JP2018510899A - 口腔用組成物 - Google Patents
口腔用組成物 Download PDFInfo
- Publication number
- JP2018510899A JP2018510899A JP2017553084A JP2017553084A JP2018510899A JP 2018510899 A JP2018510899 A JP 2018510899A JP 2017553084 A JP2017553084 A JP 2017553084A JP 2017553084 A JP2017553084 A JP 2017553084A JP 2018510899 A JP2018510899 A JP 2018510899A
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutically acceptable
- acceptable salt
- chlorhexidine
- solvate
- composition
- 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.)
- Granted
Links
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- 229910000162 sodium phosphate Inorganic materials 0.000 description 1
- 229960003339 sodium phosphate Drugs 0.000 description 1
- 235000011008 sodium phosphates Nutrition 0.000 description 1
- 229940048086 sodium pyrophosphate Drugs 0.000 description 1
- 235000019832 sodium triphosphate Nutrition 0.000 description 1
- YKLJGMBLPUQQOI-UHFFFAOYSA-M sodium;oxidooxy(oxo)borane Chemical compound [Na+].[O-]OB=O YKLJGMBLPUQQOI-UHFFFAOYSA-M 0.000 description 1
- 235000010199 sorbic acid Nutrition 0.000 description 1
- 239000004334 sorbic acid Substances 0.000 description 1
- 229940075582 sorbic acid Drugs 0.000 description 1
- 229960002920 sorbitol Drugs 0.000 description 1
- 229940037649 staphylococcus haemolyticus Drugs 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 229940071117 starch glycolate Drugs 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 229940115920 streptococcus dysgalactiae Drugs 0.000 description 1
- TYFQFVWCELRYAO-UHFFFAOYSA-L suberate(2-) Chemical compound [O-]C(=O)CCCCCCC([O-])=O TYFQFVWCELRYAO-UHFFFAOYSA-L 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 description 1
- 235000000346 sugar Nutrition 0.000 description 1
- BDHFUVZGWQCTTF-UHFFFAOYSA-M sulfonate Chemical compound [O-]S(=O)=O BDHFUVZGWQCTTF-UHFFFAOYSA-M 0.000 description 1
- 229910052717 sulfur Inorganic materials 0.000 description 1
- 239000011593 sulfur Substances 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 230000002459 sustained effect Effects 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 235000020357 syrup Nutrition 0.000 description 1
- 239000006188 syrup Substances 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- 235000012222 talc Nutrition 0.000 description 1
- 229940095064 tartrate Drugs 0.000 description 1
- 235000019640 taste Nutrition 0.000 description 1
