A method for antigen dissociation of hepatitis A virus inactivated vaccine containing aluminium adjuvant

Objective To develop a method for antigen dissociation and content determination of hepatitis A virus (HAV) inactivated vaccine containing aluminium adjuvant.Methods Buffer A:20％ diethanolamine 1.25 mL,10％ Triton X-100 0.2 mL,and PBS 8.55 mL; buffer B:3％(w/v) citric acid with pH=7.2; buffer C:20％(w/v) trisodium citrate.The above 3 buffers were used to dissociate HAV inactivated vaccine containing aluminium adjuvant in various conditions.The content of antigen of those resultant samples was determined by ELISA,and then the recovery rate was calculated to determine the best buffer and conditions of dissociation.The repeatability of established method was verified.Results Dissociation test showed that when HAV inactivated vaccine containing aluminium adjuvant was treated with buffer C at 20-28 ℃ for 1 hour,the recovery rate was the highest of 95％ or above.Coefficient of variation of repeated trials was less than 10％.Conclusions 20％(w/v) trisodium citrate is the best buffer for dissociating antigen from HAV inactivated vaccine containing aluminium adjuvant.The buffer is easy to prepare and operate with good reproducibility and high accuracy. Key words: Hepatitis A virus;  Inactivated vaccine;  Dissociation buffer;  Aluminium Adjuvant;  ELISA