action this in this method
After the mixing of invention dissolution of raw material, compound lactic acid emulsifiable paste of the present invention is made, has preparation method easy, strong operability is suitable for
The advantages that mass production, good product quality.
Third object of the present invention is to provide the application of compound lactic acid emulsifiable paste of the present invention, compound lactic acid of the present invention
It containing efficacy ingredients such as lactic acid, urea in emulsifiable paste, and added with other auxiliary materials and is used cooperatively, can be effectively relieved and treat
Ichthyosis and hand and foot chapping.
In order to realize above-mentioned purpose of the invention, the following technical scheme is adopted:
A kind of compound lactic acid emulsifiable paste, according to mass percentage, the compound lactic acid emulsifiable paste is mainly made of the following components:
Lactic acid 8%~18%, urea 5%~18%, emulsion bases 64%~87%；Wherein, the emulsion bases includes water-soluble base
Matter, oil-soluble matrix and water；Wherein, oleic acid and preservative are not included in the component formula.
In the present invention, by the way that the auxiliary material oleic acid for influencing stability in prior art lactic acid ointment is removed, so that this
Invention compound lactic acid emulsifiable paste has preferable stability；Meanwhile being acted in the present invention using the antisepsis and sterilization of lactic acid itself, thus
The preservative further added in prior art lactic acid ointment has further been omitted, has advanced optimized prescription.Compound of the present invention
Lactic acid emulsifiable paste has many advantages, such as that prescription is simple, stability is good, good effect and long shelf-life.
Optionally, in the present invention, the water-soluble base is substance that is water-soluble, and can mixing with water.
Optionally, in the present invention, the oil-soluble matrix is strong-hydrophobicity substance, such as hydro carbons, esters and grease etc..
Optionally, in the present invention, the compound lactic acid emulsifiable paste is mainly made of the following components: lactic acid 8%~18%, urea
5%~18%, oil phase substrate 25%~35%, emulsifier 9%~21%, moisturizer 8%~12%, pH adjusting agent 5%~
8%, surplus is purified water；Wherein, the emulsifier is by polyoxyethylene stearate (40) ester, glycerin monostearate and cholesterol
Composition.In the present invention, by the further selection and adjustment to aqueous phase substrate and oil phase substrate component, to further enhance
The curative effect of compound lactic acid emulsifiable paste of the present invention.
Optionally, in the present invention, according to mass percentage, the compound lactic acid emulsifiable paste is made of the following components: lactic acid
8%~18%, urea 5%~18%, oil phase substrate 25%~35%, emulsifier 9%~21%, moisturizer 8%~12%, pH
Regulator 5%~8%, surplus are purified water；Wherein, the emulsifier is by polyoxyethylene stearate (40) ester, glycerol monostearate
Ester and cholesterol composition.
Optionally, in the present invention, the content of the lactic acid can be such as, but not limited to 9%, 10%, 12%, 16%.
Optionally, in the present invention, the content of the urea can be such as, but not limited to 9%, 11%, 13%, 17%.
Optionally, in the present invention, the content of the oil phase substrate can be but be not limited to 26%, 28%, 31%, 33%.
Optionally, in the present invention, the content of the emulsifier can be but be not limited to 11%, 13%, 17%, 19%.
Optionally, in the present invention, the content of the moisturizer can be but be not limited to 9%, 10%.
Optionally, in the present invention, the content of the pH adjusting agent can be but be not limited to 6%, 7%.
Optionally, in the present invention, the water is purified water.
Optionally, in the present invention, the pH adjusting agent is ammonium hydroxide.
Optionally, in the present invention, the moisturizer is glycerol.
Optionally, in the present invention, according to mass percentage, the compound lactic acid emulsifiable paste is mainly made of the following components:
Lactic acid 10%~15%, urea 8%~15%, oil phase substrate 27%~32%, emulsifier 11%~16%, moisturizer 9%~
10%, pH adjusting agent 6%~7%, surplus is purified water.
In the present invention, by the further adjustment and optimization to each component supplementary material in compound lactic acid emulsifiable paste, thus into one
Step enhances the curative effect of compound lactic acid emulsifiable paste of the present invention.
