[关键词]
[摘要]
目的:研究不同类别及厂家的聚山梨酯80直接刺激肥大细胞RBL-2H3脱颗粒的作用,为建立完善的注射用辅料引发类过敏反应的筛选评价体系提供依据。方法:以不同剂量的聚山梨酯80处理RBL-2H3细胞,测定β-氨基己糖苷酶释放量,并通过MTT法进一步研究有脱颗粒作用的受试物对RBL-2H3细胞的毒性作用。结果:8种聚山梨酯80样品具有不同程度的直接刺激RBL-2H3细胞脱颗粒的作用,且呈浓度依赖性,其中上海试剂采购供应站提供的受试物作用极强,威尔制药口服级受试物作用较强,威尔制药A、威尔制药B、威尔制药注射级、威尔制药4个受试物作用相近,2个进口品种的作用略弱。在产生直接刺激RBL-2H3细胞脱颗粒作用的浓度下,上海试剂采购供应站的聚山梨酯80有明显的细胞毒性,并呈浓度依赖性。结论:聚山梨酯80能够直接刺激RBL-2H3细胞脱颗粒,其作用强度不同反映了产品的质量差异;上海试剂采购供应站提供的聚山梨酯80直接刺激RBL-2H3细胞脱颗粒的作用可能由其细胞毒性引起。
[Key word]
[Abstract]
Objective: To study directive effects of multiple kinds of injective excipients on the degranualation in rat mast cell line RBL-2H3 and to provide some indications for establishing a screening and evaluating method for pseudoallergy induced by different Tween 80. Methods: RBL-2H3 cells were cultured and treated with varying dose of Tween 80, and then the amount of releasing β-hexosaminidase was detected. MTT assay was demonstrated to determine the cytotoxicity of injective excipients which causing RBL-2H3 cells degranulation. Results: All of eight different Tween 80 products directly induced RBL-2H3 cells degranulation in a concentration-dependent manner while the degree of this effect was varying (Shanghai > Weier (oral) > Weier (A) = Weier (B) = Weier (injective) = Weier > Nof = Croda). Tween 80 (Shanghai) showed cytotoxicity effect in a concentration-dependent manner. Conclusion: Tween 80 can induce RBL-2H3 cells degranulation directly, and the degree of effect is related to the different quality among these products. Cell degranulation induced by Tween 80 (Shanghai) dues to its cytotoxicity.
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[基金项目]
科技部“十一五”国家科技支撑计划重点项目——药用新辅料临床前安全性评价及药品与包装材料的相容性安全研究(2008BAI55B03)