JP2023124838A - Pharmaceutical composition - Google Patents
Pharmaceutical composition Download PDFInfo
- Publication number
- JP2023124838A JP2023124838A JP2023026137A JP2023026137A JP2023124838A JP 2023124838 A JP2023124838 A JP 2023124838A JP 2023026137 A JP2023026137 A JP 2023026137A JP 2023026137 A JP2023026137 A JP 2023026137A JP 2023124838 A JP2023124838 A JP 2023124838A
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical composition
- salts
- sodium
- hydrochloride
- powder
- 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.)
- Pending
Links
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 69
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 claims abstract description 31
- 150000003839 salts Chemical class 0.000 claims abstract description 20
- 229960005489 paracetamol Drugs 0.000 claims abstract description 16
- GYDJEQRTZSCIOI-LJGSYFOKSA-N tranexamic acid Chemical compound NC[C@H]1CC[C@H](C(O)=O)CC1 GYDJEQRTZSCIOI-LJGSYFOKSA-N 0.000 claims abstract description 11
- 229960000401 tranexamic acid Drugs 0.000 claims abstract description 11
- 239000000203 mixture Substances 0.000 claims description 33
- 239000008187 granular material Substances 0.000 claims description 18
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- 238000009472 formulation Methods 0.000 claims description 16
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- 238000002360 preparation method Methods 0.000 claims description 8
- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 claims description 6
- 239000003907 antipyretic analgesic agent Substances 0.000 claims description 6
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- 229940124579 cold medicine Drugs 0.000 claims description 5
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- 239000008203 oral pharmaceutical composition Substances 0.000 claims description 3
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- CMWTZPSULFXXJA-VIFPVBQESA-N naproxen Chemical compound C1=C([C@H](C)C(O)=O)C=CC2=CC(OC)=CC=C21 CMWTZPSULFXXJA-VIFPVBQESA-N 0.000 description 1
- PLPRGLOFPNJOTN-UHFFFAOYSA-N narcotine Natural products COc1ccc2C(OC(=O)c2c1OC)C3Cc4c(CN3C)cc5OCOc5c4OC PLPRGLOFPNJOTN-UHFFFAOYSA-N 0.000 description 1
- 150000002823 nitrates Chemical class 0.000 description 1
- 239000000820 nonprescription drug Substances 0.000 description 1
- VJTXQHYNRDGLON-LTGZKZEYSA-N octotiamine Chemical compound COC(=O)CCCCC(SC(C)=O)CCSS\C(CCO)=C(/C)N(C=O)CC1=CN=C(C)N=C1N VJTXQHYNRDGLON-LTGZKZEYSA-N 0.000 description 1
- 229950011324 octotiamine Drugs 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 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
- DJWYOLJPSHDSAL-ROUUACIJSA-N pantethine Chemical compound OCC(C)(C)[C@@H](O)C(=O)NCCC(=O)NCCSSCCNC(=O)CCNC(=O)[C@H](O)C(C)(C)CO DJWYOLJPSHDSAL-ROUUACIJSA-N 0.000 description 1
- 229960000903 pantethine Drugs 0.000 description 1
- 235000008975 pantethine Nutrition 0.000 description 1
- 239000011581 pantethine Substances 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
- 229940056211 paraffin Drugs 0.000 description 1
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- 235000020733 paullinia cupana extract Nutrition 0.000 description 1
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- 235000019477 peppermint oil Nutrition 0.000 description 1
- VLTRZXGMWDSKGL-UHFFFAOYSA-N perchloric acid Chemical class OCl(=O)(=O)=O VLTRZXGMWDSKGL-UHFFFAOYSA-N 0.000 description 1
- 229940124531 pharmaceutical excipient Drugs 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
- 229960002305 phenylpropanolamine hydrochloride Drugs 0.000 description 1
- 208000026435 phlegm Diseases 0.000 description 1
- 150000003013 phosphoric acid derivatives Chemical class 0.000 description 1
- PJNZPQUBCPKICU-UHFFFAOYSA-N phosphoric acid;potassium Chemical compound [K].OP(O)(O)=O PJNZPQUBCPKICU-UHFFFAOYSA-N 0.000 description 1
- 239000011574 phosphorus Substances 0.000 description 1
- 229910052698 phosphorus Inorganic materials 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 239000006187 pill Substances 0.000 description 1
- 239000010665 pine oil Substances 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 238000006116 polymerization reaction Methods 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
- KYKNRZGSIGMXFH-ZVGUSBNCSA-M potassium bitartrate Chemical compound [K+].OC(=O)[C@H](O)[C@@H](O)C([O-])=O KYKNRZGSIGMXFH-ZVGUSBNCSA-M 0.000 description 1
- 229940086065 potassium hydrogentartrate Drugs 0.000 description 1
- 159000000001 potassium salts Chemical class 0.000 description 1
- XEIOPEQGDSYOIH-MURFETPASA-N propan-2-yl (9z,12z)-octadeca-9,12-dienoate Chemical compound CCCCC\C=C/C\C=C/CCCCCCCC(=O)OC(C)C XEIOPEQGDSYOIH-MURFETPASA-N 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
- 229960004767 proxyphylline Drugs 0.000 description 1
- 229960003447 pseudoephedrine hydrochloride Drugs 0.000 description 1
- BALXUFOVQVENIU-KXNXZCPBSA-N pseudoephedrine hydrochloride Chemical compound [H+].[Cl-].CN[C@@H](C)[C@@H](O)C1=CC=CC=C1 BALXUFOVQVENIU-KXNXZCPBSA-N 0.000 description 1
- 150000003222 pyridines Chemical class 0.000 description 1
- 235000007682 pyridoxal 5'-phosphate Nutrition 0.000 description 1
- 239000011589 pyridoxal 5'-phosphate Substances 0.000 description 1
- RADKZDMFGJYCBB-UHFFFAOYSA-N pyridoxal hydrochloride Natural products CC1=NC=C(CO)C(C=O)=C1O RADKZDMFGJYCBB-UHFFFAOYSA-N 0.000 description 1
- 229960001327 pyridoxal phosphate Drugs 0.000 description 1
- 235000019171 pyridoxine hydrochloride Nutrition 0.000 description 1
- 239000011764 pyridoxine hydrochloride Substances 0.000 description 1
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- 229950004535 rebamipide Drugs 0.000 description 1
- 210000000664 rectum Anatomy 0.000 description 1
- 235000009566 rice Nutrition 0.000 description 1
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- 239000008132 rose water Substances 0.000 description 1
- CVHZOJJKTDOEJC-UHFFFAOYSA-N saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 description 1
- 229940085605 saccharin sodium Drugs 0.000 description 1
- 229960000581 salicylamide Drugs 0.000 description 1
- 239000000523 sample Substances 0.000 description 1
- 229940048730 senega Drugs 0.000 description 1
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- 239000010243 sho-seiryu-to Substances 0.000 description 1
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- PPASLZSBLFJQEF-RKJRWTFHSA-M sodium ascorbate Substances [Na+].OC[C@@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RKJRWTFHSA-M 0.000 description 1
- 235000010378 sodium ascorbate Nutrition 0.000 description 1
- 229960005055 sodium ascorbate Drugs 0.000 description 1
- JWBPVFVNISJVEM-UHFFFAOYSA-M sodium caffeine benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1.CN1C(=O)N(C)C(=O)C2=C1N=CN2C JWBPVFVNISJVEM-UHFFFAOYSA-M 0.000 description 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 1
- XYEXKDCAGSHWSD-UHFFFAOYSA-M sodium dibunate Chemical compound [Na+].[O-]S(=O)(=O)C1=C(C(C)(C)C)C=CC2=CC(C(C)(C)C)=CC=C21 XYEXKDCAGSHWSD-UHFFFAOYSA-M 0.000 description 1
- HEMHJVSKTPXQMS-UHFFFAOYSA-M sodium hydroxide Substances [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 1
- 235000011121 sodium hydroxide Nutrition 0.000 description 1
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- JGMJQSFLQWGYMQ-UHFFFAOYSA-M sodium;2,6-dichloro-n-phenylaniline;acetate Chemical compound [Na+].CC([O-])=O.ClC1=CC=CC(Cl)=C1NC1=CC=CC=C1 JGMJQSFLQWGYMQ-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
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- 235000011076 sorbitan monostearate Nutrition 0.000 description 1
- 239000001587 sorbitan monostearate Substances 0.000 description 1
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- 235000013555 soy sauce Nutrition 0.000 description 1
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- 239000010675 spruce oil Substances 0.000 description 1
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- 239000004575 stone Substances 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 description 1
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- 239000007940 sugar coated tablet Substances 0.000 description 1
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- 235000015523 tannic acid Nutrition 0.000 description 1
- 229920002258 tannic acid Polymers 0.000 description 1
- LRBQNJMCXXYXIU-NRMVVENXSA-N tannic acid Chemical compound OC1=C(O)C(O)=CC(C(=O)OC=2C(=C(O)C=C(C=2)C(=O)OC[C@@H]2[C@H]([C@H](OC(=O)C=3C=C(OC(=O)C=4C=C(O)C(O)=C(O)C=4)C(O)=C(O)C=3)[C@@H](OC(=O)C=3C=C(OC(=O)C=4C=C(O)C(O)=C(O)C=4)C(O)=C(O)C=3)[C@@H](OC(=O)C=3C=C(OC(=O)C=4C=C(O)C(O)=C(O)C=4)C(O)=C(O)C=3)O2)OC(=O)C=2C=C(OC(=O)C=3C=C(O)C(O)=C(O)C=3)C(O)=C(O)C=2)O)=C1 LRBQNJMCXXYXIU-NRMVVENXSA-N 0.000 description 1
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- 239000008399 tap water Substances 0.000 description 1
- 235000020679 tap water Nutrition 0.000 description 1
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- 238000010998 test method Methods 0.000 description 1
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- 235000019157 thiamine Nutrition 0.000 description 1
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- 239000011721 thiamine Substances 0.000 description 1
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- UIERGBJEBXXIGO-UHFFFAOYSA-N thiamine mononitrate Chemical compound [O-][N+]([O-])=O.CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N UIERGBJEBXXIGO-UHFFFAOYSA-N 0.000 description 1
- HTJXMOGUGMSZOG-UHFFFAOYSA-N tiaramide Chemical compound C1CN(CCO)CCN1C(=O)CN1C(=O)SC2=CC=C(Cl)C=C21 HTJXMOGUGMSZOG-UHFFFAOYSA-N 0.000 description 1
- 229950010302 tiaramide Drugs 0.000 description 1
- 229960000896 tipepidine Drugs 0.000 description 1
- 229960005196 titanium dioxide Drugs 0.000 description 1
- JOXIMZWYDAKGHI-UHFFFAOYSA-N toluene-4-sulfonic acid Chemical compound CC1=CC=C(S(O)(=O)=O)C=C1 JOXIMZWYDAKGHI-UHFFFAOYSA-N 0.000 description 1
- 208000004371 toothache Diseases 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
- 229960002622 triacetin Drugs 0.000 description 1
- IMFACGCPASFAPR-UHFFFAOYSA-N tributylamine Chemical class CCCCN(CCCC)CCCC IMFACGCPASFAPR-UHFFFAOYSA-N 0.000 description 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
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- ITMCEJHCFYSIIV-UHFFFAOYSA-M triflate Chemical compound [O-]S(=O)(=O)C(F)(F)F ITMCEJHCFYSIIV-UHFFFAOYSA-M 0.000 description 1
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- CUZMOIXUFHOLLN-UMVVUDSKSA-N triprolidine hydrochloride monohydrate Chemical compound O.Cl.C1=CC(C)=CC=C1C(\C=1N=CC=CC=1)=C/CN1CCCC1 CUZMOIXUFHOLLN-UMVVUDSKSA-N 0.000 description 1
- CCXAYLQLOLXXKE-DWJAGBRCSA-K trisodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4s,5s,6s)-2-[[(3s,4ar,6ar,6bs,8as,11s,12ar,14ar,14bs)-11-carboxylato-4,4,6a,6b,8a,11,14b-heptamethyl-14-oxo-2,3,4a,5,6,7,8,9,10,12,12a,14a-dodecahydro-1h-picen-3-yl]oxy]-6-carboxylato-4,5-dihydroxyoxan-3-yl]oxy-3,4,5-t Chemical compound [Na+].[Na+].[Na+].O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@H]1CC[C@]2(C)[C@H]3C(=O)C=C4[C@@H]5C[C@](C)(CC[C@@]5(CC[C@@]4(C)[C@]3(C)CC[C@H]2C1(C)C)C)C([O-])=O)C([O-])=O)[C@@H]1O[C@H](C([O-])=O)[C@@H](O)[C@H](O)[C@H]1O CCXAYLQLOLXXKE-DWJAGBRCSA-K 0.000 description 1
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- MWOOGOJBHIARFG-UHFFFAOYSA-N vanillin Chemical compound COC1=CC(C=O)=CC=C1O MWOOGOJBHIARFG-UHFFFAOYSA-N 0.000 description 1
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- 230000037303 wrinkles Effects 0.000 description 1
- XOOUIPVCVHRTMJ-UHFFFAOYSA-L zinc stearate Chemical compound [Zn+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O XOOUIPVCVHRTMJ-UHFFFAOYSA-L 0.000 description 1
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- OENHQHLEOONYIE-JLTXGRSLSA-N β-Carotene Chemical compound CC=1CCCC(C)(C)C=1\C=C\C(\C)=C\C=C\C(\C)=C\C=C\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C OENHQHLEOONYIE-JLTXGRSLSA-N 0.000 description 1
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- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
本発明は、医薬組成物に関する。 The present invention relates to pharmaceutical compositions.
