Preparation method of freeze-dried human blood coagulation factor VIII
The invention relates to a preparation method of a freeze-dried human blood coagulation factor VIII. The preparation method comprises the following steps of collecting plasma and quick-frozen plasma;performing plasma melting and separating cryoprecipitate; dissolving cryoprecipitate; performing acid...
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Format: | Patent |
Sprache: | chi ; eng |
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Zusammenfassung: | The invention relates to a preparation method of a freeze-dried human blood coagulation factor VIII. The preparation method comprises the following steps of collecting plasma and quick-frozen plasma;performing plasma melting and separating cryoprecipitate; dissolving cryoprecipitate; performing acid precipitation; performing gel adsorption; inactivating S/D virus; performing anion exchange chromatography; performing ultrafiltration; preparing a semi-finished product; carrying out sterilizing and sub-packaging; performing freeze-drying; and carrying out dry heat virus inactivation. The preparation method disclosed by the invention is short in product remelting time, high in specific activity, stable in quality and simple to operate, and after industrialization, the utilization rate of plasma resources can be greatly improved, market supply is increased, and the situation of FVIII medication tension in the Chinese market is relieved.
本发明涉及一种冻干型人凝血因子VIII制备方法,包括以下步骤:采集血浆和速冻血浆;融浆和分离冷沉淀;冷沉淀溶解;酸沉淀;凝胶吸附;S/D病毒灭活;阴离子交换 |
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