聚山梨酯80刺激肥大细胞RBL-2H3脱颗粒作用的评价  

Study of degranulation in mast cell RBL-2H3 induced by Tween 80

作　　者：李佳[1] 金晶[1] 关翠雯[1] 李萍[1] 涂家生[2] 孙会敏[3] 黄芝瑛[1] 

机构地区：[1]中山大学药学院,广东广州510006 [2]中国药科大学药剂学教研室,江苏南京210009 [3]中国药品生物制品检定所,北京100050

出　　处：《药物评价研究》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)

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.

关 键 词：聚山梨酯80 类过敏反应 肥大细胞 β-氨基己糖苷酶 MTT 

分 类 号：R965.3[医药卫生—药理学] TQ460.4[医药卫生—药学]