解熱鎮痛成分が配合された医薬製剤の例として、特許文献1(特開2020-105108号公報)に記載のものがある。同文献には、素錠と、素錠の表面を被覆するフィルムコーティング層と、フィルムコーティング層の表面を被覆する糖衣層とを有し、素錠がアセトアミノフェン、クロルフェニラミンマレイン酸塩又はd-クロルフェニラミンマレイン酸塩、デキストロメトルファン臭化水素酸塩水和物又はデキストロメトルファン・フェノールフタリン塩、dl-メチルエフェドリン塩酸塩又はdl-メチルエフェドリンサッカリン塩、グアヤコールスルホン酸カリウムおよび無水カフェイン又はカフェイン水和物を含み、フィルムコーティング層がヒプロメロースを含む、糖衣錠について記載されている(請求項1)。 An example of a pharmaceutical formulation containing an antipyretic analgesic component is described in Patent Document 1 (Japanese Patent Application Laid-Open No. 2020-105108). In the same document, it has an uncoated tablet, a film coating layer covering the surface of the uncoated tablet, and a sugar-coating layer covering the surface of the film coating layer, and the uncoated tablet is acetaminophen, chlorpheniramine maleate or d-chlorpheniramine maleate, dextromethorphan hydrobromide hydrate or dextromethorphan phenolphthalate, dl-methylephedrine hydrochloride or dl-methylephedrine saccharin salt, potassium guaiacolsulfonate and anhydrous caffeine A dragee containing ine or caffeine hydrate and a film coating layer containing hypromellose is described (Claim 1).
アセトアミノフェンは、副作用が少なく安全性の高い解熱鎮痛成分として小児から成人にまで用いられている。一方、アセトアミノフェンの作用は緩和であるため、より高い解熱効果を発揮するという点で改善の余地があった。 Acetaminophen is used by children to adults as an antipyretic analgesic component with few side effects and high safety. On the other hand, since the action of acetaminophen is palliative, there is room for improvement in that it exhibits a higher antipyretic effect.
そこで、本発明は、優れた解熱作用を有する医薬組成物を提供する。 Accordingly, the present invention provides a pharmaceutical composition having excellent antipyretic activity.
本発明によれば、以下の医薬組成物が提供される。
[1] (A)アセトアミノフェンと、
(B)トラネキサム酸およびその塩からなる群から選択される少なくとも一種と、
を含有し、
前記成分(A)の含有量に対する前記成分(B)の含有量の質量比((B)/(A))が0.50以上1.0以下である、医薬組成物。
[2] イブプロフェンを含まない、[1]に記載の医薬組成物。
[3] 当該医薬組成物中の前記成分(A)の含有量が、当該医薬組成物全体に対して20質量%以上66質量%以下である、[1]または[2]に記載の医薬組成物。
[4] 経口医薬組成物である、[1]乃至[3]いずれか一つに記載の医薬組成物。
[5] 感冒薬または解熱鎮痛薬として用いられる、[1]乃至[4]いずれか一つに記載の医薬組成物。
[6] 固形製剤である、[1]乃至[5]いずれか一つに記載の医薬組成物。
[7] 前記固形製剤の剤形が、錠剤、細粒剤、顆粒剤またはカプセル剤である、[6]に記載の医薬組成物。
According to the present invention, the following pharmaceutical composition is provided.
[1] (A) acetaminophen;
(B) at least one selected from the group consisting of tranexamic acid and salts thereof;
contains
A pharmaceutical composition, wherein the mass ratio of the content of component (B) to the content of component (A) ((B)/(A)) is 0.50 or more and 1.0 or less.
[2] The pharmaceutical composition of [1], which does not contain ibuprofen.
[3] The pharmaceutical composition according to [1] or [2], wherein the content of the component (A) in the pharmaceutical composition is 20% by mass or more and 66% by mass or less with respect to the entire pharmaceutical composition. thing.
[4] The pharmaceutical composition according to any one of [1] to [3], which is an oral pharmaceutical composition.
[5] The pharmaceutical composition according to any one of [1] to [4], which is used as a cold medicine or an antipyretic analgesic.
[6] The pharmaceutical composition according to any one of [1] to [5], which is a solid formulation.
[7] The pharmaceutical composition of [6], wherein the dosage form of the solid preparation is tablet, fine granules, granules or capsules.
本発明によれば、優れた解熱作用を有する医薬組成物を提供することができる。 ADVANTAGE OF THE INVENTION According to this invention, the pharmaceutical composition which has the outstanding antipyretic action can be provided.
以下、本発明の実施形態について説明する。本実施形態において、組成物は、各成分をいずれも単独でまたは2種以上を組み合わせて含むことができる。
本明細書において、数値範囲を示す「~」は、以上、以下を表し、両端の数値をいずれも含む。
Embodiments of the present invention will be described below. In this embodiment, the composition can contain each component alone or in combination of two or more.
In the present specification, "-" indicating a numerical range represents above and below, and includes both numerical values at both ends.
(医薬組成物)
本実施形態において、医薬組成物は、以下の成分(A)および(B)を含む。
(A)アセトアミノフェン
(B)トラネキサム酸およびその塩からなる群から選択される少なくとも一種
成分(A)の含有量に対する前記成分(B)の含有量の質量比((B)/(A))が0.50以上1.0以下である。
以下、各成分について説明する。
(Pharmaceutical composition)
In this embodiment, the pharmaceutical composition contains the following components (A) and (B).
(A) acetaminophen (B) at least one selected from the group consisting of tranexamic acid and salts thereof Mass ratio of the content of component (B) to the content of component (A) ((B)/(A) ) is 0.50 or more and 1.0 or less.
Each component will be described below.
(成分(A))
成分(A)は、アセトアミノフェン(別名パラセタモール)である。アセトアミノフェンは、第十八改正日本薬局方に収載されている。
成分(A)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。
(Component (A))
Component (A) is acetaminophen (also known as paracetamol). Acetaminophen is listed in the Japanese Pharmacopoeia 18th Edition.
Component (A) is a known compound, can be produced by a known method, or can be commercially available.
医薬組成物への成分(A)の配合量は、限定されず、服用者の性別、年齢、症状等に応じて、適宜検討して決定すればよい。たとえば、アセトアミノフェンの成人の1日量としては、通常150~4000mgであり、好ましくは300~1500mgである。たとえば、成分(A)の小児用の1日量としては、通常10~1500mgであり、好ましくは30~900mgである。なお、投与回数はたとえば1日1~3回である。 The amount of component (A) to be added to the pharmaceutical composition is not limited, and may be determined by considering the gender, age, symptoms, etc. of the recipient as appropriate. For example, the daily dose of acetaminophen for adults is usually 150-4000 mg, preferably 300-1500 mg. For example, the daily dose of component (A) for children is generally 10-1500 mg, preferably 30-900 mg. The administration frequency is, for example, 1 to 3 times a day.
また、医薬組成物中の成分(A)の含有量は、解熱効果向上の観点から、医薬組成物全体(全組成)に対して好ましくは20質量%以上であり、より好ましくは22質量%以上であり、25質量%以上であってもよい。
また、製剤物性をより好ましいものとする観点から、医薬組成物中の成分(A)の含有量は、医薬組成物全体(全組成)に対して、たとえば80質量%以下であってもよく、好ましくは66質量%以下であり、より好ましくは60質量%以下である。
また、医薬組成物が総合感冒薬として用いられるとき、医薬組成物中の成分(A)の含有量は、医薬組成物全体(全組成)に対して、好ましくは22質量%以上であり、また、好ましくは66質量%以下である。
医薬組成物が解熱鎮痛薬として用いられるとき、医薬組成物中の成分(A)の含有量は、医薬組成物全体(全組成)に対して、好ましくは20質量%以上であり、また、好ましくは60質量%以下である。
In addition, the content of component (A) in the pharmaceutical composition is preferably 20% by mass or more, more preferably 22% by mass or more, relative to the entire pharmaceutical composition (total composition), from the viewpoint of improving the antipyretic effect. and may be 25% by mass or more.
Further, from the viewpoint of making the physical properties of the formulation more preferable, the content of component (A) in the pharmaceutical composition may be, for example, 80% by mass or less with respect to the entire pharmaceutical composition (total composition), It is preferably 66% by mass or less, more preferably 60% by mass or less.
In addition, when the pharmaceutical composition is used as a general cold remedy, the content of component (A) in the pharmaceutical composition is preferably 22% by mass or more relative to the entire pharmaceutical composition (total composition), and , preferably 66% by mass or less.
When the pharmaceutical composition is used as an antipyretic analgesic, the content of component (A) in the pharmaceutical composition is preferably 20% by mass or more of the entire pharmaceutical composition (total composition), and is also preferably is 60% by mass or less.
(成分(B))
成分(B)は、トラネキサム酸およびその塩からなる群から選択される少なくとも一種であり、好ましくはトラネキサム酸である。
成分(B)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。たとえば成分(B)は、トラネキサム酸として第18改正日本薬局方に掲載されている。
また、成分(B)のうち、トラネキサム酸塩の具体例として、フッ化水素酸塩、塩酸塩、臭化水素酸塩、ヨウ化水素酸塩等のハロゲン化水素酸塩;
硝酸塩、過塩素酸塩、硫酸塩、リン酸塩等の無機酸塩;
メタンスルホン酸塩、トリフルオロメタンスルホン酸塩、エタンスルホン酸塩等の炭素数1以上4以下のアルカンスルホン酸塩;
ベンゼンスルホン酸塩、p-トルエンスルホン酸塩等のアリールスルホン酸塩;
酢酸塩、リンゴ酸塩、フマル酸塩、コハク酸塩、クエン酸塩、アスコルビン酸塩、酒石酸塩、シュウ酸塩、マレイン酸塩等の有機酸塩;
ナトリウム塩、カリウム塩等のアルカリ金属塩;
カルシウム塩、マグネシウム塩等のアルカリ土類金属塩;
N-メチルモルホリン塩、トリエチルアミン塩、トリブチルアミン塩、ジイソプロピルエチルアミン塩、ジシクロヘキシルアミン塩、N-メチルピペリジン塩、ピリジン塩、4-ピロリジノピリジン塩、ピコリン塩等の有機アミン塩;および
グリシン塩、リジン塩、アルギニン塩、オルニチン塩、グルタミン酸塩、アスパラギン酸塩等のアミノ酸との塩からなる群から選択される一種または二種以上が挙げられる。
また、医薬組成物中の成分(B)の含有量は、たとえば、服用者の性別、年齢、症状等に応じて、適宜検討して決定してよく、1日量として、50~1500mgであってよく、好ましくは280~750mgである。なお、投与回数はたとえば1日1~3回である。
(Component (B))
Component (B) is at least one selected from the group consisting of tranexamic acid and salts thereof, preferably tranexamic acid.
