JP5450910B1 - Pharmaceutical composition containing loxoprofen - Google Patents
Pharmaceutical composition containing loxoprofen Download PDFInfo
- Publication number
- JP5450910B1 JP5450910B1 JP2013547762A JP2013547762A JP5450910B1 JP 5450910 B1 JP5450910 B1 JP 5450910B1 JP 2013547762 A JP2013547762 A JP 2013547762A JP 2013547762 A JP2013547762 A JP 2013547762A JP 5450910 B1 JP5450910 B1 JP 5450910B1
- Authority
- JP
- Japan
- Prior art keywords
- oil
- loxoprofen
- pharmaceutical composition
- mass
- salt
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 229960002373 loxoprofen Drugs 0.000 title claims abstract description 61
- 239000008194 pharmaceutical composition Substances 0.000 title abstract description 24
- YMBXTVYHTMGZDW-UHFFFAOYSA-N loxoprofen Chemical compound C1=CC(C(C(O)=O)C)=CC=C1CC1C(=O)CCC1 YMBXTVYHTMGZDW-UHFFFAOYSA-N 0.000 title 1
- BAZQYVYVKYOAGO-UHFFFAOYSA-M loxoprofen sodium hydrate Chemical compound O.O.[Na+].C1=CC(C(C([O-])=O)C)=CC=C1CC1C(=O)CCC1 BAZQYVYVKYOAGO-UHFFFAOYSA-M 0.000 claims abstract description 58
- 150000003839 salts Chemical class 0.000 claims abstract description 35
- NOOLISFMXDJSKH-KXUCPTDWSA-N (-)-Menthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@H]1O NOOLISFMXDJSKH-KXUCPTDWSA-N 0.000 claims description 21
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 claims description 19
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 14
- -1 silicate compound Chemical class 0.000 abstract description 24
- 150000003505 terpenes Chemical class 0.000 abstract description 20
- 235000007586 terpenes Nutrition 0.000 abstract description 18
- 230000003993 interaction Effects 0.000 abstract description 16
- 150000005846 sugar alcohols Polymers 0.000 abstract description 13
- 230000002452 interceptive effect Effects 0.000 abstract description 4
- 239000003921 oil Substances 0.000 description 27
- 235000019198 oils Nutrition 0.000 description 27
- 235000012239 silicon dioxide Nutrition 0.000 description 23
- 229920002451 polyvinyl alcohol Polymers 0.000 description 19
- 239000004372 Polyvinyl alcohol Substances 0.000 description 18
- 239000000203 mixture Substances 0.000 description 15
- RMAQACBXLXPBSY-UHFFFAOYSA-N silicic acid Chemical class O[Si](O)(O)O RMAQACBXLXPBSY-UHFFFAOYSA-N 0.000 description 15
- 238000003860 storage Methods 0.000 description 14
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 12
- 239000000499 gel Substances 0.000 description 11
- 238000002360 preparation method Methods 0.000 description 11
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 10
- RGOVYLWUIBMPGK-UHFFFAOYSA-N nonivamide Chemical compound CCCCCCCCC(=O)NCC1=CC=C(O)C(OC)=C1 RGOVYLWUIBMPGK-UHFFFAOYSA-N 0.000 description 10
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- HEMHJVSKTPXQMS-UHFFFAOYSA-M sodium hydroxide Substances [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 6
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- PLPRGLOFPNJOTN-UHFFFAOYSA-N narcotine Natural products COc1ccc2C(OC(=O)c2c1OC)C3Cc4c(CN3C)cc5OCOc5c4OC PLPRGLOFPNJOTN-UHFFFAOYSA-N 0.000 description 3
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- 229960003511 macrogol Drugs 0.000 description 1
- HZZOEADXZLYIHG-UHFFFAOYSA-N magnesiomagnesium Chemical compound [Mg][Mg] HZZOEADXZLYIHG-UHFFFAOYSA-N 0.000 description 1
- NEMFQSKAPLGFIP-UHFFFAOYSA-N magnesiosodium Chemical compound [Na].[Mg] NEMFQSKAPLGFIP-UHFFFAOYSA-N 0.000 description 1
- 229960000816 magnesium hydroxide Drugs 0.000 description 1
- 239000000395 magnesium oxide Substances 0.000 description 1
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 description 1
- 229960000869 magnesium oxide Drugs 0.000 description 1
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 description 1
- FQQIIPAOSKSOJM-UHFFFAOYSA-N mebhydrolin Chemical compound C1N(C)CCC2=C1C1=CC=CC=C1N2CC1=CC=CC=C1 FQQIIPAOSKSOJM-UHFFFAOYSA-N 0.000 description 1
- 229960004934 mebhydrolin Drugs 0.000 description 1
- 229960005321 mecobalamin Drugs 0.000 description 1
- 239000001098 melissa officinalis l. leaf oil Substances 0.000 description 1
- 239000001683 mentha spicata herb oil Substances 0.000 description 1
- 229930007503 menthone Natural products 0.000 description 1
- 229960005042 mequitazine Drugs 0.000 description 1
- 229910021645 metal ion Inorganic materials 0.000 description 1
- 229940098953 methixene hydrochloride Drugs 0.000 description 1
- RAOHHYUBMJLHNC-UHFFFAOYSA-N methixene hydrochloride Chemical compound [H+].O.[Cl-].C1N(C)CCCC1CC1C2=CC=CC=C2SC2=CC=CC=C21 RAOHHYUBMJLHNC-UHFFFAOYSA-N 0.000 description 1
- FGSJNNQVSUVTPW-UHFFFAOYSA-N methoxyphenamine hydrochloride Chemical compound Cl.CNC(C)CC1=CC=CC=C1OC FGSJNNQVSUVTPW-UHFFFAOYSA-N 0.000 description 1
- 229960000659 methoxyphenamine hydrochloride Drugs 0.000 description 1
- 229960001047 methyl salicylate Drugs 0.000 description 1
- JEWJRMKHSMTXPP-BYFNXCQMSA-M methylcobalamin Chemical compound C[Co+]N([C@]1([H])[C@H](CC(N)=O)[C@]\2(CCC(=O)NC[C@H](C)OP(O)(=O)OC3[C@H]([C@H](O[C@@H]3CO)N3C4=CC(C)=C(C)C=C4N=C3)O)C)C/2=C(C)\C([C@H](C/2(C)C)CCC(N)=O)=N\C\2=C\C([C@H]([C@@]/2(CC(N)=O)C)CCC(N)=O)=N\C\2=C(C)/C2=N[C@]1(C)[C@@](C)(CC(N)=O)[C@@H]2CCC(N)=O JEWJRMKHSMTXPP-BYFNXCQMSA-M 0.000 description 1
- 235000007672 methylcobalamin Nutrition 0.000 description 1
- 239000011585 methylcobalamin Substances 0.000 description 1
- 229930003658 monoterpene Natural products 0.000 description 1
- 150000002773 monoterpene derivatives Chemical class 0.000 description 1
- 235000002577 monoterpenes Nutrition 0.000 description 1
- 239000010813 municipal solid waste Substances 0.000 description 1
- UDCIYVVYDCXLSX-SDNWHVSQSA-N n-[(4-amino-2-methylpyrimidin-5-yl)methyl]-n-[(e)-5-hydroxy-3-(propyldisulfanyl)pent-2-en-2-yl]formamide Chemical compound CCCSS\C(CCO)=C(/C)N(C=O)CC1=CN=C(C)N=C1N UDCIYVVYDCXLSX-SDNWHVSQSA-N 0.000 description 1
- GFEGEDUIIYDMOX-BMJUYKDLSA-N n-[(4-amino-2-methylpyrimidin-5-yl)methyl]-n-[(z)-3-[[(z)-2-[(4-amino-2-methylpyrimidin-5-yl)methyl-formylamino]-5-hydroxypent-2-en-3-yl]disulfanyl]-5-hydroxypent-2-en-2-yl]formamide Chemical compound C=1N=C(C)N=C(N)C=1CN(C=O)C(\C)=C(CCO)/SSC(/CCO)=C(/C)N(C=O)CC1=CN=C(C)N=C1N GFEGEDUIIYDMOX-BMJUYKDLSA-N 0.000 description 1
- 229950005216 napadisilate Drugs 0.000 description 1
- 239000000820 nonprescription drug Substances 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- 229940073665 octyldodecyl myristate Drugs 0.000 description 1
- 229940041672 oral gel Drugs 0.000 description 1
- 229940100688 oral solution Drugs 0.000 description 1
- 229960000251 oxyphencyclimine hydrochloride Drugs 0.000 description 1
- GHZNWXGYWUBLLI-UHFFFAOYSA-N p-Lactophenetide Chemical compound CCOC1=CC=C(NC(=O)C(C)O)C=C1 GHZNWXGYWUBLLI-UHFFFAOYSA-N 0.000 description 1
- 229940101267 panthenol Drugs 0.000 description 1
- 235000020957 pantothenol Nutrition 0.000 description 1
- 239000011619 pantothenol Substances 0.000 description 1
- 229960005489 paracetamol Drugs 0.000 description 1
- 229960003436 pentoxyverine Drugs 0.000 description 1
- RUMOYJJNUMEFDD-UHFFFAOYSA-N perillyl aldehyde Chemical compound CC(=C)C1CCC(C=O)=CC1 RUMOYJJNUMEFDD-UHFFFAOYSA-N 0.000 description 1
- OCYSGIYOVXAGKQ-FVGYRXGTSA-N phenylephrine hydrochloride Chemical compound [H+].[Cl-].CNC[C@H](O)C1=CC=CC(O)=C1 OCYSGIYOVXAGKQ-FVGYRXGTSA-N 0.000 description 1
- 229960003733 phenylephrine hydrochloride Drugs 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
- FFNMBRCFFADNAO-UHFFFAOYSA-N pirenzepine hydrochloride Chemical compound [H+].[H+].[Cl-].[Cl-].C1CN(C)CCN1CC(=O)N1C2=NC=CC=C2NC(=O)C2=CC=CC=C21 FFNMBRCFFADNAO-UHFFFAOYSA-N 0.000 description 1
- 229960000293 pirenzepine hydrochloride Drugs 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 239000001818 polyoxyethylene sorbitan monostearate Substances 0.000 description 1
- 235000010989 polyoxyethylene sorbitan monostearate Nutrition 0.000 description 1
- 229920002689 polyvinyl acetate Polymers 0.000 description 1
- 239000011118 polyvinyl acetate Substances 0.000 description 1
