CN105535926A - Composition for preventing or treating cutaneous pruritus - Google Patents
Composition for preventing or treating cutaneous pruritus Download PDFInfo
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- CN105535926A CN105535926A CN201610118550.2A CN201610118550A CN105535926A CN 105535926 A CN105535926 A CN 105535926A CN 201610118550 A CN201610118550 A CN 201610118550A CN 105535926 A CN105535926 A CN 105535926A
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
- A61K31/728—Hyaluronic acid
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- 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
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4166—1,3-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. phenytoin
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/01—Hydrolysed proteins; Derivatives thereof
- A61K38/012—Hydrolysed proteins; Derivatives thereof from animals
- A61K38/014—Hydrolysed proteins; Derivatives thereof from animals from connective tissue peptides, e.g. gelatin, collagen
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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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- 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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- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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Abstract
Composition for preventing or treating cutaneous pruritus is characterized by comprising the following active components: (1) hydrolyzed collagen, (2) hyaluronic acid, (3) allantoin compounds, (4) octadecanol, white oil, glycerin, silicone oil, glycerin monostearate, alkylphenol ethoxylates, sodium lauryl sulfate, isooctyl palmitate, polydimethylsiloxane, VC-ethylether, a preservative, an antioxidant and perfume, wherein the allantoin compounds are allantoin and/or aldioxa compounds. The composition can effectively prevent or treat cutaneous pruritus and especially has a very good treatment effect on senile cutaneous pruritus.
Description
Technical field
The present invention relates to a kind of complex, particularly relate to a kind of complex for preventing or treat skin pruritus.
Background technology
Skin is the largest organ of human body, is the first line of defence of human body, and skin health is the key keeping health, is also that the one of beautifying skin embodies.At present, the disease of skin has a variety of, and easily touches Toxic and antibacterial etc., so the protection of skin seems very important.Current health, the sickness rate of xerosis cutis and pruritus is higher, but good medicine for external use can not carry out prevention and therapy to it.Usually, xerosis cutis and pruritus refer to without former breakout, are a kind of skin neurosis illness.Xerosis cutis and the common situation of pruritus have whole body to occur, or face, the back of the body or extremity occur.General health, xerosis cutis pruritus is with skin too dry or chap relevant.
Also there is the report used as the adjuvant of wrinkle removal, anti-ageing cosmetics of waiting for a long time by biological medical polymer hydrolysate (such as hydrolytic collagen etc.) in prior art, also there is the report that the adjuvant of biological medical polymer being eliminated in transdermal administration process skin irritation medicine uses.But report that is still that biological medical polymer hydrolysate (such as hydrolytic collagen etc.) is dry as prevention and therapy skin and skin pruritus, more using the report of these molecules (such as hydrolytic collagen etc.) as the active component of the drying of prevention and therapy body skin and pruritus.
Summary of the invention
In order to overcome the defect of prior art, present inventor conducts in-depth research.
One object of the present invention is to provide a kind of complex, and it can prevent or treat body skin drying and pruritus.
Another object of the present invention is to the purposes providing a kind of complex, it is for prevention or treatment health skin is dry and skin pruritus.
Present inventor, through studying with keen determination, finds that following technical scheme achieves the above object.
For preventing or treat a complex for skin pruritus, it is characterized in that, described complex comprises following active component:
(1) hydrolytic collagen;
(2) hyaluronic acid;
(3) allantoin compounds;
(4) octadecanol, white oil, glycerol, silicone oil, glyceryl monostearate, alkylphenol polyoxyethylene, sodium lauryl sulfate, iso-octyl palmitate, polydimethylsiloxane, VC-ethylether, antiseptic, antioxidant and spice;
Wherein, allantoin compounds is at least one in allantoin, aldioxa compound.
Wherein, hydrolytic collagen is preferably hydrolyzed bone collagen; Aldioxa compound is at least one in dihydroxy aluminum allantoin, chlorine hydroxy Al allantoin, chlorine hydroxy Al allantoin propylene glycol.
