Purification method of human immunoglobulin for intravenous injection

The invention discloses a purification method of human immunoglobulin for intravenous injection. The purification method is used for purification of a secondary sedimentation ingredient. The purification method of the human immunoglobulin for the intravenous injection is characterized by comprising...

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Bibliographische Detailangaben
Hauptverfasser: ZHANG BAOXIAN, TENG SHICHAO, LI CHANGMING, LIU YUJIANG, YANG LIU, ZHOU KANGSEN
Format: Patent
Sprache:chi ; eng
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Beschreibung
Zusammenfassung:The invention discloses a purification method of human immunoglobulin for intravenous injection. The purification method is used for purification of a secondary sedimentation ingredient. The purification method of the human immunoglobulin for the intravenous injection is characterized by comprising the following steps of: S1, dissolve: dissolving the secondary sedimentation ingredient with water for injection, and stirring for 2-4h at 2.0-8.0 DEG C to form a dissolve liquid, S2, filtration: filtering the dissolve liquid with a 0.45 micrometers filter membrane and then with a 0.2 micrometers filter membrane to form a filtrate, S3: filtrate adjustment: adjusting a pH (potential of hydrogen) of the filtrate to 5.60-6.00, a protein concentration to 10-13g/L, and conductivity to 0.2-1.90ms/cm to form a pre-chromatography liquid, S4, chromatography: performing chromatography with strong anion exchange gel, flushing the gel before the chromatography for balancing to allow a difference betweena pH of the gel and a pH