- GRLPQNLYRHEGIJ-UHFFFAOYSA-J potassium aluminium sulfate Chemical compound [Al+3].[K+].[O-]S([O-])(=O)=O.[O-]S([O-])(=O)=O GRLPQNLYRHEGIJ-UHFFFAOYSA-J 0.000 description 1
- 229940088417 precipitated calcium carbonate Drugs 0.000 description 1
- XXPDBLUZJRXNNZ-UHFFFAOYSA-N promethazine hydrochloride Chemical compound Cl.C1=CC=C2N(CC(C)N(C)C)C3=CC=CC=C3SC2=C1 XXPDBLUZJRXNNZ-UHFFFAOYSA-N 0.000 description 1
- 229960002244 promethazine hydrochloride Drugs 0.000 description 1
- 235000013772 propylene glycol Nutrition 0.000 description 1
- PXWLVJLKJGVOKE-UHFFFAOYSA-N propyphenazone Chemical compound O=C1C(C(C)C)=C(C)N(C)N1C1=CC=CC=C1 PXWLVJLKJGVOKE-UHFFFAOYSA-N 0.000 description 1
- 229960002189 propyphenazone Drugs 0.000 description 1
- 229950007142 prosultiamine Drugs 0.000 description 1
- 235000019833 protease Nutrition 0.000 description 1
- 235000007682 pyridoxal 5'-phosphate Nutrition 0.000 description 1
- 239000011589 pyridoxal 5'-phosphate Substances 0.000 description 1
- 229960001327 pyridoxal phosphate Drugs 0.000 description 1
- ZUFQODAHGAHPFQ-UHFFFAOYSA-N pyridoxine hydrochloride Chemical compound Cl.CC1=NC=C(CO)C(CO)=C1O ZUFQODAHGAHPFQ-UHFFFAOYSA-N 0.000 description 1
- 235000019171 pyridoxine hydrochloride Nutrition 0.000 description 1
- 229960004172 pyridoxine hydrochloride Drugs 0.000 description 1
- 239000011764 pyridoxine hydrochloride Substances 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 235000019192 riboflavin Nutrition 0.000 description 1
- 229960002477 riboflavin Drugs 0.000 description 1
- 239000002151 riboflavin Substances 0.000 description 1
- 229950001574 riboflavin phosphate Drugs 0.000 description 1
- 229930006696 sabinene Natural products 0.000 description 1
- 239000004248 saffron Substances 0.000 description 1
- 235000013974 saffron Nutrition 0.000 description 1
- 235000017509 safranal Nutrition 0.000 description 1
- 229960000581 salicylamide Drugs 0.000 description 1
- 229960004889 salicylic acid Drugs 0.000 description 1
- 235000019512 sardine Nutrition 0.000 description 1
- 239000000932 sedative agent Substances 0.000 description 1
- 229940125723 sedative agent Drugs 0.000 description 1
- 229940048730 senega Drugs 0.000 description 1
- 230000035807 sensation Effects 0.000 description 1
- 229950000112 serrapeptase Drugs 0.000 description 1
- 108010038132 serratiopeptidase Proteins 0.000 description 1
- 229930004725 sesquiterpene Natural products 0.000 description 1
- 150000004354 sesquiterpene derivatives Chemical class 0.000 description 1
- 235000015170 shellfish Nutrition 0.000 description 1
- GQTHJBOWLPZUOI-FJXQXJEOSA-M sodium D-pantothenate Chemical compound [Na+].OCC(C)(C)[C@@H](O)C(=O)NCCC([O-])=O GQTHJBOWLPZUOI-FJXQXJEOSA-M 0.000 description 1
- 235000017557 sodium bicarbonate Nutrition 0.000 description 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
- 229950002760 sodium gualenate Drugs 0.000 description 1
- 229940068459 sodium pantothenate Drugs 0.000 description 1
- 229960004025 sodium salicylate Drugs 0.000 description 1
- GEYJUFBPCGDENK-UHFFFAOYSA-M sodium;3,8-dimethyl-5-propan-2-ylazulene-1-sulfonate Chemical compound [Na+].CC(C)C1=CC=C(C)C2=C(S([O-])(=O)=O)C=C(C)C2=C1 GEYJUFBPCGDENK-UHFFFAOYSA-M 0.000 description 1
- GFWRVVCDTLRWPK-KPKJPENVSA-N sofalcone Chemical compound C1=CC(OCC=C(C)C)=CC=C1\C=C\C(=O)C1=CC=C(OCC=C(C)C)C=C1OCC(O)=O GFWRVVCDTLRWPK-KPKJPENVSA-N 0.000 description 1
- 229950004782 sofalcone Drugs 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000012453 solvate Substances 0.000 description 1
- 239000001587 sorbitan monostearate Substances 0.000 description 1
- 235000011076 sorbitan monostearate Nutrition 0.000 description 1
- 229940035048 sorbitan monostearate Drugs 0.000 description 1
- 235000019721 spearmint oil Nutrition 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 230000003637 steroidlike Effects 0.000 description 1
- 239000004575 stone Substances 0.000 description 1
- BDHFUVZGWQCTTF-UHFFFAOYSA-M sulfonate Chemical compound [O-]S(=O)=O BDHFUVZGWQCTTF-UHFFFAOYSA-M 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- FKHIFSZMMVMEQY-UHFFFAOYSA-N talc Chemical compound [Mg+2].[O-][Si]([O-])=O FKHIFSZMMVMEQY-UHFFFAOYSA-N 0.000 description 1
- 229950006156 teprenone Drugs 0.000 description 1
- 229930006978 terpinene Natural products 0.000 description 1
- 150000003507 terpinene derivatives Chemical class 0.000 description 1
- 229960001385 thiamine disulfide Drugs 0.000 description 1
- DPJRMOMPQZCRJU-UHFFFAOYSA-M thiamine hydrochloride Chemical compound Cl.[Cl-].CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N DPJRMOMPQZCRJU-UHFFFAOYSA-M 0.000 description 1
- 229960000896 tipepidine Drugs 0.000 description 1
- 229940042585 tocopherol acetate Drugs 0.000 description 1
- RRBYUSWBLVXTQN-UHFFFAOYSA-N tricyclene Chemical compound C12CC3CC2C1(C)C3(C)C RRBYUSWBLVXTQN-UHFFFAOYSA-N 0.000 description 1
- RRBYUSWBLVXTQN-VZCHMASFSA-N tricyclene Natural products C([C@@H]12)C3C[C@H]1C2(C)C3(C)C RRBYUSWBLVXTQN-VZCHMASFSA-N 0.000 description 1
- 229960001593 triprolidine hydrochloride Drugs 0.000 description 1
- 235000013976 turmeric Nutrition 0.000 description 1
- 239000006216 vaginal suppository Substances 0.000 description 1
- 235000016788 valerian Nutrition 0.000 description 1
- 229920002554 vinyl polymer Polymers 0.000 description 1
- 235000019154 vitamin C Nutrition 0.000 description 1
- 239000011718 vitamin C Substances 0.000 description 1
- 239000011787 zinc oxide Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
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- 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]
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Abstract
ロキソプロフェン又はその塩と、相互作用性成分との間の相互作用が抑制された医薬組成物の提供。
次の成分(A)、(B)及び(C):
(A)ロキソプロフェン又はその塩
(B)次の成分(B−1)及び(B−2)からなる群より選ばれる1種以上
(B−1)テルペン類
(B−2)多価アルコール
(C)ケイ酸化合物
を含有する医薬組成物。Provided is a pharmaceutical composition in which the interaction between loxoprofen or a salt thereof and an interactive component is suppressed.
The following components (A), (B) and (C):
(A) Loxoprofen or a salt thereof (B) One or more selected from the group consisting of the following components (B-1) and (B-2) (B-1) Terpenes (B-2) Polyhydric alcohol (C ) A pharmaceutical composition containing a silicate compound.
Description
本発明は、ロキソニン(登録商標)の有効成分としても知られるロキソプロフェンを含有する医薬組成物に関する。 The present invention relates to a pharmaceutical composition containing loxoprofen, which is also known as an active ingredient of Loxonin®.
ロキソプロフェンは、非ステロイド性消炎鎮痛剤(NSAID)の一種であり(非特許文献1)、変形性関節症、筋肉痛、外傷後の腫脹・疼痛等の疾患及び症状の消炎・鎮痛を効能効果とするゲル剤、パップ剤やテープ剤等の外用剤の有効成分として用いられている(非特許文献2)。
一方、メントール、ハッカ油等のテルペン類は、冷却感を与える目的で外用消炎鎮痛剤等に配合されており、ロキソプロフェンと共に配合された外用剤も知られている(特許文献1〜3)。また、ポリビニルアルコール等の多価アルコールは、製剤に粘稠性、粘着性等を与える目的で外用消炎鎮痛剤等に配合されている。Loxoprofen is a kind of non-steroidal anti-inflammatory analgesic (NSAID) (Non-Patent Document 1). It is effective for treating diseases such as osteoarthritis, myalgia, swelling / pain after trauma, and anti-inflammatory / analgesic symptoms It is used as an active ingredient of external preparations such as gels, poultices and tapes (Non-patent Document 2).
On the other hand, terpenes such as menthol and peppermint oil are blended in anti-inflammatory analgesics and the like for the purpose of giving a cooling sensation, and external preparations blended with loxoprofen are also known (Patent Documents 1 to 3). Moreover, polyhydric alcohols, such as polyvinyl alcohol, are mix | blended with the anti-inflammatory analgesic agent for external use, etc. in order to give viscosity, adhesiveness, etc. to a formulation.
しかしながら、ロキソプロフェン又はその塩と、下記の1及び2から選ばれる成分の1種以上との間に、保存安定性に影響を与えるような相互作用が生じるか否かについては、知られていない。
そこで、本発明者らは、まず、ロキソプロフェン又はその塩と種々の成分の保存安定性について検討したところ、ロキソプロフェン又はその塩と以下の成分1〜2のうちいずれか:However, it is not known whether or not an interaction that affects storage stability occurs between loxoprofen or a salt thereof and one or more components selected from the following 1 and 2.
