The Investigation Of Quality Control For An Inactivated HAV Vaccine

Hepatitis A which can cause Hepatic injury is an enteric infection disease resulted from being infected with hepatitis A virus. It is more susceptible to children and postadolescent in China. Until now there is no specific treatment for Hepatitis A. The common method to control the disease in China is to use the inactivated HAV vaccine. In vivo tests for human and animal showed that the inactivated HAV vaccine has better immune competent and it can efficiently prevent the transmission and prevalence. However there are still some potential safety problems such as atavism. There should be a validated method to evaluate the stability, security and immunogenicity of HAV vaccine during its process of production.In order to develop a effective quality criteria for the inactivated HAV vaccine we evaluated the protein content, antigenic content for hepatitis A virus, sterility test, Toxic substance test, pH value, identity test, abnormal toxicity test and correspondent potency test.We found that result for pre-neutralized immune serum should be...