Preparation method of infliximab freeze-dried preparation for injection

Abstract

The invention discloses a preparation method of an infliximab freeze-dried preparation for injection. Before freeze-drying, a liquid medicine contains the following components: infliximab with the concentration of 20 mg / mL, sodium phosphate with the concentration of 10 mM, polysorbate 80 with the concentration of 0.1 mg / mL and cane sugar with the concentration of 100 mg / mL; feeding the liquid medicine to a freeze dryer, and keeping a freeze drying chamber at 5 DEG C for 2 hours; cooling to -50 - -40 DEG C, and keeping for 5-8 hours; vacuumizing and sublimation drying: heating to -20 - -15 DEG C for the first time and keeping for 50-70 hours, heating to -10-0 DEG C for the second time and keeping for 8-10 hours; desorption: raising the temperature to 20-30 DEG C, keeping the temperature for 10-15 hours, reducing the temperature to 5 DEG C, and keeping the temperature for 20 minutes. The polymer content is reduced, the risk of immunogenicity of the product is reduced, the collapse problem of the product in the freeze-drying process is solved, and a freeze-drying preparation product with excellent quality is produced.

Description

technical field [0001] The invention belongs to the technical field of biopharmaceuticals, and in particular relates to a preparation method of a freeze-dried preparation of infliximab for injection. Background technique [0002] Infliximab is a human-mouse chimeric monoclonal antibody, which specifically binds TNF-α in the human body and prevents TNF-α from binding to its cell surface receptors, thereby blocking the biological activity of TNF-α, and ultimately Reduce the inflammatory response and reduce the activation of osteoclasts to achieve the purpose of controlling and relieving symptoms. Infliximab can be used to treat rheumatoid arthritis, psoriasis, ankylosing spondylitis, ulcerative colitis and Crohn's disease, etc. [0003] Like many proteins, mAbs are susceptible to multiple physical and chemical degradations, and in many cases these degradations may occur simultaneously. Physical instability mainly includes denaturation, aggregation and precipitation. The che...

AI Technical Summary

Problems solved by technology

Although this patent has prepared a freeze-dried preparation of inflixime suitable for subcutaneous administration, it is known from the test results of the preparation that the polymer content of the just-made finished product is close to 1%, and after high-temperature light, the polymer content of Body content significantly increased

In addition, compared with intravenous injection, the immunogenic effect of subcutaneous injection is stronger. Although the viscosity and osmotic pressure of the formulation are suitable for subcutaneous administration, subcutaneous administration of a formulation with a high polymer content will produce The potential for immunogenicity would be greatly increased

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