Preparation process of intravenous injection human immunoglobulin

Abstract

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.

Description

technical field [0001] The invention relates to a preparation process for intravenous injection of human immunoglobulin, which belongs to the field of biopharmaceuticals. Background technique [0002] The active ingredient of intravenous human immunoglobulin is protein, and more than 95% of it is immunoglobulin. It is made from healthy human plasma, which is separated and purified by low temperature ethanol protein separation method (press filtration separation method), removes anti-complement activity and undergoes virus inactivation treatment. At present, the production of intravenous human immunoglobulin is generally 5% low protein concentration of intravenous human immunoglobulin. Therefore, when the existing intravenous injection of human immunoglobulin is used clinically, the infusion dose is relatively high The infusion time of concentrated products is relatively long; in addition, the time to reach blood concentration is relatively long. Because its production meth...

AI Technical Summary

Problems solved by technology

Because its production method is low-temperature ethanol centrifugation, the product yield is low, the stability is not good, and sugar is used as a protective agent at the same time, which is not conducive to the clinical use of patients who avoid sugar