CN106620646A - Application of polypeptides to preparation of medicine for treating eczematous dermatitis - Google Patents

Application of polypeptides to preparation of medicine for treating eczematous dermatitis Download PDF

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CN106620646A
CN106620646A CN201710126499.4A CN201710126499A CN106620646A CN 106620646 A CN106620646 A CN 106620646A CN 201710126499 A CN201710126499 A CN 201710126499A CN 106620646 A CN106620646 A CN 106620646A
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preparation
polypeptide
eczema
dermatitis
medicine
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凌建群
余海
赵玲
顾卓敏
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GENLOCI BIOTECHNOLOGIES Inc
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GENLOCI BIOTECHNOLOGIES Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/10Peptides having 12 to 20 amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/12Aerosols; Foams
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions

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  • Proteomics, Peptides & Aminoacids (AREA)
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  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
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  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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Abstract

The invention discloses application of polypeptides to preparation of a medicine for treating eczematous dermatitis and belongs to the field of treatment of eczematous dermatitis. The invention further provides a pharmaceutical composition for treating the eczematous dermatitis. The pharmaceutical composition is prepared from an effective dose of polypeptides as an active ingredient and pharmaceutically acceptable auxiliary materials or auxiliary ingredients into a preparation. Compared with the prior art, the polypeptide preparation has the advantages of remarkable effectiveness in treatment of the eczematous dermatitis, high safety and no side effect of hormones and is suitable for treatment of eczematous dermatitis patients at all ages.

Description

A kind of purposes of polypeptide in the medicine for treating dermatitis and eczema is prepared
Technical field
The present invention relates to dermatitis and eczema therapy field, particularly a kind of polypeptide is being prepared for treating dermatitis and eczema Purposes in medicine.
Background technology
Dermatitis and eczema class illness is the common disease of dept. of dermatology, and its clinical manifestation is so that fash is symmetrical, diversity, violent scabies Itch and recurrent exerbation, easily develop into chronic disease and be characterized, the disease can betide any age, any position, any season, account for 30% or so of skin scabies secondary infection, dermatitis and eczema is apt to occur in infant, and the incidence of disease in infant is about 35.28% (Liu Victory et al.. infantile eczema pathogenic factors epidemiology survey [J]. Chinese mother and child care, 2008,23 (21):3025-3026.).
The dermatitis and eczema cause of disease is complicated, including inherence and external many factors, and the two is connected each other, synergy.Internal cause The mainly allergic constitution of patient, familial inheritance, stress, endocrine, metabolism, gastrointestinal dysfunction, infection focus etc.. In vivo in terms of pathogenesis, educational circles thinks that dermatitis and eczema is disorderly caused mainly due to the cellular immunity that T cell is mediated.There is research As a result Th1/Th2 cells loss of equilibrium in dermatitis and eczema peripheral blood in patients and skin damaged is shown, is partial to Th2 directions, such as skin damaged and outer The expression of all blood Th2 cells or the IL-4 secreted and IL-5 levels are raised, and the expression of Th1 cells or the IFN-γ secreted and IL-2 reduces (Yamanaka K, Mizutani H.The role of cytokines/chemokines in the pathogenesis of atopic dermatitis.Curr Probl Dermatol 2011,41:80-92.Xu XG et al.Xiaoyin Recipe for psoriasis induces a Th1/Th2balance drift toward Th2in peripheral blood mononuclear cells of experimental autoimmune thyroiditis rats.Chin J Integr Med 2012,18(2):137-145.)。
