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WO2014065772A1 - Agent pour le traitement de blessure d'origine diverses er procédé d'application - Google Patents

Agent pour le traitement de blessure d'origine diverses er procédé d'application Download PDF

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Publication number
WO2014065772A1
WO2014065772A1 PCT/UA2013/000035 UA2013000035W WO2014065772A1 WO 2014065772 A1 WO2014065772 A1 WO 2014065772A1 UA 2013000035 W UA2013000035 W UA 2013000035W WO 2014065772 A1 WO2014065772 A1 WO 2014065772A1
Authority
WO
WIPO (PCT)
Prior art keywords
chitoplast
chitosan
dermis
wound
sodium hydroxide
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/UA2013/000035
Other languages
English (en)
Russian (ru)
Inventor
Геннадий Федорович ТКАЧ
Александр Викторович СОЛОДОВНИК
Анатолий Михайлович СКЛЯР
Виталий Зиновиевич СИКОРА
Максим Владимирович ПОГОРЕЛОВ
Алексей Николаевич КАЛИНКЕВИЧ
Оксана Владимировна КАЛИНКЕВИЧ
Сергей Николаевич ДАНИЛЬЧЕНКО
Валентина Ивановна БУМЕЙСТЕР
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
"RESEARCH AND PRODUCTION ENTERPRISE "BIOCOMPOSIT" LLC
Original Assignee
"RESEARCH AND PRODUCTION ENTERPRISE "BIOCOMPOSIT" LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by "RESEARCH AND PRODUCTION ENTERPRISE "BIOCOMPOSIT" LLC filed Critical "RESEARCH AND PRODUCTION ENTERPRISE "BIOCOMPOSIT" LLC
Publication of WO2014065772A1 publication Critical patent/WO2014065772A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • 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
    • A61K31/716—Glucans
    • A61K31/722—Chitin, chitosan
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/38—Silver; Compounds thereof
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007—Drug-containing films, membranes or sheets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/28—Polysaccharides or their derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/46—Deodorants or malodour counteractants, e.g. to inhibit the formation of ammonia or bacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/60—Liquid-swellable gel-forming materials, e.g. super-absorbents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/102—Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
    • A61L2300/104—Silver, e.g. silver sulfadiazine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/12—Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces

Definitions

  • the invention relates to the field of medicine and the pharmaceutical industry, and can be used as a therapeutic agent for the treatment of wounds of various etiologies, II and III degree burns, prevention of scarring, hemostasis (hemostasis), etc.
  • Known helium preparation that contains synthetic polymers (Pat. 2157243 RU, IPC A 61L 15/22. Hydrogel composition and dressings from it for the treatment of wounds of various etiologies / Valuev L.I. et al .; applicant and patentee A. Pishchurov. N. - 3.N ° 991 13730/14; declaring 01.07.1999; publ. 10.10.2000), the disadvantage of which is the use of toxic monomers in its manufacture, namely acrylamide; stratification and destruction during storage, poor adhesion with a wound, as well as the inability to use this composition to form a wound cover and other methods of treating wounds without the use of auxiliary materials (linings).
  • helium preparations that contain polymers, collagen, gelatin, alginate, chitosan alone or in a composition alone with other and auxiliary substances, in particular gentamicin (Pat. 2252787 CI RU, IPC A61L15 / 28. Method for producing artificial skin matrix / Bolshakov I.N. et al .; applicant and patent holder of GOU VPO Krasnoyarsk State Medical Academy of the Ministry of Health of the Russian Federation (RU). - 3. JY ° 2003136466/15; filed on December 6, 2003; published on May 27, 2005).
  • Such compositions are characterized by a sufficiently high biocompatibility, but in the case of the presence of collagen in them or other proteins may cause an immunological reaction, and in the case of molecular crosslinking may contain residues of a toxic crosslinking agent.
  • the closest analogue of the proposed invention is a helium preparation, which contains a colloidal solution of chitosan, gentamicin and a number of auxiliary substances and methods for its use (Pat. UA 84369, IPC A61K 31/7036.
  • composition can be used exclusively as an ointment to accelerate wound healing.
  • the basis of the invention is the task of creating a chitoplast -derm and methods of using it as a wound cover for the treatment of wounds of various etiologies, which would have the properties of an improved qualitative and quantitative composition of biological materials that have adhesion to the skin, high biological activity, which ensures the creation of an optimal microenvironment for wound healing, high ability to absorb wound exudate, the absence of pyrogenic, antigenic and toxic effects, the ability to create I have a wide range of dressings for the treatment of wounds of various etiologies, means to stop bleeding.
  • chitosan - a natural polymer in the invention is due to the presence of a number of unique abilities, such as non-toxicity, elasticity, biocompatibility, biodegradability with the creation of safe monomers, the ability to model surfaces with complex relief.
  • Chitoplast-dermis is a hydrogel composition that contains chitosan and / or chitosan derivatives, actually chitosan iodide, glycerin. sodium hydroxide, acetic acid, biologically active substances, silver nanoparticles, water in the following ratio (% May):
  • This composition contains an aqueous colloid in which the polymer absorbs water or an aqueous buffer solution (acetic acid solution).
  • a hydrogel is formed by self-organization of the polymer chains of chitosan when the pH of the solution is changed, which is achieved by the addition of sodium hydroxide.
  • the concentration of sodium hydroxide affects the functional properties of the hydrogel, including its ability to absorb wound fluid, fill the wound cavity.
  • the degree of deacetylation and molecular weight of chitosan are important. In the claimed composition, chitosan has a deacetylation degree of more than 80%, and a molecular weight of 200 to 500 kDA.
  • the hydrogel composition is obtained by dissolving the polymer in a weak solution of acetic acid, followed by raising the pH to 7-7.5 and saturating with glycerol, biologically active substances and / or silver nanoparticles.
  • Silver nanoparticles are obtained by treating a 1% solution of silver nitrate with water-extractive substances of oak bark for 24-48 hours. Include nanoparticles in the hydrogel in the form of a colloidal solution.
  • Table 1 The composition of the initial solutions for obtaining chitoplapsterderma is presented in Table 1. Table 1
  • composition of the initial solutions to obtain chitoplast-dermis The composition of the initial solutions to obtain chitoplast-dermis
  • the invention also relates to the use of these compositions as wound dressings with antibacterial and wound healing effects.
  • Chitoplast - dermis (composition 1 and 2) can be used as an independent medical form by placing a tube in a sterile dish (figure 1). After applying the gel to the surface of the defect, a porous film with a thickness of 0.5 -5 mm is formed within 7-10 minutes.
  • a comparative analysis indicates that the healing of wounds treated with chitoplastderma is -. occurs faster by 2-3 days and without complications (Fig.2-5).
  • Chitoplast-dermis (composition 3) can be used to form a transparent film wound cover by irrigation on a glass or Teflon lining.
  • the formed film is treated with a solution of sodium hydroxide 1-5% for 30-120 minutes And a mixture of distilled water and glycerol 1: 1 for 30-120 minutes
  • the time and concentration of sodium hydroxide affect the rate of lysis of the film on the wound surface.
  • Non-toxic film forms during lysis of the film. glycosamine, which can be used in the biosynthesis of aminopolysaccharides of the body.
  • Gradual lysis of the film eliminates additional injury to the wound during dressings.
  • the transparency of the film makes it possible to observe the course of the wound process without removing the coating.
  • the film adheres well to the wound (Fig.6).
  • a perforated film can be used (as an aid) (hole diameter 3-5 m, perforation area 10%).
  • porous sponges By freeze drying (removing water by evaporating ice) or by freezing - gelation (Fig. 7), porous sponges (Fig. 8) can be obtained from the starting compositions 1-3 to stop bleeding and absorb exudate. Sponges obtained by the method of freezing - gelling can be used as a carrier of saline or drugs in the wet state. The release of drugs is accompanied by the absorption of exudate and toxins.
  • Composition 4 is suitable for the formation of granules by the dropwise addition of a solution of chitosan to a solution of sodium hydroxide (Fig. 9, 10). The obtained granules are washed with water and freeze-dried. Granules can be used as a sorption material, and material to stop bleeding.
  • composition 3 By combining chitoplast-dermis 1 or 2 (the lower layer, which is adjacent to the wound) and films based on composition 3 (upper layer), a two-layer wound coating can be obtained.
  • xerogel 1-2 dried to a film state (lower layer), a perforated film based on composition 3 (upper layer) and chitosan iodide (inner layer) you can get a three-layer coating.
  • xerogel 1-2 dried to a film state (lower layer), a perforated film based on composition 3 (reinforcing inner layer), chitosan iodide (binding inner layer), sponge (upper layer), a four-layer wound cover can be obtained.
  • Chitoplast-derm compositions as a wound cover can be used in the treatment of wounds with varying degrees of exudation, ensuring the creation of an optimal microenvironment for wound healing, high absorption capabilities for wound exudate, and the absence of pyrogenic, antigenic and toxic effects, which prevents the penetration of microorganisms.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Materials Engineering (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dispersion Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne un cytoplaste dermique et un procédé d'application d'une composition de celui-ci en qualité de revêtement pour blessure. L'invention se rapport au domaine de la médecine, et l'industrie chimique et pharmaceutique, et peut être utilisée comme agent thérapeutique pour le traitement de blessures d'origines diverses, de brûlures au second et troisième degré, afin de prévenir l'apparition d'escarres, de stopper les hémorragies (hémostase) et autres. Le but de l'invention est d'utiliser de la cytosine qui est un polymère naturel afin de créer une composition d'hydrogel contenant de la cytosine et/ou un dérivé de cytosine, de l'iodure de cytosine, de la glycérine, de l'hydroxyde de sodium, de l'acide acétique, des substances bioactives, des nanoparticules d'argent et de l'eau. Les résultat technique consiste en la formation d'un micro-agent de cicatrisation des blessures, en une grande capacité d'absorption des exsudats de blessures, en l'absence d'actions pyrogènes, antigènes et toxiques, en la possibilité de créer une large gamme de moyens de bandage afin de traiter des blessures d'origines diverses et de moyens pour stopper les hémorragies.
PCT/UA2013/000035 2012-10-23 2013-04-01 Agent pour le traitement de blessure d'origine diverses er procédé d'application Ceased WO2014065772A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
UAU201212165 2012-10-23
UA2012012165 2012-10-23