Optionally, in the present invention, according to mass percentage, the compound lactic acid emulsifiable paste is made of the following components: lactic acid
10%~15%, urea 8%~15%, oil phase substrate 27%~32%, emulsifier 11%~16%, moisturizer 9%~10%,
PH adjusting agent 6%~7%, surplus are purified water.
Optionally, in the present invention, according to mass percentage, polyoxyethylene stearate (40) ester 2%~6% is single hard
Glycerol 5%~10%, cholesterol 2%~5%.；Preferably, in the present invention, according to mass percentage, the tristearin
Poly- hydrocarbon oxygen (40) ester 3%~5% of acid, glycerin monostearate 6%~8%, cholesterol 2%~3%.
In the present invention, by the adjustment and optimization to emulsifier dosage of each component, so that it is multiple to further improve the present invention
The stability of square lactic acid emulsifiable paste.
Optionally, in the present invention, the oil phase substrate is albolene.
In the present invention, by the selection and adjustment to oil phase substrate used and aqueous phase substrate ingredient, to further improve
The uniformity and stability of compound lactic acid emulsifiable paste of the present invention.
Meanwhile the present invention also provides a kind of preparation method of compound lactic acid emulsifiable paste of the present invention, the method includes
Following steps: weighing oil phase substrate, cholesterol, glycerin monostearate, after mixing, is heated to being completely melt and stir and evenly mix,
Obtain oily phase；Meanwhile lactic acid and purified water are weighed, and be uniformly mixed, pH adjusting agent is then added, and it is mixed to continue stirring
It closes uniformly, is subsequently added into moisturizer, polyoxyethylene stearate (40) ester and urea, and heating stirring is arrived to being completely dissolved
Water phase；Then, under agitation, water phase is added in oily phase, and emulsifying, continues to stir to be cooled to be condensed into cream, i.e.,
Obtain the compound lactic acid emulsifiable paste.
In the present invention, to prepare the compound lactic acid emulsifiable paste after dissolution of raw material of the present invention mixing, there is preparation method simplicity,
The advantages that good product quality.
Optionally, in the present invention, the method still further comprises the step that obtained compound lactic acid emulsifiable paste is filling.
Optionally, in the present invention, the temperature being completely melt that is heated to is 60 DEG C~90 DEG C.
In the present invention, by the selection and adjustment to fusion temperature, thus guaranteeing that oil-soluble ingredients are completely melt to mix
While, will not also temperature it is excessively high caused by oil-soluble ingredients it is rotten.
Optionally, in the present invention, the temperature of the heating stirring is 60 DEG C~90 DEG C.
In the present invention, by the selection and adjustment to whipping temp, so as to so that water soluble ingredient sufficiently dissolves by heating
While, will not also temperature it is excessively high caused by the volatilization of liquid phase water soluble ingredient or rotten.
Optionally, in the present invention, the time of the emulsifying is 15min~45min；Preferably, described in the present invention
The time of emulsifying is 20min~30min.
In the present invention, by the selection and adjustment to the emulsifying time, so as to while guaranteeing fully emulsified,
Will not also the reaction time it is too long caused by whole preparation efficiency reduce.
Meanwhile the present invention also provides a kind of compound lactic acid emulsifiable pastes of the present invention in preparation treatment dermatosis treating medicine
Using.
Optionally, heretofore described skin disease is ichthyosis and hand and foot chapping.
Compared with prior art, the invention has the benefit that
(1) in compound lactic acid emulsifiable paste of the present invention, it is not necessary that oleic acid and preservative is added, thus while simplifying formula,
The shelf-life of emulsifiable paste can also be improved.
(2) the method for the present invention operating procedure is simple, by adjustment to reaction conditions such as reaction temperature and reaction time and
Optimization, also further improves the quality of emulsifiable paste obtained by the present invention, and improve whole preparation efficiency.
(3) in compound lactic acid emulsifiable paste of the present invention, added with lactic acid, urea etc. to skin diseases such as ichthyosis and hand and foot chappings
Disease has an effective component of good efficacy, and added with other auxiliary materials and being used cooperatively, therefore has preferable stability and good
Good curative effect.
Detailed description of the invention
Fig. 1 is inventive formulation and comparison drug Transdermal absorption comparative result figure.