The external cause of dermatitis and eczema include environmental pollution, radioactive source, chemicals, cosmetics, zootoxin, fishes and shrimps, dust, Exposure to Sunlight, scratch, the single or comprehensive function such as microorganism.The main original that diaper dermatitis (being commonly called as " diaper rash ") such as infant occurs Comprehensive function because being water/humidity, friction, urine, excrement and microorganism etc..Water/humidity not only cause skin fragility increase and Easy frictionally damage, and skin barrier function is died down and causes chemical toxicant to permeate or pathogenic microorganism propagation.Urine There is corrosiveness with the urokinase in excrement, protease and lipase, so as to destroy integrality (T ü z ü n Y, the Wolf of skin R,Engin B.Diaper(napkin)dermatitis:A fold(intertriginous) dermatosis.Clin Dermatol.,2015,33(4):477-82.Klunk C,Domingues E,Wiss K.An update on diaper dermatitis.Clin Dermatol.,2014,32(4):477-87.).Eczema patients and health People compares, and its skin microbial composition has fundamental difference, and more staphylococcus aureus (Ian are contained in the former skin D.Odell,et al.,Microbiome:Ecology of eczema,Nature Microbiology 2016,16135)。 The patient of contact eczema (i.e. contact dermatitis) contact with anaphylactogen or with general excitant such as acid, cleaning agent or other change The region of product contact can rubescent, itch and scorching hot.Other examples of contact eczema are included to food, cleaning agent, soap, nickel (in jewelry exist), cosmetics, fabric, clothes and spices reaction (Sultan T.Al-Otaibi et al., Management of contact dermatitis,Journal of Dermatology&Dermatologic Surgery 19(2015)86–91)。
At present, treating the medicine of dermatitis and eczema has following several classes:1. glucocorticoid, it is treat dermatitis and eczema main Medicine, there is anti-inflammatory, an anti-allergic effects, instant effect, common such as hydrocortisone, butyric acid hydrocortisone, Triamcinolone acetonide, for a long time Can cause more bad reaction using this kind of medicine, such as flush drying, pigmentation, telangiectasis and easily be formed Drug-dependent dermatitis and rebound dermatitis, should use with caution (Zhang Tangde et al., the side effect and preventing and treating [J] of external application glucocorticoid. Dermatology diagnostics magazine .2012 (4):263-266);2. immunomodulator, concrete medicine such as tacrolimus (Protopic) With Elidel (Elidel), these medicines are referred to as calcineurin inhibitor, and in 2005, FDA was sent with regard to using this The warning of a little medicines, refer to zooscopy, its be displayed in using these medicines and develop between certain form of cancer can Can association.Therefore, from the point of view of carcinogenic and other angles, seem it is problematic using calcineurin inhibitor;3. antihistamine Medicine, antihistamine can play antipruritic and antianaphylactic effect, diphenhydramine, chlorpheniramine and fenazil etc. with antagonizing histamine Generation antihistamine drug has stronger Central nervous depressant, and second generation antihistamine drug is because it is found that there is the obvious heart Dysentery and gradually decrease use (such as teldane, A Si meter azoles) (Shen Lifang et al., the effect of several antihistamine drugs be special Point and application, China and foreign countries' medical treatment, 2009 (7):176.) 4. topical antibiotic, when dermatitis and eczema occurs, skin injury is easily caused sense Dye, and infant easily scratches breakage because of scratchiness, is more easily caused bacterium intrusion.Local topical antibiotic can be with Perceived control Dye, prevents bacterium from invading, but antibiotic easily produces drug resistance.5. other, such as zinc oxide, traditional Chinese medicine, external application zinc oxide is soft Safely and effectively, application is relatively wide for cream, but it recovers relatively slow to healing and the surface of a wound, and easily causes infection;The internal therapy of traditional Chinese medicine, control outward Method and mothers and sons have good therapeutic effect to dermatitis and eczema with the tcm characteristic therapy such as controlling, but it decocts time-consuming, slowly effect.
