CN109078171A - A kind of topical composition and its application and remedy for external use - Google Patents

A kind of topical composition and its application and remedy for external use Download PDF

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CN109078171A
CN109078171A CN201811055489.7A CN201811055489A CN109078171A CN 109078171 A CN109078171 A CN 109078171A CN 201811055489 A CN201811055489 A CN 201811055489A CN 109078171 A CN109078171 A CN 109078171A
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remedy
growth factor
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topical composition
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李乾
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Cause Color Biotechnology (wuhan) Co Ltd
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Cause Color Biotechnology (wuhan) Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18Growth factors; Growth regulators
    • A61K38/1808Epidermal growth factor [EGF] urogastrone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18Growth factors; Growth regulators
    • A61K38/1825Fibroblast growth factor [FGF]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system

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  • Dermatology (AREA)
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  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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Abstract

The present invention discloses a kind of topical composition and its application and remedy for external use, the topical composition include recombinant human epidermal growth factor and recombination human basic fibroblast growth factor.Topical composition is made with recombinant human epidermal growth factor and recombination human basic fibroblast growth factor in the present invention, pass through the combination of recombinant human epidermal growth factor and recombination human basic fibroblast growth factor, when so that the topical composition being applied in the remedy for external use for the treatment of dermatoneurosis, there is significant therapeutic effect for neural functionality formication, neurodermatitis and autumn-dryness disease dermatitis etc..

Description

A kind of topical composition and its application and remedy for external use
Technical field
The present invention relates to biomedicine technical field, in particular to a kind of topical composition and its application and external curing Agent.
Background technique
The skin of normal person is to pain sensitivity caused by temperature, touching, pressure, damage, this is because being distributed in the mind in skin Experiencing through tip stimulates and is transmitted to caused by sensorium.The cacesthesia of skin refers to no external physics, chemistry, life The effect of the factors such as object is lower and the abnormal feeling that generates, including pain, picotement, myrmeciasis, not thermal sensation, gargalesthesia of hyperemia etc., In addition to gargalesthesia, before it is several feeling nowadays the still cause of disease and pathomechanism it is unknown, the knowledge of the past thinks and neurosis Related, neurosis is a kind of abnormality of nerve function, the disease for having organic change without discovery nervous system so far.Nerve Functional disease shows as formication, gargalesthesia (such as being caused by autumn-dryness disease dermatitis) and neurodermatitis etc. on the skin.
The patient of formication is frequently accompanied by local skin itch, when not itching, when especially quiet, on skin Seem the feeling for having " ant is climbing ", it can be again without finding any ant or insect in skin surface.Because the feeling of skin is wanted High-level center is transmitted to by posterior horn of spinal cord --- brain, and skin itself cannot " independent to respond " sensation reflex.So skin sense Feel abnormal, such as myrmeciasis annoyings two side of doctors and patients always, and etiology unknown is treated ineffective.
Gargalesthesia is that nerve endings is felt by caused by certain stimulation.Many people are to autumn, because being air-dried, clothes Itch scratching can occur for the position of friction, then skin mossization.Also some middle-aged and the old, autumn and winter back, buttocks or under Limb, usually itch, skin surface does not have apparent fash (such as papule, eczema, pityriasis rosea, wheal block), but itch is unbearably, Sometimes subcutaneously there is the scleroma of " cutting in and out ".
Neurodermatitis is also a kind of common cacesthesia of skin influenced by mental element, and diseased region is at symmetrical sometimes Property, usually scratching repeatedly because of gargalesthesia leads to skin mossization.Stress, anxiety are often its risk factor.Itch part Sense is also subject to attention power influence, when your tense working, does not usually feel to itch, once having a rest, just feels that part is itched.And mind Through property dermatitis can also because of stress releasing and recover without treatment.
Dermatoneurosis such as paresthesia of skin, neurodermatitis, autumn-dryness disease dermatitis etc., although endangering without life Danger, but it is usually long-drawn-out, continue half a year or several years, influences the mood or/and sleep of patient, dispersion attention influences work Make effect etc., and most of existing external preparation for skin drug is only used for by outside environmental elements, bacterium infection or trouble at present Skin itching symptom caused by person's body lesion, to the neural functionality formication for the treatment of, neurodermatitis and autumn-dryness disease The skins functional disease such as dermatitis does not have apparent therapeutic effect.
