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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)。
According to the “Biological Products Regulations”, except for the different adsorption methods of aluminum hydroxide, all the other 10 vaccines with the same process were prepared, and the free antigen content ratio in the vaccine prepared by adsorption in a 500-liter large tank was the same under the same HBsAg content The vaccine prepared by adsorption in a 10-liter bottle was 4-fold higher, with a mean of 304.1 ng / ml and 73.1 ng / ml, respectively, with adsorption rates of 97.95% and 99.51%, respectively; free antigen The former is also twice as high as the latter, and the ED50 is 47% higher. In the above range of adsorption rate, free antigen content and ED50 was positively correlated (r = 0.7179P <0.001).