Component (B) is a known compound, can be produced by a known method, or can be commercially available. For example, component (B) is listed in the Japanese Pharmacopoeia 18th Edition as tranexamic acid.
Further, among component (B), specific examples of tranexamate include hydrohalides such as hydrofluoride, hydrochloride, hydrobromide, and hydroiodide;
Inorganic acid salts such as nitrates, perchlorates, sulfates, phosphates;
alkanesulfonates having 1 to 4 carbon atoms such as methanesulfonate, trifluoromethanesulfonate and ethanesulfonate;
arylsulfonates such as benzenesulfonate and p-toluenesulfonate;
Organic acid salts such as acetate, malate, fumarate, succinate, citrate, ascorbate, tartrate, oxalate, maleate;
alkali metal salts such as sodium salts and potassium salts;
alkaline earth metal salts such as calcium salts and magnesium salts;
organic amine salts such as N-methylmorpholine salts, triethylamine salts, tributylamine salts, diisopropylethylamine salts, dicyclohexylamine salts, N-methylpiperidine salts, pyridine salts, 4-pyrrolidinopyridine salts, picoline salts; and glycine salts, lysine One or more selected from the group consisting of salts with amino acids such as salts, arginine salts, ornithine salts, glutamates, and aspartates.
In addition, the content of the component (B) in the pharmaceutical composition may be appropriately determined according to, for example, the sex, age, symptoms, etc. of the recipient, and the daily dose is 50 to 1500 mg. preferably 280-750 mg. The administration frequency is, for example, 1 to 3 times a day.
医薬組成物中の成分(B)の配合量は、具体的には、質量比((B)/(A))が以下の範囲となる量とすることができる。
すなわち、医薬組成物における質量比((B)/(A))は、解熱効果向上の観点から、0.50以上である。また、たとえば0.60以上、または、たとえば0.70以上であってもよい。
また、製剤の服用性向上の観点、および、製剤の大きさをより好適なものとする観点から、質量比((B)/(A))は、1.0以下であり、好ましくは0.95以下、より好ましくは0.85以下である。
Specifically, the amount of component (B) in the pharmaceutical composition can be such that the mass ratio ((B)/(A)) is within the following range.
That is, the mass ratio ((B)/(A)) in the pharmaceutical composition is 0.50 or more from the viewpoint of improving the antipyretic effect. It may also be, for example, 0.60 or more, or, for example, 0.70 or more.
In addition, from the viewpoint of improving the ease of administration of the formulation and from the viewpoint of making the size of the formulation more suitable, the mass ratio ((B)/(A)) is 1.0 or less, preferably 0.0. It is 95 or less, more preferably 0.85 or less.
また、医薬組成物中の成分(B)の含有量は、製剤物性をより好ましいものとする観点から、医薬組成物全体(全組成)に対して好ましくは10質量%以上であり、より好ましくは12.5質量%以上である。
また、解熱効果向上の観点から、医薬組成物中の成分(B)の含有量は、医薬組成物全体(全組成)に対して好ましくは40質量%以下であり、より好ましくは36質量%以下である。
In addition, the content of component (B) in the pharmaceutical composition is preferably 10% by mass or more relative to the entire pharmaceutical composition (total composition), more preferably It is 12.5 mass % or more.
In addition, from the viewpoint of improving the antipyretic effect, the content of component (B) in the pharmaceutical composition is preferably 40% by mass or less, more preferably 36% by mass or less, relative to the entire pharmaceutical composition (total composition). is.
(その他成分)
医薬組成物は、本発明の効果を損なわない範囲で、成分(A)および(B)以外の成分をさらに含んでもよい。たとえば医薬組成物には、通常総合感冒薬や解熱鎮痛薬に使用されているその他の成分を必要に応じて配合することができる。また、医薬組成物には、たとえば、一般用医薬品製造販売承認基準に記載されている成分を配合することができる。かかる成分として、具体的には、成分(A)以外の解熱鎮痛剤、抗ヒスタミン剤、鎮咳剤、ノスカピン類、気管支拡張剤、去痰剤、抗コリン剤、抗炎症剤、カフェイン類、ビタミン類、胃粘膜保護剤、生薬類、催眠鎮静剤および漢方処方からなる群から選択される一種または二種以上を配合することができる。
(Other ingredients)
The pharmaceutical composition may further contain components other than components (A) and (B) within a range that does not impair the effects of the present invention. For example, the pharmaceutical composition can optionally contain other ingredients that are commonly used in common cold remedies and antipyretic analgesics. In addition, the pharmaceutical composition may contain, for example, ingredients listed in the Standards for Approval for Manufacturing and Marketing of OTC Drugs. Specific examples of such components include antipyretic analgesics other than component (A), antihistamines, antitussives, noscapines, bronchodilators, expectorants, anticholinergics, anti-inflammatory agents, caffeines, vitamins, and gastric mucosa. One or two or more selected from the group consisting of protective agents, crude drugs, hypnotics and sedatives, and herbal formulations can be blended.
成分(A)以外の解熱鎮痛剤としては、たとえば、アスピリン、アスピリンアルミニウム、エテンザミド、サザピリン、サリチルアミド、ラクチルフェネチジン、イブプロフェン、イソプロピルアンチピリン、ロキソプロフェンナトリウムおよびその塩(たとえば、ロキソプロフェンナトリウム水和物)からなる群から選択される少なくとも一種、プラノプフェン、ジクロフェナクナトリウム、メフェナム酸、インドメタシンファルネシル、アセメタシン、エトドラク、ナプロキセン、メロキシカムおよびセレコキシブおよびチアラミド塩酸塩からなる群から選択される一または二以上の成分を配合することができる。 Antipyretic analgesics other than component (A) include, for example, aspirin, aspirin aluminum, ethenzamide, sazapyrin, salicylamide, lactylphenetidine, ibuprofen, isopropylantipyrine, loxoprofen sodium and salts thereof (e.g., loxoprofen sodium hydrate) at least one selected from the group consisting of pranopfen, diclofenac sodium, mefenamic acid, indomethacin farnesyl, acemethacin, etodolac, naproxen, meloxicam and celecoxib, and one or more components selected from the group consisting of tiaramide hydrochloride. can be done.
ここで、胃腸に対する負担を軽減する観点から、医薬組成物は好ましくはイブプロフェンを含まない。
同様の観点から、医薬組成物はイブプロフェンを含むとき、医薬組成物中のイブプロフェンの含有量は、医薬組成物全体に対してたとえば0.01質量%以下であってもよい。
Here, from the viewpoint of reducing gastrointestinal burden, the pharmaceutical composition preferably does not contain ibuprofen.
From a similar point of view, when the pharmaceutical composition contains ibuprofen, the content of ibuprofen in the pharmaceutical composition may be, for example, 0.01% by mass or less relative to the entire pharmaceutical composition.
抗ヒスタミン剤としては、たとえば、塩酸イソチペンジル、塩酸ジフェテロール、塩酸トリペレナミン、塩酸トンジルアミン、塩酸フェネタジン、塩酸メトジラジン、dl-クロルフェニラミンマレイン酸塩、d-クロルフェニラミンマレイン酸塩、ジフェニルジスルホン酸カルビノキサミン、ジフェニルピラリン塩酸塩、ジフェニルピラリンテオクル酸塩、ジフェンヒドラミン塩酸塩、ジフェンヒドラミンサリチル酸塩、酒石酸アリメマジン、タンニン酸ジフェンヒドラミン、トリプロリジン塩酸塩水和物、ナパジシル酸メブヒドロリン、プロメタジンメチレン二サリチル酸塩、マレイン酸カルビノキサミン、リン酸ジフェテロール、クレマスチンフマル酸塩、メキタジン、ケトチフェンフマル酸塩、プロメタジン塩酸塩、エピナスチン塩酸塩、エメダスチンフマル酸塩、フェキソフェナジン、アゼラスチン塩酸塩、セチリジン塩酸塩およびオロパタジン塩酸塩からなる群から選択される一または二以上の成分を配合することができる。 Examples of antihistamines include isothipendyl hydrochloride, diferol hydrochloride, tripelennamine hydrochloride, tondilamine hydrochloride, phenetazine hydrochloride, methdilazine hydrochloride, dl-chlorpheniramine maleate, d-chlorpheniramine maleate, carbinoxamine diphenyldisulfonate, diphenylpyraline hydrochloride. salt, diphenylpyraline teocrate, diphenhydramine hydrochloride, diphenhydramine salicylate, arimemazine tartrate, diphenhydramine tannate, triprolidine hydrochloride hydrate, mebhydroline napadisilate, promethazine methylene disalicylate, carbinoxamine maleate, diferol phosphate, clemastine One or Two or more ingredients can be combined.
鎮咳剤としては、たとえば、デキストロメトルファン、デキストロメトルファン臭化水素酸塩水和物等のデキストロメトルファンおよびその塩ならびにその水和物、塩酸アロクラミド、クロペラスチン塩酸塩、クロペラスチンフェンジゾ酸塩、コデインリン酸塩水和物、ジヒドロコデインリン酸塩、ジブナートナトリウム、デキストロメトルファン、クエン酸チペピジン、チペピジンヒベンズ酸塩、ジメモルファンリン酸塩、エプラジノン塩酸塩、ペントキシベリンクエン酸塩、ベンプロペリンリン酸塩およびクロフェダノール塩酸塩からなる群から選択される一または二以上の成分を配合することができる。 Antitussive agents include, for example, dextromethorphan, dextromethorphan such as dextromethorphan hydrobromide hydrate, salts thereof and hydrates thereof, aloclamide hydrochloride, cloperastine hydrochloride, cloperastine fendizoate, Codeine Phosphate Hydrate, Dihydrocodeine Phosphate, Dibunate Sodium, Dextromethorphan, Tipepidine Citrate, Tipepidine Hibenzate, Dimemorphan Phosphate, Eprazinone Hydrochloride, Pentoxyverine Citrate, Benproperine Phosphate One or more ingredients selected from the group consisting of salt and clofedanol hydrochloride can be blended.
ノスカピン類としては、たとえば、ノスカピンおよびノスカピン塩酸塩水和物からなる群から選択される一または二以上の成分を配合することができる。 As noscapines, for example, one or two or more ingredients selected from the group consisting of noscapine and noscapine hydrochloride hydrate can be blended.
気管支拡張剤としては、たとえば、dl-メチルエフェドリン塩酸塩、dl-メチルエフェドリンサッカリン塩、アミノフィリン、ジプロフィリン、テオフィリン、プロキシフィリン、dl-メチルエフェドリン、l-メチルエフェドリン塩酸塩、プソイドエフェドリン塩酸塩、トリメトキノール塩酸塩、フェニルプロパノールアミン塩酸塩、フェニレフリン塩酸塩、メトキシフェナミン塩酸塩およびイソプレナリン塩酸塩からなる群から選択される一または二以上の成分を配合することができる。 Bronchodilators include, for example, dl-methylephedrine hydrochloride, dl-methylephedrine saccharin salt, aminophylline, diprophylline, theophylline, proxyphylline, dl-methylephedrine, l-methylephedrine hydrochloride, pseudoephedrine hydrochloride, trimetoquinol One or two or more components selected from the group consisting of hydrochloride, phenylpropanolamine hydrochloride, phenylephrine hydrochloride, methoxyphenamine hydrochloride and isoprenaline hydrochloride can be blended.