- 229940104261 taurate Drugs 0.000 description 1
- KKEYFWRCBNTPAC-UHFFFAOYSA-L terephthalate(2-) Chemical compound [O-]C(=O)C1=CC=C(C([O-])=O)C=C1 KKEYFWRCBNTPAC-UHFFFAOYSA-L 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 239000012085 test solution Substances 0.000 description 1
- 229960002180 tetracycline Drugs 0.000 description 1
- 235000019364 tetracycline Nutrition 0.000 description 1
- 229930101283 tetracycline Natural products 0.000 description 1
- 150000003522 tetracyclines Chemical class 0.000 description 1
- RYCLIXPGLDDLTM-UHFFFAOYSA-J tetrapotassium;phosphonato phosphate Chemical compound [K+].[K+].[K+].[K+].[O-]P([O-])(=O)OP([O-])([O-])=O RYCLIXPGLDDLTM-UHFFFAOYSA-J 0.000 description 1
- 235000019818 tetrasodium diphosphate Nutrition 0.000 description 1
- 239000001577 tetrasodium phosphonato phosphate Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 229960000790 thymol Drugs 0.000 description 1
- 239000004408 titanium dioxide Substances 0.000 description 1
- 206010044008 tonsillitis Diseases 0.000 description 1
- 230000036346 tooth eruption Effects 0.000 description 1
- 230000000699 topical effect Effects 0.000 description 1
- 235000010487 tragacanth Nutrition 0.000 description 1
- 239000000196 tragacanth Substances 0.000 description 1
- 229940116362 tragacanth Drugs 0.000 description 1
- 229960000401 tranexamic acid Drugs 0.000 description 1
- GYDJEQRTZSCIOI-LJGSYFOKSA-N tranexamic acid Chemical compound NC[C@H]1CC[C@H](C(O)=O)CC1 GYDJEQRTZSCIOI-LJGSYFOKSA-N 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
- WBYWAXJHAXSJNI-VOTSOKGWSA-M trans-cinnamate Chemical compound [O-]C(=O)\C=C\C1=CC=CC=C1 WBYWAXJHAXSJNI-VOTSOKGWSA-M 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
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
- 201000008827 tuberculosis Diseases 0.000 description 1
- 230000035899 viability Effects 0.000 description 1
- 230000002747 voluntary effect Effects 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
- 229940071104 xylenesulfonate Drugs 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
- 150000003751 zinc Chemical class 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4738—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
- A61K31/4745—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/30—Zinc; Compounds thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
- A61K8/27—Zinc; Compounds thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