Therefore, the present inventors first examined the storage stability of loxoprofen or a salt thereof and various components, and as a result, either loxoprofen or a salt thereof and any of the following components 1-2:
1 l−メントールなどを包含するテルペン類
2 ポリビニルアルコールなどを包含する多価アルコール
(なお、本明細書において、上記1〜2から選ばれる成分の1種以上を「相互作用性成分」と称することがある。)Terpenes including 1 l-menthol and the like 2 Polyhydric alcohols including polyvinyl alcohol and the like (in the present specification, one or more components selected from the above 1-2 are referred to as “interactive components”) There is.)
とを混合して高温条件下において保存すると、意外にも、これらの成分の間に相互作用が生じ、安定性に問題が生じ得ることを見出した。 It was surprisingly found that when these were mixed and stored under high temperature conditions, interactions between these components occurred and problems could occur with stability.
従って、本発明の課題は、ロキソプロフェン又はその塩とテルペン類及び多価アルコールから選ばれる1種以上との間の相互作用が抑制された医薬組成物を提供することにある。 Accordingly, an object of the present invention is to provide a pharmaceutical composition in which the interaction between loxoprofen or a salt thereof and one or more selected from terpenes and polyhydric alcohols is suppressed.
そこで、本発明者らは、この問題を解決すべくさらに検討したところ、ロキソプロフェン又はその塩及び上記相互作用性成分に、さらに軽質無水ケイ酸等のケイ酸化合物を共存せしめることにより、相互作用を抑制することができることを見出し、本発明を完成した。 Therefore, the inventors of the present invention further studied to solve this problem. The present invention has been completed by finding that it can be suppressed.
すなわち、本発明は、次の成分(A)、(B)及び(C):
(A)ロキソプロフェン又はその塩
(B)次の成分(B−1)及び(B−2)からなる群より選ばれる1種以上
(B−1)テルペン類
(B−2)多価アルコール
(C)ケイ酸化合物
を含有する医薬組成物を提供するものである。That is, the present invention includes the following components (A), (B) and (C):
(A) Loxoprofen or a salt thereof (B) One or more selected from the group consisting of the following components (B-1) and (B-2) (B-1) Terpenes (B-2) Polyhydric alcohol (C ) A pharmaceutical composition containing a silicic acid compound is provided.
本発明によれば、ロキソプロフェン又はその塩と、テルペン類及び多価アルコールから選ばれる1種以上との相互作用を抑制できる。従って、保存安定性が優れた、ロキソプロフェン又はその塩と、テルペン類及び多価アルコールから選ばれる1種以上とを含有する医薬組成物を提供することができる。
また、複雑な工程を経ることなく、簡便かつ安価に、ロキソプロフェン又はその塩、並びにテルペン類及び多価アルコールから選ばれる1種以上を含有する、相互作用が抑制された医薬組成物を提供することができる。According to the present invention, interaction between loxoprofen or a salt thereof and one or more selected from terpenes and polyhydric alcohols can be suppressed. Therefore, a pharmaceutical composition containing loxoprofen or a salt thereof and one or more selected from terpenes and polyhydric alcohols with excellent storage stability can be provided.
In addition, the present invention provides a pharmaceutical composition containing one or more selected from loxoprofen or a salt thereof, and terpenes and a polyhydric alcohol with reduced interaction, without going through complicated steps. Can do.
<成分(A)>
本発明において、「ロキソプロフェン又はその塩」には、ロキソプロフェンそのもののほか、ロキソプロフェンの薬学上許容される塩、さらにはロキソプロフェンやその薬学上許容される塩と水やアルコール等との溶媒和物も含まれる。これらは公知の化合物であり、公知の方法により製造できるほか、市販のものを用いることができる。本発明において、ロキソプロフェン又はその塩としては、ロキソプロフェンナトリウム水和物(化学名: Monosodium 2-[4-[(2-oxocyclopentyl)methyl]phenyl]propanoate dihydrate)が好ましい。<Component (A)>
In the present invention, “loxoprofen or a salt thereof” includes loxoprofen itself, a pharmaceutically acceptable salt of loxoprofen, and a solvate of loxoprofen or a pharmaceutically acceptable salt thereof with water, alcohol, or the like. It is. These are known compounds, and can be produced by known methods, or commercially available products can be used. In the present invention, loxoprofen or a salt thereof is preferably loxoprofen sodium hydrate (chemical name: Monosodium 2- [4-[(2-oxocyclopentyl) methyl] phenyl] propanoate dihydrate).
また、ロキソプロフェン又はその塩の含有量は特に限定されず、所望の消炎鎮痛効果に応じて適宜検討すればよいが、ロキソプロフェンナトリウム無水物換算で、医薬組成物全質量に対し、0.01〜45質量%が好ましく、0.1〜40質量%がより好ましく、0.5〜35質量%が特に好ましい。 In addition, the content of loxoprofen or a salt thereof is not particularly limited, and may be appropriately determined according to the desired anti-inflammatory analgesic effect, but 0.01 to 45 relative to the total mass of the pharmaceutical composition in terms of loxoprofen sodium anhydride. % By mass is preferable, 0.1 to 40% by mass is more preferable, and 0.5 to 35% by mass is particularly preferable.
<成分(B−1)>
本発明において、「テルペン類」は特に限定されるものではなく、例えばモノテルペンやセスキテルペン等が挙げられる。テルペン類は環式でも鎖式でもよい。
斯様なテルペン類としては、例えば、イソボルネオール、イロン、オシメン、カルベオール、カルボタナセトン、カルボメントン、カルボン、カレン、カロン、カンフェン、カンフル、ゲラニオール、サビネン、サフラナール、シクロシトラール、シトラール、シトロネラール、シトロネル酸、シトロネロール、シネオール、シメン、シルベストレン、チモール、イソツジョール、ツジョン、テルピネオール、テルピネン、テルピノレン、トリシクレン、ネロール、ピネン、ピノカンフェオール、ピノール、ピペリテノン、フェランドラール、フェランドレン、フェンチェン、フェンチルアルコール、ペリリルアルコール、ペリリルアルデヒド、ボルネオール、ミルセン、メントール、メントン、ヨノール、ヨノン、リナロール、リモネン等が挙げられ、これらを単独で又は2種以上組み合わせて用いることができる。なお、これらのテルペン類が光学異性を有する場合、本発明においてはいずれの光学異性体をも含み、単一の光学異性体でもよく、各種光学異性体の混合物でもよい。
これらの中でも、カンフル、ゲラニオール、シトロネラール、チモール、テルピネオール、ボルネオール、メントール、リモネン等が好ましく、d−カンフル、dl−カンフル、チモール、ボルネオール、l−メントール、dl−メントールがより好ましく、l−メントール、dl−カンフルが特に好ましい。<Component (B-1)>
In the present invention, “terpenes” are not particularly limited, and examples thereof include monoterpenes and sesquiterpenes. Terpenes may be cyclic or chain type.
Examples of such terpenes include, for example, isoborneol, iron, osimene, carbeol, carbotanaseton, carbomenton, carvone, caren, caron, camphene, camphor, geraniol, sabinene, safranal, cyclocitral, citral, citronellal, citronellic acid, Citronellol, Cineol, Cymen, Silvestrene, Thymol, Isotjojol, Tujon, Terpineol, Terpinene, Terpinolene, Tricyclene, Nerol, Pinene, Pinoccampheol, Pinol, Piperithenone, Ferrandral, Ferrandrene, Fentchen, Fentyl Alcohol, Peri Lyl alcohol, perillyl aldehyde, borneol, myrcene, menthol, menthone, yonor, yonon, linalool, limonene, etc. The recited may be used in combination thereof alone or. In addition, when these terpenes have optical isomerism, any optical isomer is included in the present invention, and it may be a single optical isomer or a mixture of various optical isomers.
Among these, camphor, geraniol, citronellal, thymol, terpineol, borneol, menthol, limonene and the like are preferable, d-camphor, dl-camphor, thymol, borneol, l-menthol, dl-menthol are more preferable, l-menthol, Particularly preferred is dl-camphor.
また、上記テルペン類を医薬組成物に含有せしめる場合、上述のようなテルペン類を含む精油を用いてもよい。
斯様な精油としては、例えば、アニス油、イランイラン油、イリス油、ウイキョウ油、オレンジ油、カナンガ油、カミツレ油、カヤプト油、カラウェー油、クベブ油、グレープフルーツ油、ケイヒ油、コリアンダー油、サフラン油、サンショウ油、シソ油、シトリオドラ油、シトロネラ油、ショウキョウ油、ショウズク油、樟脳油、ジンジャーグラス油、スペアミント油、セイヨウハッカ油、ゼラニウム油、ダイウイキョウ油、チョウジ油、テレビン油、トウヒ油、ネロリ油、バジル油、ハッカ油、パルマローザ油、ピメント油、プチグレン油、ベイ油、ペニローヤル油、ヘノポジ油、ベルガモット油、ボアドローズ油、ホウショウ油、マジョラン油、マンダリン油、メリッサ油、ユーカリ油、ライム油、ラベンダー油、リナロエ油、レモン油、レモングラス油、ローズ油、ローズマリー油、ローマカミツレ油等が挙げられ、これらを単独で又は2種以上組み合わせて用いてもよい。
これらの中でも、イランイラン油、ウイキョウ油、オレンジ油、カミツレ油、ケイヒ油、シソ油、シトロネラ油、ショウキョウ油、樟脳油、セイヨウハッカ油、ゼラニウム油、チョウジ油、テレビン油、トウヒ油、ネロリ油、ハッカ油、パルマローザ油、ベルガモット油、ユーカリ油、ラベンダー油、リナロエ油、レモン油、ローズ油、ローズマリー油、ローマカミツレ油等が好ましく、樟脳油、セイヨウハッカ油、テレビン油、ハッカ油、ユーカリ油がより好ましく、ハッカ油が特に好ましい。In addition, when the terpenes are contained in a pharmaceutical composition, an essential oil containing the terpenes as described above may be used.