Summary of the invention
The main object of the present invention is to propose a kind of topical composition and its application and remedy for external use, it is desirable to provide one Kind can effectively treat the remedy for external use of dermatoneurosis.
To achieve the above object, the present invention proposes a kind of topical composition, including recombinant human epidermal growth factor and recombination Human alkaline fibroblast growth factor.
Preferably, purity >=95% of the recombinant human epidermal growth factor, specific activity >=5 × 105IU/mg。
Preferably, purity >=95% of the recombination human basic fibroblast growth factor, specific activity >=5 × 105IU/ mg。
The present invention also proposes that a kind of topical composition as described above is controlled in the external application of preparation treatment dermatoneurosis Treat the application in agent.
Preferably, the dermatoneurosis includes neural functionality formication, neurodermatitis and autumn-dryness disease At least one of dermatitis.
The present invention also proposes a kind of remedy for external use, including topical composition as described above.
Preferably, additive amount of the recombinant human epidermal growth factor in the remedy for external use be 0.0002~ 0.001g/kg;
Additive amount of the recombination human basic fibroblast growth factor in the remedy for external use be 0.0002~ 0.001g/kg。
Preferably, additive amount of the recombinant human epidermal growth factor in the remedy for external use be 0.0004~ 0.0008g/kg;
Additive amount of the recombination human basic fibroblast growth factor in the remedy for external use be 0.0004~ 0.0008g/kg。
Preferably, additive amount of the recombinant human epidermal growth factor in the remedy for external use be 0.0005~ 0.0006g/kg;
Additive amount of the recombination human basic fibroblast growth factor in the remedy for external use be 0.0005~ 0.0006g/kg。
Preferably, the remedy for external use is gelling agent, emulsion, creme, solution, liniment, lotion, ointment or cream Agent.
In technical solution provided by the invention, with recombinant human epidermal growth factor and recombination human basic fibroblast growth Topical composition is made in the factor, wherein recombinant human epidermal growth factor mainly acts on various body cells, especially to epidermis and upper Chrotoplast can promote cell division proliferation, differentiate neonatal cell of new generation while maintain and promoting the metabolism of cell, To recovery and the good functional status of cell is maintained to play an important role;And recombination human basic fibroblast growth factor is except tool Have except the biological effect similar with recombinant human epidermal growth factor, also there is the reparation and trophism to neurotrosis, Especially to the nutrition, regeneration and repair of peripheral nerve fiber, neurolemma and nerve ending;It is grown by recombinant human epidermal The combination of the factor and recombination human basic fibroblast growth factor, so that the topical composition is applied to treatment cutaneous nerve When in the remedy for external use of functional disease, have for neural functionality formication, neurodermatitis and autumn-dryness disease dermatitis etc. There is significant therapeutic effect.
Specific embodiment
It in order to make the object, technical scheme and advantages of the embodiment of the invention clearer, below will be in the embodiment of the present invention Technical solution be clearly and completely described.The person that is not specified actual conditions in embodiment, according to normal conditions or manufacturer builds The condition of view carries out.Reagents or instruments used without specified manufacturer is the conventional production that can be obtained by commercially available purchase Product.
The present invention proposes a kind of topical composition, including recombinant human epidermal growth factor and recombination human basic fibroblast cell Growth factor.
The topical composition is mainly applicable in the remedy for external use of preparation treatment dermatoneurosis.It can With understanding, the topical composition be used to prepare treatment dermatoneurosis remedy for external use when, can first with After its medically receivable pharmaceutical salts or carrier compounding, then Material (such as lotion Material, creme with conventional skin preparations for extenal use Material etc.) mixing, and then it is prepared into remedy for external use, it can also be directly by the topical composition and conventional external preparation for skin The Material of agent mixes and is prepared into remedy for external use.
The remedy for external use that the topical composition is prepared can be used for treating the skin as caused by abnormality of nerve function Cacesthesia, the especially dermatoneurosis as caused by abnormality of nerve function, including neural functionality formication, mind Through at least one of property dermatitis and autumn-dryness disease dermatitis, neural functionality formication can be effectively eliminated, is alleviated by nerve Pruitus caused by dermatitis and/or autumn-dryness disease dermatitis, also has significant therapeutic effect to senile pruritus.
