SI9500039B - Nov kombiniran postopek čiščenja Vankomicin hidroklorida - Google Patents

Nov kombiniran postopek čiščenja Vankomicin hidroklorida Download PDF

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Publication number
SI9500039B
SI9500039B SI9500039A SI9500039A SI9500039B SI 9500039 B SI9500039 B SI 9500039B SI 9500039 A SI9500039 A SI 9500039A SI 9500039 A SI9500039 A SI 9500039A SI 9500039 B SI9500039 B SI 9500039B
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SI
Slovenia
Prior art keywords
process according
antibiotic
ethanol
water
mobile phase
Prior art date
Application number
SI9500039A
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English (en)
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SI9500039A (en
Inventor
Zlatko Pflaum
Robert Turkalj
Original Assignee
Lek,
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lek, filed Critical Lek,
Priority to SI9500039A priority Critical patent/SI9500039B/sl
Priority to EP96901183A priority patent/EP0809652B1/en
Priority to ES96901183T priority patent/ES2205012T3/es
Priority to DK96901183T priority patent/DK0809652T3/da
Priority to JP8524215A priority patent/JPH10513196A/ja
Priority to AT96901183T priority patent/ATE247665T1/de
Priority to AU45003/96A priority patent/AU4500396A/en
Priority to PCT/SI1996/000003 priority patent/WO1996024615A1/en
Priority to US08/875,443 priority patent/US5853720A/en
Priority to DE69629551T priority patent/DE69629551T2/de
Priority to CA002210990A priority patent/CA2210990C/en
Publication of SI9500039A publication Critical patent/SI9500039A/sl
Publication of SI9500039B publication Critical patent/SI9500039B/sl

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Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K9/00Peptides having up to 20 amino acids, containing saccharide radicals and having a fully defined sequence; Derivatives thereof
    • C07K9/006Peptides having up to 20 amino acids, containing saccharide radicals and having a fully defined sequence; Derivatives thereof the peptide sequence being part of a ring structure
    • C07K9/008Peptides having up to 20 amino acids, containing saccharide radicals and having a fully defined sequence; Derivatives thereof the peptide sequence being part of a ring structure directly attached to a hetero atom of the saccharide radical, e.g. actaplanin, avoparcin, ristomycin, vancomycin

Claims (16)

1 PATENTNI ZAHTEVKI 1. Nov postopek za čiščenje vankomicinskih antibiotikov, značilen po tem, da kombinira preparativno kromatografijo na silikagelni koloni z alkalno vodno-metanolno mobilno fazo in obarjanje z etanolom iz solno-vodno-etanolne raztopine za stranske frakcije, ki obsega naslednje stopnje: a) koncentriranje nakisanih združenih stranskih frakcij antibiotika s koncentracijami do približno 1,5 g/1 z reverzno osmozo b) dodajanje NaCl in mešanje, da dosežemo raztopitev soli in kristalizacijo antibiotika c) dodajanje etanola k nastali suspenziji pri sobni temperaturi, da povzročimo prvo raztapljanje kristaliziranega antibiotika in nadaljnje dodajanje etanola (v celoti štirikrat več etanola kot vode), da povzročimo obarjanje antibiotika d) ohlajevanje dobljene suspenzije na približno 5 °C in centrifugiranje e) razsoljevanje antibiotika na reverzni osmozi in nadaljevanje postopka, kot je uporabljen za glavno frakcijo.
2. Postopek po zahtevku 1, značilen po tem, da pripravimo končni produkt z obarjanjem iz solno-vodno-etanolne raztopine.
3. Postopek po zahtevku 2, značilen po tem, da posušimo končni produkt na razpršilnem sušilniku.
4. Postopek po zahtevku 2, značilen po tem, da pripravimo končni produkt z liofilizacijo iz etanolne raztopine antibiotika. 2
5. Postopek po zahtevku 4, značilen po tem, da liofiliziramo iz raztopine z dodatkom do največ 12 % etanola.
6. Postopek po zahtevku 1, značilen po tem, da ga uporabljamo za čiščenje vankomicina in vankomicin hidroklorida.
7. Postopek po zahtevku 1, značilen po tem, daje koncentracija antibiotika pri nanosu na kolono ter pred začetkom izsoljevanja okrog 50 do okrog 120 g/1.
8. Postopek po zahtevku 7, značilen po tem, daje koncentracija antibiotika pri nanosu na kolono ter pred začetkom izsoljevanja okrog 80 g/1.
9. Postopek po zahtevku 1, značilen po tem, daje masno razmerje med antibiotikom in silikagelom na koloni okrog 1 : 100.
10. Postopek po zahtevku 1, značilen po tem, daje mobilna faza 0,35 %-ni NH4HCO3 v 7 %-nem metanolu.
11. Postopek po zahtevku 1, značilen po tem, daje pretok mobilne faze med okrog 20 in okrog 100 1/min.
12. Postopek po zahtevku 1, značilen po tem, daje pH mobilne faze med okrog 7,9 in okrog 8,5.
13. Postopek po zahtevku 1, značilen po tem, daje temperatura v koloni okrog 15 °C.
14. Postopek po zahtevku 1, značilen po tem, da izsoljujemo z okrog 10 do okrog 20 % NaCl glede na vodo. 3
15. Postopek po zahtevku 1, značilen po tem, da izsoljujemo z okrog 15 % NaCl glede na vodo.
16. Postopek po zahtevku 1, značilen po tem, da pridobimo tako čist antibiotik, daje uporaben tako peroralno kot parenteralno.
SI9500039A 1995-02-07 1995-02-07 Nov kombiniran postopek čiščenja Vankomicin hidroklorida SI9500039B (sl)