Such essential oils include, for example, anise oil, ylang ylang oil, iris oil, fennel oil, orange oil, cananga oil, chamomile oil, kayap oil, caraway oil, kubeb oil, grapefruit oil, cinnamon oil, coriander oil, saffron oil Oil, salamander, perilla oil, citriodora oil, citronella oil, ginger oil, gingergrass oil, gingergrass oil, spearmint oil, mint oil, geranium oil, geranium oil, clove oil, turpentine oil, spruce oil , Neroli oil, basil oil, peppermint oil, palmarosa oil, pimento oil, petitgren oil, bay oil, peniroyal oil, henoposi oil, bergamot oil, bored rose oil, pepper oil, marjolan oil, mandarin oil, melissa oil, eucalyptus oil, lime Oil, lavender oil, linaloe oil, lemon , Lemongrass oil, rose oil, rosemary oil, Roman chamomile oil, and the like, may be used in combination thereof alone or.
Among these, ylang ylang oil, fennel oil, orange oil, chamomile oil, cinnamon oil, perilla oil, citronella oil, ginger oil, camphor oil, mint oil, geranium oil, clove oil, turpentine oil, spruce oil, neroli oil Mint oil, palmarosa oil, bergamot oil, eucalyptus oil, lavender oil, linaloe oil, lemon oil, rose oil, rosemary oil, roman chamomile oil, camphor oil, mint oil, turpentine oil, mint oil, eucalyptus oil Is more preferred, and mint oil is particularly preferred.
また、テルペン類の含有量は特に限定されないが、医薬組成物全質量に対して0.01〜45質量%が好ましく、0.1〜40質量%がより好ましく、0.5〜35質量%が特に好ましい。また、上記精油を用いる場合、医薬組成物全質量に対し、精油として、0.1〜50質量%が好ましく、0.5〜40質量%がより好ましく、1〜35質量%が特に好ましい。 Moreover, although content of terpenes is not specifically limited, 0.01-45 mass% is preferable with respect to the pharmaceutical composition total mass, 0.1-40 mass% is more preferable, 0.5-35 mass% is preferable. Particularly preferred. Moreover, when using the said essential oil, 0.1-50 mass% is preferable as an essential oil with respect to pharmaceutical composition total mass, 0.5-40 mass% is more preferable, 1-35 mass% is especially preferable.
また、本発明の医薬組成物に含まれるロキソプロフェン又はその塩とテルペン類との含有比は特に限定されないが、ロキソプロフェン又はその塩をロキソプロフェンナトリウム無水物換算で1質量部に対し、テルペン類を0.01〜15質量部含有するものが好ましく、0.1〜10質量部含有するものがより好ましく、0.5〜7質量部含有するものが特に好ましい。また、上記精油を用いる場合、ロキソプロフェン又はその塩をロキソプロフェンナトリウム無水物換算で1質量部に対し、精油を0.1〜40質量部含有するものが好ましく、0.25〜30質量部含有するものがより好ましく、0.5〜20質量部含有するものが特に好ましい。 In addition, the content ratio of loxoprofen or a salt thereof and terpenes contained in the pharmaceutical composition of the present invention is not particularly limited. What contains 01-15 mass parts is preferable, What contains 0.1-10 mass parts is more preferable, What contains 0.5-7 mass parts is especially preferable. Moreover, when using the said essential oil, what contains 0.1-40 mass parts of essential oil with respect to 1 mass part of loxoprofen or its salt in conversion of loxoprofen sodium anhydride is preferable, and contains 0.25-30 mass parts Are more preferable, and those containing 0.5 to 20 parts by mass are particularly preferable.
<成分(B−2)>
本発明において、「多価アルコール」とは、同一分子内に水酸基を2個以上有するアルコールを意味し、例えば、プロピレングリコール、グリセリン、1,3−ブチレングリコール、ソルビトール、マンニトール、ジプロピレングリコール、ポリビニルアルコール、マクロゴール等が挙げられる。これらの中でも、グリセリン、1,3−ブチレングリコール、ソルビトール、マンニトール、ジプロピレングリコール、ポリビニルアルコールが好ましく、ポリビニルアルコールがより好ましい。<Component (B-2)>
In the present invention, the “polyhydric alcohol” means an alcohol having two or more hydroxyl groups in the same molecule. For example, propylene glycol, glycerin, 1,3-butylene glycol, sorbitol, mannitol, dipropylene glycol, polyvinyl Examples include alcohol and macrogol. Among these, glycerin, 1,3-butylene glycol, sorbitol, mannitol, dipropylene glycol, and polyvinyl alcohol are preferable, and polyvinyl alcohol is more preferable.
「ポリビニルアルコール」は、ポリ酢酸ビニルをけん化して得られる重合物であり、公知の方法で製造することができ、また、市販品を用いることもできる。ポリビニルアルコールの原料となる酢酸ビニルの重合度は適宜調整することができ、また、けん化度も適宜調整することができる。酢酸ビニルの重合度及びけん化度は、特に限定されるものではなく、適宜検討して決定すればよい。重合度としては、200〜3500程度が好ましく、300〜2200程度が特に好ましい。また、けん化度としては、65〜100モル%が好ましく、78〜97モル%がより好ましい。中でも、けん化度が78〜96モル%のもの(ポリビニルアルコール(部分けん化物)と称される。)及び97モル%以上のもの(ポリビニルアルコール(完全けん化物)と称される。)が更に好ましく、78〜96モル%のものが特に好ましい。 “Polyvinyl alcohol” is a polymer obtained by saponifying polyvinyl acetate, and can be produced by a known method, or a commercially available product can also be used. The degree of polymerization of vinyl acetate used as a raw material for polyvinyl alcohol can be adjusted as appropriate, and the degree of saponification can also be adjusted as appropriate. The polymerization degree and saponification degree of vinyl acetate are not particularly limited, and may be determined by appropriate examination. The degree of polymerization is preferably about 200 to 3500, and particularly preferably about 300 to 2200. Moreover, as a saponification degree, 65-100 mol% is preferable and 78-97 mol% is more preferable. Among them, those having a saponification degree of 78 to 96 mol% (referred to as polyvinyl alcohol (partially saponified product)) and those having 97 mol% or more (referred to as polyvinyl alcohol (completely saponified product)) are more preferable. 78 to 96 mol% is particularly preferable.
また、多価アルコールの含有量は特に限定されないが、医薬組成物全質量に対して、0.005〜80質量%が好ましく、0.01〜70質量%がより好ましく、0.02〜60質量%がさらに好ましく、0.1〜50質量%がさらにより好ましく、0.2〜40質量%が特に好ましい。 The content of the polyhydric alcohol is not particularly limited, but is preferably 0.005 to 80% by mass, more preferably 0.01 to 70% by mass, and 0.02 to 60% by mass with respect to the total mass of the pharmaceutical composition. % Is further preferable, 0.1 to 50% by mass is even more preferable, and 0.2 to 40% by mass is particularly preferable.
また、本発明の医薬組成物に含まれるロキソプロフェン又はその塩と、多価アルコールとの含有比は特に限定されないが、ロキソプロフェン又はその塩をロキソプロフェンナトリウム無水物換算で1質量部に対し、多価アルコールを0.005〜80質量部含有するものが好ましく、0.01〜70質量部含有するものがより好ましく、0.02〜60質量部含有するものがさらに好ましく、0.1〜50質量部含有するものがさらにより好ましく、0.2〜40質量部含有するものが特に好ましい。 In addition, the content ratio of loxoprofen or a salt thereof and a polyhydric alcohol contained in the pharmaceutical composition of the present invention is not particularly limited. Is preferably 0.005 to 80 parts by mass, more preferably 0.01 to 70 parts by mass, more preferably 0.02 to 60 parts by mass, and 0.1 to 50 parts by mass Even more preferred are those containing 0.2 to 40 parts by weight.
<成分(C)>
本発明において、「ケイ酸化合物」としては、ケイ酸化合物そのもののほか、ケイ酸化合物の塩が挙げられる。斯かるケイ酸化合物の塩としては、無機塩が好ましい。
また、上記無機塩としては、金属塩が挙げられ、その金属イオンを構成する金属としては、マグネシウム、カルシウム等のアルカリ土類金属;ナトリウム等のアルカリ金属;アルミニウム等の13族の金属等が挙げられる。<Component (C)>
In the present invention, examples of the “silicic acid compound” include silicate compounds and salts of silicate compounds. As a salt of such a silicic acid compound, an inorganic salt is preferable.
Examples of the inorganic salt include metal salts, and examples of the metal constituting the metal ion include alkaline earth metals such as magnesium and calcium; alkali metals such as sodium; and group 13 metals such as aluminum. It is done.
上述のようなケイ酸化合物の具体例としては、含水二酸化ケイ素、含水ケイ酸マグネシウム、含水ケイ酸マグネシウム(天然)等の含水ケイ酸化合物又はその塩;軽質無水ケイ酸等の軽質無水ケイ酸又はその塩;二酸化ケイ素、合成ケイ酸アルミニウム、合成ケイ酸マグネシウムナトリウム、ケイ酸カルシウム、ケイ酸マグネシウム、ケイ酸マグネシウムアルミニウム、ケイ酸アルミン酸マグネシウム、メタケイ酸アルミン酸マグネシウム等のケイ酸又はその塩の他、ケイソウ土、ベントナイト、カオリン等が挙げられる。これらは単独で用いてもよく、2種以上組み合せて用いてもよい。これらの中でも、含水二酸化ケイ素、含水ケイ酸マグネシウム、含水ケイ酸マグネシウム(天然)、軽質無水ケイ酸、二酸化ケイ素、ケイ酸カルシウム、ケイ酸アルミン酸マグネシウム、メタケイ酸アルミン酸マグネシウム、カオリンが好ましく、相互作用の抑制の観点から、軽質無水ケイ酸が特に好ましい。
なお、上記ケイ酸化合物は公知の物であり、公知の方法により製造できるほか、市販のものを用いることができる。Specific examples of the silicic acid compound as described above include hydrous silicic acid compounds such as hydrous silicon dioxide, hydrous magnesium silicate, hydrous magnesium silicate (natural) or salts thereof; light anhydrous silicic acid such as light anhydrous silicic acid; Salts thereof: Silicic acid such as silicon dioxide, synthetic aluminum silicate, synthetic sodium magnesium silicate, calcium silicate, magnesium silicate, magnesium aluminum silicate, magnesium aluminate silicate, magnesium magnesium silicate, or salts thereof Diatomaceous earth, bentonite, kaolin and the like. These may be used alone or in combination of two or more. Among these, hydrous silicon dioxide, hydrous magnesium silicate, hydrous magnesium silicate (natural), light anhydrous silicic acid, silicon dioxide, calcium silicate, magnesium aluminate, magnesium metasilicate, and kaolin are preferable. From the viewpoint of suppressing the action, light anhydrous silicic acid is particularly preferable.
