JP2014518897A - 噴霧乾燥ラクトバチルス株/細胞およびヘリコバクターピロリに対するその使用 - Google Patents
噴霧乾燥ラクトバチルス株/細胞およびヘリコバクターピロリに対するその使用 Download PDFInfo
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- JP2014518897A JP2014518897A JP2014514099A JP2014514099A JP2014518897A JP 2014518897 A JP2014518897 A JP 2014518897A JP 2014514099 A JP2014514099 A JP 2014514099A JP 2014514099 A JP2014514099 A JP 2014514099A JP 2014518897 A JP2014518897 A JP 2014518897A
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- lactobacillus
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- helicobacter pylori
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
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Abstract
Description
本発明の意味する範囲内で、「ラクトバチルス細胞」という用語(広い意味で乳酸菌またはラクトバチルス)は、乳酸の発酵に炭水化物、特にグルコースおよびラクトースを必要とし、生合成にエムデン・マイヤーホフ経路を主に使う微生物を含む。分類学上、ラクトバチルス細胞は乳酸菌科に属する。グラム陽性で、胞子を形成せず、一般的に不動性である。ラクトバチルス細胞は嫌気性であるが、ヘミン(チトクローム、カタラーゼ)を含まないにも拘らず耐気性である(Schleifer et al., System. Appl.Microb.:18,461−467(1995)またはLudwiq et al., System. Appl.Microb.15:487−501(1992))。ラクトバチルス細胞またはその種は、炭水化物発酵パターンに基づいて、特にAPI試験(ビオメリュー社製)によって決定できる。本発明によれば、同種発酵性乳酸発酵または異種発酵性乳酸発酵に適した種がその中に特に含まれる。更に好ましいのは、乳酸桿菌、ラクトバチルスヘルヴェティクス、イエンセン乳酸桿菌、好酸性乳酸桿菌、ブルガリア乳酸桿菌、ラクトバチルスアミロボラス、デルブリュック乳酸桿菌、ラクトバチルスカゼイ、ラクトバチルスクリスパタス、ガセリ菌、ラクトバチルスジョンソニー、ラクトバチルスパラカゼイ、プロテクト乳酸菌、ラクトバチルスラムノサス、ラクトバチルスカルバタスおよびラクトバチラスプランタルム(以上は全て同種発酵性)、更にラクトバチラスブレビス、ブーフナー乳酸桿菌、ラクトバチルスフルクティヴォランス、ラクトバチルスヒルガルディー、発酵乳酸桿菌、ラクトバチルスロイテリ、ラクトバチルスヴィリデセンスおよびビフィドバクテリウムビフィドゥム(以上は全て異種発酵性)からなる群から選択されるラクトバチルス細胞である。本出願者が提出した適切なラクトバチルス細胞は、例えば、DSM17646、DSM17647、DSM17648、DSM17649、DSM17650、DSM17651、DSM17652およびDSM17653(前出)である。本発明によれば、発酵乳酸桿菌、ラクトバチラスブレビス、ラクトバチルスロイテリ、ブーフナー乳酸桿菌およびプロテクト乳酸菌が好ましい。
ラクトバチルス株は冷凍状態で保存した。MRS培地(55g/L、pH6.5、Difco、USA)の固定相(4−8 OD600/mL)で培養した培養物1mLを50%(v/v)滅菌グリセリン溶液500μLと混合し、その混合物を−80℃で冷凍した。
ヒトの消化管、特に胃の培養条件下でヘリコバクターピロリと共凝集できる噴霧乾燥ラクトバチルスは、以下に記載の方法で製造した。
