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。
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 （ShanghaiWeier （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.
出处
《药物评价研究》
CAS
2010年第5期379-383,共5页
Drug Evaluation Research
基金
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)