Antibacterial peptide is a class basic polypeptide, is typically made up of 12~50 or so amino acid, with broad spectrum antibacterial.Mesh Before, antibacterial peptide database (APD, http://aps.unmc.edu/AP/) totally 2798 kinds of antibacterial peptides biological from 6 classes have been included, Wherein, 282 kinds from bacterium, 4 kinds from Archimycetes, 8 kinds from protist, 13 kinds from fungi, 341 kinds from plant, 2096 kinds from animal.In addition to antibacterial action, different antibacterial peptides also have different effects, and such as Melittin is to U937 people's list Nuclear leukocyte disease cell, Du145 prostate gland cancer cells, SKOV3 ovarian cancer cells, B16 mouse melanin tumor cells, BEL-7402 Human liver cancer cell has suppression or killing action (S.Saini, et al., Melittin activates endogenous phospholipase D during cytolysis of human monocytic leukemia cells,Toxicon, vol.37,no.11,pp.1605–1619,1999.P.J.Russell,et al.,Cytotoxic properties of immunoconjugates containing melittin-like peptide 101against prostate cancer: in vitro and in vivo studies,Cancer Immunology,Immunotherapy,vol.53,no.5, pp.411–421,2004.);LL-37 be used for promote venous leg ulcerations healing local treatment (A.et al.,(2014).Treatment with LL-37is safe and effective in enhancing healing of hard-to-heal venous leg ulcers:a randomized, placebo-controlled clinical trial.Wound Repair Regen.22,613–621.doi:10.1111/wrr.12211), LL-37 promotes wound healing Mechanism it is not clear, but may relate to promoting epidermization, Angiogenesiss and inflammation wound repair component;Bovine lactoferrin exists Immune system (Mattsby- can be adjusted to the induction of TNF-α and IL-6 by suppressing LPS (TLR4) in THP-1 cells Baltzer,et al.L.A.(1996).Lactoferrin or a fragment thereof inhibits the endotoxin-induced interleukin-6response in human monocytic cells.Pediatr.Res.40,257–262.);The hyaluronic acid derivatives preparation of human lactoferrin derivative PXL01 is used for pre- Anti- postoperative adhesions (Wiig, etal. (2014) .PXL01in sodium hyaluronate for improvement of hand recovery after flexor tendon repair surgery:randomized controlled trial.PLoSONE 9:e110735.)。
Applicant is found that under study for action polypeptide of the present invention, and the polypeptide is a kind of antibacterial peptide, and anti-with regard to it before this The multinomial patent of the characteristic applies such as microorganism, prior art only reported the anti-microbial property of the polypeptide, have no that it has treatment The report of dermatitis and eczema.
The content of the invention
For the defect of prior art, applicant has surprisingly found that polypeptide of the present invention has preferably effect to dermatitis and eczema Really, for the defect of prior art, the primary and foremost purpose of the present invention is to provide a kind of polypeptide and is preparing for treating dermatitis and eczema Purposes in medicine, second object of the present invention is to provide a kind of pharmaceutical composition for treating dermatitis and eczema, it is characterised in that: Said composition is, with the polypeptide of effective dose as active component, to add pharmaceutically acceptable auxiliary material or complementary composition system Into preparation.Third object of the present invention is to provide a kind of method for treating dermatitis and eczema.
The amino acid sequence of polypeptide of the present invention is SEQ ID:NO.1.
Content in the present invention, without being mass percent under specified otherwise.
The implication for the treatment of dermatitis and eczema of the present invention is included but is not limited to:Improve or alleviate the related disease of eczema Shape, the time for shortening symptoms last, not deteriorating condition state, postpone or slow down the progress of disease.
In one embodiment, the present invention provides a kind of use of polypeptide in the medicine for treating dermatitis and eczema is prepared On the way, the peptide concentration is 0.01%-1%.
In one embodiment, the present invention provides a kind of use of polypeptide in the medicine for treating dermatitis and eczema is prepared On the way, the peptide concentration is 0.02%-0.2%.
The medicine is external solid preparation, semisolid preparation or liquid preparation.Preferred solid pharmaceutical preparation is freeze dried powder. Preferred semisolid preparation is paste or gel preparation, and preferred liquid preparation is spray.
In one embodiment, the present invention provides a kind of pharmaceutical composition for treating dermatitis and eczema, it is characterised in that:Should Composition is, with the polypeptide of effective dose as active component, to add pharmaceutically acceptable auxiliary material or complementary composition is made Preparation.
