KR920700684A - t-PA pro의 안정화 - Google Patents

t-PA pro의 안정화

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KR920700684A
KR920700684A KR1019910700935A KR910700935A KR920700684A KR 920700684 A KR920700684 A KR 920700684A KR 1019910700935 A KR1019910700935 A KR 1019910700935A KR 910700935 A KR910700935 A KR 910700935A KR 920700684 A KR920700684 A KR 920700684A
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mmol
acid
sodium citrate
pharmaceutical
pharmaceutical formulation
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울리히 코너트
라이너 루돌프
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헤르베르트 포우크베트· 베른트 콜프
뵈링거 만하임 게엠베하
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Publication of KR920700684A publication Critical patent/KR920700684A/ko

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Abstract

내용 없음

Description

t-PA pro 의 안정화
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음

Claims (21)

  1. 다음 화합물들, 즉 a)아스코르빈산, b)EDTA, c)다음 구조식의 아미노 화합물, R1R2N-R-X의 식중, X는 SO3H, CH(NH2)-CO2H, CO2H, H, NH2또는 OH, R은 C1-9-알킬렌 C3-6, 사이클로알킬렌 또는 벤질리덴, R1및 R2는 각각 H또는 C1-3알킬, d)구아니디노부티르산, e) 디메틸바이구아나이드, f)아르기닌, g) 글루코사민, 플럭토스, h)피리미딘 뉴클레오시드 및 피리미딘 뉴클레오타이드, i) 하나 이상의 하이드록실, 케토 및/ 또는 또다른 카복실 그룹으로 치환된 카복실산류로 구성된 그룹에서 선택된 최소한 하나의 화합물 및 시트르산염을 함유하는 것을 특징으로 하는 pH가 4.5-6이고 효소활성이 최소한 0.1MU/ml인 비글리코실화 t-PA의 제약학적 제제.
  2. 제1항에 있어서, 아미노 화합물이 타우린, 4-아미노부탄올-1, 5-아미노펜탄올-1,6-아미노헥산올-1, 1,9-디아미노노난, 1,8-디아미노옥탄, 1,7-디아미노헵탄, 1,6-디아미노헥산, 1,5-디아미노펜탄, 1,4-아미노부탄, 또는 1,3-아미노프로판, 라이신, 오르니틴, 8-아미노옥탄산, 7-아미노헵탄산, ε-아미노카프론산, δ-아미노발레린산, γ-아미노부티르산, 트라넥사민산 또는 p-아미노메틸벤조산인 것을 특징으로 하는 의약 제조물.
  3. 제1항에 있어서, 하나이상의 하이드록실, 케토 및 또는 또 다른 카복실 그룹으로 치환된 카복실산의 말산, 젖산, 푸마르산 또는 2-옥소글루타르산인 것을 특징으로 하는 제약학적 제제.
  4. 제1항에 있어서, 하나 이상의 아미노산을 부가적으로 함유하는 것을 특징으로 하는 제약학적 제제.
  5. 제1항 내지 제4항중 어느 한 항에 있어서, 시트르산염 농도가 5-100mmol/l, 바람직하게는 50mmol/l인 것을 특징으로하는 제약학적 제제.
  6. 제1항 내지 제5항중 어느 한 항에 있어서, 염화물 이온을 부가적으로 함유하는 것을 특징으로 하는 제약학적 제제.
  7. 제1항에 있어서, 50mmol/l의 시트르산나트륨(pH6), 및 0.1-1mmol/l, 바람직하게 0.2-0.3mol/l의 아스코르빈산을 함유하는 것을 특징으로 하는 제약학적 제제.
  8. 제1항에 있어서, 50mmol/l의 시트르산나트륨(pH6), 및 1-200mmol/l, 바람직하게 10-100mmol/l의 EDTA를 함유하는 것을 특징으로 하는 제약학적 제제.
  9. 제1항에 있어서, 50mmol/l의 시트르산나트륨(pH6), 및 0.1-0.5mmol/l, 바람직하게 0.1-0.3mol/l의 타우린을 함유하는 것을 특징으로 하는 제약학적 제제.
  10. 제1항에 있어서, 50mmol/l의 시트르산나트륨/HCI(pH6), 및 0.5-20mmol/l,라이신, 오르니틴, 8-아미노옥탄산, 7-아미노헵탄산, ε-아미노카프론산, δ-아미노발레린산.-아미노부티르산, 트라넥사민산 또는 p-아미노케틸벤조산을 함유하는 것을 특징으로 하는 제약학적 제제.
  11. 제1항에 있어서, 50mmol/l의 시트르산나트륨(pH6), 및 10-100mmol/l의 4-아미노부탄올-1,5-아미노펜탄올-1,6-아미노헥산올-1, 1,3-디아미노프로판, 1,4-디아미노부탄, 1,5-디아미노펜탄, 1,6-디아미노헥산, 1,7-디아미노헵탄, 1,8-디아네노옥탄 또는 1,9-디아미노노난을 함유하는 것을 특징으로 하는 제약학적 제제.
  12. 제1항에 있어서, 50mmol/l의 시트르산나트륨/HCI (pH6), 및 10-200mmol/l, 바람직하게 50-100mmol/l의 구아니디노부티르산 또는 아르기닌을 함유하는 것을 특징으로 하는 제약학적 제제.
  13. 제1항에 있어서, 50mmol/l의 시트르산나트륨/HCI (pH6), 및 50-400mmol/l, 바람직하게 100-300mmol/l의 디메틸비구아나이드를 함유하는 것을 특징으로 하는 제약학적 제제.
  14. 제1항에 있어서, 50mmol/l의 시트르산나트륨/HCI (pH6), 및 1-500mmol/l, 바람직하게 10-300mmol/l의 글루코사민 또는 프럭토스를 함유하는 것을 특징으로 하는 제약학적 제제.
  15. 제1항에 있어서, 50mmol/l의 시트르산나트륨/HCI (pH6), 및 1-300mmol/l, 바람직하게 10-300mmol/l의 티미딘, 시토신 또는 우리딘을 함유하는 것을 특징으로 하는 제약학적 제제.
  16. 제1항에 있어서, 50mmol/l의 시트르산나트륨(pH6), 및 0.001-1mmol/l, 바람직하게 0.1-0.5mmol/l의 말산, 젖산, 푸마르산 또는 2-옥소글루타르산을 함유하는 것을 특징으로 하는 제약학적 제제.
  17. 제1항에 있어서, 50mmol/l의 시트르산나트륨(pH6) 및 제1항의 a)-i)그룹에서 선택된 물질의 겹합체를 함유하는 것을 특징으로 하는 제약학적 제제.
  18. 통상적인 제약학적 부가제, 보조제 및/또는 담체 물질과 함께 활성물질로서 전기한 항중 어느 한 항의 조성물로 특징되는 t-PA활성을 갖는 단백질을 기본으로 하는 의약.
  19. 제1항의 a)-i) 그룹중 최소한 하나의 물질과 함께 비글리코실화 t-PA를 적당한 제약학적 투여 형태로 전환시키는 것을 특징으로 하는, 제1항 내지 제18항중 어느 한 항의 제약학적 제제를 제조하는 방법.
  20. 제19항에 있어서 제약학적 투여 형태가 주사액 또는 동결건조물인 것을 특징으로 하는 방법.
  21. 제1항 내지 제18항중 어느 한 항의 제약학적 제제를 제조하는데 비글리코실화 t-PA를 사용하는 방법.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019910700935A 1989-12-20 1990-12-19 t-PA pro의 안정화 KR920700684A (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE3942143A DE3942143A1 (de) 1989-12-20 1989-12-20 T-pa pro stabilisierung
DEP39421430 1989-12-20
PCT/EP1990/002251 WO1991008766A1 (de) 1989-12-20 1990-12-19 t-PA pro STABILISIERUNG

