不同生产工艺聚山梨酯80的Beagle犬类过敏反应研究

Anaphylactoid Study for Polysorbate 80 Made by Different Production Technique in Beagle Dogs

目的研究新工艺和传统工艺生产的聚山梨酯80对Beagle犬产生的类过敏反应,为聚山梨酯80的质量控制和临床安全合理用药提供参考。方法使用Beagle犬单次静脉注射新工艺和传统工艺生产的聚山梨酯80各3个批次。观察给药后动物的反应症状,并检测血浆中的组胺含量。结果新工艺生产的聚山梨酯80引起的动物行为学症状反应评分和组胺水平均明显低于传统工艺生产的聚山梨酯80。结论使用新的生产工艺,提高聚山梨酯80的质量,能够在一定程度上降低聚山梨酯80引发的类过敏反应。

Objective To investigate the allergenicity of polysorbate 80 made by different production technique in Beagle dogs and provide the support for the quality control of production and clinical application of polysorbate 80.Methods 6 batches of polysorbate 80 made by new production technique and traditional production technique were injected into Beagle dogs to induce the anaphylactoid reactions respectively.Then the symptoms of dogs were observed.The contents of histamine in plasma were detected.Results The index of symptoms and the increasing levels of plasma histamine induced by the polysorbate 80 made by new production technique were obviously less than the polysorbate 80 made by traditional production technique.Conclusion The polysorbate 80 made by new production technique could partly reduce the anaphylactoid reactions in Beagle dogs.