In one embodiment, the present invention provides a kind of pharmaceutical composition for treating dermatitis and eczema, the peptide concentration For 0.01%-1%.
In one embodiment, the present invention provides a kind of pharmaceutical composition for treating dermatitis and eczema, the peptide concentration For 0.02%-0.2%.
The medicine is external solid preparation, semisolid preparation or liquid preparation.Preferred solid pharmaceutical preparation is freeze dried powder. Preferred semisolid preparation is paste or gel preparation, and preferred liquid preparation is spray.
In one embodiment, the present invention relates to a kind of method for treating dermatitis and eczema, it comprises the steps: Polypeptide formulations of the present invention are applied to the position affected by dermatitis and eczema, the amino acid sequence of the polypeptide is SEQ ID: NO.1.The position affected by dermatitis and eczema can include the position with the thereof adjacent of performance dermatitis and eczema symptom.Dermatitis Eczema symptom is included but is not limited to:Discomfort, itch is scorching hot, fash, sends out blister, Epidermal necrosis, furfur, discoloration, and/or pigment heavy Excessively.
The invention provides a kind of known peptide treats the new application of dermatitis and eczema, and in addition to anti-microbial effect, can Can also have the effect for adjusting immune system, promoting wound healing, compared with prior art, the polypeptide formulations treatment dermatitis and eczema Effect is preferable;Polypeptide good water-retaining property of the present invention, can prevent cutaneous lesion to be dried the symptom aggravation for causing;It is of the present invention many Peptide is safe, and final catabolite is amino acid, is had no adverse reaction;Because the polypeptide is by making with microbial cell film With and antibacterial, be difficult to make bacterium to produce drug resistance.
Specific embodiment
The invention provides a kind of polypeptide is used to treat the purposes of dermatitis and eczema, the polypeptide is amino without specified otherwise Acid sequence is SEQ ID:NO.1.
If not specializing, the conventional meanses that technological means used is well known to those skilled in the art in embodiment, In embodiment, each raw material of addition is commercially available unless otherwise indicated.
Polypeptide of the present invention is a kind of antibacterial peptide, and data with existing only discloses the polypeptide tool antibiotic effect.Applicant In research process, it is found surprisingly that polypeptide of the present invention has the effect for the treatment of eczema, concrete cure mechanism is also indefinite, But based on the existing document of other antibacterial peptides, applicant courageously speculates, the polypeptide disclosed by the invention may have it is various not Know function, it eliminates the microorganism in dermatitis and eczema region, keep moisture of skin, promote on the basis of body immune system is adjusted Enter blood circulation and the healing of skin damaged, be finally reached the effect for the treatment of dermatitis and eczema.
The present invention provides a kind of pharmaceutical composition for treating dermatitis and eczema, it is characterised in that:Said composition is with effective agent The polypeptide of amount is active component, adds pharmaceutically acceptable auxiliary material or preparation made by complementary composition.
The auxiliary material can be sucrose, starch, dextrin, magnesium stearate, sorbierite, mannitol, lactose, microcrystalline cellulose, The combination of one or more of customary adjuvant in the pharmaceutical preparations such as superfine silica gel powder, carboxymethylcellulose calcium, water, it is specifically chosen any Or which plant auxiliary material should according to made by required formulation determining.Described complementary composition refers to that the polypeptide can be improved Curative effect or can also treat the medicine such as glucocorticoid, antibiotic or other Chinese medicines of eczema.
Polypeptide of the present invention can make various formulations when preparing for the medicine for treating dermatitis and eczema, described dose Type should be pharmaceutically acceptable formulation, generally refer to the polypeptide and be included in the formulation, and/or treated with this A kind of other components in patient material mutually compatible in chemistry and/or in toxicology or composition.The formulation can be wrapped Include spray, emulsion, suspension, paste, dressing, washing lotion, gel, pulvis or other solids, semi-solid or fluid composition. Such composition can be included:NMF, hydrating agents, bleeding agent, preservative, emulsifying agent, naturally occurring or synthetic oil, surface-active Agent, gel, thickener, wax, odour absorbents, colouring agent, coloring agent, pulvis, viscosity modifier and water, and mineral matter, Polyphenol, organosilicon, vitamin etc..
