中国药物评价2018,Vol.35Issue(6):441-443,3.
抗PD-1/PD-L1注射液对小鼠的异常毒性评价
Abnormal Toxicity Evaluation of Anti-PD-1/PD-L1 Injection in Mice
周莹 1王丽洁 1梁羽1
作者信息
- 1. 苏州大学卫生与环境技术研究所,江苏 苏州 215000
- 折叠
摘要
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-L1injection 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.关键词
免疫抑制剂/抗PD-1/PD-L1注射液/异常毒性Key words
Immune inhibitors/Anti-PD-1/PD-L1 Injection/Abnormal toxicity分类
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周莹,王丽洁,梁羽..抗PD-1/PD-L1注射液对小鼠的异常毒性评价[J].中国药物评价,2018,35(6):441-443,3.