去痰剤としては、たとえば、グアイフェネシン、グアヤコールスルホン酸カリウム、クレゾールスルホン酸カリウム、ブロムヘキシン塩酸塩、l-カルボシステイン、l-エチルシステイン塩酸塩、l-メチルシステイン塩酸塩、アンブロキソール塩酸塩、塩化アンモニウム、l-メントール、アンモニア・ウイキョウ精、桜皮エキス、メチルシステイン塩酸塩およびフドステインからなる群から選択される一または二以上の成分を配合することができる。 Expectorants include, for example, guaifenesin, potassium guaiacolsulfonate, potassium cresolsulfonate, bromhexine hydrochloride, l-carbocysteine, l-ethylcysteine hydrochloride, l-methylcysteine hydrochloride, ambroxol hydrochloride, ammonium chloride , l-menthol, ammonia/fennel essence, cherry bark extract, methylcysteine hydrochloride and fudosteine.
抗コリン剤としては、たとえば、ベラドンナ総アルカロイド、ロートエキス、ダツラエキスおよびヨウ化イソプロパミドからなる群から選択される一または二以上の成分を配合することができる。 As anticholinergic agents, for example, one or two or more ingredients selected from the group consisting of belladonna total alkaloids, Rohto extract, Datura extract and isopropamide iodide can be blended.
抗炎症剤としては、たとえば、グリチルリチン酸及びその塩類、セラペプターゼ、ブロメライン、セミアルカリプロティナーゼ、プロナーゼ、セアプローゼ、プロクターゼおよびリゾチーム塩酸塩からなる群から選択される一または二以上の成分を配合することができる。 As the anti-inflammatory agent, for example, one or two or more components selected from the group consisting of glycyrrhizic acid and its salts, serrapeptase, bromelain, semi-alkaline proteinase, pronase, seaprose, proctase and lysozyme hydrochloride can be blended. .
カフェイン類としては、たとえば、安息香酸ナトリウムカフェイン、カフェイン水和物および無水カフェインからなる群から選択される一または二以上の成分を配合することができる。 As caffeine, for example, one or two or more ingredients selected from the group consisting of sodium caffeine benzoate, caffeine hydrate and anhydrous caffeine can be blended.
ビタミン類としては、たとえば、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、プロスルチアミンおよびベンフォチアミン等のビタミンB1およびその誘導体ならびにそれらの塩類;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およびリン酸リボフラビンナトリウム等のビタミンB2およびその誘導体ならびにそれらの塩類;パントテン酸、パンテノール、パンテチン、パントテン酸カルシウムおよびパントテン酸ナトリウム等のビタミンB5およびその誘導体ならびにそれらの塩類;ピリドキシン塩酸塩およびピリドキサールリン酸エステル等のビタミンB6およびその誘導体ならびにそれらの塩類;シアノコバラミンおよびメコバラミン等のビタミンB12およびその誘導体ならびにそれらの塩類;アスコルビン酸、アスコルビン酸ナトリウムおよびアスコルビン酸カルシウム等のビタミンCおよびその誘導体ならびにそれらの塩類;ならびに、ヘスペリジンおよびその誘導体ならびにそれらの塩類からなる群から選択される一または二以上の成分を配合することができる。 Vitamins include, for example, thiamine, thiamine chloride hydrochloride, thiamine nitrate, disetiamine hydrochloride, cetotiamine hydrochloride, fursultiamine, fursultiamine hydrochloride, octotiamine, sicothiamine, thiamine disulfide, bis-butiamine, bis vitamin B1 and its derivatives and their salts such as bentiamine, prosultiamine and benfotiamine; vitamin B2 and its derivatives and their salts such as riboflavin, riboflavin phosphate, riboflavin butyrate and riboflavin sodium phosphate; pantothene vitamin B5 and its derivatives and their salts such as acid, panthenol, pantethine, calcium pantothenate and sodium pantothenate; vitamin B6 and its derivatives and their salts such as pyridoxine hydrochloride and pyridoxal phosphate; cyanocobalamin and mecobalamin and the like vitamin B12 and its derivatives and their salts; vitamin C and its derivatives and their salts such as ascorbic acid, sodium ascorbate and calcium ascorbate; and hesperidin and its derivatives and their salts One or more ingredients can be blended.
胃粘膜保護剤としては、たとえば、グリシン、ケイ酸マグネシウム、合成ケイ酸アルミニウム、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ルノアセテート(アルミニウムグリシネート)、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・炭酸水素ナトリウムの共沈生成物、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・炭酸マグネシウム・炭酸カルシウムの共沈物、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、メタケイ酸アルミン酸マグネシウム、アルジオキサ、銅クロロフィリンナトリウム、銅クロロフィリンカリウム、メチルメチオニンスルホニウムクロリド、スクラルファート、セトラキサート塩酸塩、ソファルコン、ゲファルナート、テプレノンおよびレバミピドからなる群から選択される一または二以上の成分を配合することができる。 Gastric mucosa protective agents include, for example, glycine, magnesium silicate, synthetic aluminum silicate, synthetic hydrotalcite, magnesium oxide, dihydroxyaluminum arnoacetate (aluminum glycinate), aluminum hydroxide gel, dry aluminum hydroxide gel, water Aluminum oxide/sodium bicarbonate coprecipitate, aluminum hydroxide/magnesium carbonate mixed dry gel, aluminum hydroxide/magnesium carbonate/calcium carbonate coprecipitate, magnesium hydroxide/aluminum potassium sulfate coprecipitate, carbonate One or more ingredients selected from the group consisting of magnesium, magnesium aluminometasilicate, aldioxa, sodium copper chlorophyllin, potassium copper chlorophyllin, methylmethionine sulfonium chloride, sucralfate, cetraxate hydrochloride, sofalcone, gefarnate, teprenone and rebamipide can be blended.
生薬類としては、たとえば、マオウ、ナンテンジツ、オウヒ、オンジ、カンゾウ、キキョウ、シャゼンシ、シャゼンソウ、セキサン(石蒜)、セネガ、バイモ、ウイキョウ、オウバク、オウレン、ガジュツ、カミツレ、ケイヒ、ゲンチアナ、ゴオウ、獣胆(ユウタンを含む。)、シャジン、ショウキョウ、ソウジュツ、チョウジ、チンピ、ビャクジュツ、ジリュウ、チクセツニンジン、ニンジン、アカメガシワ、アセンヤク、インヨウカク、エンゴサク、オウゴン、オウセイ、カノコソウ、カロニン、キョウニン、クコシ、クコヨウ、ケイガイ、ケツメイシ、ゲンノショウコ、コウジン、コウブシ、ゴミシ、サイシン、サンショウ、シオン、ジコッピ、シャクヤク、ジャコウ、シンイ、センキュウ、ゼンコ、センブリ、ソウハクヒ、ソヨウ、タイサン、トウキ、トコン、バクモンドウ、ハンゲ、バンコウカ、ハンピ、ビャクシ、ブクリョウ、ボウイ、ボタンピ、ボレイ、ロクジョウ等の生薬およびこれらの抽出物(エキス、チンキ、乾燥エキス等)からなる群から選択される一または二以上の成分を配合することができる。 Examples of herbal medicines include Ephedra, Nantenjitsu, Peppermint, Onji, Glycyrrhiza, Bellflower, Shazenshii, Shazensou, Seksan (Stone garlic), Senega, Fritillaria, Fennel, Phellodendron bark, Japanese coptis, Cedar, Chamomile, Cinnamon, Gentian, Chinese gourd, animal Bile (including gall), shoji, ginger, sojutsu, clove, chimpi, bayakujutsu, jiryu, chiksettsu carrot, carrot, red-clawed wrinkle, asenyak, inyoukaku, corydalis, scutellaria root, Chinese walnut, valerian, caronin, kyounin, wolfberry, kukoyo . One or two or more ingredients selected from the group consisting of herbal medicines such as hampi, juniper, bukuryo, bowie, botanpi, borey, and rokujo and their extracts (extracts, tinctures, dried extracts, etc.) can be blended.
催眠鎮静剤としては、たとえば、ブロムワレリル尿素(ブロモバレリル尿素)およびアリルイソプロピルアセチル尿素からなる群から選択される一または二以上の成分を配合することができる。 As a hypnotic sedative, for example, one or two or more ingredients selected from the group consisting of bromvalerylurea (bromovalerylurea) and allylisopropylacetylurea can be blended.
また、漢方処方としては、たとえば、葛根湯、葛根湯加桔梗、桂枝湯、香蘇散、柴胡桂枝湯、小柴胡湯、小青竜湯、麦門冬湯、半夏厚朴湯、麻黄湯およびこれらの抽出物(エキス、チンキ、乾燥エキス等)を配合することができる。 Kampo prescriptions include, for example, Kakkonto, Kakkonto Kakikyo, Keishito, Kososan, Saikokeishito, Shosaikoto, Shoseiryuto, Bakumondoto, Hangekobokuto, Maoto, and these. extracts (extracts, tinctures, dry extracts, etc.) can be blended.
さらに、医薬組成物には、本発明の効果を損なわない範囲で、製剤を製造するために必要な医薬品添加物を配合することができる。たとえば、医薬品添加物として、薬食審査発1204第1号(薬事行政法令)、医薬品添加物辞典2021(日本医薬品添加剤協会編集、薬事日報社)および第8版食品添加物公定書(日本食品添加物協会)等に記載されているものを配合することができる。具体的には、賦形剤、結合剤、崩壊剤、崩壊補助剤、流動化剤、滑沢剤、可塑剤、コーティング剤、糖衣剤、光沢化剤、着色剤、矯味剤、甘味剤、香料、および、着香剤・香料からなる群から選択される一または二以上の成分を医薬組成物に配合することができる。 Furthermore, the pharmaceutical composition may contain pharmaceutical additives necessary for producing the formulation as long as they do not impair the effects of the present invention. For example, as a pharmaceutical additive, PFSB/ELD Notification No. 1204 No. 1 (Pharmaceutical Affairs Administrative Law), Pharmaceutical Additives Dictionary 2021 (edited by the Japan Pharmaceutical Excipients Association, Yakuji Nippo) and the 8th Edition Food Additives Official Code (Japanese Food Additives Additives Association), etc. can be blended. Specifically, excipients, binders, disintegrants, disintegration aids, fluidizers, lubricants, plasticizers, coating agents, sugar coating agents, glossing agents, coloring agents, flavoring agents, sweetening agents, flavoring agents , and one or more ingredients selected from the group consisting of flavoring agents and fragrances can be added to the pharmaceutical composition.