Preferably, the medicine is external solid preparation, semisolid preparation or liquid preparation.Preferred solid pharmaceutical preparation is to freeze Dry powder doses.Preferred semisolid preparation is paste or gel preparation, and preferred liquid preparation is spray.
Polypeptide of the present invention can be obtained by chemical synthesis, also can be expressed, be isolated and purified by technique for gene engineering To (concrete grammar can be found in Sambrook et al., Molecular Cloning:A Laboratory Manual, Cold Spring Harbor Laboratory Press, Cold Spring Harbor, NY, 1989), that is, application reference people exists First to file patent (application number:201310245373.0, denomination of invention:A kind of preparation method and application of antibacterial peptide) described in it is many The preparation method of peptide.
This part embodiment further illustrates present disclosure, but should not be construed as limiting the invention.Do not carrying on the back In the case of spirit of the invention and essence, the modification made to the inventive method, step or condition or replacement belong to this Bright scope.
The preparation of the lyophilized formulations of the present invention of embodiment 1
Auxiliary material mannitol, arginine are dissolved, is mixed with polypeptide of the present invention, adjustment pH value to 7.2 constitutes per milliliter Liquid contain polypeptide, 32mg mannitol, 15mg arginine described in 1mg, through filtering bacterium after, freeze-drying, as lyophilized formulations.
The preparation of the spray agent of the present invention of embodiment 2
For ease of transporting and preserving, polypeptide of the present invention is prepared into into lyophilized formulations, can be prepared as needed when using For spray agent:It is by lyophilized formulations physiological saline or the conventional solvent dissolving of medical science, the peptide concentration scope after dissolving 0.01%-1%, in being fitted into satisfactory sprayer, you can spraying is used.
The preparation of the paste of the present invention of embodiment 3
The medical ventolin of 54%-54.9%, 45% liquid paraffin are heated under agitation 65 DEG C, are melted Thing.0.01%-1% polypeptides of the present invention are added in the temperature, and stirs the mixture of gained until being moistened completely Compound.Then suspended matter is processed into 5min with Ultra Turrax instruments in 65 DEG C in 24000rpm, is allowed to homogenize.Will To composition slowly cool to 25 DEG C, obtain paste of the present invention.
The preparation of the gel of the present invention of embodiment 4
After the Carbomer of 0.5%-2% is stirred, hyaluronic acid, the 0.06%- of 1%-3.5% is added 0.1% glycerine and the polypeptide of the present invention of 0.01%-1%, after continuing to stir, that is, obtain of the present invention solidifying Jelly.
The water-retaining property of the polypeptide of the present invention of embodiment 5
4% trehalose, polypeptide solution described in 0.5g/ml are prepared, the water of 10% mass ratio is added in glycerine, be coated with On the culture dish for posting 3M adhesive plasters, weigh sample quality and be counted as m1.
The sample for weighing is placed in desiccator, and places 20ml saturated ammonium sulfate solution in desiccator, maintained Certain humidity, respectively at 4h, 8h weighs the quality of sample and is counted as m2.
Moisturizing rate=m2/m1 × 100%.
Result of the test is shown in Table 1
The water retention situation of table 1 compares
Time 10% glycerine Trehalose The polypeptide
4h 231% - 182% 59.4%
8h 294% - 327% 51.1%
As shown in table 1, though the water retention of polypeptide of the present invention is not so good as glycerine, used in general moisture-keeping cosmetics The water retention of trehalose wants high many.