Specific embodiment
Embodiment of the present invention is described in detail below in conjunction with embodiment, but those skilled in the art will
Understand, the following example is merely to illustrate the present invention, and is not construed as limiting the scope of the invention.It is not specified in embodiment specific
Condition person carries out according to conventional conditions or manufacturer's recommended conditions.Reagents or instruments used without specified manufacturer is
The conventional products that can be obtained by commercially available purchase.
Embodiment 1:
According to mass percent, lactic acid 12%, urea 15%, ammonium hydroxide 6%, albolene 30%, stearic acid are weighed respectively
Poly- hydrocarbon oxygen (40) ester 3%, glycerin monostearate 6%, cholesterol 3%, glycerol 10% and purified water 15%.
Then, compound lactic acid emulsifiable paste is prepared in accordance with the following steps:
(1) after mixing albolene, cholesterol, glycerin monostearate, 70 DEG C are heated to, and stir and evenly mix, made each
Component is completely melt to arrive oily phase.
(2) lactic acid, purified water are then stirred into uniform solution, add ammonium hydroxide, be uniformly mixed, and is added
Glycerol, polyoxyethylene stearate (40) ester, urea, are heated to 70 DEG C, then stirring and dissolving to get arrive water phase.
(3) under agitation, water phase is added in oily phase, emulsifying 30min.
(4) by gained mixed solution continue stirring be cooled to be condensed into cream to get arrive embodiment 1 compound lactic acid emulsifiable paste,
And it further dispenses filling.
The emulsifiable paste of embodiment 1 is milky, pH 4.4.By microexamination, the emulsion droplet size of emulsifiable paste is equal in embodiment 1
Less than 8 μm, 3000rpm is centrifuged 30 minutes, not stratified, be not demulsified.
Embodiment 2
According to mass percent, lactic acid 12%, urea 15%, ammonium hydroxide 6%, albolene 35%, stearic acid are weighed respectively
Poly- hydrocarbon oxygen (40) ester 4%, glycerin monostearate 8%, cholesterol 2%, glycerol 10% and purified water 8%.
Then, the emulsifiable paste of embodiment 2 is prepared according to 1 the method for embodiment, and further dispenses filling.
Emulsifiable paste obtained by embodiment 2 is milky, pH 4.5.Through microexamination, the emulsion droplet size of 2 emulsifiable paste of embodiment
Respectively less than 8 μm, 3000rpm is centrifuged 30 minutes, not stratified, be not demulsified.
Embodiment 3:
According to mass percent, lactic acid 12%, urea 15%, ammonium hydroxide 6%, albolene 32%, stearic acid are weighed respectively
Poly- hydrocarbon oxygen (40) ester 5%, glycerin monostearate 7%, cholesterol 2%, glycerol 8% and purified water 13%.
Then, the emulsifiable paste of embodiment 3 is prepared according to 1 the method for embodiment, and further dispenses filling.
Emulsifiable paste obtained by embodiment 3 is milky, pH 4.5.Through microexamination, the emulsion droplet size of 3 emulsifiable paste of embodiment
Respectively less than 8 μm, 3000rpm is centrifuged 30 minutes, not stratified, be not demulsified.
Experimental example
In order to further detect the stability and efficacy of compound lactic acid emulsifiable paste obtained by the present invention, also carried out in the present invention
Following experimental study, specific as follows:
1, thermal cycling test
Compound lactic acid emulsifiable paste obtained by Examples 1 to 3 and control drug (are implemented according to prior art CN1108940A
Obtained emulsifiable paste in example method) carry out thermal cycling test.
Experimental condition: each group sample is first placed in the fresh-keeping chamber of refrigerator (about 5~10 DEG C), and (48 hours) take out afterwards within two days
It is placed in 40 DEG C of baking oven, so circulation three times, after the test, investigate, and test result is shown in Table 1 by sampling.
1 stability thermal cycling test result of table
Test result shows: the made sample of Examples 1 to 3 is after thermal cycling test, and emulsifiable paste property is stablized, control drug
After thermal cycling test, there is water-oil separating phenomenon in centrifugation, and compound lactic acid stability of cream of the invention is better than control drug.