- A61K8/36—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/40—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
- A61K8/43—Guanidines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
- A61K8/4906—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with one nitrogen as the only hetero atom
- A61K8/4926—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with one nitrogen as the only hetero atom having six membered rings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
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- A—HUMAN NECESSITIES
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q17/00—Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings
- A61Q17/005—Antimicrobial preparations
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Birds (AREA)
- Inorganic Chemistry (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Dermatology (AREA)
- General Chemical & Material Sciences (AREA)
- Oncology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Communicable Diseases (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Emergency Medicine (AREA)
- Cosmetics (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
(I)mRNAレベル(例:mRNAのレベルの0.0001から50%、例えば1から30%、5から25%または10から20%);および/または
(II)ウリジン(例えば[3H]ウリジン)取り込みレベル(例:[3H]ウリジン取り込みのレベルの0.0005から50%、例えば1から40%、15から35%または20から30%)
を有する。
連鎖球菌(Streptococci)(例えば、β−溶血性化膿性連鎖球菌(ストレプトコッカス・アガラクチア(Strept. agalactiae)、ストレプトコッカス・カニス(Strept. canis)、ストレプトコッカス・ジスガラクチア・ジスガラクチア(Strept. dysgalactiae dysgalactiae)、ストレプトコッカス・ジスガラクチア・エキシミリス(Strept. dysgalactiae equisimilis)、ストレプトコッカス・エキ・エキ(Strept. equi equi)、ストレプトコッカス・エキ・ズーエピデミクス(Strept. equi zooepidemicus)、ストレプトコッカス・イニアエ(Strept. iniae)、ストレプトコッカス・ポルシヌス(Strept. porcinus)およびストレプトコッカス・ピオジェネス(Strept. pyogenes)など)、微好気性化膿性連鎖球菌(ストレプトコッカス・「ミレリ」、例えば、ストレプトコッカス・アンギノサス(Strept. anginosus)、ストレプトコッカス・コンステラタス・コンステラタス(Strept. constellatus constellatus)、ストレプトコッカス・コンステラタス・ファリンギディス(Strept. constellatus pharyngidis)およびストレプトコッカス・インターメディウス(Strept. intermedius))、「ミティス」(α−溶血性ストレプトコッカス・「ビリダンス」、例えば、ストレプトコッカス・ミティス(Strept. mitis)、ストレプトコッカス・オラリス(Strept. oralis)、ストレプトコッカス・サンギニス(Strept. sanguinis)、ストレプトコッカス・クリスタタス(Strept. cristatus)、ストレプトコッカス・ゴルドニ(Strept. gordonii)およびストレプトコッカス・パラサンギニス(Strept. parasanguinis))、「サリバリウス」(非溶血性、例えば、ストレプトコッカス・サリバリウス(Strept. salivarius)およびストレプトコッカス・ベスチブラリス(Strept. vestibularis))および「ミュータンス」(歯表面の連鎖球菌、例えば、ストレプトコッカス・クリセチ(Strept. criceti)、ストレプトコッカス・ミュータンス(Strept. mutans)、ストレプトコッカス・ラッチ(Strept. ratti)およびストレプトコッカス・ソブリヌス(Strept. sobrinus))群の口腔内連鎖球菌、ストレプトコッカス・アシドミニマス(Strept. acidominimus)、ストレプトコッカス・ボビス(Strept. bovis)、ストレプトコッカス・ファカリス(Strept. faecalis)、ストレプトコッカス・エキナス(Strept. equinus)、ストレプトコッカス・ニューモニエ(Strept. pneumoniae)およびストレプトコッカス・スイス(Strept. suis)、または別途A、B、C、D、E、G、L、P、UもしくはV群連鎖球菌として分類される連鎖球菌);
