WO2005058878A1 - Agent de prevention et/ou agent de traitement de la dysmenorrhee - Google Patents

Agent de prevention et/ou agent de traitement de la dysmenorrhee Download PDF

Info

Publication number
WO2005058878A1
WO2005058878A1 PCT/JP2004/018714 JP2004018714W WO2005058878A1 WO 2005058878 A1 WO2005058878 A1 WO 2005058878A1 JP 2004018714 W JP2004018714 W JP 2004018714W WO 2005058878 A1 WO2005058878 A1 WO 2005058878A1
Authority
WO
WIPO (PCT)
Prior art keywords
dysmenorrhea
symptoms
therapeutic agent
pranlukast hydrate
prophylactic
Prior art date
Application number
PCT/JP2004/018714
Other languages
English (en)
Japanese (ja)
Inventor
Kenzo Nakao
Ken Mizushima
Hajime Yamamotoya
Toshio Takakuwa
Original Assignee
Ono Pharmaceutical Co., Ltd.
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 Ono Pharmaceutical Co., Ltd. filed Critical Ono Pharmaceutical Co., Ltd.
Priority to JP2005516318A priority Critical patent/JPWO2005058878A1/ja
Publication of WO2005058878A1 publication Critical patent/WO2005058878A1/fr

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D405/00—Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom
    • C07D405/02—Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom containing two hetero rings
    • C07D405/04—Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom containing two hetero rings directly linked by a ring-member-to-ring-member bond
    • 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
    • A61K31/41—Heterocyclic 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12—Antidiarrhoeals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system