The mass ratio of hydrolytic collagen, hyaluronic acid and allantoin compounds is 5-15:1-6:1-6; The mass ratio of hydrolytic collagen, hyaluronic acid and allantoin compounds is preferably 6-12 ︰ 2-5 ︰ 2-5; The mass ratio of hydrolytic collagen, hyaluronic acid and allantoin compounds is more preferably 10:3:2; The weight average molecular weight of collagen protein is 1000 ~ 20000Da; Described hyaluronic weight average molecular weight is 50 ~ 13000kDa.
In alkylphenol polyoxyethylene, described " alkyl " can be selected from carbon number is 6 ~ 20, preferably 8 ~ 15, and the more preferably alkyl of 9 ~ 12; Concrete alkylphenol polyoxyethylene is at least one in hexyl phenol polyethenoxy ether, OPEO, NPE, decyl phenol polyethenoxy ether, dodecyl phenol polyethenoxy ether, myristyl phenol polyethenoxy ether, cetyl phenol polyethenoxy ether, octadecyl phenol polyethenoxy ether, eicosyl phenol polyethenoxy ether.
VC-ethylether is VCE, and No. CAS is 86404-04-8.
The present invention also provides a kind of purposes of above-mentioned complex, and it is for prevention or treatment skin pruritus.
Complex of the present invention can prevent efficiently or treat skin pruritus, especially for senile skin pruritus, has extraordinary therapeutic effect.
In the present invention, described " number " all represents " weight portion ", unless specifically stated otherwise; Described " percentage ratio " all represents " percentage by weight ", unless specifically stated otherwise; Described " ratio " all represents " mass ratio ", unless specifically stated otherwise.
< complex >
In the present invention, complex (complex) is a kind of aggregation, wherein between each component by interacting (physics, chemistry etc.) combine, there is certain function or obvious physicochemical characteristic.
According to a specific embodiment of the present invention, complex comprises following active component: (1) hydrolytic collagen; (2) hyaluronic acid; (3) allantoin compounds; (4) octadecanol, white oil, glycerol, silicone oil, glyceryl monostearate, alkylphenol polyoxyethylene, sodium lauryl sulfate, iso-octyl palmitate, polydimethylsiloxane, VC-ethylether, antiseptic, antioxidant and spice.
So-called " active component " refers to the necessary component that can play a key effect when preventing or treat dry and pruritus.If lack wherein a kind of active component, then the effect of prevention or treatment pruritus will receive impact.In prior art, although there is record hydrolytic collagen, hyaluronic acid, allantoin compounds being respectively used to cosmetics, still not using record that this three kinds of components combinationally use as active component.Present inventor finds, above-mentioned three kinds of components is combinationally used as active component, can have synergism, plays the effect of prevention or treatment skin pruritus well.
In above-mentioned complex of the present invention, the consumption of above-mentioned four kinds of components is not particularly limited.In order to better improve the effect of prevention hand skin pruritus, preferably, hydrolytic collagen, hyaluronic acid and allantoin compounds mass ratio are 5-15:1-6:1-6.More preferably, the mass ratio of hydrolytic collagen, hyaluronic acid and allantoin compounds is 6-12:2-5:2-5.More preferably, the mass ratio of hydrolytic collagen, hyaluronic acid and allantoin compounds is 10:3:2.Now, the effect of better treatment skin pruritus can be reached.
Present inventor finds, as long as said hydrolyzed collagen protein, hyaluronic acid and allantoin compounds three kinds of components exist, can play the effect of prevention or treatment skin pruritus.
Although above-mentioned complex is still not clear for the mechanism of preventing or treating xerosis cutis and pruritus, but we infer there is following reason: allantoin compounds has emollescence to skin, thus is conducive to hydrolytic collagen and hyaluronic infiltration; Hydrolytic collagen (being especially hydrolyzed bone collagen) has growth promoting effects effect to Skin Cell, accelerates to make skin renewal speed; And the reparation that collagen protein carries out skin is also worked in coordination with in hyaluronic acid moisturizing.Above-mentioned three kinds of complex synergism, thus effectively prevent or treatment skin pruritus.
Complex of the present invention can be prepared by the method for this area routine.
In the present invention, described complex can use as hand care or medicine that is dry as treatment and pruritus uses.Complex of the present invention can adopt vacuum packaging; Or also can will be filled with in the noble gas such as nitrogen, carbon dioxide during the packing of product one or more.