In addition, the said silicic acid compound is a well-known thing, besides being able to manufacture by a well-known method, a commercially available thing can be used.
また、ケイ酸化合物の含有量は特に限定されないが、相互作用抑制作用の観点から、医薬組成物全質量に対して0.1〜45質量%が好ましく、0.5〜40質量%がより好ましく、1〜35質量%が特に好ましい。 Further, the content of the silicate compound is not particularly limited, but is preferably 0.1 to 45% by mass, more preferably 0.5 to 40% by mass with respect to the total mass of the pharmaceutical composition, from the viewpoint of the interaction suppressing action. 1 to 35% by mass is particularly preferable.
また、本発明の医薬組成物に含まれるロキソプロフェン又はその塩と、ケイ酸化合物との含有比は特に限定されず、相互作用抑制作用の観点から、ロキソプロフェン又はその塩をロキソプロフェンナトリウム無水物換算で1質量部に対し、ケイ酸化合物を0.1〜45質量部含有するものが好ましく、0.5〜40質量部含有するものがより好ましく、1〜35質量部含有するものが特に好ましい。 Moreover, the content ratio of loxoprofen or a salt thereof contained in the pharmaceutical composition of the present invention and a silicate compound is not particularly limited, and loxoprofen or a salt thereof is 1 in terms of loxoprofen sodium anhydride from the viewpoint of interaction inhibition action. Those containing 0.1 to 45 parts by mass of the silicate compound relative to parts by mass are preferred, those containing 0.5 to 40 parts by mass are more preferred, and those containing 1 to 35 parts by mass are particularly preferred.
本発明の医薬組成物は、例えば、第十六改正日本薬局方 製剤総則等に記載の公知の方法により製造することができる。また、剤形は、特に限定されるものではなく、固形状、半固形状、液状のいずれの形状であってもよく、その利用目的等に応じて医薬品において通常利用される形状とすることができる。具体的には、経口投与する製剤(錠剤、カプセル剤、顆粒剤、散剤、経口液剤、シロップ剤、経口ゼリー剤等)、膣に適用する製剤(膣錠、膣用坐剤等)、皮膚等に適用する製剤(外用固形剤、外用液剤、スプレー剤、軟膏剤、クリーム剤、ゲル剤、貼付剤等)などの、第十六改正日本薬局方 製剤総則に記載の剤形とすることができる。
本発明においては、半固形状又は液状の製剤(たとえば、含水組成物)であるのが好ましく、特に、経口液剤、シロップ剤、外用液剤、スプレー剤、軟膏剤、クリーム剤、ゲル剤、又は貼付剤であるのが好ましく、リニメント剤、ローション剤、外用エアゾール剤、ポンプスプレー剤、軟膏剤、クリーム剤、ゲル剤、テープ剤又はパップ剤であるのが特に好ましい。The pharmaceutical composition of the present invention can be produced by, for example, a known method described in the 16th revised Japanese Pharmacopoeia General Rules for Preparations. The dosage form is not particularly limited, and may be any of solid, semi-solid, and liquid shapes, and may be a shape usually used in pharmaceuticals depending on the purpose of use and the like. it can. Specifically, preparations for oral administration (tablets, capsules, granules, powders, oral solutions, syrups, oral jelly, etc.), preparations applied to the vagina (vagina tablets, vaginal suppositories, etc.), skin, etc. The dosage form described in the 16th revision of the Japanese Pharmacopoeia General Formulations for preparations such as solid preparations for external use, solutions for external use, sprays, ointments, creams, gels, patches, etc. .
In the present invention, a semi-solid or liquid preparation (for example, a water-containing composition) is preferable, and in particular, an oral solution, syrup, external solution, spray, ointment, cream, gel, or patch. Preferably, it is a liniment, lotion, external aerosol, pump spray, ointment, cream, gel, tape or poultice.
本発明の医薬組成物の服用経路としては、経口及び経皮、経膣等の非経口が挙げられ、本発明においては、非経口が好ましく、経皮投与が特に好ましい。 Examples of the route of taking the pharmaceutical composition of the present invention include oral, transdermal, and parenteral such as transvaginal. In the present invention, parenteral is preferred, and transdermal administration is particularly preferred.
本発明の医薬組成物には、医薬成分として、ロキソプロフェン又はその塩、テルペン類、多価アルコール及びケイ酸化合物以外の薬物、例えば、鎮痛成分、抗炎症成分、抗ヒスタミン成分、殺菌成分、収れん・保護成分、血行促進成分、温感成分、局所麻酔成分、鎮咳剤、ノスカピン類、気管支拡張剤、去痰剤、催眠鎮静剤、ビタミン類、抗炎症剤、胃粘膜保護剤、制酸剤、抗コリン剤、生薬類、漢方処方等からなる群より選ばれる1種又は2種以上を含んでいてもよい。 In the pharmaceutical composition of the present invention, as a pharmaceutical ingredient, a drug other than loxoprofen or a salt thereof, terpenes, polyhydric alcohol and silicate compound, for example, analgesic ingredient, anti-inflammatory ingredient, antihistamine ingredient, bactericidal ingredient, astringent Protective ingredients, blood circulation promoting ingredients, warmth ingredients, local anesthetic ingredients, antitussives, noscapine, bronchodilators, expectorants, hypnotic sedatives, vitamins, anti-inflammatory agents, gastric mucosal protective agents, antacids, anticholinergics 1 type, or 2 or more types selected from the group consisting of herbal medicines, Chinese medicine prescriptions and the like may be included.
鎮痛成分としては、例えば、アスピリン、アスピリンアルミニウム、アセトアミノフェン、イソプロピルアンチピリン、イブプロフェン、エテンザミド、サザピリン、サリチルアミド、サリチル酸、サリチル酸エチレングリコール、サリチル酸グリコール、サリチル酸ナトリウム、サリチル酸メチル、チアラミド塩酸塩、ラクチルフェネチジン等が挙げられる。
抗炎症成分としては、例えば、グアイアズレンスルホン酸ナトリウム、グリチルリチン酸、グリチルレチン酸、グリチルリチン酸二カリウム等が挙げられる。As an analgesic component, for example, aspirin, aspirin aluminum, acetaminophen, isopropylantipyrine, ibuprofen, ethenzamide, sazapyrine, salicylamide, salicylic acid, ethylene glycol salicylate, glycol salicylate, sodium salicylate, methyl salicylate, thiaramide hydrochloride, lactylphenetidine Etc.
Examples of the anti-inflammatory component include sodium guaiazulene sulfonate, glycyrrhizic acid, glycyrrhetinic acid, dipotassium glycyrrhizinate and the like.
抗ヒスタミン成分としては、例えば、アゼラスチン塩酸塩、アリメマジン酒石酸塩、イソチペンジル塩酸塩、イプロヘプチン塩酸塩、エピナスチン塩酸塩、エメダスチンフマル酸塩、ケトチフェンフマル酸塩、トリプロリジン塩酸塩、トリペレナミン塩酸塩、トンジルアミン塩酸塩、フェネタジン塩酸塩、プロメタジン塩酸塩、プロメタジンメチレン二サリチル酸塩、メキタジン、メトジラジン塩酸塩、メブヒドロリンナパジシル酸塩等が挙げられる。 Antihistamine components include, for example, azelastine hydrochloride, alimemazine tartrate, istipendil hydrochloride, iproheptin hydrochloride, epinastine hydrochloride, emedastine fumarate, ketotifen fumarate, triprolidine hydrochloride, tripelenamine hydrochloride, tondilamine Examples thereof include hydrochloride, phenetazine hydrochloride, promethazine hydrochloride, promethazine methylene disalicylate, mequitazine, methodirazine hydrochloride, and mebhydroline napadisilate.
殺菌成分としては、例えば、塩化ベンザルコニウム等が挙げられる。収れん・保護成分としては、例えば、酸化亜鉛等が挙げられる。血行促進成分としては、酢酸トコフェロール、ニコチン酸ベンジル、ヘパリン類似物質、ポリエチレンスルホン酸ナトリウム等が挙げられる。温感成分としては、例えば、ノナン酸バニリルアミド、カプサイシン、トウガラシ等が挙げられる。局所麻酔成分としては、例えば、リドカイン、チョウジ油、ベラドンナエキス等が挙げられる。 Examples of the sterilizing component include benzalkonium chloride. Examples of the astringent / protective component include zinc oxide. Examples of the blood circulation promoting component include tocopherol acetate, benzyl nicotinate, heparin-like substances, sodium polyethylene sulfonate, and the like. Examples of the warm sensation component include nonanoic acid vanillylamide, capsaicin, red pepper and the like. Examples of the local anesthetic component include lidocaine, clove oil, belladonna extract and the like.
鎮咳剤としては、例えば、アロクラミド塩酸塩、エプラジノン塩酸塩、カルベタペンタンクエン酸塩、クロペラスチン塩酸塩、クロペラスチンフェンジゾ酸塩、ジブナートナトリウム、ジメモルファンリン酸塩、チペピジンクエン酸塩、チペピジンヒベンズ酸塩等が挙げられる。 Antitussives include, for example, aloclamide hydrochloride, eprazinone hydrochloride, carbetapentane enoate, cloperastine hydrochloride, cloperastine phendizoate, dibutate sodium, dimemorphan phosphate, tipepidine citrate, And tipepidine hibenzate.
ノスカピン類としては、例えば、ノスカピン塩酸塩、ノスカピン等が挙げられる。
気管支拡張剤としては、例えば、トリメトキノール塩酸塩、フェニレフリン塩酸塩、メトキシフェナミン塩酸塩等が挙げられる。Examples of noscapine include noscapine hydrochloride and noscapine.
Examples of the bronchodilator include trimethquinol hydrochloride, phenylephrine hydrochloride, methoxyphenamine hydrochloride and the like.
