JP2017109973A - 機能性胃腸症改善剤 - Google Patents
機能性胃腸症改善剤 Download PDFInfo
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- JP2017109973A JP2017109973A JP2015247711A JP2015247711A JP2017109973A JP 2017109973 A JP2017109973 A JP 2017109973A JP 2015247711 A JP2015247711 A JP 2015247711A JP 2015247711 A JP2015247711 A JP 2015247711A JP 2017109973 A JP2017109973 A JP 2017109973A
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- bacillus subtilis
- improving agent
- functional gastroenteropathy
- functional
- tablet
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Abstract
Description
(1)バチルス・ズブチリスを有効成分として含む機能性胃腸症改善剤;
(2)バチルス・ズブチリスの培養物を有効成分として含む、上記(1)に記載の機能性胃腸症改善剤;
(3)前記培養物が大豆培養物である、上記(2)に記載の機能性胃腸症改善剤;
(4)バチルス・ズブチリスの芽胞を含む、上記(3)に記載の機能性胃腸症改善剤。
(5)前記バチルス・ズブチリスがC−3102株(FERM BP−1096)である、上記(1)〜(4)のいずれかに記載の機能性胃腸症改善剤;
(6)経口摂取により機能性胃腸症を改善させる、上記(1)〜(5)のいずれかに記載の機能性胃腸症改善剤;
(7)錠剤である、上記(1)〜(6)のいずれかに記載の機能性胃腸症改善剤;
(8)錠剤が素錠である、上記(7)に記載の機能性胃腸症改善剤;
(9)錠剤が糖衣錠である、上記(7)に記載の機能性胃腸症改善剤;
(10)麦芽糖及びでんぷんを含む、上記(7)〜(9)のいずれかに記載の機能性胃腸症改善剤;
(11)1錠あたり2.0×108〜9.0×1010CFUのバチルス・ズブチリスを含む上記(7)〜(10)のいずれか1項に記載の機能性胃腸症改善剤;
(12)1錠あたり4.0×108〜2.0×1010CFUのバチルス・ズブチリスを含む上記(11)に記載の機能性胃腸症改善剤;
(13)1日あたり1〜5錠服用されることを特徴とする、上記(11)又は(12)に記載の機能性胃腸症改善剤;
(14)1日あたり2.0×109〜2.0×1010CFUのバチルス・ズブチリスを摂取できるように製剤化されている、上記(1)〜(13)のいずれかに記載の機能性胃腸症改善剤;
(15)少なくとも2カ月間服用される、上記(1)〜(14)のいずれかに記載の機能性胃腸症改善剤。
1.1 有効成分:バチルス・ズブチリス
本発明の機能性胃腸症改善剤は、バチルス・ズブチリス(Bacillus subtilis)を有効成分として含む。バチルス属の菌は古くからヒトの食生活に深くかかわっており、その機能性についての情報は多いが、機能性胃腸症に対する効果は未だ報告されていない。
(1)グラム陽性
(2)卵円形の芽胞を形成
(3)桿菌
(4)運動性:あり
(5)好気性
(6)カタラーゼ:陽性
(7)50℃における発育:+
(8)pH5.7における発育:+
(9)クエン酸塩の利用:+
(10)糖類からの酸生成の有無:アラビノース、グルコース、キシロース、マンニット:+
(11)VP反応:+
(12)デンプンの加水分解:+
(13)硝酸塩の還元性:+
(14)インドールの生成:−
(15)ゼラチンの加水分解:+
(16)カゼインの加水分解:+
(17)液体培地での被膜形成:+
(18)牛乳の凝固:−
(19)牛乳のペプトン化:+
配列1:5'−GCCCCGCACATACGAAAAGACTGGCTGAAA−3'(配列番号1)
配列2:5'−GGATCCCACGTTGTGATTAAAAGCAGCGAT−3'(配列番号2)
(1)プラスミドDNAを有しない。
(2)ゲノムDNAを調製し、制限酵素NotIまたはSfiIで消化してアガロース電気泳動により分離したときの消化パターンは図1に示されるとおりである。
(3)B.cerous抗菌物質を産生する。