< hydrolytic collagen >
Collagen protein is mainly distributed in mammiferous connective tissue, all very important to the formation of animal and human's body skin, blood vessel, skeleton, muscle tendon, tooth and cartilage.Hydrolytic collagen of the present invention with animal skins, bone, muscle or squama for prepared by raw material.Described animal includes but not limited to pig, cattle, oxygen, fish, Rhopilema esculenta etc.These hydrolytic collagen are prepared by the disclosed method such as CN101948900A, CN101643766B, CN101322677B, CN101156643A.
They are incorporated herein by as a reference.In the present invention, preferably, hydrolytic collagen can be that to derive from bone, skin or muscle tendon be the collagen protein that raw material obtains; More preferably, hydrolytic collagen of the present invention is selected from hydrolysis bone collagen.
Hydrolytic collagen of the present invention can be prepared by method well known in the art.Such as, take Java tilapia skin as raw material, after being shredded by fish skin, add normal hexane, remove foreign protein with sodium hydroxide solution after defat, then use acetic acid extraction collagen protein, obtain collagen through concentrated, lyophilization.Preparing the method for collagen protein with the collagen extracted: adding water by extracting the collagen obtained, dissolving, then utilizing protease to carry out enzymolysis, obtaining hydrolytic collagen through concentrating, after spraying dry.For another example, make raw material with Corii Sus domestica, scrape fat, cutting, cut and mix the immersion of rear alkali, continuation acid soak after washing, then pull an oar, after protease hydrolysis, isolate supernatant and be neutralized to neutrality, namely spraying dry obtains hydrolytic collagen.
In a specific embodiment of the present invention, the weight average molecular weight of hydrolytic collagen, between 500 ~ 20000Da, is preferably between 1000 ~ 3000Da.In another detailed description of the invention of the present invention, the weight average molecular weight of hydrolytic collagen, between 500 ~ 20000Da, is preferably between 100 ~ 5000Da.Wherein, Da is dalton, represents the unit of weight average molecular weight.
In the composites of the present invention, in order to better improve the effect of prevention and therapy xerosis cutis and pruritus, collagen protein is preferably 5-15 weight portion, is more preferably 6-12 weight portion; Be preferably 10 weight portions again.
< hyaluronic acid >
Hyaluronic acid is the natural heteropolysaccharide be alternately connected to form by D-glucuronic acid and N-acetyl group-GLUCOSAMINE residue.Hyaluronic acid is present in pericellular gel, the connective tissue basic substance of vertebrate organism, synovium of joint liquid, vitreous body and umbilical cord.Hyaluronic acid as the mechanical support of many histiocytes (such as skin, tendon, muscle and cartilage), and has and such as organizes aquation, lubrication and the function such as cell migration and differentiation in organism.
Hyaluronic acid of the present invention can be obtained by the method for this area routine, such as, obtained by methods such as cockscomb extraction, the extraction of people's umbilical cord, fermentable.Cockscomb extracts and realizes (CN1064372A) mainly through enzymatic degradation.Microbe fermentation method is such as the recombinant expression carrier by building hyaluronan synthase gene Has and UDP-glucose dehydrogenase gene coexpression in escherichia coli, this recombinant expression carrier transformation of E. coli is obtained engineering colon bacillus, and fermentation this project escherichia coli obtain hyaluronic acid (CN102154190A).In addition, can the novel microorganism of usage chain Coccus, and fermentation obtains hyaluronic acid (CN1085728A).At this, the full text of above-mentioned patent is incorporated herein as a reference.In addition, hyaluronic acid of the present invention can also be obtained by the disclosed method of CN102134287A, CN102124120A, CN102154405A or CN102154401A.The full text of above-mentioned patent is incorporated herein as a reference.
Hyaluronic acid of the present invention comprises unmodified hyaluronic acid or derivatives of hyaluronic acids.Preferably, hyaluronic acid of the present invention is selected from unmodified hyaluronic acid.In the present invention, so-called unmodified hyaluronic acid is exactly the hyaluronic acid not carrying out chemical modification.