密閉した15mLチューブ中のMRS培地を使って、ラクトバチルス細胞を37℃で24時間培養した。噴霧乾燥ラクトバチルスを検査するため、噴霧乾燥粉末を濃度10mg/mLのPBSに再懸濁した。ヘリコバクターピロリは、微好気性条件下の三角フラスコ中で、10%ウシ胎児血清(Biochrom)を加えたブルセラ・ブロス(28g/L、pH7.0、BD、USA)によって37℃で約2日培養した。培養後、ヘリコバクターピロリ細胞の形態を顕微鏡下で分析した。S状形態を有する細胞または球状形態を有する細胞についてアッセイを行った。混合形態を有する培養物も検査した。
生体内条件下に於ける共凝集体の安定性を試験するため、実施例3の実験を行った。5分間の振盪後形成されたラクトバチルス細胞とヘリコバクターピロリ細胞との共凝集体の懸濁物を、1分間ピペッティングすることにより、あるいは高速で2分間振盪することにより、強力な剪断力の下に置いた。その後、該共凝集体を顕微鏡的および巨視的に分析した。噴霧乾燥ラクトバチルス細胞とヘリコバクターピロリを含む共凝集体のサイズは減少しながったが、噴霧乾燥していないラクトバチルス細胞とヘリコバクターピロリの共凝集体のサイズは減少した。
本発明の一種類のラクトバチルス株または複数種類のラクトバチルス株の細胞を実施例1および2に従って取得し、噴霧乾燥する。次に、噴霧乾燥した粉末を直径約1mm未満の粒子サイズになるまですり潰す。その結果得られた微粒子を以下の割合(重量パーセント)で賦形剤および/または補助剤と混合する:20%の微粒子、2%の二酸化珪素(Syloid AL−IFP、GRACE Davidson)、1%のステアリン酸マグネシウム(MF−2−V、Ackros)、77%の微結晶セルロース(Avicel PH 112、FMC)。
密閉した15mLチューブ中のMRS培地を使って、ラクトバチルス細胞を37℃で24時間培養した。噴霧乾燥ラクトバチルス細胞を検査するため、噴霧乾燥粉末を濃度10mg/mLのPBSに再懸濁した。ヘリコバクターピロリは、微好気性条件下の三角フラスコ中で、10%ウシ胎児血清(Biochrom)を加えたブルセラ・ブロス(28g/L、pH7.0、BD、USA)によって37℃で約2日培養した。培養後、ヘリコバクターピロリ細胞の形態を顕微鏡下で分析した。S状形態を有する細胞または球状形態を有する細胞についてアッセイを行った。混合形態を有する培養物も検査した。
Claims (15)
- 組成物であって、ヒトまたは動物におけるヘリコバクターピロリ感染症の治療および予防用の噴霧乾燥ラクトバチルス細胞を含んでなる、組成物。
- 請求項1に記載の組成物において、噴霧乾燥ラクトバチルス細胞を含み、本質的に単量体および/または二量体の形態で存在することを特徴とする、組成物。
- 請求項1または2に記載の組成物において、a)ラクトバチルス細胞は噴霧乾燥され、b)取得された噴霧乾燥ラクトバチルス細胞は生理適合性の担体に導入されることを特徴とする、組成物。
- 請求項1〜3のいずれか一項に記載の組成物において、胃媒体に投与した後、インサイチューでヘリコバクターピロリとの間に共凝集体を形成することを特徴とする、組成物。
- 請求項1〜4のいずれか一項に記載の組成物において、前記共凝集体は50μm以上であり、特に500μm超であることを特徴とする、組成物。
- 請求項1〜5のいずれか一項に記載の組成物において、前記ラクトバチルス細胞は、乳酸桿菌、ラクトバチルスヘルヴェティクス、イエンセン乳酸桿菌、好酸性乳酸桿菌、ブルガリア乳酸桿菌、ラクトバチルスアミロボラス、デルブリュック乳酸桿菌、ラクトバチルスカゼイ、ラクトバチルスクリスパタス、ガセリ菌、ラクトバチルスジョンソニー、ラクトバチルスパラカゼイ、プロテクト乳酸菌、ラクトバチルスラムノサス、ラクトバチルスカルバタスおよびラクトバチラスプランタルム、ラクトバチラスブレビス、ブーフナー乳酸桿菌、ラクトバチルスフルクティヴォランス、ラクトバチルスヒルガルディー、発酵乳酸桿菌、ラクトバチルスロイテリ、ラクトバチルスヴィリデセンス、DSM17646、DSM17647、DSM17648、DSM17649、DSM17650、DSM17651、DSM17652、DSM17653からなる群から選択され、特に発酵乳酸桿菌、ラクトバチラスブレビス、ラクトバチルスロイテリ、ブーフナー乳酸桿菌およびプロテクト乳酸菌であることを特徴とする、組成物。