Definitions

  • the present invention relates to a preventive and / or therapeutic agent for dysmenorrhea, comprising pranlukast hydrate as an active ingredient.
  • Dysmenorrhea is a pathological condition that accompanies menstruation before the onset of menstruation and that accompanies menstruation, and mainly includes pain (for example, menstrual pain, lower abdominal pain, back pain, etc.). This is a syndrome that appears as a symptom.
  • lower abdominal symptoms eg, lower abdominal tension, lower abdominal discomfort, etc.
  • lower back symptoms eg, lower back malaise, etc.
  • digestive symptoms eg, Stomach pain, nausea, vomiting, diarrhea, anorexia, loss of appetite, etc.
  • vascular neurological symptoms eg, headache, heavy headache, cold sweat, palpitations, etc.
  • mental symptoms eg, frustration, irritability, depression, etc.
  • Symptoms such as general symptoms (eg, general malaise, fatigue), dizziness, nausea, flushing of the face, sweating or increased salivary secretion are also observed.
  • Dysmenorrhea is a frequent gynecological disease, and the number of dysmenorrhea patients is on the rise at present.
  • Dysmenorrhea is classified into two types: organic (secondary) dysmenorrhea and functional (primary) dysmenorrhea.
  • Organic dysmenorrhea is dysmenorrhea in which an organic lesion causing pain is present in the pelvic cavity.
  • functional dysmenorrhea has no organic lesions, and many etiologies such as theories of endocrine ataxia, dysgenesis, and neurological factors have been advocated, but the cause is still unknown. is there.
  • dysmenorrhea is mainly caused by pain
  • nonsteroidal anti-inflammatory drugs are mainly used to relieve analgesia.
  • NSAIDs have side effects such as gastrointestinal disorders, patient compliance is poor and long-term administration is difficult.
  • many patients do not have sufficient analgesic effects with the use of NSAIDs. Therefore, development of a preventive / therapeutic agent for dysmenorrhea (particularly functional dysmenorrhea) which is excellent in efficacy and safety and can be administered for a long period of time has been eagerly desired.
  • Patent Document 1 JP 2002-187855 A
  • An object of the present invention is to provide a prophylactic and / or therapeutic agent for dysmenorrhea (particularly functional dysmenorrhea) which is excellent in efficacy and safety and can be administered to a patient for a long period of time.
  • a preventive and / or therapeutic agent for dysmenorrhea comprising plannorecast hydrate as an active ingredient
  • the dysmenorrhea is at least one selected from pain, lower abdominal symptoms, lumbar symptoms, gastrointestinal symptoms, vascular nerve symptoms, psychiatric symptoms, systemic symptoms, dizziness, nausea, hot flush, sweating, and increased salivation.
  • the prophylactic and / or therapeutic agent or the therapeutic agent according to the above (1) which is accompanied by the above-mentioned symptoms and ameliorates at least one of the symptoms.
  • the daily dosage of pranlukast hydrate for a patient is 450 mg, and 2 capsules containing 112.5 mg of pranlukast hydrate should be administered twice a day, two capsules at a time.
  • (11) a method for preventing and / or treating dysmenorrhea in a mammal, which comprises administering an effective amount of pranlukast hydrate to the mammal,
  • the present invention provides a safe and more effective agent for preventing and / or treating dysmenorrhea, and can prevent and / or treat various symptoms of dysmenorrhea.
  • Prevention and / or treatment of dysmenorrhea includes suppression, alleviation, mild Includes reduction or improvement.
  • the “dysmenorrhea” in the present invention includes organic dysmenorrhea and functional dysmenorrhea.
  • Plannorecast hydrate which is the active ingredient of the present invention, has the formula (A)
  • Production of pranlukast hydrate can be carried out, for example, according to the method described in JP-A-61-050977.
  • the toxicity of pranlukast hydrate was extremely low, confirming that it is safe enough for use as a pharmaceutical.
  • the minimum lethal dose was 2000 mg / kg or more when administered orally or subcutaneously to mice or rats (both male and female).
  • Pranlukast hydrate is a symptom of dysmenorrhea pain (eg, menstrual pain, lower abdominal pain, lower back pain, etc.), lower abdominal symptoms (eg, lower abdominal tension, lower abdominal discomfort, etc.), lower back symptoms ( For example, lumbar fatigue, gastrointestinal symptoms (eg, stomach pain, nausea, vomiting, diarrhea, loss of appetite, loss of appetite, etc.), vascular nerve symptoms (eg, headache, severe headache, cold sweat, increased palpitation, etc.), mental disorders It can prevent and / or treat symptoms (eg, frustration, irritability, depression, etc.), systemic symptoms (eg, general malaise, easy fatigue, etc.), dizziness, nausea, hot flush, sweating, increased salivation, and the like.
  • symptoms eg, frustration, irritability, depression, etc.
  • systemic symptoms eg, general malaise, easy fatigue, etc.
  • dizziness nausea, hot flush, sweating, increased salivation, and the like.
  • hydrates is useful as a treatment for various symptoms of dysmenorrhea and may also be useful as a root treatment for dysmenorrhea.
  • a medicament containing pranlukast hydrate as an active ingredient can be used systemically or locally.