Priority Applications (11)

Application Number Priority Date Filing Date Title
SI9500039A SI9500039B (sl) 1995-02-07 1995-02-07 Nov kombiniran postopek čiščenja Vankomicin hidroklorida
EP96901183A EP0809652B1 (en) 1995-02-07 1996-02-06 New combined process for the purification of vancomycin hydrochloride
ES96901183T ES2205012T3 (es) 1995-02-07 1996-02-06 Nuevo procedimiento combinado para la purificacion de clorhidrato de vancomicina.
DK96901183T DK0809652T3 (da) 1995-02-07 1996-02-06 Kombineret fremgangsmåde til rensning af vancomycinhydrochlorid
JP8524215A JPH10513196A (ja) 1995-02-07 1996-02-06 バンコマイシン塩酸塩の精製のための新規な組合された方法
AT96901183T ATE247665T1 (de) 1995-02-07 1996-02-06 Kombinierter prozess zur reinigung von vancomycin hydrochlorid
AU45003/96A AU4500396A (en) 1995-02-07 1996-02-06 New combined process for the purification of vancomycin hydrochloride
PCT/SI1996/000003 WO1996024615A1 (en) 1995-02-07 1996-02-06 New combined process for the purification of vancomycin hydrochloride
US08/875,443 US5853720A (en) 1995-02-07 1996-02-06 Combined process for the purification of vancomycin hydrochloride
DE69629551T DE69629551T2 (de) 1995-02-07 1996-02-06 Kombinierter prozess zur reinigung von vancomycin hydrochlorid
CA002210990A CA2210990C (en) 1995-02-07 1996-02-06 New combined process for the purification of vancomycin hydrochloride

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
SI9500039A SI9500039B (sl) 1995-02-07 1995-02-07 Nov kombiniran postopek čiščenja Vankomicin hidroklorida

Publications (2)

Publication Number Publication Date
SI9500039A SI9500039A (en) 1996-08-31
SI9500039B true SI9500039B (sl) 2002-02-28

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Family Applications (1)

Application Number Title Priority Date Filing Date
SI9500039A SI9500039B (sl) 1995-02-07 1995-02-07 Nov kombiniran postopek čiščenja Vankomicin hidroklorida

Country Status (11)

Country Link
US (1) US5853720A (sl)
EP (1) EP0809652B1 (sl)
JP (1) JPH10513196A (sl)
AT (1) ATE247665T1 (sl)
AU (1) AU4500396A (sl)
CA (1) CA2210990C (sl)
DE (1) DE69629551T2 (sl)
DK (1) DK0809652T3 (sl)
ES (1) ES2205012T3 (sl)
SI (1) SI9500039B (sl)
WO (1) WO1996024615A1 (sl)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI233932B (en) * 2001-08-24 2005-06-11 Theravance Inc Process for purifying glycopeptide phosphonate derivatives
CA2506236C (en) * 2002-11-18 2018-07-17 Vicuron Pharmaceuticals Inc. Compositions and uses of dalbavancin for treatment of bacterial infections
KR100554481B1 (ko) * 2004-06-30 2006-03-03 씨제이 주식회사 반코마이신 염산염의 정제방법
CN100408596C (zh) * 2005-11-30 2008-08-06 上海医药工业研究院 供hplc分析的万古霉素发酵液前处理方法
EP1798237A1 (en) * 2005-12-16 2007-06-20 Pharmatex Italia Srl Process for the purification of macrolide antibiotics
KR101101663B1 (ko) * 2009-01-13 2011-12-30 (주) 제노텍 반코마이신 습체의 정제방법
JP2011153119A (ja) * 2010-01-27 2011-08-11 Mylan Seiyaku Ltd バンコマイシンまたはその塩を含有する錠剤
AU2012204462A1 (en) * 2011-01-05 2013-07-11 Hospira, Inc. Spray drying vancomycin
CN104043104B (zh) 2013-03-15 2018-07-10 浙江创新生物有限公司 含盐酸万古霉素的喷雾干粉及其工业化制备方法
CN104610434B (zh) * 2013-11-01 2019-06-07 浙江医药股份有限公司新昌制药厂 一种盐酸万古霉素的分离纯化方法
CN104991028B (zh) * 2015-07-31 2017-10-31 北京市药品检验所 Lc‑ms测试物中不挥发性缓冲盐含量的降低方法
CN105461786B (zh) * 2016-01-23 2018-11-16 雅赛利(台州)制药有限公司 一种盐酸万古霉素的分离纯化工艺

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2577133B2 (ja) * 1989-11-27 1997-01-29 スティフティング フォール ド テフニスヘ ウェッテンスハッペン 船舶のプロペラ
US5235037A (en) * 1991-08-15 1993-08-10 American Cyanamid Company Vancomycin precipitation process

Also Published As

Publication number Publication date
ATE247665T1 (de) 2003-09-15
DE69629551T2 (de) 2004-06-17
EP0809652A1 (en) 1997-12-03
SI9500039A (en) 1996-08-31
JPH10513196A (ja) 1998-12-15
US5853720A (en) 1998-12-29
ES2205012T3 (es) 2004-05-01
CA2210990A1 (en) 1996-08-15
WO1996024615A1 (en) 1996-08-15
DK0809652T3 (da) 2003-12-08
CA2210990C (en) 2001-07-03
AU4500396A (en) 1996-08-27
EP0809652B1 (en) 2003-08-20
DE69629551D1 (de) 2003-09-25

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