以下のような他のグラム陽性菌:
乳酸菌;小球菌;ロチア・デントカリオサ(Rothia dentocariosa);ペプトコッカス(Peptococcus)属(例えば、ペプトコッカス・ニガー(Peptococcus niger));ペプトストレプトコッカス(Peptostreptococcus)属;アラクニア・プロピオニカ(Arachnia propionica)(プロピオニバクテリウム・プロピオニクス(Propionibacterium propionicus));ソロバクテリウム・ムーレイ(Solobacterium moorei);およびコリネバクテリウム。
腸内細菌科、例えば、大腸菌(Escherichia coli)、エンテロバクター属(例えば、エンテロバクター・クロアカ(Enterobacter cloacae));腸球菌(例えば、エンテロコッカス・ファカリス(Enterococcus faecalis)およびエンテロコッカス・ファシウム(Enterococcus faecium));真正細菌;シュードモナス属(例えば、シュードモナス・エルギノーサ(Ps. aeruginosa)、シュードモナス・マルトフィリア(Ps. maltophilia)(ステノトロフォモナス・マルトフィリア(Stenotrophomonas maltophilia))、シュードモナス・アルカリジェネス(Ps. alcaligenes)、シュードモナス・クロロラフィス(Ps. chlororaphis)、シュードモナス・フルオレセンス(Ps. fluorescens)、シュードモナス・ルテオラ(Ps. luteola)、シュードモナス・メンドシナ(Ps. mendocina)、シュードモナス・モンテイリ(Ps. monteilii)、シュードモナス・オリジハビタンス(Ps. oryzihabitans)、シュードモナス・ペルトシノゲナ(Ps. pertocinogena)、シュードモナス・シューダルカリジェネス(Ps. pseudalcaligenes)、シュードモナス・プチダ(Ps. putida)およびシュードモナス・スツゼリ(Ps. stutzeri));
ヘモフィルス・パラインフルエンザエ(Haemophilus parainfuenzae)およびヘモフィルス・パラフロフィルス(Haemophilus paraphrophilus);レプトトリキア・ブッカリス(Leptotrichia buccalis);マイコプラズマ;
バクテロイデス属(例えば、バクテロイデス・フラギリス(Bacteroides fragilis);バクテロイデス・ジンジバリス(Bacteroides gingivalis);バクテロイデス・インテルメディウス(Bacteroides intermedius)、バクテロイデス・メラニノゲニクス(Bacteroides melaninogenicus);およびバクテロイデス・ロエシェイイ(Bacteroides loescheii));
アグレガチバクター・アクチノミセテムコミタンス(Aggregatibacter actinomycetemcomitans);ブフネラ・アフィディコラ(Buchnera aphidicola);
カンピロバクター属(例えば、カンピロバクター・コリ(Campylobacter coli);カンピロバクター・スプトルム(Campylobacter sputorum);およびカンピロバクター・ウプサリエンシス(Campylobacter upsaliensis));エイケネラ・コローデンス(Eikenella corrodens);
アクチノバチルス属(例えば、アクチノバチルス・アクチノミセテムコミタンス(Actinobacillus actinomycetemcomitans)、アクチノバチルス・ホミニス(Actinobacillus hominis)およびアクチノバチルス・リグニエレシ(Actinobacillus lignieresii));
アクチノミセス属(例えば、アクチノミセス・イスラエリ(Actinomyces israelii)、アクチノミセス・ビスコーサス(Actinomyces viscosus)、およびアクチノミセス・ネスランディ(Actinomyces naeslundii));
トレポネーマ属(トレポネーマ・レフリンゲンス(Treponema refringens);トレポネーマ・デンチコラ(Treponema denticola));
タンネレラ・フォルシチア(Tannerella forsythia);
ベイロネラ属(Veillonella);
センチペーダ・ペリオドンティイ(Centipeda periodontii);