  • the dose of pranlukast hydrate varies depending on age, body weight, symptom, therapeutic effect, administration method or treatment time, but may be individually and specifically administered so as to obtain the desired effect of the present invention.
  • the daily dose of a human patient is preferably about 25 mg to about 25 OO mg, more preferably 112.5 mg strength, about 450 mg, more preferably about 225 mg strength, and even more preferably about 225 mg strength, 450 mg strength.
  • oral administration either oral administration or parenteral administration is preferably used, but oral administration is more preferred.
  • the daily dose per patient may be less than or greater than the above range.
  • pranlukast hydrate When pranlukast hydrate is produced as the above-mentioned medicament, it can be made into a formulation known per se.
  • the preparation can be a solid preparation or liquid for oral administration, or an injection, an external preparation, a suppository or an inhalant for parenteral administration.
  • Examples of the solid preparation for oral administration for oral administration include tablets, pills, capsules, powders, and granules.
  • plannorecast hydrate is mixed or granulated with force as it is (e.g., stirring granulation method, fluidized bed granulation method, dry granulation method, tumbling stirring fluidization).
  • Layer granulation method, etc. and manufactured according to a conventional method (for example, capsule filling for capsules, tableting for tablets, etc.).
  • the above additives may be used alone or in combination of two or more.
  • additives include excipients (eg, ratatose, mannitol, darcos, microcrystalline cellulose, corn starch, etc.), binders (eg, hydroxypropyl cellulose, polybutylpyrrolidone, magnesium aluminate metasilicate, etc.), Dispersant (example For example, corn starch and the like), disintegrants (for example, calcium cellulose glycolate), lubricants (for example, magnesium stearate), stabilizers, dissolution aids (for example, daltamic acid, aspartic acid, etc.), Water-soluble polymers [for example, celluloses (for example, hydroxypropinoresenorelose, hydroxypropinolemethinoresenorelose, methinoresenorelose, etc.), synthetic polymers (for example, polyethylene glycol, polyvinylinolepyrrolidone, polybutyla) Or sweeteners (eg, sucrose, powdered sugar, sucrose, fructose,
  • Reduced maltose water powdered reduced maltose water, glucose fructose liquid sugar, fructose dextrose liquid sugar, honey, sonorebitone, manoletitone, mannitore, xylitotone, erythritone, aspartame, saccharin, saccharin sodium and the like.
  • the granules or tablets may be coated with a coating agent (eg, sucrose, gelatin, hydroxypropylcellulose, hydroxypropylmethylcellulose phthalate, etc.) if necessary, or the coating may be made up of two or more layers. There may be.
  • the above excipients are appropriately selected, uniformly mixed with plannorecast hydrate, or in the form of granules, or in the form of granules coated with an appropriate coating agent.
  • May be filled into a forceps capsule, or glycerin, sorbitol, or the like may be added to a suitable capsule base (eg, gelatin) to form an encapsulation with a plastic base having increased plasticity.
  • a suitable capsule base eg, gelatin
  • coloring agents or preservatives sulfur dioxide, parabens (methyl paraoxybenzoate, ethyl ethyl paraoxybenzoate, propyl paraoxybenzoate)] and the like can be added.
  • Capsules include hard capsules or soft capsules.
  • one or more tablets, or capsules be administered at a time, preferably one to about two.
  • tablets or capsules are prepared so as to contain pranlukast hydrate in an amount of about 50-250 mg, preferably 100-120 mg, especially about 112.5 mg per 1 capsule or capsule. Is preferred.
  • Liquid preparations for oral administration include liquid preparations, suspensions, emulsions, syrups, dissolving preparations (for example, dry syrup lj) and elixirs.
  • a liquid preparation for internal use pranlukast hydrate is dissolved, suspended or emulsified in a diluent generally used for the liquid preparation for internal use (for example, purified water, ethanol or a mixture thereof).
  • this solution can be used as wetting agents, suspending agents, emulsifiers, sweeteners, flavors, Agents, preservatives or buffers, and the like.
  • dry syrup IJ can be produced by, for example, mixing pranlukast hydrate with, for example, sucrose, powdered sugar, sucrose, fructose, glucose or lactose.
  • the dry syrup IJ may be granulated according to a conventional method.
  • Dosage forms for parenteral administration include external preparations and injections.
  • Examples of the dosage form of the external preparation include an ointment, a gel, a cream, a compress, a patch, a liniment, a spray, an inhalant, and a spray.
  • the ointment is manufactured by a known method.
  • An ointment is produced, for example, by mixing or melting pranlukast hydrate with a base.
  • the ointment base is selected from known or commonly used ones.
  • Ointment bases include, for example, higher fatty acids or higher fatty acid esters (adipic acid, myristic acid, palmitic acid, stearic acid, oleic acid, adipic acid ester, myristic acid ester, palmitic acid ester, stearic acid ester, oleic acid ester) ), Waxes (beetle, spermaceti, ceresin, etc.), surfactants (polyoxyethylene alkyl ether phosphate ester, etc.), higher alcohols (cetanol, stearyl alcohol, cetostearyl alcohol, etc.), silicone oil (dimethyl Polysiloxanes), hydrocarbons (hydrophilic petrolatum, white petrolatum,
