JP2017088603A - 膣炎の治療 - Google Patents
膣炎の治療 Download PDFInfo
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- JP2017088603A JP2017088603A JP2016220187A JP2016220187A JP2017088603A JP 2017088603 A JP2017088603 A JP 2017088603A JP 2016220187 A JP2016220187 A JP 2016220187A JP 2016220187 A JP2016220187 A JP 2016220187A JP 2017088603 A JP2017088603 A JP 2017088603A
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- HSSLDCABUXLXKM-UHFFFAOYSA-N resorufin Chemical compound C1=CC(=O)C=C2OC3=CC(O)=CC=C3N=C21 HSSLDCABUXLXKM-UHFFFAOYSA-N 0.000 description 1
- 201000005404 rubella Diseases 0.000 description 1
- 239000012449 sabouraud dextrose agar Substances 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 230000001568 sexual effect Effects 0.000 description 1
- 201000010153 skin papilloma Diseases 0.000 description 1
- 230000000391 smoking effect Effects 0.000 description 1
- 239000000934 spermatocidal agent Substances 0.000 description 1
- 229960005322 streptomycin Drugs 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- FBWNMEQMRUMQSO-UHFFFAOYSA-N tergitol NP-9 Chemical compound CCCCCCCCCC1=CC=C(OCCOCCOCCOCCOCCOCCOCCOCCOCCO)C=C1 FBWNMEQMRUMQSO-UHFFFAOYSA-N 0.000 description 1
- 230000000699 topical effect Effects 0.000 description 1
- 229940025703 topical product Drugs 0.000 description 1
- 150000003852 triazoles Chemical class 0.000 description 1
- 210000004291 uterus Anatomy 0.000 description 1
- 244000000072 vaginal pathogen Species 0.000 description 1
- 210000003905 vulva Anatomy 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 230000003442 weekly effect Effects 0.000 description 1
- 230000029663 wound healing Effects 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
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
-
- 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
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
- A61K33/08—Oxides; Hydroxides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
-
- 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
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
- A61K9/0036—Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms
-
- 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
- A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
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- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
-
- 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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- A61P31/10—Antimycotics
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- A61P33/00—Antiparasitic agents
- A61P33/02—Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
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- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