(4)アンピシリン、クロラムフェニコール、シプロフロキサシン、エリスロマイシン、ゲンタマイシン、カナマイシン、リネゾリド、キヌプリスチン/ダルフォプリスチン、リファムピン、ストレプトマイシン、テトラサイクリン、トリメトプリム、バンコマイシンに対して耐性を有しない(いずれも最小阻害濃度0.03〜4μg/ml)。
バチルス・ズブチリスは、培地として微生物培養に通常使用される炭素源、窒素源、無機物等を含む液体培地又は固体培地を用いて培養することができる。炭素源としては、バチルス・ズブチリスが資化可能な炭素源であればよく、例えばグルコース、フルクトース、スクロース、スターチ、糖蜜等を、また窒素源としては、例えばペプトン、カゼイン加水分解物、肉エキス、硫安等を挙げることができる。更に、必要に応じて燐酸、カリウム、マグネシウム、カルシウム、ナトリウム、鉄およびマンガン等の塩類、ビタミン類、アミノ酸類、界面活性剤等を添加することもできる。また、これらの合成培地の他、大豆油かすなどの天然物由来物質を用いて培養してもよい。培養条件としては、好気的条件が好ましく、培養装置としては例えばジャーファーメンターによる通気撹拌液体培養、棚式固体培養、自動製麹培養装置等が好ましい。培養温度は20〜50℃、特に30〜45℃が好ましく、培養時間は12時間〜7日間、培養初発pHはpH5〜9、特に好ましくはpH6〜8である。
本発明の機能性胃腸症改善剤は、経口摂取により機能性胃腸症に伴う胃腸症状、例えば、消化不良、下痢、腹痛、軟便等を改善させる。
本発明は、バチルス・ズブチリス又はその培養物と薬理学的に許容しうる担体を含む錠剤(錠剤として製剤化された機能性胃腸症改善剤)を提供する。
1.糖衣錠の調製
市販大豆油かす造粒品10kgに水5kgを加えて121℃、60分間殺菌し、予め前培養しておいたバチルス・ズブチリスC−3102株(生命工学工業技術研究所寄託番号 FERM BP−1096)の培養液を接種し、37℃程度で、60.5時間培養することにより、バチルス・ズブチリスC−3102株の大豆培養物を製造した。このようにして得られた培養物を乾燥粉砕し、下記の表に示す他の成分を配合して、糖衣錠を製造した。糖衣錠の組成を表1、2に示す。
RomeIII基準により機能性胃腸症もしくはそれに準ずると医師が認めた22〜77歳の外来通院可能な42名を対象とし、このうち21名に3錠あたり4.5×109CFUのバチルス・ズブチリスC−3102株を含む糖衣錠を1日3錠、2ヶ月間摂取させ、残り21名には、プラセボとしてデキストリンを含む錠剤を2ヶ月間摂取させた。1ヶ月ごとに、胃腸症状を評価するGastrointestinal Symptom Rating Scale (GSRS)アンケートを実施した。プラセボ群のうち2名は脱落したため、結果的にC−3102株群21名、及びプラセボ群19名が解析対象となった。摂取8週目においてプラセボ群と比較し、有意な改善がみられた項目を表3に示す。
(1)GSRSスコア
消化不良スコア(腹鳴・膨満感・曖気・放屁)、下痢スコア(下痢・軟便・便意切迫)、および全体スコアの変化をグラフに示した。摂取4、8週間後に、消化不良スコアおよび全体スコアが、摂取8週間後に下痢スコアが有意に改善することが確認された(図2)。
投与8週目の時点で、プラセボ群と比較して、C−3102株群では15項目中5項目(腹鳴、膨満感、放屁、下痢、軟便)の有意な改善が確認された。また、各評価項目を統合した評価では、消化不良スコア(腹鳴+膨満感+気+放屁)および下痢スコア(下痢+軟便+便意切迫)の有意な改善が確認され、全てを統合した全体スコアでも有意な改善が確認された。以上の結果から、バチルス・ズブチリスC−3102株が、機能性胃腸症の症状改善作用を有することが明らかとなった。
バチルス・ズブチリスC−3102株群はプラセボ群と比較して、有用菌の一種であるフィーカリバクテリウム属の腸内フローラに占める割合(占有率)が、摂取4、8週目において有意に増加していた(図3及び図5)。フィーカリバクテリウム属は、大腸で酪酸を産生する主要な菌であり、酪酸には、過剰な免疫応答を抑制する制御性T細胞の分化を促進し、炎症を抑制することがわかっている。
また、胃腸症状に関するGSRSスコアと占有率の変化との相関解析から、胃腸症状が悪い人ほど、コリオバクテリウム科の菌属、およびホールディマニア属の占有率が高いことが明らかになった。これらの2菌属は、バチルス・ズブチリスC−3102株群ではプラセボ群に比較して、摂取8週目において占有率が有意に減少していた。(図4)。以上の結果から、バチルス・ズブチリスC−3102株の摂取により、有用菌(炎症を抑制するとされる菌)が増加し、胃腸症状の悪化と関連している可能性がある2菌属が減少することが確認された。
ピロリ菌の陽性率については、C−3102株群及びプラセボ群のいずれにおいても、試験の前後(0週及び8週)で変化はなかった。