In the topical composition, the functionality of each component is as follows:
Epidermal growth factor (Epidermal Growth Factor, EGF), 6045 dalton of molecular weight, effector cell It is distributed widely in vivo, it is related with the metabolism of cell and mitosis, EGF receptor (Epidermal is generally distributed on cell membrane Growth Factor Receptor, EGFR), the as cell surface receptor of EGF is a kind of multi-functional glycoprotein, is distributed in Mammal includes the surface of nearly all cell such as epithelial cell, fibroblast, spongiocyte, horn cell, EGFR letter Number access plays an important role to physiology courses such as the growth of cell, proliferation and differentiation.
Basic fibroblast growth factor (Basic Fibroblast Growth Factor, bFGF) is containing 155 The cationic polypeptide of the mitogenesis of amino acid, molecular weight are 16~18.5KD.The seperated interior and body of the biological effect of bFGF Outer two large divisions.Effect is very strong in vivo, to fibroblast, osteocyte, cartilage cell, vascular endothelial cell, adrenal gland Cortex and medullary epithelium, neuron and Deiter's cells etc. have very strong rush cell division, proliferation activity.Cell in vitro training In supporting, its effect can be played in low concentration.BFGF is important factor,mitogenic and form occurs and the induction of differentiation The factor.The effect of its principal biological has: (1) as angiogenesis factor;(2) promote wound healing and tissue repair;(3) promote Regeneration;(4) nerve regneration etc. is participated in.
Since this century, people utilize technique for gene engineering and microbial fermentation engineering technology, by EGF the and bFGF base of people Because cloning into coli expression carrier, people EGF and people bFGF expression engineered strain is had developed, is sent out by Escherichia coli biology Ferment obtains recombinant human epidermal growth factor (Recombinant Human then by extraction and purification step Epidermal Growth Factor, rhEGF, abbreviation EGF) and recombination human basic fibroblast growth factor (Recombinant Human Basic Fibroblast Growth Factor, rhbFGF, abbreviation bFGF or FGF2).Mesh Before, EGF is using work very extensive, that there are promotion mitosis, proliferation, differentiation and growth to maintain to the various cells of whole body With EGF is applied in pharmacy and skin care field, for example, EGF ointment can be used for the upper of burn wound and chronic ulcer Skin regeneration, EGF eye drops can be used for the Regeneration and Repair of corneal abrasion and ulcer of the cornea.And bFGF is for maincenter and peripheral nervous system Function maintenance, nutrition, regeneration and the reparation of system also show powerful function, wherein and ox bFGF comes into Chinese Pharmacopoeia, Skin repair is also had been used to the compound cream of EGF cooperation.
In technical solution provided by the invention, topical composition is made with rhEGF and rhbFGF, the rhEGF and RhbFGF derives from human body, and protein structure is very homologous with people, will not cause the adverse reaction of immunogenicity, use peace Quan Xinggao.Wherein, rhEGF mainly acts on various body cells, especially to epidermis and epithelial cell, cell division can be promoted to increase The metabolism of cell is grown, differentiates neonatal cell of new generation while maintaining and promoting, to recovery and maintains the good of cell Functional status plays an important role;And rhbFGF is gone back in addition to having the biological effect similar with recombinant human epidermal growth factor With the reparation and trophism to neurotrosis, especially to the nutrition of peripheral nerve fiber, neurolemma and nerve ending, again Raw and repair;By the combination of rhEGF and rhbFGF, so that the topical composition is applied to treatment cutaneous nerve function When in the remedy for external use of disease, have for neural functionality formication, neurodermatitis and autumn-dryness disease dermatitis etc. aobvious The therapeutic effect of work.
In an embodiment of topical composition provided by the invention, the technical parameter of the rhEGF is as follows: rhEGF's Specific activity >=5 × 10 of purity >=95%, rhEGF5IU/mg (rhEGF albumen).Wherein, specific activity refers to unit milligram albumen The biological activity unit of matter, this is the important indicator that recombinant protein drug is different from chemicals.
Further, the technical parameter of the rhbFGF is as follows: the specific activity of purity >=95%, rhbFGF of rhbFGF >= 5×105IU/mg.Using with above-mentioned technical parameter rhEGF and rhbFGF as the raw material for forming the topical composition, have Conducive to the raising topical composition to the therapeutic effect of dermatoneurosis.
