【摘要】 本文对制备ＤＴＰ—ｒＨＢ联合疫苗的实验条件进行了初步探索，并优选最佳配方制备的三批连续中试产品经安全、效力试验测定，结果表明，联合疫苗中各组分均能达到相应规程要求，抗原间无干扰作用，相容性好。联合疫苗中的ｒＨＢ免疫应答较单价苗明显提高（Ｐ＜ ０．０５），有增强作用。ＨＢｓＡｇ含量以２０ μｇ／ｍ ｌ为宜，稳定性试验证明，该联合疫苗质量稳定、安全、有效。更多还原

【Abstract】 We studied the effeclive factors which were involved in producting DTP—rHB combined Vaccine in laboratory and chose the optimum conditions.We produced 3 lots of combined vaccine continuously on alarge scale and performed safety and potency test.The results showed that these vaccine reached the same level of the corresponding prescription.Constituent of these vaccine shamed a good compatibility and no interference was found in it.Additionaly,the immune response of rHB in the combined vaccine is higher than that of monovalent vaccine and this prove that there is an inhancement effect.It is suitable for the combination in a concentration at 20 μg/ml of HBsAg.The result of stbility test showed that the combined vaccine is safe and effective.更多还原