フラボバクテリア科、例えば、カプノサイトファガ属(例えば、カプノサイトファガ・カニモルサス(Capnocytophaga canimorsus)、カプノサイトファガ・シノデグミ(Capnocytophaga cynodegmi)、カプノサイトファガ・ジンジバリス(Capnocytophaga gingivalis)、カプノサイトファガ・グラヌロサ(Capnocytophaga granulosa)、カプノサイトファガ・ヘモリティカ(Capnocytophaga haemolytica)、カプノサイトファガ・オクラセア(Capnocytophaga ochracea)およびカプノサイトファガ・スプチゲナ(Capnocytophaga sputigena));
ポルフィロモナス属(例えば、ポルフィロモナス・アサカロリティカ(Porphyromonas asaccharolytica)、ポルフィロモナス・カンジンジバリス(Porphyromonas cangingivalis)、ポルフィロモナス・カノリス(Porphyromonas canoris)、ポルフィロモナス・カンサルシ(Porphyromonas cansulci)、ポルフィロモナス・カトニエ(Porphyromonas catoniae)、ポルフィロモナス・サーカムデンタリア(Porphyromonas circumdentaria)、ポルフィロモナス・クレビオリカニス(Porphyromonas crevioricanis)、ポルフィロモナス・エンドドンタリス(Porphyromonas endodontalis)、ポルフィロモナス・ジンジバリス(Porphyromonas gingivalis)、ポルフィロモナス・ギンギビカニス(Porphyromonas gingivicanis)、ポルフィロモナス・レビ(Porphyromonas levii)およびポルフィロモナス・マカカエ(Porphyromonas macacae));
フソバクテリウム属(例えば、フソバクテリウム・ヌクレアタム・ヌクレアタム(F. nucleatum nucleatum)、フソバクテリウム・ヌクレアタム・フシフォルム(F. nucleatum fusiforme)、フソバクテリウム・ヌクレアタム・ポリモルファム(F. nucleatum polymorphum)、フソバクテリウム・ヌクレアタム・ビンセンチ(F. nucleatum vincentii)、フソバクテリウム・ペリオドンチカム(F. periodonticum);
ビブリオ・スプトルム(Vibrio sputorum);
プレボテラ属(例えば、プレボテラ・メラニノゲニカ(Prevotella melaninogenica)およびプレボテラ・インターメディア(Prevotella intermedia));
ウォリネラ・スクシノゲネス(Wolinella succinogenes);および
ゲメラ属(例えば、ゲメラ・ベルゲリ(Gemella bergeri)、ゲメラ・ヘモリサンス(Gemella haemolysans)、ゲメラ・モルビロラム(Gemella morbillorum)およびゲメラ・サンギニス(Gemella sanguinis))。
カンジダ(例えば、カンジダ・アルビカンス(Candida albicans)、カンジダ・グラブラータ(Candida glabrata)、カンジダ・グイリエルモンジイ(Candida guilliermondii)、カンジダ・クルセイ(Candida krusei)、カンジダ・パラプシローシス(Candida parapsilosis)、カンジダ・トロピカリス(Candida tropicalis)およびカンジダ・ペリクロサ(Candida pelliculosa));および
トルロプシス・グラブラタ(Torulopsis glabrata)。
ブドウ球菌、例えばスタフィロコッカス・オーレウス(Staph. aureus)(メチシリン感受性(すなわち、MSSA)もしくはメチシリン耐性(すなわち、MRSA))およびスタフィロコッカス・エピデルミディス(Staph. epidermidis);バクテロイデス属、例えばバクテロイデス・ロエシェイイ(Bacteroides loescheii);センチペーダ・ペリオドンティイ(Centipeda periodontii);エイケネラ・コローデンス(Eikenella corrodens);腸内細菌科;フソバクテリウム・ヌクレアタム・ヌクレアタム(F. nucleatum nucleatum);フソバクテリウム・ヌクレアタム・ポリモルファム(F. nucleatum polymorphum);フソバクテリウム・ヌクレアタム・ビンセンチ(F. nucleatum vincentii);フソバクテリウム・ペリオドンチカム(F. periodonticum);ポルフィロモナス・エンドドンタリス(Porphyromonas endodontalis);ポルフィロモナス・ジンジバリス(Porphyromonas gingivalis);プレボテラ・メラニノゲニカ(Prevotella melaninogenica);プレボテラ・インターメディア(Prevotella intermedia);ソロバクテリウム・ムーレイ(Solobacterium moorei);タンネレラ・フォルシチア(Tannerella forsythia);およびトレポネーマ・デンチコラ(Treponema denticola)などがある。
好ましくは、細菌はブドウ球菌である。より好ましくは、細菌はスタフィロコッシ・オーレウス(Staphylococci aureus)である。