去痰剤としては、例えば、アンモニア・ウイキョウ精、塩化アンモニウム等が挙げられる。 Examples of expectorants include ammonia, fennel, ammonium chloride and the like.
催眠鎮静剤としては、アリルイソプロピルアセチル尿素やブロムワレリル尿素等が挙げられる。
ビタミン類としては、ビタミンB1、ビタミンB2、ビタミンB5、ビタミンB6、ビタミンB12、ビタミンC、ヘスペリジン及びその誘導体並びにそれらの塩類等(例えば、チアミン、チアミン塩化物塩酸塩、チアミン硝化物、ジセチアミン塩酸塩、セトチアミン塩酸塩、フルスルチアミン、フルスルチアミン塩酸塩、オクトチアミン、シコチアミン、チアミンジスルフィド、ビスイブチアミン、ビスベンチアミン、プロスルチアミン、ベンフォチアミン、リボフラビン、リボフラビンリン酸エステル、リボフラビン酪酸エステル、リン酸リボフラビンナトリウム、パンテノール、パンテチン、パントテン酸ナトリウム、ピリドキシン塩酸塩、ピリドキサールリン酸エステル、シアノコバラミン、メコバラミン、アスコルビン酸、アスコルビン酸ナトリウム、アスコルビン酸カルシウム、ヘスペリジン等)が挙げられる。Examples of the hypnotic sedative include allyl isopropyl acetyl urea and bromvalerylurea.
Vitamins include vitamin B 1 , vitamin B 2 , vitamin B 5 , vitamin B 6 , vitamin B 12 , vitamin C, hesperidin and derivatives thereof, and salts thereof (for example, thiamine, thiamine chloride hydrochloride, thiamine nitrification) , Dicetiamine hydrochloride, cetothiamine hydrochloride, fursultiamine, fursultiamine hydrochloride, octothiamine, chicotiamine, thiamine disulfide, bisbutiamine, bisbenchamine, prosultiamine, benfotiamine, riboflavin, riboflavin phosphate , Riboflavin butyrate, sodium riboflavin phosphate, panthenol, panthetin, sodium pantothenate, pyridoxine hydrochloride, pyridoxal phosphate, cyanocobalamin, mecobalamin, ascorbic acid, ascorb Sodium binate, calcium ascorbate, hesperidin, etc.).
抗炎症剤としては、グリチルリチン酸及びその誘導体並びにそれらの塩類(例えば、グリチルリチン酸二カリウム、グリチルリチン酸モノアンモニウム等)、セアプローゼ、セミアルカリプロティナーゼ、セラペプターゼ、プロクターゼ、プロナーゼ、ブロメライン等が挙げられる。 Examples of the anti-inflammatory agent include glycyrrhizic acid and derivatives thereof and salts thereof (for example, dipotassium glycyrrhizinate, monoammonium glycyrrhizinate), seaprose, semi-alkaline proteinase, serrapeptase, proctase, pronase, bromelain and the like.
胃粘膜保護剤としては、ゲファルナート、セトラキサート塩酸塩、ソファルコン、テプレノン、メチルメチオニンスルホニウムクロリド等が挙げられる。
制酸剤としては、アミノ酢酸、合成ヒドロタルサイト、酸化マグネシウム、ジヒドロキシアルミニウムアミノアセテート、水酸化アルミナマグネシウム、水酸化アルミニウムゲル、乾燥水酸化アルミニウムゲル、水酸化アルミニウム・炭酸マグネシウム混合乾燥ゲル、水酸化アルミニウム・炭酸水素ナトリウムの共沈生成物、水酸化アルミニウム・炭酸カルシウム・炭酸マグネシウムの共沈生成物、水酸化マグネシウム、水酸化マグネシウム・硫酸アルミニウムカリウムの共沈生成物、炭酸マグネシウム、炭酸水素ナトリウム、沈降炭酸カルシウム、無水リン酸水素カルシウム、リン酸水素カルシウム、烏賊骨、石決明、ボレイ等が挙げられる。Examples of the gastric mucosa protective agent include gefarnate, cetraxate hydrochloride, sofalcone, teprenone, methylmethionine sulfonium chloride and the like.
As antacids, aminoacetic acid, synthetic hydrotalcite, magnesium oxide, dihydroxyaluminum aminoacetate, magnesium hydroxide alumina, aluminum hydroxide gel, dry aluminum hydroxide gel, aluminum hydroxide / magnesium carbonate mixed dry gel, hydroxylation Aluminum / sodium bicarbonate coprecipitation product, aluminum hydroxide / calcium carbonate / magnesium carbonate coprecipitation product, magnesium hydroxide, magnesium hydroxide / potassium aluminum sulfate coprecipitation product, magnesium carbonate, sodium bicarbonate, Precipitated calcium carbonate, anhydrous calcium hydrogen phosphate, calcium hydrogen phosphate, bandit bone, stone decision, volley and the like can be mentioned.
抗コリン薬としては、オキシフェンサイクリミン塩酸塩、ジサイクロミン塩酸塩、メチキセン塩酸塩、チペピジウム臭化物、メチルベナクチジウム臭化物、ピレンゼピン塩酸塩、ヨウ化イソプロパミド、ヨウ化ジフェニルピペリジノメチルジオキソラン等が挙げられる。 Examples of the anticholinergic agents include oxyphencyclimine hydrochloride, dicyclomine hydrochloride, methixene hydrochloride, chipepidium bromide, methylbenactidium bromide, pirenzepine hydrochloride, isopropamide iodide, diphenylpiperidinomethyldioxolane iodide, etc. .
生薬類としては、アカメガシワ(赤芽柏)、アセンヤク(阿仙薬)、アルニカ、インヨウカク(淫羊霍)、ウイキョウ(茴香)、ウコン(鬱金)、エンゴサク(延胡索)、オウゴン(黄岑)、オウセイ(黄精)、オウバク(黄柏)、オウヒ(桜皮)、オウレン(黄連)、オンジ(遠志)、ガジュツ(我朮)、カノコソウ(鹿子草)、カミツレ、カロニン(か楼仁)、キキョウ(桔梗)、キョウニン(杏仁)、クコシ(枸杞子)、クコヨウ(枸杞葉)、ケイガイ(荊芥)、ケイヒ(桂皮)、ケツメイシ(決明子)、ゲンチアナ、ゲンノショウコ(現証拠)、コウカ(紅花)、コウブシ(香附子)、ゴオウ(牛黄)、ゴミシ(五味子)、サイシン(細辛)、サンシシ(山梔子)、サンショウ(山椒)、シオン(紫苑)、ジコッピ(地骨皮)、シコン(紫根)、シャクヤク(芍薬)、ジャコウ(麝香)、シャジン(沙参)、シャゼンシ(車前子)、シャゼンソウ(車前草)、獣胆(ユウタン(熊胆)を含む)、ショウキョウ (生姜)、ジリュウ(地竜)、シンイ(辛夷)、セイヨウトチノキ、セキサン(石蒜)、セネガ、センキュウ(川きゅう)、ゼンコ(前胡)、センブリ(千振)、ソウジュツ(蒼朮)、ソウハクヒ(桑白皮)、ソヨウ(蘇葉)、タイサン(大蒜)、チクセツニンジン(竹節人参)、チンピ(陳皮)、トウキ(当帰)、トコン(吐根)、ナンテンジツ(南天実)、ニンジン(人参)、バイモ(貝母)、バクモンドウ(麦門冬)、ハンゲ(半夏)、バンコウカ(番紅花)、ハンピ(反鼻)、ビャクシ(白し)、ビャクジュツ(白朮)、ブクリョウ(茯苓)、ボタンピ(牡丹皮)、ヨウバイヒ(楊梅皮)、ロクジョウ(鹿茸)等の生薬及びこれらの抽出物(エキス、チンキ、乾燥エキス等)等が挙げられる。 Herbal medicines include Akamegashiwa (red buds), Asenyaku (Asenyaku), Arnica, Yinakukaku (Oyakukan), Fennel (Yellow), Turmeric (Yongyin), Engosaku (Yankou), Ogon (Yellow), Ousei (Yellow) , Owaku (yellow cocoon), Spruce (cherry bark), Oulen (yellow ren), Onji (distant), Gajutsu (Iso), valerian grass (Chicken grass), Chamomile, Caronin (Karojin), Kyo-kyo (Ki bell), Kyonin (Kyojin), Kukoshi (Birch), Kukoyo (Kashiwaha), Keigai (Kashiwagi), Keihi (Kinshikashi), Ketsumeishi (Kemeko), Gentiana, Gennoshouko (current evidence), Kouka (Safflower), Koubushi (Kagoshi), Gooh (beef yellow), trash (gomiko), saishin (spicy), sanshishi (mountain coconut), sansho (mountain candy), zion (purple vine), dicoppi (geal skin), sicon (purple root), peony (Glaze), musk (shaka), shajin (shasan), shazenshi (car front child), shazenso (car front grass), beast gall (including yutan (bear gall)), gyoza (ginger), giryu (earth dragon) 、 Shinyi (Pepper), Horse Chestnut 、 Sexan (Sardine potato) 、 Senega 、 Senkyu (Ryukyu) 、 Zenko (Mae-hu) 、 Sembli (Senshu) 、 Soujutsu (蒼朮) 、 Sohakuhaku (Mulberry white skin) 、 Soyo (Soba) ), Taisan (Daegu), Chikutsutsujinjin (Takebushi Ginseng), Chimpi (Chen), Touki (Toshiki), Tokon (Nangen), Nantenjitsu (Nan Tenji), Carrot (Ginseng), Baimo (shellfish mother), Bakumondou (Bummun winter), Hange (half-summer), Bankou (Banka), Hampi (anti-nasal), Byakushi (white), Byakujutsu (white birch), Bukryu (茯苓), Buttonpi (peony skin), Yobaihi (楊 umehi) ) 、 Rokujo (deer) etc. Examples include drugs and extracts thereof (extracts, tinctures, dried extracts, etc.).
漢方処方としては、ケイシトウ(桂枝湯)、コウソサン(香蘇散)、サイコケイシトウ(柴胡桂枝湯)、ショウサイコトウ(小柴胡湯)、バクモンドウトウ(麦門冬湯)、ハンゲコウボクトウ(半夏厚朴湯)等が挙げられる。 Herbal formulas include Keishito (Keishaeyu), Kousosan (Kousosan), Psychokeito (Shibako Keiedo), Shosai Koto (Koshisaifuto), Bakumondou (Bakumon Fuyuto), Hangekou Bokuto (Hankatsu Koboku-yu).
