摘要
目的研究3种注射用新辅料乙交酯-丙交酯共聚物(PLGA)、乙二醇单甲醚-聚乳酸嵌段共聚物(mPEG-PDLLA)和羟丙基-β-环糊精(HP-β-CD)能否引起Beagle犬产生类过敏或过敏反应,为临床研究和应用提供依据。方法使用Beagle犬于1、3、5d致敏共3次,末次致敏后第14d激发。观察给药后反应症状,检测常规血液学指标、血浆中组胺、IgE、IgG和IgM含量。结果上述各项指标在首次给药后和激发日激发后均未见明显异常改变。结论 PLGA、mPEG-PDLLA和HP-β-CD在本实验剂量下不能引起Beagle犬产生类过敏或过敏反应。
Objective To evaluate the allergenicity of PLGA,mPEG-PDLLA and HP-β-CD in Beagle Dogs.Methods Sensitized on day 1,3 and 5,and provocated on day 14 after last sensitization.Clinical observation,hematology parameters,plasma histamine,IgE,IgG and IgM were evaluated respectively.Results No obviously abnormalities related to anaphylactoid and anaphylactic reactions were observed after dosing.Conclusion PLGA,mPEG-PDLLA and HP-β-CD could not induce anaphylactoid and anaphylactic reactions in Beagle dogs.
出处
《中国药事》
CAS
2011年第7期640-642,669,共4页
Chinese Pharmaceutical Affairs
基金
科技部"十一五"国家科技支撑计划重点项目(编号2008BAI55B03)
