JP2008174561A - コロストリニン、およびその使用方法 - Google Patents
コロストリニン、およびその使用方法 Download PDFInfo
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- JP2008174561A JP2008174561A JP2008031513A JP2008031513A JP2008174561A JP 2008174561 A JP2008174561 A JP 2008174561A JP 2008031513 A JP2008031513 A JP 2008031513A JP 2008031513 A JP2008031513 A JP 2008031513A JP 2008174561 A JP2008174561 A JP 2008174561A
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- colostrinin
- colostrum
- treatment
- sheep
- ifn
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Abstract
【解決手段】コロストリニンを栄養補助剤として使用し、固体又は液体の形態で供せられるコロストリニンの使用方法。特に、生理的に許容可能な賦形剤と組み合わせて生成された、隔離した形態でのコロストリニンを包含する経口薬としての使用方法。該栄養補助剤は、化学療法の対象にされた乳児、小児、成人、及び/又は悪液質に羅漢した成人、又は慢性疾患により体重減少した成人のための栄養補助食品として有用である。
【選択図】図1
Description
1974年、ヤヌツ(Janusz)ら(FEBS Lett.,49,276−279) 「プロリンが豊富なペプチド(PRP)−ヒツジ初乳からの免疫修飾ペプチド」(Archivum Immunologiae et Therapiae Experimentalis,1993,41,275−279)
(i)16,000ダルトン乃至26,000ダルトンの範囲の分子量を有する。
(ii)たとえば、pHを低下させることにより、カゼインなど蛋白質を除去するステップ、
(iii)たとえば、
(a)イオン交換クロマトグラフィによる脂質および蛋白質の除去後に形成されるホエーを処理するステップと、
(b)リン酸緩衝食塩水で溶出し、免疫グロブリン、たとえばヒツジのIgG2に結合したコロストリニンを含有する画分を採集するステップと、により免疫グロブリンに結合したコロストリニンを分離するステップと、
(iv)免疫グロブリンから、たとえばクロマトグラフィをふるい分けすることによりコロストリニンを分離するステップと、
(v)さらに免疫グロブリンからコロストリニンを分離し、
(a)分子量30,000ダルトン以下の画分を脱塩するステップと、
(b)免疫グロブリンに抗体に導入することにより、このクラスの蛋白質を除去し、最終産物を得るステップと、によりコロストリニンを精製するステップ。
分子量6000ダルトンの3つの非共有結合サブユニットから構成される分子量18000ダルトンのヒツジのコロストリニンにおいて、各サブユニットは以下のアミノ酸組成を有した:
コロストリニンは、授乳開始後24時間までの分娩後に取られるヒツジ初乳から得た。脂肪およびカゼインの一部を除去するために、35000xgで材料を遠心分離した。得られたIg画分をDEAEセルロースカラムにかけ、ポリペプチドコロストリニンと複合した免疫グロブリンIgG2を分離し、カラムからの溶出時にSephadex G−100でのカラムクロマトグラフィによりIgG2からコロストリニンを分離し、さらにSephadex G−100でクロマトグラフィを行った。次に、このペプチドの画分をヒツジIgG2に対する抗体と結合したセファロースのカラムにかけ、IgG2汚染の痕跡を除去した。得られた製剤をSephadex G−25により脱塩し、凍結乾燥させたのち、温度+4℃または−20℃で保存した。
組成およびアミノ酸配列Val−Glu−Ser−Tyr−Val−Pro−Leu−Phe−Proを有するノナペプチドNPは、実施例Iで生成されたコロストリニンから得た。
以下の組成物による吸引用の錠剤型における投与単位
組成:
活性成分: 実施例Iに従って得られたコロストリニン
(Colostrinin(登録商標))ポリペプチド 0.0001g
安定剤: 不純物として主にI.P.S.を
含まないアルブミン 0.000135g
潤滑剤/結合剤:ステアリン酸マグネシウム 0.003g
賦形剤: マニトール 0.15g(0.1497g)
上の成分を0.0001M NaCl中に懸濁した。吸引用錠剤は、アルツハイマー病を含む主に初期および後期の痴呆、および各種病期の老年性痴呆の治療、非特異的免疫刺激および免疫矯正を必要とする慢性細菌性およびウイルス性感染症および各種薬剤が原因の後天性免疫不全の治療のために使用される。また、特に精神病患者のうつ状態における情動障害で使用し、福利の一般的感情を改善して気分を安定化させるとともに、解毒期間後の薬物依存症、および興奮薬依存患者における補助回収としても用いられる。コロストリニンTMは人工栄養と関連した栄養不全を矯正するために新生児および小児において用いることもできる。
以下の組成物により粘膜に適用するためのゲルの形状での製剤
活性成分: 実施例Iに従って得られたコロストリニンTMポリペプチド
安定剤: アルブミン
ゲル賦形剤: ペクチン、ゼラチン、カルボキシメチルセルロースの
ナトリウム塩および炭化水素ゲルを含有するオラバーゼ−
プレイン(Orabase-Plain(登録商標)
ポリペプチドコロストリニンTM0.0003gおよびアルブミン0.0015gをゲル賦形剤1ml当たりで使用した。こうして調製された投与単位は、主に口腔および上気道の細菌性およびウイルス性感染症の周期性治療のために使用される。
筋内、皮下または静脈内注射の形状での製剤。
安定剤: 不純物を含まないヒトアルブミン
