WO2015152771A1 - Procédé de production d'un hydrogel médicinal - Google Patents

Procédé de production d'un hydrogel médicinal Download PDF

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Publication number
WO2015152771A1
WO2015152771A1 PCT/RU2015/000206 RU2015000206W WO2015152771A1 WO 2015152771 A1 WO2015152771 A1 WO 2015152771A1 RU 2015000206 W RU2015000206 W RU 2015000206W WO 2015152771 A1 WO2015152771 A1 WO 2015152771A1
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WO
WIPO (PCT)
Prior art keywords
mixture
medicine
sodium
dimethyl sulfoxide
sodium alginate
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PCT/RU2015/000206
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English (en)
Russian (ru)
Inventor
Наталия Дмитриевна ОЛТАРЖЕВСКАЯ
Герман Евсеевич КРИЧЕВСКИЙ
Мария Анатольевна КОРОВИНА
Лариса Борисовна САВИЛОВА
Original Assignee
Общество с ограниченной ответственностью "КОЛЕТЕКС"
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Publication of WO2015152771A1 publication Critical patent/WO2015152771A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/63Arthropods
    • A61K35/64Insects, e.g. bees, wasps or fleas
    • A61K35/644Beeswax; Propolis; Royal jelly; Honey
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/17Amides, e.g. hydroxamic acids having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/41641,3-Diazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4425Pyridinium derivatives, e.g. pralidoxime, pyridostigmine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/498Pyrazines or piperazines ortho- and peri-condensed with carbocyclic ring systems, e.g. quinoxaline, phenazine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/513Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088Compounds having three or more nucleosides or nucleotides
    • A61K31/711Natural deoxyribonucleic acids, i.e. containing only 2'-deoxyriboses attached to adenine, guanine, cytosine or thymine and having 3'-5' phosphodiester links
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • 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
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/20Interleukins [IL]
    • A61K38/2006IL-1
    • 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
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents

Definitions

  • the invention relates to the medical and pharmaceutical industries
  • a known method of obtaining a therapeutic composition for intravesical therapy of chronic cystitis (Mirkin Y.B. Intravesical therapy of chronic cystitis // http://urotoday.ru/issue/6-2012/article/vnutripuzyrnaya-terapiya-khronicheskogo-tsistita.
  • the method is based on the introduction in the polymer composition of sodium alginate and hyaluronic acid, drugs dioxidine and lidocaine.
  • the disadvantages of this method include the fact that the therapeutic composition obtained in this way loses its viscosity characteristics during ⁇ -sterilization.
  • the closest is a method of producing a therapeutic hydrogel, including the introduction of a drug into a polymer composition from a number of polysaccharides, gamma sterilization of 6-15 kGy (MA Korovina, “Development of a methodology and technology for creating therapeutic textile and hydrogel applications for targeted local drug delivery in radiation Therapy of Oncological Diseases (Theory and Practice) ”: Dis. ... Doctor of Technical Sciences: 05.19.02 / M.A. Korovin. - M, 2011. p.194-195).
  • the polymer-thickener sodium alginate is introduced into distilled water and thoroughly mixed on a slow-moving mixer until it is completely dissolved and a homogeneous gel is obtained, and then a drug is added to the composition.
  • the composition is thoroughly mixed in a kneading machine until a homogeneous mass is formed.
  • the disadvantages of this method include the fact that the therapeutic composition obtained in this way also loses its viscosity characteristics during ⁇ -sterilization, and for a short time it retains biological stability before ⁇ -sterilization due to the possibility of high contamination.
  • the objective of the invention is to provide a method for producing a biopolymer composition with a medicinal product, preserving more than 80% of its rheological, including viscosity properties during ⁇ -sterilization, increasing the time to maintain biological stability before ⁇ -sterilization, preventing the formation of microflora during the process an increase in the time of prolongation of the action of drugs.
  • the concentration of the drug is proposed to choose from 0, 25 to 20 mass%, with the use of a drug selected from the series as a drug: ⁇ -aminocaproic acid or its mixture with lidocaine hydrochloride; Actovegin; a mixture of mexidol, dimethyl sulfoxide, hydrocortisone acetate and actovegin; propolis; nettles; chamomile or a mixture of nettle and chamomile; a mixture of nettle, chamomile and ⁇ -aminocaproic acid; metronidazole; dimethyl sulfoxide or a mixture of metronidazole and dimethyl sulfoxide; mexidol; sodium deoxyribonucleate or a mixture of sodium deoxyribonucleate and blueberries; a mixture of sodium dersoxyribonucleate and lidocaine hydrochloride; 5-fluorouracil; interleukin-1 beta; urea a mixture of dimethyl
  • the proposed method eliminates the growth of microflora in the treatment hydrogel, avoiding large economic losses, allows delaying ⁇ -sterilization and does not allow the viscosity of the treatment hydrogel to drop during ⁇ -sterilization, provides the required period of prolongation of the drug.
  • hyaluronic acid and 5 g of sodium alginate are poured into a 150 ml water tank, pour 94 ml of distilled water and mix thoroughly, leave for 60 minutes. Then they are mixed and 5% by mass of ⁇ -aminocaproic acid is introduced, mixed, after which sorbic acid at a concentration of 0.12% by mass is added to the composition with constant stirring until a homogeneous consistency is obtained. Pack and carry out gamma sterilization in a dose of bcGy.
  • Example 10 1 g of hyaluronic acid and 5 g of sodium alginate are poured into a 150 ml water tank, pour 94 ml of distilled water and mix thoroughly, leave for 60 minutes. Then it is mixed and 0.3% by weight of Actovegin is introduced, mixed, After which sorbic acid is introduced into the composition with constant stirring at a concentration of 0.15% by mass, until a homogeneous consistency is obtained. Pack and carry out gamma sterilization in a dose of bcGy.
  • the proposed method allows the manufacturer to produce high-quality products without unjustified economic losses, increase the processability by increasing the storage time and the possibility of reducing the biodegradability of the gel until sterilization, maintain the necessary viscosity characteristics of the gel while achieving its sterility during sterilization, allows you to create hydrogels with a wide range of drugs without changes in the technological equipment of the production cycle.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Botany (AREA)
  • Biotechnology (AREA)
  • Insects & Arthropods (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Pain & Pain Management (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Animal Husbandry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne les industries médicale et pharmaceutique. Le procédé consiste à introduire dans une composition polymère de la série des polysaccharides une préparation médicinale, une stérilisation 6-15 kGr. La nouveauté consiste en ce que l'on introduit dans la composition polymérique contenant la préparation médicinale, en remuant constamment, de l'acide sorbique ou ses sels hydrosolubles, ou de l'acide benzoïque ou ses sels hydrosolubles, ou un mélange de ces sels, ou un antibiotique dans une concentration de 0,05-1,00 % en masse jusqu'à obtenir une consistance homogène. En outre, on propose d'utiliser en tant que composition polymérique un mélange d'alginate de sodium et d'acide hyaluronique ou d'hyaluronate de sodium, avec un rapport de composants de 5:1 ou un mélange d'alginate de sodium et de pectine avec un rapport de composants de 6:1 ou de l'alginate de sodium gonflé. La concentration de la préparation médicinale peut être appliqué dans une fourchette de 0,25 à 20 % en masse, et on utilise en tant que préparation médicinale un produit choisi parmi: acide ε-aminocapronique ou son mélange avec de l'hydrochlorure de lidocaïne, Actovegin, mélange de Mexidol, diméthylsulfoxyde, acétate d'hydrocortisone et Actovegin, propolis, orties, camomille ou mélange d'orties et de camomille, mélange d'orties, de camomille et d'acide -aminocapronique, métronidazol, diméthylsulfoxyde ou mélange de métronidazol et de diméthylsulfoxyde, Mexidol, désoxyribonucléate de sodium ou mélange de désoxyribonucléate de sodium et de myrtille, mélange de désoxyribonucléate de sodium et d'hydrochlorure de lidocaïne, 5-fluorouracile, interleukine-1 bêta, urée, mélange de diméthylsulfoxyde et d'acétate d'hydrocortisone, dioxydine.
PCT/RU2015/000206 2014-04-01 2015-03-31 Procédé de production d'un hydrogel médicinal WO2015152771A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
RU2014112519 2014-04-01
RU2014112519/15A RU2563232C1 (ru) 2014-04-01 2014-04-01 Способ получения лечебного гидрогеля