  • the gel is produced by a known method.
  • the gel is produced, for example, by melting plannorecast hydrate in a gel base.
  • the gel base is selected from known or commonly used ones.
  • the gel base include lower alcohols (ethanol, isopropyl alcohol, etc.), gelling agents (carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropinoresenorelose, ethinoresenorelose, etc.), neutralization Agents (triethanolanolamine, diisopropanolamine, etc.), surfactants (polyethylene glycol monostearate, etc.) ), Gums, water, absorption enhancers or rash preventive agents, and one or more selected from these are used in combination.
  • the gel preparation may contain a preservative, an antioxidant or a flavoring agent.
  • the cream is produced by a known method. Creams are produced, for example, by melting or emulsifying pranlukast hydrate in a base.
  • the cream base is selected from those known or commonly used. Examples of the cream base include higher fatty acid esters, lower alcohols, hydrocarbons, polyhydric alcohols (propylene glycol, 1,3-butylene glycol, etc.), higher alcohols (2-hexyldecanol, cetanol, etc.). , Emulsifiers (polyoxyethylene alkyl ethers, fatty acid esters, etc.), water, absorption promoters, anti-rash agents, etc., and one or more selected from these are used in combination. . Further, the cream may contain a preservative, an antioxidant or a flavoring agent.
  • the poultice is produced by a known method.
  • the poultice is produced by, for example, melting pranlukast hydrate in a base, forming a kneaded product, and spreading and applying the mixture on a support.
  • the compress base is selected from those known or commonly used.
  • the compress base examples include thickeners (polyacrylic acid, polyvinylpyrrolidone, gum arabic, starch, gelatin, methylcellulose, etc.), wetting agents (urea, glycerin, propylene glycol, etc.), fillers (kaolin, zinc oxide) Talc, calcium, magnesium, etc.), water, a solubilizing agent, a tackifier or an anti-rash agent, and one or more selected from these are used. Further, the poultice may contain a preservative, an antioxidant or a flavoring agent.
  • the patch is produced by a known method.
  • the patch is produced, for example, by dissolving pranlukast hydrate in a patch base and spreading it on a support.
  • the base for the patch is selected from known or commonly used ones. Examples of the base for application include a polymer base, oils and fats, higher fatty acids, tackifiers and rash preventives, and one or two or more selected from these are used.
  • the liniment is manufactured by a known method.
  • liniment is prepared by adding pranlukast hydrate to water, alcohol (ethanol, polyethylene glycol, etc.), higher fatty acid, It is manufactured by dissolving, suspending or emulsifying one or more selected from serine, soap, emulsifier, suspending agent and the like.
  • the liniment may contain a preservative, an antioxidant or a flavoring agent.
  • Examples of injections for parenteral administration include solutions, suspensions or emulsions, and solid injections that are dissolved or suspended in a solvent before use.
  • the injection is used by dissolving, suspending or emulsifying pranlukast hydrate in a solvent.
  • the solvent include distilled water for injection, physiological saline, vegetable oil, propylene glycol, polyethylene glycol, and alcohols such as ethanol. These solvents are used alone or in combination of two or more.
  • the injection may contain a stabilizer, a solubilizing agent (glutamic acid, aspartic acid, polysorbate 80 (registered trademark), etc.), a suspending agent, an emulsifier, a soothing agent, a buffer or a preservative. Good.
  • a stabilizer for example, a freeze-dried product can be produced, and then sterilized or dissolved in sterile distilled water for injection or other solvents before use.
  • dosage forms for parenteral administration include, for example, sprays, inhalants and sprays. These preparations may contain a buffering agent other than commonly used diluents to provide isotonicity with stabilizers such as sodium bisulfite, for example, isotonic agents such as sodium chloride, sodium citrate or citric acid. May contain an agent. Methods for producing sprays are described in detail, for example, in US Pat. Nos. 2,868,691 and 3,095,355.
  • Examples of the inhalant include an aerosol, a powder for inhalation, and a liquid for inhalation.
  • the inhalant may be in the form of being dissolved or suspended in water or another suitable medium before use. These inhalants are manufactured according to a known method.
  • Inhalants include, for example, in the case of liquids for inhalation, preservatives (benzalkonium chloride, paraben, etc.), coloring agents, buffering agents (sodium phosphate, sodium acetate, etc.), tonicity agents (sodium chloride, sodium chloride, etc.). Concentrated glycerin), a thickener (such as a carboxyvinyl polymer), or an absorption enhancer, if necessary.
  • Powders for inhalation include lubricants (stearic acid and its salts, etc.) and binders (starch, It is manufactured by appropriately selecting an excipient (eg, a string), an excipient (eg, lactose, cellulose), a coloring agent, a preservative (eg, salt of Hibenzalkonidum, paraben) or an absorption enhancer, as necessary.
  • lubricants stearic acid and its salts, etc.
