WO2004011032A1 - Preparation externe - Google Patents

Preparation externe Download PDF

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Publication number
WO2004011032A1
WO2004011032A1 PCT/JP2003/009446 JP0309446W WO2004011032A1 WO 2004011032 A1 WO2004011032 A1 WO 2004011032A1 JP 0309446 W JP0309446 W JP 0309446W WO 2004011032 A1 WO2004011032 A1 WO 2004011032A1
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WO
WIPO (PCT)
Prior art keywords
external preparation
preparation according
wound healing
disinfectant
pectin
Prior art date
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PCT/JP2003/009446
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English (en)
Japanese (ja)
Inventor
Takayuki Ishii
Katsunori Morishita
Tomoaki Takigawa
Toshiaki Sato
Original Assignee
Mikasa Seiyaku Co., Ltd.
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Application filed by Mikasa Seiyaku Co., Ltd. filed Critical Mikasa Seiyaku Co., Ltd.
Priority to JP2004524148A priority Critical patent/JP4712380B2/ja
Priority to AU2003252694A priority patent/AU2003252694A1/en
Publication of WO2004011032A1 publication Critical patent/WO2004011032A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • 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
    • 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
    • A61K31/13—Amines
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/473—Quinolines; Isoquinolines ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
    • 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
    • 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
    • A61K31/717—Celluloses
    • 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
    • A61K31/719—Pullulans
    • 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
    • A61K31/732—Pectin
    • 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
    • A61K31/734—Alginic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/16—Emollients or protectives, e.g. against radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P23/00—Anaesthetics
    • A61P23/02—Local anaesthetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/02—Nutrients, e.g. vitamins, minerals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10—Antimycotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents

Definitions

  • the present invention relates to an external preparation containing a medicinal ingredient generally known as an external preparation, which also exhibits an effective action of promoting wound healing when applied to a skin disease or the like accompanied by a wound.
  • the present invention relates to an external preparation obtained by blending a wound healing promoting component with an external preparation applied to a part, skin or mucous membrane.
  • skin moisturizing agents anti-inflammatory agents, anti-allergic agents, local anesthetics, vitamins, and other drugs are used for skin and mucosal diseases associated with wounds, but depending on the disease associated with wounds and mucosal damage. There were also many drugs that would benefit from the inclusion of a wound healing promoter.
  • Disinfectants and disinfectants are examples of negative effects on wound healing. Disinfectants and disinfectants are widely used for disinfecting and disinfecting wounds, skin and mucous membranes, or for preventing bacterial infection. When these disinfectants are applied to wounds, they show bactericidal and disinfecting effects, but delay wound healing (Kramer S A. J Vase Nurs 17, 17, 23–23, 1 999; E ffectofpovid on e-iocl in eon wo und healing: arevi ew), and disinfectants are known to have an adverse effect on wound healing.
  • wound healing promoters are used for treatment of pressure ulcers and skin ulcers, etc.If wounds are infected with bacteria, apply the wound healing promoter after disinfecting the wound with a disinfectant / disinfectant There is a need. Wound dressings are also suitable for wounds infected with bacteria. There are also problems such as inapplicability.
  • a preparation that simultaneously exerts a bactericidal / disinfecting action and a wound healing promoting action it is desirable to use a preparation that simultaneously exerts a bactericidal / disinfecting action and a wound healing promoting action. That is, the combination of a disinfectant and a wound healing promoter is considered to be very useful. However, not all combinations of disinfectants and wound healing promoters are acceptable. It goes without saying that a combination preparation of a bactericidal / disinfectant and a wound healing promoter is stable in terms of formulation, but it must be a formulation that simultaneously exerts bactericidal / disinfecting action and a wound healing promoting action.
  • Sucrose / povidonodo is used clinically as a formulation containing a disinfectant and a wound healing promoter.
  • bactericidal and disinfecting effects are observed, there are reports that healing is delayed despite the inclusion of sucrose as a component that promotes wound healing. It has not been.
  • urea preparations are an example where it is better to incorporate a wound healing promoter.
  • Urea preparations have been used as an active ingredient for external use on the skin because they have excellent effects on the skin, such as keratin water retention and keratolytic exfoliation.
