三种重组乙型肝炎疫苗异常毒性检查对动物影响的比较  

Comparison of the Effects of Three Recombinant Hepatitis B Vaccines on Animals for Abnormal Toxicity Test

作　　者：曹春然[1] 刘洪艳[1] 李雪梅[1] 吴伟 朱春玥[1] 王佳帅 CAO Chunran;LIU Hongyan;WU Wei;LI Xuemei;ZHU Chunyue;WANG Jiashuai(Beijing Institute for Drug Control,NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 102206,China)

机构地区：[1]北京市药品检验所,国家药品监督管理局仿制药研究与评价重点实验室,中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《实验动物科学》2021年第4期56-61,共6页Laboratory Animal Science

基　　金：药用辅料生物安全性评价方法指导原则,国家药典委员会,药品医疗器械审评审批制度改革专项课题,编号ZG2016-5-03。

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。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 the3 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 vacc

关 键 词：重组乙型肝炎疫苗 药用辅料 ICR小鼠 Hartley豚鼠 

分 类 号：R-332[医药卫生]