Below by with the topical composition be used to prepare treatment dermatoneurosis remedy for external use when, directly It is mixed with the Material of conventional skin preparations for extenal use and is prepared into for remedy for external use and is illustrated.The present invention also proposes outside one kind With therapeutic agent, including topical composition as described above.In the embodiment of remedy for external use provided by the invention, the external application Therapeutic agent further includes Material, and the Material that the Material is preferably soft, non-stimulated to skin can select the use of this field routine In any Material of skin preparations for extenal use, can also according to existing external preparation for skin therapeutic agent Material general constituent voluntarily It prepares, ingredient usually contains water, oil, grease, moisturizer, surfactant, thickener, skin conditioning agent, pH adjusting agent And preservative etc., the selection or preparation of the Material are the state of the art, and this will not be repeated here.
In a preferred embodiment of remedy for external use provided by the invention, the rhEGF is in the remedy for external use Additive amount be 0.0002~0.001g/kg, additive amount of the rhbFGF in the remedy for external use be 0.0002~ 0.001g/kg, i.e., are as follows: the content in every kilogram of remedy for external use containing the rhEGF and rhbFGF is respectively 0.0002 ~0.001g and 0.0002~0.001g.It is described outer made of the rhEGF and rhbFGF is prepared within the scope of this additive amount With therapeutic agent after being coated on skin, functionality formication can be effectively eliminated, alleviated by neurodermatitis and/or autumn-dryness disease Pruitus caused by dermatitis, and it is quick.
In another preferred embodiment of remedy for external use provided by the invention, the rhEGF is in the remedy for external use In additive amount be 0.0004~0.0008g/kg, additive amount of the rhbFGF in the remedy for external use be 0.0004~ 0.0008g/kg, i.e., are as follows: the content in every kilogram of remedy for external use containing the rhEGF and rhbFGF is respectively 0.0004 ~0.0008g and 0.0004~0.0008g.It is described made of the rhEGF and rhbFGF is prepared within the scope of this additive amount Remedy for external use, more preferably to the therapeutic effect of functionality formication, neurodermatitis and/or autumn-dryness disease dermatitis.
In the another preferred embodiment of remedy for external use provided by the invention, the rhEGF is in the remedy for external use In additive amount be 0.0005~0.0006g/kg, additive amount of the rhbFGF in the remedy for external use be 0.0005~ 0.0006g/kg, i.e., are as follows: the content in every kilogram of remedy for external use containing the rhEGF and rhbFGF is respectively 0.0005 ~0.0006g and 0.0005~0.0006g.It is described made of the rhEGF and rhbFGF is prepared within the scope of this additive amount Remedy for external use, it is best to the therapeutic effect of functionality formication, neurodermatitis and/or autumn-dryness disease dermatitis.
In the various embodiments described above of remedy for external use provided by the invention, the rhEGF and rhbFGF are in the external application It is available to functionality formication, nerve as long as the additive amount in therapeutic agent meets the content range of above-mentioned offer The significant remedy for external use of therapeutic effect of property dermatitis and/or autumn-dryness disease dermatitis, the rhEGF and rhbFGF are controlled in the external application The adding proportion treated in agent is not specifically limited, and can also be preferably the rhEGF and rhbFGF in the remedy for external use Mass ratio be 1:1, under this adding proportion, the mass effect of obtained remedy for external use it is further preferred that.
During the preparation process, the topical composition can be added is in gel, emulsus, frost to the remedy for external use Uniformly mixed in the Materials of forms such as shape, solution shape, paste, it is corresponding be made for gelling agent, emulsion, creme, solution, liniment, Lotion, ointment or paste, to adapt to the use demand of different users.It should be noted that the remedy for external use Dosage form can also be not limited to above-mentioned dosage form, but be added with the topical composition, convenient for users to routine use, to function Property formication, neurodermatitis and/or autumn-dryness disease dermatitis there is significant curative effect, and have no toxic side effect.
Technical solution of the present invention is described in further detail below in conjunction with specific embodiment, it should be understood that following real It applies example to be only used to explain the present invention, be not intended to limit the present invention.
The preparation of 1 externally-applied ointment of embodiment
(1) raw material weighs: rhEGF 0.005g, rhbFGF 0.005g, ointment Material 5kg, wherein ointment Material is matched Side is as shown in table 1 below.