  • urine is irritating to the skin and mucous membranes and cannot be applied to wounds. From these facts, there is a demand for a drug that can heal wounds quickly and accurately while having a water-retaining effect in the stratum corneum and that can be applied to sites with wounds.
  • An object of the present invention is to provide an external preparation having an excellent wound healing promoting action and an original pharmacological effect of an external preparation, and capable of efficiently treating a skin disease accompanied by a wound.
  • the present invention is an external preparation containing a medicinal component and a wound healing promoting component, wherein the wound healing promoting component comprises a wound healing promoting hydrophilic polymer.
  • the wound healing promoting effect and the original pharmacological effect of the external preparation can be sufficiently exhibited only by blending a wound healing promoting hydrophilic polymer with a conventionally used external preparation. It has the advantage of being able to be used in the original mode of use of the agent, and as a result, exhibits great effects in both production and use.
  • the wound healing-promoting hydrophilic polymer used in the present invention is preferably a polymer that exhibits a wound healing promoting effect of at least 20% in a rat defect wound test, and contains at least one or more of these.
  • the type and structure are not particularly limited as long as it is selected, but preferred wound healing promoting hydrophilic polymers include pectin, alginic acid, carboxymethylcellulose, gum arabic, and pullulan. ⁇ ⁇ ⁇ Kuching, alginic acid and carboxymethylcellulose also include their salts.
  • pectin which can be used in the present invention pectin of natural origin, its partial hydrolyzate and physiologically acceptable salts thereof are used.
  • the physiologically acceptable salt is not particularly limited as long as it is physiologically acceptable.
  • the molecular weight of these pectins is from about 30,000 to about 800,000, preferably from about 30,000 to about 750,000, more preferably about 60,000. 0 to about 600,000, particularly preferably about 200,000 to about 500,000.
  • the origin of Pectin is not particularly limited.
  • the molecular weight means the molecular weight of the main peak measured by gel filtration (TSK-ge LG 400 PW).
  • Pectin has a degree of esterification of 20% or more, preferably 30 to 80%.
  • the ester is preferably a methyl ester, but may be another ester such as a C 2 -C 6 alkyl ester.
  • the carboxymethylcellulose that can be used in the present invention is not particularly limited.
  • Carboxymethylcellulose having a degree of oxidation of 0.4 to 2.0, preferably 0.6 to 1.2, and most preferably 0.65 to 1.0, or a salt thereof is usually used.
  • the viscosity of the 1% solution is 5 to 3,000 OmPas, preferably 10 to 2, OOOmPas, most preferably 30 to 1,500 mPa's. s is usually used.
  • alginic acid that can be used in the present invention alginic acid, its derivatives and physiologically acceptable salts thereof are used.
  • the physiologically acceptable salt is not particularly limited as long as it is physiologically acceptable. Examples of the alginic acid derivative include propylene glycol alginate.
  • Pharmaceutical ingredients that can be used in the present invention are medically acceptable, and include one or more components that are expected to exhibit a medicinal effect when applied to a wound, skin or mucous membrane, and are classified into those types.
  • typical examples thereof include generally widely used bactericides, disinfectants, skin moisturizers, anti-inflammatory agents, anti-allergic agents, local anesthetics, vitamins and the like.
  • the germicidal disinfectant that can be used in the present invention is not particularly limited as long as it contains at least one bactericidal / disinfecting agent.
  • Suitable germicidal / disinfecting agents include povidone and podholm, Iodine and iodine complexes such as iodine tincture and resorcinol, benzalkonium chloride, benzethonium chloride, decalinium chloride, cetylpyridinium chloride, cresyl soap, and other disinfecting stone compounds, silver and mercury compounds, erythromycin, gentamicin, Examples include antibiotics such as kanamycin, antifungals, acrinol, chlorhexidine dalconate, and the like.
  • Examples of the skin moisturizing agent which can be used in the present invention include polyhydric alcohols such as glycerin, propylene glycol, 1,3-butylene glycol, polyethylene glycol, dipropylene glycol, xylitol, sorbitol, free amino acids, urea, Natural moisturizing factors such as lactic acid and citrate, heparin-like substances, collagen, elastin, chondroitin sulfate, dermatan sulfate, fibronectin, hyaluronic acid, ceramide, chitosan, and hydantoin (Japanese Patent Application Laid-Open No. 9-2788645) And the like, but are not limited thereto.