2, toxicity research
Toxicological study is carried out to emulsifiable paste made from Examples 1 to 3, specific testing result is as follows:
(1) skin irritation detection
The compound lactic acid emulsifiable paste and excipient control group of Examples 1 to 3 preparation are continuously to rabbit intact skin and damaged skin
After skin is administered 7 days, stimulation score value is 0 point within 1~72 hour；Pathological examination results, compound lactic acid emulsifiable paste group and excipient control
Group rabbit intact skin and damaged skin are similar with the histological change of blank control group at drug withdrawal 1 hour and drug withdrawal 72 hours.
Compound lactic acid emulsifiable paste acts on rabbit intact skin and damaged skin without obvious stimulation.
(2) skin hypersensitivity detects
The compound lactic acid emulsifiable paste group and excipient group of the embodiment of the present invention 1~3 are 0% to the sensitization rate of guinea pig skin,
Without sensitization.
By toxicological study result as described above it is found that compound lactic acid emulsifiable paste of the invention is acted on without obvious stimulation and sensitization
Property, without toxic side effect, clinical application safety.
3, accelerated test
Each group sample is placed in 30 DEG C ± 2 DEG C of temperature, relative humidity is placed 6 months under conditions of being 65% ± 5%, difference
In the 0th, 1,2,3,6 the end of month sample detection.
Sample: being respectively adopted the emulsifiable paste in the embodiment of the present invention 1 and control drug is (real according to prior art CN1108940A
Apply emulsifiable paste obtained in a method)
2 accelerated test result of table
The result shows that: accelerated test 6 months, character, content, pH value and the microexamination of drug had no significant change,
It is centrifuged not stratified, limit test of microbe qualification, packaging material appearance no abnormality seen.Illustrate that formulation stability of the invention is good.
4, in vitro transdermal test
(1) preparation of isolated skin
The skin for taking sucking pig abdomen shaving, is laid in skin on clean glass plate, makes cuticula downward, use pocket knife
It is stained with physiological saline and rejects subcutaneous fat, tissue and capillary, it is clean with physiological saline repeated flushing, it dries stand-by.
(2) in vitro transdermal experiment
Pigskin is put into Franz diffusion cell, upward, the effective area of diffusion cell is 12.56cm to keratoderma2.It takes
Emulsifiable paste sample 1g is uniformly applied to skin surface, and physiological saline 7ml is added in reception tank.It is placed in 37 DEG C of thermostat water baths, revolving speed
300r/min.Whole receiving liquids are taken out respectively at 0.5,1,2,4,6,8,12h, reinject the new liquid of 7ml.It, will after 12h is sampled
Emulsifiable paste is remained on skin to scrape into beaker, and gas chromatography and purple is respectively adopted in remaining emulsifiable paste on the receiving liquid and skin of taking-up
Outside-visible spectrophotometry detection lactic acid and urea content, and calculate the unit plane accumulation of different time points lactic acid and urea
Product infiltration capacity and intradermal residual quantity.Using the time as abscissa, it is ordinate that unit area, which accumulates infiltration capacity, makees linear regression, obtains
Equation of linear regression, slope are percutaneous rate.
Test specimen: using in the embodiment of the present invention 1 emulsifiable paste and control drug it is (real according to prior art CN1108940A
Apply emulsifiable paste obtained in a method).
The calculation formula that unit area accumulates infiltration capacity Q is as follows:
Q in formulanUnit area infiltration capacity (q=sample concentration * receiving liquid sampling amount/release area) is surveyed for n-th.
It accumulates within residual quantity -12 hours on skin after measured amount -12h sampling on skin before intradermal residual flow amount=Transdermal absorption
Infiltration capacity.
Further, shown in experiment contrast result table 3 specific as follows, table 4 and Figure of description Fig. 1: 3 lactic acid of table is transdermal
Absorb Comparative result
4 urea Transdermal absorption Comparative result of table
It is shown by table 3~4 and Figure of description Fig. 1 comparing result, the compound lactic acid emulsifiable paste of technical solution of the present invention preparation
Lower than control drug, intradermal residual quantity is higher than control drug for its Percutaneous permeability and percutaneous rate, because this product is local skin use
Medicine, skin residual quantity is more, and transit dose and percutaneous rate are fewer, can preferably play local drug action.The result shows that this
Product part drug effect is better than control drug.