1 externally-applied ointment Material formula of table
(2) preparation of externally-applied ointment: the raw material for preparing ointment Material being added in heating stirrer by the formula in table 1, 80 DEG C are heated to, cools down after stirring 10min with the revolving speed of 100rpm, drops to 40 DEG C hereinafter, into blender to Material temperature RhEGF and rhbFGF is added, 5min is then stirred with the revolving speed of 40rpm, externally-applied ointment, discharging packing is made.
The preparation of 2 external-application cream of embodiment
(1) raw material weighs: rhEGF 0.005g, rhbFGF 0.005g, white shape Material 5kg, wherein white shape Material is matched Side is as shown in table 2 below.
2 external application frost shape Material formula of table
(2) preparation of external-application cream: the raw material for preparing white shape Material being added in heating stirrer by the formula in table 2, 80 DEG C are heated to, cools down after stirring 10min with the revolving speed of 100rpm, drops to 40 DEG C hereinafter, into blender to Material temperature RhEGF and rhbFGF is added, 5min is then stirred with the revolving speed of 40rpm, external-application cream, discharging packing is made.
The preparation of 3 external application lotion of embodiment
(1) raw material weighs: rhEGF 0.004g, rhbFGF 0.004g, emulsus Material 5kg, wherein emulsus Material is matched Side is as shown in table 3 below.
3 external application emulsus Material formula of table
(2) preparation of external application lotion: the raw material for preparing emulsus Material being added in heating stirrer by the formula in table 3, 80 DEG C are heated to, cools down after stirring 10min with the revolving speed of 100rpm, drops to 40 DEG C hereinafter, into blender to Material temperature RhEGF and rhbFGF is added, 5min is then stirred with the revolving speed of 40rpm, external application lotion, discharging packing is made.
The preparation of 4 external application nanoemulsion essence of embodiment
(1) raw material weighs: rhEGF 0.004g, rhbFGF 0.004g, Essence Material 5kg, wherein Essence Material Formula it is as shown in table 4 below.
4 external application Essence Material formula of table
(2) preparation of external application nanoemulsion essence:
A, allantoin (No. 10 raw materials in table 4) are added in the plastic bottle of heat-resisting resistance to microwave, add water 150mL, then plus Heat is covered tightly to rock to powder after bottle cap and is completely dissolved to 80~90 DEG C, and allantoin solution is made, spare;
B, it takes glycerol (No. 2 raw materials in table 4) to be divided into two bottles, takes wherein one bottle of addition Sodium Hyaluronate (8 in table 4 Number raw material), it mixes well and glycerol-Sodium Hyaluronate mixture is made, it is spare;Then by another bottle of glycerol and hydrogenated olive oil, Tocopherol acetate, bisabolol and Tween-80 (4,5,6 and No. 7 raw materials in table 4) mixing, concussion mix 2min, then fall Enter in water, 5min is emulsified with the revolving speed high speed of 5000rpm, then stand 10min defoaming, mixed solution is made, it is spare;
It c, will be remaining in allantoin solution obtained above, glycerol-Sodium Hyaluronate mixture and mixed solution and table 4 The mixing of all raw materials, 10min is stirred with the revolving speed of 100rpm, adds rhEGF and rhbFGF, then with the revolving speed of 40rpm 5min is stirred, external application nanoemulsion essence, discharging packing is made.Obtained nanoemulsion essence is as clear as crystal, at room temperature Oil-free water stratification or grease hydro-planing after standing 7.
Embodiment 5
It is same as Example 1, the difference is that the quality for weighing rhEGF and rhbFGF in step (1) is 0.001g.
Embodiment 6
It is same as Example 1, the difference is that the quality for weighing rhEGF and rhbFGF in step (1) is 0.002g.
Embodiment 7
It is same as Example 1, the difference is that weighing rhEGF in step (1) and the quality of rhbFGF is 0.0025g。
Embodiment 8
It is same as Example 1, the difference is that weighing rhEGF in step (1) and the quality of rhbFGF is 0.00275g。
Embodiment 9
It is same as Example 1, the difference is that the quality for weighing rhEGF and rhbFGF in step (1) is 0.003g.
Embodiment 10
It is same as Example 1, the difference is that weighing rhEGF in step (1) and the quality of rhbFGF is respectively 0.0025g and 0.005g.