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KR920700684A true KR920700684A (ko) 1992-08-10

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US (1) US5352453A (ko)
EP (1) EP0458939B1 (ko)
JP (1) JPH0657661B2 (ko)
KR (1) KR920700684A (ko)
AT (1) ATE103178T1 (ko)
AU (1) AU633684B2 (ko)
CA (1) CA2046929C (ko)
DE (2) DE3942143A1 (ko)
FI (1) FI96000C (ko)
HU (2) HUT59610A (ko)
LV (1) LV10199B (ko)
NO (1) NO305583B1 (ko)
WO (1) WO1991008766A1 (ko)

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DE3942141A1 (de) * 1989-12-20 1991-06-27 Boehringer Mannheim Gmbh K2p pro-stabilisierung
WO1992018157A1 (de) * 1991-04-16 1992-10-29 Boehringer Mannheim Gmbh Pharmazeutische verpackungseinheit enthaltend plasminogenaktivatoren zur mehrfachbolusgabe
ATE173739T1 (de) * 1992-04-30 1998-12-15 Cor Therapeutics Inc Stabile zusammensetzung von polypeptiden
US6001480A (en) * 1993-06-11 1999-12-14 Zexel Corporation Amorphous hard carbon film and mechanical parts coated therewith
DE4405426A1 (de) * 1994-02-21 1995-08-24 Boehringer Mannheim Gmbh Pharmazeutisches Präparat enthaltend Plasminogenaktivator (t-PA) oder dessen Derivate
US6576265B1 (en) 1999-12-22 2003-06-10 Acell, Inc. Tissue regenerative composition, method of making, and method of use thereof

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DE3718889A1 (de) * 1987-06-05 1988-12-22 Behringwerke Ag Verfahren zur herstellung einer loesung hoher spezifischer volumenaktivitaet von einem protein mit gewebe-plasminogenaktivator (t-pa)-aktivitaet, loesung, enthaltend protein mit t-pa-aktivitaet und verwendung der loesung in der human- und veterinaermedizin
AU4187389A (en) * 1988-08-02 1990-03-05 Invitron Corporation Method for preparing tpa compositions
US4980165A (en) * 1989-01-27 1990-12-25 Genetics Institute, Inc. Pharmaceutical formulations of plasminogen activator proteins
DE3942141A1 (de) * 1989-12-20 1991-06-27 Boehringer Mannheim Gmbh K2p pro-stabilisierung
JPH0813750B2 (ja) * 1990-03-01 1996-02-14 持田製薬株式会社 経口用トロンビン製剤

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AU633684B2 (en) 1993-02-04
CA2046929A1 (en) 1991-06-21
JPH0657661B2 (ja) 1994-08-03
HU208637B (en) 1993-12-28
NO913118D0 (no) 1991-08-09
ATE103178T1 (de) 1994-04-15
WO1991008766A1 (de) 1991-06-27
FI96000B (fi) 1996-01-15
NO305583B1 (no) 1999-06-28
FI96000C (fi) 1996-04-25
LV10199A (lv) 1994-10-20
FI913909A0 (fi) 1991-08-19
AU7037591A (en) 1991-07-18
EP0458939B1 (de) 1994-03-23
DE59005128D1 (de) 1994-04-28
HUT59610A (en) 1992-06-29
DE3942143A1 (de) 1991-06-27
NO913118L (no) 1991-08-09
LV10199B (en) 1995-04-20
JPH03505465A (ja) 1991-11-28
US5352453A (en) 1994-10-04
EP0458939A1 (de) 1991-12-04
HU912742D0 (en) 1992-01-28
CA2046929C (en) 1997-01-14

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