In the present invention, derivatives of hyaluronic acids includes but not limited to: hyaluronic esters, hyaluronic salt, hyaluronic amide-type, crosslinked hyaluronic acid, hyaluronic percarboxylic acids compound, hyaluronic deacetylated thing or hyaluronic O-hydrosulphate.Preferably, hyaluronic esters, hyaluronic salt, hyaluronic amide-type or crosslinked hyaluronic acid is comprised for derivatives of hyaluronic acids of the present invention.More preferably, be hyaluronic salt for derivatives of hyaluronic acids of the present invention.
In the present invention, hyaluronic salt can be the salt that hyaluronic acid and organic and/or inorganic base are formed, and includes but not limited to hyaluronate sodium, potassium hyaluronate, hyaluronic acid magnesium or calcium hyauronate.
In the present invention, derivatives of hyaluronic acids can be hyaluronic esters and the derivant as described in Publication about Document: US5,356,883; US6,548,081; US4,851,521; US6,027,741; US2003181689; EP1095064; EP0341745; WO02/18450 and WO2004/035629.At this, the full text of above-mentioned patent is incorporated herein as a reference.
In the present invention, hyaluronic esters can be the ester that hyaluronic acid is formed with the alcohol of aliphatic series, araliphatic, cyclic aliphatic, aromatics, ring-type and heterocycle.
In the present invention, hyaluronic amide-type can be the amide formed with the amine of aliphatic series, araliphatic, cyclic aliphatic, aromatics, ring-type and heterocycle.
In the present invention, hyaluronic percarboxylic acids compound can be the hyaluronic percarboxylic acids compound obtained by the primary hydroxyl of oxidation N-acetyl group-GLUCOSAMINE unit.Hyaluronic deacetylated thing is derive from the derivatives of hyaluronic acids that N-acetyl group-GLUCOSAMINE unit is deacetylated or formed.
In the composites of the present invention, described hyaluronic weight average molecular weight is 50 ~ 13000kDa, is preferably 100 ~ 5000kDa, is more preferably 300 ~ 3000kDa.
In order to better improve the effect of prevention and therapy xerosis cutis and pruritus, hyaluronic acid is preferably 1-6 weight portion, is more preferably 2-5 weight portion, then is preferably 3 weight portions.
< allantoin compounds >
In the present invention, described complex comprises active component: allantoin compounds.Allantoin compounds comprises allantoin and/or aldioxa compound.Allantoin (C
4h
6n
4o
3) be Allantion, the pathological observation of its urea moiety to skin effect shows, mainly change into cuticular degeneration, regional cutin expands and thickens, edema and occur crack in epidermis spine cell, degeneration that dermal collagen fiber is slight, illustrates that it has the effect making horny layer dissolve degeneration and increase moisture of skin.The outlet capacity of taking the photograph of horny layer of epidermis mainly relies on the electro-dense cement substrate connecting Keratinocytic non-keratin, and the whole wetness action of keratin to skin itself is less, allantoin skin care is because it can increase and promote to engage the hydratability of substrate, keratin can also be acted on, the ability of its Bound moisture is increased, makes skin become smooth, moisten and pliable and tough.The carbamide part of allantoin has antifungal and antibacterial effect, it is clinical that allantoin is just widely used in department of dermatologry as external preparation, for health, ichthyosis, psoriasis, multiple keratosa dermatosis, expansion creates and the treatment of clean wound surface and peptic ulcer provides new effective way.Allantoin of the present invention obtains by method disclosed in CN1271728A, CN102617476A, CN1765888A or CN1528749A.
Allantoin is not only alkali compounds, and be a kind of weak acid, for acid salt compound, also can be used as weak base simultaneously, so, allantoin can generate slaine and adduct with many materials, these slaines and adduct not only keep the nature of allantoin, nor lose by the intrinsic property of the material of addition.
Aldioxa compound provides one extensively effective function for treating dermatosis.Because aluminum ions convergence and the desirable characteristic of allantoin obtain sufficient combination.The existence of allantoin improves the effect of aluminum salt, and eliminates some patients stimulation of generation to aluminum salt allergy.Experiment also shows, aldioxa salt nonirritant, without anaphylaxis, can be used as antiperspirant deodorizer, wetting agent and skin contraction agent.