The specific embodiments described in this specification only illustrate that spirit of the invention.Skill belonging to the present invention
The technical staff in art field can make various modifications or additions to the described embodiments or using similar side
Formula substitution, however, it does not deviate from the spirit of the invention or beyond the scope of the appended claims.
Although illustrate and describing the present invention with specific embodiment, it will be appreciated that without departing substantially from of the invention
Many other change and modification can be made in the case where spirit and scope.It is, therefore, intended that in the following claims
Including belonging to all such changes and modifications in the scope of the invention.
Claims (8)
1. a kind of compound lactic acid emulsifiable paste, which is characterized in that according to mass percentage, the compound lactic acid emulsifiable paste is mainly by following
Component is made: lactic acid 8%~18%, urea 5%~18%, albolene 25%~35%, emulsifier 9%~21%, glycerol
8%~12%, pH adjusting agent 5%~8%, surplus is purified water；
Wherein, the emulsifier is made of polyoxyethylene stearate (40) ester, glycerin monostearate and cholesterol；
Wherein, oleic acid and preservative are not included in the component formula.
2. compound lactic acid emulsifiable paste according to claim 1, which is characterized in that according to mass percentage, the compound cream
Yogurt cream is mainly made of the following components: lactic acid 10%~15%, urea 8%~15%, albolene 27%~32%, emulsification
Agent 11%~16%, glycerol 9%~10%, pH adjusting agent 6%~7%, surplus are purified water.
3. compound lactic acid emulsifiable paste according to claim 2, which is characterized in that according to mass percentage, the stearic acid
Poly- hydrocarbon oxygen (40) ester 2%~6%, glycerin monostearate 5%~10%, cholesterol 2%~5%.
4. the preparation method of compound lactic acid emulsifiable paste described in any one of claims 1 to 3, which is characterized in that the method includes
Following steps: weighing albolene, cholesterol, glycerin monostearate, after mixing, is heated to being completely melt and stir and evenly mix,
Obtain oily phase；Meanwhile lactic acid and purified water are weighed, and be uniformly mixed, pH adjusting agent is then added, and it is mixed to continue stirring
It closes uniformly, is subsequently added into glycerol, polyoxyethylene stearate (40) ester and urea, and heating stirring arrives water to being completely dissolved
Phase；Then, under agitation, water phase is added in oily phase, and emulsifying, continue stirring be cooled to be condensed into cream to get
The compound lactic acid emulsifiable paste.
5. according to the method described in claim 4, it is characterized in that, the temperature being completely melt that is heated to is 60 DEG C~90
℃。
6. according to the method described in claim 4, it is characterized in that, the temperature of the heating stirring is 60 DEG C~90 DEG C.
7. according to the method described in claim 4, it is characterized in that, the time of the emulsifying is 15min~45min.
8. compound lactic acid emulsifiable paste according to any one of claims 1 to 3 is in preparation treatment ichthyosis and rhagadia manus et pedis disease drug
In application.
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| US5561166A (en) * | 1993-07-28 | 1996-10-01 | Beiersdorf, Inc. | Urea/lactate topical compositions for dry skin |
| CN1063631C (en) * | 1994-03-23 | 2001-03-28 | 华西医科大学附属第一医院 | Lactic acid ointment |
| US7276249B2 (en) * | 2002-05-24 | 2007-10-02 | Elan Pharma International, Ltd. | Nanoparticulate fibrate formulations |
| US6720312B2 (en) * | 2001-03-16 | 2004-04-13 | Heartland Health Solutions, Llc | Method for controlling the membrane structure of a starch granule |
| US20030129242A1 (en) * | 2002-01-04 | 2003-07-10 | Bosch H. William | Sterile filtered nanoparticulate formulations of budesonide and beclomethasone having tyloxapol as a surface stabilizer |
| US20040147452A1 (en) * | 2002-07-31 | 2004-07-29 | Yu Ruey J | Non-amphoteric glutathione derivative compositions for tropical application |
| US8101664B2 (en) * | 2007-01-19 | 2012-01-24 | Quinnova Pharmaceuticals, Inc. | Urea foam |
| CN102440911A (en) * | 2010-10-08 | 2012-05-09 | 何晓磊 | Preparation method of skin protection urea cream |
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