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Abstract
Description
通常の(健康な)場合、性が成熟した女性の膣細菌叢(vaginale Microbiom)は、大部分が種々のラクトバチラス類(民族性に応じて、ラクトバチラス・クリスパタス、L.ガセリ、L.iners、L.ジェンセニイ)から構成され、これは特に、最適なpHを保ち、病原体の増殖を抑制する。種々の環境因子の影響下では、自然の膣内フローラは攻撃され、不均衡(ディスバイオシス)のために病原性細菌の蔓延が生じ得る。
膣真菌症:
膣真菌症は、細菌性膣症の次に、膣の感染の2番目に多い原因である。
妊娠
抗生物質の摂取
糖尿病
免疫抑制剤
癌療法の薬剤
コルチゾン含有薬剤
ストレスまたは精神的負荷
カンジダ・アルビカンス(DSM Nr.1386)[4]を、ごく普通に多くの場合に使用される方法に従って、酵母グルコースクロラムフェニコール(YGC)寒天上で培養し、その後液体培地(Sabouraudブロス)に移した。
上記の実験を以下の2点を変更して繰り返した:
−試験期間を7時間に延ばした
−培養液のアリコートを、5時間のインキュベーション後に、実際の細胞数の測定のために希釈し、Sabouraud寒天上に播種し、インキュベーション後にコロニー数の計測により評価を行った。
実験のさらなる繰り返しにおいて、上記試験結果を裏付けるために、代わりの物質代謝活性測定(Vialightアッセイ)[8]を選択した。図4(柱;それぞれ左から0、0.1%および1%ゼオライト)は、3、4および5時間インキュベーション後の試験群を示す。見て分かるとおり、ここでもなお、本発明の物質を用いて、ブロス培養液におけるカンジダ・アルビカンスの物質代謝活性の低下を達成することができる。
カンジダ・パラプシローシスを、ごく普通に多くの場合に使用される方法に従って、まずYGC寒天上で培養し、それに引き続いて液体培地(Sabouraudブロス)に移してインキュベートした。
3x12ml Sabouraudブロス
3x12ml Sabouraudブロス、1%ゼオライト
3x12ml Sabouraudブロスおよび5%ゼオライト。
ブランク値の決定のために、全ての培地のアリコートについて細菌なしでもインキュベートし、試験を行った。
カンジダ・パラプシローシスに対する1mg/mlおよび0.2mg/mlの濃度の本発明物質の作用:
カンジダ・パラプシローシスを、ごく普通に多くの場合に使用される方法に従って、まずYGC寒天上で培養し、それに引き続いて液体培地(Sabouraudブロス)に移してインキュベートした。
3x12ml Sabouraudブロス
3x12ml Sabouraudブロス、0.1%ゼオライト
3x12ml Sabouraudブロスおよび0.02%ゼオライト。
ブランク値の決定のために、全ての培地のアリコートについて細菌なしでもインキュベートし、試験を行った。
細菌性腟症は、膣炎の最も頻度の高い形態を示す。
より低い社会経済学的状態(→ストレス)
頻繁な膣洗浄
喫煙
頻繁に相手が変わる避妊なしでの性交
子宮における避妊具
より高い用量の殺精子剤ノノキシノール−9の頻繁な使用
妊娠外に、メトロニダゾールで7日間治療する(2x500mg/日)。別の手段は、2%膣クリームの形態のメトロニダゾールまたはクリンダマイシンの局所投与からなる(期間:7日間)。7日間にわたる1日2回の500mgメトロニダゾールの局所投与のための膣錠の使用もまた可能である。さらに、クリンダマイシンの膣内使用のための膣坐剤もある(1日1回100mg、3日間)。
ガードネレラ・バジナリスに対する1mg/ml(0.1%M/V)および10mg/ml(1%M/V)の濃度の本発明物質の作用:
ガードネレラ・バジナリス(DSM No.4944)[5]を、ごく普通に多くの場合に使用される方法に従ってCasman寒天上で培養し、引き続き液体培地(TSB+5% ウマ血清)に移した。
さらに少ない開始細胞数(5x104細胞/ml)を用いて増殖試験を繰り返し、比較結果を示した。図8参照(バー;左から0%、0.1%および1%ゼオライト)。
ラクトバチラス・クリスパタス(Lactobacillus crispatus)(DSM No.20584)[6]を、ごく普通に多くの場合に使用される方法に従ってMan Rogosa Sharp(MRS)寒天上で嫌気的に培養し、引き続き液体培地(MRSブロス)に移した。
ラクトバチラス・ジェンセニイ(Lactobacillus jensenii)(DSM No.20557)[12]を、ごく普通に多くの場合に使用される方法に従ってMan Rogosa Sharp(MRS)寒天上で嫌気的に培養し、引き続き液体培地(MRSブロス)に移した。
増殖実験を、インキュベーション期間を延ばして繰り返した。物質代謝活性の測定(Vialightアッセイ)を、上記と同様の方法において4および7時間後に実施した。図13に、測定結果の評価をグラフで示す。本発明物質のL.ジェンセニイに対する増殖促進効果は、試験8における3時間後よりもさらに明確に見られる。
ラクトバチラス・カゼイ(Lactobacillus casei)(DSM No.20011)[11]を、ごく普通に多くの場合に使用される方法に従ってMan Rogosa Sharp(MRS)寒天上で嫌気的に培養し、引き続き液体培地(MRSブロス)に移した。
ラクトバチラス・クリスパタス(DSM No.20584)[6]およびガードネレラ・バジナリス(DSM No.4944)[5]を、ごく普通に多くの場合に使用される方法に従って、最初に純粋培養において培養した。
1x10ml培地(7mlTSB+5%ウマ血清および3mlMRSブロス)
1xG.バジナリス
1xG.バジナリス+0.5%ゼオライト
1xL.クリスパタス
1xL.クリスパタス+0.5%ゼオライト
1xL.クリスパタス+G.バジナリス(5:1)A
1xL.クリスパタス+G.バジナリス+0.5%ゼオライト(5:1)A
1xL.クリスパタス+G.バジナリス(5:1)B
1xL.クリスパタス+G.バジナリス+0.5%ゼオライト(5:1)B
