KR960006939A - 분배제로서 카프릴산 나트륨을 사용하는 저온 알부민 분별법 - Google Patents

분배제로서 카프릴산 나트륨을 사용하는 저온 알부민 분별법 Download PDF

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KR960006939A
KR960006939A KR1019950024363A KR19950024363A KR960006939A KR 960006939 A KR960006939 A KR 960006939A KR 1019950024363 A KR1019950024363 A KR 1019950024363A KR 19950024363 A KR19950024363 A KR 19950024363A KR 960006939 A KR960006939 A KR 960006939A
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albumin
sodium caprylate
product
solution
plasma
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KR1019950024363A
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KR100418821B1 (ko
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에이. 테놀드 로버트
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제임스 에이. 깁린
바이엘 코포레이션
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/76—Albumins
    • C07K14/765—Serum albumin, e.g. HSA
    • 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
    • Y10S530/00—Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof
    • Y10S530/827—Proteins from mammals or birds
    • Y10S530/829—Blood
    • 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
    • Y10S530/827—Proteins from mammals or birds
    • Y10S530/829—Blood
    • Y10S530/83—Plasma; serum

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Medicinal Chemistry (AREA)
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  • Bioinformatics & Cheminformatics (AREA)
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  • Engineering & Computer Science (AREA)
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  • Public Health (AREA)
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  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)

Abstract

5NTU 이하의 혼탁도 수준을 갖는 고도로 안정한 혈장-유도된 치료 알부민 용액이 상대적으로 저온에서 카프릴산 나트륨을 코흔 분획 Ⅱ + Ⅲ 또는 Ⅳ-1 용출액에 가함에 의해 제조될 수 있다. 카프릴산 나트륨은 불필요한 단백질로부터 알부민을 분리하기 위한 분배제로서 작용한다. 바람직한 양태에서, 알부민 공급 용액온도는 승온되고 pH가 증가되며 초기 용액 콜로이드를 파괴시키고 콜로이드 불필요한 글로블린 및 제조시 파괴층을 유지하는 분산층으로 부터 알부민-함유 상등액을 분배하기에 충분한 조건하에서 대략 6시간 동안 반응시킨다. 이것은 스캐빈저 분자일 경향이 있기 때문에, 알부민은 카프릴산 나트륨을 함유하는 완충액에 대해 투석여과에 의해서 선택적으로 안정화하므로써 높은 알부민 단량체 농도와 낮은 혼탁도 수준을 보장한다. 선택적 안정화를 위해 요구되는 양을 알부민 분자상에 이용가능한 결합 부위의 양에 의해 결정된다.

Description

분배제로서 카프릴산 나트륨을 사용하는 저온 알부민 분별법
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음

Claims (19)

  1. 비-알부민 단백질 및 오염된 제조시 파괴층으로부터 알부민을 분리하기 위해 분배제로서 카프릴산 나트륨을 사용하는 단계를 포함하는 개선점을 갖는 혈장 단백질의 혼합물로부터 혈장-유도된 치료 용액을 제조하는 방법.
  2. 제1항에 있어서, 혈장-유도된 치료 용액이 알부민 용액, 알파-1 프로테아제 역제제 및 안티트롬빈 Ⅲ를 포함하는 방법.
  3. 제1항에 있어서, 비-알부민 단백질을 감마, 알파, 및 베타 글로블린 및 산 당단백질을 포함하는 용액으로부터 선택하는 방법.
  4. 제1항에 있어서, 제조시 파괴층이 다가 금속 이온과 용매를 포함하는 방법.
  5. 제1항에 있어서, 카프릴산 나트륨을 약 20 내지 30℃ 범위에 온도에서 알부민-함유 용액에 가하는 방법.
  6. 제1항에 있어서, 알부민-함유 용액의 pH가 약 5.25 내지 5.6인 방법.
  7. 제1항에 있어서, 카프릴산 나트륨을 약 0.04M 내지 0.08M 카프릴산 나트륨 범위의 양으로 알부민-함유 용액에 가하는 방법.
  8. 제1항에 있어서, 카프릴산 나트륨-처리된 용액을 약2 내지 8시간 범위의 기간동안 항온처리하는 방법.
  9. 제1항에 있어서, 알부민-함유 용액을 약 5.4 내지 5.6의 pH 수준으로 만들고, 약 20 내지 30℃온도까지 승온시키고 약 0.04M 내지 0.08M의 농도를 성취하기 위해 카프릴산 나트륨을 가하는 동안 혼합시키고 약 2 내지 8 시간 동안 항온처리하는 방법.
  10. 제1항에 있어서, 혈장 단백질의 혼합물이 코흔 분획 Ⅱ+Ⅲ 용출액 또는 코흔 분획 Ⅳ-Ⅰ용출액을 포함하는 방법.
  11. 제1항에 있어서, 혈장 단백질이 코흔 분획 Ⅳ-1 용출액을 포함하는 방법.
  12. 제1항에 있어서, 혈장 단백질의 혼합물이 코흔 분획 Ⅱ+Ⅲ 용출액을 포함하는 방법.
  13. 제9항에 있어서, 알부민-함유 용액을 약 pH 5.4로 만들고, 약 30℃까지 가열하고 대략 0.06M 카프릴산 나트륨으로 처리하고 약 6시간 동안 항온처리하는 방법.
  14. 제1항에 따른 방법으로 제조된 알부민 제품.
  15. 제14항에 있어서, 약제학적으로 허용되는 담체중의 제품.
  16. 제15항에 있어서, 정맥 투여용 제품.
  17. 제16항에 있어서, 알부민의 농도 범위가 0 내지 20ppb인 제품.
  18. 제17항에 있어서, 알부민이 중량-중량 기준으로 약 1 내지 40%를 포함하는 제품.
  19. 제18항에 있어서, pH가 5.4 내지 5.6인 제품.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019950024363A 1994-08-10 1995-08-08 분배제로서카프릴산나트륨을사용하는저온알부민분획법 KR100418821B1 (ko)

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Application Number Priority Date Filing Date Title
US08/288,180 US5561115A (en) 1994-08-10 1994-08-10 Low temperature albumin fractionation using sodium caprylate as a partitioning agent
US08/288180 1994-08-10
US08/288,180 1994-08-10

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KR960006939A true KR960006939A (ko) 1996-03-22
KR100418821B1 KR100418821B1 (ko) 2004-05-20

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US (1) US5561115A (ko)
EP (1) EP0696595B1 (ko)
JP (1) JP3874029B2 (ko)
KR (1) KR100418821B1 (ko)
CN (1) CN1150004C (ko)
AT (1) ATE172744T1 (ko)
AU (1) AU684202B2 (ko)
CA (1) CA2155630C (ko)
DE (1) DE69505610T2 (ko)
DK (1) DK0696595T3 (ko)
ES (1) ES2123874T3 (ko)

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CA2155630A1 (en) 1996-02-11
ES2123874T3 (es) 1999-01-16
CA2155630C (en) 2007-10-23
JP3874029B2 (ja) 2007-01-31
ATE172744T1 (de) 1998-11-15
EP0696595B1 (en) 1998-10-28
DK0696595T3 (da) 1999-07-12
CN1150004C (zh) 2004-05-19
KR100418821B1 (ko) 2004-05-20
AU2839095A (en) 1996-02-22
DE69505610D1 (de) 1998-12-03
JPH08176010A (ja) 1996-07-09
CN1120439A (zh) 1996-04-17
AU684202B2 (en) 1997-12-04
US5561115A (en) 1996-10-01
EP0696595A1 (en) 1996-02-14
DE69505610T2 (de) 1999-03-25

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