Protein low-temperature separation of ethanol to achieve self-control after the impact of the quality of human serum albumin.docVIP

 PAGE \* MERGEFORMAT 10 Protein low-temperature separation of ethanol to achieve self-control after the impact of the quality of human serum albumin [Abstract] Objective cold ethanol plasma protein separation process to achieve self-control after separation of human serum albumin and harvest rates of quality indicators evaluated. Methods in accordance with ‘The People’s Republic of China Pharmacopoeia The 2005 edition of the relevant provisions of the three methods and standards for low-temperature ethanol fractionation of human serum albumin samples were measured indicators, and measurement results with self-control before the products were compared. The results of continuous measurement of plasma protein separation to achieve self-control groups after 42 samples of human serum albumin, and of the process to achieve self-control pre-approved product for 35 consecutive test results are compared and found that the purity of human serum albumin, harvest rates were significantly increased; more polymer significantly decreased, other indicators (ion concentration, absorbance, etc.) no significant changes, and product quality is stable, in line with ‘The 2005 edition of Chinese Pharmacopoeia three relevant requirements. Conclusion of the quality index human serum albumin, harvest rates compared to low-temperature ethanol protein separation process to achieve self-control, further improve the inherent quality of human plasma proteins at the same time, a comprehensive process to enhance the separation of the levels, making plasma protein separation process in the temperature, ethanol concentration, ionic strength and protein content and other factors become more easy to control, making products of the quality index is more stable, narrowing the gap between groups, more in line with GMP management requirements. [Keywords:] plasma protein separation; control; purity; polymer Human serum albumin (HAS) with the maintenance of intravascular colloid osmotic pressure,