本発明の医薬組成物は、NSAIDの一種であるロキソプロフェン又はその塩を含有することから、医療用医薬品やOTC医薬品として用いることができ、具体的には、変形性関節症、筋肉痛及び外傷後の腫脹・疼痛から選ばれる疾患並びに症状の消炎・鎮痛等の効能又は効果を有し、鎮痛・抗炎症剤等として有用である。 Since the pharmaceutical composition of the present invention contains loxoprofen, which is a kind of NSAID, or a salt thereof, it can be used as a medical drug or an OTC drug. Specifically, osteoarthritis, myalgia and after trauma It is useful as an analgesic / anti-inflammatory agent, etc., because it has efficacy or effect such as anti-inflammatory / analgesic disease selected from swelling and pain.
以下に実施例を挙げて本発明を詳細に説明するが、本発明はこれら実施例に限定されるものではない。
[試験例1]ロキソプロフェンナトリウム水和物とl−メントールの相互作用の検討
以下に示すサンプル1−A〜1−Bをそれぞれ調製後80℃で1日間保存し、保存開始直前及び1日保存後におけるサンプル中の混合物の状態を評価し、相互作用の有無を確認した。
結果を表1に示す。EXAMPLES The present invention will be described in detail below with reference to examples, but the present invention is not limited to these examples.
[Test Example 1] Examination of interaction between loxoprofen sodium hydrate and l-menthol Samples 1-A to 1-B shown below were each prepared and stored at 80 ° C for 1 day, immediately before the start of storage and after storage for 1 day. The state of the mixture in the sample was evaluated, and the presence or absence of interaction was confirmed.
The results are shown in Table 1.
[サンプル1−A]
ロキソプロフェンナトリウム水和物(大和薬品工業製:商品名 日本薬局方 ロキソプロフェンナトリウム水和物)2g及びl−メントール(高砂香料製:商品名 l−メントール)2gを混合し、この混合物をガラス瓶に入れて、サンプル1−Aを得た。
[サンプル1−B]
ロキソプロフェンナトリウム水和物(大和薬品工業製:商品名 日本薬局方 ロキソプロフェンナトリウム水和物)2g、l−メントール(高砂香料製:商品名 l−メントール)2g及び軽質無水ケイ酸(日本アエロジル製:商品名 アエロジル300)2gを混合し、この混合物をガラス瓶に入れて、サンプル1−Bを得た。[Sample 1-A]
Loxoprofen sodium hydrate (Daiwa Pharmaceutical Co., Ltd .: trade name: Japanese Pharmacopoeia Loxoprofen Sodium Hydrate) 2g and l-menthol (Takasago Fragrance: trade name 1-menthol) 2g are mixed, and this mixture is put in a glass bottle. Sample 1-A was obtained.
[Sample 1-B]
Loxoprofen sodium hydrate (manufactured by Yamato Pharmaceutical Co., Ltd .: trade name: Japanese Pharmacopoeia Loxoprofen sodium hydrate) 2 g, l-menthol (trade name: l-menthol), 2 g of light anhydrous silicic acid (manufactured by Nippon Aerosil Co., Ltd .: product) Name Aerosil 300) 2g was mixed and this mixture was put into a glass bottle to obtain Sample 1-B.
表1記載の試験結果に示すとおり、ロキソプロフェンナトリウム水和物とl−メントールのみを混合した混合物は、1日保存後に相互作用が生じ湿潤した。
一方、ロキソプロフェンナトリウム水和物及びl−メントールに、さらに軽質無水ケイ酸を加えて混合した混合物は、1日保存後も保存開始直前と同様に白色粉体の状態が保たれていた。
以上の試験結果から、軽質無水ケイ酸を包含するケイ酸化合物が、ロキソプロフェン又はその塩と、l−メントールを包含するテルペン類との相互作用を抑制する作用を有することが明らかとなった。As shown in the test results shown in Table 1, the mixture in which only loxoprofen sodium hydrate and l-menthol were mixed interacted and became wet after storage for 1 day.
On the other hand, a mixture obtained by adding light anhydrous silicic acid to loxoprofen sodium hydrate and l-menthol was mixed and maintained in a white powder state just before the start of storage even after storage for 1 day.
From the above test results, it became clear that silicic acid compounds including light anhydrous silicic acid have an action of suppressing the interaction between loxoprofen or a salt thereof and terpenes including l-menthol.
[試験例2]ロキソプロフェンナトリウム水和物とポリビニルアルコールの相互作用の検討
以下に示すサンプル2−A〜2−Bをそれぞれ調製後80℃で5日間保存し、保存開始直前及び5日保存後におけるサンプル中の混合物の状態を評価し、相互作用の有無を確認した。
結果を表2に示す。[Test Example 2] Examination of interaction between loxoprofen sodium hydrate and polyvinyl alcohol Samples 2-A to 2-B shown below were each prepared and stored at 80 ° C. for 5 days, immediately before the start of storage and after storage for 5 days. The state of the mixture in the sample was evaluated to confirm the presence or absence of interaction.
The results are shown in Table 2.
[サンプル2−A]
ロキソプロフェンナトリウム水和物(大和薬品工業製:商品名 日本薬局方 ロキソプロフェンナトリウム水和物)2g及びポリビニルアルコール(部分けん化物)(日本合成化学工業製:商品名 ゴーセノールEG−40)2gを混合し、この混合物をガラス瓶に入れて、サンプル2−Aを得た。[Sample 2-A]
Loxoprofen sodium hydrate (manufactured by Daiwa Pharmaceutical Co., Ltd .: trade name, Japanese Pharmacopoeia Loxoprofen sodium hydrate) 2 g and polyvinyl alcohol (partially saponified product) (manufactured by Nippon Synthetic Chemical Industry Co., Ltd .: trade name Gosenol EG-40) are mixed. This mixture was put in a glass bottle to obtain Sample 2-A.
[サンプル2−B]
ロキソプロフェンナトリウム水和物(大和薬品工業製:商品名 日本薬局方 ロキソプロフェンナトリウム水和物)2g、ポリビニルアルコール(部分けん化物)(日本合成化学工業製:商品名 ゴーセノールEG−40)2g及び軽質無水ケイ酸(日本アエロジル製:商品名 アエロジル300)2gを混合し、この混合物をガラス瓶に入れて、サンプル2−Bを得た。[Sample 2-B]
Loxoprofen sodium hydrate (manufactured by Yamato Pharmaceutical Co., Ltd .: trade name, Japanese Pharmacopoeia Loxoprofen sodium hydrate) 2 g, polyvinyl alcohol (partially saponified product) (manufactured by Nippon Synthetic Chemical Industry Co., Ltd .: trade name Gohsenol EG-40) and light anhydrous silica 2 g of acid (product name: Aerosil 300 manufactured by Nippon Aerosil Co., Ltd.) was mixed, and this mixture was put in a glass bottle to obtain Sample 2-B.
表2記載の試験結果に示すとおり、ロキソプロフェンナトリウム水和物とポリビニルアルコールのみを混合した混合物は、5日保存後に相互作用が生じ変色した。
一方、ロキソプロフェンナトリウム水和物及びポリビニルアルコールに、さらに軽質無水ケイ酸を加えて混合した混合物は、5日保存後も保存開始直前と同様に白色粉体の状態が保たれていた。
以上の試験結果から、軽質無水ケイ酸を包含するケイ酸化合物が、ロキソプロフェン又はその塩と、ポリビニルアルコールを包含する多価アルコールとの相互作用を抑制する作用を有することが明らかとなった。As shown in the test results shown in Table 2, the mixture in which only loxoprofen sodium hydrate and polyvinyl alcohol were mixed exhibited interaction and discoloration after storage for 5 days.
On the other hand, a mixture of loxoprofen sodium hydrate and polyvinyl alcohol added with light anhydrous silicic acid was mixed and maintained in a white powder state just after the start of storage even after storage for 5 days.
From the above test results, it became clear that a silicic acid compound including light silicic acid anhydride has an action of suppressing the interaction between loxoprofen or a salt thereof and a polyhydric alcohol including polyvinyl alcohol.
製造例1(ゲル剤)
常法により、100g中に以下の成分を含有するゲル剤を製造した。
ロキソプロフェンナトリウム水和物 1.13g
l−メントール 3g
1,3−ブチレングリコール 5g
軽質無水ケイ酸 0.1g
クロルフェニラミンマレイン酸塩 0.1g
ヒドロキシプロピルメチルセルロース 1g
カルボキシビニルポリマー 1.2g
トリエタノールアミン 1.5g
エタノール 20g
精製水 全量100gProduction Example 1 (Gel)
By a conventional method, a gel containing the following components in 100 g was produced.
Loxoprofen sodium hydrate 1.13g
l-Menthol 3g
1,3-butylene glycol 5g
Light anhydrous silicic acid 0.1g
Chlorpheniramine maleate 0.1g
Hydroxypropyl methylcellulose 1g
Carboxyvinyl polymer 1.2g
Triethanolamine 1.5g
Ethanol 20g
100g of purified water
製造例2(テープ剤)
常法により、100g中に以下の成分を含有するテープ剤(プラスター剤)を製造した。
ロキソプロフェンナトリウム水和物 1.13g
l−メントール 6g
合成ケイ酸アルミニウム 0.5g
クロルフェニラミンマレイン酸塩 0.1g
SIS共重合体 30g
ポリイソブチレン 20g
水素添加ロジングリセリンエステル 25g
ジブチルヒドロキシトルエン 0.5g
クロタミトン 2g
流動パラフィン 全量100gProduction Example 2 (Tape)
By a conventional method, a tape preparation (plaster agent) containing the following components in 100 g was produced.
