The invention relates to a preparation process of intravenous injection
human immunoglobulin, belonging to the field of pharmaceuticals. On a basis of a traditional preparation process of intravenous injection
human immunoglobulin with the
low protein concentration of 5 percent, a filter pressing method is adopted instead of a centrifuging method in an extraction process. During hyperfiltration, the
protein concentration is adjusted to 3-6 percent, a pH value is adjusted to 6.4-6.6 with 0.5 mol / L of NaOH; then, 1 mol / L
phosphoric acid-NaOH
buffer solution is added to adjust the electrical
conductivity which is measured to be 0.175-0.205 s / m at a temperature T of 19 DEG C; and a
chromatography method is adopted to carrying out
column chromatography and purification by using upper
ion exchange columns after the electrical
conductivity is adjusted. The
protein impurities can be effectively removed, the
protein purify and the product yield are improved;
maltose or
glycin is used as a protector, which benefits the improvement of the stability of the intravenous injection
human immunoglobulin; and the
glycin is used as the protector, which satisfies the clinical use of diabetics. According to the invention, the intravenous injection human immunoglobulin with the
protein concentration of 5-11 percent can be obtained.