KR910002467A - lgM을 함유하는 정맥내 투여용 폴리클로날 면역글로블린 제제 및 이의 제조방법 - Google Patents

lgM을 함유하는 정맥내 투여용 폴리클로날 면역글로블린 제제 및 이의 제조방법 Download PDF

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KR910002467A
KR910002467A KR1019890010555A KR890010555A KR910002467A KR 910002467 A KR910002467 A KR 910002467A KR 1019890010555 A KR1019890010555 A KR 1019890010555A KR 890010555 A KR890010555 A KR 890010555A KR 910002467 A KR910002467 A KR 910002467A
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immunoglobulin
preparation
gel filtration
propiolactone
lgm
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KR1019890010555A
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KR0152256B1 (ko
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묄러 볼프강
디흐텔뮬러 헤르베르트
코테 노르베르트
룬드니크 디터
피에카크제크 데틀레프
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하. 쉴로이스너
바이오테스트 파마 게엠바하
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/12—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S424/00—Drug, bio-affecting and body treating compositions
    • Y10S424/806—Drug, bio-affecting and body treating compositions involving IgM
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S530/00—Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof
    • Y10S530/863—Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof involving IgM

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  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
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  • Genetics & Genomics (AREA)
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  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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  • Medicinal Preparation (AREA)

Abstract

내용 없음

Description

lgM을 함유하는 정맥내 투여용 폴리클로날 면역글로블린 제제 및 이의 제조방법
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음

Claims (14)

  1. (a) 면역글로블린의 전체량을 기준으로 하여 최소한 50중량％의 lgM을 함유하고, (b) 항보체 활성이 낮으며, (c) 수용액중에서 안정하고, (d) 비루스가 유리되어 있음을 특징으로 하는, 세균 감염의 치료 및 예방을 위한 정맥내 투여용 폴리클로날 면역 글로블린 제제.
  2. 제1항에 있어서, 몇몇 종류의 모노클로날 lgM항체의 혼합물로 이루어짐을 특징으로 하는 면역글로브린 제제,
  3. 제1항 또는 2항에 있어서, 하나 이상의 모노클로날 lgM 항체를 추가로 함유함을 특징으로 하는 면역글로블린 제제.
  4. 제1 내지 3항중 어느 한 항에 있어서, 추가의 단백질, 바람직하게는 사람 알부민, 당, 바람직하게는 말토스, 또는 아미노산의 혼합물을 추가로 함유함을 특징으로 하는 면역글로블린 체제.
  5. 제1 내지 4항중 어느 한 항에 있어서, 1 내지 20g.100㎖, 바람직하게는 3 내지 5g/100㎖의 단백질 농도를 갖는 용액의 형태로 존재함을 특징으로 하는 면역글로블린 제제.
  6. 사람, 동물, 또는 세균기원의 면역글로블린-함유 혈장으로부터 분리함을 특징으로 하여, 제1항 내지 5항중 어느 한항에 따른 면역글로블린 제제를 제조하는 방법.
  7. 제6항에 있어서, 면역글로블린-함유 분획물을 음이온 교환기로 처리하고, 염수 또는 pH 구배로 용출시키며, 용출물을 겔 여과시키고, 음이온-교환 크로마토그래피 또는 겔 여과시키기 전 또는 후에 β-프로피올락톤 및 PEG 4000으로 처리하여, 임의로 가열시킴을 특징으로 하는 방법.
  8. 제7항에 있어서, 음이온 교환기가 DEAE-트리스아크릴-LS, QA-트리스아크릴 또는 QMA-악셀임을 특징으로 하는 방법.
  9. 제7항 또는 8항에 있어서, 겔 여과용 겔이 세파크릴 S400HR 또는 S300HR임을 특징으로 하는 방법.
  10. 제7항 내지 9항중 어느 한 항에 있어서, 제제를 음이온-교환 크로마토그래피 또는 겔 여과시키기 전 또는 후에 0 내지 10℃, 바람직하게는 5℃ 및 pH 4.5 내지 5에서 β-프로피올락톤 또는 β-프로피올락톤 및 자외선 및 1 내지 3％ PEG 4000으로 처리함을 특징으로 하는 방법.
  11. 제7항 내지 10항중 어느 한 항에 있어서, 가열을 40 내지 60℃에서 0.5 내지 5시간, 바람직하게는 57℃에서 1시간 동안 수행함을 특징으로 하는 방법.
  12. 제7항 내지 11항중 어느 한 항에 있어서, 제제를 겔 여과시키기 전 또는 후에 용매 및 세제, 바람직하게는 트리-n-부틸포스페이트 및 트윈 80으로 처리함을 특징으로 하는 방법.
  13. 제7항 내지 11항중 어느 한 항에 있어서, 제제를 겔 여과시키기 전 또는 후에 저온살균시킴을 특징으로 하는 방법.
  14. 제7항 내지 13항중 어느 한 항에 있어서, 단백질, 바람직하게는 사람 알부민, 당, 바람직하게는 말토스, 또는 아미노산의 혼합물을 제제에 가함을 특징으로 하는 방법.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019890010555A 1988-07-27 1989-07-26 면역글로불린을 함유하는 정맥내투여용 폴리클로날 면역글로불린 제제 및 이의 제조방법 KR0152256B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DEP3825429.8? 1988-07-27
DE3825429A DE3825429C2 (de) 1988-07-27 1988-07-27 Verfahren zur Herstellung eines intravenös verabreichbaren polyklonalen Immunglobulin-Präparates mit hohem IgM-Gehalt
DEP3825429.8 1988-07-27

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KR910002467A true KR910002467A (ko) 1991-02-25
KR0152256B1 KR0152256B1 (ko) 1998-10-15

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US (1) US5190752A (ko)
EP (1) EP0352500B1 (ko)
JP (1) JPH0662437B2 (ko)
KR (1) KR0152256B1 (ko)
AT (1) ATE94075T1 (ko)
CA (1) CA1341505C (ko)
DE (2) DE3825429C2 (ko)
ES (1) ES2059640T3 (ko)
PT (1) PT91170B (ko)

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CA1341505C (en) 2006-05-09
PT91170B (pt) 1995-06-30
ATE94075T1 (de) 1993-09-15
EP0352500A3 (en) 1990-07-25
EP0352500B1 (de) 1993-09-08
US5190752A (en) 1993-03-02
JPH0662437B2 (ja) 1994-08-17
KR0152256B1 (ko) 1998-10-15
PT91170A (pt) 1990-02-08
DE58905514D1 (de) 1993-10-14
JPH0278635A (ja) 1990-03-19
DE3825429C2 (de) 1994-02-10
DE3825429A1 (de) 1990-02-01
EP0352500A2 (de) 1990-01-31
ES2059640T3 (es) 1994-11-16

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