(a)製薬上許容し得る塩;および/または
(b)溶媒和物(水和物など)
を意味する。
有効成分の生物学的(例えば、殺細菌または抗微生物)活性を求めるのに用いることができる試験手順としては、
(a)臨床的に潜在性の細菌に対する殺細菌活性;および
(b)対数期細菌に対する抗微生物活性
を測定する上での当業者に公知のものがある。
(1)細菌培養物を静止(stationary)期まで増殖させる段階;
(2)静止(stationary)期培養物を、増殖細菌を死滅させるのに十分な濃度および/または時間で1以上の抗微生物剤で処理することで、表現型的に抵抗性の下位個体群を選択する段階;
(3)表現型的に抵抗性の下位個体群のサンプルを1以上の試験化合物または薬剤とともにインキュベートする段階;および
(4)表現型的に抵抗性の下位個体群に対する抗微生物効果を評価する段階
を含むことができる。
S.オーレウス(S. aureus)に対する、クロルヘキシジンジグルコン酸塩と組み合わせた4−メチル−8−フェノキシ−1−(2−フェニルエチル)−2,3−ジヒドロ−1H−ピロロ[3,2−c]キノリン塩酸塩(HT61 HCl)の抗微生物活性を、両方の活性剤の濃度を変えながら評価した。製剤は、下記の表1(Table 1)に示した方法に従って調製した。
上記製剤F013(1)から(5)のそれぞれのS.オーレウス(S. aureus)に対する効力を、阻害アッセイを用いて評価した。S.オーレウス(S. aureus)培養液を、当業界で公知の方法に従って増殖させた。上記製剤を細菌培養液で希釈して、33倍希釈から33792倍希釈とした。培養物の光学密度を、曝露24時間後に読み取った。下記に示した透明ウェルは増殖阻害である。影付きウェルは増殖である。
1.製剤(1)、(2)および(3)の最小阻害濃度は、製剤を2112倍まで希釈した時に認められる。
2.製剤(4)および(5)の最小阻害濃度は、製剤を66倍希釈した時に認められる。
製剤(1)から(3)を、S.オーレウス(S. aureus)細菌培養液によって66倍、132倍、264倍、528倍、1056倍、2112倍および4224倍希釈し、CFUカウントを8時間にわたって行った。図1から3には対数期S.オーレウス(S. aureus)に対する各希釈製剤についての時間−殺菌曲線を示している。
クロルヘキシジンジグルコン酸塩と組み合わせたHT61 HClの、S.オーレウス(S. aureus)に対する抗微生物活性におけるアルコールの効果を評価した。それら製剤は、下記の表2(Table 2)に示した方法に従って調製した。
上記製剤(6)および(7)のそれぞれのS.オーレウス(S. aureus)に対する効力を、阻害アッセイを用いて評価した。それらの製剤を、66倍で開始し、段階的に上昇させて67584倍まで細菌培養液で希釈した。培養物の光学密度を、曝露24時間後に読み取った。下記に示した透明ウェルは増殖阻害である。影付きウェルは増殖である。
クロルヘキシジンジグルコン酸塩と組み合わせたHT61 HClの抗微生物活性をさらに調べるため、クロルヘキシジンジグルコン酸塩濃度を変えながら0.01重量/体積%HT61 HClを用いてS.オーレウス(S. aureus)に対して実験を行った。
製剤は、下記の表3(Table 3)に示した方法に従って調製した。
図4、5および6には、240分(4時間)にわたり対数期S.オーレウス(S. aureus)に対して行った時間−殺菌試験の結果を含めている。
図5は、製剤F016A、F016B、F016CおよびF016Dについての時間−殺菌曲線を示している。
図6は、Corsodyl(登録商標)Daily Defence Mouthwash 0.06%と、0.01重量/体積%のHT61 HClのみを含む製剤についての、時間−殺菌曲線を示す図である。Corsodyl(登録商標)Daily Defence Mouthwash0.06%は、GlaxoSmithKlineによって製造される市販製品であり、0.06重量/体積%のクロルヘキシジンジグルコン酸塩を含む。
図4から6のそれぞれについてのゼロ値までの時間を、下記の表4(Table 4)に示している。
・0.04重量/体積%および0.03重量/体積%クロルヘキシジンジグルコン酸塩で、ゼロまでの時間は120分から45分に減る。
・0.015重量/体積%クロルヘキシジンジグルコン酸塩で、ゼロまでの時間は240分から120分に減る。
クロルヘキシジンジグルコン酸塩と組み合わせたHT61 HClのS.オーレウス(S. aureus)に対する抗微生物活性における界面活性剤の効果も評価した。界面活性剤(この場合、Cremophor(登録商標)RH40)を含まない製剤を、下記の表5(Table 5)に示したように調製した。次に、これらを上記実施例で調製した界面活性剤を含む製剤と比較した。
図7から14は、対数期S.オーレウス(S. aureus)に対する240分にわたる時間−殺菌試験の結果を含む。
図7は、2倍、4倍、8倍および16倍希釈でのF021E製剤についての時間−殺菌曲線を示す図である。F021E製剤については、上記の表3(Table 3)に示している。それは、0.01重量/体積%のHT61 HCl、0.06重量/体積%のクロルヘキシジングルコン酸塩を含み、界面活性剤(Cremophor(登録商標)RH40)を含まない。
次に、図8から14は、2倍、4倍、8倍および16倍希釈でのF021F、F021I、F021J、F021K、F021L、F021MおよびF021N製剤についての時間−殺菌曲線を示す図である。