Embodiment 6
1. object
The dermatitis and eczema patient for selecting Inst. of Dermatology, Chinese Academy of Medical Sciences to accept for medical treatment in May, 2016 in May, 2015 72, patient has different degrees of fash, itch, papulo-vesicle, oozes out skin damaged etc., and symptom is mainly distributed on face, private parts, ear Afterwards, four limbs bend the positions such as side, breast, hand.Patient is randomly divided into into four groups, 1 group of control group and 3 groups for the treatment of groups, treatment group presses The content of peptides is divided into:Low dose group (0.02%), middle dose group (0.1%), high dose group (0.2%), 18 per group.Four The physical data no significant differences (P > 0.05) such as group Gender, age, the course of disease, disease, with comparativity.
2. method
Control group uses butyric acid hydrocortisone ointment (trade name:You Zhuoer, Tianjin Pharmaceutical Group Corp., Ltd's production, Chinese medicines quasi-word H10940095) affected part is applied to, treatment group is respectively using the more of 3 kinds of variable concentrations described in the embodiment of the present invention Peptide formulations are sprayed or are applied in affected part, and low dose group is that, from the polypeptide spray described in embodiment 2, middle dose group is from reality The polypeptide paste described in example 3 is applied, high dose group is from the peptide-based gel agent described in embodiment 4, using daily 2 times;Spraying or The time is smeared for 3 days to 2 weeks, according to the rehabilitation situation of skin, Schultz-Charlton, pruritis are disappeared, and are just discontinued medication.Medication 1 month afterwards, random access sees whether recurrence by respondent.
3. evaluation criterion
After medication, cure:Fash all disappears, and pruritis disappear;It is effective:Symptom mitigation;It is invalid:Deflorescence < 30%, pruritis mitigate unobvious.
Efficient=cure rate+obvious effective rate
4. result
There is no obvious adverse reaction in test group, control group appearance 1 is scorching hot to be dried furfur, voluntarily disappears during medication Lose and do not affect treatment, the results are shown in Table 2.
2 four groups of therapeutic effects of table compare (%, n)
Effect of the polypeptide of the present invention of embodiment 7 to diaper rash
From in January, 2015 in attached second pediatric hospital of Zhejiang University of Traditional Chinese Medicine and affiliated hospital of Hangzhou Pedagogic University youngster Section begins to use 0.01% polypeptide spray agent described in embodiment 2 to carry out local treatment to infant diaper rash, by with zinc oxide Formulations Comparative observes curative effect.
1. object and method
The diaper rash infant 129 of the medical age≤90d in 1.1 packet in October, -2016 in January, 2015 the Supreme People's Court and the Supreme People's Procuratorates, the male sex 46, women 83.Divide 3 degree again according to skin damaged degree.I degree:Local flush;II degree:With protuberance fash;III degree:Fash has Diffusate or erosion.Wherein I degree 57, II degree 47, III degree 25.By the medical date, control group and treatment group are classified as, Control group 41, treatment group 88, two groups of infant sexes, age, the course of disease, skin damaged degree comparing difference are not statistically significant, and (P is equal >0.05), with comparativity, situation is relatively shown in Table 3.
3 two groups of ordinary circumstances of table compare
1.2 method:Two groups of cases warm water cleaning buttocks and perineums after each stool and urine, with fur towel solid carbon dioxide part is wiped And more changing babies' napkin.Polypeptide spray agent 3-5 sprays described in embodiment 2 are sprayed at skin damaged during each changing babies' napkin for the treatment of group;Control group Smear oxidation zinc preparation (Johnson & Johnson's stern protection cream) during changing babies' napkin at skin damaged every time.
1.3. curative effect judging standard:The observation curative effect time limit is 7 days after treatment, fully recovers:Skin damaged pathology disappeared in 7 days;It is good Turn:Skin damaged pathology mitigates but does not disappear within the 7th day in treatment;It is invalid:7 days skin damageds for the treatment of are unchanged or increase.Effectively case is referred to The summation of recovery from illness case and improvement case.