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WO2015152771A1 true WO2015152771A1 (fr) 2015-10-08

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WO (1) WO2015152771A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111773259A (zh) * 2020-08-07 2020-10-16 李伟泽 一种修复阴道黏膜损伤的植物药水凝胶制剂及其制备方法

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2653411C1 (ru) * 2017-07-27 2018-05-08 Общество с ограниченной ответственностью "КОЛЕТЕКС" Способ получения лечебного гидрогеля

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US5972326A (en) * 1995-04-18 1999-10-26 Galin; Miles A. Controlled release of pharmaceuticals in the anterior chamber of the eye
RU2209074C2 (ru) * 2001-08-29 2003-07-27 Общество с ограниченной ответственностью "Олимп" Состав для лечения ожогов
US20060222616A1 (en) * 2003-08-28 2006-10-05 Tadashi Yoneda Cosmetic composition comprising a and a lipopeptide
WO2006138518A1 (fr) * 2005-06-17 2006-12-28 Combinatorx, Incorporated Polytherapie destinee au traitement de troubles immuno-inflammatoires
WO2010105634A1 (fr) * 2009-03-17 2010-09-23 United Technologies Ut Ag Utilisation d'interleukine-1 bêta dans des compositions cosmétiques et ses procédés
RU2409371C1 (ru) * 2009-08-17 2011-01-20 Республиканское Унитарное производственное предприятие "Белмедпрепараты" Обезболивающее, гемостатическое и ранозаживляющее средство
CA2609754C (fr) * 2005-04-27 2012-01-10 Shenzhen Phlora Biotechnology Limited Compositions d'acide benzoique et de saccharides pour reguler et maintenir la flore bacterienne et l'acidite du vagin
RU2483755C1 (ru) * 2012-04-26 2013-06-10 Общество с ограниченной ответственностью "КОЛЕТЕКС" Салфетка для лечения ран

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US5972326A (en) * 1995-04-18 1999-10-26 Galin; Miles A. Controlled release of pharmaceuticals in the anterior chamber of the eye
RU2209074C2 (ru) * 2001-08-29 2003-07-27 Общество с ограниченной ответственностью "Олимп" Состав для лечения ожогов
US20060222616A1 (en) * 2003-08-28 2006-10-05 Tadashi Yoneda Cosmetic composition comprising a and a lipopeptide
CA2609754C (fr) * 2005-04-27 2012-01-10 Shenzhen Phlora Biotechnology Limited Compositions d'acide benzoique et de saccharides pour reguler et maintenir la flore bacterienne et l'acidite du vagin
WO2006138518A1 (fr) * 2005-06-17 2006-12-28 Combinatorx, Incorporated Polytherapie destinee au traitement de troubles immuno-inflammatoires
WO2010105634A1 (fr) * 2009-03-17 2010-09-23 United Technologies Ut Ag Utilisation d'interleukine-1 bêta dans des compositions cosmétiques et ses procédés
RU2409371C1 (ru) * 2009-08-17 2011-01-20 Республиканское Унитарное производственное предприятие "Белмедпрепараты" Обезболивающее, гемостатическое и ранозаживляющее средство
RU2483755C1 (ru) * 2012-04-26 2013-06-10 Общество с ограниченной ответственностью "КОЛЕТЕКС" Салфетка для лечения ран

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KOROVINA M.A.: "«Razrabotka metodologii i tekhnologii sozdaniia lechebnykh tekstilnykh i gidrogelevykh applikatsii dlia napravlennoi mestnoi dostavki lekarstv pri luchevoi terapii onkologicheskikh zabolevanii (teoriia i praktika)»", AVTOREFERAT DISSERTATSII NA SOISKANIE UCHENOI STEPENI DOKTORA TEKHNICHESKIKH NAUK, 2011, pages 4 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111773259A (zh) * 2020-08-07 2020-10-16 李伟泽 一种修复阴道黏膜损伤的植物药水凝胶制剂及其制备方法
CN111773259B (zh) * 2020-08-07 2021-08-31 李伟泽 一种修复阴道黏膜损伤的植物药水凝胶制剂及其制备方法

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