  • polyhydric alcohols such as glycerin, propylene glycol, 1,3-butylene glycol, polyethylene glycol, dipropylene glycol, xylitol, sorbitol, free amino acids, urea
  • Anti-inflammatory agents that can be used in the present invention include, for example, azulene, aminoethyl benzoate, ibuprofen, indomethacin, glycyrrhizic acid, glycyrrhetinic acid, 7-lantoin, copper chlorophyllin, ketoprofen, methyl salicylate, salicylate glycol ester, diclofenac, suprofen, naproxen
  • Non-steroidal anti-inflammatory drugs or their salts including coX2 selective inhibitors such as piroxicam, felbinac, bufexamac, flurbiprofen, and meloxicam, celecoxib, oral fuecoxib, or salts thereof, alclomethasone, clobesol, Vesuvone, diflucortron, difluprednate, diflorazone, dexamethasone, deprodone, triamcinolone aceton
  • anti-allergic agent examples include diphenhydramine, carpinoxamine, dimenhydrinate, diphenirubiralin, clemastine, pyrilamine, triberenamine, chlorpheniramine, triprolysin, dimethindene, promethazine, alimimazine, isothidyl.
  • Antihistamines or their salts such as hydroxyzine, meclizine, homochlorcyclidine, cyprohepdin, or salts thereof, mexidin, terfenadine, epinastine, astemizole, ebastine, cetirizine, oral ratadine, cromoglycic acid, tranilast, ketotifen, azelastine , Oxatomide, Amlexanox, Repirinast, Ibudilast, Emilo last, Tazanolast, Ozadarrell, Splatast, Seratrodast Emadasu Chin, pranlukast, antiallergics or a salt such as crotamiton, Shikurosu porins, evening Kurorimusu, but we include an immunosuppressant drug or a salt thereof is one bets like methotrexate, but not limited to. These may be used alone or as a mixture of two or more.
  • Examples of the local anesthetic which can be used in the present invention include, for example, procarin, oxybuprocaine, ethyl amino benzoate, piberidyl acetylaminoethyl benzoate, cocaine, tetracaine, lidocaine, terikin, propitin Power In, Hexochikai , Dimethisoquine, promoxine, benzocaine, benzyl alcohol, catalysin, paletoxicaine, pyro-in, pro-inamide, propara-in, oral oxyn-in, hexylcaine, metabutemin, methtaboxin, pyridoxine, jib Power in, bupipa power in, mepiva power in, oxesazein, and salts thereof, but are not limited thereto. These may be used alone or as a mixture of two or more.
  • vitamin preparations examples include vitamin A, vitamin B group, bimin (:, vitamin D, vitamin E, vitamin K, vitamin ⁇ , nicotinic acid, pantothenic acid, folic acid, and derivatives thereof, and the like. However, these are not limited thereto, and they may be used alone or in combination of two or more.
  • the mixing ratio of the two components used in the present invention is selected within a range sufficient to exhibit the respective effects, but the wound healing-promoting hydrophilic polymer is preferably 0.01 to 60% by weight, More preferably, it is used in an amount of 3 to 30% by weight.
  • the external preparation of the present invention is not particularly limited in other optional components, dosage forms, and the like as long as it contains the above-mentioned components.
  • the external preparation of the present invention exhibits an excellent wound healing promoting effect without impairing the performance as an original external preparation.
  • Examples of the dosage form of the external preparation of the present invention include semisolid preparations such as ointments, creams, and gels, powder preparations, granules, sticks, sheets (including films), and suppositories. And liquid preparations such as aqueous solutions, suspensions, lotions and emulsions. In addition, these can be used as sprays if necessary. Further, as a patch, a patch, a plaster, a patch and the like can be mentioned, and an ointment, a cream, a gel, a stick, a sheet (including a film), and a cataplasm are preferable.
  • the application site of the external preparation of the present invention is not limited by the application range of the existing external preparation such as skin and mucous membrane. That is, depending on the type of existing topical preparation, it can be used for whole body skin and mucous membrane.
