摘要
目的探讨4种不同种类药物豚鼠全身主动过敏试验的设计特点,为药物临床前过敏反应的合理评价提供参考。方法采用豚鼠全身主动过敏试验对甘精胰岛素注射液、人脐带间充质干细胞注射液、注射用头孢美唑钠、鱼腥草注射液4种不同类型药物进行过敏性评价,观察激发给药后豚鼠全身主动过敏反应。结果阳性对照组和人脐带间充质干细胞注射液平行对照组豚鼠在激发给药后30 min内均出现了过敏反应症状,阴性对照组在激发给药后3 h内均未见明显异常和过敏反应症状,其他受试物各剂量组在激发给药后3 h内均未见明显异常和过敏反应症状,判定4种药物过敏反应均为阴性。结论由于豚鼠对某些抗生素类药物高度敏感,对中药注射剂药物的类过敏反应无法识别,亟需建立新的致敏反应评价模型和检测指标,以真实评价药物的临床过敏反应。
Objective To provide reference for proper preclinical anaphylaxis evaluation of drugs by exploring key factors of experimental design for four types of drugs（ insulin glargine injection,human umbilical cord mesenchymal stem cells injection,cefmetazole injection,houttuynia injection） evaluated with active systemic anaphylaxis test of guinea pigs.Methods Systemic active systemic anaphylactic reactions of guinea pigs were observed after the challenge dosing of four different types of drugs. Results Positive anaphylactic reactions were observed in guinea pigs of the positive control group and h UCMSC injection parallel control group（ with human serum albumin） 30 minutes after the challenge dosing. No significant abnormality and anaphylactic reactions were observed for the other test drug groups within 3 hours after the challenge dosing. The active systemic anaphylaxis reactions of the four types of drugs were negative. Conclusion Because of guinea pigs＇ hypersensitivity to some antibiotics and non-identification of pseudoallergic reactions of some drugs,new evaluation models and parameters need to be developed quickly to assess the clinical anaphylactic reaction properly.
出处
《军事医学》
CAS
CSCD
北大核心
2016年第5期405-408,共4页
Military Medical Sciences
基金
国家科技重大新药创制项目(2015ZX09501007-005)
关键词
全身主动过敏试验
抗生素
类过敏反应
active systemic anaphylaxis test
antibiotics
pseudoallergic reaction
