鱼腥草注射液静脉给药不良反应实验研究Ⅱ.豚鼠过敏反应研究

Experimental study on adverse reaction by Intravenous Yuxingcao injection Ⅱ. Allergy research for guinea pigs

目的:探讨鱼腥草注射液及聚山梨酯80注射液的过敏原性。方法:以Ⅰ型超敏反应为模型,豚鼠腹腔注射致敏,在末次致敏后的第11天用致敏量的2倍量进行激发,观察过敏反应情况。结果:含聚山梨酯80的鱼腥草注射液、香丹注射液、聚山梨酯80注射液对豚鼠过敏实验均出现阳性结果,其中聚山梨酯80含量达5mg/ml时为明显阳性,聚山梨酯80含量在3mg/ml以下时为弱阳性,不含聚山梨酯80的香丹注射液豚鼠过敏实验结果为阴性;不同来源的聚山梨酯80均可引起豚鼠过敏反应,制备工艺中加热灭菌处理对聚山梨酯80的过敏反应没有影响。结论:含聚山梨酯80的鱼腥草注射液及香丹注射液均可引起豚鼠过敏反应,其原因可能为其中所含聚山梨酯80所致,过敏反应强弱与聚山梨酯80浓度有关,与加热灭菌与否无关。

Objective： Approach the reasons of the serious adverse reactions on clinic of Yuxingcao injection and polysorbate 80 injections. Methods： By type I hypersensitive model, peritoneum injection allergen to guinea pigs to immunize, and inject double doses of allergen to stimulate in the 11 days after the last sensitized. Observe the anaphylaxis situation of guinea pigs, which were injected in different commodities sources of Yuxingcao injection ,Xiangdan injection and Polysorbate 80 injection. Results： Yuxingcao injection ,Xiangdan injection and Polysorbate 80 injection which include polysorbate 80 is positive on guinea pigs, it＇s obviously positive reaction when the content of polysorbate 80 to 5mg/ml, and no mole than 3mg/ml became weak positive, lt＇s negative reaction on guinea pigs which injected Xiangdan injection missing polysorbate 80. All the different sources of polysorbate 80 can cause .allergic reactions. The occurrence of allergic reactions has nothing to do with heating sterilization. Conclusions： Both Yuxingcao injection and Xiangdan injection including polysorbate 80 can cause hypersensitivity ,the reason may be connect with polysorbate 80. The anaphylaxis strength is related to the concentration of polysorbate 80.