- 請求項1〜6のいずれか一項に記載の組成物において、医薬組成物または食品組成物は、特に食品または食糧および/またはペットおよび/または家畜用の飼料および/または食品補助剤の形態で存在し、任意に補助剤および添加剤を含んでなることを特徴とする、組成物。
- 任意に抗生物質などの更に適切な活性成分と組み合わせた、ヘリコバクターピロリの除菌療法用の、請求項1〜7のいずれか一項に記載の組成物。
- ヒトまたは動物においてヘリコバクターピロリ感染症に使用するための、噴霧乾燥ラクトバチルス細胞または請求項1に記載の組成物を含んでなる、医薬製品。
- ヒトまたは動物においてヘリコバクターピロリ感染症に使用するための、噴霧乾燥ラクトバチルス細胞または請求項1に記載の組成物を含んでなる、食品補助剤。
- 請求項1に記載の組成物を生産するための方法であって、前記噴霧乾燥ラクトバチルス細胞を生理適合性の担体と混合する、方法。
- 請求項10に記載の組成物を生産するための方法であって、前記ラクトバチルス細胞はまず(i)任意に播種し濃縮され、(ii)発酵され、そして(iii)噴霧乾燥される、方法。
- 医薬組成物および/または食品組成物を生産するための噴霧乾燥ラクトバチルス細胞の使用であって、特にヘリコバクターピロリ感染症により引き起こされる疾患、特に消化系疾患、例えば胃炎、胃潰瘍および胃癌、腹部不快感、特に上腹部の不快感、胃重感、胃痙攣、胃痛、上腹部の疼痛または圧迫、上腹部の灼熱感、慢性反復性腹痛、永続的満腹感、食欲不振、空腹時疼痛、膨満感、胸焼け、下痢、異常な便通、吐き気、疾患および嘔吐、食物不耐性、吸収不良、胃不調(機能性消化不良)、胃炎、粘膜損傷または胃十二指腸潰瘍の予防および/または治療のための、使用。
- 任意に抗生物質などの更に適切な活性成分と組み合わせた、ヘリコバクターピロリの除菌療法のための、噴霧乾燥ラクトバチルス細胞の使用。
- 医薬製品または食品補助剤であって、ヘリコバクターピロリ感染症により引き起こされる疾患、特に消化系疾患、例えば胃炎、胃潰瘍および胃癌、腹部不快感、特に上腹部の不快感、胃重感、胃痙攣、胃痛、上腹部の疼痛または圧迫、上腹部の灼熱感、慢性反復性腹痛、永続的満腹感、食欲不振、空腹時疼痛、膨満感、胸焼け、下痢、異常な便通、吐き気、疾患および嘔吐、食物不耐性、吸収不良、胃不調(機能性消化不良)、胃炎、粘膜損傷または胃十二指腸潰瘍に使用するための、特にその予防および治療のため並びに任意に抗生物質などの更に適切な活性成分と組み合わせたヘリコバクターピロリの除菌療法に使用するための、医薬製品または食品補助剤。
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JP2020516684A (ja) * | 2017-04-11 | 2020-06-11 | セルバトゥス リミテッド | 炎症及び炎症性疾患の治療法 |
JP7494110B2 (ja) | 2017-04-11 | 2024-06-03 | セルバトゥス リミテッド | 炎症及び炎症性疾患の治療法 |
Also Published As
Publication number | Publication date |
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MX354047B (es) | 2018-02-09 |
MX2013014340A (es) | 2014-07-09 |
CN103648511A (zh) | 2014-03-19 |
ES2600963T3 (es) | 2017-02-13 |
EP2717890B1 (de) | 2016-08-10 |
BR112013031325A2 (pt) | 2017-06-06 |
EA201391823A1 (ru) | 2014-04-30 |
EP2717890A1 (de) | 2014-04-16 |
EA028340B1 (ru) | 2017-11-30 |
CN103648511B (zh) | 2018-12-07 |
US20140147427A1 (en) | 2014-05-29 |
PL2717890T3 (pl) | 2017-12-29 |
JP6062931B2 (ja) | 2017-01-18 |
WO2012168468A1 (de) | 2012-12-13 |
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