Common several aldioxa compounds have dihydroxy aluminum allantoin (Al (OH)
2c
4h
5n
4o
3), chlorine hydroxy Al allantoin propylene glycol ([Al
2(OH)
4clC
4h
5n
4o
3] C
3h
8o
2) and chlorine hydroxy Al allantoin (Al
2(OH)
4clC
4h
5n
4o
3).
Below in conjunction with specific embodiment, the present invention is further illustrated, but protection scope of the present invention is not limited to this.The hyaluronic acid used in following examples is the hyaluronic acid not carrying out chemical modification.
Embodiment 1
Formula: hydrolysis bone collagen, chlorine hydroxy Al allantoin propylene glycol and hyaluronic total amount 0.75g (mass ratio of three is 10 ︰ 3 ︰ 2), octadecanol 8.5g, white oil 3g, polydimethylsiloxane 4.5g, iso-octyl palmitate 3g, glycerol 8g, glyceryl monostearate 1g, NPE 0.60g, sodium lauryl sulfate 0.40g, essence 0.5g, Preservative qs, adds water to 100g.
Technique: hydrolysis bone collagen, chlorine hydroxy Al allantoin propylene glycol and hyaluronic acid are mixed according to the above ratio, then other component mixing and emulsifying under the temperature conditions of 90 DEG C and except spice 30 minutes, lower the temperature with the speed of 1 DEG C per minute again, temperature adds spice when dropping to 55 DEG C, can obtain product for subsequent use after emulsifying.
Embodiment 2
Formula: hydrolysis bone collagen, chlorine hydroxy Al allantoin propylene glycol and hyaluronic total amount 1.00g (mass ratio of three is 15 ︰ 6 ︰ 6), octadecanol 8.5g, white oil 3g, polydimethylsiloxane 4.5g, iso-octyl palmitate 3g, glycerol 8g, glyceryl monostearate 1g, NPE 0.60g, sodium lauryl sulfate 0.40g, essence 0.5g, Preservative qs, adds water to 100g.
Technique: except formula difference, other process conditions are identical with embodiment 1.
Embodiment 3
Formula: hydrolysis bone collagen, chlorine hydroxy Al allantoin propylene glycol and hyaluronic total amount 3.00g (mass ratio of three is 5 ︰ 1 ︰ 1), octadecanol 8.5g, white oil 3g, polydimethylsiloxane 4.5g, iso-octyl palmitate 3g, glycerol 8g, glyceryl monostearate 1g, NPE 0.60g, sodium lauryl sulfate 0.40g, essence 0.5g, Preservative qs, di-tert-butyl-4-methy phenol (BHT) 0.02g, diazonium alkyl imidazole urea (extremely U.S. II) 0.02g, EDETATE SODIUM 0.05g, adds water to 100g.
Technique: except formula difference, other process conditions are identical with embodiment 1.
Embodiment 4
Formula: hydrolysis bone collagen, chlorine hydroxy Al allantoin propylene glycol and hyaluronic total amount (mass ratio of three is 10 ︰ 3 ︰ 2) 3.00g, add water to 100g.
Technique: except formula difference, other process conditions are identical with embodiment 1.
Embodiment 5
Except chlorine hydroxy Al allantoin propylene glycol is replaced with allantoin, other composition and engineering condition is identical with embodiment 1.
Embodiment 6
Except chlorine hydroxy Al allantoin propylene glycol is replaced with allantoin, other composition and engineering condition is identical with embodiment 2.
Embodiment 7
Except chlorine hydroxy Al allantoin propylene glycol is replaced with allantoin, other composition and engineering condition is identical with embodiment 3.
Embodiment 8
Except chlorine hydroxy Al allantoin propylene glycol is replaced with dihydroxy aluminum allantoin, other composition and engineering condition is identical with embodiment 1.
Embodiment 9
Except chlorine hydroxy Al allantoin propylene glycol is replaced with dihydroxy aluminum allantoin, other composition and engineering condition is identical with embodiment 2.