1.4. statistical method:Statistical procedures are carried out using SPSS11.5 softwares, enumeration data adopts x2Inspection, metering Data is checked or F inspections using t.
2 results
After 2.1 two groups of comparitive studies are treated 7 days, two groups of curative effects are shown in Table 4, Jing contingency table Chi-square Tests, and difference has and shows very much Write meaning (x2=15.006, P=0.001), simultaneously, it is 85.4% (35/41) that control group is efficient to ECDC, and treatment group is efficient to be 96.6% (85/88), difference significance (x2=5.430, P=0.020).9 refractory patients are III degree, to treating nothing The wounds secretion of effect carries out Bacteria Culture, and as a result control group case has 2 visible white beads bacteria growings, control group and Treatment group's case respectively has 1 MRSE growth.Have albicans growth 2 use instead many described in sprinkling embodiment 2 Peptide formulations after 3 days the surface of a wound be clearly better.
4 two groups of comparitive studies of table (%, n)
2.2 two groups of diaper rash regression times compare that rejecting 9 is invalid and in 4 observation periods improvement and after the patient that do not fully recover, Fully recover at 120 in patient, control group diaper rash regression time is 4.42 ± 1.46 days, treatment group's diaper rash regression time is 3.64 ± 1.03 days, difference significance (t=3.223, P=0.002).
2.3 different skin damaged degree healing times compare in two groups of 120 recovery from illness patients, the healing time of different skin damaged degree Relatively it is shown in Table 2, it is seen that in I degree patients, two groups of healing time difference nonsignificances (P > 0.05), but at II degree and III degree 's
The different skin damaged degree healing times of 5 two groups of table compare
In patient, treatment group's healing time is shorter than control group, difference significance (P < 0.05).In treatment group, lead to Cross F inspections and show that polypeptide formulations described in embodiment 2 are different to different skin damaged healing times, the faster (F=of the lighter healing of skin damaged 5.694, P=0.005) display, is compared two-by-two, I degree healing time is shorter than III degree, difference has highly significant meaning (P= , but I degree and II degree, II degree and III degree healing time difference nonsignificance (P=0.401, P=0.108) 0.004).
A situation arises compares during two groups of neonates treat and do not find obvious adverse reaction for 2.4 two groups of bad reactions.
As a result show, polypeptide formulations treatment group described in embodiment 2 is efficient higher than control group, difference significance, and 7 Its Ureteral Calculus phase, treatment group is most of to cure case, and what control group was not healed has 2 Jing embodiments of candida albicans infection Described in 2 polypeptide formulations treatment after substantially work, two groups of recovery from illness cases the deflorescence time relatively in, it is many described in embodiment 2 The peptide formulations treatment group deflorescence time is 4.42 ± 1.46 days, hence it is evident that be shorter than 3.64 ± 1.03 days of control group, difference has aobvious Write meaning.
Relatively show in the healing time of different skin damaged degree, I degree diaper rash treatment groups are with control group healing time without aobvious Write difference, and II degree and polypeptide formulations treatment group healing time described in III degree of diaper rash embodiment 2 it is shorter than control group, difference has aobvious Write meaning.In polypeptide formulations treatment group described in embodiment 2, different skin damaged healing times are different, and the heavier healing time of skin damaged is more It is long, meet and lapse to rule.
Embodiments of the invention are the foregoing is only, the scope of the claims of the present invention is not thereby limited, it is every using this Equivalent structure or equivalent flow conversion that bright description is made, or directly or indirectly it is used in other related technology necks Domain, is included within the scope of the present invention.
SEQUENCE LISTING
<110>Jiangsu Ji Rui Bioisystech Co., Ltd
<120>A kind of purposes of polypeptide in the medicine for treating dermatitis and eczema is prepared
<160> 1
<170> PatentIn version 3.3
<210> 1
<211> 18
<212> PRT
<213>Artificial sequence
<400> 1
Gly Arg Phe Lys Arg Phe Arg Lys Lys Phe Lys Lys Leu Phe Lys Lys
1 5 10 15
Leu Ser

Claims (14)

1. a kind of purposes that polypeptide is used in the medicine for treating dermatitis and eczema in preparation, it is characterised in that the amino of the polypeptide Acid sequence is SEQ ID NO.1.
