KR880003633A - 정맥주사용 면역글로불린 제제의 제조방법 - Google Patents

정맥주사용 면역글로불린 제제의 제조방법 Download PDF

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KR880003633A
KR880003633A KR870004967A KR870004967A KR880003633A KR 880003633 A KR880003633 A KR 880003633A KR 870004967 A KR870004967 A KR 870004967A KR 870004967 A KR870004967 A KR 870004967A KR 880003633 A KR880003633 A KR 880003633A
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treated
under conditions
fraction
ionic strength
precipitate
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KR870004967A
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KR960001473B1 (ko
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야히로 우에무라
가쓰히로 우리유
카즈오 다께찌
유다까 히라오
다다까즈 스야마
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마쓰시다렌조
가부시끼가이샤 미도리쥬지
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • 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
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0023—Heat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
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  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biomedical Technology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

내용 없음

Description

정맥주사용 면역글로불린 제제의 제조방법
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음

Claims (13)

  1. (a)면역글로불린-함유 분획을 pH 4-6, 이온강도 0.0001-0.1 M 및 온도 0-4℃의 조건하에서 분자량 1,000-10,000인 폴리에틸렌글리콜 4-10W/V%로 처리하고, 상징액을 회수하고 ; (b) 공정(a)에서 얻은 상징액을 pH 6-9, 이온강도 0.0001-0.1M 및 온도 0-4℃의 조건하에서 분자량 1,000-10,000인 폴리에틸렌글리콜 10-15W/V%로 처리하고, 결과로 얻어진 침전을 회수하고 ; (c) 필요한 어떤 공정에서든지, 상기 면역글로불린을 오염바이러스를 불활성하기에 충분한 조건으로 안정제의 존재하에서 가열처리하여 정맥주사용 면역글로불린 제제를 제조하는 방법.
  2. 제1항에 있어서, 공정(b)의 다음에 pH 5-8이고, 이온강도 0.01-0.2M인 조건하에서 고정화된 사람혈액형 물질로 처리하고, 비흡착분획을 회수하는 공정을 더 포함하는 제조방법.
  3. 제1항 및 제2항에 있어서, 공정(b)로 부터의 침전을 수성용매에 용해시키고, 이 용액을 pH 5-8, 이온강도 0.01-0.2M인 조건하에서 음이온 교환제로 처리하고, 비흡착분획을 회수하는 공정을 더 포함하는 제조방법.
  4. 제2항에 있어서, 공정(b)로 부터의 침전 또는 제3항에서 기술된 이온교환체 처리에 의해 얻은 비흡착분획을 pH 5-8이고, 이온강도 0.01-0.2M인 조건하에서 고정화 디아미노 화합물로 처리하고, 비흡착분획을 회수하고, 상기 분획을 고정화된 사람혈액형물질로 처리하는 공정을 포함하는 제조방법.
  5. 제1-4항중 한 항에 있어서, 가열처리가 함습도 3%이하인 건조 조건에서 행해지는 제조방법.
  6. 제5항에 있어서, 가열처리가, 고정화된 사람혈액형물질로 처리된 뒤에, 비흡착분획회수공정으로 부터 얻은 조글로불린분획에 대해 적용되는 제조방법.
  7. 제1-4항중 한 항에 있어서, 가열처리가 용액상태에서 행해지는 제조방법.
  8. 제7항에 있어서, 가열처리를 공정(b)의 다음에 수행하고, 다음에 공정(a)와 (b)를 반복처리하는 제조방법.
  9. 제7항에 있어서, 오염바이러스를 불활성화하기에 충분한 조건으로, 안정제 존재하에서 출발물질 분획을 가열처리한 후, (a) pH 4-6, 이온강도 0.0001-0.1M이고 온도 0-4℃인 조건하에서 분자량 1,000-10,000인 폴리에틸렌글리콜 4-10W/V%로 처리하고 계속하여 상징액을 회수하고 ; (b) 공정(a)로부터의 상징액을 PH7-9, 이온강도 0.0001-0.1M이고 온도 0-4℃인 조건하에서 분자량 1,000-10,000인 폴리에틸렌글리콜 10-15W/V%로 처리하고 계속하여 침전을 회수하는 제조방법.
  10. 제9항에 있어서, 공정(b)로부터의 침전을 수성용매에 용해시키고, 음이온 교환체로 처리하는 제조방법.
  11. 제10항에 있어서, 음이온교환체 처리를 pH 5-8이고, 이온강도 0.01-0.2M인 조건하에서 행하는 제조방법.
  12. 제10항 또는 제11항에 있어서, 공정(b)로 부터의 침전을 수성용매에 용해시키고 음이온교환체로 처리한 후, 비흡착분획을 회수하고 고정화된 사람혈액형물질 처리를 행하는 제조방법.
  13. 제10항 또는 제11항에 있어서, 공정(b)로 부터의 침전을 수성용매에 용해시키고, 고정화된 사람혈액형물질 처리하고, 비흡착분획을 회수하고, 계속하여 음이온교환체로 더 처리하는 제조방법.
KR1019870004967A 1986-05-19 1987-05-19 정맥 주사용 면역글로불린 제제의 제조 방법 KR960001473B1 (ko)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
JP114421 1986-05-19
JP11442186 1986-05-19
JP23475786 1986-09-30
JP234757 1986-09-30
JP21481 1987-01-31
JP62021481A JPH0662436B2 (ja) 1986-05-19 1987-01-31 静注用免疫グロブリン製剤の製造方法

Publications (2)

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KR880003633A true KR880003633A (ko) 1988-05-28
KR960001473B1 KR960001473B1 (ko) 1996-01-31

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KR1019870004967A KR960001473B1 (ko) 1986-05-19 1987-05-19 정맥 주사용 면역글로불린 제제의 제조 방법

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Country Link
US (1) US5132406A (ko)
EP (1) EP0246579B1 (ko)
JP (1) JPH0662436B2 (ko)
KR (1) KR960001473B1 (ko)
DE (1) DE3786832T2 (ko)
ES (1) ES2042519T3 (ko)

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JP2012513425A (ja) 2008-12-22 2012-06-14 エフ．ホフマン−ラ ロシュ アーゲー 免疫グロブリンの精製
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Also Published As

Publication number Publication date
KR960001473B1 (ko) 1996-01-31
JPH0662436B2 (ja) 1994-08-17
EP0246579A3 (en) 1989-05-17
DE3786832D1 (de) 1993-09-09
JPS63183539A (ja) 1988-07-28
EP0246579B1 (en) 1993-08-04
DE3786832T2 (de) 1993-11-11
EP0246579A2 (en) 1987-11-25
US5132406A (en) 1992-07-21
ES2042519T3 (es) 1993-12-16

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