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WO2014065772A1 true WO2014065772A1 (fr) 2014-05-01

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2564567C1 (ru) * 2014-11-26 2015-10-10 Федеральное государственное бюджетное образовательное учреждение высшего профессионального образования "Мордовский государственный университет им. Н.П. Огарёва" Способ получения биокомпозита

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4275194A (en) * 1977-11-26 1981-06-23 Nihon Tennen Gas Kogyo Co., Ltd. Chitosan-iodine adduct
US4833237A (en) * 1984-07-31 1989-05-23 Fuji Spinning Co., Ltd. Process for producing granular porous chitosan
UA84369C2 (uk) * 2007-05-25 2008-10-10 Алексей Анатольевич Хоценко Лікарський засіб на хітозановій основі з бактерицидною та ранозагоювальною дією, застосування та спосіб лікування
RU2422133C1 (ru) * 2009-11-26 2011-06-27 Федеральное государственное унитарное предприятие "Государственный научно-исследовательский институт особо чистых биопрепаратов" Федерального медико-биологического агентства Гидрофильный гель, способ его получения (варианты), раневое покрытие и перевязочное средство на его основе
RU2455995C2 (ru) * 2007-10-03 2012-07-20 Контипро Биотек с.р.о. Препарат для заживления ран и предотвращения адгезии повязки к ране, содержащий хитозан-глюкановый комплекс

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4275194A (en) * 1977-11-26 1981-06-23 Nihon Tennen Gas Kogyo Co., Ltd. Chitosan-iodine adduct
US4833237A (en) * 1984-07-31 1989-05-23 Fuji Spinning Co., Ltd. Process for producing granular porous chitosan
UA84369C2 (uk) * 2007-05-25 2008-10-10 Алексей Анатольевич Хоценко Лікарський засіб на хітозановій основі з бактерицидною та ранозагоювальною дією, застосування та спосіб лікування
RU2455995C2 (ru) * 2007-10-03 2012-07-20 Контипро Биотек с.р.о. Препарат для заживления ран и предотвращения адгезии повязки к ране, содержащий хитозан-глюкановый комплекс
RU2422133C1 (ru) * 2009-11-26 2011-06-27 Федеральное государственное унитарное предприятие "Государственный научно-исследовательский институт особо чистых биопрепаратов" Федерального медико-биологического агентства Гидрофильный гель, способ его получения (варианты), раневое покрытие и перевязочное средство на его основе

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2564567C1 (ru) * 2014-11-26 2015-10-10 Федеральное государственное бюджетное образовательное учреждение высшего профессионального образования "Мордовский государственный университет им. Н.П. Огарёва" Способ получения биокомпозита

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