2. purposes as claimed in claim 1, it is characterised in that the concentration of the polypeptide is 0.01%-1%.
3. purposes as claimed in claim 2, it is characterised in that the concentration of the polypeptide is 0.02%-0.2%.
4. the arbitrary purposes as described in claim 1-3, it is characterised in that the medicine is external solid preparation, semi-solid system Agent or liquid preparation.
5. purposes as claimed in claim 4, it is characterised in that described solid pharmaceutical preparation is freeze dried powder.
6. purposes according to claim 4, is characterized in that:Described semisolid preparation is paste or gel.
7. purposes according to claim 4, is characterized in that:Described liquid preparation is spray.
8. a kind of pharmaceutical composition for treating dermatitis and eczema, it is characterised in that:Said composition is will with effective dose such as right Ask the polypeptide described in 1 to be active component, add pharmaceutically acceptable auxiliary material or preparation made by complementary composition.
9. pharmaceutical composition as claimed in claim 8, it is characterised in that the concentration of the polypeptide is 0.01%-1%.
10. pharmaceutical composition as claimed in claim 9, it is characterised in that the concentration of the polypeptide is 0.02%-0.2%.
The 11. arbitrary pharmaceutical compositions as described in claim 8-10, it is characterised in that described pharmaceutical composition is external solid Preparation, semisolid preparation or liquid preparation.
12. pharmaceutical compositions as claimed in claim 11, it is characterised in that described solid pharmaceutical preparation is freeze dried powder.
13. pharmaceutical compositions according to claim 11, is characterized in that:Described semisolid preparation is paste or gel system Agent.
14. pharmaceutical compositions according to claim 11, is characterized in that:Described liquid preparation is spray.
CN201710126499.4A 2017-03-04 2017-03-04 Application of polypeptides to preparation of medicine for treating eczematous dermatitis Pending CN106620646A (en)

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CN111214644A (en) * 2020-03-16 2020-06-02 中国人民解放军第四军医大学 Application of Fenmu polypeptide in preparation of medicine for inhibiting II type herpes simplex virus infection
CN113117047A (en) * 2019-12-30 2021-07-16 浙江瀛康生物医药有限公司 Polypeptide anti-inflammatory and itching-relieving composition
CN113797111A (en) * 2020-06-17 2021-12-17 江苏吉锐生物技术有限公司 Dandruff-removing and alopecia-preventing composition and application thereof
CN114586745A (en) * 2020-12-07 2022-06-07 江苏吉锐生物技术有限公司 Application of polypeptide in preventing and reducing spread of pollinating insects to plant epidemic diseases

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WO2011011797A2 (en) * 2009-07-24 2011-01-27 The Board Of Trustees Of The Leland Stanford Junior University Cytokine compositions and methods of use thereof
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CN109439686A (en) * 2018-11-23 2019-03-08 天津农学院 A kind of recombinant attenuated salmonella LH430 and its preparation method and application
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CN111214644A (en) * 2020-03-16 2020-06-02 中国人民解放军第四军医大学 Application of Fenmu polypeptide in preparation of medicine for inhibiting II type herpes simplex virus infection
CN113797111A (en) * 2020-06-17 2021-12-17 江苏吉锐生物技术有限公司 Dandruff-removing and alopecia-preventing composition and application thereof
CN113797111B (en) * 2020-06-17 2023-05-05 江苏吉锐生物技术有限公司 Composition for removing dandruff and preventing alopecia and application thereof
CN114586745A (en) * 2020-12-07 2022-06-07 江苏吉锐生物技术有限公司 Application of polypeptide in preventing and reducing spread of pollinating insects to plant epidemic diseases

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Application publication date: 20170510