乙型肝炎疫苗中游离抗原对免疫效果的影响

将按《生物制品规程》制备除氢氧化铝吸附方式不同外，其余所有过程均一致的疫苗各１０批，在ＨＢｓＡｇ含量相同前提下，于５００公升大罐内吸附制备的疫苗中游离抗原含量比在１０公升瓶内吸附制备的疫苗高４倍，两者均数分别为３０４．１ｎｇ／ｍｌ和７３．１ｎｇ／ｍｌ，吸附率分别为９７．９５％和９９．５１％；用ＲＰＨＡ测定游离抗原滴度前者也比后者高２倍；动物免疫效价（ＥＤ５０）高４７％。在上述吸附率范围内，游离抗原含量与ＥＤ５０呈正相关（ｒ＝０．７１７９Ｐ＜０．００１）。

The Effect of Dissociated Hepatitis B virus Surface Antigen(HBsAg) on Immunol Efficiency

According to the National Biological Products Requirements,various hepatitis B vaccines were produced under the same proceedings except two ways of the aluminium hydroxide adsorption.The adsorbate rate of the two ways was over 97%.The concentration of HBsAg dissociated from aluminium hydroxide Gel in vaccine prepared from adsorbent way in 500L tank was 3041ng/ml,four times more than those of adsorbent way in 10L bottle and animal immune effect(ED 50 ) of vaccine prepared from adsorbent way in 500L tank was also better than that of prepared from adsorbent way in 10L bottle.The correlation between the concentration of HBsAg dissociated from aluminium hydroxide gel and the ED 50 was positive(r=0.7179,p<0 001)