  • binders starch, It is manufactured by appropriately selecting an excipient (eg, a string), an excipient (eg, lactose, cellulose), a coloring agent, a preservative (eg, salt of Hibenzalkonidum, paraben) or an absorption enhancer, as necessary.
  • a nebulizer (atomizer, nebulizer) is usually used to administer the inhalable liquid, and a powder inhaler is usually used to administer the inhalable powder.
  • Other compositions for parenteral administration include suppositories for rectal administration and pessaries for vaginal administration, which contain pranlukast hydrate and are formulated in a conventional manner.
  • the agent for preventing and / or treating dysmenorrhea of the present invention can be used in combination with other agents.
  • the other drugs are: 1) supplement and / or enhance the therapeutic effect of plannorecast hydrate, 2) kinetics of pranlukast hydrate 'improved absorption, reduced dosage, And / or 3) it is preferably used to reduce the side effects of pranlukast hydrate.
  • the concomitant preparation of pranlukast hydrate and another drug may be in the form of a combination preparation containing both components in one preparation, or may be in the form of separate preparations.
  • the preparations may be administered simultaneously with a time difference between the administrations of the two preparations.
  • administration with a time difference may be performed by administering plannorecast hydrate first and then administering another drug, or administering another drug first and administering plannorecast hydrate later.
  • Each administration method may be the same or different.
  • the other drug may be a small molecule compound or a high molecular weight protein, polypeptide, polynucleotide (DNA, RNA, gene), antisense, decoy or antibody, or vaccine. And so on.
  • the dose of the other drug can be appropriately selected based on the dose clinically used.
  • the mixing ratio of pranlukast hydrate and other drugs can be appropriately selected depending on the age and weight of the administration subject, administration method, administration time, target disease, symptoms, types of other drugs, and the like. For example, 0.01 to 100 parts by weight of another drug may be used for 1 part by weight of pranlukast hydrate.
  • Other drugs may be arbitrarily administered in combination of one or more of the following homologous groups and heterogeneous groups at appropriate ratios.
  • Other drugs include, for example, analgesics [eg, non-steroidal anti-inflammatory drugs (NSAIDs)], muscle relaxants, tranquilizers, herbal medicines and the like.
  • NSAIDs non-steroidal anti-inflammatory drugs
  • Analgesics include, for example, sazapyrine, sodium salicylate, aspirin, aspirin'dialuminate, diflunisal, indomethacin, suprofen, ⁇ fenamate, dimethyl isopropyl azulene, bufexamac, fuerbinac, diclofenac sodium, tramethine sodium , Crinolinole, fenbufen, napmetone, proglumetacin, indomethacin pharmacin, inacemethasin, proglumetasin maleate, ampfenac sodium, mofezolac, etodolac, ibuprofen, ibuprofen piconol, naproxen, flurbiprofen, flurbiprofen axetil Ketoprofen, Fenoprofen Calcium, Thiaprofen, Oxaprozin, Pranoprofen, Loxop Fennamidine, alumin
  • Examples of the muscle relaxant include triperisone hydrochloride, chlorzoxazone, chlormezanone, metocanolebamol, fenprobamate, pridinol mesylate, clofenesin rubbamate, baclofen, eperisone hydrochloride, afloqualone, tizanidine hydrochloride, alclodinum chloride, and chloride.
  • Examples of the tranquilizer include chlordiazepoxide, diazepam, cloxazolam, oxazepam, oxazolam, medazepam, bromazepam, lorazepam, prazepam, fludiazepam, dipotassium chlorazepate, mexazolam, alprazolame, flutazolameframepramazepam And ethyl mouth frazepate, clotiazebam, etizolam or hydroxyzine.
  • herbal medicines include, for example, Tokishakuyakusan, Kamishoyosan, Keishibukuryogan, Kyukyogaito, Tokikenchuto, Tokakujokito, Sankoshashinto, Orenjokutoto, Hanatsu Koboku-to, Saiko Keishi-to, Shimotsu-yu, Juzen-taiho-yu, Gozoku-san, girls' flower, Onkyo-to, Onsen-shi, etc. are mentioned.
  • other drugs include those that have been discovered to date as well as those that will be discovered based on the mechanism described above.
  • pranlukast hydrate (trade name: ONON capsules) was administered at 450 mg / day (2 capsules containing 112.5 mg after breakfast and 2 capsules after dinner) for 8 weeks He examined the effectiveness of the chief complaint against menstrual pain. The efficacy of menstrual pain was evaluated using the visual analogue scale (VAS) of pain and the amount of anti-inflammatory analgesic (sodium oral xoprofen, trade name: loxonin). The VAS evaluates the degree of menstrual pain on a 10-point scale.
  • VAS visual analogue scale
  • the left end (Ocm) is 0 (no pain at all) and the right end (10cm) is 10 (the strongest you can imagine).
  • the pain at the time of measurement was measured in cm.
  • the number of anti-inflammatory analgesics used per menstrual pain was evaluated.
  • the patient required about 34 tablets / day X 4 days during the period of menstruation.
  • the VAS before taking pranlukast hydrate was 10 points, 8 points after 4 weeks and 6 points after 8 weeks, and the degree of menstrual pain was reduced.
  • the use of anti-inflammatory analgesics was 11 tablets before taking the drug, but it was possible to reduce it to 6 tablets after 4 weeks and 1 tablet after 8 weeks.
  • Pranlukast hydrate is very useful as a preventive and / or therapeutic agent for dysmenorrhea (particularly functional dysmenorrhea).