Loxoprofen sodium hydrate 1.13g
l-Menthol 6g
Synthetic aluminum silicate 0.5g
Chlorpheniramine maleate 0.1g
SIS copolymer 30g
Polyisobutylene 20g
Hydrogenated rosin glycerin ester 25g
Dibutylhydroxytoluene 0.5g
Crotamiton 2g
100g liquid paraffin
製造例3(ゲル剤)
常法により、100g中に以下の成分を含有するゲル剤(ゲルクリーム剤)を製造した。
ロキソプロフェンナトリウム水和物 1.13g
ポリビニルアルコール 0.2g
ベントナイト 0.1g
サリチル酸グリコールエステル 2g
カルボキシビニルポリマー 1g
グリセリン 10g
オクチルドデカノール 10g
モノステアリン酸グリセリン 0.5g
ステアリン酸ポリオキシル 0.5g
ミリスチン酸イソプロピル 5g
ラウロマクロゴール 1.5g
トリエタノールアミン 1g
精製水 全量100gProduction Example 3 (Gel)
By a conventional method, a gel (gel cream) containing the following components in 100 g was produced.
Loxoprofen sodium hydrate 1.13g
Polyvinyl alcohol 0.2g
Bentonite 0.1g
Salicylic acid glycol ester 2g
Carboxy vinyl polymer 1g
Glycerin 10g
Octyldodecanol 10g
0.5 g of glyceryl monostearate
Polyoxyl stearate 0.5g
5g isopropyl myristate
Lauro Macrogol 1.5g
Triethanolamine 1g
100g of purified water
製造例4(パップ剤)
常法により、100g中に以下の成分を含有するパップ剤を製造した。
ロキソプロフェンナトリウム水和物 1.13g
l−メントール 3g
ポリビニルアルコール 0.8g
カオリン 8g
軽質無水ケイ酸 0.5g
ポリアクリル酸部分中和物 7g
カルメロースナトリウム 5g
クロタミトン 2g
濃グリセリン 25g
ポリソルベート80 0.3g
水酸化アルミニウムゲル 0.05g
酸化チタン 1g
タルク 2g
酒石酸 0.6g
エデト酸ナトリウム水和物 0.1g
亜硫酸水素ナトリウム 0.3g
精製水 全量100gProduction Example 4 (cataplasm)
By a conventional method, a cataplasm containing 100% of the following components was produced.
Loxoprofen sodium hydrate 1.13g
l-Menthol 3g
Polyvinyl alcohol 0.8g
Kaolin 8g
Light anhydrous silicic acid 0.5g
7g of partially neutralized polyacrylic acid
Carmellose sodium 5g
Crotamiton 2g
Concentrated glycerin 25g
Polysorbate 80 0.3g
Aluminum hydroxide gel 0.05g
Titanium oxide 1g
Talc 2g
Tartaric acid 0.6g
Edetate sodium hydrate 0.1g
Sodium bisulfite 0.3g
100g of purified water
製造例5(ローション剤)
常法により、100g中に以下の成分を含有するローション剤を製造した。
ロキソプロフェンナトリウム水和物 1.13g
ハッカ油 6g
ケイ酸アルミン酸マグネシウム 0.1g
ノナン酸バニリルアミド 0.1g
クロルフェニラミンマレイン酸塩 0.5g
アジピン酸ジイソプロピル 5g
イソプロパノール 40g
ヒドロキシプロピルメチルセルロース 0.1g
ポリエチレングリコール 1g
亜硫酸水素ナトリウム 0.2g
精製水 全量100gProduction Example 5 (Lotion)
By a conventional method, a lotion preparation containing the following components in 100 g was produced.
Loxoprofen sodium hydrate 1.13g
Peppermint oil 6g
Magnesium aluminate silicate 0.1g
Nonanoic acid vanillylamide 0.1 g
Chlorpheniramine maleate 0.5g
Diisopropyl adipate 5g
Isopropanol 40g
Hydroxypropyl methylcellulose 0.1g
Polyethylene glycol 1g
Sodium bisulfite 0.2g
100g of purified water
製造例6(テープ剤)
常法により、100g中に以下の成分を含有するテープ剤(プラスター剤)を製造した。
ロキソプロフェンナトリウム水和物 1.13g
l−メントール 1g
ケイ酸マグネシウム 0.5g
ノナン酸バニリルアミド 0.12g
クロルフェニラミンマレイン酸塩 0.5g
SIS共重合体 30g
ポリイソブチレン 20g
水素添加ロジングリセリンエステル 25g
ジブチルヒドロキシトルエン 0.5g
クロタミトン 2g
流動パラフィン 全量100gProduction Example 6 (Tape)
By a conventional method, a tape preparation (plaster agent) containing the following components in 100 g was produced.
Loxoprofen sodium hydrate 1.13g
l-Menthol 1g
Magnesium silicate 0.5g
Nonanoic acid vanillylamide 0.12 g
Chlorpheniramine maleate 0.5g
SIS copolymer 30g
Polyisobutylene 20g
Hydrogenated rosin glycerin ester 25g
Dibutylhydroxytoluene 0.5g
Crotamiton 2g
100g liquid paraffin
製造例7(クリーム剤)
常法により、100g中に以下の成分を含有するクリーム剤を製造した。
ロキソプロフェンナトリウム水和物 1.13g
dl−カンフル 4g
ポリビニルアルコール 0.2g
軽質無水ケイ酸 0.5g
ノナン酸バニリルアミド 0.12g
カルボキシビニルポリマー 0.8g
エデト酸ナトリウム水和物 0.01g
亜硫酸水素ナトリウム 0.1g
ミリスチン酸オクチルドデシル 10g
アジピン酸ジイソプロピル 5g
モノステアリン酸グリセリン 2g
モノステアリン酸ソルビタン 0.5g
モノステアリン酸ポリオキシエチレンソルビタン 1g
パラベン 0.2g
水酸化ナトリウム 0.1g
精製水 全量100gProduction Example 7 (Cream)
A cream containing the following components in 100 g was produced by a conventional method.
Loxoprofen sodium hydrate 1.13g
dl-Camphor 4g
Polyvinyl alcohol 0.2g
Light anhydrous silicic acid 0.5g
Nonanoic acid vanillylamide 0.12 g
Carboxy vinyl polymer 0.8g
Edetate sodium hydrate 0.01g
Sodium bisulfite 0.1g
Octyldodecyl myristate 10g
Diisopropyl adipate 5g
2g glyceryl monostearate
Sorbitan monostearate 0.5g
1g polyoxyethylene sorbitan monostearate
Paraben 0.2g
Sodium hydroxide 0.1g
100g of purified water
製造例8(パップ剤)
常法により、100g中に以下の成分を含有するパップ剤を製造した。
ロキソプロフェンナトリウム水和物 1.13g
l−メントール 3g
ポリビニルアルコール 2g
カオリン 2.5g
ノナン酸バニリルアミド 0.1g
ポリアクリル酸部分中和物 7g
カルメロースナトリウム 5g
N−メチル−2−ピロリドン 2g
濃グリセリン 25g
ポリソルベート80 0.3g
水酸化アルミニウムゲル 0.05g
酸化チタン 1g
タルク 2g
酒石酸 0.6g
エデト酸ナトリウム水和物 0.1g
亜硫酸水素ナトリウム 0.3g
精製水 全量100gProduction Example 8 (cataplasm)
By a conventional method, a cataplasm containing 100% of the following components was produced.
Loxoprofen sodium hydrate 1.13g
l-Menthol 3g
Polyvinyl alcohol 2g
Kaolin 2.5g
Nonanoic acid vanillylamide 0.1 g
7g of partially neutralized polyacrylic acid
Carmellose sodium 5g
N-methyl-2-pyrrolidone 2g
Concentrated glycerin 25g
Polysorbate 80 0.3g
Aluminum hydroxide gel 0.05g
Titanium oxide 1g
Talc 2g
Tartaric acid 0.6g
Edetate sodium hydrate 0.1g
Sodium bisulfite 0.3g
100g of purified water
本発明によれば、ロキソプロフェン又はその塩と相互作用性成分との相互作用を抑制できる。従って、保存安定性が優れた、ロキソプロフェン又はその塩、及び相互作用性成分を含む医薬組成物を提供することができる。本発明の医薬組成物は、NSAIDの一種であるロキソプロフェンを含有することから、例えば、変形性関節症、筋肉痛及び外傷後の腫脹・疼痛から選ばれる疾患並びに症状の消炎・鎮痛等に有効な医薬組成物として好適に利用できる。 According to the present invention, the interaction between loxoprofen or a salt thereof and an interactive component can be suppressed. Therefore, it is possible to provide a pharmaceutical composition comprising loxoprofen or a salt thereof and an interactive component, which has excellent storage stability. Since the pharmaceutical composition of the present invention contains loxoprofen, which is a kind of NSAID, it is effective for, for example, diseases selected from osteoarthritis, myalgia and swelling / pain after trauma, as well as anti-inflammatory / analgesic symptoms. It can be suitably used as a pharmaceutical composition.
Claims (2)
(A)ロキソプロフェン又はその塩
(B)l−メントール
(C)軽質無水ケイ酸
を含有する貼付剤。 The following components (A), (B) and (C):
A patch comprising (A) loxoprofen or a salt thereof (B) l-menthol (C) light silicic anhydride .
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JP2017173892A Active JP6397100B2 (en) | 2012-06-22 | 2017-09-11 | Pharmaceutical composition 3 containing loxoprofen |
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JP2020083613A Active JP6913795B2 (en) | 2012-06-22 | 2020-05-12 | Pharmaceutical composition containing loxoprofen 5 |
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JP2020002044A (en) * | 2018-06-27 | 2020-01-09 | 小林製薬株式会社 | External pharmaceutical composition |
JP2020002045A (en) * | 2018-06-27 | 2020-01-09 | 小林製薬株式会社 | External pharmaceutical composition |
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JP2022122784A (en) * | 2021-02-10 | 2022-08-23 | コスメディ製薬株式会社 | Antioxidant-containing transdermal absorption preparation |
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JP2018021066A (en) | 2018-02-08 |
JPWO2013191293A1 (en) | 2016-05-26 |
JP2021165312A (en) | 2021-10-14 |
JP2015013847A (en) | 2015-01-22 |
JP2018184479A (en) | 2018-11-22 |
JP6210872B2 (en) | 2017-10-11 |
JP6397100B2 (en) | 2018-09-26 |
JP6913794B2 (en) | 2021-08-04 |
JP6913795B2 (en) | 2021-08-04 |
JP2020122014A (en) | 2020-08-13 |
JP2020117543A (en) | 2020-08-06 |
WO2013191293A1 (en) | 2013-12-27 |
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