JP4011532B2 - ビフィズス菌およびそれを含有する製剤 - Google Patents
ビフィズス菌およびそれを含有する製剤 Download PDFInfo
- Publication number
- JP4011532B2 JP4011532B2 JP2003314690A JP2003314690A JP4011532B2 JP 4011532 B2 JP4011532 B2 JP 4011532B2 JP 2003314690 A JP2003314690 A JP 2003314690A JP 2003314690 A JP2003314690 A JP 2003314690A JP 4011532 B2 JP4011532 B2 JP 4011532B2
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- Prior art keywords
- bifidobacterium longum
- preparation
- biologically pure
- pure culture
- vitamins
- 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.)
- Expired - Lifetime
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- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 description 1
- LWIHDJKSTIGBAC-UHFFFAOYSA-K potassium phosphate Substances [K+].[K+].[K+].[O-]P([O-])([O-])=O LWIHDJKSTIGBAC-UHFFFAOYSA-K 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 108010009004 proteose-peptone Proteins 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
- ZUFQODAHGAHPFQ-UHFFFAOYSA-N pyridoxine hydrochloride Chemical compound Cl.CC1=NC=C(CO)C(CO)=C1O ZUFQODAHGAHPFQ-UHFFFAOYSA-N 0.000 description 1
- 229960002477 riboflavin Drugs 0.000 description 1
- 239000001632 sodium acetate Substances 0.000 description 1
- 235000017281 sodium acetate Nutrition 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 235000010356 sorbitol Nutrition 0.000 description 1
- 239000008347 soybean phospholipid Substances 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 239000003765 sweetening agent Substances 0.000 description 1
- 230000002195 synergetic effect Effects 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 229960003495 thiamine Drugs 0.000 description 1
- DPJRMOMPQZCRJU-UHFFFAOYSA-M thiamine hydrochloride Chemical compound Cl.[Cl-].CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N DPJRMOMPQZCRJU-UHFFFAOYSA-M 0.000 description 1
- 239000004408 titanium dioxide Substances 0.000 description 1
- 239000012588 trypsin Substances 0.000 description 1
- 235000019155 vitamin A Nutrition 0.000 description 1
- 239000011719 vitamin A Substances 0.000 description 1
- 229940011671 vitamin b6 Drugs 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
- 150000003751 zinc Chemical class 0.000 description 1
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Description
(1)スカドビとトロバレッティ(scardovi & Trovatelli)の方法(1965)による6−ホスホケトラーゼテスト(6-phosphoketolase test):両株とも陽性
(2)糖の発酵性を、以下の培地:(ポリペプトン 10g、酵母エキス 1.5g、Tween80 0.3ml、リン酸二カリウム 0.66g、酢酸ナトリウム 3H2O 1.5g、クエン酸二アンモニウム 0.66g、硫酸マグネシウム 7H2O 0.07g、硫酸マンガン 4H2O 0.015g、ブロモクレゾーム・パープル(purple bromocresol) 0.056g、水 1000ml)を添加したAPI50ギャラリー(API 50 galleries)で調べた。その結果を表1に示す。
1.5.5〜7.5の間に調整されたpHでの発酵;
2.遠心分離による、培養ブロス(culture broth)からの細菌バイオマスの分離;