図7から14に示した時間−殺菌試験からのゼロ値までの時間を、下記の表6から12(Tables 6 to 12)に示している。
従って、口腔用組成物が界面活性剤を含まないことが有利である。
低濃度のクロルヘキシジンを含む市販製品より改善された本発明の口腔用組成物の効力を示すため、時間−殺菌試験を用い、製剤F021FからLと、同等な重量/体積%のクロルヘキシジンまで希釈したCorsodyl(登録商標)Dailyとの間で比較を行った。比較は、F021L(0.01重量/体積%のクロルヘキシジンジグルコン酸塩および0.01重量/体積%のHT61 HCl含有)およびCB12について得られた時間−殺菌曲線間でも行った。
図15は、F021F製剤と、0.05重量/体積%のクロルヘキシジン濃度まで希釈したCorsodyl(登録商標)Dailyについての、時間−殺菌曲線を示す図である。
図16は、F021I製剤と、0.04重量/体積%のクロルヘキシジン濃度まで希釈したCorsodyl(登録商標)Dailyについての、時間−殺菌曲線を示す図である。
図17は、F021J製剤と、0.03重量/体積%のクロルヘキシジン濃度まで希釈したCorsodyl(登録商標)Dailyについての、時間−殺菌曲線を示す図である。
図18は、F021K製剤と、0.02重量/体積%のクロルヘキシジン濃度まで希釈したCorsodyl(登録商標)Dailyについての、時間−殺菌曲線を示す図である。
図19は、F021L製剤と、0.01重量/体積%のクロルヘキシジン濃度まで希釈したCorsodyl(登録商標)Dailyについての、時間−殺菌曲線を示す図である。
図20は、F021L製剤と、CB12についての、時間−殺菌曲線を示す図である。
S.オーレウス(S. aureus)に対するクロルヘキシジン二酢酸塩(CHD二酢酸塩)および酢酸亜鉛と組み合わせた4−メチル−8−フェノキシ−1−(2−フェニルエチル)−2,3−ジヒドロ−1H−ピロロ[3,2−c]キノリン酢酸塩(HT61酢酸塩)の抗微生物活性を評価した。製剤は、下記の表18(Table 18)に示すように調製した。
市販のCB12(0.3重量/体積%の酢酸亜鉛および0.025重量/体積%のクロルヘキシジン二酢酸塩含有)と組み合わせた製剤F029A、F029BおよびF029Cをそれぞれ、細菌S.オーレウス(S. aureus)の培養液で2倍希釈した。次に、CFUカウントを、曝露後0、5、10、15、20、30、40、50、60および120分に実施した。
実施例7は、組成物使用から1時間、3時間および6時間後の口臭に対する本発明の口腔用組成物の効果を評価するものである。
適格基準
1.被験者インフォームドコンセント用紙に記述された試験への自発的参加。
2.所定の試験期間および試験時間での試験施設における試験が可能であること。
3.官能検査値>2、およびH2S>100ppb。
除外基準
1.感染症の病歴(例えば、肝炎、HIV、結核)。
2.重症う食、重度歯肉炎、高度歯周炎、口内がこう瘡。
3.試験開始前1ヶ月以内または試験期間中の抗生物質投薬。
4.抗微生物剤を含む薬用スイーツの消費。
5.試験中の口腔衛生習慣の変化。
6.試験前日および試験当日の口臭に関連する食品(例えばニンニク)の消費、および試験当日の強い香りの化粧品の使用。
7.実質的偽生歯(Substantial false dentition)。
試験参加資格を有していた志願者(被験者)32名を無作為化し、6週間にわたり週1回検査室に通わせた。被験者全員が、全ての処置、すなわち水(F)、0.2重量/体積%クロルヘキシジン(E)、市販のCB12洗口液(D)または下記の表20(Table 20)に詳述の、本願請求項に係る口腔用組成物A、BもしくはCのうちの一つを用いた。CB12洗口液(Meda Pharmaceuticals,UKによって製造)は、0.3重量/体積%の酢酸亜鉛とともに0.025重量/体積%のクロルヘキシジン二酢酸塩を含む。
Claims (23)
- 4−メチル−8−フェノキシ−1−(2−フェニルエチル)−2,3−ジヒドロ−1H−ピロロ[3,2−c]キノリンまたはその製薬上許容し得る塩および/または溶媒和物、並びに約0.001重量/体積%から約0.06重量/体積%のクロルヘキシジンまたはその製薬上許容し得る塩および/または溶媒和物を含む口腔用組成物であって、当該組成物が洗口液の形態である、口腔用組成物。
- 前記組成物が約0.01重量/体積%から約0.05重量/体積%、好ましくは約0.01重量/体積%から約0.03重量/体積%のクロルヘキシジンまたはその製薬上許容し得る塩および/または溶媒和物を含む、請求項1に記載の口腔用組成物。
- 前記組成物が約0.01重量/体積%から約0.03重量/体積%の4−メチル−8−フェノキシ−1−(2−フェニルエチル)−2,3−ジヒドロ−1H−ピロロ[3,2−c]キノリンまたはその製薬上許容し得る塩および/または溶媒和物を含む、請求項1または請求項2に記載の口腔用組成物。
- 前記組成物がさらに亜鉛化合物を含む、前記請求項のいずれか1項に記載の口腔用組成物。
- 前記亜鉛化合物が酢酸亜鉛である、請求項4に記載の口腔用組成物。
- 前記組成物が界面活性剤を含まない、前記請求項のいずれか1項に記載の口腔用組成物。
- 4−メチル−8−フェノキシ−1−(2−フェニルエチル)−2,3−ジヒドロ−1H−ピロロ[3,2−c]キノリンまたはその製薬上許容し得る塩および/または溶媒和物、クロルヘキシジンまたはその製薬上許容し得る塩および/または溶媒和物、並びに亜鉛化合物を含む口腔用組成物。