賦形剤としては、たとえば、アメ粉、アルファー化デンプン、イソマルト、カカオ脂、加水分解デンプン乾燥物、カラメル、カルメロース、カルメロースカルシウム、カルメロースナトリウム、含水二酸化ケイ素、含水無結晶酸化ケイ素、乾燥水酸化アルミニウムゲル、乾燥バレイショデンプン、カンゾウ末、カンテン、カンテン末、寒梅粉、キシリトール、クロスカルメロースナトリウム、クロスポビドン、ケイ酸アルミン酸マグネシウム、ケイ酸カルシウム、ケイ酸マグネシウム、軽質無水ケイ酸、ケイヒ末、結晶セルロース、結晶セルロース・カルメロースナトリウム、結晶セルロース(微粒子)、結晶セルロース(粒)、合成ケイ酸アルミニウム、合成ケイ酸アルミニウム・ヒドロキシプロピルスターチ・結晶セルロース、合成ヒドロタルサイト、コムギデンプン、米粉、コメデンプン、β-シクロデキストリン、重質無水ケイ酸、水酸化アルミナマグネシウム、水酸化アルミニウムゲル、水酸化アルミニウム・炭酸水素ナトリウム共沈物、水酸化アルミニウム・炭酸マグネシウム・炭酸カルシウム共沈物、水酸化マグネシウム、D-ソルビトール、タルク、炭酸カルシウム、炭酸マグネシウム、沈降炭酸カルシウム、低置換度カルボキシメチルスターチナトリウム、低置換度ヒドロキシプロピルセルロース、デンプングリコール酸ナトリウム、トウモロコシデンプン、トウモロコシデンプン造粒物、トレハロース水和物、二酸化ケイ素、乳糖およびその水和物、乳糖造粒物、白糖、バレイショデンプン、微結晶セルロース、ヒドロキシプロピルスターチ、ヒドロキシプロピルセルロース、ヒプロメロース(2208)、ヒプロメロース(2906)、ヒプロメロース(2910)、ヒプロメロースフタル酸エステル(200731)、ヒプロメロースフタル酸エステル(220824)、微粒二酸化ケイ素、部分アルファー化デンプン、プルラン、粉糖、粉末還元麦芽糖水アメ、粉末セルロース、粉末セルロース(平均重合度:800~1100)、ポビドン(K25)、ポビドン(K30)、ポビドン(K90)、ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレン硬化ヒマシ油60、ポリオキシエチレン(105)ポリオキシプロピレン(5)グリコール、ポリオキシエチレン(160)ポリオキシプロピレン(30)グリコール、ポリスチレンスルホン酸ナトリウム、ポリソルベート80、ポリビニルアセタールジエチルアミノアセテート、ポリビニルアルコール・ジエチレングリコール混合物、マルチトール、マルトース水和物、D-マンニトール、D-マンニトール・クロスポビドン・D-ソルビトール・含水二酸化ケイ素混合物、無水ケイ酸水和物、無水乳糖、無水リン酸水素カルシウム、無水リン酸水素カルシウム造粒物、メタクリル酸コポリマーLD、メタケイ酸アルミン酸マグネシウム、メチルアクリレート・メタクリル酸コポリマー、メチルアクリレート・メチルメタクリレート、メチルセルロース、リン酸水素カルシウム水和物、リン酸水素カルシウム造粒物、リン酸水素ナトリウム水和物、リン酸二水素カリウム、リン酸二水素カルシウム水和物、リン酸二水素ナトリウムおよびエリスリトールからなる群から選択される一または二以上の成分を配合することができる。 Excipients include, for example, candy powder, pregelatinized starch, isomalt, cacao butter, dried hydrolyzed starch, caramel, carmellose, carmellose calcium, carmellose sodium, hydrous silicon dioxide, hydrous amorphous silicon oxide, dry water Aluminum oxide gel, dried potato starch, licorice powder, agar, agar powder, cold plum powder, xylitol, croscarmellose sodium, crospovidone, magnesium aluminate silicate, calcium silicate, magnesium silicate, light anhydrous silicic acid, cinnamon powder , crystalline cellulose, crystalline cellulose/carmellose sodium, crystalline cellulose (fine particles), crystalline cellulose (granules), synthetic aluminum silicate, synthetic aluminum silicate/hydroxypropyl starch/crystalline cellulose, synthetic hydrotalcite, wheat starch, rice flour, Rice starch, β-cyclodextrin, heavy silicic anhydride, magnesium alumina hydroxide, aluminum hydroxide gel, aluminum hydroxide/sodium hydrogen carbonate coprecipitate, aluminum hydroxide/magnesium carbonate/calcium carbonate coprecipitate, hydroxide Magnesium, D-sorbitol, talc, calcium carbonate, magnesium carbonate, precipitated calcium carbonate, low-substituted carboxymethyl starch sodium, low-substituted hydroxypropylcellulose, sodium starch glycolate, corn starch, corn starch granules, trehalose hydration silicon dioxide, lactose and its hydrates, lactose granules, sucrose, potato starch, microcrystalline cellulose, hydroxypropyl starch, hydroxypropyl cellulose, hypromellose (2208), hypromellose (2906), hypromellose (2910), hypromellose (2910), Promellose phthalate (200731), hypromellose phthalate (220824), fine silicon dioxide, partially pregelatinized starch, pullulan, powdered sugar, powdered reduced maltose starch syrup, powdered cellulose, powdered cellulose (average degree of polymerization: 800) ~ 1100), povidone (K25), povidone (K30), povidone (K90), polyoxyethylene hydrogenated castor oil, polyoxyethylene hydrogenated castor oil 60, polyoxyethylene (105) polyoxypropylene (5) glycol, polyoxy Ethylene (160) polyoxypropylene (30) glycol, sodium polystyrene sulfonate, polysorbate 80, polyvinyl acetal diethylaminoacetate, polyvinyl alcohol/diethylene glycol mixture, maltitol, maltose hydrate, D-mannitol, D-mannitol/crospovidone/ D-sorbitol/hydrated silicon dioxide mixture, anhydrous silicic acid hydrate, anhydrous lactose, anhydrous calcium hydrogen phosphate, anhydrous calcium hydrogen phosphate granules, methacrylic acid copolymer LD, magnesium aluminometasilicate, methyl acrylate/methacrylic acid Copolymer, methyl acrylate/methyl methacrylate, methyl cellulose, calcium hydrogen phosphate hydrate, calcium hydrogen phosphate granules, sodium hydrogen phosphate hydrate, potassium dihydrogen phosphate, calcium dihydrogen phosphate hydrate, phosphorus One or two or more ingredients selected from the group consisting of sodium dihydrogenate and erythritol can be blended.
結合剤としては、たとえば、アラビアゴム、アラビアゴム末、カンテン、カンテン末、寒梅粉、コポリビドン、ゼラチン、セラック、低置換度ヒドロキシプロピルセルロース、トウモロコシデンプン、ヒドロキシエチルセルロース、ヒドロキシエチルメチルセルロース、ヒドロキシプロピルスターチ、ヒドロキシプロピルセルロース、ビニルピロリドン・酢酸ビニル共重合体、ヒプロメロース(2208)、ヒプロメロース(2906)、ヒプロメロース(2910)、ヒプロメロース酢酸エステルコハク酸エステル、ヒプロメロースフタル酸エステル(200731)、ヒプロメロースフタル酸エステル(220824)、フマル酸・ステアリン酸・ポリビニルアセタールジエチルアミノアセテート・ヒドロキシプロピルセルロース2910混合物、プルラン、ポビドン(K25)、ポビドン(K30)、ポビドン(K90)、ポリビニルアルコール(たとえば、ポリビニルアルコール(完全ケン化物)、ポリビニルアルコール(部分ケン化物))、ポリビニルアルコール・ポリエチレングリコール・グラフトポリマー、メタクリル酸コポリマーL、メタクリル酸コポリマーLD、メタクリル酸コポリマーS、メタクリル酸ブチル・メタクリル酸メチルコポリマー、メタケイ酸アルミン酸マグネシウムおよびメチルセルロースからなる群から選択される一または二以上の成分を配合することができる。 Binders include, for example, gum arabic, gum arabic powder, agar, agar powder, kanbai powder, copolyvidone, gelatin, shellac, low-substituted hydroxypropyl cellulose, corn starch, hydroxyethyl cellulose, hydroxyethyl methyl cellulose, hydroxypropyl starch, hydroxy Propyl cellulose, vinylpyrrolidone-vinyl acetate copolymer, hypromellose (2208), hypromellose (2906), hypromellose (2910), hypromellose acetate succinate, hypromellose phthalate (200731), hypromellose phthalate (220824), fumaric acid/stearic acid/polyvinyl acetal diethylaminoacetate/hydroxypropyl cellulose 2910 mixture, pullulan, povidone (K25), povidone (K30), povidone (K90), polyvinyl alcohol (e.g. polyvinyl alcohol (fully saponified)) , polyvinyl alcohol (partially saponified product)), polyvinyl alcohol/polyethylene glycol/graft polymer, methacrylic acid copolymer L, methacrylic acid copolymer LD, methacrylic acid copolymer S, butyl methacrylate/methyl methacrylate copolymer, magnesium aluminometasilicate and methyl cellulose One or two or more components selected from the group consisting of can be blended.
崩壊剤としては、たとえば、アルファー化デンプン、カルメロース、カルメロースカルシウム、カルメロースナトリウム、クロスカルメロースナトリウム、クロスポピドン、低置換度カルボキシメチルスターチナトリウム、低置換度ヒドロキシプロピルセルロース、デンプングリコール酸ナトリウム、トウモロコシデンプン、バレイショデンプン、ヒドロキシプロピルスターチおよび部分アルファー化デンプンからなる群から選択される一または二以上の成分を配合することができる。 Disintegrants include, for example, pregelatinized starch, carmellose, carmellose calcium, carmellose sodium, croscarmellose sodium, crospovidone, low-substituted carboxymethyl starch sodium, low-substituted hydroxypropylcellulose, sodium starch glycolate, corn One or more ingredients selected from the group consisting of starch, potato starch, hydroxypropyl starch and partially pregelatinized starch can be blended.
崩壊補助剤としては、たとえば、カルメロース、カルメロースカルシウム、カルメロースナトリウム、クロスカルメロースナトリウム、軽質無水ケイ酸、結晶セルロース、デンプングリコール酸ナトリウムおよびヒドロキシプロピルスターチからなる群から選択される一または二以上の成分を配合することができる。 Examples of disintegrating aids include one or more selected from the group consisting of carmellose, carmellose calcium, carmellose sodium, croscarmellose sodium, light anhydrous silicic acid, crystalline cellulose, sodium starch glycolate and hydroxypropyl starch. components can be blended.
流動化剤としては、たとえば、含水二酸化ケイ素、軽質無水ケイ酸、結晶セルロース、合成ケイ酸アルミニウム、重質無水ケイ酸、水酸化アルミナマグネシウム、第三リン酸カルシウム、タルク、トウモロシデンプン、メタケイ酸アルミン酸マグネシウムおよびリン酸水素カルシウム造粒物からなる群から選択される一または二以上の成分を配合することができる。 Fluidizing agents include, for example, hydrous silicon dioxide, light anhydrous silicic acid, crystalline cellulose, synthetic aluminum silicate, heavy anhydrous silicic acid, magnesium aluminate hydroxide, tribasic calcium phosphate, talc, corn starch, and alumina metasilicate. One or two or more components selected from the group consisting of magnesium and calcium hydrogen phosphate granules can be blended.
滑沢剤としては、たとえば、含水二酸化ケイ素、含水無晶形酸化ケイ素、グリセリン脂肪酸エステル、ケイ酸マグネシウム、軽質無水ケイ酸、硬化油、重質無水ケイ酸、ショ糖脂肪酸エステル、ステアリルアルコール、ステアリン酸、ステアリン酸亜鉛、ステアリン酸アルミニウム、ステアリン酸カルシウム、ステアリン酸ポリオキシル40、ステアリン酸マグネシウム、ダイズ硬化油、タルク、フマル酸ステアリルナトリウム、ミツロウ、無水ケイ酸水和物、メタケイ酸アルミン酸マグネシウムおよびモノステアリン酸グリセリンからなる群から選択される一または二以上の成分を配合することができる。 Examples of lubricants include hydrous silicon dioxide, hydrous amorphous silicon oxide, glycerin fatty acid ester, magnesium silicate, light anhydrous silicic acid, hydrogenated oil, heavy anhydrous silicic acid, sucrose fatty acid ester, stearyl alcohol, and stearic acid. , zinc stearate, aluminum stearate, calcium stearate, polyoxyl 40 stearate, magnesium stearate, hydrogenated soybean oil, talc, sodium stearyl fumarate, beeswax, anhydrous silicate hydrate, magnesium aluminometasilicate and monostearic acid. One or two or more ingredients selected from the group consisting of glycerin can be blended.
可塑剤としては、たとえば、クエン酸トリエチル、グリセリン、グリセリン脂肪酸エステル、中鎖脂肪酸トリグリセリド、トリアセチン、濃グリセリン、ヒマシ油、プロピレングリコール、ポリオキシエチレン(105)ポリオキシプロピレン(5)グリコール、ポリソルベート80、マクロゴール400、マクロゴール600、マクロゴール1500、マクロゴール4000、マクロゴール6000、マクロゴール6000NF、モノステアリン酸グリセリン、リノール酸イソプロピルおよび流動パラフィンからなる群から選択される一または二以上の成分を配合することができる。 Examples of plasticizers include triethyl citrate, glycerin, glycerin fatty acid ester, medium-chain fatty acid triglyceride, triacetin, concentrated glycerin, castor oil, propylene glycol, polyoxyethylene (105) polyoxypropylene (5) glycol, polysorbate 80, Contains one or more ingredients selected from the group consisting of Macrogol 400, Macrogol 600, Macrogol 1500, Macrogol 4000, Macrogol 6000, Macrogol 6000NF, glyceryl monostearate, isopropyl linoleate and liquid paraffin. can do.