  • various components acceptable in the production of pharmaceuticals that is, aqueous components, oil components, water-soluble polymers, oil-soluble polymers, and oxidized components, as long as the effects of the present invention are not impaired.
  • Inhibitor, surfactant, freshener, buffer, ⁇ A stabilizer, antibacterial and preservative, etc. can be appropriately compounded.
  • aqueous component examples include lower alcohols such as ethanol, propyl alcohol and isopropyl alcohol; polyhydric alcohols such as glycerin and sorbitol; dalicols such as ethylene glycol, propylene glycol, butylene glycol, and polyethylene glycol; sucrose; Examples include sugars such as lactose, maltose, mannitol, erythritol, and xylitol, sugar alcohols, and purified water.
  • lower alcohols such as ethanol, propyl alcohol and isopropyl alcohol
  • polyhydric alcohols such as glycerin and sorbitol
  • dalicols such as ethylene glycol, propylene glycol, butylene glycol, and polyethylene glycol
  • sucrose examples include sugars such as lactose, maltose, mannitol, erythritol, and xylitol, sugar alcohols, and purified water.
  • oils component examples include saturated hydrocarbons such as white petrolatum and liquid paraffin, waxes such as salami beeswax and carnauba wax, oils and fats such as soybean oil and hard fat, stearyl alcohol, oleyl alcohol, and higher alcohols such as cholesterol.
  • saturated hydrocarbons such as white petrolatum and liquid paraffin
  • waxes such as salami beeswax and carnauba wax
  • oils and fats such as soybean oil and hard fat
  • fatty acids such as coals, isopropyl adipate, isopropyl sebacate, octyldodecyl myristate, and cetyl lactate
  • fatty acids such as palmitic acid, stearic acid, and oleic acid
  • silicone oils such as methylpolysiloxane.
  • water-soluble polymers examples include plant polymers such as guar gum, karaya gum, carrageenan, agar, starch, tragacanth gum, and oral cast bean gum; microbial polymers such as xansu gum, dextran, collagen, casein, and gelatin.
  • Alginic acid polymers such as methylcellulose, methylcellulose, methylhydroxypropylcellulose, nitrocellulose, sodium cellulose sulfate, cellulosic polymers such as crystal cell mouth, polyvinyl methyl ether, Polymer, polyoxyethylene-based polymer, polyacrylic acid-based polymer, polyvinyl alcohol, polyvinylpyrrolidone, and the like.
  • oil-soluble polymer examples include an acrylic acid / alkyl methacrylate copolymer.
  • surfactant examples include sorbitan monolaurate, sorbitan sesquioleate, sorbitan trioleate, polyoxyethylene sorbitan monolaurate, polyethylene glycol monoolate, polyoxyethylene alkyl ester, polyglycol ester, and lauroyl ester Evening amide, fatty acid isopropanolamide, maltitol hydroxyaliphatic ether, alkylated poly Nonionic surfactants such as sugars, alkyl darcosides, sugar esters, etc., cationic surfactants such as stearyl trimethylammonium chloride, lauryl amine oxide, sodium palmitate, sodium laurate, potassium lauryl sulfate, alkyl Examples thereof include anionic surfactants such as triethanolamine sulfate, linear dodecylbenzene sulfate, polyoxyethylene hydrogenated castor oil, maleic acid, and acylmethyltaurine, and naturally-derived surfactants such as lecithin
  • antioxidants examples include tocopherol, ascorbic acid, erythorbic acid, propyl gallate, BHT (dibutylhydroxytoluene), and BHA (butylhydroxyanisole).
  • cooling agent examples include menthol and camphor.
  • the buffer for example, disodium hydrogen phosphate-monocitrate, dihydrogen phosphate-disodium hydrogen phosphate, disodium citrate-disodium hydrogen phosphate and the like can be mentioned.
  • Examples of the pH regulator include organic acids such as citric acid, acetic acid, malic acid, lactic acid, and tartaric acid, and metal salts thereof, amine salts such as monoethanolamine, jetanolamine, and triethanolamine, phosphoric acid, Inorganic acids such as boric acid and hydrochloric acid; metal salts thereof; hydroxide salts such as sodium hydroxide and potassium hydroxide; and carbonate salts such as sodium carbonate.
