抗PD-1/PD-L1注射液的异常毒性评价

抗PD-1/PD-L1注射液的异常毒性评价

周莹,王丽洁,梁羽

苏州大学卫生与环境技术研究所,苏州大学卫生与环境技术研究所,苏州大学卫生与环境技术研究所

收稿日期:2018-08-21 修回日期:2018-09-20 出版日期:2018-12-25 发布日期:2018-12-25

Abnormal Toxicity Evaluation of Anti-PD-1/PD-L1 Injection

Zhou Ying, and

Sanitation Environment Technology Institute,Soochow University,SuZhou,JiangSu,215000,Sanitation Environment Technology Institute,Soochow University,SuZhou,JiangSu,215000,Sanitation Environment Technology Institute,Soochow University,SuZhou,JiangSu,2

Received:2018-08-21 Revised:2018-09-20 Online:2018-12-25 Published:2018-12-25

摘要/Abstract

摘要： 目的：评价抗程序性死亡受体1（PD-1）/程序性死亡配体1（PD-L1）注射液异常毒性，为其安全使用提供参考。方法：参照2015年版《中华人民共和国药典》（四部）中“异常毒性检查法”，对4批次抗PD-1/PD-L1注射液同时进行小鼠异常毒性试验，细化异常毒性试验临床观察指标记分标准，观察期7 d内对实验组和对照组小鼠异常毒性反应症状进行记分。结果：给药后7 d内4批次抗PD-1/PD-L1注射液实验组和对照组小鼠各器官系统临床观察指标记分均为0且全部健全，7 d后4批次实验组和对照组小鼠体重均增加，实验组小鼠与对照组相比体重增长差异无统计学意义（P>0.05）。结论：4批次抗PD-1/PD-L1注射液对小鼠均无潜在异常毒性影响。

Abstract: Objective：To evaluate abnormal toxicity of the anti-PD-1/PD-L1 injection and provide reference for its safe drug-usage. Methods： According to “test for abnormal toxicity” in Chinese Pharmacopoeia（2015 edition，Vol.Ⅳ）， 4 batches of anti-PD-1 / PD-L1 injection were simultaneously tested for abnormal toxicity. Specifying the scoring criteria for clinical observation indexes of abnormal toxicity test. Symptoms of the experimental group and control group within 7 days were recorded and scored. Results： The scores of clinical observation indexes of all organs in the experimental group and the control group were 0.No abnormal toxic reaction or death occurred in the experimental group or the control group of the four batches of Anti-PD-1/PD-L1 Injection within 7 days after injection. The body mass of the experimental group showed no significant difference from that of the control group (P>0.05). Conclusion： Four batches of Anti-PD-1/PD-L1 Injection has no potential abnormal toxicity in mice.

周莹,王丽洁,梁羽. 抗PD-1/PD-L1注射液的异常毒性评价[J]. .

Zhou Ying, and. Abnormal Toxicity Evaluation of Anti-PD-1/PD-L1 Injection[J]. .

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