コーティング剤としては、たとえば、アクリル酸エチル・メタクリル酸メチルコポリマー分散液、アセチルグリセリン脂肪酸エステル、アミノアルキルメタクリレートコポリマーE、アラビアゴム、アラビアゴム末、アンモニオアルキルメタクリレートコポリマー、エチルセルロース、エチルセルロース水分散液、オクチルデシルトリグリセリド、オパドライOY-6950、オパドライOY-L-28900、オパドライOY-LS-20291、オパドライOY-LS-23016、オパドライOY-S-7135、オパドライOY-S-8471、オパドライOY-S-9607、オパドライOY-S-22829、オパドライOY-S-22835、オパドライOY-S-22961、オパドライOY-S-28924、オパドライYS-1-7003白、オパドライYS-1-12524-A、オパドライYS-1-14762-A、オパドライYS-1-15585-A、オパドライYS-1-19025A、オパドライYS-2-19114-A、オパドライIIイエロー、オパドライクリアー(YS-2-19114-A)、オパドライIIグレイ85F17659、オパドライ白03K280000、オパドライピンク(02F34337)、オパドライIIピンク、オパドライIIピンク85F97191、オパドライIIブルー(85G20427)、オパドライIIベージュ85F17438、オパドライホワイト(15B180002)、オパドライホワイトOY-LS-28914、オパドライホワイトYS-1-18177-A、オパドライホワイト(YS-1-18202-A)、オパドライIIホワイト(33G28523)、オパドライIIホワイト(85F28751)、オパドライIIホワイト(OY-LS-28914)、オパドライIIライトブルー(85G20426)、オパドライIIライトベージュ85F17498、オパドライIIレッド(32K15441)、カルナウバロウ、カルメロースカルシウム、カルメロースナトリウム、含水二酸化ケイ素、乾燥水酸化アルミニウムゲル、乾燥メタクリル酸コポリマーLD、クエン酸トリエチル、グリセリン、グリセリン脂肪酸エステル、ケイ酸マグネシウム、軽質無水ケイ酸、軽質無水ケイ酸含有ヒドロキシプロピルセルロース、結晶セルロース、合成ケイ酸アルミニウム、合成ヒドロタルサイト、酸化チタン、酸化マグネシウム、ジメチルアミノエチルメタアクリレート・メチルメタアクリレートコポリマー、ショ糖脂肪酸エステル、水酸化アルミニウムゲル、ステアリルアルコール、ステアリン酸、ステアリン酸アルミニウム、ステアリン酸カルシウム、ステアリン酸ポリオキシル40、ステアリン酸マグネシウム、精製ゼラチン、精製セラック、精製白糖、ゼラチン、セラック、D-ソルビトール、D-ソルビトール液、タルク、炭酸カルシウム、炭酸マグネシウム、沈降炭酸カルシウム、低置換度ヒドロキシプロピルセルロース、濃グリセリン、白色セラック、白糖、パラフィン、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース2910・酸化チタン・マクロゴール混合物、ヒプロメロース(2208)、ヒプロメロース(2906)、ヒプロメロース(2910)、ヒプロメロース酢酸エステルコハク酸エステル、ヒプロメロースフタル酸エステル(200731)、ヒプロメロースフタル酸エステル(220824)、フマル酸・ステアリン酸・ポリビニルアセタールジエチルアミノアセテート・ヒドロキシプロピルメチルセルロース2910混合物、プルラン、プレミックス添加剤Opadry White、ベントナイト、ポリオキシエチレン硬化ヒマシ油40、ポリオキシエチレン硬化ヒマシ油60、ポリオキシエチレン(105)ポリオキシプロピレン(5)グリコール、ポリオキシエチレン(160)ポリオキシプロピレン(30)グリコール、ポリスチレンスルホン酸ナトリウム、ポリソルベート80、ポリビニルアセタールジエチルアミノアセテート、ポリビニルアルコール(部分ケン化物)、マクロゴール300、マクロゴール400、マクロゴール600、マクロゴール1500、マクロゴール1540、マクロゴール4000、マクロゴール6000、マクロゴール6000EP、マクロゴール20000、マクロゴール35000、D-マンニトール、無水クエン酸、無水ケイ酸水和物、無水フタル酸、無水リン酸水素カルシウム、メタクリル酸コポリマーL、メタクリル酸コポリマーLD、メタクリル酸コポリマーS、メタケイ酸アルミン酸マグネシウム、メチルメタクリレート・メタアクリル酸・メチルメタアクリレートコポリマー、モノステアリン酸アルミニウム、モノステアリン酸グリセリン、モノステアリン酸ソルビタン、モノラウリン酸ソルビタン、硫酸カルシウム、フマル酸およびDL-リンゴ酸からなる群から選択される一または二以上の成分を配合することができる。 Coating agents include, for example, ethyl acrylate/methyl methacrylate copolymer dispersion, acetylglycerin fatty acid ester, aminoalkyl methacrylate copolymer E, gum arabic, gum arabic powder, ammonioalkyl methacrylate copolymer, ethyl cellulose, ethyl cellulose aqueous dispersion, octyl Decyl Triglyceride, Opadry OY-6950, Opadry OY-L-28900, Opadry OY-LS-20291, Opadry OY-LS-23016, Opadry OY-S-7135, Opadry OY-S-8471, Opadry OY-S-9607, Opadry OY-S-22829, Opadry OY-S-22835, Opadry OY-S-22961, Opadry OY-S-28924, Opadry YS-1-7003 White, Opadry YS-1-12524-A, Opadry YS-1- 14762-A, Opadry YS-1-15585-A, Opadry YS-1-19025A, Opadry YS-2-19114-A, Opadry II Yellow, Opadry Clear (YS-2-19114-A), Opadry II Gray 85F17659 , Opadry White 03K280000, Opadry Pink (02F34337), Opadry II Pink, Opadry II Pink 85F97191, Opadry II Blue (85G20427), Opadry II Beige 85F17438, Opadry White (15B180002), Opadry White OY-LS-28914, Opadry Dry White YS-1-18177-A, Opadry White (YS-1-18202-A), Opadry II White (33G28523), Opadry II White (85F28751), Opadry II White (OY-LS-28914), Opadry II Light Blue (85G20426), Opadry II Light Beige 85F17498, Opadry II Red (32K15441), Carnauba Wax, Carmellose Calcium, Carmellose Sodium, Hydrous Silicon Dioxide, Dry Aluminum Hydroxide Gel, Dry Methacrylic Acid Copolymer LD, Triethyl Citrate, Glycerin , glycerin fatty acid ester, magnesium silicate, light anhydrous silicic acid, hydroxypropyl cellulose containing light anhydrous silicic acid, crystalline cellulose, synthetic aluminum silicate, synthetic hydrotalcite, titanium oxide, magnesium oxide, dimethylaminoethyl methacrylate/methyl meta Acrylates copolymer, sucrose fatty acid ester, aluminum hydroxide gel, stearyl alcohol, stearic acid, aluminum stearate, calcium stearate, polyoxyl 40 stearate, magnesium stearate, refined gelatin, refined shellac, refined sucrose, gelatin, shellac, D- Sorbitol, D-sorbitol liquid, talc, calcium carbonate, magnesium carbonate, precipitated calcium carbonate, low-substituted hydroxypropylcellulose, concentrated glycerin, white shellac, sucrose, paraffin, hydroxypropylcellulose, hydroxypropylmethylcellulose 2910, titanium oxide, macrogol mixture, hypromellose (2208), hypromellose (2906), hypromellose (2910), hypromellose acetate succinate, hypromellose phthalate (200731), hypromellose phthalate (220824), fumaric acid, stearic acid, Polyvinyl Acetal Diethylaminoacetate-Hydroxypropyl Methylcellulose 2910 Mixture, Pullulan, Premixed Additive Opadry White, Bentonite, Polyoxyethylene Hydrogenated Castor Oil 40, Polyoxyethylene Hydrogenated Castor Oil 60, Polyoxyethylene (105) Polyoxypropylene (5) Glycol, polyoxyethylene (160) polyoxypropylene (30) glycol, sodium polystyrene sulfonate, polysorbate 80, polyvinyl acetal diethylaminoacetate, polyvinyl alcohol (partially saponified product), macrogol 300, macrogol 400, macrogol 600, macrogol Goal 1500, Macrogol 1540, Macrogol 4000, Macrogol 6000, Macrogol 6000EP, Macrogol 20000, Macrogol 35000, D-mannitol, anhydrous citric acid, anhydrous silicic acid hydrate, phthalic anhydride, anhydrous hydrogen phosphate Calcium, methacrylic acid copolymer L, methacrylic acid copolymer LD, methacrylic acid copolymer S, magnesium aluminometasilicate, methyl methacrylate/methacrylic acid/methyl methacrylate copolymer, aluminum monostearate, glyceryl monostearate, sorbitan monostearate, One or two or more ingredients selected from the group consisting of sorbitan monolaurate, calcium sulfate, fumaric acid and DL-malic acid can be blended.
糖衣剤としては、たとえば、アラビアゴム、アラビアゴム末、エチルセルロース、カルナウバロウ、カルメロースナトリウム、結晶セルロース、酸化チタン、ステアリン酸、ステアリン酸ポリオキシル40、精製ゼラチン、精製セラック、精製白糖、ゼラチン、セラック、タルク、沈降炭酸カルシウム、白色セラック、白糖、ヒドロキシプロピルセルロース、ヒプロメロース(2208)、ヒプロメロース(2910)、プルラン、ポビドン(K25)、ポビドン(K30)、ポビドン(K90)、ポリオキシエチレン(105)ポリオキシプロピレン(5)グリコール、ポリビニルアルコール(部分ケン化物)、マクロゴール1500、マクロゴール4000、マクロゴール6000およびD-マンニトールからなる群から選択される一または二以上の成分を配合することができる。 Sugar coating agents include, for example, gum arabic, gum arabic powder, ethyl cellulose, carnauba wax, carmellose sodium, crystalline cellulose, titanium oxide, stearic acid, polyoxyl 40 stearate, refined gelatin, refined shellac, refined sucrose, gelatin, shellac, and talc. , precipitated calcium carbonate, white shellac, sucrose, hydroxypropyl cellulose, hypromellose (2208), hypromellose (2910), pullulan, povidone (K25), povidone (K30), povidone (K90), polyoxyethylene (105) polyoxypropylene (5) One or two or more ingredients selected from the group consisting of glycol, polyvinyl alcohol (partially saponified product), macrogol 1500, macrogol 4000, macrogol 6000 and D-mannitol can be blended.
光沢化剤としては、たとえば、カルナウバロウ、精製セラック、マクロゴール400、マクロゴール1500、マクロゴール4000、マクロゴール6000およびミツロウからなる群から選択される一または二以上の成分を配合することができる。 As the brightening agent, for example, one or two or more components selected from the group consisting of carnauba wax, refined shellac, macrogol 400, macrogol 1500, macrogol 4000, macrogol 6000 and beeswax can be blended.