機能性胃腸症を訴える被験者では、バチルス・ズブチリスC−3102株を摂取することにより、胃腸症状の改善、炎症抑制作用がある酪酸を産生する主要な菌であるFaecalibacterium prausnitziiの増加、機能性胃腸症の症状スコアと正相関のある菌の減少が認められた。
実施例1にしたがい、バチルス・ズブチリスC−3102株の大豆培養物を製造した。得られた培養物を乾燥粉砕し、下記の表に示す他の成分を配合して、糖衣を施さない素錠を製造した。
第十六改正日本薬局方に準じて崩壊性試験を実施し、素錠の崩壊性を実施例1の糖衣錠と比較した。結果を下表に示す。
アルミパウチ中で23ヶ月及び36ヶ月保存(20℃)したときの保存安定性(菌数推移)を素錠と糖衣錠で比較した。結果を下表に示す。
3錠あたり5×109CFUのバチルス・ズブチリスC−3102株を含む素錠を調製し、便秘傾向者(男性5名、女性1名、合計6名)に、1日3錠(1日1回、原則として朝食後摂取)、4週間連続摂取させ、摂取期間中の排便回数を記録した。結果を図2に示す。
3錠あたり7×109CFUのバチルス・ズブチリスC−3102株を含む素錠及び糖衣錠を調製し、45〜54歳の女性30名に素錠(15名)もしくは糖衣錠(15名)を6日間服用させ、体調変化、飲みやすさ(粒の大きさや粒の数が気になるか否か)についてアンケート調査を実施した。結果を下表に示す。
バチルス・ズブチリスC−3102株大豆培養物と食用油脂を混合し、常法により下記成分からなるソフトカプセル剤皮の中に充填し、1粒380mgのソフトカプセルを得た。
内容物
バチルス・ズブチリスC−3102株大豆培養物 100mg
食用油脂 150mg
剤皮
ゼラチン 100mg
グリセリン 30mg
下記成分を配合し、常法に従って造粒し、5g入りスティック顆粒を製造した。
配合
バチルス・ズブチリスC−3102株大豆培養物 5%
CMCNa 適宜
デキストリン 適宜
下記成分を配合し、常法に従って、水10kgを加えて液剤を調製した。
配合
バチルス・ズブチリスC−3102株大豆培養物 100g
液糖 4000g
DL−酒石酸ナトリウム 1g
クエン酸 50g
ビタミンC 50g
ビタミンE 150g
シクロデキストリン 25g
塩化カリウム 5g
硫酸マグネシウム 2g
配列番号2:合成DNA(リバースプライマー)
Claims (15)
- バチルス・ズブチリスを有効成分として含む機能性胃腸症改善剤。
- バチルス・ズブチリスの培養物を有効成分として含む、請求項1に記載の機能性胃腸症改善剤。
- 前記培養物が大豆培養物である、請求項2に記載の機能性胃腸症改善剤。
- バチルス・ズブチリスの芽胞を含む、請求項3に記載の機能性胃腸症改善剤。
- 前記バチルス・ズブチリスがC−3102株(FERM BP−1096)である、請求項1〜4のいずれか1項に記載の機能性胃腸症改善剤。
- 経口摂取により機能性胃腸症を改善させる、請求項1〜5のいずれか1項に記載の機能性胃腸症改善剤。
- 錠剤である、請求項1〜6のいずれか1項に記載の機能性胃腸症改善剤。
- 錠剤が素錠である、請求項7に記載の機能性胃腸症改善剤。
- 錠剤が糖衣錠である、請求項7に記載の機能性胃腸症改善剤。
- 麦芽糖及びでんぷんを含む、請求項7〜9のいずれか1項に記載の機能性胃腸症改善剤。
- 1錠あたり2.0×108〜9.0×1010CFUのバチルス・ズブチリスを含む請求項7〜10のいずれか1項に記載の機能性胃腸症改善剤。
- 1錠あたり4.0×108〜2.0×1010CFUのバチルス・ズブチリスを含む請求項11に記載の機能性胃腸症改善剤。
- 1日あたり1〜5錠服用されることを特徴とする、請求項11又は12に記載の機能性胃腸症改善剤。
- 1日あたり2.0×109〜2.0×1010CFUのバチルス・ズブチリスを摂取できるように製剤化されている、請求項1〜13のいずれか1項に記載の機能性胃腸症改善剤。
- 少なくとも2カ月間服用される、請求項1〜14のいずれか1項に記載の機能性胃腸症改善剤。
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JP2020078273A (ja) * | 2018-11-13 | 2020-05-28 | 株式会社サイキンソー | 腸内dysbiosis判定システム |
JP7295547B2 (ja) | 2018-11-13 | 2023-06-21 | 株式会社サイキンソー | 腸内dysbiosis判定システム |
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