  • Antibacterial and preservatives include, for example, benzoate, salicylate, sorbate, dehydroacetate, paraoxybenzoate, 2,4,4'-trichloro-2'-hydroxydiphenyl ether, benzalkonium chloride , Ethanol and the like.
  • Table 1 shows the results of the gel (Meiji Seika Co., Ltd.). As is evident from the results, the combination of ⁇ -kutin and povidonodo (Formulation No. 4) showed a clearly stronger wound healing promoting effect than the povidone-doped formulation (Formulation No. 2) or the comparative drug.
  • the pectin used in these cases was a pectin having a molecular weight of about 300,000 and a degree of (methyl) esterification of 74%, unless otherwise specified.
  • test drug was prepared based on macrogol.
  • a negative value for the wound healing promoting effect indicates that healing is delayed compared to the control.
  • Table 2 shows the results of the test drug prepared by dissolving (suspending) in water and Isodin (trademark) liquid (Meiji Seika Co., Ltd.), which is a comparative drug.
  • the combination of Pectin and Povidonide (Formulation No. 8) showed a clearly stronger wound healing promoting effect than the Povidonold formulation (Formulation No. 6) or the comparative drug.
  • the test drug was prepared by dissolving (suspending) it in water.
  • Table 3 shows the results of the test drug prepared using white petrolatum as a base and the comparative drug Elis Mouth Shin TM Ointment (Dainippon Pharmaceutical Co., Ltd.). Erythromycin formulation (Formulation No. 10) 'and the comparative drug delayed wound healing. In contrast, a combination of Pectin and erythromycin (Formulation No. 12) clearly showed a strong wound healing promoting effect.
  • Table 3 shows the results of the test drug prepared using white petrolatum as a base and the comparative drug Elis Mouth Shin TM Ointment (Dainippon Pharmaceutical Co., Ltd.).
  • the test drug was prepared based on white petrolatum.
  • a negative value for the wound healing promoting effect indicates that healing is delayed compared to the control.
  • Table 4 shows the results of the test drug and the comparative drug Hibitene (trademark) gel (Sumitomo Pharmaceutical Co., Ltd. ⁇ AstraZeneca Co., Ltd.), which were prepared using the ⁇ / W emulsion base. Chlorhexidine gluconate (Formulation No. 14) and a comparative drug delayed wound healing. In contrast, a combination of pectin and chlorhexidine dalconate (Formulation No. 16) clearly showed a strong wound healing promoting effect.
  • test drug was prepared based on an O-type emulsion base.
  • a negative value for the wound healing promoting effect indicates that healing is delayed compared to the control.
  • Table 5 shows the results of the test drugs prepared based on white P-serine. As is evident from the results, even with the combination of sodium alginate, carboxymethylcellulose mono-Na or pullulan and povidonodo (formulation no. It showed a healing promoting effect. NNNNNN
  • test drug was prepared based on a 0 ZW type emulsion base.
  • S taphylococcusepide rm idis cell suspension (10 6 cells / mL) Add 4.5 g or 4.5 mL of each test preparation to 10 OmL, and immediately shake at 37 ° C and 100 rpm to obtain the sample solution. And After 10 minutes and 20 minutes from the start of shaking, 0.2 mL of 0.1 mo 17L thiosulfate Na solution was added to inactivate povidone, and the cells were cultured at 37 ° C for 48 hours. As a control, 4.5 mL of sterilized physiological saline was added to 10 OmL of a 10 6 cells // mL bacterial suspension, and the test was carried out in the same manner as for each preparation.
  • Isodine TM gel (Meiji Seika Co., Ltd.) and Isodine TM liquid (Meiji Seika Co., Ltd.), which are comparative drugs, exhibited antibacterial activity.
  • antibacterial activity was also observed with the combination of Pectin and Povidonol (Formulation Nos. 4 and 25). This And showed antibacterial activity even when mixed with Pectin.
  • Example 3 Examining the molecular weight of Pectin and its effect on promoting wound healing
  • the molecular weight indicates the molecular weight of the main peak measured by gel filtration.