1xL.クリスパタス+G.バジナリス(10:1)A
1xL.クリスパタス+G.バジナリス+0.5%ゼオライト(10:1)A
1xL.クリスパタス+G.バジナリス(10:1)B
1xL.クリスパタス+G.バジナリス+0.5%ゼオライト(10:1)B
ラクトバチラス・クリスパタス(DSM No.20584)[6]およびL.ジェンセニイ(DSM No.20557)[12]を、ごく普通に多くの場合に使用される方法に従って、液体培地において嫌気的に培養した。栄養培地として本発明の物質(10mg/ml)を添加しない、および当該物質を添加したMRSブロスを使用し、これらを実験の前に同一の培地中で予め馴化した。飽和した培養液のアリコートを遠心分離し、上清を下記のようにガードネレラ・バジナリスに対するそれらの増殖抑制作用に関して試験した。
カンジダ・アルビカンスを、ごく普通に多くの場合に使用される方法に従って、液体培地(Sabouraudブロス)で培養した。トーマ血球計算盤を用いて細胞数を決定した後に、それぞれ1x105個細胞/mlの12個の試験液(培養液)を調製し、ここで、3つの培養液にはゼオライト粉末を添加せず(コントロール)、3つの培養液には10mg/mlの量で標準のサイズ分布のゼオライト粉末を添加し、別の3つの培養液には10mg/mlの量で超微細ゼオライト粉末を添加し、さらに3つの培養液には10mg/mlの量で粗ゼオライト粉末を添加した。試験培養液を37℃において好気条件下で振とうしながらインキュベートした。
試験手順は以下の通りであった:
カンジダ・グラブラータを、ごく普通に多くの場合に使用される方法に従って、液体培地(Sabouraudブロス)で培養した。トーマ血球計算盤を用いて細胞数を決定した後に、それぞれ6x105個細胞/mlの12個の試験液(培養液)を調製し、ここで、3つの培養液にはゼオライト粉末を添加せず(コントロール)、3つの培養液には10mg/mlの量で標準のサイズ分布のゼオライト粉末を添加し、別の3つの培養液には10mg/mlの量で超微細ゼオライト粉末を添加し、さらに3つの培養液には10mg/mlの量で粗ゼオライト粉末を添加した。試験培養液を37℃において好気条件下で振とうしながらインキュベートした(110rpm)。
図29の増殖曲線に基づいてわかるように、標準製品を用いたこれらの試験条件下でも(一番下の短い破線の曲線)、粗ゼオライト粉末(上から2番目の長い破線の曲線)を用いた場合よりも明らかに強力な増殖抑制効果が達成される。
[1] Hainer, B.,L. (2011) Vaginitis: Diagnosis and Treatment; American Academy of Family Physicians; http://www.sonoma.edu/users/w/wilkosz/n540a−07/VaginitisDX and TX.pdf
[2] AWMF online: S1−Leitlinie: Bakterielle Vaginose (BV) in Gynaekologie und Geburtshilfe; AWMF − Leitlinien−Register Nr. 015/28; aktueller Stand: 07/2013.
[3] AWMF online: S2k−Leitlinie: Vulvovaginalkandidose; AWMF−Register Nr. 015/072; Stand 12/2013.
[4] Candida albicans DSM Nr. 1386
https://www.dsmz.de/catalogues/details/culture/DSM−1386.html?tx_dsmzresources_pi5%5BreturnPid%5D=304
[5] Gardnerella vaginalis DSM Nr. 4944
https://www.dsmz.de/catalogues/details/culture/DSM−4944.html?tx_dsmzresources_pi5%5BreturnPid%5D=304
[6] Lactobacillus crispatus DSM Nr. 20584
https://www.dsmz.de/catalogues/details/culture/DSM−20584.html?tx_dsmzresources_pi5%5BreturnPid%5D=304
[7] Rampersad, S., N. (2012) Multiple Applications of Alarm Blue as an Indicator of Metabolic Function and Cellular Health in Cell Viability Bioassays; Review, Sensors 2012, 12, 12347−12360.
[8] VialightTM MDA plus - High sensitivity microbial detection kit with extended signal stability; Lonza LT07−122.
[9] Protokoll zur mikrobiologischen Untersuchung S0811−01
[10] Protokoll zur mikrobiologischen Untersuchung S0903−19
[11] Lactobacillus casei DSM Nr. 20011
https://www.dsmz.de/catalogues/details/culture/DSM−20011.html?tx_dsmzresources_pi5%5BreturnPid%5D=304
[12] Lactobacillus jensenii DSM Nr. 20557
https://www.dsmz.de/catalogues/details/culture/DSM−20557.html?tx_dsmzresources_pi5%5BreturnPid%5D=304
[13] EnzytecTM D/L Milchsaeure Art.Nr. E1255 − Gebrauchsanleitung; r−Biopharm.