着色剤としては、たとえば、黄酸化鉄、黄色5号プレミックス、褐色酸化鉄、カーボンブラック、カラメル、β-カロテン、カンゾウエキス、黒酸化鉄、酸化チタン、三二酸化鉄、三二酸化鉄・グリセリン懸濁液、食用青色1号、食用青色2号アルミニウムレーキ、食用黄色4号、食用黄色4号アルミニウムレーキ、食用黄色5号、食用赤色2号、食用赤色3号、食用赤色102号、銅クロロフィリンナトリウム、銅クロロフィル、リボフラビン、リボフラビン酪酸エステル、リボフラビンリン酸エステルナトリウム、緑茶末およびローズ油からなる群から選択される一または二以上の成分を配合することができる。 Coloring agents include, for example, yellow iron oxide, yellow No. 5 premix, brown iron oxide, carbon black, caramel, β-carotene, licorice extract, black iron oxide, titanium oxide, iron sesquioxide, iron sesquioxide/glycerol suspension Turbidity, Food Blue No. 1, Food Blue No. 2 Aluminum Lake, Food Yellow No. 4, Food Yellow No. 4 Aluminum Lake, Food Yellow No. 5, Food Red No. 2, Food Red No. 3, Food Red No. 102, Sodium Copper Chlorophyllin , copper chlorophyll, riboflavin, riboflavin butyrate, riboflavin sodium phosphate, green tea powder and rose oil.
矯味剤としては、たとえば、エリスリトール、塩化ナトリウム、オウバク末、オウヒエキス、オウレン、オウレン末、オノニス根乾燥エキス、オレンジ、オレンジ油、カカオ末、果糖、カラメル、カンゾウ、カンゾウエキス、カンゾウ粗エキス、カンゾウ末、キシリトール、クエン酸カルシウム、クエン酸水和物、クエン酸ナトリウム水和物、グリチルリチン酸、グリチルリチン酸三ナトリウム、グリチルリチン酸二アンモニウム、グリチルリチン酸二ナトリウム、グリチルリチン酸モノアンモニウム、L-グルタミン酸、L-グルタミン酸L-アルギニン、L-グルタミン酸塩酸塩、L-グルタミン酸ナトリウム、グレープフルーツエキス、黒砂糖、ケイヒチンキ、ケイヒ末、ケイヒ油、コンブ末、サッカリン、サッカリンナトリウム水和物、サフラン、サフランチンキ、サンショウチンキ、サンショウ末、酒石酸、D-酒石酸、酒石酸水素カリウム、DL-酒石酸ナトリウム、ショウキョウチンキ、ショウキョウ末、スクラロース、ステビアエキス、ステビア抽出精製物、精製カンゾウエキス末、精製白糖、センブリ、ソヨウ末、D-ソルビトール、タイソウ末、タウリン、タラクサシ根・草乾燥エキス、タンニン酸、チョウジチンキ、チョウジ油、チンピチンキ、トウガラシ、トウガラシチンキ、トウガラシ末、トウヒチンキ、トウヒ末、トレハロース水和物、ニガキ末、梅肉エキス、白糖、フラクトオリゴ糖、粉糖、タウマチン、ペパーミントパウダー、マルトース水和物、D-マンニトール、dl-メントール、l-メントール、メントールパウダー、リュウノウ、リュウノウ末、緑茶末、DL-リンゴ酸、DL-リンゴ酸ナトリウム、レモン油およびローズ油からなる群から選択される一または二以上の成分を配合することができる。 Flavoring agents include, for example, erythritol, sodium chloride, Phellodendron bark powder, Peppermint extract, coptis, Coptis powder, dried ononis root extract, orange, orange oil, cacao powder, fructose, caramel, licorice, licorice extract, licorice crude extract, licorice powder , xylitol, calcium citrate, citric acid hydrate, sodium citrate hydrate, glycyrrhizic acid, trisodium glycyrrhizinate, diammonium glycyrrhizinate, disodium glycyrrhizinate, monoammonium glycyrrhizinate, L-glutamic acid, L-glutamic acid L-arginine, L-glutamic acid hydrochloride, sodium L-glutamate, grapefruit extract, brown sugar, cinnamon tincture, cinnamon powder, cinnamon oil, kelp powder, saccharin, sodium saccharin hydrate, saffron, saffron tincture, Japanese pepper tincture, Japanese pepper powder, tartaric acid, D-tartaric acid, potassium hydrogen tartrate, DL-sodium tartrate, ginger tincture, ginger powder, sucralose, stevia extract, purified stevia extract, refined licorice extract powder, refined sucrose, assembly, soy sauce powder, D- Sorbitol, turmeric powder, taurine, taraxa root/grass dried extract, tannic acid, clove tincture, clove oil, chimp tincture, red pepper, red pepper tincture, red pepper powder, spruce tincture, spruce powder, trehalose hydrate, bittersweet powder, plum extract, Sucrose, fructo-oligosaccharide, powdered sugar, thaumatin, peppermint powder, maltose hydrate, D-mannitol, dl-menthol, l-menthol, menthol powder, ryuno, ryuno powder, green tea powder, DL-malic acid, DL-malic acid One or more ingredients selected from the group consisting of sodium, lemon oil and rose oil can be blended.
甘味剤としては、たとえば、アスパルテーム、アセスルファムカリウム、アマチャ、アマチャ末、還元麦芽糖水アメ、カンゾウ、カンゾウエキス、カンゾウ末、キシリトール、グリチルリチン酸二カリウム、グリチルリチン酸二ナトリウム、グリチルリチン酸モノアンモニウム、グリチルリチン酸モノカリウム、サッカリン、サッカリンナトリウム水和物、スクラロース、ステビアエキス、ステビア抽出精製物、精製白糖、精製白糖球状顆粒、白糖、粉末還元麦芽糖水アメ、タウマチン、マルチトール、D-マンニトールおよびエリスリトールからなる群から選択される一または二以上の成分を配合することができる。 Sweeteners include, for example, aspartame, acesulfame potassium, amacha, amacha powder, reduced maltose starch syrup, licorice, licorice extract, licorice powder, xylitol, dipotassium glycyrrhizinate, disodium glycyrrhizinate, monoammonium glycyrrhizinate, monoglycyrrhizinate Selected from the group consisting of potassium, saccharin, saccharin sodium hydrate, sucralose, stevia extract, purified stevia extract, refined sucrose, refined sucrose spherical granules, sucrose, powdered reduced maltose syrup, thaumatin, maltitol, D-mannitol and erythritol One or more ingredients can be blended.
香料としては、たとえば、オレンジフレーバー、オレンジフレーバーパウダーSH-1171-A、オレンジミクロンH-800092、ガラナエキス、香料(スイートオレンジ)、香料(ストロベリー)、香料(レモン)、黒糖フレーバー、ストロベリーエッセンス、ストロベリーフレーバーB86173、チェリーフレーバー181612、デントミント1148J、バナナパウダーフレーバー、ピーチエッセンス、ヒノキ6E-84211、ブラックカレントフレーバー290012SYM、フルーツエッセンス、ペパーミントNAEFCOPO551957685、ペパーミントミクロンH-81550、ミックスフレーバーパウダー、メロンパウダーフレーバー、l-メントールおよびメントールL163592SYMからなる群から選択される一または二以上の成分を配合することができる。 Flavors include, for example, orange flavor, orange flavor powder SH-1171-A, orange micron H-800092, guarana extract, flavor (sweet orange), flavor (strawberry), flavor (lemon), brown sugar flavor, strawberry essence, strawberry Flavor B86173, cherry flavor 181612, dent mint 1148J, banana powder flavor, peach essence, cypress 6E-84211, black current flavor 290012SYM, fruit essence, peppermint NAEFCOPO551957685, peppermint micron H-81550, mix flavor powder, melon powder flavor, l- One or two or more components selected from the group consisting of menthol and menthol L163592SYM can be blended.
着香剤・香料としては、たとえば、ウイキョウ末、ウイキョウ油、エチルバニリン、オレンジ、オレンジエキス、オレンジエッセンス、オレンジ油、カミツレ油、カラメル、カンゾウ末、d-カンフル、dl-カンフル、ケイヒ末、ケイヒ油、シトロネラー油、シュガーフレーバー、スペアミント油、チェリーフレーバー、チョウジ油、チリフレーバー、トウヒチンキ、トウヒ油、パインオイル、ハッカ油、バニラフレーバー、バニリン、ビターエッセンス、ビタベース、ヒマラヤスギ油、フルーツフレーバー、フレーバーG1、ヘスペリジンペパーミントエッセンス、ベルガモット油、ベルモットフレーバー、d-ボルネオール、dl-ボルネオール、マッチャ、ミックスフレーバー、ミントフレーバー、dl-メントール、l-メントール、ユーカリ油、ラベンダー油、リュウノウ、リュウノウ末、レモンパウダー、レモン油、ローズ水、ローズ油、ロート油およびローマカミツレ油からなる群から選択される一または二以上の成分を配合することができる。 Flavoring agents and fragrances include, for example, fennel powder, fennel oil, ethyl vanillin, orange, orange extract, orange essence, orange oil, chamomile oil, caramel, licorice powder, d-camphor, dl-camphor, cinnamon powder, cinnamon Oil, citronella oil, sugar flavor, spearmint oil, cherry flavor, clove oil, chili flavor, spruce tincture, spruce oil, pine oil, peppermint oil, vanilla flavor, vanillin, bitter essence, vita base, cedar oil, fruit flavor, flavor G1 , hesperidin peppermint extract, bergamot oil, vermouth flavor, d-borneol, dl-borneol, matcha, mixed flavor, mint flavor, dl-menthol, l-menthol, eucalyptus oil, lavender oil, ryuno, ryuno powder, lemon powder, lemon One or two or more ingredients selected from the group consisting of oil, rose water, rose oil, funnel oil and Roman chamomile oil can be blended.
次に、医薬組成物の性状等を説明する。
医薬組成物は、医薬組成物の保存安定性向上の観点から、具体的には固形製剤である。
固形製剤の剤形は、限定されず、たとえばカプセル剤、丸剤、顆粒剤、細粒剤、散剤、および錠剤が挙げられ、服用容易性に優れる観点から、好ましくは錠剤、細粒剤、顆粒剤またはカプセル剤である。これらの固形製剤は、必要に応じて公知の方法により、糖衣やフィルムコーティング等により被覆されていてもよい。たとえば、錠剤は、素錠、フィルムコーティング錠または糖衣錠であってもよい。
Next, the properties and the like of the pharmaceutical composition will be described.
The pharmaceutical composition is specifically a solid preparation from the viewpoint of improving the storage stability of the pharmaceutical composition.
The dosage form of the solid preparation is not limited, and examples thereof include capsules, pills, granules, fine granules, powders, and tablets. From the viewpoint of excellent ease of administration, tablets, fine granules, and granules are preferred. drug or capsule. These solid preparations may be coated with sugar coating, film coating, or the like by a known method, if necessary. For example, tablets may be uncoated tablets, film-coated tablets or sugar-coated tablets.
また、医薬組成物は、容易に摂取できるという観点から、たとえば経口医薬組成物である。
医薬組成物は、優れた解熱効果を有することから、たとえば総合感冒薬等の感冒薬または解熱鎮痛薬として好適に用いられる。たとえば、各種成分を添加することで、かぜの諸症状、中でも発熱、悪寒、頭痛、のどの痛み、鼻水、鼻づまり、せき、たん、関節の痛み、筋肉の痛み、くしゃみ等の症状を有する患者に対し、これらの症状を緩和するために投与することができる。
Moreover, the pharmaceutical composition is, for example, an oral pharmaceutical composition from the viewpoint of being easily ingested.
Since the pharmaceutical composition has an excellent antipyretic effect, it is suitably used as an antipyretic analgesic or cold medicine such as general cold medicine. For example, by adding various ingredients, patients who have cold symptoms, especially fever, chills, headache, sore throat, runny nose, stuffy nose, cough, phlegm, joint pain, muscle pain, sneezing, etc. can be administered to alleviate these symptoms.
