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The study aims to prepare human immunoglobulin by chromatography combined with low-temperature ethanol, detect the effect of impurities removal in the preparation process and the effect of chromatography on product quality.
Human immunoglobulin (pH 4) was prepared by one-step anion-exchange chromatography from FII precipitated from healthy human plasma. It was further separated and purified by low-temperature ethanol-protein separation. The distribution of molecular size, IgA content, IgG content and IgG subclasses distribution, protein secondary structure of IgG were determined and analyzed. The effect of IgA and IgM removal of intravenous human immunoglobulin (pH 4) prepared by low-temperature ethanol protein separation and anion exchange purification was compared.
The precipitation of component II was dissolved by 5-fold volume of water for injection, and the dissolution rate of IgG was higher after stirring for 2 h. The content of IgA in intravenous human immunoglobulin (pH 4) prepared by anion exchange chromatography combined with low-temperature ethanol was controlled below 100 μg·mL-1, consistent with the distribution of molecular size and IgG isoforms of commercial products. The virus inactivation flux of nanofilms (20 nm) was increased.
Anion exchange chromatography can reduce the residual amount of IgA, IgM and other impurities in IVIG products, improve the permeability of nano-film (20 nm), and has no significant effect on the key quality of IVIG products.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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