  • a partial hydrolyzate of pectin was prepared by treating pectin (molecular weight about 300,000, esterification degree 74%) with pectinase.
  • the molecular weight is T
  • the molecular weight of the main peak was determined using a standard sample (Standard P-82, Showa Denko).
  • Wound healing promoting action was observed from a peak molecular weight of about 3,000 to about 300,000. As the peak molecular weight increased, the wound healing promoting effect became stronger, and a peak molecular weight of 200,000 or more ( Formulation Nos. 26 and 27) were found to have a strong wound healing promoting effect.
  • Example 4 Examination of the degree of esterification of pectin and the effect of promoting wound healing
  • the molecular weights of Pectin A are about 300,000, and that of Pectin B and Vectin C are about 250,000.
  • Table 8 shows the results of the wound healing promoting effect of pectins having different degrees of esterification. Vectin with a degree of esterification of 31 to 74% exhibited a wound healing promoting effect. On the other hand, no effect of promoting wound healing was observed with pectic acid having a degree of esterification of 0%.
  • Example 5 Guinea pig rough skin improvement test
  • a rough skin model was prepared according to the method of Sagi V et al. (Skin Res Tecno 6; 372000). However, for the purpose of the present invention, it was necessary to prepare a more severe rough skin model, so that the concentration of the surfactant for causing rough skin, i.e., sodium lauryl sulfate, was increased, and the Hartley guinea pig was used as a severe rough skin model. After shaving the back coat, a 2.5 cm X 2.5 cm cloth immersed in 5% aqueous sodium lauryl sulfate solution was applied once a day for 5 minutes for 3 consecutive days. Skin roughness was produced.
  • TEWL transdermal water loss
  • Skin roughness improvement promotion effect (%) X 100 Average value of control group No.
  • a skin external ointment having the composition shown in Table 9 was prepared in a mortar using white ⁇ -serine as a base, and the effects of promoting wound healing and improving skin roughness were examined. Unless otherwise specified, the blending amount is shown in% by weight.
  • the preparations containing Pectin (Formulation Nos. 35 and 36) showed an extremely high wound healing promoting effect as compared with Comparative Preparations 1 and 2 containing no Pectin.
  • a preparation containing urea (Formulation No. 35, Comparative Preparation 2) was found to have an effect of improving skin roughness. That is, it was clarified that the preparation containing urea and pectin (formulation No. 35) had an effect of promoting wound healing and an effect of improving skin roughness.
  • the preparation containing Pectin (Formulation Nos. 37 and 38) showed an extremely high wound healing promoting effect as compared with Comparative Preparations 3 and 4 containing no Pectin.
  • the preparations containing urea (Formulation No. 37, Comparative Preparation 4) were found to have an effect of improving skin roughness.
  • a preparation containing urea and pectin (Formulation No. 37) had an effect of promoting wound healing and improving skin roughness.
  • the preparations containing Pectin showed an extremely high wound healing promoting effect as compared with the comparative preparations 5 and 6 containing no Pectin.
  • Formulations containing urea were found to have an effect of improving skin roughness.
  • a preparation containing urea and pectin had an effect of promoting wound healing and an effect of improving skin roughness.

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Abstract

L'invention concerne une préparation externe renfermant un composé de médicament et un composé favorisant la guérison de blessure, un polymère hydrophile tel que la pectine étant utilisé comme composé favorisant la guérison de blessures, de manière à permettre un traitement efficace d'une maladie cutanée avec blessure.