3.凍結および凍結乾燥の工程のあいだ細胞の活性を保護するための、プロテイド、炭化水素および無機塩から選ばれる適切な凍結保護物質の添加と、またできる限り、酵素分解および酸性pH条件に対する菌株の耐性を増大させる範囲でのタンパク質性沈殿物(カゼインのすい臓のペプトン、カゼインの加水分解物、ダイズのすい臓のペプトンおよび酵母エキスの混合物)の添加ののちの、細菌バイオマスの凍結乾燥;
4.凍結乾燥された培養物の粉砕と顆粒化。
工業的発酵における播種時に使用されるビフィドバクテリウム ロンガムW11株の「初代培養物」は、ザ ベルジャン コーディネイテッド コレクションズ オブ マイクロオーガニズムズ−BCCM LMG−コレクション−ラボラトリウム フォール ミクロバイオロジー(Laboratorium voor Microbiologie)、ユニバジテイト ゲント(Universiteit Gent)に寄託されているもの(該寄託機関に発送され受理された菌株で、純度と生存が確認され、受託番号LMG P−21586として登録された菌株)と厳密に同じものである。
−大豆ペプトン 5g
−酵母エキス 5g
−グルコース 10g
−無水K2HPO4 2g
−MgCl2・6H2O 0.5g
−ZnSO4・7H2O 0.25g
−CaCl2・2H2O 0.15g
−ツイーン80 1ml
−システイン塩酸塩 0.5g
−蒸留水 全量が1000mlとなるよう添加
1.6.5〜7.0の間に調整されたpHでの発酵;
2.遠心分離による培養ブロスからの細菌バイオマスの分離;
3.その後の凍結および凍結乾燥の工程のあいだ菌体の活性を保護することを目的として、プロテイド、炭化水素および無機塩から選ばれる凍結保護物質の溶液を用いる、またできる限り、酵素分解および酸性pH条件に対する菌の耐性を賦与することを目的として、タンパク性沈殿物を含有させることによる、細菌バイオマスの保護;
4.凍結乾燥;
5.凍結乾燥された培養物の粉砕と顆粒化;
6.凍結乾燥された培養物の混合(blending);
7.包装。
ビフィドバクテリウム ロンガムW11a株の生物学的に純粋な細菌培養物を、ザ ベルジャン コーディネイテッド コレクションズ オブ マイクロオーガニズムズ−BCCM LMG−コレクション−ラボラトリウム フォール ミクロバイオロジー、ユニバジテイト ゲントに寄託されているもの(該寄託機関で純度と生存が確認され、受託番号LMG P−21587として登録された菌株)と厳密に一致するビフィドバクテリウム ロンガム株の「初代培養物」から出発して、実施例1に記載の方法にしたがって調製した。
試験は、1群2匹のマウスからなる4群で実施した。各マウスに、1.6×109CFU/60μlに等しい濃度でビフィドバクテリウム ロンガムLMG P−21586を含有するグルコース溶液を2回投与した。2回目の投与は最初の投与の16時間後であった。
ビフィドバクテリウム ロンガムW11の生菌体約2×1010個に相当する生物学的に純粋な細菌培養物250mg、フルクトオリゴ糖2500mgおよびビタミンB1、B2、B6およびB12を含有し、水またはミルクに溶解されるための3gの重さのバッグ製剤を例として報告する。
ビタミン類をActilight(登録商標)950Pのアリコートと混合する第1工程を実施し、ついで網の目が0.5mmの篩にかける。この第1の混合物をActilight(登録商標)950Pの第2のアリコートに添加し、第2の混合工程を実施する。最後に、ビフィドバクテリウム ロンガムW11の細菌培養物、Actilight(登録商標)950Pの残りのアリコートおよびそのほかの成分を混合物に添加して、さらに撹拌し、ついで0.8mmの篩にかける。
半減期を決めるために、製剤調製直後(0時間)、および22℃で1、2および3ヵ月保存後にそれぞれ、菌量を測定することにより、前記バッグに関する安定性試験を実施した。1、2および3ヵ月後のデータの分析から、これらの期間では死亡率は非常に低く、各量に対する生菌体の数は、2年後で、前記バッグ処方において5×109個以上であることが分かった。この結果より、該調製が本発明の所望する範囲に充分適当であることが分かった。
下記処方の軟ゲルカプセルを調製した。
Claims (18)
- ビフィドバクテリウム ロンガムLMG P−21586株から製造される生物学的に純粋な培養物。
- ビフィドバクテリウム ロンガムLMG P−21587株から製造される生物学的に純粋な培養物。
- 請求項1または2記載の生物学的に純粋な培養物をプロバイオティクスとして含有してなることを特徴とする、胃腸の健康を助けるための栄養食品用製剤。
- ビフィドバクテリウム ロンガムLMG P−21586株の生物学的に純粋な培養物に由来する生菌体1×107〜1×1011個の菌量を含有する、胃腸の健康を助けるための栄養食品用製剤。
- ビフィドバクテリウム ロンガムLMG P−21587株の生物学的に純粋な培養物に由来する生菌体1×107〜1×1011個の菌量を含有する、胃腸の健康を助けるための栄養食品用製剤。
- 前記製剤がさらにプレバイオティクスをオリゴ糖の形で含有することを特徴とする請求項4または5記載の製剤。
- 前記オリゴ糖が重合度2〜10のフルクトオリゴ糖またはイヌリンであることを特徴とする請求項6記載の製剤。
- 前記製剤がさらにビタミン類を含有することを特徴とする請求項4、5、6または7記載の製剤。
- 前記ビタミン類がビタミンE、B1、B2、B6およびB12であることを特徴とする請求項8記載の製剤。
- 前記製剤がカプセル剤、錠剤、パケット剤、トローチ剤、液状懸濁剤、乾燥経口補助剤、液状経口補助剤、バイアル剤、ミルク、ヨーグルト、フレッシュチーズ、アイスクリーム、発酵穀物製品、粉末ミルク、小児用製品および家畜用製品から選択されることを特徴とする請求項4、5、6、7、8または9記載の製剤。
- 請求項1または2記載の生物学的に純粋な培養物をプロバイオティクスとして含有してなることを特徴とする、下痢、胃腸炎、便秘、過敏性腸、憩室疾患および慢性炎症性腸疾患からなる群より選択される腸の病変を予防および/または治療するための医薬用製剤。