By taking externally-applied ointment prepared by above-described embodiment 1 as an example, neural function is treated to remedy for external use provided by the invention The curative effect of property formication, neurodermatitis and autumn-dryness disease dermatitis is verified, controlling including clinical case and typical case Clinical trial is treated, test method and result are as follows:
1, clinical case
(1) case selection: clinical observation is carried out to 600 patients with dermatoneurosis, selection suffers from function Property patient each 100 of formication, neurodermatitis and autumn-dryness disease dermatitis, as tri- test groups of A, B, C, three tests Patient is randomly divided into treatment 50 and control group 50 respectively in group, wherein the age minimum 20 years old in 300 patients, most Greatly 55 years old, the qualification for the treatment of group and control group was almost the same, and no significant difference is comparable.
(2) diagnostic criteria:
1. functionality formication: (a) cutaneous manifestations are all gone well, and occasionally have a little scratch;(b) in quiet waking state Under, skin has " myrmeciasis ", or " worm climbs sense ", but there is no ants or insect to creep on the skin;(c) can also after more changing one's clothes Occur, recurrent exerbation;(d) temporary extinction under motion state or when labour, also occurs that when quiet, no particular law.
2. neurodermatitis: (a) this disease is young and middle-aged common, first there is violent itch, after have skin lesion;(b) fash is flat more Angular papule, lichenification, no exudation;(c) fash is mainly in neck, four limbs stretch side, lumbosacral region, popliteal nest, vulva;(d) course of disease It is chronic, normal recurrent exerbation;(e) antidiastole is needed to exclude eczema, lichen planus, ox-hide moss, pruritus, primary cutaneous amyloid Primary cutaneous or the secondary diseases such as change.
3. autumn-dryness disease dermatitis: (a) being apt to occur in the middle-aged and the old;(b) season is sent out well after September part early autumn or mid-autumn, weather When dry.Sustainable entire winter and spring.It disappears when most summer has set ins;(c) waist is apt to occur in hereinafter, especially buttocks and shin Ridge before bone;(d) there is the papule being dispersed in sometimes, skin has scratch, and it is coarse, there is slight lichenification sometimes.Subcutaneous tissue is abundant Place, as buttocks, the subcutaneous of thigh will appear the nodositas lump to cut in and out.Gargalesthesia aggravates when clothes rubs or when scratching. Without sheet skin lesion and the scales of skin that peel off;(e) antidiastole is needed to exclude allergic dermatitis, ox-hide moss, eczema, wheal block, pruritus senilis.
(3) treatment method: smearing in site of disease and be administered, and each medication is primary sooner or later daily, 3~5g is administered every time, wherein control Treatment group smears externally-applied ointment prepared by the embodiment of the present invention 1, and control group smears the clear ointment of wet poison, counts and treat after medication cycle Effect.
(4) efficacy determination:
1. functionality formication, continuous use 14 days.
(a) effective: myrmeciasis disappears, and does not recur in 1 year;(b) effectively: attack times are significantly reduced or are recurred in 1 year; (c) invalid: symptom is without improvement.
2. neurodermatitis, continuous use 30 days.
(a) effective: flat polygonal papule, lichenification disappear, and do not recur in 1 year;(b) effectively: skin lesion reduces, gargalesthesia Weaken or is recurred in 1 year;(c) invalid: skin lesion and itch are without improvement.
3. autumn-dryness disease dermatitis, continuous use 30 days.
(a) effective: skin restores normal, and gargalesthesia disappears.Next year remains dormant after autumn;(b) effectively: gargalesthesia weakens, or slow Next year breaks out once again after autumn after solution;(c) invalid: itch is not relieved.
Curative effect statistical result is as shown in table 5 below.
The curative effect statistical result of the externally-applied ointment of 5 embodiment 1 of table preparation
By the statistical result in table 5 it is found that compared to the clear ointment of existing wet poison, the externally-applied ointment of preparation of the embodiment of the present invention It is more significant to the therapeutic effect of functionality formication, neurodermatitis and autumn-dryness disease dermatitis, and have no adverse reaction.
2, typical case
One: Mr. Li of case, male, 45 years old, civilian post.Readme over nearly three months skin usually have ant in the upper sense creeped Feel, often betide abdomen and femoribus internus, especially quiet down and write article or occur suddenly when seeing computer, searches and have no repeatedly Ant or other insects.Inspection is shown in skin without abnormal appearance, no fash and hyperemia.It is diagnosed as neural functionality formication. Abdomen and thigh skin are smeared with externally-applied ointment prepared by the embodiment of the present invention 1, once in the morning and once at night, myrmeciasis disappears after 1 week, continues With no relapse in 1 week, 1 year.