Embodiment 10
Except chlorine hydroxy Al allantoin propylene glycol is replaced with dihydroxy aluminum allantoin, other composition and engineering condition is identical with embodiment 3.
Embodiment 11
Except chlorine hydroxy Al allantoin propylene glycol is replaced with chlorine hydroxy Al allantoin, other composition and engineering condition is identical with embodiment 1.
Embodiment 12
Except chlorine hydroxy Al allantoin propylene glycol is replaced with chlorine hydroxy Al allantoin, other composition and engineering condition is identical with embodiment 2.
Embodiment 13
Except chlorine hydroxy Al allantoin propylene glycol is replaced with chlorine hydroxy Al allantoin, other composition and engineering condition is identical with embodiment 3.
Therapeutic effect is tested
1. clinical object
The product of embodiment 1 ~ 13 is carried out clinical trial, observes the efficacy and saferry clinical research of its treatment xerosis cutis and pruritus.
2. concrete grammar
1) clinical grouping:
Select 30 routine patient's random packet, autologous control clinical trial respectively.
Treatment group: the product of the embodiment 1 ~ 13 in the present invention.
Matched group: carbamide Silicone oil cream, every only 20 grams, PLA 307 hospital preparation center product batch number: always No. (2006) B05036, word processed.
2) administrated method
Patient body local skin this product, every day 2 times, early/evening is each once, shares 3 weeks, avoids fish and shrimp seafood, stimulation spicy food at treatments period, not the Organic substance such as contact food, soap, alkaline matter and gasoline.
3) therapeutic evaluation
Clinical efficacy is evaluated as according to evaluating as foundation using subjective index and objective indicator rank scores.
In clinical evaluation, objective indicator comprises: squama, keratinization, chap, and all marks by 4 grades (0 ~ 3).Wherein 0 is without squama, and 1 is a small amount of white fine debris, and 2 is between 1 ~ 3, and 3 is the thicker squama of sepia; 0 is without keratinization, and 1 is slightly coarse, and 2 is comparatively coarse between 1 ~ 3, and 3 for obviously to thicken; 0 is that 1 is crack that is tiny, that be only limitted to epidermis, and 2 is that between 1 ~ 3, crack reaches high dermis mild pain more deeply without chapping, and 3 have obvious ache influence movable for crack reaches corium deep layer.
In clinical evaluation, subjective index comprises: pruritus, drying, pain, all marks by 4 grades (0 ~ 3).0 is without any gargalesthesia, and 1 is slight gargalesthesia, and 2 for itching, and can stand, and 3 for itch very much, impact sleep and work; 0 is without dry, and 1 is slight dry, and 2 is between 1 ~ 3, and 3 is obviously dry, without moist; 0 is without pain, and 1 causes mild pain for even by stimulation, and 2 for walk or activity causes pain, and 3 is obvious ache influence work.
4) the standard of curative effect evaluation
(1) curative effect index improves percentage rate: calculate main, the total mark of objective indicator before and after treatment respectively, finally show that curative effect improves percentage rate.
(2) curative effect index improves percentage rate=(before treatment the rear integration of integration-treatment) front integration × 100% of/treatment;
(3) therapeutic evaluation:
Recovery from illness: skin lesion disappears substantially, resolution of symptoms, improves and is greater than 90%;
Effective: sings and symptoms improvement is greater than 60%, is less than 90%;
Take a turn for the better: sings and symptoms improvement is greater than 20%, is less than 60%;
Invalid: sings and symptoms improvement is less than 20%.
4. effective percentage=(effective number of cases+recovery from illness number of cases)/all cases number × 100%.
3. clinical test results
The product of embodiment 1 ~ 13 is carried out clinical trial, observes the efficacy and saferry clinical research of its treatment xerosis cutis and pruritus.Treatment group and matched group objective indicator, subjective index, overall performane scoring have obvious decline in 1,2,3 week after the treatment, more all have statistical significance (P<0.01) with before treatment.The effective percentage (effective+recovery from illness) for the treatment of group objective indicator is 93.33%, and the effective percentage (effective+recovery from illness) of subjective index is 100%, and the total effective rate of subjective index and objective indicator is 96.67%.The corresponding index of matched group is the effective percentage of objective indicator is 93.33%, and the effective percentage of subjective index is 96.67%, total effective percentage is 96.67%.No significant difference between two groups.1 routine Adverse Event was there is not in treatment group and matched group in 3 week course for the treatment of.Therefore, the product of embodiment 1 ~ 13 can treat xerosis cutis and pruritus, and instant effect, good effect, safety are high.
