| abstract |
The present invention relates to a tetravalent mixed vaccine (hereinafter referred to as "DTwPH mixed vaccine") containing diphtheria, tetanus toxoid and pertussis and hepatitis B surface antigen, and a method for producing the same.n n n More specifically, diphtheria and tetanus toxoid are adsorbed on aluminum phosphate gel (AlPO₄gel), and hepatitis B surface antigen is adsorbed on aluminum hydroxide gel (Al (OH) ₃gel), and the pH of the final undiluted vaccine of DTwPH is 6.5 to 7.5. The present invention provides a DTwPH mixed vaccine prepared by adjusting the concentration of each component, in particular, aluminum hydroxide gel to 15 to 35 µgAl / mL, and a method of preparing the same.n n n The DTwPH mixed vaccine of the present invention prevents the aggregation of the final stock solution and adhesion to the vial, and also maintains the immunogenicity of the hepatitis B surface antigen, and the titer of each component can be higher than the biological standard.n n n In addition, gelatin may be added to the final DTwPH mixed vaccine or stored in a silicone coating bottle to more effectively prevent aggregation and adhesion of the DTwPH mixed vaccine final stock. |