- ビフィドバクテリウム ロンガムLMG P−21586株の生物学的に純粋な培養物に由来する生菌体1×10 7 〜1×10 11 個の菌量を含有する、下痢、胃腸炎、便秘、過敏性腸、憩室疾患および慢性炎症性腸疾患からなる群より選択される腸の病変を予防および/または治療するための医薬用製剤。
- ビフィドバクテリウム ロンガムLMG P−21587株の生物学的に純粋な培養物に由来する生菌体1×10 7 〜1×10 11 個の菌量を含有する、下痢、胃腸炎、便秘、過敏性腸、憩室疾患および慢性炎症性腸疾患からなる群より選択される腸の病変を予防および/または治療するための医薬用製剤。
- 前記製剤がさらにプレバイオティクスをオリゴ糖の形で含有することを特徴とする請求項12または13記載の製剤。
- 前記オリゴ糖が重合度2〜10のフルクトオリゴ糖またはイヌリンであることを特徴とする請求項14記載の製剤。
- 前記製剤がさらにビタミン類を含有することを特徴とする請求項12、13、14または15記載の製剤。
- 前記ビタミン類がビタミンE、B1、B2、B6およびB12であることを特徴とする請求項16記載の製剤。
- 前記製剤がカプセル剤、錠剤、パケット剤、トローチ剤、液状懸濁剤、乾燥経口補助剤、液状経口補助剤、バイアル剤、小児用製品および家畜用製品から選択されることを特徴とする請求項12、13、14、15、16または17記載の製剤。
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IT000564A ITBO20020564A1 (it) | 2002-09-06 | 2002-09-06 | Bifidobatteri e preparazioni che li contengono. |
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EP (2) | EP1398369B1 (ja) |
JP (1) | JP4011532B2 (ja) |
KR (1) | KR100574455B1 (ja) |
CN (1) | CN100386427C (ja) |
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DE (2) | DE60316995T2 (ja) |
DK (2) | DK1398369T3 (ja) |
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IT (1) | ITBO20020564A1 (ja) |
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US9289418B2 (en) | 2013-03-15 | 2016-03-22 | Cedars-Sinai Medical Center | Methods of diagnosis, selection, and treatment of diseases and conditions caused by or associated with methanogens |
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CN104095180A (zh) * | 2013-04-12 | 2014-10-15 | 中国科学院烟台海岸带研究所 | 一种益生菌菊粉片及其制备方法 |
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DE69219768T2 (de) * | 1992-07-06 | 1997-08-28 | Societe Des Produits Nestle S.A., Vevey | Milchbakterien |
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Publication number | Publication date |
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ATE376053T1 (de) | 2007-11-15 |
CN100386427C (zh) | 2008-05-07 |
EP1609852A1 (en) | 2005-12-28 |
US20040047850A1 (en) | 2004-03-11 |
EP1398369B1 (en) | 2006-08-02 |
CA2436752C (en) | 2010-02-02 |
ES2268226T3 (es) | 2007-03-16 |
SI1398369T1 (sl) | 2006-12-31 |
DE60316995T2 (de) | 2008-07-24 |
ITBO20020564A1 (it) | 2004-03-07 |
SI1609852T1 (sl) | 2008-02-29 |
CN1480528A (zh) | 2004-03-10 |
DE60307191D1 (de) | 2006-09-14 |
DK1398369T3 (da) | 2006-10-23 |
ATE335071T1 (de) | 2006-08-15 |
EP1398369A1 (en) | 2004-03-17 |
KR100574455B1 (ko) | 2006-04-27 |
JP2004097222A (ja) | 2004-04-02 |
DE60307191T2 (de) | 2007-07-26 |
PT1609852E (pt) | 2008-01-25 |
KR20040022386A (ko) | 2004-03-12 |
CA2436752A1 (en) | 2004-03-06 |
ES2293419T3 (es) | 2008-03-16 |
EP1609852B1 (en) | 2007-10-17 |
US6960341B2 (en) | 2005-11-01 |
PT1398369E (pt) | 2006-12-29 |
DE60316995D1 (de) | 2007-11-29 |
DK1609852T3 (da) | 2007-12-27 |
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