Two: Mr. Zhao of case, male, 22 years old, main suit: certain medic has itch, hand when local skin on the right side of the nape of the neck Feel coarse, has two weeks.It touches and wants to grab, examination is reviewed in readme over nearly one month more nervous.Physical examination discovery: neck is big On the right side of vertebra at 4cm, skin has one 2 × 3cm lichenification, it is seen that flat polygonal papule, it is slight rubescent, and it is de- gently to scrape no scales of skin that peel off It falls.Surrounding skin and other body parts skin no abnormality seen.Diagnosis: neurodermatitis.It advises with the preparation of the embodiment of the present invention 1 Externally-applied ointment smears skin lesion part, each primary daily morning and evening, is used continuously 30 days, skin abnormality and gargalesthesia disappear, after 1 year It leaves school, no relapse.
Three: Mrs Chen of case, female, 55 years old, hospital laboratory was retired fastly.On October 2nd, 2014 is medical.Readme is every over 3 years To after autumn, hip and shank are itched, and are just disappeared after the Beginning of summer in the coming year.Once in the used Cremor Mentholi Compositus of hospital, the clear ointment of wet poison, fluorine Light ointment, in vain.Physical examination: side shows scratch before and after both legs, and buttocks two sides also show scratch, without obvious fash, according to it Medical history and the characteristic for meeting autumn to break out, are diagnosed as autumn-dryness disease dermatitis.With the embodiment of the present invention 1 prepare externally-applied ointment smear buttocks and Double lower limb skin, it is each primary daily morning and evening, be used continuously 30 days, pruritis disappears, skin scratch disappears, winter in 2015 with It visits, no relapse.
The above is only a preferred embodiment of the present invention, is not intended to limit the scope of the invention, for this field For technical staff, the invention may be variously modified and varied.All within the spirits and principles of the present invention, made any Modification, equivalent replacement, improvement etc. should all be included within the scope of the present invention.

Claims (10)

1. a kind of topical composition, which is characterized in that including recombinant human epidermal growth factor and recombination human basic fibroblast cell Growth factor.
2. topical composition as described in claim 1, which is characterized in that the purity of the recombinant human epidermal growth factor >= 95%, specific activity >=5 × 105IU/mg。
3. topical composition as described in claim 1, which is characterized in that the recombination human basic fibroblast growth factor Purity >=95%, specific activity >=5 × 105IU/mg。
4. the topical composition as described in claims 1 to 3 any one is controlled in the external application of preparation treatment dermatoneurosis Treat the application in agent.
5. topical composition as claimed in claim 4 answering in the remedy for external use of preparation treatment dermatoneurosis With, which is characterized in that the dermatoneurosis includes neural functionality formication, neurodermatitis and autumn-dryness disease skin At least one of inflammation.
6. a kind of remedy for external use, which is characterized in that including the topical composition as described in claims 1 to 3 any one.
7. remedy for external use as claimed in claim 6, which is characterized in that the recombinant human epidermal growth factor is in the external application Additive amount in therapeutic agent is 0.0002~0.001g/kg;
Additive amount of the recombination human basic fibroblast growth factor in the remedy for external use be 0.0002~ 0.001g/kg。
8. remedy for external use as claimed in claim 7, which is characterized in that the recombinant human epidermal growth factor is in the external application Additive amount in therapeutic agent is 0.0004~0.0008g/kg;
Additive amount of the recombination human basic fibroblast growth factor in the remedy for external use be 0.0004~ 0.0008g/kg。
9. remedy for external use as claimed in claim 8, which is characterized in that the recombinant human epidermal growth factor is in the external application Additive amount in therapeutic agent is 0.0005~0.0006g/kg;
Additive amount of the recombination human basic fibroblast growth factor in the remedy for external use be 0.0005~ 0.0006g/kg。
10. remedy for external use as claimed in claim 6, which is characterized in that the remedy for external use is gelling agent, emulsion, frost Agent, solution, liniment, lotion, ointment or paste.
CN201811055489.7A 2018-09-10 2018-09-10 A kind of topical composition and its application and remedy for external use Pending CN109078171A (en)

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