賦形剤: 滅菌、非発熱水
ポリペプチドコロストリニンTM0.0003g、アルブミン0.0015gおよび抗菌剤として、0.001%Merthiolate、すなわちethylmercurithiosalicylic asidのナトリウム塩を1mlアンプル当たりで使用した。こうして得られた投与単位は主に細菌性感染症およびウイルス性感染症の周期的治療のために用いられる。
筋内、皮下または静脈内注射の形状での製剤。
安定剤: 不純物を含まないヒトアルブミン
賦形剤: 滅菌、非発熱水
NP0.0003g、アルブミン0.0015gおよび抗菌剤として、0.001%Merthiolate、すなわちethylmercurithiosalicylic asidのナトリウム塩を1mlアンプル当たりで使用した。こうして得られた投与単位は主に細菌性感染症およびウイルス性感染症の周期的治療のために用いられる。
周期的治療で実施例IIIにおける状態の剤型の薬剤を服用したボランティア健常者および患者から採取した血液のin vitroでのポリペプチドコロストリニンTMによるサイトカインの誘導を以下の通り実施する。
(表1)
健常ボランティアおよびアルツハイマー病患者の全血中に存在するリンパ球の培養におけるヒツジからのコロストリニンTM(シリーズA1993)によるサイトカインの誘導。
(表2)
健常ボランティアおよび各種疾患患者の全血を用いた実験におけるヒツジからのコロストリニンTM(シリーズA1993)によるインターフェロン(IFN)の産生刺激の例
────────────────────────────────────
注:IFN の存在についてのバイオ試験では各種類のインターフェロンの濃度を測定するが、ELISA試験では免疫活性IFN−γの濃度のみを測定する。
<実施例VIII>
ウロルワフの専門家地区病院婦人産科より得た臍帯血。分娩後4〜6時間に採取した臍帯血のリンパ球におけるin vitroコロストリニンTMによるサイトカインの誘導を以下のようにして実施する。
臍帯血(CBL)から分離したリンパ球の培養におけるコロストリニンTM(シリーズA1996)によるサイトカインの誘導
N−試験したCBL試料の数
スチューデントt検定における差コロストリニンTMの有意性の確率
−「欠」はIFNおよびTNFについてp<0.001。
臍帯血は未熟幹細胞が豊富であり、これらには造血細胞および各種免疫活性細胞の再生能があるため、得られた結果は、コロストリニンTMは幹細胞の成熟を大幅に促進することを示している。得られた結果は、各種類の免疫不全の治療や、たとえば損傷、感染、化学療法および放射線治療後に造血系を刺激するために、コロストリニンTMを使用することが可能である。生物医学的試験において、同様の活性の天然源の物質はきわめて稀にしか見られない。
中枢神経系の障害を治療する方法は、アルツハイマー病の初期および中期のボランティア患者群で試験した。投与単位を実施例Iおよび実施例IIIにおいて規定したコロストリニンTM0.00015gを含む吸引用の錠剤型で食間に投与した。最初に、1日1錠を3週間使用し、2〜4週間治療を中断し、1日2錠を3週間投与することにより治療を反復した。コロストリニンTM治療により低反応性または耐性の状態が誘発された。これはIFNおよび腫瘍壊死因子TNF−αの合成能がないことで明らかにされる。この現象により活性剤の活動を量的に測定することができる。
中枢神経系の障害を治療する方法は、アルツハイマー病の初期および中期のボランティア患者群で試験した。投与単位を実施例IIにおいて規定したNP0.00015gを含む吸引用の錠剤型で食間に投与した。最初に、1日1錠を3週間使用し、3週間治療を中断し、1日2錠を3週間投与することにより治療を反復した。NP治療により低反応性または耐性の状態が誘発された。これはIFNおよび腫瘍壊死因子TNF−αの合成能がないことで明らかにされる。この現象により活性剤の活動を量的に測定することができる。
Claims (4)
- 隔離した形態でのコロストリニンの栄養補助剤としての使用。
- 請求項1に記載した使用において、化学療法の対象にされた乳児、小児、成人、及び/又は悪液質に羅漢した成人、又は慢性疾患により体重減少した成人のための栄養補助剤としてのコロストリニンの使用。
- 請求項1又は請求項2に記載した使用において、前記栄養補助剤が固体又は液体の形態で供せられることを特徴とするコロストリニンの栄養補助剤としての使用。
- 生理的に許容可能な賦形剤と組み合わせて生成された、隔離した形態でのコロストリニンを包含する経口薬を有することを特徴とする栄養補助剤。
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EP1080111B1 (en) | 1998-05-27 | 2012-07-25 | Gemma Biotechnology Ltd. | The induction of antiobiotic peptides by lait (scd14) protein |
AU777968B2 (en) * | 1998-06-10 | 2004-11-04 | Albert B. Crum | Prophylactic and therapeutic nutritional supplement for creation/maintenance of health-protective intestinal microflora and enhancement of the immune system |
GB9813031D0 (en) * | 1998-06-16 | 1998-08-12 | Regen Biotech Limited | Dietary supplement |
GB9912852D0 (en) * | 1999-06-02 | 1999-08-04 | Regen Therapeutics Plc | Peptides |
