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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。
In this paper, the experimental conditions for the preparation of the DTP-rHB combination vaccine were initially explored, and three batches of the best continuous-time pilot products prepared by the best formulation were tested by safety and efficacy tests. The results showed that all the components in the combination vaccine reached the corresponding regulations Requirements, no interference between antigens, good compatibility. The rHB immune response in the combination vaccine significantly increased (P <0.05) compared with the monovalent vaccine, with an enhancement effect. HBsAg content of 20 μg / m l is appropriate, stability test showed that the quality of the combination vaccine is stable, safe and effective.