The present invention is not limited to above-mentioned embodiment, and when not deviating from flesh and blood of the present invention, any distortion that it may occur to persons skilled in the art that, improvement, replacement all fall into scope of the present invention.
Claims (6)
1. for preventing or treat a complex for skin pruritus, it is characterized in that, described complex comprises following active component:
(1) hydrolytic collagen;
(2) hyaluronic acid;
(3) allantoin compounds;
(4) octadecanol, white oil, glycerol, silicone oil, glyceryl monostearate, alkylphenol polyoxyethylene, sodium lauryl sulfate, iso-octyl palmitate, polydimethylsiloxane, VC-ethylether, antiseptic, antioxidant and spice;
Wherein, allantoin compounds is at least one in allantoin, aldioxa compound.
2. a kind of complex for preventing or treat skin pruritus according to claim 1, it is characterized in that, described hydrolytic collagen is preferably hydrolyzed bone collagen; Described aldioxa compound is at least one in dihydroxy aluminum allantoin, chlorine hydroxy Al allantoin, chlorine hydroxy Al allantoin propylene glycol.
3. a kind of complex for preventing or treat skin pruritus according to claim 1, is characterized in that, the mass ratio of hydrolytic collagen, hyaluronic acid and allantoin compounds is 5-15:1-6:1-6.
4. a kind of complex for preventing or treat skin pruritus according to claim 1, is characterized in that, the mass ratio of hydrolytic collagen, hyaluronic acid and allantoin compounds is preferably 6-12 ︰ 2-5 ︰ 2-5; The mass ratio of hydrolytic collagen, hyaluronic acid and allantoin compounds is more preferably 10:3:2; The weight average molecular weight of described collagen protein is 1000 ~ 20000Da; Described hyaluronic weight average molecular weight is 50 ~ 13000kDa.
5. a kind of complex for preventing or treat skin pruritus according to claim 1, is characterized in that, in described alkylphenol polyoxyethylene, described " alkyl " can be selected from carbon number is 6 ~ 20, preferably 8 ~ 15, and the more preferably alkyl of 9 ~ 12; Concrete alkylphenol polyoxyethylene is at least one in hexyl phenol polyethenoxy ether, OPEO, NPE, decyl phenol polyethenoxy ether, dodecyl phenol polyethenoxy ether, myristyl phenol polyethenoxy ether, cetyl phenol polyethenoxy ether, octadecyl phenol polyethenoxy ether, eicosyl phenol polyethenoxy ether.
6. a kind of complex for preventing or treat skin pruritus according to claim 1, is characterized in that, described VC-ethylether is VCE, and No. CAS is 86404-04-8.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610118550.2A CN105535926A (en) | 2016-03-02 | 2016-03-02 | Composition for preventing or treating cutaneous pruritus |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20050208114A1 (en) * | 1998-03-24 | 2005-09-22 | Petito George D | Composition and method for healing tissues |
| CN102988962A (en) * | 2012-11-09 | 2013-03-27 | 北京化工大学 | Composition for preventing or treating pruritus cutanea |
| KR20140007654A (en) * | 2012-07-10 | 2014-01-20 | 김동우 | Skin adhesive device using by cereals paper sheet |
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2016
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20050208114A1 (en) * | 1998-03-24 | 2005-09-22 | Petito George D | Composition and method for healing tissues |
| KR20140007654A (en) * | 2012-07-10 | 2014-01-20 | 김동우 | Skin adhesive device using by cereals paper sheet |
| CN102988962A (en) * | 2012-11-09 | 2013-03-27 | 北京化工大学 | Composition for preventing or treating pruritus cutanea |
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| Title |
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| 卫建明等: "优生骨胶原软膏治疗皮肤瘙痒症的疗效和安全性临床研究", 《明胶科学与技术》 * |
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Application publication date: 20160504 |