PCT/JP2003/009446 2002-07-26 2003-07-25 Preparation externe WO2004011032A1 (fr)

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WO2006109734A1 (fr) * 2005-04-08 2006-10-19 Mie University Agent externe pour traiter des plaies
EP1803464A1 (fr) * 2004-09-17 2007-07-04 CellGenTech, Inc. Preparation externe pour le traitement des ulceres cutanes
WO2007119486A1 (fr) * 2006-03-22 2007-10-25 Cellgentech, Inc. Composition liquide pour application externe et préparation pour application externe pour le traitement d'ulcère cutané
JP2008505680A (ja) * 2004-07-08 2008-02-28 オールトレイセル・ディベロップメント・サービシズ・リミテッド 皮膚の創傷の出血を制御するための送達システム
JP2008513467A (ja) * 2004-09-17 2008-05-01 デュレクト コーポレーション 制御されたデリバリーシステム
JP2009179571A (ja) * 2008-01-29 2009-08-13 Cellgentech Inc Ｇ−ｃｓｆの外用での創傷治療効果の増強剤
JP2010100606A (ja) * 2008-09-25 2010-05-06 Ai System Product:Kk 塗薬
US8956644B2 (en) 2006-11-03 2015-02-17 Durect Corporation Transdermal delivery systems
JP2015516189A (ja) * 2012-03-21 2015-06-11 フォンダツィオーネ・イスティトゥート・イタリアーノ・ディ・テクノロジャＦｏｎｄａｚｉｏｎｅ Ｉｓｔｉｔｕｔｏ Ｉｔａｌｉａｎｏ Ｄｉ Ｔｅｃｎｏｌｏｇｉａ 抗菌性および生分解性特性を有する重合体複合材料およびその使用
FR3023166A1 (fr) * 2014-07-07 2016-01-08 Rivadis Sas Lab Utilisation d'une composition pharmaceutique renfermant une pectine a titre de principe actif, dans la prevention et/ou le traitement des lesions cutanees impliquant un caractere inflammatoire
JP2017501227A (ja) * 2013-12-19 2017-01-12 エヴォフェム，インク． アルギン酸をベースとする抗菌性化合物を使用して炎症と疾患を阻害するための組成物及び方法
CN108742718A (zh) * 2018-03-23 2018-11-06 苏州德锐特成像技术有限公司 一种可快速溶胀的自粘附微针贴片及其制备方法
US10471001B2 (en) 2002-06-25 2019-11-12 Durect Corporation Short duration depot formulations
US11083796B2 (en) 2005-07-26 2021-08-10 Durect Corporation Peroxide removal from drug delivery vehicle
US11400019B2 (en) 2020-01-13 2022-08-02 Durect Corporation Sustained release drug delivery systems with reduced impurities and related methods
US11419835B2 (en) 2016-10-04 2022-08-23 Evofem, Inc. Method of treatment and prevention of bacterial vaginosis
US11439610B2 (en) 2012-06-13 2022-09-13 Evofem, Inc. Compositions and methods for enhancing the efficacy of contraceptive microbicides

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JPH06508641A (ja) * 1992-04-10 1994-09-29 フセソユズニ　ナウチノ−イススレドバテルスキ　インスティテュト　メディツィンスキフ　ポリメロフ 医薬組成物
EP0567311A2 (fr) * 1992-04-22 1993-10-27 E.R. Squibb & Sons, Inc. Gel hydrocolloidal applicable sur les plaies
JPH0698932A (ja) * 1992-09-18 1994-04-12 Arukea Kk 皮膚保護材組成物
JPH06145060A (ja) * 1992-11-10 1994-05-24 Nippon B X I Kk 創傷被覆材用組成物
EP0689841A1 (fr) * 1994-06-27 1996-01-03 Kowa Company, Ltd. Préparation en poudre pour la guérison de peau blessée
JPH0940563A (ja) * 1995-07-28 1997-02-10 Nippon Kayaku Co Ltd 褥瘡・皮膚潰瘍治療組成物
JPH09169655A (ja) * 1995-12-21 1997-06-30 Iwaki Seiyaku Kk 皮膚潰瘍用外用散剤
WO1997046246A1 (fr) * 1996-06-05 1997-12-11 Tomifarm S.R.L. Preparations complexes caracterisees par une teneur en betaine
JPH10236949A (ja) * 1997-02-27 1998-09-08 Unie Colloid Kk 経皮吸収性薬剤被覆膜
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JPH10338638A (ja) * 1997-06-05 1998-12-22 Toa Yakuhin Kk 損傷皮膚修復用製剤