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Epidemiology (AREA)
  • Neurology (AREA)
  • Pregnancy & Childbirth (AREA)
  • Pain & Pain Management (AREA)
  • Gynecology & Obstetrics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Diabetes (AREA)
  • Hospice & Palliative Care (AREA)
  • Otolaryngology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Plural Heterocyclic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

L'invention concerne un agent de prévention et/ou un agent de traitement de la dysménorrhée, contenant comme principe actif de l'hydrate de pranlukast, présentant d'excellentes propriétés en termes d'efficacité et de fiabilité et permettant de prévenir et/ou de traiter des symptômes de dysménorrhée, comme les douleurs abdominales basses, des douleurs lombaires, des troubles digestifs, des troubles nerveux et vasculaires, des troubles mentaux, des troubles systémiques, des vertiges, la nausée, les rougeurs du visage, la transpiration et une sécrétion accrue de la salive.
PCT/JP2004/018714 2003-12-16 2004-12-15 Agent de prevention et/ou agent de traitement de la dysmenorrhee WO2005058878A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2005516318A JPWO2005058878A1 (ja) 2003-12-16 2004-12-15 月経困難症の予防および／または治療剤

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2003-417675 2003-12-16
JP2003417675 2003-12-16

Publications (1)

Publication Number Publication Date
WO2005058878A1 true WO2005058878A1 (fr) 2005-06-30

Family

ID=34697074

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2004/018714 WO2005058878A1 (fr) 2003-12-16 2004-12-15 Agent de prevention et/ou agent de traitement de la dysmenorrhee

Country Status (3)

Country Link
JP (1) JPWO2005058878A1 (fr)
KR (1) KR20060123329A (fr)
WO (1) WO2005058878A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011519870A (ja) * 2008-05-21 2011-07-14 テイコク ファーマ ユーエスエー インコーポレーテッド 非ステロイド性抗炎症薬の経皮投与による月経困難症の治療

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102370755A (zh) * 2010-08-11 2012-03-14 沈士成 一种治疗脑性眩晕的汤剂药物

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6150977A (ja) * 1984-08-20 1986-03-13 Ono Pharmaceut Co Ltd 新規な縮合ベンズ（チオ）アミド、それらの製造方法およびそれらを有効成分として含有する薬剤
JP2002187855A (ja) * 2000-12-18 2002-07-05 Tochigi Rinsho Byori Kenkyusho:Kk 子宮内膜症の予防又は治療薬
WO2002089787A1 (fr) * 2001-05-09 2002-11-14 Laxdale Limited Potentialisation des effets therapeutiques des acides gras