(製造方法)
本実施形態において、医薬組成物は、たとえば成分(A)、(B)および適宜その他の成分を配合する工程を含む。
さらに具体的には、医薬組成物は、その剤形に応じて第十八改正日本薬局方等に記載された方法に従って製造し、製剤とすることができる。
たとえば、医薬組成物の剤形が錠剤の場合、日本薬局方製剤総則「錠剤」の項に準じて製造することができる。また、医薬組成物の剤形が顆粒剤の場合、日本薬局方製剤総則「顆粒剤」の項に準じて製造することができる。
また、医薬組成物に配合される成分・添加物の配合禁忌等を回避する観点、および、組成物の保存安定性をさらに向上する観点から、適宜、顆粒分け、多層化等により、所定の成分が互いに接触しないように製剤化してもよい。
(Production method)
In this embodiment, the pharmaceutical composition includes, for example, the step of blending components (A), (B) and optionally other components.
More specifically, the pharmaceutical composition can be prepared according to the method described in the Japanese Pharmacopoeia, 18th Edition, etc. according to the dosage form to prepare a formulation.
For example, when the dosage form of the pharmaceutical composition is a tablet, it can be produced according to the Japanese Pharmacopoeia General Rules for Preparations, Section "Tablet". In addition, when the dosage form of the pharmaceutical composition is granules, it can be produced according to the Japanese Pharmacopoeia General Rules for Preparations, Section "Granules".
In addition, from the viewpoint of avoiding contraindications of ingredients and additives to be mixed in the pharmaceutical composition, and from the viewpoint of further improving the storage stability of the composition, the prescribed ingredients are appropriately added by granulation, multi-layering, etc. may be formulated so that they do not come in contact with each other.
医薬組成物、具体的には固形製剤の包装形態については、適宜、瓶包装、SP包装(Strip Package)、スティック包装、PTP(Press Through Package)、パウチ包装等とすることができる。これらにより一旦包装して気密保存してもよい。さらにそれらをピロー包装してもよい。また、それらを箱等に格納してもよい。SP包装、スティック包装、PTP包装、ピロー包装に用いられる材料としては、限定されず、たとえば、ポリ塩化ビニルフィルム、ポリ塩化ビニリデンフィルム、ポリエチレン、ポリプロピレンフィルム、ポリエチレンテレフタレートフィルム、ポリエチレンフィルム等の単層の樹脂フィルムやこれら樹脂フィルムを組み合わせた複層のフィルムやこれら樹脂フィルムにアルミニウム箔を付着させたものを用いることができる。複層のフィルムはたとえばラミネートフィルムとしてもよい。さらに、必要に応じて乾燥剤、脱酸素剤や脱臭剤とともに封入することができる。 Pharmaceutical compositions, specifically solid preparations, may be appropriately packaged in bottle packaging, SP packaging (Strip Package), stick packaging, PTP (Press Through Package), pouch packaging, or the like. They may be once packaged and airtightly preserved. Furthermore, they may be pillow-wrapped. Alternatively, they may be stored in a box or the like. The material used for SP packaging, stick packaging, PTP packaging, and pillow packaging is not limited. A resin film, a multi-layer film obtained by combining these resin films, or a film obtained by attaching an aluminum foil to these resin films can be used. A multilayer film may be, for example, a laminate film. Furthermore, it can be enclosed together with a desiccant, an oxygen absorber, and a deodorant, if necessary.
本実施形態において得られる医薬組成物は、成分(A)および(B)を特定の割合で含むため、優れた解熱作用が発揮される。 Since the pharmaceutical composition obtained in this embodiment contains the components (A) and (B) in a specific ratio, it exhibits excellent antipyretic action.
以上、本発明の実施形態について述べたが、これらは本発明の例示であり、上記以外の様々な構成を採用することもできる。 Although the embodiments of the present invention have been described above, these are examples of the present invention, and various configurations other than those described above can also be adopted.
以下、実施例を挙げて本実施形態を具体的に説明するが、本実施形態はこれらの実施例に限定されるものではない。 EXAMPLES The present embodiment will be specifically described below with reference to Examples, but the present embodiment is not limited to these Examples.
(試験例1)解熱効果試験
(1)被検物質
アセトアミノフェンはSpecGX LLC社製のものを、トラネキサム酸は協和ファーマケミカル社製のものをそれぞれ使用した。
これらの被験物質は、カルボキシメチルセルロースナトリウム中に懸濁または溶解させて調製した。
(Test Example 1) Antipyretic Effect Test (1) Test Substances Acetaminophen manufactured by SpecGX LLC and tranexamic acid manufactured by Kyowa Pharma Chemical Co., Ltd. were used.
These test substances were prepared by suspending or dissolving them in sodium carboxymethylcellulose.
(2)発熱誘発物質
発熱誘発物質としてSigma-Aldrich社製のパン酵母を使用した。パン酵母を生理食塩水に溶解して20%(w/v)懸濁液として調製した。
(2) Pyrogenic substance Baker's yeast manufactured by Sigma-Aldrich was used as a pyrogenic substance. Baker's yeast was dissolved in physiological saline to prepare a 20% (w/v) suspension.
(3)使用動物
Slc:SD雄性ラット6週齢(日本エスエルシー社製)を7日間の検疫期間及び7日間の馴化後に使用した。動物は温度22±3℃、湿度50±20%、照明時間8~20時に制御されたラット飼育室内で飼育した。固形試料(ラボMRストック、日本農産工業社製)及び水道水を自由に摂取させ、1週間予備飼育した後、体重推移及び一般状態に異常の認められなかった7週齢のラットについて、体温測定用プローブを直腸に挿入して馴化を行い、翌日、直腸温を測定した。得られた直腸温を基に層別連続無作為化法により群分けを行った。
(3) Animals used Slc: SD male rats aged 6 weeks (manufactured by Japan SLC) were used after a 7-day quarantine period and 7-day acclimatization. Animals were housed in a controlled rat breeding room with a temperature of 22±3° C., a humidity of 50±20% and a lighting time of 8-20 hours. Solid samples (Labo MR Stock, Nihon Nosan Kogyo Co., Ltd.) and tap water were given ad libitum, and after pre-raising for 1 week, body temperature was measured for 7-week-old rats in which no abnormal changes in body weight or general condition were observed. The probe was inserted into the rectum for acclimatization, and the rectal temperature was measured the next day. Based on the obtained rectal temperature, grouping was performed by a stratified continuous randomization method.
(4)試験方法
群分け後、直腸温を測定し、その直後にラットの頸背部に酵母を皮下投与して発熱を誘発後、各被験物質を投与し、その1.5時間後に直腸温を測定することで被験物質の解熱効果を評価した。各群について3匹のラットを用い、3匹の直腸温の平均値を算出した。
(4) Test method After grouping, the rectal temperature was measured, immediately after that, yeast was subcutaneously administered to the back of the rat's neck to induce fever, each test substance was administered, and rectal temperature was measured 1.5 hours later. The antipyretic effect of the test substance was evaluated by measuring. Three rats were used for each group, and the average rectal temperature of the three animals was calculated.
(5)試験結果
試験結果を図1に示す。図1に示したように、対照群では酵母投与後39.2℃まで直腸温が上昇したが、アセトアミノフェンの単独投与(100mg/kg:比較例1)により38.7℃まで発熱が抑制された。トラネキサム酸単独投与(28mg/kg:比較例2、および、50mg/kg:比較例3)では、いずれも、解熱効果は全く認められなかった。
しかし、アセトアミノフェン100mg/kgに対して、解熱作用の知られていないトラネキサム酸を50~100mg/kgの量で併用することでアセトアミノフェンの解熱効果が更に高まり、38.2~38.3℃まで抑制された(実施例1~3)。
(5) Test results The test results are shown in FIG. As shown in Fig. 1, in the control group, the rectal temperature rose to 39.2°C after yeast administration, but fever was suppressed to 38.7°C by single administration of acetaminophen (100 mg/kg: Comparative Example 1). was done. No antipyretic effect was observed in either administration of tranexamic acid alone (28 mg/kg: Comparative Example 2 and 50 mg/kg: Comparative Example 3).
However, when 50 to 100 mg/kg of tranexamic acid, which is not known to have antipyretic action, is used in combination with 100 mg/kg of acetaminophen, the antipyretic effect of acetaminophen is further enhanced. It was suppressed to 3°C (Examples 1-3).
(製剤例)錠剤
以下の表1および表2に示す組成で、常法により錠剤を製造する。なお、所望により剤皮を塗布する。表1に総合感冒薬の製剤例(単位:9錠中(mg))を示し、表2に解熱鎮痛薬の製剤例(単位:1回量中(mg))を示す。
(Formulation example) Tablets Tablets are produced by a conventional method with the compositions shown in Tables 1 and 2 below. If desired, a coating is applied. Table 1 shows formulation examples of common cold medicines (unit: in 9 tablets (mg)), and Table 2 shows formulation examples of antipyretic analgesics (unit: in one dose (mg)).
(製剤例)錠剤
以下の表3~表12に示す組成で、常法により錠剤を製造する。なお、所望により剤皮を塗布する。表3~表12ともに、解熱鎮痛薬の製剤例(製剤例1A~150Aにおいては単位:1回量(1錠)中(mg))である。
(Formulation Example) Tablets Tablets are produced by a conventional method with the compositions shown in Tables 3 to 12 below. If desired, a coating is applied. Both Tables 3 to 12 are formulation examples of antipyretic analgesics (in Formulation Examples 1A to 150A, the unit is (mg) in a single dose (1 tablet)).
(製剤例)細粒剤
以下の表13~表18に示す組成で、常法により細粒剤を製造する。表13~表18ともに、解熱鎮痛薬の製剤例(製剤例1B~108Bにおいては単位:1回量(1包)中(mg))である。
(Formulation Example) Fine Granules Fine granules are produced by a conventional method with the compositions shown in Tables 13 to 18 below. Both Tables 13 to 18 are formulation examples of antipyretic analgesics (in formulation examples 1B to 108B, units: per dose (1 package) (mg)).
以上、本発明の好ましい実施形態および実施例を説明したが、本発明はこれらに限定されることはない。本発明の趣旨を逸脱しない範囲で、構成の付加、省略、置換、およびその他の変更が可能である。 Although preferred embodiments and examples of the present invention have been described above, the present invention is not limited to these. Configuration additions, omissions, substitutions, and other changes are possible without departing from the scope of the present invention.
本発明の医薬組成物は、アセトアミノフェンと、トラネキサム酸およびその塩からなる群から選択される少なくとも一種と、を含み、優れた解熱作用を有する。
本発明の医薬組成物は、たとえば解熱剤、鎮痛剤として、中でも、頭痛、月経痛(生理痛)、歯痛、抜歯後疼痛、咽喉痛、腰痛、関節痛、筋肉痛、肩こり痛、耳痛、打撲痛、骨折痛、ねんざ痛、外傷痛等の鎮痛、悪寒・発熱時の解熱に好適に用いられ、又、感冒治療剤として、かぜの諸症状(たとえば鼻水、鼻づまり、せき、たん、のどの痛み、発熱、悪寒、頭痛、くしゃみ、関節の痛み、筋肉の痛み)の緩和に好適に用いられる。
The pharmaceutical composition of the present invention contains acetaminophen and at least one selected from the group consisting of tranexamic acid and salts thereof, and has excellent antipyretic action.
The pharmaceutical composition of the present invention can be used, for example, as an antipyretic or analgesic, among others, headache, menstrual pain (menstrual pain), toothache, pain after tooth extraction, sore throat, lumbago, arthralgia, muscle pain, stiff shoulder pain, earache, bruise. It is suitable for analgesia such as pain, bone fracture pain, sprain pain, trauma pain, etc., and for alleviating fever in the case of chills and fever. It is preferably used for relieving pain, fever, chills, headache, sneezing, joint pain, muscle pain).
Claims (7)
(B)トラネキサム酸およびその塩からなる群から選択される少なくとも一種と、
を含有し、
前記成分(A)の含有量に対する前記成分(B)の含有量の質量比((B)/(A))が0.50以上1.0以下である、医薬組成物。 (A) acetaminophen;
(B) at least one selected from the group consisting of tranexamic acid and salts thereof;
contains
A pharmaceutical composition, wherein the mass ratio of the content of component (B) to the content of component (A) ((B)/(A)) is 0.50 or more and 1.0 or less.
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