[14] Candida glabrata ATCC Nr. 2001
https://www.atcc.org/〜/ps/2001.ashx
Claims (4)
- 哺乳動物およびヒトの膣疾患、例えば細菌性膣症、外陰膣カンジダ症およびトリコモナス症の治療において使用するための、および健康な膣細菌叢を回復するための、0.2〜10μmの粒度を有するクリノプチロライト。
- 重金属を含まないことを特徴とする、請求項1に記載のクリノプチロライト。
- 1種または複数種の以下の添加物質:
−薬学的に許容可能な担体材料、
−生存可能な微生物および/またはその抽出物、
−健康な膣細菌叢のための栄養素(例えば乳酸など)、
−健康な膣細菌叢のために膣内環境に有利に影響を及ぼす物質(例えばエストラジオール、有機酸など)、
と使用することを特徴とする、請求項1または2に記載のクリノプチロライト。 - 以下の投与形態:
フォーム、坐剤、膣錠剤、膣坐剤、ゲル剤、エアゾール剤、散剤、洗浄、灌注、クリーム剤/軟膏、懸濁剤、
のうちの1つで局所的に使用されることを特徴とする、請求項1〜3のいずれか1つに記載のクリノプチロライト。
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EP15194288.5A EP3167890A1 (de) | 2015-11-12 | 2015-11-12 | Behandlung von vaginitis |
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CN117535208B (zh) * | 2024-01-04 | 2024-03-29 | 四川厌氧生物科技有限责任公司 | 一种卷曲乳杆菌及其在女性生殖道健康中的应用 |
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US6353146B1 (en) * | 1998-04-20 | 2002-03-05 | Playtex Products, Inc. | Fibrous articles having odor adsorbtion ability and method of making same |
PT956858E (pt) * | 1998-04-30 | 2002-04-29 | Renata Maria Anna Caval Vesely | Composicoes farmaceuticas contendo lactobacilos para o tratamento de infeccoes vaginais |
ES2234981T3 (es) * | 1999-04-26 | 2005-07-01 | Tihomir Lelas | Zeolitas micronizadas para su utilizacion como preparaciones farmaceuticas. |
KR20060128125A (ko) * | 2005-06-09 | 2006-12-14 | 인하대학교 산학협력단 | 만델산을 유효성분으로 함유하는 질염 치료제 |
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US8173101B2 (en) | 2006-07-04 | 2012-05-08 | Gaston Glock | Method for removal of heavy metals |
US20100104615A1 (en) * | 2006-12-15 | 2010-04-29 | Ellen Ab | Absorbent article comprising lactic acid producing bacteria |
WO2009133413A1 (en) * | 2008-04-28 | 2009-11-05 | Novatech D.O.O. | Formulation based on micronized clinoptilolite as a therapeutic agent for removal of toxins, bacteria and viruses from organism |
WO2010057849A1 (de) * | 2008-11-21 | 2010-05-27 | Froximun Ag | Verfahren zur reduktion der konzentration von aminen und deren salzen |
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JP2021513569A (ja) * | 2018-02-08 | 2021-05-27 | ベーツェーエスカー バイオシッド ゲゼルシャフト ミット ベシュレンクテル ハフツング | 抗菌及び殺精子潤滑剤 |
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CN106974932A (zh) | 2017-07-25 |
KR102335607B1 (ko) | 2021-12-06 |
CA2947570C (en) | 2021-08-10 |
AU2016247097B2 (en) | 2021-12-02 |
KR20170055932A (ko) | 2017-05-22 |
TR201904382T4 (tr) | 2019-04-22 |
JP6792420B2 (ja) | 2020-11-25 |
EP3167890A1 (de) | 2017-05-17 |
EP3167891A1 (de) | 2017-05-17 |
EP3167891B1 (de) | 2019-01-23 |
US20170136060A1 (en) | 2017-05-18 |
BR102016026252A2 (pt) | 2017-05-23 |
CA2947570A1 (en) | 2017-05-12 |
ES2719223T3 (es) | 2019-07-09 |
CN106974932B (zh) | 2021-05-04 |
AU2016247097A1 (en) | 2017-06-01 |
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