US6500798B1 (en) | 1999-08-17 | 2002-12-31 | Board Of Regents, The University Of Texas System | Use of colostrinin, constituent peptides thereof, and analogs thereof, as oxidative stress regulators |
EP1224217A4 (en) * | 1999-08-17 | 2006-05-24 | Univ Texas | USE OF COLOSTRININ, THOSE FORMING PEPTIDES, AND ANALOGS FROM INDUCING CYTOKINES |
US6903068B1 (en) * | 1999-08-17 | 2005-06-07 | Board Of Regents, The University Of Texas System | Use of colostrinin, constituent peptides thereof, and analogs thereof for inducing cytokines |
US6852685B1 (en) * | 1999-08-17 | 2005-02-08 | Board Of Regents, The University Of Texas System | Use of colostrinin, constituent peptides thereof, and analogs thereof to promote neuronal cell differentiation |
DE60036638T2 (de) * | 1999-08-17 | 2008-02-21 | The University Of Texas System, Austin | Verwendung von colostrinin, dessen peptidbestandteile und deren analoga zur förderung der neuronalen zelldifferenzierung |
US7119064B2 (en) * | 1999-08-17 | 2006-10-10 | Board Of Regents, The University Of Texas System | Use of colostrinin, constituent peptides thereof, and analogs thereof as modulators of intracellular signaling molecules |
GB0001825D0 (en) * | 2000-01-26 | 2000-03-22 | Regen Therapeutics Plc | Peptides |
WO2002013850A1 (en) * | 2000-08-17 | 2002-02-21 | The University Of Texas System | Use of colostrinin, constituent peptides thereof, and analogs thereof as oxidative stress regulators |
AU2000269179A1 (en) * | 2000-08-17 | 2002-02-25 | The University Of Texas System | Use of colostrinin, constituent peptides thereof, and analogs thereof to promoteneural cell differentiation |
AU2000267883A1 (en) * | 2000-08-17 | 2002-02-25 | Regen Therapeutics Plc | Use of colostrinin, constituent peptides thereof, and analogs thereof for inducing cytokines |
GB0029777D0 (en) * | 2000-12-06 | 2001-01-17 | Regen Therapeutics Plc | Peptides |
HUP0200172A2 (hu) * | 2002-01-15 | 2003-11-28 | András Bertha | Eljárás tumorellenes hatóanyag kinyerésére |
US20050042300A1 (en) * | 2002-10-22 | 2005-02-24 | Istvan Boldogh | Use of colostrinin, constituent peptides thereof, and analogs thereof as inhibitors of apoptosis and other cellular damage |
EP1613648B1 (en) * | 2003-03-11 | 2007-12-12 | Regen Therapeutics PLC | Purification of peptides from colostrum |
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RU2642650C2 (ru) | 2011-12-30 | 2018-01-25 | Инномед С.А. | Комбинация факторов роста, цитокинов, антибактериальных/антивирусных факторов, факторов стволовых клеток, белков комплемента с3а/с4а, иммуноглобулинов и хемотаксических факторов |
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1997
- 1997-10-03 RU RU99109093/15A patent/RU2217152C2/ru not_active IP Right Cessation