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6150977A (ja) * 1984-08-20 1986-03-13 Ono Pharmaceut Co Ltd 新規な縮合ベンズ（チオ）アミド、それらの製造方法およびそれらを有効成分として含有する薬剤
JP2002187855A (ja) * 2000-12-18 2002-07-05 Tochigi Rinsho Byori Kenkyusho:Kk 子宮内膜症の予防又は治療薬
WO2002089787A1 (fr) * 2001-05-09 2002-11-14 Laxdale Limited Potentialisation des effets therapeutiques des acides gras

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011519870A (ja) * 2008-05-21 2011-07-14 テイコク ファーマ ユーエスエー インコーポレーテッド 非ステロイド性抗炎症薬の経皮投与による月経困難症の治療

Also Published As

Publication number Publication date
KR20060123329A (ko) 2006-12-01
JPWO2005058878A1 (ja) 2007-07-12

Similar Documents

Publication Publication Date Title
EP1246668B1 (fr) Composition pharmaceutique lyophilisee a action rapide s'administrant par voie orale utilisee pour traiter la migraine
WO2002096406A1 (fr) Compositions medicinales
CZ156598A3 (cs) Použití flurbiprofenu k přípravě léčiva k léčení bolesti v krku
KR101400064B1 (ko) 건식 직타 속붕괴성 정제
AU2017317950A1 (en) Sublingual pharmaceutical composition of edaravone and (+)-2-borneol
JP5828609B2 (ja) 持続性解熱鎮痛消炎剤
JP5542309B2 (ja) 経口医薬組成物
JP2587441B2 (ja) 製薬学的組成物
JP7399502B2 (ja) びらん性変形性手関節症の治療のためのモンテルカスト
JP2007008831A (ja) 口内炎治療のための口腔用組成物
WO2006003910A1 (fr) Agents de prévention et/ou thérapeutiques pour la maladie de ménière
JPH08295637A (ja) 口腔部局所投与剤
WO2005058878A1 (fr) Agent de prevention et/ou agent de traitement de la dysmenorrhee
JP2014070024A (ja) フェニルプロピオン酸系消炎鎮痛薬を含有する医薬組成物
WO2004050110A1 (fr) Composition medicamenteuse
JP2023503373A (ja) 新規多機能オリゴペプチド
TWI850283B (zh) 用於治療糜爛性手部骨關節炎的孟魯司特
ES2940736B2 (es) Uso combinado de imiquimod y de un hidrolizado de caseina para el tratamiento de condilomas
JP2000219625A (ja) 医薬組成物
US20180318228A1 (en) Method for a slow release of drugs from orally dissolving capsules
JP2000119186A (ja) スクラルファート含有局所投与用医薬組成物
JP2003342186A (ja) 鼻炎用内服液剤組成物
KR20060120204A (ko) 삼출성 중이염의 예방 및/또는 치료제
WO2005063253A1 (fr) Composition medicinale pour le traitement de symptomes allergiques
WO2024078468A1 (fr) Utilisation d'un dérivé de stilbène dans la prévention et/ou le traitement d'ulcères

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BW BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE EG ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NA NI NO NZ OM PG PH PL PT RO RU SC SD SE SG SK SL SY TJ TM TN TR TT TZ UA UG US UZ VC VN YU ZA ZM ZW

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): GM KE LS MW MZ NA SD SL SZ TZ UG ZM ZW AM AZ BY KG KZ MD RU TJ TM AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LT LU MC NL PL PT RO SE SI SK TR BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
WWE Wipo information: entry into national phase

Ref document number: 2005516318

Country of ref document: JP

WWE Wipo information: entry into national phase

Ref document number: 1020067011716

Country of ref document: KR

NENP Non-entry into the national phase

Ref country code: DE

WWW Wipo information: withdrawn in national office

Country of ref document: DE

WWP Wipo information: published in national office

Ref document number: 1020067011716

Country of ref document: KR

122 Ep: pct application non-entry in european phase