Abstract: Objective To observe and compare the effects of 3 recombinant hepatitis B vaccines on the weight gain and post-injection status of animals and to explore the effects of different pharmaceutical excipients on animals used for abnormal toxicity testing. Method The animal weight data and the observation status of the animals in the abnormal toxicity test of recombinant hepatitis B vaccine (Hansenula ploymorpha) , recombinant hepatitis B vaccine (Saccharomyces cerevisiae) and recombinant hepatitis B vaccine ( CHO Cell) , were collected from March 2016 to February 2018. The weight data statistically analyzed using IBM SPSS Statistics 23 analysis software to summarize the state of animals after vaccination. Result All of the vaccine passed the inspection. After the vaccination, the animals showed no abnormal state. Compared the weight gain of mice in the blank control group and the 3 hepatitis B vaccine administration groups, the differences were not statistically significant ( P > 0. 05) . The average weight gain of mice in the recombinant hepatitis B vaccine (S. cerevisiae) administration group was greater than that of the recombinant hepatitis B vaccine ( CHO Cell) and the recombinant hepatitis B vaccine ( H. ploymorpha) , the difference is significant (P<0. 05) . To compare the weight gain of guinea pigs in the blank control group and the 3 hepatitis B vaccine administration groups, the difference between guinea pigs in the recombinant hepatitis B vaccine ( CHO Cell) group and the blank control group was statistically significant (P<0. 05) , and the differences between the other 2 groups of animals and the blank control group were not statistically significant (P>0. 05) . To compare the administration of the 3 vaccines, there was no significant difference in the weight gain of guinea pigs in the medicine group (P>0. 05) . Conclusion There was no obvious difference in the general state of the animals, and none of the peritoneal irritation symptoms in mice caused by aluminum adjuvants recorded in the literature were observed; the effect of three recombinant hepatitis B vaccines on the weight gain of mice within 7 days after administration. In contrast, there was no significant effect on the weight gain of guinea pigs within 7 days after administration.

摘要:目的 观察和比较三种重组乙型肝炎疫苗异常毒性检查对动物体质量增长情况和注射后状态的影响,探讨采用不同药用辅料生产的重组乙型肝炎疫苗检查对动物的影响。 方法 汇总 2016 年 3 月—2018 年 2 月,重组乙型肝疫苗(汉逊酵母 Hansenula ploymorpha) 、 重组乙型肝疫苗( 酿酒酵母 Saccharomyces cerevisiae) 和重组乙型肝炎疫苗( CHO 细胞)的异常毒性检查中的动物体质量和注射后状态情况,采用 IBM SPSS Statistics 23 分析软件进行统计分析。 结果 疫苗的异常毒性检查结果均符合规定。 注射疫苗后,动物均未见异常。 比较空白对照组 ICR 小鼠和三 种 乙 型 肝 炎 疫 苗 给 药 组 ICR 小 鼠 体 质 量 增 长 值, 差 异 没 有 统 计 学 意 义 ( P > 0. 05 ) , 重 组 乙 型 肝 疫 苗( S. cerevisiae)给 药 组 小 鼠 的 体 质 量 增 长 的 平 均 值 大 于 重 组 乙 型 肝 炎 疫 苗 ( CHO 细 胞) 和 重 组 乙 型 肝 疫 苗( H. ploymorpha)给药组小鼠的体质量增长值,差异有统计学意义( P< 0. 05) ;比较空白对照组 Hartley 豚鼠和三种乙型肝炎疫苗给药组 Hartley 豚鼠的体质量增长值,重组乙型肝炎疫苗( CHO 细胞) 组豚鼠与空白对照组豚鼠的差异,有统计学意义( P<0. 05) ,其他两组动物与空白对照组动物的差异无统计学意义( P> 0. 05) ,比较三种疫苗的给药组豚鼠的体质量增长值,差异没有统计学意义( P> 0. 05) 。 结论 本研究中的实验动物一般状态观察未见明显差别,均没有观察到文献记载的因铝佐剂导致的 ICR 小鼠腹膜刺激症状;三种重组乙型肝炎疫苗对 ICR 小鼠给药后 7 d 内的体质量增长值影响不同;对 Hartley 豚鼠给药后 7 d 内的体质量增长值未见明显影响。