JPH1149672A (ja) * 1997-08-07 1999-02-23 Sato Seiyaku Kk 創傷治療用外用剤
EP0963757A2 (fr) * 1998-05-15 1999-12-15 Hogy Medical Co., Ltd. Agent hémostatique
EP1057481A1 (fr) * 1998-11-18 2000-12-06 Medical Industries Corporation Agents utiles pour reparer des sites tissulaires endommages
JP2001097848A (ja) * 1999-09-30 2001-04-10 Kobayashi Pharmaceut Co Ltd 外用剤組成物
JP2002226378A (ja) * 2001-01-30 2002-08-14 Mikasa Seiyaku Co Ltd 再上皮化促進剤
JP2002226373A (ja) * 2001-01-31 2002-08-14 Mikasa Seiyaku Co Ltd 褥瘡・皮膚潰瘍および創傷治療用製剤
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US10471001B2 (en) 2002-06-25 2019-11-12 Durect Corporation Short duration depot formulations
JP2008505680A (ja) * 2004-07-08 2008-02-28 オールトレイセル・ディベロップメント・サービシズ・リミテッド 皮膚の創傷の出血を制御するための送達システム
EP1803464A4 (fr) * 2004-09-17 2009-09-09 Cellgentech Inc Preparation externe pour le traitement des ulceres cutanes
JP2009073839A (ja) * 2004-09-17 2009-04-09 Durect Corp 制御されたデリバリーシステム
JP2008513467A (ja) * 2004-09-17 2008-05-01 デュレクト コーポレーション 制御されたデリバリーシステム
US8153149B2 (en) 2004-09-17 2012-04-10 Durect Corporation Controlled delivery system
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US8846072B2 (en) 2004-09-17 2014-09-30 Durect Corporation Controlled delivery system
EP1803464A1 (fr) * 2004-09-17 2007-07-04 CellGenTech, Inc. Preparation externe pour le traitement des ulceres cutanes
WO2006109734A1 (fr) * 2005-04-08 2006-10-19 Mie University Agent externe pour traiter des plaies
US11083796B2 (en) 2005-07-26 2021-08-10 Durect Corporation Peroxide removal from drug delivery vehicle
JPWO2007119486A1 (ja) * 2006-03-22 2009-08-27 セルジェンテック株式会社 皮膚潰瘍治療のための外用液状組成物および外用製剤
WO2007119486A1 (fr) * 2006-03-22 2007-10-25 Cellgentech, Inc. Composition liquide pour application externe et préparation pour application externe pour le traitement d'ulcère cutané
US8956644B2 (en) 2006-11-03 2015-02-17 Durect Corporation Transdermal delivery systems
JP2009179571A (ja) * 2008-01-29 2009-08-13 Cellgentech Inc Ｇ−ｃｓｆの外用での創傷治療効果の増強剤
JP2010100606A (ja) * 2008-09-25 2010-05-06 Ai System Product:Kk 塗薬
JP2015516189A (ja) * 2012-03-21 2015-06-11 フォンダツィオーネ・イスティトゥート・イタリアーノ・ディ・テクノロジャＦｏｎｄａｚｉｏｎｅ Ｉｓｔｉｔｕｔｏ Ｉｔａｌｉａｎｏ Ｄｉ Ｔｅｃｎｏｌｏｇｉａ 抗菌性および生分解性特性を有する重合体複合材料およびその使用
US11439610B2 (en) 2012-06-13 2022-09-13 Evofem, Inc. Compositions and methods for enhancing the efficacy of contraceptive microbicides
JP2017501227A (ja) * 2013-12-19 2017-01-12 エヴォフェム，インク． アルギン酸をベースとする抗菌性化合物を使用して炎症と疾患を阻害するための組成物及び方法
JP2020125298A (ja) * 2013-12-19 2020-08-20 エヴォフェム，インク． アルギン酸をベースとする抗菌性化合物を使用して炎症と疾患を阻害するための組成物及び方法
US11337989B2 (en) 2013-12-19 2022-05-24 Evofem, Inc. Compositions and methods for inhibiting inflammation and diseases using an alginic acid-based antimicrobial compound
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US11419835B2 (en) 2016-10-04 2022-08-23 Evofem, Inc. Method of treatment and prevention of bacterial vaginosis
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CN108742718A (zh) * 2018-03-23 2018-11-06 苏州德锐特成像技术有限公司 一种可快速溶胀的自粘附微针贴片及其制备方法
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