聚乙二醇修饰的牛血红蛋白血液代用品抗原性和免疫原性的研究

Study on antigenicity and immunogenicity of PEG modified bovine hemoglobin for blood substitute

目的建立聚乙二醇修饰的牛血红蛋白血液代用品抗原性和免疫原性评价方法。方法用酶联方法测定供试品的抗原性残留量,用豚鼠过敏试验研究供试品的免疫原性,通过比较推算供试品抗原性残留量的安全性限值。结果供试品的抗原性残留量大于2 3%时,豚鼠会出现不同程度的过敏反应;供试品的抗原性残留量小于或等于2 3%时,豚鼠无过敏反应发生;供试品抗原性残留量的最高限值为2 3%。

PurposeTo establish methods used for evaluating antigenicity and immunogenicity of PEG modified bovine hemoglobin for blood substitute.MethodsAntigenicity residue and immunogenicity of samples were tested by ELISA and guinea pig hypersensitive test respectively. Antigenicity residue limit was defined by comparing these two results.ResultsIf antigenicity residue was more than 23%,guineas pig would have hyper-sensitive reaction. Guineas pig would have no hypersensitive reaction when antigenicity residue was no more than 23%. Antigenicity residue limit for samples should be no more than 23%. ConclusionMethods were primarily established and used for evaluating antigenicity and immunogenicity of PEG modified bovine hemoglobin for blood substitute.