- 前記亜鉛化合物が酢酸亜鉛である、請求項7に記載の口腔用組成物。
- 前記組成物が約0.001重量/体積%から約0.06重量/体積%のクロルヘキシジンまたはその製薬上許容し得る塩および/または溶媒和物を含む、請求項7または請求項8に記載の口腔用組成物。
- 微生物感染の予防および/または治療のために使用される、前記請求項のいずれか1項に記載の口腔用組成物。
- 微生物感染に関連する微生物を死滅させるために使用される、請求項1から9のいずれか1項に記載の口腔用組成物。
- 微生物感染の予防および/または治療のための、特にそのような感染に関連する微生物を死滅させるための医薬品製造における、約0.001重量/体積%から約0.06重量/体積%のクロルヘキシジンまたはその製薬上許容し得る塩および/または溶媒和物と組み合わせた、4−メチル−8−フェノキシ−1−(2−フェニルエチル)−2,3−ジヒドロ−1H−ピロロ[3,2−c]キノリンまたはその製薬上許容し得る塩および/または溶媒和物の使用。
- 微生物感染の予防および/または治療のための、特にそのような感染に関連する微生物を死滅させるための、約0.001重量/体積%から約0.06重量/体積%のクロルヘキシジンまたはその製薬上許容し得る塩および/または溶媒和物と組み合わせた、4−メチル−8−フェノキシ−1−(2−フェニルエチル)−2,3−ジヒドロ−1H−ピロロ[3,2−c]キノリンまたはその製薬上許容し得る塩および/または溶媒和物の使用。
- 微生物感染の予防および/または治療のための、特にそのような感染に関連する微生物を死滅させるための医薬品製造における、クロルヘキシジンまたはその製薬上許容し得る塩および/または溶媒和物並びに亜鉛化合物と組み合わせた、4−メチル−8−フェノキシ−1−(2−フェニルエチル)−2,3−ジヒドロ−1H−ピロロ[3,2−c]キノリンその製薬上許容し得る塩および/または溶媒和物の使用。
- 微生物感染の予防および/または治療のための、特にそのような感染に関連する微生物を死滅させるための、クロルヘキシジンまたはその製薬上許容し得る塩および/または溶媒和物並びに亜鉛化合物と組み合わせた、4−メチル−8−フェノキシ−1−(2−フェニルエチル)−2,3−ジヒドロ−1H−ピロロ[3,2−c]キノリンまたはその製薬上許容し得る塩および/または溶媒和物の使用。
- 前記感染が細菌感染である、請求項12から15のいずれか1項に記載の使用。
- 前記感染が口腔細菌感染である、請求項12から16のいずれか1項に記載の使用。
- 前記感染がブドウ球菌によって引き起こされる、請求項16または請求項17に記載の使用。
- 前記感染がスタフィロコッカス・オーレウス(Staphylococcus aureus)によって引き起こされる、請求項18に記載の使用。
- 4−メチル−8−フェノキシ−1−(2−フェニルエチル)−2,3−ジヒドロ−1H−ピロロ[3,2−c]キノリンまたはその製薬上許容し得る塩および/または溶媒和物、並びに約0.001重量/体積%から約0.06重量/体積%のクロルヘキシジンまたはその製薬上許容し得る塩および/または溶媒和物を含む口腔用組成物を哺乳動物に投与することを含み、当該組成物が洗口液の形態である、哺乳動物における微生物感染の治療または予防方法。
- 4−メチル−8−フェノキシ−1−(2−フェニルエチル)−2,3−ジヒドロ−1H−ピロロ[3,2−c]キノリンまたはその製薬上許容し得る塩および/または溶媒和物、クロルヘキシジンまたはその製薬上許容し得る塩および/または溶媒和物、並びに亜鉛化合物を含む口腔用組成物を哺乳動物に投与することを含み、当該組成物が洗口液の形態である、哺乳動物における微生物感染の治療または予防方法。
- 約0.001重量/体積%から約0.06重量/体積%のクロルヘキシジンまたはその製薬上許容し得る塩および/または溶媒和物と組み合わせた、4−メチル−8−フェノキシ−1−(2−フェニルエチル)−2,3−ジヒドロ−1H−ピロロ[3,2−c]キノリンまたはその製薬上許容し得る塩および/または溶媒和物の洗口液としての使用。
- クロルヘキシジンまたはその製薬上許容し得る塩および/または溶媒和物並びに亜鉛化合物と組み合わせた、4−メチル−8−フェノキシ−1−(2−フェニルエチル)−2,3−ジヒドロ−1H−ピロロ[3,2−c]キノリンまたはそれの製薬上許容し得る塩および/または溶媒和物の洗口液としての使用。
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GBGB1515824.9A GB201515824D0 (en) | 2015-09-07 | 2015-09-07 | Oral composition |
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WO2021127674A1 (en) | 2019-12-16 | 2021-06-24 | Colgate-Palmolive Company | Oral care compositions containing inulin |
CN110772518A (zh) * | 2019-12-20 | 2020-02-11 | 陕西科技大学 | 血根碱在抑制路邓葡萄球菌生长中的应用 |
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