骨肽类注射剂类过敏反应评价研究

Evaluation of anaphylactoid reactions induced by osteopeptide injections

目的采用小鼠耳廓蓝染实验对骨肽类注射剂类过敏反应进行评价,探究不同剂量的骨肽类注射剂引起类过敏反应的情况。方法分别以磷酸组胺、组胺盐酸盐、组胺作为阳性药,筛选适宜的阳性模型;对不同剂量下的骨肽类注射剂进行小鼠耳廓蓝染实验,以蓝染率及伊文思蓝(evans blue,EB)升高率作为类过敏评价指标。结果以磷酸组胺作为阳性药建立的阳性模型,具有明显的类过敏反应。部分骨肽类注射剂在高、中剂量下呈不同程度的阳性反应,低剂量下均呈阴性反应。结论通过小鼠耳廓蓝染实验得到的检测结果,直观评价了不同剂量下骨肽类注射剂的类过敏反应,对其他复杂基质药物类过敏反应的评估和研究具有借鉴意义。

Objective The mouse ear blue staining test was used to evaluate anaphylactoid reactions to different injected doses of osteopeptide.Methods The positive model was selected by using histamine phosphate,histamine hydrochloride and histamine as the positive drugs.Mouse ear blue staining tests were performed by injecting different doses of osteopeptide.The rate of blue staining and the rising rate of evans blue were used as the indices for evaluating the anaphylactoid reactions.Results The positive model established by histamine phosphate as the positive drug exhibited obvious anaphylactoid reactions.The osteopeptide injections showed positive reactions to various degrees at high and medium doses and negative reactions at low doses.Conclusions Based on the result of the mouse ear staining test,the anaphylactoid reactions to osteopeptide injections at different doses were intuitively evaluated.These data may be used as a reference for the evaluation of anaphylactoid reactions of other complex matrix preparations.