PHARMACEUTICAL FORMULATION COMPRISING HEPATITIS B VIRUS NEUTRALIZING HUMAN ANTIBODY

摘要

A pharmaceutical agent containing a HBV(hepatitis B virus) neutralization human antibody, buffer, isotonic adjusting agent, and surfactant is provided to stabilize the antibody, and maintain the activity of antibody in a long time. A pharmaceutical agent comprises 0.1-50 mg/ml of human HBV(hepatitis B virus) neutralization antibody, 10-100 mmol/l of buffer, 20-250 mmol/l isotonic adjusting agent, and 0.001-1.0 weight% of surfactant. Antibody is a HBIG-Gene to HBV surface antigen which is produced from HBAb-49(KCLRF-BP-00054) cell line. The buffer is citrate salt, acetate salt, phosphate salt, or their free acid, base or salt or their mixture. The isotonic adjusting agent is sodium chloride, or potassium chloride. The surfactant is polyoxyethylene sorbitan fatty acid ester.