- 1997-10-03 IL IL12921197A patent/IL129211A/en not_active IP Right Cessation
- 1997-10-03 WO PCT/GB1997/002721 patent/WO1998014473A1/en active IP Right Grant
- 1997-10-03 EP EP97944005A patent/EP0932623A1/en not_active Withdrawn
- 1997-10-03 US US09/269,845 patent/US6852700B1/en not_active Expired - Lifetime
- 1997-10-03 BR BR9712259-9A patent/BR9712259A/pt not_active Application Discontinuation
- 1997-10-03 CA CA2266859A patent/CA2266859C/en not_active Expired - Fee Related
- 1997-10-03 KR KR10-1999-7002904A patent/KR100508764B1/ko not_active IP Right Cessation
- 1997-10-03 AR ARP970104585A patent/AR013612A1/es unknown
- 1997-10-03 CN CN97198535A patent/CN1131712C/zh not_active Expired - Fee Related
- 1997-10-03 ZA ZA9708885A patent/ZA978885B/xx unknown
- 1997-10-03 CN CNA031466095A patent/CN1535722A/zh active Pending
- 1997-10-03 JP JP10516329A patent/JP2001501929A/ja active Pending
- 1997-10-03 TR TR1999/01022T patent/TR199901022T2/xx unknown
- 1997-10-03 CZ CZ0114999A patent/CZ298215B6/cs not_active IP Right Cessation
- 1997-10-03 AU AU45651/97A patent/AU4565197A/en not_active Abandoned
- 1997-10-03 GB GB9908331A patent/GB2333453B/en not_active Expired - Fee Related
- 1997-10-03 KR KR1020057004215A patent/KR20050046766A/ko not_active Application Discontinuation
- 1997-10-03 HU HU9904368A patent/HUP9904368A3/hu unknown
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2004
- 2004-12-03 US US11/003,854 patent/US20050152985A1/en not_active Abandoned
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2008
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GB2333453A (en) | 1999-07-28 |
HUP9904368A2 (hu) | 2000-06-28 |
CA2266859C (en) | 2012-05-08 |
PL316416A1 (en) | 1998-04-14 |
PL185442B1 (pl) | 2003-05-30 |
KR20000048886A (ko) | 2000-07-25 |
US20050152985A1 (en) | 2005-07-14 |
KR100508764B1 (ko) | 2005-08-17 |
WO1998014473A1 (en) | 1998-04-09 |
IL129211A0 (en) | 2000-02-17 |
US6852700B1 (en) | 2005-02-08 |
JP2001501929A (ja) | 2001-02-13 |
HUP9904368A3 (en) | 2000-07-28 |
KR20050046766A (ko) | 2005-05-18 |
IL129211A (en) | 2004-08-31 |
CN1535722A (zh) | 2004-10-13 |
GB2333453B (en) | 2001-05-30 |
GB9908331D0 (en) | 1999-06-09 |
AU4565197A (en) | 1998-04-24 |
EP0932623A1 (en) | 1999-08-04 |
RU2217152C2 (ru) | 2003-11-27 |
BR9712259A (pt) | 2000-01-25 |
TR199901022T2 (xx) | 1999-07-21 |
GB2333453A8 (en) | 2000-11-27 |
CZ298215B6 (cs) | 2007-07-25 |
AR013612A1 (es) | 2001-01-10 |
CN1238782A (zh) | 1999-12-15 |
CN1131712C (zh) | 2003-12-24 |
CA2266859A1 (en) | 1998-04-09 |
ZA978885B (en) | 1999-07-26 |
CZ114999A3 (cs) | 2000-06-14 |
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